U.S. patent application number 12/342490 was filed with the patent office on 2009-04-23 for connector to cassette interface system.
Invention is credited to David M. Domash, James J. Foster.
Application Number | 20090105657 12/342490 |
Document ID | / |
Family ID | 38957447 |
Filed Date | 2009-04-23 |
United States Patent
Application |
20090105657 |
Kind Code |
A1 |
Domash; David M. ; et
al. |
April 23, 2009 |
Connector to cassette interface system
Abstract
The disclosed connector to cassette interface system includes a
set of individual keyed connectors having a shroud on the lower
portion. The perimeter of each shroud includes an array of tabs or
protrusions keyed to one of a corresponding array of skirted
portals in the cassette cover. The tabs or protrusions on the
shroud portion of each individual keyed connector may further serve
to prevent rotation of each connector beyond about 60.degree..
Inventors: |
Domash; David M.; (Irvine,
CA) ; Foster; James J.; (Santa Ana, CA) |
Correspondence
Address: |
ALCON
IP LEGAL, TB4-8, 6201 SOUTH FREEWAY
FORT WORTH
TX
76134
US
|
Family ID: |
38957447 |
Appl. No.: |
12/342490 |
Filed: |
December 23, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11487842 |
Jul 17, 2006 |
7484769 |
|
|
12342490 |
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Current U.S.
Class: |
604/174 |
Current CPC
Class: |
A61M 39/10 20130101;
A61M 2205/6045 20130101; A61M 5/347 20130101; A61M 2205/276
20130101; A61M 2039/1094 20130101; A61M 39/12 20130101; Y10T 29/494
20150115 |
Class at
Publication: |
604/174 |
International
Class: |
A61M 5/32 20060101
A61M005/32 |
Claims
1. A connector to cassette assembly interface system comprising: a
cassette assembly, said cassette assembly including: a cassette
cover and a cassette body constructed and arranged to fit together
to have a space therebetween; said cassette cover including a
plurality of portals formed therein, each of said portals including
a skirt portion extending from the bottom of said cassette cover
into said space between said cassette cover and said cassette body;
said cassette body including a plurality of tubular openings
constructed and arranged to align with said portals in said
cassette cover; a plurality of connectors having an upper portion
and a lower portion, wherein said lower portion includes a luer
fitting surrounded by a shroud, said shroud having a unique
exterior surface configuration; and said skirt portion of said
portal including a pattern of unique openings constructed and
arranged to engage one of said plurality of connectors.
2. The connector to cassette interface system as defined in claim 1
wherein said unique exterior surface configuration includes the
size and shape of said shroud.
3. The connector to cassette interface system as defined in claim 2
wherein the size and shape of said shroud is dependent on the sex
and shape of said luer fitting.
4. The connector to cassette interface system as defined in claim 1
wherein said unique exterior surface configuration of said shroud
includes one or more tabs extending from said shroud.
5. The connector to cassette interface system as defined in claim 4
wherein said unique exterior surface configuration comprises a size
of said tabs.
6. The connector to cassette interface system as defined in claim 1
wherein said upper portion of each of said connectors includes at
least one wing for facilitating rotation of said connectors.
7. The connector to cassette interface system as defined in claim 1
wherein each of said plurality of tubular openings includes a
unique pattern of stops arranged around said tubular opening to
engage extensions from said unique exterior surface configuration
and to limit rotation of said connector after said connector has
been inserted through said cassette cover.
8. The connector to cassette interface system as defined in claim 1
wherein each of said skirt portions includes an opening with a
surface that limits rotation of said connector after said connector
has been inserted through said cassette cover.
9. A connector for insertion into a cassette assembly, said
cassette assembly having a cover and a body, said cassette cover
having a plurality of portals formed therein wherein each of said
portals includes a unique skirt having a plurality of shaped
openings formed therein, and said cassette body has a plurality of
tubular openings aligned with said portals, said connector
comprising: an upper portion having at least one wing formed
thereon for facilitating rotation of said connector; a lower
portion; a central flange separating said upper portion from said
lower portion; said lower portion including a luer fitting
surrounded by a shroud; said shroud being sized according to the
sex and size of said luer fitting; said shroud further including a
plurality of tabs extending therefrom; wherein said size of said
shroud and the configuration of said plurality of tabs on said
shroud is made for interfitment with one or more of the plurality
of portals.
