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`US 20040111078Al
`
`(19) United States
`(12) Patent Application Publication
`Miyahara
`
`(10) Pub. No.: US 2004/0111078 Al
`Jun. 10, 2004
`(43) Pub. Date:
`
`(54) CONNECTOR SYSTEM FOR STERILE
`CONNECTION
`
`(52) U.S. Cl. ............................................ 604/414; 604/905
`
`(75)
`
`Inventor: Hideyasu Miyahara, Hiroshima-shi
`(JP)
`
`(57)
`
`ABSTRACT
`
`Correspondence Address:
`MERCHANT & GOULD PC
`P.O. BOX 2903
`MINNEAPOLIS, MN 55402-0903 (US)
`
`(73) Assignee: JMS Co., Ltd., Hiroshima-shi (JP)
`
`(21) Appl. No.:
`
`10/628,850
`
`(22)
`
`Filed:
`
`Jul. 28, 2003
`
`Related U.S. Application Data
`
`(63)
`
`Continuation-in-part of application No. 10/353,112,
`filed on Jan. 27, 2003.
`
`(30)
`
`Foreign Application Priority Data
`
`Jan. 25, 2002
`
`(JP) ...................................... 2002-017075
`
`Publication Classification
`
`(51)
`
`Int. Cl.7 ............................ A61M 5/32; A61B 19/00
`
`A connector system for sterile connection includes a male
`type connector having a tube connecting portion at a rear end
`portion thereof, a protective cap for the patient side connec(cid:173)
`tor, an inner cap held in the protective cap and including a
`ring-shaped portion that supports a disinfectant-impregnated
`member therein, and a female type connector including an
`outer cylinder and an inner cylinder fixed at one end of the
`outer cylinder, where the inner cylinder includes an internal
`end portion located inside the outer cylinder and an external
`end portion exposed outside the outer cylinder. When the
`protective cap is fitted with the male type connector, the
`disinfectant-impregnated member contacts with the male
`type connector. When the protective cap is removed there(cid:173)
`from, the inner cap becomes retained in the male type
`connector. When such a male type connector is connected
`with the female type connector, the internal end portion of
`the inner cylinder penetrates through the disinfectant-im(cid:173)
`pregnated member and a septum. When the connection is
`released, the inner cap is detached from the male type
`connector.
`
`18
`
`102
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`Patent Application Publication
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`Jun. 10, 2004 Sheet 1 of 9
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`US 2004/0111078 Al
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`FIG. 1B
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`FIG. 1C
`
`FIG. 1D
`
`FIG. 1E
`
`FIG. 1F
`
`FIG. 16
`
`1
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`2
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`CDP
`[~::~ :1 =~
`
`4
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`5b
`
`1
`5 ~
`
`~.1:;;;(::J
`
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`Patent Application Publication
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`Jun. 10, 2004 Sheet 2 of 9
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`US 2004/0111078 Al
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`18
`
`1
`~
`
`102
`
`FIG.2
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`Patent Application Publication
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`Jun. 10, 2004 Sheet 3 of 9
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`US 2004/0111078 Al
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`19c
`
`102
`
`12
`
`FIG.3
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`Patent Application Publication
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`Jun. 10, 2004 Sheet 4 of 9
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`US 2004/0111078 Al
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`20
`
`FIG.4
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`Patent Application Publication
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`Jun. 10, 2004 Sheet 5 of 9
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`US 2004/0111078 Al
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`FIG.5A
`
`30
`
`3
`,J-
`
`31
`
`31
`
`31
`
`FIG.5B
`
`' '
`30b
`
`FIG.5C
`
`30a
`
`30b
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`Patent Application Publication
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`Jun. 10, 2004 Sheet 6 of 9
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`FIG.6
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`Patent Application Publication
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`Jun. 10, 2004 Sheet 7 of 9
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`US 2004/0111078 Al
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`4
`·r-7
`
`43c
`
`43a
`
`FIG. 7
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`Patent Application Publication
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`Jun. 10, 2004 Sheet 8 of 9
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`US 2004/0111078 Al
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`1~
`
`101
`
`21
`
`32 3
`
`\
`
`2
`
`FIG.SA
`
`FIG.SB
`
`FIG.SC
`
`FIG.SD
`
`FIG.SE
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`Patent Application Publication
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`Jun. 10, 2004 Sheet 9 of 9
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`US 2004/0111078 Al
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`42
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`4
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`18
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`43
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`FIG.9A
`
`FIG.9B
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`FIG.9C
`
`FIG.9D
`
`FIG.9E
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`US 2004/0111078 Al
`
`Jun. 10,2004
`
`1
`
`CONNECTOR SYSTEM FOR STERILE
`CONNECTION
`
`[0001] This application is a continuation-in-part of U.S.
