Abstract:
Apparatuses and methods for providing sterile connection during, for example, dialysis therapy. The present invention provides a connector and a cap therefore that easily and readily attaches to a dialysate container and a catheter inserted into a patient&#39;s peritoneal cavity. The connector and the cap enable the dialysate to readily transport between the container and the peritoneal cavity while minimizing the potential of contamination therein due to, for example, handling during use. The connector includes a shell that encloses a cap. The cap houses a slit septum and also includes a sealed disinfectant within an interior receptacle. When the catheter or catheter set attaches to the cap, the seal breaks and the disinfectant spreads over the threads between the catheter set and the cap.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     The present invention relates generally to medical treatments. More specifically, the present invention relates to medical connectors for use in medical treatments, such as Peritoneal Dialysis (“PD”).  
         [0002]     Due to disease, insult or other causes, a person&#39;s renal system can fail. In renal failure of any cause, there are several physiological derangements. The balance of water, minerals and the excretion of daily metabolic load is no longer possible in renal failure. During renal failure, toxic end products of nitrogen metabolism (urea, creatinine, uric acid, and others) can accumulate in blood and tissues.  
         [0003]     Kidney failure and reduced kidney function have been treated with dialysis. Dialysis removes waste, toxins and excess water from the body that would otherwise have been removed by normal functioning kidneys. Dialysis treatment for replacement of kidney functions is critical to many people because the treatment is life saving. One who has failed kidneys could not continue to live without replacing at least the filtration functions of the kidneys.  
         [0004]     PD uses a dialysis solution or dialysate, which is infused into a patient&#39;s peritoneal cavity. The dialysate contacts the patient&#39;s peritoneal membrane in the peritoneal cavity. Waste, toxins, and excess water pass from the patient&#39;s bloodstream through the peritoneal membrane and into the dialysate. The transfer of waste, toxins, and water from the bloodstream into the dialysate occurs by diffusion and osmosis because there is an osmotic gradient across the peritoneal membrane. The spent dialysate is drained from the patient&#39;s peritoneal cavity to remove the waste, toxins and water from the patient. New dialysate replaces the spent dialysate and the process repeats.  
         [0005]     During dialysis therapy, a dialysis fluid exchange generally includes draining spent dialysis fluid from the peritoneal cavity and filling the peritoneal cavity with fresh dialysate. Keeping track of the amounts or volumes of dialysis solution drained from and supplied to the peritoneal cavity is important for proper dialysis therapy. A typical amount of dialysate solution drained from and supplied to the peritoneal cavity of an adult during an exchange can be roughly two to three liters. Dialysis fluid exchanges have been performed manually, usually by the patient, or automatically, by an automated dialysis machine.  
         [0006]     In the manual PD technique, known as Continuous Ambulatory Peritoneal Dialysis (“CAPD”), a catheter is implanted into the peritoneal cavity of the patient. A dialysis solution (“dialysate”) is introduced through the catheter into the peritoneal cavity of a patient. Typically, a container of the dialysate connects to a connector, which in turn couples to the catheter. To start the flow of dialysate into the peritoneal cavity, a clamp on a tube connecting the container to the connector is loosened or a valve is opened. In many cases the container is located vertically above the patient and gravity fed into the peritoneal cavity.  
         [0007]     In the Automated Peritoneal Dialysis technique (“APD”), dialysis machines use one or more fluid pumps to perform the dialysate exchanges. The pump pumps spent dialysate fluid out of the peritoneal cavity during the drain mode and pumps dialysate into the cavity during the fill mode.  
         [0008]     In either PD technique, once the dialysate reaches the patient, dialysis of urea, toxic waste and the like takes place between the dialysate and the blood passing through blood vessels in the peritoneum, which is the lining of the peritoneal cavity. The dialysate remains in the peritoneal cavity for several hours. Thereafter, the dialysate is removed from the peritoneal cavity carrying with it diffused breakdown products from the blood. In CAPD, one method for removing the spent dialysate is to lower the dialysate container outside of the body and let the dialysate drain into the container.  
         [0009]     The spent container is disconnected and discarded, wherein a new container of dialysate fluid is attached and the process is repeated. This process may be repeated several times or continuously repeated. Because many patients perform the PD (CAPD or APD) procedure themselves, it is important that the connector which connects the dialysate container to the catheter is easy to use and provides a secure connection.  
         [0010]     A frequent problem that occurs with PD is peritoneal infection or peritonitis which can readily occur given the repeated disconnecting and reattaching of the dialysate containers. Peritonitis results if connections are made between the peritoneal catheter and the connector communicating with the dialysis container in a manner that permits even a very small number of microorganisms to enter the catheter. The microorganisms will be flushed into the peritoneal cavity. Peritonitis can occur even when extreme caution is observed in making and unmaking the connections. Peritonitis can be painful and can temporarily diminish the hydraulic permeability of the peritoneal membrane, rendering the renal treatment less successful.  