10. The connector as defined in claim 9 wherein said luer fitting
is recessed within said shroud.
11. The connector as defined in claim 9 wherein a size of said
plurality of tabs is made for interfitment with one or more of the
plurality of portals.
12. The connector as defined in claim 9 wherein the connector is
color coded.
13. The connector as defined in claim 9 wherein: said tubular
openings have an array of stops formed thereabout; and wherein said
tabs contact at least one stop after first being inserted through a
portal and then being rotated no more than about 60.degree..
14. A cassette for engagement with a connector having a lower
portion which includes a luer fitting surrounded by a shroud, said
shroud having a unique diameter and a unique array of tabs
extending therefrom, said cassette comprising: a cassette cover,
said cassette cover having a plurality of portals formed thereon,
each of said portals characterized by a skirt portion having a
unique size and a unique array of openings formed therein; and a
cassette body having a plurality of tubular openings formed
therein, said tubular openings being constructed and arranged to
align with said portals when said cassette cover is placed on said
cassette body; whereby each portal on said cassette cover is keyed
to a single connector.
15. The cassette as defined in claim 14 wherein said skirt portion
provides for the engagement with a luer fitting of a sex opposite
to the sex of the luer fitting within the shroud.
16. The cassette as defined in claim 14 wherein said skirt portion
includes a stepped ramp.
17. The cassette as defined in claim 16 wherein said stepped ramp
is for engagement with one of said tabs.
18. The cassette as defined in claim 14 wherein said portal is
color coded.
19. The cassette as defined in claim 14 wherein said cassette body
further comprises an array of stops formed around said tubular
openings.
20. The cassette as defined in claim 19 wherein said array of stops
surrounding each tubular opening is positioned to engage the
tabs.
21. The cassette as defined in claim 20 wherein said stops have
different heights constructed and arranged to engage shrouds of
different lengths.
22. The cassette as defined in claim 14 wherein said skirt portions
each have an opening with a surface that limits a rotation of said
connector after said connector has been inserted into said
cassette.
23. A method for preventing mismatch of a set of connectors with a
set of portals formed in a cassette, said method comprising the
steps of: forming each portal with a depending skirt, said
depending skirt having a size and a pattern of openings therearound
different from the other portals formed in the cassette; and
forming a connector having a size and a pattern of protrusions
therearound to engage one of the portals.
24. The method as defined in claim 23 wherein each connector is
rotated by manual engagement of a set of wings extending from said
connector.
25. The method as defined in claim 23 wherein each connector is
formed to have a shroud surrounding a luer fitting.
Description
[0001] This application is a continuation of U.S. application Ser.
No. 11/487,842 filed Jul. 17, 2006.
FIELD
[0002] The present invention pertains to the connection of sources
of fluid to a piece of medical/surgical equipment; more
particularly, the present invention pertains to a system for
mounting connectors to a cassette assembly used with a piece of
medical/surgical equipment.
BACKGROUND
[0003] Many pieces of medical/surgical equipment are built to
manage the flow of a set of different fluids associated with the
performance of certain medical/surgical procedures. Such fluids may
include air, liquid irrigation fluids, liquid antibiotics, blood,
or in the case of eye surgery, tissue that has been removed and
aspirated from the eye via a probe or handpiece. Typically, the
conduit for such fluids in a piece of medical/surgical equipment is
a section of silicone tubing. Those setting up a piece of
medical/surgical equipment for a particular medical/surgical
procedure connect individual sections of silicone tubing, one to
another, to assure that the needed fluids are placed where they
need to be at the proper time during the medical/surgical
procedure.
[0004] Connection of silicone tubing sections, one to another, is
accomplished using a variety of different types of fittings. One of
the more popular types of fittings used with silicone tubing
sections in medical/surgical equipment is a luer fitting. In a luer
fitting a tapered male luer fitting engages a similarly tapered
female luer fitting. The male and female luer fittings may be held
together by a set of internally and externally threaded connectors
which surround the male and female luer fittings once they have
been mated together. When the male and female tapered luer fittings
have been mated together and the threaded connectors have been
threadably engaged together around the male and female luer
fittings, a secure connection is made between two sections of
silicone tubing permitting the leak-free flow of a fluid
therethrough.