`application Ser. No. 10/343,112, filed Jan. 27, 2003, which
`is incorporated herein in its entirety.
`
`BACKGROUND OF THE INVENTION
`
`[0002] 1. Field of the Invention
`
`[0003] The present invention relates to a connector sys(cid:173)
`tem, particularly to a system for sterile connection, e.g. as
`part of a system for conveying fluids to or from a patient.
`This is useful, for example, for connecting a patient side
`transfer tube ( extension tube) with a container of dialysis
`solution when a dialysis solution for peritoneal dialysis is
`exchanged. More particularly, the present invention relates
`to a connector system for sterile connection provided with a
`function of securely disinfecting a connecting portion with
`a simple operation when the connecting and detaching are
`repeated.
`
`[0004] 2. Related Background Art
`
`[0005] Peritoneal dialysis is a medical treatment method in
`which a dialysis solution is stored in a patient's abdominal
`cavity by way of a peritoneal catheter that is implanted
`surgically in the patient's abdominal cavity beforehand, so
`that impurities accumulated in the body are filtered using
`capillary vessels in the peritoneum. The patient undertakes
`daily activities while a transfer tube ( extension tube), which
`is used continuously for a half year, is connected to the end
`of the catheter. Then the patient himself connects a bag
`containing a dialysis solution with a front end of the transfer
`tube four times per day to exchange the dialysis solution in
`the abdominal cavity.
`
`[0006] The most serious problem to be addressed for
`carrying out the peritoneal dialysis is bacteria in the air or
`attached to the skin mistakenly entering into the abdominal
`cavity during the operation of exchanging the dialysis solu(cid:173)
`tion as required four times per day. If bacteria enter into the
`abdominal cavity, these bacteria cause inflammation of the
`peritoneum to develop peritonitis. As a result, for treating
`the peritonitis, the catheter might be extracted in bad cases,
`which leads to a situation incapable of continuing the
`peritoneal dialysis. Furthermore, the peritonitis repeated for
`a long term degrades the function of a peritoneum, and as a
`result, sufficient efficiencies of the dialysis cannot be
`obtained, or the patient might suffer from sclerosing encap(cid:173)
`sulating peritonitis (SEP) that is intractable and leads to bad
`prognosis, including possible death.
`
`[0007] Thus, in the peritoneal dialysis, it is important,
`when the dialysis solution is exchanged, to reduce the
`contamination by bacteria of a connector that connects a
`transfer tube and a container of dialysis solution. Conven(cid:173)
`tionally, products for connecting tubes by melting with a
`heated copper plate or for disinfecting a connecting portion
`with ultraviolet rays are available commercially for prevent(cid:173)
`ing the contamination by bacteria. However, since these
`products necessarily require units dedicated to the products,
`a patient always has to carry the unit. Moreover, in the event
`of problems with the unit, serious problems might occur.
`
`[0008] Meanwhile, in connection methods that do not use
`such units, a male and female screw type connector still is
`
`utilized. In these methods, since a channel for the dialysis
`solution necessarily becomes open in the connecting opera(cid:173)
`tion, it is virtually impossible to prevent the contamination
`by bacteria.
`
`[0009] As for connecting members that do not require
`units and can prevent the contamination by bacteria, various
`structures have been examined until now. Examples of those
`ideas are a structure using a septum, which is pushed open
`to realize the fitting for connection, a structure where a lid
`member is opened and closed automatically when connec(cid:173)
`tors are fitted, and a structure where fitting is realized by
`breaking a film covering a connecting portion.
`
`[0010] However, all of those structures have problems in
`that their mechanism becomes complicated, their size
`becomes large and the required functions cannot be obtained
`sufficiently, and therefore none of them have been put into
`practical use.
