Note: Descriptions are shown in the official language in which they were submitted.
DEVICE FOR PROVIUING ANTIBACTERIAL RADIATI _
Technical Field and Prior Art
In various fields of medicine and elsewhere, and
particularly in continuous ambulatory peritoneal dialys~s (CAPD)
there is a need to make and break connections between peritoneal
tubing communicating with the peritoneal cavity and a source of
peritoneal dialysis âOl ution with substantially sterile
procedure. At the same time it is desirable for patients
lU undergoing CAPD or another form of peritoneal dialysis on a
chronic basis to be released from close supervision by medical
personnel and per~itted to do the dialysis solution exchange
procedures independently at their homes or places of work.
However, the need for maintenance of substantially sterile
procedure remains critical if peritonitis is to be avoided,
particularly in the case of patients on CAPD.
In response to this, various systems for irradiation of
connectors haYe been proposed, and one has been commercially
developed, in which at least the outer connector is made of
ultraviolet transparent material, and after tlle connectors are
brought together but ~efore seals are released to permit flo~ of
solution through the newly fomed connection, the connectors ar~
irradiated with ultraviolet light for antibacterial effect
outside and inside the connectors. See Popo~ich and Moncrief
U.S. Patent 4,475,900 entitled "PERlTONEhL DlAlYSIS METHOD";
Kulin et al. U.S. Patent 4.412,834 entitled "ANTIMICROBIAL
ULTRAVIOLET IRRADIATION OF CONNECTOR FOR CONTIIYUOUS AMBULATORY
PERITONEAL DIALYSIS"; and Hogan U.S. Patent 4,433,244 entitled
"APPARATUS FOR IRRADIATING TU81NG CONNECTORS". In all of
the three U.S. patents, ultrdviolet radiation is used for
anti~acterial effect in the newly formed connection.
r~, ~
Patients who are undergoing peritoneal dialysis on a chronic
basis are often elderly, ill, and debilitated. The disease
which requires their life maintenance of dialysis interferes
with nerve conductivity which, in turn, reduces their manual
dexterity. Accordingly, it becomes desirable in the case of
many patients to provide them with all assistance possible in
the making and breaking of connections during peritoneal
dialysis and particularly CAPD operations.
In response to this, automatic systems for making and
breaking connections have been provided. For example, the
Steri-Track device which has been used and which is described in
an article entitled "CAPD for the Blind" from the periodical
Nephrology Nurse, March/April, 1981, pp. 53-54. This device is
a self-contained portable device. When doing bag exchanges, a
fresh bag of dialyzate is placed into a stationary end of
a holder. At this point the protective tab of the bag is removed,
and a spike is taken from the discharge bag and fitted into the
grooves of a sliding plate. The patient now manipulates the
sliding plate toward the bag with the result that the spike will
plunge into the port of the bag with alleged 98 percent
probability.
Also, Munsch et al. U.S. Patent 4,541,829 shows an improved
device for automatic connection and disconnection of connectors in
CAPD and the like.
In accordance with this invention~ an automatic connection
and disconnection system is provided, preferably in conjunction
with a radiation system for exerting antibacterial effect on
connectors before or after joining, in a peritoneal dialysis
system or other system as may be desired. By this invention an
advancement system of the first and second means that carry the
respective connectors is provided so that, preferably, even a
debilitated person can exert the amount of force necessary to make
and break the connection between the connectors, while the
connectors traYel along a mechanically-defined path for reliability
of operation.
An aspect of this invention is as follows:
2a
In radiation sterilization apparatus for a pair of
connectors to be joined together, said connectors being carried
at the ends of flow conduits, and said apparatus comprising a
housing, means within said housing for providing antibacterial
radiation, and first and second means for respectively holding
said connectors witllin said housing in a position to be
irradiated by said radiation, the improvement comprising, in
combination, drawer means carrying said first and second means
to permit exposure of said connectors to antibacterial radiation
when said drawer means is closed and to permit manual access to
said connectors when mounted in said firs~ and second means when
the drawer means is opened, at least one of said first and
second means being moYable by control means operable from
outside said housing between first and second positions, to
cause connectors carried in the first and second means to be
separated from each other in the first position, and to cause
said carried connectors to be joined to~ether in the second
position.
This and other advantages an~ features are more fully
described in the description below.
uescription of the Invention
In accordance with this invention apparatus for
automatically connecting and disconnecting a pair of connectors
is provided. The apparatus includes first and second means for
respectively holding the connectors, the first and second means
being relatively movable between first and second positions, to
1~ cause connectors carried in the first and second means to be
separated from each other in the first position, and tG cause
the carried connect~rs to be joined together in the second
position. Typically, the relatively movable relationship of the
first and second means is accomplished by having the first means
1~ s~ationary and the second means mova~le. However, the converse
may bP true and, if desired, both of the means may be movable.
