U.S. patent application number 11/563425 was filed with the patent office on 2007-05-10 for dialysis connector and cap having an integral disinfectant.
This patent application is currently assigned to Baxter International Inc.. Invention is credited to Raf Castellanos, Brian Connell, Bill Griswold, Tom Johnson.
Application Number | 20070106205 11/563425 |
Document ID | / |
Family ID | 27659897 |
Filed Date | 2007-05-10 |
United States Patent
Application |
20070106205 |
Kind Code |
A1 |
Connell; Brian ; et
al. |
May 10, 2007 |
DIALYSIS CONNECTOR AND CAP HAVING AN INTEGRAL DISINFECTANT
Abstract
Apparatuses and methods for providing sterile connection during,
for example, dialysis therapy. The present invention provides a
connector and a cap therefore that easily and readily attaches to a
dialysate container and a catheter inserted into a patient's
peritoneal cavity. The connector and the cap enable the dialysate
to readily transport between the container and the peritoneal
cavity while minimizing the potential of contamination therein due
to, for example, handling during use. The connector includes a
shell that encloses a cap. The cap houses a slit septum and also
includes a sealed disinfectant within an interior receptacle. When
the catheter or catheter set attaches to the cap, the seal breaks
and the disinfectant spreads over the threads between the catheter
set and the cap.
Inventors: |
Connell; Brian; (Evanston,
IL) ; Griswold; Bill; (Bristol, WI) ;
Castellanos; Raf; (Roselle, IL) ; Johnson; Tom;
(Gurnee, IL) |
Correspondence
Address: |
BAXTER HEALTHCARE CORPORATION
1 BAXTER PARKWAY
DF2-2E
DEERFIELD
IL
60015
US
|
Assignee: |
Baxter International Inc.
Deerfield
IL
|
Family ID: |
27659897 |
Appl. No.: |
11/563425 |
Filed: |
November 27, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10074532 |
Feb 11, 2002 |
|
|
|
11563425 |
Nov 27, 2006 |
|
|
|
Current U.S.
Class: |
604/29 ; 604/246;
604/28; 604/30 |
Current CPC
Class: |
A61M 39/20 20130101;
A61M 39/162 20130101; A61M 2039/1033 20130101; A61M 39/14 20130101;
A61M 1/282 20140204; A61M 2039/1072 20130101; A61M 1/1668 20140204;
A61M 1/285 20130101 |
Class at
Publication: |
604/029 ;
604/028; 604/030; 604/246 |
International
Class: |
A61M 1/00 20060101
A61M001/00; A61M 5/00 20060101 A61M005/00 |
Claims
1. A cap for use in a connector making a resealable fluid path
comprising: a body defining a fluid flow passage and a disinfectant
receptacle; a disinfectant maintained within the disinfectant
receptacle; and a seal disposed within the body that seals the
disinfectant between the seal and the disinfectant receptacle.
2. The cap of claim 1, wherein the body defines an opening that
receives a fluid communication member capable of displacing the
seal when received by the body.
3. The cap of claim 2, wherein the disinfectant disperses between
an outer wall of the fluid communication member and an inner wall
of the body when the seal is displaced.
4. The cap of claim 1, wherein the body defines a plurality of
outer threads.
5. The cap of claim 4, wherein the outer threads engage a plurality
of mating threads of a shell and enable the shell to translate with
respect to the body so that the shell causes a sealed end of the
body to be pierced.
6. The cap of claim 1, wherein the body defines a plurality of
inner threads.
7. The cap of claim 6, wherein the inner threads engage a plurality
of mating threads of a fluid communication member and enable the
fluid communication member to translate with respect to the body so
that the fluid communication member causes the seal to be
displaced.
8. The cap of claim 1, wherein the seal is moveable.
9. The cap of claim 1, wherein the body includes a tube portion
that defines the fluid flow passage and the disinfectant receptacle
is disposed about the tube portion.
10. The cap of claim 1, wherein a portion of the fluid flow passage
is sized to house a member that deforms to seal about a tube.
