`Kruger et a1.
`
`.
`
`US 005205821A
`[11] Patent Number:
`[45] Date of Patent:
`
`-
`
`5,205,821
`Apr. 27, 1993
`
`[54] TERMINAL SELF-RELEASING FLUID
`RESERVOIR
`[75] Inventors: Robert J. Kruger, Arlington Heights;
`Con A. I
`,?s’ waukegan; Sheldon
`M. Weeker, Libertyville, all of I11.
`.
`.
`_
`[73] Ass'gnee' :rbott Laboratones’ Abbott Park’
`'
`[21] Appl. No.: 786,462
`[22] Flled:
`Nov‘ 1’ 1991
`[51] Int. Cl.5 ........................................... .. A61M 37/00
`[52] US. Cl. ...................................... .. 604/91; 604/89;
`604/283
`[58] Field of Search ................... .. 604/ 83, 89, 91, 256,
`604/233, 905, 232, 236, 238, 269; 133/89, 91, 96
`R, 96 T; 215/2, 211
`References Cited
`U.S. PATENT DOCUMENTS
`2,735,430 2/1956
`3)
`115,137 12/1963
`3:
`187,749 6/1965
`3,295,525 1/1967
`3,811,441
`5/1974
`3,986,645 10/1976
`4,432,764 2/1984
`
`[56]
`
`4,991,629 2/ 1991 Ernesto et a1. ...................... .. 138/89
`~
`FOREIGN PATENT DOCUMENTS
`
`(b63640 11/1982 European Pat. Off. .......... .. 604/256
`Primary Examiner-C. Fred Rosenbaum
`Assistant Examiner-C. Maglione
`Attorney, Agent, or Firm-A. Nicholas Trausch;
`Thomas M. Breininger
`[57]
`ABSTRACT
`A terminal reservoir capping device according to the
`present invention includes a hollow member having
`?rst and second open ends. A ?rst plug seals the ?rst
`open end such that the plug is inwardly clisplaceable
`into the hollow member, A second plug seals the second
`open end. A chamber is de?ned by the hollow member
`and the ?rst and second plugs. A reservoir of disinfect
`ing ?uid or therapeutic drug is provided in the chamber.
`Axially extending from the ?rst end of the hollow mem
`ber is a mechanism for engaging and advancing the tube
`connector into the chamber so as to inwardly displace
`the first plug into the chamber. The plug self-releases
`and allows dispersal of the reservoir ?uid into the tube
`connector.
`
`14 Claims, 2 Drawing Sheets '
`
`CCI 2005
`
`1
`
`
`
`US. Patent
`
`Apr. 27, 1993
`
`Sheet 1 of 2
`
`5,205,821
`
`
`
`I'lll'llll Ill].
`
`2
`
`
`
`US. Patent
`
`Apr 27 1993
`
`Sheet 2 of 2
`
`5,205,821
`
`
`
`8
`
`No
`
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`1
`
`TERMINAL SELF-RELEASING FLUID
`RESERVOIR
`
`FIELD OF THE INVENTION
`This invention generally pertains to a capping device
`for connectable tubing used in medical procedures, and
`more speci?cally, to a capping device containing a ?uid
`reservoir releasable when joined to a connector in ?uid
`communication with a patient catheter or a ?uid admin
`istration set, for example.
`
`s... 5
`
`20
`
`BACKGROUND OF THE INVENTION
`Various medical procedures involve the intermittent
`administration of drugs or ?uids through medical tubing
`to a patient catheter. This allows the patient to be ambu
`latory between and/or during the medical procedures.
`Procedures such as the intermittent infusion of antibiot
`ics often involve an intravenously placed catheter. Pro
`cedures such as peritoneal dialysis involve a surgically
`implanted catheter. These catheters terminate outside
`the patient’s skin with tube connectors mateable to the
`disposable administration tubing set of the ?uid or drug
`
`sources.
`
`’
`
`5,205,821
`2
`accidently spilled prior to or during connection to the
`catheter.
`The antibacterial closure system of Peluso, U.S. Pat.
`No. 4,624,664 discloses a capping device whose disin
`fecting reservoir is exposed once a cover plug is re
`moved. The connector cap and cover of Dadson et al.,
`U.S. Pat. No. 4,938,161 likewise discloses a cap whose
`reservoir is open and prone to accidental spillage prior
`to or during connection to the catheter connector.
