ATTACHEMENT DEVICE FOR MEDICAL FLUIDS BAG

Abstract: An attachement device for inserting and removing the spike (13) for obtaining fluids from a medical fluid bag (10) such as an IV bag or a bag for peritoneal dialysis comprises a base (14) holding the spike (13) positioned to be inserted into the neck (11) of the bag (10), opposed toggles (16, 17) pivoting on the base (14) which engage the neck (11) of the bag (10) during insertion and push the neck (11) onto the spike (13). During removal of the spike (13) the toggles (16, 17) operate an engagement (20) which contacts the end of the neck (11) and pushes the spike (13) out of the neck (11) of the bag (10). The device has a hand operable slide (21) which affects the motions of the toggles (16, 17) and the toggles (16, 17) have dependent legs (18, 19) ending in the engagement (20). The attachment device is designed to protect the end of the spike (13) and to prevent contamination.

Description: ATTACHMENT DEVICE FOR MEDICAL FLUIDS BAG INTRODUCTION It is difficult for even a trained professional with all his faculties intact to spike an IV bag or a bag for peritoneal dialysis without difficulty and without contaminating the spike. Removing the bag from the spike and putting a new one on is even more difficult. This is because the elastic neck or tubing of the bag grips the spike and makes it hard to pull out the spike, particularly after the spike has been in the bag for a couple of hours. Peritoneal dialysis involves introducing dialyzing solution into the abdominal cavity through a hollow needle. Waste products in the bloodstream make their way through the peritoneum into the solution which is then drained away. By repeated renewals of the solution fairly effective purification of the blood can be achieved. If one takes into consideration that a patient on peritoneal dialysis is usually fairly ill and is many times an older person and emotionally upset, perhaps with diabetes and failing eyesight, one can visualize the problems that an ambulatory patient may have in properly spiking a peritoneal dialysis bag and doing so without contaminating the spike. In emergencies, such as emergency blood transfusions by ambulance attendants, paramedics, and military corpsman under battle conditions, mistakes can readibly be made with consequent contamination and there has been a desideratum for a method of reliably spiking medical fluid bags in these situations where the medic is operating under considerable tension and excitement. OMPI THIS INVENTION This invention is addressed to the above and other problems of the same nature and proposes an attachment device for facilitating the insertion and removal of a 5 spike into a medical fluids bag such as one containing a dialysis solution, an IV solution, or whole or synthetic blood. The device of the invention, besides mechanically assisting through a lever action afforded by opposing toggles or nippers the insertion and - removal of the spike, also serves to guide the fluids bag onto the spike for reliable centering of the spike and can if desired be designed to shield the spike from accidental contamination. The mechanical action afforded by the attachment device of this invention 5 overcomes the binding or gripping effect given by elastic material of the neck of the bag on the spike. In brief compass, the present invention is an attachment device to insert and remove an access spike into a medical fluids container through the wall or 0 seal at the end of an elongated neck on the container. The attachment device is designed to mate with the neck of the bag, which are standardized in size and shape. The attachment device comprises a base plate having two pivots each of which mounts a pinch or toggle arm. The 5 inner ends of the pinch arm when aligned with the line drawn between the pivots are spaced apart a distance less than the thickness of the neck of the fluid container but in the open or closed position lie apart a distance greater than the thickness of the neck. A 0 hand operable slide serves to actuate the pinch arms through push arms attached to the outer ends of the pinch arm. The innerends of the pinch arms contain pull arms directed downwardly towards the spike and ending in an engagement or connector that serves to 5 engage the end of the fluid container when the spike is being removed from the bag. The pull arms are spaced apart when the device is in the open position a distance greater than the width of the neck and serve ς to guide the end of the neck to the spike. In operation the device, held by its base, is inserted onto the neck of the bag with the slide and the pinch arms in the open position until the spike starts to penetrate the neck. When some resistance is in encountered, the hand is then transferred to the slide which operates over the base and pushes the slide forward towards the bag causing the pinch arms to exert their toggle action gripping the neck and pivoting to the closed position, drawing the neck onto the spike ■^5 while so doing. The spike is then positively held onto and into the bag by the closed position of the pinch arms. The gripping/pulling action of the pinch arms is reversed during removal of the spike by the hand pulling the slide away from the bag and the pinch arms Q operate an engagement which contacts the end of the neck forcing it off the spike. By appropriate design of the lengths of the pinch arms on either side of their pivot points such mechanical advantage or leverage as desired can be 5 achieved. With very little design difficulty the slide can be so designed that in the closed position of the attachment device a cover attached to the slide can fully encase the top of the spike with the bottom being 0 encompassed by the base and the sides being encompassed by the pull arms. This helps to offset the possibility of accidental contamination. THE DRAWINGS In the drawings: 5 Fig. 1 is a plan sectional view of the attachment device in its open position placed ready to insert the needle thereof into the end wall of the neck of a medical fluids bag; Fig. 2 is a like illustration showing the attachment device in its closed position