         [0011]     Methods to prevent peritonitis have included thoroughly cleansing the connector and the tube connecting the dialysate container before the connection is made. For instance, the connector can be immersed in povidone iodine, betadine or other type of disinfectant. These methods however are messy, time consuming, effort consuming, inconsistent and may be subject to overkill in order to achieve consistently effective results. Hospital workers, as another precaution, typically wear sterile rubber gloves to prevent or guard against any possible peritoneal invasion of bacteria. However, the spread of contamination can still occur due to, for example, a cut in the glove or other like condition.  
         [0012]     Accordingly, the frequent connections that must be made and broken between the catheter residing in the peritoneal cavity and a succession of dialysate containers has created a need to ensure the sterilization of connectors used in performing CAPD and APD. Attempts have been made to saturate an absorbent material with disinfectant and dispose the material in the connector such that it contacts the tube/connector interface. A need still exists however to improve the efficiency, effectiveness and cost of providing sterile connections for PD.  
         [0013]     A continuing need therefore exists to provide a simple and effective method and apparatus for performing PD, including CAPD and APD both in hospitals and at a patient&#39;s home.  
       SUMMARY OF THE INVENTION  
       [0014]     The present invention relates to a connector and a cap that are easily and readily attachable to a dialysate container and a catheter inserted into a patient&#39;s peritoneal cavity. The connector and the cap enable the dialysate to be readily transported between the container and the peritoneal cavity while minimizing the potential of contamination therein due to, for example, handling during use.  
         [0015]     To this end, in an embodiment of the present invention, a connector includes a shell that encloses a cap. The cap houses a slit septum. The cap also includes a sealed disinfectant within an interior receptacle. The seal in an embodiment is a crosslinked elastomeric seal, e.g., a silicone seal. In one embodiment, the disinfectant includes a povidone iodine or PVP-I. The connector is also initially packaged including a tip protector that encloses the shell/cap assembly and provides a barrier to microbial contamination prior to use.  
         [0016]     In another embodiment of the present invention, a cap for use in a connector making a resealable fluid path is provided. The cap includes a body that defines a fluid flow passage and a disinfectant receptacle. The receptacle houses the disinfectant. A seal is disposed within the body. The seal seals the disinfectant between the seal and the receptacle.  
         [0017]     In an embodiment, the body defines an opening that receives a fluid communication member. The fluid communication member is capable of displacing the seal when the body receives the member.  
         [0018]     In an embodiment, the disinfectant disperses between an outer wall of the fluid communication member and an inner wall of the body when the seal is displaced.  
         [0019]     In an embodiment, the body defines outer threads.  
         [0020]     In an embodiment, the outer threads engage mating threads of a shell and enable the shell to translate with respect to the body. The translating shell causes a sealed end of the body to be pierced.  
         [0021]     In an embodiment, the body defines inner threads.  
         [0022]     In an embodiment, the inner threads engage mating threads of a fluid communication member and enable the member to translate with respect to the body. The translating member causes the seal to be displaced.  
         [0023]     In an embodiment, the seal is moveable.  
         [0024]     In an embodiment, the body includes a tube portion that defines the fluid flow passage. The disinfectant receptacle resides about the tube portion.  
         [0025]     In an embodiment, a portion of the passage is sized to house a member that deforms to seal about a tube.  
         [0026]     In an embodiment, the member automatically closes when the tube is removed from the member.  
         [0027]     In still another embodiment of the present invention, a connector for making a resealable fluid path is provided. The connector includes a cap that defines a fluid flow passage. The cap seals an amount of disinfectant, such as a continuous quantity thereof. A shell moveably engages the cap. The shell includes a fluid communication member. The fluid communication member is capable of piercing a sealed end of the cap and fluidly communicating with the fluid flow passage when the shell moves with respect to the cap.  
         [0028]     In an embodiment, the disinfectant includes povidone iodine.  
         [0029]     In an embodiment, the connector includes a tip protector that engages the shell.  
         [0030]     In an embodiment, the shell attaches to a fluid line running to a dialysate container and the cap attaches to a fluid line running to a patient.  
         [0031]     In an embodiment, the sealed end of the cap includes a slit septum.  
         [0032]     In an embodiment, the connector includes an elastomeric seal that seals the disinfectant about the fluid flow passage.  