`In general, all of the known capping devices require
`a‘ high degree of manual dexterity by the patient to
`prepare and properly connect the connector cap. Also,
`known devices open the antiseptic or drug reservoir
`prior to connection to the connector. Accidental spill
`age prior to connection could decrease the effectiveness
`of the drug or disinfectant or stain the patient and his
`clothing.
`Thus it is a primary object of this invention to pro
`vide a self-contained, disposable, easy to use terminal
`capping device having a drug or disinfectant reservoir
`for connectable medical tubing.
`It is another object that the drug or disinfectant in the
`capping device be self-releasing so as to minimize acci
`dental spilling or leakage, especially before connec
`tions.
`It is another object that the device allow the con
`tained disinfectant to cover the outside rim and engag
`ing parts of the connector and diffuse throughout the
`internal pathway of the connector.
`A terminal capping device according to the present
`invention includes a hollow cylindrical body member
`having ?rst and second open ends. A ?rst plug seals the
`first open end such that the plug is inwardly displace
`able into the cylindrical body member. A second plug
`seals the second open end.‘ A chamber is de?ned by the
`cylindrical body member and the ?rst and second plugs.
`A reservoir of disinfecting ?uid or drug is provided in
`the chamber. Axially extending from the ?rst end of the
`cylindrical body member is a mechanism for engaging
`and advancing the tube connector into the chamber so
`as to inwardly displace the ?rst plug into the chamber.
`This allows dispersal of the reservoir ?uid into the tube
`connector.
`
`25
`
`It is very important to protect and disinfect the reus
`able connector on the patient catheter before and after
`the procedure so as to reduce the possibility of infec
`tion. For example, it is important to reduce the risk of
`peritonitis infection in peritoneal dialysis patients since
`30
`peritoneal membrane injury may lead to premature
`termination of peritoneal dialysis therapy.
`Continuous ambulatory peritoneal dialysis (CAPD)
`allows a patient to perform peritoneal dialysis during a
`near normal daily routine. The CAPD patient manually
`performs 3 to 6 ?uid exchanges daily wherever he may
`be. However, due to the number of exchanges and the
`variety of environments, CAPD has a high peritonitis
`rate.
`There are currently a number of connector caps in
`use for sealing and protecting the catheter connection
`after disconnecting from the dialysis solution adminis
`tration set. Many of the caps require the user to apply a
`separately packaged disinfectant to the ‘cap in order to
`disinfect the connector of the peritoneal catheter. This
`procedure is time consuming, messy and prone to acci
`dential spills. Often, the disinfection is only partially
`accomplished which increases the chance of infection.
`Other connector caps, such as disclosed inthe anti~
`bacterial protective cap of Genatempo et al., U.S. Pat.
`No. 4,440,207 are provided with absorbents containing
`a disinfectant. However, these absorbents may dry out,
`may not contain enough disinfectant to provide effec
`tive disinfection, or do not deliver the disinfectant to the
`area of contamination. Also these caps tend to leak
`when being connected.
`A few connector caps contain internal reservoirs of
`disinfectant that can be engaged with the connector to
`disinfect the connector while it is not in use. The disad
`vantage of these known connectors is that they require
`-a great deal of manual dexterity to prepare them for use.
`Furthermore, they create the potential for accidental
`spillage and/or leakage because the reservoirs are open
`prior to connection. For example, the antiseptic end cap
`of Lopez, U.S. Pat. No. 4,432,764 requires the user to
`unscrew a cover plug from the end cap prior to use.
`With the plug removed, the reservoir is open and can be
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a sectional view of the terminal capping
`device of the present invention and a tube connector
`prior to engagement;
`FIG. 2 is a sectional view of the capping device and
`tube connector of FIG. 1 after engagement;
`FIG. 3 is a sectional view of an alternate embodiment
`of a capping device for use for with alternate embodi
`ment of a tube connector, prior to engagement; and
`FIG. 4 is a sectional view of the capping device and
`tube connector of FIG. 3 after engagement.
`
`60
`
`DETAILED DESCRIPTION OF THE
`DRAWINGS
`Referring now to FIG. 1, the terminal capping device
`10 of the present invention is shown with a conn'ectable
`tube connector 12 in ?uid communication with a patient
`catheter, for example. The connector 12 may also be the
`distal end of an administration set. The speci?c connec
`tor shown in FIG. 1 is a male luer adapter and has
`external threads 16, but the present invention is applica
`ble to any type of connectable medical tubing.