`
`SUMMARY OF THE INVENTION
`
`[0011] Therefore, with the foregoing in mind, 1t 1s an
`object of the present invention to provide a connector system
`for sterile connection that enables connection with a simple
`operation for avoiding the contamination by bacteria, with(cid:173)
`out substantially increasing the size of the conventional
`connectors.
`
`[0012] The connector system for sterile connection of the
`present invention includes: a male type connector including
`a tube connecting portion at a rear end portion thereof; a
`protective cap having a substantially cylindrical shape with
`a closed first end and being capable of connecting and
`disconnecting with/from a front end side of the male type
`connector; an inner cap including a ring-shaped portion that
`supports a disinfectant-impregnated member therein, the
`inner cap being retained inside the protective cap in an initial
`state; and a female type having a double-cylinder structure
`in which an inner cylinder is fixed at one end portion of an
`outer cylinder, the inner cylinder including an internal end
`portion located inside the outer cylinder and an external end
`portion exposed outside the outer cylinder and capable of
`connecting with a tube. In the example of a peritoneal
`dialysis system, the male type connector may be the patient
`side, the female type connector may be the circuit side, and
`the external end portion of the inner cylinder of the circuit
`side connector may be capable of connecting with a front
`end of a circuit in a container of dialysis solution. A channel
`for solution is connected by fitting the outer cylinder of the
`female type connector with the male type connector. When
`the protective cap is fitted with the male type connector, the
`inner cap assumes a state of being retained at the front end
`side of the male type connector. When the protective cap is
`removed from the male type connector, the inner cap is
`detached from the protective cap because of a retaining force
`at the front end side of the male type connector. When the
`male type connector with the inner cap retained at the front
`end thereof is connected with the female type connector, the
`internal end portion of the inner cylinder penetrates through
`the disinfectant-impregnated member in the inner cap, so
`that the channel is opened. When the connection between the
`male type connector and the female type connector is
`released, the inner cap is retained inside the female type
`connector and is detached from the front end of the male
`type connector.
`
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`US 2004/0111078 Al
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`Jun. 10,2004
`
`2
`
`[0013] With this configuration, the front end portion of the
`male type connector continues to be disinfected by the
`disinfectant-impregnated member in the inner cap. In addi(cid:173)
`tion, when connecting with the circuit side connector, the
`inner cylinder of the female type connector also is disin(cid:173)
`fected by the disinfectant-impregnated member, so that
`bacteria do not intrude into the channel. Furthermore, every
`time the dialysis solution is exchanged, the inner cap is
`exchanged automatically into a new one, and therefore this
`system always is disinfected by a new disinfectant-impreg(cid:173)
`nated member without a complicated procedure.
`[0014] Preferably, the male type connector includes a
`septum member at a front end portion thereof for protecting
`the channel, and when the male type connector with the
`inner cap retained at the front end thereof is connected with
`the female type connector, the internal end portion of the
`inner cylinder penetrates through the disinfectant-impreg(cid:173)
`nated member in the inner cap and the septum member of the
`male type connector, so that the channel is opened.
`[0015] Preferably, the inner cap includes a plurality of
`engaging legs extending from an outer edge portion of the
`ring-shaped portion in a direction along an axis of the ring.
`An engaging convexity is formed at a front end of each of
`the engaging legs so as to protrude inward. Engaging
`concavities are formed on an outer surface of the front end
`portion of the patient side connector so as to allow engage(cid:173)
`ment with the engaging convexities formed at the engaging
`legs of the inner cap. An inner cap retaining portion is
`formed on an inner wall inside the protective cap, where a
`retaining force exerted by the engagement between the
`engaging convexity of the inner cap and the engaging
`concavity of the male type connector is larger than a force
`exerted by the inner cap retaining portion of the protective
`cap to retain the inner cap. When the protective cap with the
`inner cap retained therein is fitted with the male type
`connector, the engaging convexities of the inner cap engage
`with the engaging concavities of the male type connector,
`and when the protective cap is removed from the male type
`connector, the retaining of the inner cap by the inner cap
`retaining portion of the protective cap is released due to the
`retaining of the inner cap at the engaging concavities of the
`patient side connector, so that the inner cap is detached from
`the protective cap while being fitted with the front end of the
`male type connector.
