FRANGIBLE SPIKE CONNECTOR FOR A SOLUTION BAG

Abstract: A one-piece unitary frangible spike connector (10) for insertion into solution containers (16) includes a spike body formed with a closure (22) on one end thereof and a tubing receptacle (26) on the other end thereof. An internal conduit (32, 34) extends from the tubing receptacle through the spike body partially into the closure. The frangible spike connector is broken apart along a reduced diameter portion (28) tapered or formed at an angle to form a spike (30) connected to the conduit (34) on the spike body when the closure (22) is broken off the spike body.

Description: F ANG I BLE SP I KE CONNECTOR FOR A SOLUT I ON BAG BACKGROUND OF THE INVENTION The present invention concerns a spike connector of the type utilized to connect a tubing set to a medi¬ cal solution container or bag. More particularly, the present invention is directed to a unitary molded one- piece frangible spike connector. Many medical solution containers typically have an outlet port extending therefrom, with the port having a transverse diaphragm adapted for breakage by a spike from a tubing set. When the spike is inserted into the port, the transverse diaphragm is broken and the medi¬ cal liquid can flow from the medical container through the spike and the tubing set to the patient. In certain applications a sterile medical solution is utilized and it is important that the sterility of the system be maintained. For example, in peritoneal dialysis a dialysate solution is introduced into a patient's peritoneal cavity and is thereafter drained from the peritoneal cavity to the original solution container or elsewhere. The medical procedure known as continuous am¬ bulatory peritoneal dialysis (CAPD), described in U.S. Patent No. 4,239,041, has rapidly grown in clinical ac¬ ceptance as the technique of choice for maintaining many patients who have lost kidney function. Peri- toneal dialysis solution is inserted in the peritoneal cavity, whereby diffusion exchange takes place between the solution and the bloodstream across the peritoneal membrane, to remove by diffusion the waste products which are normally excreted through the kidneys, typi- cally solutes such as sodium and chlorine ions and the other materials normally excreted by the body such as urea, creatinine and water. In the CAPD technique, the patient is surgically equipped with an implanted catheter which communicates between the peritoneal cavity and the exterior. Peri¬ toneal dialysis solution is passed into the peritoneal cavity where dialysis of urea and the like takes place between the solution and the blood passing through blood vessels in the peritoneum, which is the lining of the peritoneal cavity. Thereafter, this peritoneal dialysis solution is removed from the peritoneal cavi¬ ty, carrying with it diffused breakdown products from the blood. Fresh dialysis solution is then passed into the peritoneal cavity, and this process of filling and emptying is repeated several times. In the CAPD technique, as with all techniques of peritoneal dialysis, peritonitis is one of the most significant risks. Peritonitis can result if connec¬ tions are made between the peritoneal catheter and a set communicating with a source of dialysis solution in a manner which permits even a very small number of mi¬ croorganisms to enter the catheter and to be flushed into the peritoneal cavity. Examples of other areas where sterile connections are desirably made, and in which the present invention may be utilized, can include the processing of blood and its fractions, the mixing of sterile solutions, connecting Foley catheters with urinary drainage bags, and hemodialysis or blood oxygenation procedures espe¬ cially with patients who have diminished immunological capability. Also, the invention may be used to provide sterile conditions to a protective enclosure surround¬ ing an indwelling catheter or the like. Many types of spike connectors and connector as¬ semblies have been proposed for use with such solution containers. Various types of sterilization also have been suggested, alone or in conjunction with various spike connectors. Typically, the spike connector as¬ semblies are multipiece units which have a molded body with a metal needle inserted therein and a cover member inserted thereover. Molded spike connectors also have been utilized with sterilization techniques and/or with separate covers for the spike connector assemblies. Each of these prior assemblies require numerous pieces and multiple assemby steps. It would be desirable to have a unitary one-piece spike connector, which also includes an integral cover for the spike connector and can be formed in a single step. SUMMARY OF THE INVENTION In accordance