1111111111111111 IIIIII IIIII 11111 1111111111 1111111111 111111111111111 11111 1111111111 11111111
`US 20030153865Al
`
`(19) United States
`(12) Patent Application Publication
`Connell et al.
`
`(10) Pub. No.: US 2003/0153865 Al
`Aug. 14, 2003
`( 43) Pub. Date:
`
`(54) DIALYSIS CONNECTOR AND CAP HAVING
`AN INTEGRAL DISINFECTANT
`
`(76)
`
`Inventors: Brian Connell, Evanston, IL (US); Bill
`Griswold, Bristol, WI (US); Raf
`Castellanos, Roselle, IL (US); Tom
`Johnson, Gurnee, IL (US)
`
`Correspondence Address:
`BAXTER HEALTHCARE CORPORATION
`RENAL DIVISION
`1 BAXTER PARKWAY
`DF3-3E
`DEERFIELD, IL 60015 (US)
`
`(21) Appl. No.:
`
`10/074,532
`
`(22) Filed:
`
`Feb. 11, 2002
`
`Publication Classification
`
`(51)
`
`Int. Cl.7 ...................................................... A61M 1/00
`
`(52) U.S. Cl. ................................................. 604/28; 604/29
`
`(57)
`
`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'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.
`
`BAXTER EXHIBIT 1010
`Page 1 of 12
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`

`

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`Patent Application Publication Aug. 14,2003 Sheet 1 of 3
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`BAXTER EXHIBIT 1010
`Page 2 of 12
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`BAXTER EXHIBIT 1010
`Page 2 of 12
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`Patent Application Publication Aug. 14, 2003 Sheet 2 of 3
`
`US 2003/0153865 Al
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`BAXTER EXHIBIT 1010
`Page 3 of 12
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`

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`Patent Application Publication Aug. 14, 2003 Sheet 3 of 3
`
`US 2003/0153865 Al
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`BAXTER EXHIBIT 1010
`Page 4 of 12
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`US 2003/0153865 Al
`
`Aug. 14, 2003
`
`1
`
`DIALYSIS CONNECTOR AND CAP HAVING AN
`INTEGRAL DISINFECTANT
`
`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'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 replac(cid:173)
`ing at least the filtration functions of the kidneys.
`
`[0004] PD uses a dialysis solution or dialysate, which is
`infused into a patient's peritoneal cavity. The dialysate
`contacts the patient's peritoneal membrane in the peritoneal
`cavity. Waste, toxins, and excess water pass from the
`patient'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'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 auto(cid:173)
`matically, 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 break(cid:173)
`down 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 perito(cid:173)
`neal 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 commu(cid:173)
`nicating with the dialysis container in a maimer that permits
`even a very small number of microorganisms to enter the
`catheter. The microorganisms will be flushed into the peri(cid:173)
`toneal cavity. Peritonitis can occur even when extreme
`caution is observed in making and unmaking the connec(cid:173)
`tions. Peritonitis can be painful and can temporarily dimin(cid:173)
`ish the hydraulic permeability of the peritoneal membrane,
`rendering the renal treatment less successful.
`
`[0011] Methods to prevent peritonitis have included thor(cid:173)
`oughly 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 how(cid:173)
`ever are messy, time consuming, effort consuming, incon(cid:173)
`sistent 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's home.
`
`BAXTER EXHIBIT 1010
`Page 5 of 12
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`

`

`US 2003/0153865 Al
`
`Aug. 14, 2003
`
`2
`
`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'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 povi(cid:173)
`done iodine or PVP-1. The connector is also initially pack(cid:173)
`aged 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]
`the disinfectant disperses
`In an embodiment,
`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.
`
`[0023] The translating member causes the seal to be
`displaced.
`
`[0024]
`
`In an embodiment, the seal is moveable.
`
`[0025]
`In an embodiment, the body includes a tube portion
`that defines the fluid flow passage. The disinfectant recep(cid:173)
`tacle resides about the tube portion.
`
`[0026]
`In an embodiment, a portion of the passage is sized
`to house a member that deforms to seal about a tube.
`
`[0027]
`In an embodiment, the member automatically
`closes when the tube is removed from the member.
`
`[0028]
`In still another embodiment of the present inven(cid:173)
`tion, 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.
`
`[0029]
`In an embodiment, the disinfectant includes povi(cid:173)
`done iodine.
`
`[0030]
`In an embodiment, the connector includes a tip
`protector that engages the shell.
`
`[0031]
`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.
`
`[0032]
`In an embodiment, the sealed end of the cap
`includes a slit septum.
`
`[0033]
`In an embodiment, the connector includes an elas(cid:173)
`tomeric seal that seals the disinfectant about the fluid flow
`passage.
`
`[0034]
`In still another embodiment of the present inven(cid:173)
`tion, 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.
`
`[0035]
`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 commu(cid:173)
`nication with the second member.
`
`[0036]
`In an embodiment, the sealed end of the cap seals
`about the first member when the first member pierces the
`sealed end.
`
`[0037]
`In an embodiment, the sealed end of the cap reseals
`when the first member is removed from the cap.
`
`[0038]
`In an embodiment, rupturing the seal includes
`threading the second member into the cap and exerting
`pressure on the seal.
`
`[0039]
`In an embodiment, connecting the second member
`includes displacing the disinfectant between the cap and the
`second member.
`
`[0040]
`In an embodiment, the method further includes
`maintaining the disinfectant between the cap and the second
`member after the seal is displaced.
`
`[0041]
`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
`
`[0042]
`In an embodiment, the method includes removing
`a tip protector and connecting the second member in place
`of the tip protector.
`
`[0043]
`In still another embodiment of the present inven(cid:173)
`tion, 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
`
`BAXTER EXHIBIT 1010
`Page 6 of 12
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`