`[0016]
`In the above configuration, preferably, on the outer
`surface of the patient side connector, a circumferential step
`portion extending in a circumferential direction is formed so
`that a diameter at the front end side of the male type
`connector is smaller than that at a base end side, and a guide
`groove is formed so as to extend from the circumferential
`step portion toward the base end. The guide groove includes
`an inclined portion that is inclined with respect to an axis of
`the male type connector. On the inner wall close to an
`opening end portion of the protective cap, a guide protrusion
`is formed, and on the inner wall and extending toward the
`closed end side of the protective cap, a rotation blocking step
`portion is formed, the rotation blocking step portion being
`capable of contacting with the engaging legs of the inner cap
`so as to block a rotational action of the inner cap. When the
`male type connector is inserted into an opening of the
`protective cap with the guide protrusion of the protective cap
`facing the guide groove of the male type connector, and then
`the protective cap and the male type connector are rotated
`
`while being urged axially toward each other, the guide
`protrusion slides along the guide groove, so that the male
`type connector is pulled into an inside of the protective cap
`by a driving force resulting from a screw action by the
`inclined portion of the guide groove, and the engaging
`convexities of the inner cap, whose rotation is blocked by
`the rotation blocking step portion, engage with the engaging
`concavities of the male type connector.
`[0017]
`In the above configuration, preferably, the male
`type connector includes a blocking wall at the front end
`portion thereof, which is capable of contacting with a side
`face portion of the engaging leg of the inner cap when the
`inner cap is fitted thereto. The outer cylinder of the female
`type connector includes: a guide protrusion formed on an
`inner wall close to an open end portion thereof, the guide
`protrusion being formed to correspond to the guide protru(cid:173)
`sion of the protective cap; a guide step portion including an
`inclined portion that is inclined with respect to an axis of the
`female type connector; and an inner cap retaining portion
`formed at an inside of the connector and being capable of
`retaining the inner cap. When the male type connector with
`the inner cap retained therein is inserted into the opening of
`the female type connector with the guide protrusion of the
`outer cylinder facing the guide groove of the male type
`connector, and then the female type connector and the male
`type connector are rotated while being urged axially toward
`each other, the guide protrusion slides along the guide
`groove, so that the male type connector is pulled into the
`inside of the female type connector by a driving force
`resulting from a screw action by the inclined portion of the
`guide groove. At the same time the front ends of the
`engaging legs of the inner cap slide along the inclined
`portion of the guide step portion of the female type connec(cid:173)
`tor while rotation of the inner cap is blocked by the blocking
`wall of the male type connector, so that a force in the axis
`direction acts on the inner cap so as to separate the inner cap
`from the male type connector, resulting in the release of the
`engagement between the inner cap and the male type con(cid:173)
`nector, and the inner cap assumes a state of being retained
`by the inner cap retaining portion of the outer cylinder. The
`two guide protrusions (i.e., of the male type connector and
`of the protective cap) are formed so that they will act in the
`same manner and perform a similar function.
`[0018]
`In the above configuration, preferably, the inner
`cap retaining portion of the circuit side connector is config(cid:173)
`ured with a horizontal step portion provided at the innermost
`of the guide step portion. When the front ends of the
`engaging legs of the inner cap contact with the horizontal
`step portion, the inner cap is prevented from moving in the
`axis direction toward the opening of the outer cylinder so as
`to be retained in the female type connector.
`[0019]
`In the above configuration, preferably, the inner
`cap retaining portion of the female type connector is con(cid:173)
`figured by setting the dimensions of constituting elements so
`that at least portions of the inner wall of the inside of the
`outer cylinder contact with an outer circumferential surface
`of the ring-shaped portion of the inner cap or so that at least
`portions of the outer wall of the internal end portion of the
`inner cylinder contact with an inner circumferential surface
`of the ring-shaped portion of the inner cap, whereby the
`inner cap is retained by the thus generated frictional force.
`[0020]
`In the above configuration, preferably, the inner
`cap retaining portion of the protective cap is configured with
`
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`US 2004/0111078 Al
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`Jun. 10,2004
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`3
`
`a convex stripe formed on the inner wall of the inside of the
`protective cap, and the convex stripe contacts with an outer
`circumferential surface of the ring-shaped portion of the
`inner cap, so that the inner cap is retained by the thus
`generated frictional force.
