CA1227012A - Device for providing antibacterial radiation - Google Patents

Abstract

DEVICE FOR PROVIDING ANTIBACTERIAL RADIATION

Abstract of the Disclosure Apparatus for automatically connecting and disconnecting a pair of connectors includes first and second relatively movable means to carry the connectors and to move them bask and forth between connected and disconnected positions. The apparatus may also have means for providing radiation for antibacterial effect on the connectors, typically ultraviolet radiation, and a drawer arrangement to provide access for connectors into the apparatus.

Description

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.

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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.

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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.

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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.

Claims (3)

THAT WHICH IS CLAIMED IS:

1. 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 within 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 first and second means when the drawer means is opened, at least one of said first and second means being movable 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 together in the second position.

2. The apparatus of Claim 1 in which said means for providing radiation is a source of ultraviolet radiation.

3. The apparatus of Claim 2 in which said apparatus carries a pair of connectors in the first and second means for respectively holding said connectors, one of said connectors being a port of a peritoneal dialysis solution bag, and the other of said connectors being attached to tubing which, in turn, connects with the peritoneal cavity of a patient.