         [0033]     In still another embodiment of the present invention, a method for providing a sterile connection of a dialysate line is provided. The method includes providing a cap that has a passage and maintains a seal that houses a disinfectant. A first member connects to a first end of the cap. The first member then fluidly communicates with a first dialysate line. A second member connects to a second end of the cap so as to displace the seal and the disinfectant. The second member then fluidly communicates with a second dialysate line.  
         [0034]     In an embodiment, connecting the first member includes moving the first member so as to pierce a sealed end of the cap, which places the first member in fluid communication with the second member.  
         [0035]     In an embodiment, the sealed end of the cap seals about the first member when the first member pierces the sealed end.  
         [0036]     In an embodiment, the sealed end of the cap reseals when the first member is removed from the cap.  
         [0037]     In an embodiment, rupturing the seal includes threading the second member into the cap and exerting pressure on the seal.  
         [0038]     In an embodiment, connecting the second member includes displacing the disinfectant between the cap and the second member.  
         [0039]     In an embodiment, the method further includes maintaining the disinfectant between the cap and the second member after the seal is displaced.  
         [0040]     In an embodiment, the method includes removing the first member from the cap such that the sterile connection between the cap and the second member is maintained  
         [0041]     In an embodiment, the method includes removing a tip protector and connecting the second member in place of the tip protector.  
         [0042]     In still another embodiment of the present invention, a method for providing PD is provided. The method includes the steps of providing a first member in fluid communication with a dialysate container, a second member in fluid communication with a peritoneal cavity of a patient, and a cap that has a sealed first end, a second end, a passage and maintains a seal that houses a disinfectant; connecting the first member to the sealed first end of the cap; connecting the second member to the second end of the cap so as to displace the seal and the disinfectant thereby causing the first member to pierce the sealed first end of the cap; filling the peritoneal cavity with an amount of fresh dialysate fluid; and removing the first member to automatically reseal the first end of the cap.  
         [0043]     In an embodiment, the method includes removing an amount of spent dialysate fluid from the peritoneal cavity prior to filling the peritoneal cavity with the fresh dialysate fluid.  
         [0044]     In an embodiment, the method includes connecting another first member to the first end, removing spent dialysate fluid from the peritoneal cavity and refilling the peritoneal cavity with fresh dialysate fluid.  
         [0045]     In different embodiments, the filling and removing steps are performed manually or automatically.  
         [0046]     It is therefore an advantage of the present invention to provide a dialysis connector that eliminates the need for the use and therefore handling of an additional cap to seal a catheter subsequent to use.  
         [0047]     Moreover, an advantage of the present invention is to provide a dialysis connector that reduces the likelihood of peritonitis.  
         [0048]     Another advantage of the present invention is to provide a dialysis cap that remains attached to a catheter set after use.  
         [0049]     Still another advantage of the present invention is to provide a connector and a cap therefore having a septum that automatically reseals upon removal of the cap from a shell that couples to the dialysate container.  
         [0050]     A further advantage of the present invention is to provide a dialysis connector employing a sealed disinfectant in conjunction with a releasable and resealable cap, which effectively minimizes the spread of microbial contamination to a catheter transfer set, and thus to the patient, during dialysis therapy.  
         [0051]     Yet another advantage of the present invention is to provide a cap for use in PD, including CAPD and APD that contains a disinfectant and that cannot spill the disinfectant when a tip protector is removed.  
         [0052]     Yet a further advantage of the present invention is to provide a cap for use in CAPD and APD that contains a continuous amount of a disinfectant and does not require an absorbent material to hold the disinfectant.  
         [0053]     Still further, an advantage of the present invention is to provide a resealable cap enclosed within a protective shell prior to insertion of a catheter set.  
         [0054]     Additionally, it is an advantage of the present invention to provide a resealable cap having a sealed disinfectant that displaces across threads of the cap and the transfer set.  
         [0055]     Additional features and advantages of the present invention are described in, and will be apparent from, the following Detailed Description of the Invention and the Figures. 
     
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0056]      FIG. 1A  is a perspective view of one embodiment of the dialysis connector and cap therefore of the present invention.  
         [0057]      FIG. 1B  is a schematic sectional view showing an embodiment of an interface between the shell and the tip protector.  
         [0058]      FIG. 1C  is a schematic sectional view showing another embodiment of an interface between the shell and the tip protector.  
         [0059]      FIG. 2  is a perspective view illustrating a part of the process for connecting the connector and cap of the present invention to a transfer set, which connects a catheter to a patient.  
         [0060]      FIG. 3  is a perspective view illustrating another part of the process for connecting the connector and cap of the present invention to a transfer set, which connects a catheter to a patient.  
         [0061]      FIG. 4  is an elevation view illustrating one step for using the connector and cap of the present invention to insert and/or remove a medical fluid into/from a patient.  