with the spike fully inserted into the bag; Fig. 3 is a perspective top view of another form of the attachment device; Fig. 4 is a perspective bottom view; and Fig. 5 is a plan view illustrating how the slide, the toggles with their operating arms, and the neck engagement can be integrated into a single molded plastic piece, suitably articulated. DESCRIPTION Referring to Figs. 1 and 2, a medical fluids bag 10 has a neck 11 ending in a self-sealing penetrable wall 12, as is known. The attachment device shown in section consists of the spike 13 removably mounted to a base 14. The fluid tube 15 running to the patient connects with spike 13. Toggles 16 and 17 are pivotedly mounted on base 14 with the lengths of the arms on either side of the pivots being sufficient to give about a 2 to 1 mechanical advantage. The space between the inner ends of the toggles when they are at their midpoints on line with the line between the pivots is less than the width of neck 11 whereby when in the mid position they pinch and grab " neck 11. The inner ends of toggles 16 and 17 are connected to dependent pull arms 18 and 19 which end in an engagement or connector 20. Connector 20 is open in a center portion to allow the free movement of spike 13 therethrough. Pinch arms 16 and 17, pull arms OMP - 18 and 19 and connector 20 are interconnected for articulated movement. Pinch arms 16 and 17 are actuated by means of a hand operated slide 21 moving back and forth under base 14 which slide has push arm 22 connecting to the outer end of toggle 16 and push arm 23 connecting to the outer end of toggle 17, the arms being connected in a manner to permit articulation. In operation, the attachment device held primarily by the base 14 is brought while in its open position as shown in Fig. 1 onto the neck 11 of the fluids bag with the inner ends of toggles 16 and 17 and their dependent arms 18 and 19 serving as guides. Neck 11 is inserted until spike 13 commences penetration of the end wall 12 and meets some resistance. At this point the action of the hand is transferred to the slide 21 and slide 21 is pushed toward bag 10 causing toggle 16 and 17 to pivot through their mid position to the closed position and in so doing to pinch and grab the neck of the bag forcing it onto the spike as shown in Fig. 2. Preferably the neck of the bag is constructed to engage the ends of toggle 16 and ' 17 to facilitate the grabbing, pushing action of the toggle. This can be done, for example, by having an enlarged peripheral ring or ridge appropriately molded into the neck of the bag or by placing serrated depressions on the neck to engage like ridges on the tips of toggles 16 and 17. The necks on most commercial bags have a ring stiffener in them where the sealing membrane is, and the pinch arms can be designed to grab this stiffener to push the neck onto the spike. With reference to Fig. 2, when the device is in its fully seated closed position, toggles 16 and 17 have moved free of the bag thus permitting unrestricted flow from the bag to the spike. It is desirable when a sharp pointed spike 13 is used not to have the spike centered precisely on the median line between the two toggles. This is because the sharp end of the spike might engage the inner wall of the neck because of the pinching action of the toggles and enter the wall of the neck puncturing it. This possibility can be overcome by placing spike 13 at a slight angle with respect to the median line between the two toggles with the face of the tip of the spike being closer to the wall on that side. This also helps the neck to better find and center on the spike. The attachment device and the spike is removed from the bag by reversing the operation. After the. spike has been resident in the end wall 12 of the bag for sometime, the tubing tends to grip the spike rather firmly making initial movement difficult. This is overcome with this invention by the toggle action of the attachment device. To remove the attachment device slide 21 in a natural movement is pulled by hand from the position shown in Fig. 2 to the position shown in Fig. 1. This causes toggles 16 and 17 to pivot toward the open position and arms 18 and 19 to bring connector 20 into contact with the face of the neck pushing the neck off the spike, or conversely pushing the spike out from the bag. When during removal the attachment device has reached the position shown in Fig. 1 it can be removed the remainder of the way by simply sliding it off the neck of the bag without difficulty by continued action of the hand pulling on slide 21. Figs. 3, 4 and 5 illustrate an embodiment of the device made of molded plastic so as to be inexpensive and disposable. The base 31 is planar and ends in a turned up end wall 32 which serves to engage and hold spike 33. The base carried two pivots 34 and 35. The fSE upper ends of 34 and 35 are used to help retain a top cover 36 which is also secured to end wall 32 of the base. Top cover 36 besides adding rigidity to the structure serves as a guide for hand operated slide 37, r the ends of which are turned around to engage the edges of top piece 36. Slide 37 has a tongue 38 that extends over the trough containing spike 33 when the attachment device is in its open position thus serving, along with the base, to protect the spike from contamination. ^ Q Mounted for movement between the top piece 36 and base 31 are toggles 50 and 51 articulately connected at the outer ends to push arms 52 and 53 respectively which are in turn attached to slide 37. Toggles 50 and 51 have bores 54 and 55 respectively which are mounted ^ on pivots 34 and 35, respectively. The inner ends of the toggles 50 and 51 are connected by articulated joints to dependent pull arms 56 and 57, respectively, which in turn are articulately connected to an engagement piece or connector 58. Connector 58 has a 0 center opening to permit passage of spike 33. In this design, the ends of the toggles or nippers 50 or 51, rather than being rounded, have faces on the ends engaging the neck of the fluids bag which enhance the gripping pulling/pushing action of the nippers. 5 Thus arm 50 has faces 16 and 62 and arm 51 has faces 61 and 63. As mentioned previously these faces can be serrated or roughened in some manner to enhance their gripping and holding action. It can be appreciated that the base 31, the arms 56 0 and -57, and the slide 37 with its tongue 38 form a trough or guide aiding in the insertion of the neck of the bag and the guiding of it onto the spike. In another version of the attachment device it may be desirable to do away with shield 38 to permit the user to apply an antispetic to the spike before use. OMPI