with the present invention, a fran¬ gible spike connector is provided having an integral closure therewith. The spike conduit of the frangible spike connector cannot be internally contaminated prior to use since the internal conduit of the spike is cov¬ ered by the closure. The frangible spike connector includes a spike body with a tubing receptacle in one end and the clo¬ sure on the opposite end closing the conduit. When the frangible spike connector is mounted on the tubing or tubing set, the closure prevents contamination into the spike conduit and prevents the spike from inadvertently being utilized or accidentally causing a puncture wound. The body includes a tapered or beveled edge therearound along which the body fractures when broken to provide the spike. The tubing receptacle and spike closure can take many forms and can include wings or flat portions for ease in fracturing the frangible spike connector. Preferably, the frangible spike con- nector is a one-piece molded assembly, from which the closure can be broken off to expose the spike and con¬ duit for insertion into the solution container. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a view of a first frangible spike con¬ nector embodiment of the present invention on a tubing set coupled to the port of a medical solution con¬ tainer; FIG. 2 is an enlarged plan view of the frangible spike connector of FIG. 1; FIG. 3 is a perspective view of the frangible spike connector of FIG. 1, being broken apart; FIG. 4 is an enlarged cross-sectional view of the frangible spike connector of FIG. 1; FIG. 5 is a partial cross-sectional view of the frangible spike connector of FIG. 4, broken apart; FIG. 6 is a perspective view of a second embodi¬ ment of the frangible spike connector of the present invention; FIG. 7 is an enlarged cross-sectional view of the frangible spike connector of FIG. 6; FIG. 8 is a perspective view of a third embodiment of the frangible spike connector of the present inven- tion; and FIG. 9 is a perspective view of a further embodi¬ ment of the frangible spike connector of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIG. 1, a first embodiment of the frangible spike connector of the present invention is designated generally by the reference numeral 10. The frangible spike connector is connected to a tubing set 12, which includes, for example purposes only, a first tubing segment 14, which is connected at one end to a conventional medical solution container or bag 16. The other end of the tubing segment 14 is connected to a conventional Y connector 18. A second tubing segment 20 is also connected at one end to the Y connector 18 and at the other end to the frangible spike connector 10. One example of a utilization of the tubing set 12, is in the CAPD technique. The Y connector 18 preferab- ly is a luer connector and is coupled to the patient (not illustrated) and the fluid from the bag 16 is in¬ troduced into the patient. The frangible spike connec¬ tor 10 can be fractured when it is desired to utilize the segment 20 to drain the fluid from the patient where a sterile outer spike surface is not needed. The spike then can be inserted into a second drain con¬ tainer or bag (not illustrated). Until the frangible spike connector 10 is fractured, no contamination can occur inside the frangible spike connector 10, which is sealed by the tubing segment 20 on one end and a closure 22 on the other end, as best illustrated in FIGS. 2-5. Referring to FIG. 2, the frangible spike connector 10 is formed, such as by conventional injection mold- ing, having a spike body 24 on one end and the closure 22 on the other end. The spike body 24 includes a tubing receptacle 26 into which the tubing 20 is seal- ingly inserted in a conventional manner. The closure 22 is connected to the spike body 24 by a beveled re- duced thickness portion 28. Referring to FIG. 3, when' it is desired to utilize the frangible spike connector 10, a user grasps the receptacle 26 with one hand and the closure 22 with the other hand and breaks the two apart along the bevel portion 28 forming a spike 30. The closure 22 is dis¬ carded and the spike 30 is inserted into a container port (not illustrated). The portion 28 also can be tapered to form a tapered spike, if so desired. The structure of the one-piece molded frangible spike connector 10 is best illustrated in Figs. 4 and 5. The tubing receptacle 26 includes an internal con- duit 32, sized to accommodate the tubing 20 therein. The conduit 32 communicates with a conduit or pas¬ sageway 34 formed in the spike body 24 and ending in a closed end 36 in the closure 22. Thus, the conduits 32 and 34 are sealed from outside exposure when mounted on the tubing 20, until the frangible spike connector 10 