The first and second means can respectively hola the
connectors within a housing, and means can be present within the
housing for providing antibacterial radiation, for example
ultraviolet light. Also, the housing defines drawer means, the
drawer means carrying the first and second means for holding the
connectors, to permit exposure of the connectors to
antibacterial radiation when the drawer n~eans is closed, but to
permit manual access to the connectors when the drawer means is
opened.
uescription of the Drawings
In the drawings, Figure 1 is a fragmentary, perspective view
of apparatus of this invention, shown to be holding a pair of
connectors for use in peritoneal dialysis.
Figure ~ is a fragmentary, perspective vie~ of the apparatus
of Figure 1, showing it in an intermediate configuration of use.
Fiyure ~ is a fragmentary, perspective view similar to
Figure 1, showing the apparatus of this invention after the
~2~
connection between the connectors has been made and the
antibacterial radiation process has been applied.
Figures 4 and 5 are fragmentary perspective views of the
second means and the rack and gear means of this invention,
shown in different positions.
Figure 6 is a fragmentary, longitudinal sectional view of
the apparatus of this invention with the drawer closed.
Figure 7 is a sectional view taken along line 7-7 of Figure
6.
Figure 8 is a fragmentary sectional view taken along line
8-8 of Figure 7.
Figure 9 is a fragmentary transverse sectional view of the
apparatus of this invention taken along line 9-9.
Description of Specific Embodiment
Referring to Figures 1-3, the apparatus 10 of this invention
includes housing 12 and a slide drawer 14. A convoluted
ultraviolet bulb 16 within housing 12 may define a channel 18
(Figure 10) between the respective convolutions of bulb 16 into
which the respective connectors 20, 22 may be placed by closing
of drawer 14 for ultraviolet irradiation thereof. Connector 20
may connect to peritoneal transfer set tubing 21, while
connector 22 may be a flexible, diaphragm-containing tube
carried by peritoneal dialysis solution bag 24.
The design of apparatus 10 including housing 12, drawer 14,
and ultraviolet bulb 16 may be generally similar to the design
disclosed in the cited Hogan U.S. Patent 4,433,244, except for
the design changes described herein. Also, the housing, drawer,
and ultraviolet bulb used in this invention may be generally
similar in design except as otherwise indicated herein to the
germicidal chamber currently available to the public from
Travenol Laboratories, Inc. for irradiating connections in CAPD
with ultraviolet radiation.
Connector 22 is positioned within a separable, molded me~ber
which comprises shaping sleeve 26 proportioned to receive the
flexible end of connector 22 and to shape it as shown in Figure
3 into a desired, circular configuration, to receive the spike
28 of connector 20, puncturing diaphragm 30 in a conventional
manner. The molded member containing sleeve 26 also carries
hexagonal flange 32, which can fit in first means 34 for holding
connector 22, which is shown to be a generally U-shape~ trough,
receiYing flange 32 and holding the structure in position.
1~ The molded member also includes sliding clamp m~mber 3~,
positioned in a slide box 38, which may be of the general design
of analogous structure shown in Lueders et al. U.S.
Patent 4,473,369 entitled "CONTINUOUS AMBULATORY PERITONEAL
DIALYSIS CLAMPING SYSTEM", to serve as a slide clamp to
control flow through the flexible tubing which comprises
connector 22, connected to peritoneal dialysis solution
bag 24.
Second connector 20 is carried by second means 40 for
holdlng the connector. Second means 40, as shown by Figures
4-7, may be carried as part of a rack and gear system including
rack 42 and gear 44. Rack 42 is attached to and can move ~ith
p7ate 43, while gear 44 is in a fixed position. Second means 40
is shown to be attached to rack 42 and to slide in a track
yroove 46 defined by the front panel 48 of dra~er 14.
ùear 44 rotates about shaft 50, which terminates in handle
51. As handle Sl is rotated, gear 44 correspondingly rotates,
to move rack 42 between the respective first and second
positions illustrated respectiYely in Figures 1 and 4, and
Figures 3 and 5. Rack and gear systems 42, 44 can be purchased
from Cunningham Industries of Stamford, Connecticut.
It can be seen tha~ tee~h 52 of gear 44 define increasing
pitch ~distance) from the center of each gear tooth 52 to the
center or axis of rotation 54, extending approximately 180
about gear 44, so that the pitch or distance of gear tooth 52a
~7~
from center of rotation 54 is much greater than the
corresponding pitch or distance of gear tooth 52b.
It can also be seen that teeth 56 of rack 42 are
correspondingly not in parallel array with axis of rack movement
58 between the first and second positions, but are positioned at
differing distances from axis 5~ so that rack tooth 56a is
closer to axis 5~ than rack tooth ~b. The spacing from axis 58
of the respective teeth 56 corresponds inversely to the
differing pitches of gear teeth 52 so that rack 4~ can move in
relatively linear motion along axis 5~. ~pecifically, the sum
of the pitch of each gear tooth 52 and the distance from axis 58
of a rack tooth 56 meshing against such gear tooth is
substantially constant. In other words, the sum of the pitch 53
of gear tooth 52a from axis of rotation 54 and the perpendicular
distance 55 of rack tooth 56a from axis 58 tFigure 4) should be
substantially equal to the corresponding pitch of gear tooth 52b
plus the distance from axis 58 of gear tooth 56b~ Thus as the
pitch of each gear tooth increases, the perpendicular distance
of each rack tooth from axis 58 correspondingly decreases. This
~u permits substantially linear, perpendicular motion of rack 42
relative to axis of rotation 54.