[0005] Because different sets of fluids are associated with each
procedure that can be performed with a piece of medical/surgical
equipment, some pieces of medical/surgical equipment use
replaceable manifolds or cassettes to facilitate the grouping of
the necessary tubing connections. In this manner, the appropriate
set of fluids needed to perform a selected medical/surgical
procedure from the set of available medical/surgical procedures
enabled by a piece of medical/surgical equipment is provided.
[0006] To distinguish between connections when multiple tubing
connections are placed close to one another, engineers and
designers of medical/surgical equipment typically use different
sizes of luer fittings. However, engineers and designers quickly
run out of luer fitting size options when multiple types of fluids
are used.
[0007] The existing problem of properly mating a plurality of luer
fittings together with the limited number of luer fitting
connection sizes available has been solved in the prior art by the
use of silicone tubing sleeves which are used during the
pre-connection process. In one particular prior art solution,
pre-attached silicone tubing sleeves have been used to attach
bottle spike tubing to a manifold or cassette used with a piece of
medical/surgical equipment while maintaining the male luer
geometry. Pre-attached prior art silicone tubing sleeves are used
primarily to provide stress relief for the connections to silicone
tubing sections and to enable pre-attachment of prior art silicone
tubing sections to the manifolds or cassettes used in
medical/surgical equipment.
[0008] It has been found that prior art pre-attached silicone
tubing sleeves are costly and difficult to incorporate into the
automated manufacture of medical/surgical equipment. In addition,
prior art silicone tubing sleeves are difficult to place over the
recessed fittings located in the manifold or cassette assembly.
Prior art silicone tubing sleeves are also not as simple to remove
and reapply as typical luer fittings. Further, pre-attached prior
art silicone tubing sleeves cannot be aseptically connected to the
manifold or cassette assembly.
[0009] There are additional drawbacks to the pre-attached prior art
silicone tubing sleeves. Some pre-attached prior art silicone
tubing sleeves cannot endure the rigors of shipping. Pre-attached
prior art silicone tubing sleeves do not allow for physical lockout
of a connector when an improper connection with a manifold or
cassette assembly is attempted.
[0010] It is well known that improper or cross connection of fluids
to a piece of medical/surgical equipment presents a patient safety
issue and can result in the creation of a dangerous condition.
Accordingly, a need remains in the art for a connector to cassette
assembly interface system that can be used to facilitate the set up
of a piece of medical/surgical equipment for a particular
medical/surgical procedure. The connector to cassette assembly
interface system should provide secure connectors for luer
fittings, provide a lockout if an improper connection is attempted,
and protect the male and female portions of the luer fitting from
contamination.
SUMMARY
[0011] The connector to cassette assembly interface system of the
present invention provides secure connections for luer fittings,
provides a lockout if an improper connection is attempted, and
protects the male and female portions of the luer fitting from
contamination.
[0012] The disclosed connector to cassette assembly interface
system includes a manifold or cassette assembly having a cover
portion and a body portion. The cover portion of the manifold or
cassette assembly includes a plurality of skirted portals formed on
its underside. Aligned with the skirted portals are a plurality of
tubular openings formed in the body portion of the manifold or
cassette assembly.
[0013] Mating with the individual skirted portals formed on the
underside of the cover portion of the manifold or cassette assembly
are a set of individual keyed connectors. Each individual keyed
connector has an upper portion and a lower portion. The lower
portion of each individual keyed connector has a luer fitting
surrounded by a shroud. The exterior surface of the shroud contains
a unique surface configuration which acts a key portion whose shape
is tied to the type of fluid flowing through the connector.
Specifically, the key portion on the bottom of the lower portion of
the shroud includes a set of protrusions which match a set of
corresponding recesses formed in each skirted portal. By matching
the set of protrusions extending outwardly from the shroud with the
set of recesses in each skirted portal in the cover portion of the
manifold or cassette assembly, the health care professional
connecting the sections of silicone tubing used to transport the
set of needed fluids to the piece of medical/surgical equipment can
assure that the connectors only enter the cassette assembly at the
proper predetermined locations for the needed fluids.