`
`[0021]
`In the above configuration, preferably, on the outer
`surface of the front end portion of the male type connector,
`a convex stripe is formed so as to extend in the axis direction
`to a portion close to a joining portion between the guide
`groove and the circumferential direction step portion, and
`when the protective cap or the female type connector is
`combined with the male type connector, the convex stripe
`guides the guide protrusion of each of the protective cap and
`the female type connector to the guide groove.
`
`[0022] The female type connector used in the above
`connector system for sterile connection includes a double(cid:173)
`cylinder structure in which an inner cylinder is fixed at one
`end portion of an outer cylinder. The inner cylinder includes
`an internal end portion located inside the outer cylinder and
`an external end portion exposed outside the outer cylinder.
`
`[0023] The protective cap assembled member used in the
`above connector system for sterile connection includes: the
`protective cap having a substantially cylindrical shape
`whose one end is closed; and the inner cap retained at an
`inside of the protective cap and including a ring-shaped
`portion with a disinfectant-impregnated member supported
`therein. On an inner wall of the inside of the protective cap,
`an inner cap retaining portion for retaining the inner cap is
`formed. The inner cap includes a plurality of engaging legs
`extending from an outer edge portion of the ring-shaped
`portion in a direction along an axis of the ring, and an
`engaging convexity is formed at each of the engaging legs
`so as to protrude inward. The inner cap is retained by the
`inner cap retaining portion so that the front ends of the
`engaging legs are directed toward an opening of the protec(cid:173)
`tive cap.
`
`[0024] The male type connector used in the above con(cid:173)
`nector system for sterile connection includes engaging con(cid:173)
`cavities formed on an outer surface of the front end portion
`thereof so as to allow engagement with the engaging con(cid:173)
`vexities formed at the engaging legs of the inner cap.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0025] FIGS. lA to lG are front cross-sectional views
`showing each element constituting a connector system for
`sterile connection according to one embodiment of the
`present invention and their operation.
`
`[0026] FIG. 2 is a perspective view showing a male type
`connector constituting the connector system for sterile con(cid:173)
`nection according to the embodiment of the present inven(cid:173)
`tion.
`
`[0027] FIG. 3 is a front view showing the male type
`connector.
`
`[0028] FIG. 4 is a cross-sectional view showing a protec(cid:173)
`tive cap constituting the connector system for sterile con(cid:173)
`nection according to the embodiment of the present inven(cid:173)
`tion.
`
`[0029] FIG. SA is a perspective view showing an inner
`cap constituting the connector system for sterile connection,
`
`FIG. 5B is a plan view of the same and FIG. SC is a
`cross-sectional view of the same.
`
`[0030] FIG. 6 is a cross-sectional view showing a female
`type connector constituting the connector system for sterile
`connection.
`
`[0031] FIG. 7 is a cross-sectional view of the female type
`connector in perspective.
`
`[0032] FIGS. SA to SE are cross-sectional views illustrat(cid:173)
`ing the operation of fitting the protective cap with the patient
`side connector, which constitute the connector system for
`sterile connection according to the embodiment of the
`present invention.
`
`[0033] FIGS. 9A to 9E are cross-sectional views illustrat(cid:173)
`ing the operation of connecting the male type connector and
`the female type connector according to the same.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`[0034] The following describes a configuration of a con(cid:173)
`nector system for sterile connection according to one
`embodiment of the present invention, with reference to
`FIGS. 1 to 7. The present embodiment is described with
`respect to a peritoneal dialysis system as one example. In
`this embodiment the male type connector can be considered
`as on the patient side and the female type connector on the
`circuit side. "Patient side" and "circuit side" may be used in
`place of "male type" and "female type" respectively in the
`discussion of this embodiment. As indicated by an exploded
`view of FIG. lA, this connector system for sterile connec(cid:173)
`tion includes a patient side connector 1, a protective cap 2,
`an inner cap 3 and a circuit side connector 4.
`
`[0035] The patient side connector 1 is connected to a front
`end of an extension tube Sa that leads to a peritoneal catheter
`implanted in a patient's abdominal cavity. The circuit side
`connector 4 is connected to an extension tube Sb as a front
`end of a circuit in a container of dialysis solution, such as a
`twin bag, BF and APD. The inner cap 3 initially is supplied
`in a state of being supported in the protective cap 2, as
`shown on the right side of FIG. 1B. The inner cap 3 is
`equipped with a disinfectant-impregnated member, such as
`a disinfecting sponge impregnated with a disinfectant, which
`will be described later. The outline of a function of each
`element constituting this connector system for sterile con(cid:173)
`nection will be described below, with reference to FIGS. 1B
`to lG.