`

`US 2003/0153865 Al
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`Aug. 14, 2003
`
`3
`
`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.
`[0044]
`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.
`[0045]
`In an embodiment, the method includes connecting
`another first member to the first end, removing spent dialy(cid:173)
`sate fluid from the peritoneal cavity and refilling the peri(cid:173)
`toneal cavity with fresh dialysate fluid.
`[0046]
`In different embodiments, the filling and removing
`steps are performed manually or automatically.
`[0047]
`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.
`[0048] Moreover, an advantage of the present invention is
`to provide a dialysis connector that reduces the likelihood of
`peritonitis.
`[0049] Another advantage of the present invention is to
`provide a dialysis cap that remains attached to a catheter set
`after use.
`[0050] 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.
`[0051] 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.
`[0052] 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.
`[0053] 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.
`[0054] 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.
`[0055] Additionally, it is an advantage of the present
`invention to provide a resealable cap having a sealed disin(cid:173)
`fectant that displaces across threads of the cap and the
`transfer set.
`[0056] 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
`[0057] FIG. lA is a perspective view of one embodiment
`of the dialysis connector and cap therefore of the present
`invention.
`
`[0058] FIG. 1B is a schematic sectional view showing an
`embodiment of an interface between the shell and the tip
`protector.
`[0059] FIG. lC is a schematic sectional view showing
`another embodiment of an interface between the shell and
`the tip protector.
`[0060] 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.
`[0061] 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.
`[0062] 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.
`[0063] 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.
`[0064] 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.
`[0065] 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
`[0066] 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 pro(cid:173)
`vides 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.
`[0067] 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 Dialy(cid:173)
`sis ("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.
`[0068] Referring now to the figures, and in particular to
`FIGS. lA to lC, a connector of the present invention is
`illustrated. FIG. lA illustrates that the connector 10 includes
`a cap 12. Generally, the components of the present inven(cid:173)
`tion, 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.
`
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`US 2003/0153865 Al
`
`Aug. 14, 2003
`
`4
`
`[0069] The components of the connector 10 are con(cid:173)
`structed 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 compress(cid:173)
`ible 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.
`[0070] The cap 12 includes a body 14 that is injection
`molded or blow molded to define a desired shape. Although
`FIG. lA shows one embodiment of the connector 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.
`[0071] 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. IA 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 alterna(cid:173)
`tively be made from any other type of rubber or compress(cid:173)
`ible material such as neoprene, vinyl, viton, buna-n, butyl,
`EPDM, latex or the like.
`[0072] 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.
`[0073]
`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.
`[0074]
`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 embodi(cid:173)
`ment, 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 embodi(cid:173)
`ment, 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.
`[0075] 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 com(cid:173)
`posed 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 ster(cid:173)
`ilization and/or ethylene oxide.
`[0076]
`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.
`[0077] 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.
`[0078] 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 exter(cid:173)
`nal 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.
`[0079] 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. lA. 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.
`
`In the illustrated embodiment, the body 14 defines
`[0080]
`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
`
`BAXTER EXHIBIT 1010
`Page 8 of 12
`
`

`

`US 2003/0153865 Al
`
`Aug. 14, 2003
`
`5
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`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.
`
`[0081]
`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.
`
`[0082] 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 embodi(cid:173)
`ment 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.
`
`[0083]
`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.
`
`[0084] 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.
`
`[0085] 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.
`
`[0086]
`It s