is broken apart as illustrated in FIG. 5. A second embodiment of the frangible spike connec¬ tor of the invention is designated generally by the reference numeral 40 in Figs. 6 and 7. The same reference numerals are utilized for the portions of the frangible spike connector 40 which are unchanged from those of the frangible spike connector 10. The fran¬ gible spike connector 40 has an extended tubular por¬ tion 42 forming a tubing mandrel which extends the pas- sageway 34 into the conduit 32. An outer wall 44 of the tubular portion 42 is spaced from an inner wall 46 of the conduit 32 and forms an annular recess 48, into which the tubing 20 can be inserted over the mandrel 42. A third embodiment of the frangible spike connec¬ tor of the invention is designated generally by the reference numeral 50 in FIG. 8. The frangible spike connector 50 is substantially the same as the frangible spike connector 40, with the addition of a pair of tabs or wings 52, 54. The tabs 52, 54 can be grasped by the user to insert the spike 30 into the drainage container and also to aid in orienting the frangible spike con¬ nector 50 to break the closure 22 from the spike body 24 to form the spike 30. A further embodiment of the frangible spike con¬ nector of the invention is designated generally by the reference numeral 60 in FIG. 9. The frangible spike connector 60 includes a flat tip 62 molded thereto to aid the user in orienting the frangible spike connector 60 to break the closure 22 from the spike body 24. One primary use of the frangible spike connectors 10, 40, 50 and 60 is in a CAPD set 12, illustrated in Fig. 1. The set 12 will at least include the tubing segments 14 and 20, a luer type Y connector and cover therefor and the frangible spike connectors 10, 40, 50 and 60 and the tubing segment 14 will be connected to either a cap (not illustrated) or a container, such as the container 16. The frangible spike connectors 10, 40, 50 and 60 generally are intended for drainage or other uses wherein the outer surface can be non- sterile, however, the frangible spike connectors 10, 40, 50 and 60 could also be sterilized on the outside for other uses. Many modifications and variations of the present invention are possible in light of the above teachings. The dimensions of the frangible spike connectors 10, 40, 50 and 60 are not critical. The angle and depth of the bevel portion 28 are not critical and can be re¬ placed by a conical reduction in thickness if desired. The frangible spike connectors 10, 40, 50 and 60 can be formed from any suitable, preferably moldable, material which has sufficient mechanical properties and is non- toxic to the fluids utilized therewith. Generally, the moldable material will be a plastic or plastic like material. One actual frangible spike connector 40 is formed from molded polycarbonate material having a wall thickness of the portion 28 of .013 inches formed at an angle of 45° to the axis of the frangible spike connec¬ tor 40. The diameter of the closure 22 is .200 inches, the outer receptable 26 is .380 inches and the length of the frangible spike connector 40 is 1.973 inches. The material and the thickness of the reduced diameter portion 28 controls the force necessary to be utilized by the user to break the closure 22 from the spike body 24. It is, therefore, to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described. What is claimed and desired to be secured by Let¬ ters Patent of the United States is:

Claims: CLAIMS 1. A unitary frangible spike connector, compris¬ ing: a spike body having a tubing receptacle formed at one end and a closure formed at a second end thereof, said spike body including a reduced size portion con¬ necting said spike body to said closure and a pas¬ sageway opening into said tubing receptacle and extend¬ ing partially into said closure, said reduced size por¬ tion adapted to be broken to separate said closure from said spike body forming a spike and exposing said pas¬ sageway. 2. The frangible spike connector defined in claim 1 including said reduced size portion formed in a narrow bevel around said spike body. 3. The frangible spike connector defined in claim 2 wherein said spike body and closure are an elongated tubular member and said bevel portion is formed at an angle to said elongated member. 4. The frangible spike connector defined in claim 1 including a tubing mandrel formed in said tubing receptacle in communication with said pas¬ sageway. 5. The frangible spike connector defined in claim 1 wherein said spike body and said closure are formed from a molded plastic material. 6. The frangible spike connector defined in claim 1 wherein said tubing receptacle includes a pair of orientation wings extending outwardly therefrom. 