`The capping device 10 includes a hollow body 20,
`preferably semi-rigid and cylindrical, having a ?rst
`
`4
`
`
`
`3
`open end 22 and a second open end 24. The ?rst open
`end has a radially inward extending annular ?ange 26
`extending from the cylindrical body so as to create an
`ori?ce 28. The diameter of the ori?ce is smaller than the
`inner diameter of the cylindrical body 10.
`A ?rst plug 30 includes a plug portion 32 and a radial
`?ange portion 34. The plug 30 is made of a suitable
`medical material more resilient than the material of the
`hollow body 20. The plug portion 32 includes an inte
`gral seal ring 35 and is of proper diameter to sealingly
`engage by a friction ?t in the ori?ce 28. The ?ange
`portion 34 abuts the face of the circumferential ?ange
`26 on the inside (i.e., chamber side) of the hollow body.
`The ?rst plug is sealingly engaged in the ori?ce 28 with
`the plug ?ange 34 abutting the inside or inward face of
`the body ?ange 26. Thus the plug 30 is inserted into
`position from the open second end 24 of the hollow
`body. The outer diameter of the plug ?ange 34 is
`smaller than the inner diameter of the hollow body 20 to
`allow the plug to be inserted through the hollow body.
`The indented portion 37 of the plug facilitates a ?xture
`being used to sealingly seat the plug 30 in the ori?ce 28.
`The second open end 24 of the hollow body can be
`closed by any closure member that is sealable across the
`open end. For example, a ?at disc can be circumferen
`tially ?xed onto the end of the hollow body.
`Alternatively, a second plug 38 can be used. The
`second plug 38 is of larger diameter than the ?rst plug
`and includes a plug portion 40 and a ?ange portion 42.
`The plug portion 42 is of proper diameter to engage in
`the second open end of the hollow cylindrical body.
`The ?ange portion 42 abuts the circumferential edge of
`the cylindrical body. The second plug is ?xed in place
`by adhesive bonding or ultrasonic welding or other
`suitable bonding techniques to prevent removal.
`The cylindrical body 20 and the two end plugs 30 and
`40 when sealingly in place form a sealed, enclosed
`chamber 46. After the ?rst plug 30 is sealingly engaged
`in the ori?ce 28, but before the second plug 40 is perma
`nently sealed to the cylindrical body 20, the chamber 46
`is only partially ?lled with a medical substance 48 so as
`to allow the ?rst plug to be displaced into the chamber.
`The ?rst end of the cylindrical body 20 includes an
`axial extension 50. The extension includes any of a
`known variety of engaging and advancing construc
`tions such as, for example, threaded ?tments or luer
`connections.
`In the embodiment of FIG. 1, the axial extension is a
`female luer adapter and includes internal threads 52
`' adapted to mate with the external threads 16 of the male
`luer connector 12. The internal threads 52 engage and
`advance the tube connector 12 towards the chamber 46.
`As shown in FIG. 2, as the patient merely screws the
`cap 10 onto the connector 12, the tube connector ad
`vances into contact with the ?rst plug 30 and displaces
`the plug into the part-?lled chamber 46. The reservoir
`?uid 46 can now diffuse into and around the connector
`12.
`An alternate embodiment of the connector and cap
`ping device is shown in FIGS. 3 and 4. The connector
`60 of FIG. 3 includes a skirt 62 having internal threads
`64. An axial ?ow projection 66 provides ?ow communi
`cation to the tube 14.
`The capping device 70 is constructed similar to the
`previously described capping device 10, except that the
`axial extension 72 has external threads 74 which engage
`and mate with internal threads 64 of the connector. As
`the threads are advanced on each other, the ?ow pas
`
`25
`
`35
`
`40
`
`45
`
`50
`
`55
`
`65
`
`5,205,821
`
`l0
`
`15
`
`20
`
`4
`sage axial projection 66 contacts the ?rst plug 30. Upon
`further advancement, the axial projection pushes the
`plug 30 into the chamber 46 and causes the reservoir
`?uid to disperse into and around the end of the connec
`tor 60.
`When used as a capping device for a peritoneal dialy
`sis connector, the medical substance 48 would be a
`disinfectant ?uid, preferably povidone-iodine. Other
`suitable disinfectants include chlorhexidine. The vol
`ume of the chamber 46 for a terminal peritoneal dialysis
`capping device is on the order of 1.0 ml and is approxi
`mately 60% ?lled with either a ?uid or a powder.