         [0062]      FIG. 5  is an elevation view illustrating another step for using the connector and cap of the present invention to insert and/or remove a medical fluid into/from a patient.  
         [0063]      FIG. 6  is an elevation view illustrating a further step for using the connector and cap of the present invention to insert and/or remove a medical fluid into/from a patient.  
         [0064]      FIG. 7  is an elevation view illustrating still another step for using the connector and cap of the present invention to insert and/or remove a medical fluid into/from a patient. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0065]     The present invention provides a connector and a cap therefore that includes a disinfectant for any system requiring a connection, such as a connection of a first length of tubing or other conduit to a second length of tubing or other conduit, such as for PD. The present invention provides a safe and easy connection and method for introducing a disinfectant for a user/patient. The connector and cap therefore do not create a mess and do not make the user/patient perform special handling in order not to spill the disinfectant contained therein.  
         [0066]     The method and apparatus for the present invention can be used to perform Continuous Ambulatory Peritoneal Dialysis (“CAPD”) and Automated Peritoneal Dialysis (“APD”), collectively referred to herein as Peritoneal Dialysis (“PD”). It should be appreciated, however, that the connector and cap and method for using same can be used in a variety of other applications, particularly applications that insert a medical fluid into the body of a patient.  
         [0067]     Referring now to the figures, and in particular to  FIGS. 1A  to  1 C, a connector  10  of the present invention is illustrated.  FIG. 1A  illustrates that the connector  10  includes a cap  12 . Generally, the components of the present invention, including the cap  12 , are made of a plastic material such as polyethylene, polypropylene, nylon, polystyrene, polyester, PVC, a blend of various plastics or any other plastic or synthetic material that is capable of being washed and sterilized or substantially sterilized. As is illustrated below, certain components of the connector  10  seal to other components. These sealing components are generally made from compressible materials such as compressible rubber, e.g., silicone or the like.  
         [0068]     The components of the connector  10  are constructed into desired shapes via any known method for producing plastic or rubber pieces, such as a molding process, e.g., an injection molding process. The compressible or rubber pieces may alternatively be cut and/or stamped from a larger piece of the compressible or rubber material. In alternative embodiments, one or more of the components, i.e., the plastic components, may alternatively be constructed from a metal, e.g., a noncorrosive metal such as stainless steel or aluminum, and may be formed via any known method of forming or stamping same.  
         [0069]     The cap  12  includes a body  14  that is injection molded or blow molded to define a desired shape. Although  FIG. 1A  shows one embodiment of the connector  10  and the cap  12 , the body  14  of the cap  12  may be made in a variety of different shapes and sizes to mate with and/or work with various systems for introducing medical fluids into a patient. The various systems can be provided by other manufacturers or by the assignee of this invention. In one embodiment, the body  14  defines the following components or features.  
         [0070]     The body  14  defines at least one receptacle  16 . The receptacle  16  is a well or other liquid containing shape that encompasses a void except for a sealable side. The body  14  can define a variety of different receptacles  16 ; however,  FIG. 1A  shows an embodiment wherein the body  14  defines a single receptacle  16 . A seal  18  encloses or caps off the receptacle  16 . The seal  18  in an embodiment is a crosslinked elastomeric seal made from silicone. The seal may alternatively be made from any other type of rubber or compressible material such as neoprene, vinyl, viton, buna-n, butyl, EPDM, latex or the like.  
         [0071]     The seal  18  can be made from solid or sponge rubber. In an embodiment, the seal  18  may be clear so that the user or patient can see a disinfectant  20  housed between the seal and the receptacle  16 . In an embodiment, the seal  18  is coated with or impregnated with a disinfectant, which acts to further sterilize the connector  10 .  
         [0072]     In an embodiment, the seal  18  compresses against the walls of the receptacle  16 , so that the disinfectant  20  residing within the receptacle  16  in any suitable form and/or manner cannot initially escape, even if the cap  12  of the connector  10  is turned so that the seal  18  faces downward and even if the patient or user moves, manipulates, shakes or otherwise causes the disinfectant  20  to move within the receptacle  16 .  
         [0073]     In an embodiment, the seal  18 , compressed within the walls of the receptacle  16 , is translatable so that the seal  18  can move towards an end of the receptacle  16 . The method for translating the seal  18  is set forth in detail below in connection with FIGS.  3  to  7 . In an alternative embodiment, the seal  18  is thin or otherwise frangible, e.g., is constructed from a thin plastic or metal-coated plastic sheet. The sheet is designed to rip when the patient or user applies pressure to the sheet, wherein the disinfectant flows through the ruptured sheet of the seal  18 . In the alternative embodiment, the seal  18  would not compress against the walls of the receptacle  16 ; rather, a suitable adhesive would be used to secure the seal  18  to the receptacle  16 , or the seal  18  could be adhered to the receptacle  16  via a known heat-shrinking or heating process.  