Claims: 84/00293 - 8 - CLAIMS 1. A device to insert and remove an access spike into a wall of a fluid container, said wall being at the end of an elongated neck on said container, 5 characterized by: a. a base (14) ; b. two pivots (34,35) on said base; c. a pinch arm (16,17) mounted for rotation on each said pivot, the inner ends of the pinch arms when 10 aligned with a line drawn between said pivots being spaced apart a distance less than the thickness of said neck (11) but in the open position lying apart a distance greater than said thickness; d. push arms (52,53) of substantially equal 15 length pivotedly connected to the outer ends of said pinch arms and movable back and forth on a line generally parallel to the longitudinal axis of said neck; e. a hand operable slide (21) connecting the 20.other ends of said push arms; f. pull arms (18,19) of substantially equal length pivotedly connected to the inner end of said push arms in the same direction as said pull arms and generally parallel thereto; 25 g. a connector (20) pivotedly connected to the other ends of said pull arms and spacing them apart a distance greater than. the thickness of said wall and neck; h. a hollow spike (13) affixed to said base and 30 at least generally aligned with said longitudinal axis, the one end of the spike facing said wall being adapted to penetrate said wall and at all times lying inside of the line of said connector but being free to move relative to said connector; and 35 OM i. a fluid conduit (15) affixed to the other end of said spike; said hand operable slide when one end of said spike is brought into contact with said wall with said push arms in the open position serving by motion towards said pivots to swing said push arms through a position where the ends thereof are in their closest position to a closed position opposite of said open position with the ends of said push arms during travel engaging said neck and pulling said base towards and said spike into said wall. 2. The device of claim 1 characterized in that said pull arms and said base form a guide channel for said neck. 3. The device of claim 2 characterized in that said base is planar and said slide includes a cover moving therewith on the side opposite mid base and encasing said spike when said slide is in said closed position. 4. The device of claim 1 characterized in that when sair 1 spike is inserted into said wall and said pinch arms are moved from the closed to the open position, said connector engages the end of said neck causing said pivots and base to move away from said neck and extract said spike. 5. An attachment device mating with the neck of a liquid container having an elongated neck ending in a penetrable end wall, said attachment device characterized by: a. a nipper having two spaced-apart arms pivoting on a base and in the closest position thereof operating to engage and squeeze said neck; b. a base having two pivots each mounting one of said arms; - 10 - c. an engagement tube mounted to said base substantially on the center line between said arms and positioned to penetrate said end wall when said attachment device is in the closed operating position; 5 d. hand operable means operating said nipper, causing the arms thereof to pivot from an open position through said closest position to said closed operating position and to draw said neck inserted therebetween towards said engagement tube and effect penetration of I Q said end wall thereby; and e. legs pivotedly attached to the inner ends of said arms and dependent therefrom towards said engagement tube, and a connector connecting the other ends of said legs, said connector permitting the j movement of said engagement tube therethrough and contacting the end of said neck when said hand operable means moves said nipper from said closed operating position towards said open position and effecting thereby motion of said base away from said neck and 20 said tube from said end wall. 6. A connector for a fluid container having a hollow neck, characterized by: a. a base; b. a hollow spike positioned on said base to 2 penetrate the end of said neck as said neck is moved toward said hollow spike; c. a toggle adjacent the path of travel of said neck and pivoting on said base, the midpoint of arcuate travel of the end of said toggle pinching said neck and 50 said end of said toggle pushing said neck at said midpoint of travel and forcing said neck toward said hollow spike as said toggle moves to the closed position thereof; d. guide means on said base for directing said 35 neck along its longitudinal axis over said base, said - 11 - guide means including means to retain said neck against lateral motion; e. a leg articuately attached to said end of said toggle, dependent therefrom towards said hollow spike and an engagement at the end of said leg adapted to engage the end of said neck when said neck is seated in said connector and said toggle is moved from said closed position to the open position thereof; and f. a hand operated means for effecting motion of said toggle from said closed position to said open position. 7. The connector of claim 5, having a pair- of said toggles opposed one to another and with each toggle having said leg dependent therefrom and connected to said engagement, said toggle and legs serving as said guide means, and characterized in that said base is planar and said hand operated means is a slide operating over and against said base. O PI

Inventors: OSCARSSON ROLF A, OSCARSSON, ROLF, A.
Applicants: OSCARSSON ROLF A, OSCARSSON, ROLF, A.
Application year: 1983
Main classification: A61J1
IPC codes: A61J1, A61M5, A61M39