`It is envisioned that the capping device 10 or 70 could
`also be used as a reservoir for other medical solutions,
`such as heparin or saline to ?ush the catheter at the end
`of an infusion procedure. It is also envisioned within the
`scope of this invention to modify the capacity of the
`chamber 46 and include therein antiseptic and therapeu
`tic drugs such as liquid or powder antibiotics for quick
`and safe connection for infusion to an implanted cathe
`ter. Furthermore, a diagnostic ?uid could easily be
`introduced into the ?uid ?ow. Thus, a terminal reser
`voir device with the self-releasing plug would facilitate
`intermittent administration of the various medical sub
`stances quickly and safely.
`Alternatively, the enclosed chamber 46 could be
`initially sealed empty. This would allow the terminal
`reservoir to be used to safely collect a sample of the
`?uid in the medical tubing for further diagnostic pur
`poses.
`All of the embodiments described above are con
`structed of suitable medical class materials so as to be
`compatible with the ?uids and medical substance con
`tained in the capping device and ?owing in the tubing.
`Furthermore, the capping device of the present in
`vention can be readily sterilized after ?lling and ?nal
`sealing at the second end by traditional methods such as
`radiation or autoclaving. For some uses, such as a disin
`fectant reservoir for CAPD use, the capping device
`does not necessarily have to be sterilized.
`The foregoing invention can be practiced by those
`skilled in the art. Such skilled persons will appreciate
`that the terminal reservoir device of the present inven
`tion is not necessarily restricted to the particular pre
`ferred embodiments presented herein. The scope of the
`invention is to be de?ned by the terms of the following
`claims in the spirit and meaning of the preceding de
`scription.
`'
`We claim:
`1. A terminal reservoir device for a connectable tube
`connector, comprising:
`a hollow member having ?rst and second open ends;
`?rst means for sealing said ?rst open end, said ?rst
`sealing means being inwardly displaceable into the
`hollow member;
`second means for sealing said second open end;
`an enclosed chamber de?ned by said hollow member,
`said ?rst sealing means and second sealing means;
`and
`means axially extending from said ?rst end of said
`hollow member for engaging and advancing the
`connectable tube connector toward said chamber
`so as to inwardly displace the ?rst sealing means
`into said chamber, wherein said ?rst sealing means
`is a ?rst plug member sealingly engageable in the
`?rst open end of the hollow member from the di
`rection of the second end only.
`
`5
`
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`5,205,821
`5
`6
`2. The terminal reservoir device of claim 1 further
`partially ?lled with said medical substance before said
`including a medical substance contained in said en-,
`second plug is sealingly engaged in said second open
`closed chamber.
`end.
`3. The terminal reservoir device of claim 2 wherein
`7. The terminal reservoir device of claim 6 wherein
`said ?rst open end includes a radially inward extending
`said engaging and advancing means includes an inter- _
`annular ?ange de?ning an ori?ce and wherein said ?rst
`nally threaded axial extension.
`_ plug member includes a plug portion and a ?ange por
`8. The terminal reservoir device of claim 6 wherein
`tion, said plug portion having a sealing friction ?t in said
`said engaging and advancing means includes an exter
`ori?ce and said ?ange portion abutting said annular
`nally threaded axial extension.
`?ange.
`9. The terminal reservoir device of claim 6 wherein
`4. The terminal reservoir device of claim 3 wherein
`said medical substance is a disinfectant.
`said second sealing means is a member adapted to seal
`10. The terminal reservoir device of claim 9 wherein
`ingly close the second open end after the medical sub
`said disinfectant is povidone iodine.
`stance is positioned in said hollow member.
`11. The terminal reservoir device of claim 2 wherein
`5. The terminal reservoir device of claim 4 wherein
`said medical substance is a disinfectant.
`said closing member is a second plug member including
`12. The terminal reservoir device of claim 2 wherein
`a second plug portion sealingly engageable in the hol
`said medical substance is a therapeutic drug.
`lo'w member and a second ?ange portion abutting said
`13. The terminal reservoir device of claim 2 wherein
`second open end.
`said medical substance is a dignostic ?uid.
`6. The terminal reservoir device of claim 5 wherein
`14. The terminal reservoir device of claim 1 wherein
`said ?ange portion of said ?rst plug has a smaller diame
`said chamber is an empty reservoir suitable for collect
`ter than said hollow member so that said ?rst plug is
`ing a ?uid sample.
`sealingly engaged in said ori?ce and said chamber is
`
`# ‘ i i i
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`10
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`25
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`6
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`
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