         [0074]     The disinfectant  20  is adaptable to be any suitable type, form and/or amount of disinfectant that can sterilize or substantially sterilize plastic, rubber, metal or other like materials. In an embodiment, the disinfectant  20  is composed of povidone iodine. It should be appreciated that the povidone iodine can be provided in any suitable form and/or amount thereof. In an embodiment, a povidone iodine gel may have been subjected to gamma irradiation, steam sterilization and/or ethylene oxide.  
         [0075]     In another embodiment, the disinfectant is or includes iodine-containing antimicrobials. In a further embodiment, the disinfectant uses or includes a povidone iodine (not in gel form) that is or may be subjected to gamma irradiation and/or steam sterilization. In still another embodiment, the disinfectant is or includes betadine. It should be appreciated that the disinfectant  20  of the present invention can alternatively be any desired disinfectant known to those of skill in the art.  
         [0076]     The body  14  of the cap  12  also in an embodiment defines internal threads  22  and external threads  24 . In the illustrated embodiment, the internal threads  22  and external threads  24  reside on the same end of the cap  12 . The purpose of the inner and outer threads will be shown below. It is important to note, however, that the relative relationship between the internal threads  22  and the external threads  24  is not important to the operation of the present invention. In general, the body  14  of the cap  12  enables the first member to move along the central axis of the body  14  via one of the set of threads. The body  14  of the cap  12  also enables a second member to move along the central axis of the body  14 . It is not important which member moves by engaging the internal threads  22  and which member moves in the other direction by engaging the external threads  24 . An important aspect of the present invention, rather, is that two separate members may move inward and outward relative to the body  14  of the cap  12 .  
         [0077]     The inner threads  22  and the outer threads  24  may have any thread pitch desired by the implementor of the present invention. In the illustrated embodiment, the external threads  24  are slightly tapered, for example, at about one degree. In an alternative embodiment, the threads are straight, such as in a lead screw or ball screw. In the illustrated embodiment, the external threads  24  enable one member to translate relative to another, wherein the member eventually bottoms out or has a limited range of travel with respect to the external threads  24 . Likewise, the inner threads  22  may be straight threads that allow a member to rotate freely in and out of the body  14  or the inner threads  22  may be tapered such that the member bottoms out as it inserts into the body  14 .  
         [0078]     The body  14  defines a passage  26  that enables a medical fluid such as a dialysate to move from one end of the cap  12  to another. The passage  26  can alternatively be the opening defined by the inner threads  22  and does not have to include the reduced tubing piece illustrated as the passage  26  in  FIG. 1A . The passage  26 , however, is sized to have approximately the same inner diameter as the tubes or catheters carrying the dialysate back and forth from a dialysate container and the peritoneal cavity of the patient.  
         [0079]     In the illustrated embodiment, the body  14  defines a housing  28  at an end opposing the internal and external threads  22 ,  24 . The housing  28  is sized to hold a septum  30 . The housing  28  is swaged to the septum  30  or otherwise holds the septum  30  in a snug manner. The septum  30  cannot move in either axial direction relative to the body  14 . The body  14  defines an end wall  32  having a smaller inner diameter than that of the housing  28 , which also holds the compressible septum  30  in place. A suitable adhesive may also be employed to hold the septum  30  within the housing  28 .  
         [0080]     In an embodiment, the septum  30  is cylindrical as is the body  14  and the connector  10  in general. However, the septum  30 , the body  14 , and the connector  10  can each have alternative shapes such as being square or rectangular.  
         [0081]     The septum  30  in an embodiment is made of a compressible or rubber material. The septum can be made from any type of rubber, including any of the above listed rubbers. As is well known in the art, the septum  30  defines a slit (not illustrated) which enables a tube or other type of fluid communication member to pass through a back wall  34  of the septum  30 . The septum  30  in the illustrated embodiment generally defines a cap- or nut-shaped rubber or otherwise compressible piece having the back wall  34  and a cylindrical side wall  35  that extends from the back wall  34 . The nut-shaped or cap-shaped septum in an embodiment is made as one piece, wherein the slit is made in the back wall  34 . A tube or fluid communication member then inserts and resides inside a hollow chamber defined by the septum  30  and at some point is able to pass through the back wall  34 .  