`
`[0036] The patient side connector 1 is connected to the
`front end of the extension tube Sa, which is used during a
`long term use for a half year. The protective cap 2 is fitted
`with the patient side connector 1 always during daily activi(cid:173)
`ties for protecting the front end of the connector. For this
`purpose, as shown in FIG. lB, the protective cap 2 that
`supports a newly-prepared inner cap 3 therein is opposed to
`the patient side connector 1, and they are fitted with each
`other as shown in FIG. lC. In this state, the disinfectant(cid:173)
`impregnated member provided in the inner cap 3 contacts
`with an end face of the patient side connector 1 so as to
`perform a disinfecting function.
`
`[0037] When a dialysis solution is exchanged, firstly, the
`protective cap 2 is removed from the patient side connector
`1. In this removal operation, the inner cap 3 is transferred
`
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`US 2004/0111078 Al
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`Jun. 10,2004
`
`4
`
`from the protective cap 2 to the patient side connector 1 as
`shown in FIG. 1D. In this exchanging operation of the
`dialysis solution, as shown in FIG. lE, the circuit side
`connector 4 is opposed to the patient side connector 1 and,
`as shown in FIG. lF, is connected with the patient side
`connector 1, thus forming a channel leading from the twin
`bag or the like to the patient's abdominal cavity. When the
`dialysis solution has been exchanged, as shown in FIG. lG,
`the connection between the patient side connector 1 and the
`circuit side connector 4 is released. Then, the inner cap 3
`finally is transferred to the circuit side connector 4 in
`accordance with the operation that will be described later,
`and is discarded together with the circuit side connector 4.
`[0038] Each of the above constituting elements will be
`described below in detail. The patient side connector 1, as
`shown in FIGS. 2 and 3, includes a substantially cylindri(cid:173)
`cal-shaped main body 10 made of resin, a septum supporting
`member 11 made of resin, which is fitted to a front end of
`the main body 10, and an O ring 101. At a base end (rear
`end) of the main body 10, a tube-shaped tube connecting
`portion 12 is formed for the connection with the extension
`tube (not illustrated). On either side of the tube connecting
`portion 12, a knob 102 is provided for supporting firmly
`when the patient side connector 1 is rotated.
`[0039]
`Inside the main body 10, a channel is formed so as
`to penetrate from its front end to the tube connecting portion
`12. On an outer surface of the central portion of the main
`body 10, a guide groove 13 is formed. A pair of the guide
`grooves 13 is provided symmetrically with respect to the
`axis of the main body 10, and one of the guide grooves 13
`is located on the reverse side of FIG. 2. The pair of guide
`grooves 13 is not necessarily required, and only one guide
`groove may function sufficiently. The guide groove 13
`includes an axis direction portion 13a extending in the axis
`direction of the main body 10, an inclined portion 13b that
`is inclined and a circumferential portion 13c extending along
`the circumferential direction. The axis direction portion 13a
`on the front end side ends with a step portion 14 formed on
`the outer surface of the main body 10. The step portion 14
`is formed in the circumferential direction so that an outer
`diameter of the main body 10 at the front end side becomes
`smaller than at the base end side.
`
`[0040] On the outer surface of a front end portion of the
`main body 10, an engaging concavity 15 is formed. The
`engaging concavity 15 is provided for supporting the inner
`cap 3 as indicated by alternate long and short dash lines in
`FIG. 3. This structure will be further described later. The
`septum supporting member 11 has a fitting hole 16, and the
`septum supporting member 11 is fixed to the main body 10
`by the fitting between this fitting hole 16 and a protrusion 17
`provided on the main body 10. At a central portion of the
`septum supporting member 11, a septum member such as a
`rubber septum (member with a slit) 18 is provided so as to
`protect the channel and ensure liquid-tightness. On a side
`surface of the septum supporting member 11 and a side
`surface of the front end portion of the main body 10,
`blocking walls 19a and 19b respectively are formed. A
`convex stripe 19c is provided for guiding a guide protrusion
`21, etc., formed on an inner wall of the protective cap 2,
`which will be described later, to the axis direction portion
`13a of the guide groove 13. Note here that the septum 18 is
`effective for ensuring liquid-tightness in the connecting state
`with the circuit side connector 4, but this element is not
`
`essential. Therefore, the liquid-tight seal may be ensured by
`other methods. In such cases, since the septum supporting
`member 11 is not used, the blocking walls 19a, 19b and the
`convex stripe 19c are formed directly on the main body 10.