[0014] The upper portion of each individual keyed connector
preferably includes finger engagement wings for manually rotating
the keyed connector once the keyed connector has been inserted into
the skirted portal formed in the cover portion of the manifold or
cassette assembly.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0015] A better understanding of the connector to cassette
interface system of the present invention may be had by reference
to the drawing figures, wherein:
[0016] FIG. 1 is a perspective view of a manifold or cassette
assembly together with a set of connectors;
[0017] FIG. 2A is a perspective view of a keyed connector showing a
luer fitting within the lower portion;
[0018] FIG. 2B is a perspective view of the keyed connector
illustrated in FIG. 2A showing its upper portion;
[0019] FIG. 3 is an exploded view of the manifold or cassette
assembly together with the set of keyed connectors as shown in FIG.
1;
[0020] FIG. 4A is a perspective view of the top of the cover
portion of the manifold or cassette assembly;
[0021] FIG. 4B is a perspective view of the bottom of the cover
portion of the manifold or cassette assembly;
[0022] FIG. 4C is a perspective view of the body portion of the
manifold or cassette assembly;
[0023] FIG. 5 is a perspective view, in partial section, showing a
set of individual connectors mounted in the manifold or cassette
assembly;
[0024] FIG. 6 is a perspective view of a first alternative of a
shroud and skirted portal engagement; and
[0025] FIG. 7 is a perspective view of a second alternative of a
shroud and skirted portal engagement including a ratchet
mechanism.
DESCRIPTION OF THE EMBODIMENTS
[0026] It is the purpose of the disclosed invention to provide a
connector to cassette interface system that has the following
features: [0027] 1) A lock-out system for use when connecting a set
of silicone tubing sections to a manifold or cassette assembly
which uses an array of unique key geometries on each connector to
remove the risk of cross connection between tubing sections.
Specifically: [0028] a) A set of tabs or protrusions extending from
the lower portion of each connector which provide a unique key
geometry to assure proper connection of a tubing section with a
port on a manifold or cassette assembly; [0029] b) A connection
portion on each connector which allows a health care professional
to manually grasp each connector and easily plug the connector into
the manifold or cassette assembly without contaminating the
fittings portion. [0030] 2) Aseptic mounting of a set of keyed
connectors to a manifold or cassette assembly. Specifically: [0031]
a) A shroud having a diameter sufficient to surround the luer
fitting; [0032] b) A shroud having a length to prevent touch
contamination of the luer fitting.
[0033] While the disclosed connector to cassette interface system
has been designed for use with an ophthalmic surgical system, those
of ordinary skill in the art will understand that the disclosed
connector to cassette assembly interface system may be used with a
wide variety of different types of medical/surgical equipment which
require connections to predetermined sets of fluids for proper
performance of one or more procedures.
[0034] The connector to cassette interface system 10 which meets
the purposes described above appears in FIG. 1. The general design
of each individual keyed connector 20 appears in FIGS. 2A and 2B.
FIG. 3 is an exploded view showing the mounting of individual
connectors 20 into the manifold or cassette assembly 50. Once the
individual connectors are inserted through the skirted portals in
the cover portion 70 of the manifold or cassette assembly 50 into
the body portion 90 of the manifold or cassette assembly 50, they
are preferably turned about 60.degree. to a position where they
contact either forward stops 92 or back stops 94 formed in the body
portion 90 of the manifold or cassette assembly 50 as shown in
FIGS. 4C and 5.
[0035] To assure proper interfitment of the keyed connectors 20
with the manifold or cassette assembly 50, the connectors 20 are
designed to have a variety of different individual key designs
formed around the outer surface of the bottom of the shroud 40 as
shown in FIG. 3. The arrangement of the array of extensions,
protrusions, or tabs 22, 24, 26, 28, 30, 32, 34 on the shroud 40
create various key configurations. Shroud 40 length and shroud 40
diameter may also used to create various shroud 40 key
configurations. While substantially circular shrouds are shown in
the preferred embodiment, those of ordinary skill in the art will
understand that the upper portion 41 of the shroud can be circular
and the lower portion 43 of the shroud 40 can be formed to have
straight sides as in a triangle, rectangle, pentagon, etc.