         [0082]     In the illustrated embodiment, the connector  10  is configured so that the external threads  24  of the body  14  mate with internal threads of a shell  36 . The shell  36  is a plastic or metal piece and may be of the same material as the body  14  of the cap  12 . The shell  36  defines the internal threads  38  that mate with the external threads  24  of the body  14 . The shell  36  can thus translate in either axial direction relative to the body  14  by rotating in a clockwise or counterclockwise direction about the body  14 .  
         [0083]     The shell  36  defines a tube or port  40 , which in an embodiment is integrally formed with the shell  36 , e.g., through an injection molding or blow molding process. The tube  40  extends inwardly into a cavity defined by the shell  36  and into the body  14  of the cap  12  through an opening defined by the end wall  32  of the body  14 . The tube  40  also inserts into the cavity defined by the septum  30 . When the shell  36  rotates about the outer threads  24  of the body  14  to a packaging position, an end  41  of the tube  40  abuts or is directly adjacent to the back wall  34  of the septum  30 . For example, there may be a gap of about 0.010 in. (0.25 mm.) between the end  41  of the tube  40  and the back wall  34  of the septum  30 .  
         [0084]     The tube or port  40  also extends outwardly from the shell  36 . The tube or port  40  sealingly connects to a tube (not illustrated) that runs to a dialysate container or a container housing the medical fluid that transfers through the connector  10  of the present invention. In an embodiment, the tube connecting to the dialysate bag press fits or sealingly fits over the port  40  in such a way that the dialysate does not leak from the interface of the flexible tube running to the dialysate container and the port  40 . The tube of the dialysate bag can also connect to the port  40  via a solvent bond.  
         [0085]     It should be appreciated that the dialysate is generally transferred back and forth, to and from, the dialysate container under its own weight and generally does not require an external pump or pressure system to drive the flow. Therefore, the fluid is not under substantial pressure and the seal required for the port  40  is not difficult to achieve. In an alternative embodiment, a hose clamp or other type of releasably fastenable device may be used to bolster the seal made between the flexible tube running to the dialysate bag and the port  40 . Such interface is made readily and without requiring the patient or user to have an excessive amount of strength or to perform overly intricate operations.  
         [0086]     A tip protector  42  fits over the shell  36  and at the same time fits into the interior cavity defined by the internal threads  22  of the body  14 . The tip protector  42  is made in an embodiment of any of the plastic materials described above. The tip protector  42  defines a ring or handle  44  that enables the user or patient to remove the tip protector  42  from the shell  36  to begin using the connector  10 . That is, the connector  10  is initially packaged with the tip protector  42 . The first time the user or patient uses the tip protector  42 , the user or patient removes the tip protector and discards it.  
         [0087]     The tip protector  42  serves a number of purposes in protecting the connector  10  prior to use. The tip protector  42  provides a microbial barrier. The tip protector  42  disallows bacteria and other harmful airborne agents from entering the body  14  of the cap  12  prior to use. Just before attaching the cap  12  to a mating connector (see mating connector  60  in  FIGS. 2 through 7 ), the patient or operator removes the tip protector  42 . In this way, the inside of the body  14  of the cap  12  is only exposed to open air for a very short amount of time.  
         [0088]     In an embodiment, for example, when the connector  10  is to be used for CAPD, the tip protector  42  also sets the shell  36  at the appropriate distance relative to the body  14  for packaging the connector  10 . That is, the tip protector  42  helps to set the end  41  of the tube  40  of the shell  36  directly adjacent to the back wall  34  of the septum  30 .  
         [0089]     Prior to use, the tube  40  does not insert into or open up the slit (not illustrated) in the back wall  34  of the septum  30 . However, it is desirable not to have the end of the tube or port  40  too far away from the back wall  34  of the septum  30  upon packaging the connector  10  for a couple of reasons. First, it is desirable to package the connector  10  in as small a space as possible. If the connector  10  is packaged so that the end  41  resides away from the back wall  34 , then the connector  10  is longer in an axial direction than it needs to be. Second, it is desirable not to make the user or patient rotate the shell  36  more than is necessary to insert the tube  40  through the slit of the back wall  34  of the septum  30  to begin using the connector  10 .  
         [0090]      FIGS. 1A and 1B  illustrate that the tip protector  42  in an embodiment defines threads  46  that engage some of the internal threads  38  of the shell  36 . The shell  36  only threads into the tip protector  42  so far before the shell  36  bottoms out against a cylinder  48  defined by the tip protector  42 .  FIG. 1B  illustrates that in an embodiment, the outside of the shell  36  includes a taper  35  at the end of the portion of the shell  36  defining the threads  38 . As the tip protector  42  threads into the shell  36 , the taper  35  increasingly presses against the inside of the cylinder  48 . In an embodiment, the cylinder  48  of the tip protector  42  defines a stepped portion  47  that facilitates the engagement between the taper  35  of the shell  36  and the tip protector  42 .  