11. The cap of claim 10, wherein the member automatically closes
when the tube is removed from the member.
12. A method for providing a sterile connection of a dialysate line
comprising the steps of: providing a cap that has a passage and
maintains a seal that houses a disinfectant; connecting a first
member to a first end of the cap wherein the first member is in
fluid communication with a first dialysate line; and connecting a
second member to a second end of the cap so as to displace the seal
and the disinfectant wherein the second member is in fluid
communication with a second dialysate line.
13. The method of claim 12, wherein connecting the first member
includes moving the first member so as to pierce a sealed end of
the cap, placing the first member in fluid communication with the
second member.
14. The method of claim 13, wherein the sealed end of the cap seals
about the first member when the first member pierces the sealed
end.
15. The method of claim 13, wherein the sealed end of the cap
reseals when the first member is removed from the cap.
16. The method of claim 12, wherein rupturing the seal includes
threading the second member into the cap and exerting pressure on
the seal.
17. The method of claim 12, wherein connecting the second member
includes displacing the disinfectant between the cap and the second
member.
18. The method of claim 12, which includes maintaining the
disinfectant between the cap and the second member after the seal
is displaced.
19. The method of claim 12, which includes removing the first
member from the cap such that the sterile connection between the
cap and the second member is maintained.
20. The method of claim 12, which includes removing a tip protector
and connecting the second member in place of the tip protector.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention relates generally to medical
treatments. More specifically, the present invention relates to
medical connectors for use in medical treatments, such as
Peritoneal Dialysis ("PD").
[0002] Due to disease, insult or other causes, a person's renal
system can fail. In renal failure of any cause, there are several
physiological derangements. The balance of water, minerals and the
excretion of daily metabolic load is no longer possible in renal
failure. During renal failure, toxic end products of nitrogen
metabolism (urea, creatinine, uric acid, and others) can accumulate
in blood and tissues.
[0003] Kidney failure and reduced kidney function have been treated
with dialysis. Dialysis removes waste, toxins and excess water from
the body that would otherwise have been removed by normal
functioning kidneys. Dialysis treatment for replacement of kidney
functions is critical to many people because the treatment is life
saving. One who has failed kidneys could not continue to live
without replacing at least the filtration functions of the
kidneys.
[0004] PD uses a dialysis solution or dialysate, which is infused
into a patient's peritoneal cavity. The dialysate contacts the
patient's peritoneal membrane in the peritoneal cavity. Waste,
toxins, and excess water pass from the patient's bloodstream
through the peritoneal membrane and into the dialysate. The
transfer of waste, toxins, and water from the bloodstream into the
dialysate occurs by diffusion and osmosis because there is an
osmotic gradient across the peritoneal membrane. The spent
dialysate is drained from the patient's peritoneal cavity to remove
the waste, toxins and water from the patient. New dialysate
replaces the spent dialysate and the process repeats.
[0005] During dialysis therapy, a dialysis fluid exchange generally
includes draining spent dialysis fluid from the peritoneal cavity
and filling the peritoneal cavity with fresh dialysate. Keeping
track of the amounts or volumes of dialysis solution drained from
and supplied to the peritoneal cavity is important for proper
dialysis therapy. A typical amount of dialysate solution drained
from and supplied to the peritoneal cavity of an adult during an
exchange can be roughly two to three liters. Dialysis fluid
exchanges have been performed manually, usually by the patient, or
automatically, by an automated dialysis machine.
[0006] In the manual PD technique, known as Continuous Ambulatory
Peritoneal Dialysis ("CAPD"), a catheter is implanted into the
peritoneal cavity of the patient. A dialysis solution ("dialysate")
is introduced through the catheter into the peritoneal cavity of a
patient. Typically, a container of the dialysate connects to a
connector, which in turn couples to the catheter. To start the flow
of dialysate into the peritoneal cavity, a clamp on a tube
connecting the container to the connector is loosened or a valve is
opened. In many cases the container is located vertically above the
patient and gravity fed into the peritoneal cavity.