~ rawer 14 is conventionally slidable into and out of housing
1~, taking first means 3~ and second means 40 for holding the
respective connectors with it. As shown, first means 34, the
U-shaped trough, is open at the top and def;ned in a side ~all
of drawer 14. ~n the opposite side wall of drawer 14 an open
slot 6~ is provided to receive connector 20 of tubing 21 in
slidng relation to it. Housing 12 carries hori~ontal slots to
intersect the slots defined by first means ~4 and slot 6~, to
3~ permit closing of drawer 14 with the respective connectors in
place. The specific design may be similar to the currently
available Travenol germicidal chamber or the previously cited
Hogan U.S. Pate~t 4,433,244.
~'7~
Turning particularly to Figure 7, drawer 14 is shown to
carry pivotable latch hook means 66, which is positionèd to
latch against latch wall 6~ of housing 1~ as the latch engaging
site (see Figures 1, 3, and 7) for engagement of pivotable latch
hook 66 and latch wall 6~ in the first position of second means
4u, i.e., when the connectors are separated, and when the drawer
means 14 is closed. As sho~n in Figure 7, latch hook means ~
defines an angled face 6~ which causes latch hook ~6 to deflect
upwardly as drawer 14 is closed when it impinges latch wall 68.
1~ As drawer 14 completes the closing action, latch hook 66 falls
back again as shown in Figure 7, to prevent reopening of the
drawer in that position.
However, as shown in Figures 1 and 3, the latch wall 68 only
extends across a portion of the widtil of housing 1~, with a
reduced height wall 7U occupying substantially the remainder of
the width of the housing. Accordingly~ as second connector
holding means 40 is moved by rotation of handle 51 toward the
first, connected position, latch hook 6~ which is carried with
it is moved out of engagement with latch wall 6~, being capable
of passing over the top of reduced height ~all 70. Thus drawer
14 can be opened after closing, when handle 51 is rotated as
sho~n in Figure ~ to move second means 4~ into the first,
connected position.
~ther designs of latch means and latch engaging site may
25 also be used.
Referring to Figures ~ and ~, it can be seen that second
connector holding means 4~ defines a pair of slots 72, 74 for
receiYing corresponding flanges 75 of a connector 2~ dS shown in
Figures 1 and 3. A separate partially cylindrical portion 76 is
also provided, defining spring arm means for releasably
retaining connector 20. Thus, connector 2~ can snap into and
out of retained relationship with second means 40.
For use of the apparatus of this inYention, a patient on
CAP~ has typically drained spent dialysis solution from his
peritoneal cavity through tubing ?l and connector ~ into a bag
24. He then inserts connector 2~ into ~irst and second holding
means ~4, 4U with drawer 14 and handle 51 in the position of
Figure 3. Handle 51 is then rotated to the Figure l position,
separating connector ~U from connector tubing 22. Bag 24 and
connector tubing ~ are then replaced with a fresh bag 24 and
tubing 2~, and drawer 14 is closed to begin irradiation. Line
~l may be closed off with a slide clamp or the like in
conventional manner. The molded structure comprising sleeve 26
lU is placed onto port 22 of the fresh bag of dialysis solution 24
to seat it in the first connector holding means ~4 with slide
clamp 36 being closed.
Ultraviolet lamp system 16 is activated by the closing of
the dra~er in a manner ~hich may be similar to the electronic
system of the Travenol germicidal chamber, with the ultraYiolet
irradiation continuing until the desired level o~ irradiation is
achieved. This can be signaled to the patient by known
circuitry, ancl an indicator light or buzzer, follo~ing which the
patient rotates handle 51 again to the configuration shown in
2~ Figure ~, causing the respective connectors to connect into flow
relationship with each other. Thereafter, the patient opens
drawer 14 again as in Figure ~, and remoYes the newly connected
system. He then spens clamp 36 and the clamp on tubing 21 to
cause tlle fresh peritoneal dialysis solution to flow from bag 24
through tubing ~l into the patient's peritoneal cavity.
As the result of this, even a debili1:ated patient can make
connections with ease~ and with improYed reliability of aseptic
conditions, ~ith the ultraviolet light irradiation greatly
reducing the risk of contamination and consequent peritonitis.
3U The respectiYe parts exposed to ultra~iolet light such as spike
~ and sleeve ~6, may be made of known ultraYiolet transparent
materials so that their interiors as ~ell as their exteriors may
be irradiated for antibacterial effect.
~7~
The above has been offerPd for illustrative purposes only,
and is not intended to limit the scope of the invention of this
application, whiGh is as defined in the claims below.