         [0091]     Thus, when the connector  10  is packaged, the tip protector  42  can be placed against or abutted against the body  14  of the cap  12  before the shell  36  threads onto the body  14  and onto the threads  46  of the tip protector  42 . The shell  36  threads over the external threads  24  of the body  14  and passes or translates past the body  14  a desired distance defined by the threads  46  of the tip protector  42 . It is at this point that the end  41  of the tube  40  abuts or is directly adjacent to the end wall  34  of the septum  30 .  
         [0092]     It should be appreciated that the cylinder  48  of the tip protector  42  is not threaded and does not threadingly engage the shell  36  so that the cylinder  48  simply slides over and translates relative to the shell  36 . It should also be appreciated that to remove the tip connector  42 , the user holds the shell  36  and rotates the ring  44  a number of turns.  
         [0093]      FIG. 1C  illustrates an alternative embodiment that is used, for example, when the connector  10  performs APD. The tip protector  42  simply slides and possibly slightly press fits onto or into the body  14  of the cap  12 . Here, the tip protector  42  does not define the threads  46 . The shell  36  may or may not be tapered and may contain a stepped member  37 , wherein the member  37  is intended to slightly frictionally engage the inner wall of the cylinder  48 . The internal threads  38  of the shell  36  stop before reaching the inner portion  39  of the shell  36  that abuts the tip protector  42 .  
         [0094]     When the connector is initially packaged, the body  14  cannot move relative to the shell  36  until the tip connector  42  is removed. This is important to ensure that the seal  18  is not ruptured or displaced prior to using the connector  10 . The tip protector  42  also includes an inner extension  50  that extends into the chamber created by the internal threads  22  of the body  14 . The extension  50  extends so that it abuts or is directly adjacent to the seal  18 . This ensures that prior to use, the seal  18  does not loosen and move away from the receptacle  16  to thereby create a leaky connector  10 . Thus, it should be appreciated that the tip connector  42  enables the connector  10  to be handled and shipped without destroying the seal  18  and/or losing the disinfectant  20  maintained by the seal  18 .  
         [0095]     Referring now to  FIGS. 2 and 3 , one embodiment for connecting the connector  10  of the present invention to a mating connector  60  is illustrated. The connector  10  may be adapted to operate with many different types of connectors or devices that provide a catheter  62  that inserts into the peritoneal cavity of the patient. In an embodiment, the connector  10  is adapted to attach to a transfer set that is illustrated in  FIG. 2  as the connector  60 . The transfer set in one embodiment is a MiniSet™ manufactured by the BAXTER INTERNATIONAL INC. Although the MiniSet™  60  is one operable embodiment of the transfer set or catheter device, the connector  10  can operate with any type of device that couples to a tube or catheter, which inserts into the patient&#39;s peritoneal cavity.  
         [0096]     In  FIG. 2 , the tip protector  42  is unsecured or removed from the shell  36  of the connector  10 . The port  40  of the shell  36  of the connector  10  is illustrated as sealingly connecting to a flexible tube  64  that runs to the dialysate container or bag.  
         [0097]      FIG. 3  illustrates that after inserting the connector  10  onto the connector or transfer set  60 , the shell  36  connected to the tube  64  threads off of and away from the cap  12 . The connector  10  threads onto the connector or transfer set  60  using the internal threads  22  defined by the body  14  of the cap  12 , which are exposed when the tip protector  42  is removed.  
         [0098]      FIG. 3  illustrates a point in the process when the patient has completed the transfer of the dialysate from the dialysate container into the peritoneal cavity, or  FIG. 3  illustrates a point in the process when the patient or user has finished draining spent dialysate from the peritoneal cavity into the dialysate container. In either situation, when the shell  36  threads off of the container  10 , the cap  12  of the container  10  remains fixed to the connector or transfer set  60  and thereby caps off the transfer set  60 . In this manner, because the sterility of cap  12  is maintained and cap  12  remains functional, a separate cap which would normally have to be taken off and re-placed onto the transfer set  60  before and after each use is no longer necessary.  
         [0099]     Referring now to FIGS.  4  to  7 , one embodiment of a method for removing spent dialysate and inserting new dialysate into a patient in a substantially sterilized environment is illustrated.  FIG. 4  illustrates a point in the process when the tip protector  42  has been removed and the transfer set or connector  60  is ready to be connected to the connector  10 . At this point, the connector or transfer set  60  has not engaged the seal  18  to thereby rupture or displace the seal, which displaces the disinfectant  20 . The connector or transfer set  60  includes external threads  64  that mates with the internally facing threads  22  of the body  14  of the cap  12 .  