[0036] The array of openings or portals 72, 74, 76, 78, 80, 82, 84
which form the key features on the cassette assembly 50 together
with the skirts 73, 75, 77, 79, 81, 83, 85 under each opening 72,
74, 76, 78, 80, 82, 84 prevent misconnection of tubing sets to the
cassette assembly 50. Although in a preferred embodiment the tubing
connectors 22, 24, 26, 28, 30, 32, 34 and the openings 72, 74, 76,
78, 80, 82, 84 in the cassette cover portion 70 of the manifold or
cassette assembly 50 will be color coded, a physical lock-out
mechanism will not allow a tubing connector 20 to be misplaced in a
hole in the cover portion 70 of the manifold or cassette assembly
50. The key interface between the shrouds 40 and the array of
openings to match connectors 20 to the cover portion 70 of the
manifold or cassette assembly 50 is designed so that fittings with
common luer geometry are incapable of being connected to the wrong
port in the cover portion of the manifold or cassette assembly
50.
[0037] By utilizing a varying number of key tabs and varying sizes
of key tabs, a misconnection of common luer geometry interfaces is
prevented. The geometry of the location and size of the tabs on
each shroud portion 40 of each keyed connector 20 is reflected on
the specific cassette port with a unique key-hole pattern. In
addition, a stop system may be located in the body portion 90 of
the manifold or cassette assembly 50 to prevent a keyed connector
20 from rotating more than about 60.degree. after passing into the
cassette assembly 50. The array of stops 92, 94 as shown in FIG. 4C
and FIG. 5 are positioned in the body portion 90 of the manifold or
cassette assembly 50 around the tubular openings 95 to physically
contact the protrusions or tabs on each shroud 40 once the
connector is rotated about 60.degree. in a clockwise manner. The
height of the stops 92, 94 can be established by the length of the
shroud and/or the location of the tabs on each individual keyed
connector 20.
[0038] The interface between the manifold or cassette assembly 50
and the individual keyed connectors 20 also provides a method for
securely pre-connecting the desired set of connectors 20 to the
manifold or cassette assembly 50 for shipping. Such pre-connection
of the desired set of connectors 20 further minimizes errors and
reduces set-up time at a patient care facility.
[0039] The shroud portion 40 of each individual keyed connector 20
is sized to have a length which prevents touching of the recessed
luer fitting 45 within each connector 20 so that each luer fitting
45 will remain aseptic. As previously indicated, the diameter and
the length of each shroud 40 may also function as a physical key
feature along with the tabs on each connector 20 to provide another
way of making the individual keyed connectors 20 unique.
[0040] Removing each connector 20 requires about a 60.degree.
counter clock wise turn and axial removal. Turning of each
connector is facilitated by a pair of wings 33 on the top portion
of each connector 20. A flange 35 both separates the top portion 31
of each keyed connector 20 from the shroud 40 and limits the depth
of insertion of each keyed connector 20 into the cassette assembly
50.
[0041] Each individual keyed connector including a unique array of
key features provides a repeatable method of applying and removing
tubing sets from a cassette assembly 50 in a sterile manner. The
key features on the bottom 43 of each shroud 40 of each individual
keyed connector 20 and the stops 92 and 94 surrounding the tubular
openings 95 in the cassette body 90 also provide a 60.degree.
positive engagement and mitigate the risk of the disconnection of
the tubing sections from the manifold or cassette assembly 50
during shipment. The key features on each individual keyed
connector 20 also provide a mechanism similar to the luer lock
interface without the need to unscrew core pins when the luer
connectors are molded.
[0042] As may be seen in FIG. 6 cassette cover portion 70 may be
alternatively formed with a skirt 141 having slots 142 and openings
143 formed therein for allowing tabs 22 of connector 20 to access
openings 143. Surfaces 144 and 145 of skirt 141 provide a rotation
stop for tab 22. As shown in FIG. 7, cassette cover portion 70 may
be alternatively formed with a skirt 146 having a stepped
engagement ramp 147 that acts as a ratchet mechanism for tabs 22
when connector 20 is rotated with respect to manifold or cassette
assembly 50. An audible click preferably occurs when tabs 22 engage
each step of ramp 147.
[0043] While the disclosed connector to cassette assembly interface
system has been disclosed according to its preferred and alternate
embodiments, those of ordinary skill in the art will understand
that numerous other embodiments have been enabled by the foregoing
disclosure. Such other embodiments shall be included within the
scope and meaning of the appended claims.
* * * * *