7. The frangible spike connector defined in claim 1 wherein said closure includes a flat tip orientation portion extending therefrom. 8. A frangible spike connector, comprising: a molded one-piece cylindrical spike body includ¬ ing an enlarged cylindrical tubing receptacle formed on one end thereof and a cylindrical closure formed on the other end thereof, a passageway extending from said tubing receptacle and opening thereto through said spike body and terminating in said closure, said clo¬ sure connected to said spike body by a reduced diameter portion, which reduced diameter portion is adapted to be broken to separate said closure from said spike body to form a spike thereon and exposing said passageway. 9. The frangible spike connector defined in claim 8 including said reduced diameter portion formed in a narrow bevel around said spike body at an angle to said passageway. 10. The frangible spike connector defined in claim 8 including a tubing mandrel formed in said tubing receptacle in communication with said pas¬ sageway. 11. The frangible spike connector defined in claim 8 wherein said spike body and said closure are formed from a molded plastic material. 12. The frangible spike connector defined in claim 8 wherein said tubing receptacle includes a pair of orientation wings extending outwardly therefrom. 13. The frangible spike connector defined in claim 8 wherein said closure includes a flat tip orientation portion extending therefrom. 14. A method of forming a spike connector, com¬ prising: forming a unitary elongated spike body with a closure on one end thereof and a tubing receptacle on the other end thereof, forming a reduced thickness fracturable portion therebetween and forming a pas¬ sageway from said tubing receptacle through said spike body and partially into said closure; and breaking said spike body away from said closure along said fracturable portion to form a spike on said spike body and exposing said passageway. 15. The method defined in claim 14 including forming said spike body and closure in an elongated tubular member and forming said fracturable portion as a bevel of reduced diameter at an angle to said pas- sageway. 16. The method defined in claim 14 including forming a tubing mandrel in said tubing receptacle com¬ municating with said passageway. 17. The method defined in claim 14 including molding said spike body and said closure from a plastic material. 18. The method defined in claim 14 including forming a pair of orientation wings extending outwardly from said tubing receptacle. 19. The method defined in claim 14 including forming a flat orientation tip extending from said closure opposite said spike body. 20. A tubing set for utilization with equipment for continuous ambulatory peritoneal dialysis in which solution is coupled via the set to the patient's tube which communicates with the patient's peritoneal cavity and the solution also is coupled via the set to drain the solution from the cavity, said tubing set compris¬ ing: a first flexible tubing segment capped at one end and connected to one side of a Y-type connector carried at the other end for connecting to the patient's tube; and a second flexible tubing segment connected at one end to the other side of said Y-type connector and at the other end to a unitary spike connector, said con- nector including a spike body having a tubing recep¬ tacle formed at one end and a closure formed at a sec¬ ond end thereof, said spike body including a reduced size portion connecting said spike body to said closure and a passageway opening into said tubing receptacle and extending partially into said closure, said reduced size portion adapted to be broken to separate said clo¬ sure from said spike body forming a spike and exposing said passageway. 21. The set defined in claim 20 including said reduced size portion formed in a narrow bevel around said spike body. 22. The set defined in claim 21 wherein said spike body and closure are an elongated tubular member and said bevel portion is formed at an angle to said elongated member. 23. The set defined in claim 20 including a tubing mandrel formed in said tubing receptacle in com¬ munication with said passageway. 24. The set defined in claim 20 wherein said spike body and said closure are formed from a molded plastic material. 25. The set defined in claim 20 wherein said tubing receptacle includes a pair of orientation wings extending outwardly therefrom. 26. The set defined in claim 20 wherein said closure includes a flat tip orientation portion extend¬ ing therefrom.

Inventors: KARRASCH FRANK, MAKARYK WALTER, KARRASCH, FRANK, MAKARYK, WALTER
Applicants: BAXTER INT, BAXTER INTERNATIONAL INC.
Application year: 1990
Main classification: A61M5
IPC codes: A61J3, A61M1, A61M5