         [0100]     When the user or patient desires to connect the catheter from the peritoneal cavity to the connector  10 , the user or patient threads the connector or transfer set  60  (connecting to the catheter extending to the peritoneal cavity) into the body  14  of the cap  12  so that ends  66  of the connector transfer set  60  engage the seal  18  and either move it or rupture it (best seen in  FIG. 5 ). That is, the ends  66  apply a translational force to the seal  18  which causes the seal  18  to compress against the disinfectant  20 . Eventually, as the user screws the connector  60  into the body  14 , the pressure becomes too much for the seal to handle, whereby the seal either moves so that the disinfectant leaves the receptacle  16  and squirts out around the seal  18  and the ends  66  pierce, or the seal ruptures (thin sheet seal embodiment described above) and the disinfectant  20  runs out over the external threads  64  of connector  60 .  
         [0101]     In the illustrated embodiment, the seal  18  remains intact but moves or displaces the disinfectant  20  to run out over the outside of the threads  64  of the connector  60 , so that microorganisms contained thereon are substantially destroyed. The seal  18  as illustrated may be made in a teardrop-type shape wherein the blunt end of the teardrop has more sealing force than the tapered or sharper end of the seal  18 . In this manner, the sharper or tapered end may slightly deform as the blunt end is dragged along the surface of the receptacle  16 .  
         [0102]     The mating connector  60  in an embodiment is sized to engage and slide along the passage  26  of the body  14 . This also aids in dispersing the disinfectant  20  onto the outside of the mating connector  60  to disinfect the engaging threads. That is, the disinfectant will take the path of least resistance and tend to move into the open cavity defined between the outside of the connector  60  and an inner wall of the body  14 , rather than squeezing through the friction fit between the inner opening of the connector  60  and the passage  26 .  
         [0103]     Referring now to  FIG. 6 , after the mating connector or transfer set  60  bottoms out against the body  14 , i.e., pushes the seal  18  all the way against the receptacle  16  of body  14 . The assembly of the connector  10  to the mating connector  60  is now complete, so that the sealed end of the body  14  made by the slit septum  30  can be unsealed or opened. To break the seal of the septum  30 , the user or patient rotates the shell or shell  36  relative to the body  14  wherein the threads of the shell  36  turn against the threads of the body  14 . The shell  36  thereby translates towards the mating connector  60 , so that the tube or port  40  of the shell  36  pierces through the back wall  34  of the septum  30  and through the slit defined by the back wall  34 . At this point, fluid communication exists between the peritoneal cavity of the patient and the dialysate bag.  
         [0104]     Thus, at the point illustrated in  FIG. 6 , the dialysate fluid may flow in either direction. That is, if the patient is removing spent dialysate from the peritoneal cavity, the dialysate fluid can flow from the catheter in the cavity into the mating connector  60 , through the passage  26  of the body  14 , out the port  40  and into the flexible tube  64  running to the dialysate container or bag.  
         [0105]     In CAPD, to remove the spent dialysate from the peritoneal cavity, the user or patient typically opens a clamp on the upstream side of the mating connector  60  or integrally formed with the mating connector  60 , wherein the spent dialysate runs into an awaiting container. The flex tube  64  typically runs to a “Y” connection, wherein one leg extends to the spent dialysate container and another leg extends to a new dialysate bag. When the old dialysate has been drained into the spent bag, the operator opens a fill-bag clamp that enables the new dialysate to run from the flexible tube  64 , to the port  40 , through the septum  30 , through the passage  26 , into the internal diameter of the mating connector  60  and into the catheter leading into the peritoneal cavity. With APD, one or more pumps automatically pull the spent dialysate from the patient&#39;s peritoneal cavity and places fresh dialysate into same.  
         [0106]      FIGS. 4, 5  and  6  illustrate one complete cycle of flushing old or spent dialysate and replenishing new dialysate into the peritoneal cavity. With both CAPD and APD, the cycle is repeated a number of times. Obviously, many other different types of medical fluids may be substituted for the dialysate described herein, wherein a number of medical procedures may be performed using the connector  10  having the cap  12  of the present invention.  
         [0107]     Referring now to  FIG. 7 , when the transfer of fluids has been exchanged, the user or patient removes the shell  36  from the cap  12 , so that the tube  40  of the shell  36  removes from the septum  30 . When removed, the slit in the wall  34  of the septum  30  closes and the end of the body  14  is once again sealed. The body  14  remains in the threaded position with respect to the mating connector  60 , so that the disinfectant  20  is maintained between the mating threads and the open area between the mating connector  60  and the body  14 .  
         [0108]     It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.