`
`[0041] The protective cap 2 may be made of resin and, as
`shown in FIG. 4, has a hollow structure with a substantially
`cylindrical shape whose front end is closed. On an inner wall
`close to an opening 20 of the protective cap 2, a guide
`protrusion 21 is formed and located on a projected portion
`22 that projects like a rectangular island. A rotation-blocking
`step portion 22a is formed with an edge of the projected
`portion 22 along the axis direction. Although a pair of the
`guide protrusions 21 and a pair of the projected portions 22
`are provided symmetrically, only one of them is illustrated
`in this drawing. On an inner circumferential surface of the
`closed end of the protective cap 2, a convex stripe 23 is
`formed. At this portion, the inner cap 3 is placed as indicated
`by the alternate long and short dash lines, and the inner cap
`3 is supported by frictional engagement between the outer
`circumferential surface of a ring-shaped portion 30 (FIG. 5)
`of the inner cap 3 and the convex stripe 23. By inserting the
`patient side connector 1 into the opening 20, the protective
`cap 2 is fitted with the front end of the patient side connector
`1. In this operation, the guide protrusion 21 engages with the
`guide groove 13 in the patient side connector 1, and a mutual
`positional relationship between the protective cap 2 and the
`patient side connector 1 is guided by the engagement, so that
`the fitting is conducted. This operation will be described
`later.
`
`[0042] The inner cap 3 may be made of resin and, as
`shown in FIGS. 5A-C, includes the ring-shaped portion 30
`and two engaging legs 31. Inside the ring-shaped portion 30,
`a disinfecting sponge 32 is installed. Inside the ring-shaped
`portion 30, inward protrusions 30a and 30b are formed at
`plural portions. The inward protrusions 30a are arranged at
`an upper end in the axis direction, whereas the inward
`protrusions 30b are arranged at a lower end in the axis
`direction. Between the inward protrusions 30a and 30b, the
`disinfecting sponge 32 is supported. A straight-line or cross(cid:173)
`shaped slit (not illustrated) may be provided in the disin(cid:173)
`fecting sponge 32 so that an internal end portion 41b of the
`circuit side connector 4, which will be described later, can
`penetrate therethrough, and the disinfecting sponge 32 is
`impregnated with a disinfectant such as Isodine. The engag(cid:173)
`ing legs 31 protrude outward in the radial direction from the
`outer circumferential surface of the ring-shaped portion 30.
`At a front end of each of the engaging legs 31, an engaging
`convexity 33 is formed so as to protrude inward. As previ(cid:173)
`ously described, the inner cap 3 initially is held in the
`protective cap 2 as shown in FIG. 4. When the protective
`cap 2 is fitted with the patient side connector 1, the engaging
`convexity 33 of the inner cap 3 engages with the engaging
`convexity 15 of the patient side connector 1. Thereby, the
`inner cap 3 is retained on the septum supporting member 11.
`
`[0043] As stated above, the inner cap 3 is retained in the
`protective cap 2 by the friction engagement with the convex
`stripe 23 in the protective cap 2. Also, the inner cap 3 is
`retained on the patient side connector 1 by the engagement
`between the engaging concavity 15 of the patient side
`connector 1 and the engaging convexity 33 of the inner cap
`3. These modes for retaining the inner cap 3 are set so that
`
`BAXTER EXHIBIT 1009
`Page 14 of 18
`
`

`

`US 2004/0111078 Al
`
`Jun. 10,2004
`
`5
`
`the retaining force by the friction engagement in the pro(cid:173)
`tective cap 2 becomes smaller than the retaining force on the
`patient side connector 1.
`[0044] FIGS. 6 and 7 show the structure of the circuit side
`connector 4. As shown in FIG. 6, the circuit side connector
`4 has a double-cylinder