[0007] In the Automated Peritoneal Dialysis technique ("APD"),
dialysis machines use one or more fluid pumps to perform the
dialysate exchanges. The pump pumps spent dialysate fluid out of
the peritoneal cavity during the drain mode and pumps dialysate
into the cavity during the fill mode.
[0008] In either PD technique, once the dialysate reaches the
patient, dialysis of urea, toxic waste and the like takes place
between the dialysate and the blood passing through blood vessels
in the peritoneum, which is the lining of the peritoneal cavity.
The dialysate remains in the peritoneal cavity for several hours.
Thereafter, the dialysate is removed from the peritoneal cavity
carrying with it diffused breakdown products from the blood. In
CAPD, one method for removing the spent dialysate is to lower the
dialysate container outside of the body and let the dialysate drain
into the container.
[0009] The spent container is disconnected and discarded, wherein a
new container of dialysate fluid is attached and the process is
repeated. This process may be repeated several times or
continuously repeated. Because many patients perform the PD (CAPD
or APD) procedure themselves, it is important that the connector
which connects the dialysate container to the catheter is easy to
use and provides a secure connection.
[0010] A frequent problem that occurs with PD is peritoneal
infection or peritonitis which can readily occur given the repeated
disconnecting and reattaching of the dialysate containers.
Peritonitis results if connections are made between the peritoneal
catheter and the connector communicating with the dialysis
container in a manner that permits even a very small number of
microorganisms to enter the catheter. The microorganisms will be
flushed into the peritoneal cavity. Peritonitis can occur even when
extreme caution is observed in making and unmaking the connections.
Peritonitis can be painful and can temporarily diminish the
hydraulic permeability of the peritoneal membrane, rendering the
renal treatment less successful.
[0011] Methods to prevent peritonitis have included thoroughly
cleansing the connector and the tube connecting the dialysate
container before the connection is made. For instance, the
connector can be immersed in povidone iodine, betadine or other
type of disinfectant. These methods however are messy, time
consuming, effort consuming, inconsistent and may be subject to
overkill in order to achieve consistently effective results.
Hospital workers, as another precaution, typically wear sterile
rubber gloves to prevent or guard against any possible peritoneal
invasion of bacteria. However, the spread of contamination can
still occur due to, for example, a cut in the glove or other like
condition.
[0012] Accordingly, the frequent connections that must be made and
broken between the catheter residing in the peritoneal cavity and a
succession of dialysate containers has created a need to ensure the
sterilization of connectors used in performing CAPD and APD.
Attempts have been made to saturate an absorbent material with
disinfectant and dispose the material in the connector such that it
contacts the tube/connector interface. A need still exists however
to improve the efficiency, effectiveness and cost of providing
sterile connections for PD.
[0013] A continuing need therefore exists to provide a simple and
effective method and apparatus for performing PD, including CAPD
and APD both in hospitals and at a patient's home.
SUMMARY OF THE INVENTION
[0014] The present invention relates to a connector and a cap that
are easily and readily attachable to a dialysate container and a
catheter inserted into a patient's peritoneal cavity. The connector
and the cap enable the dialysate to be readily transported between
the container and the peritoneal cavity while minimizing the
potential of contamination therein due to, for example, handling
during use.
[0015] To this end, in an embodiment of the present invention, a
connector includes a shell that encloses a cap. The cap houses a
slit septum. The cap also includes a sealed disinfectant within an
interior receptacle. The seal in an embodiment is a crosslinked
elastomeric seal, e.g., a silicone seal. In one embodiment, the
disinfectant includes a povidone iodine or PVP-I. The connector is
also initially packaged including a tip protector that encloses the
shell/cap assembly and provides a barrier to microbial
contamination prior to use.
[0016] In another embodiment of the present invention, a cap for
use in a connector making a resealable fluid path is provided. The
cap includes a body that defines a fluid flow passage and a
disinfectant receptacle. The receptacle houses the disinfectant. A
seal is disposed within the body. The seal seals the disinfectant
between the seal and the receptacle.
[0017] In an embodiment, the body defines an opening that receives
a fluid communication member. The fluid communication member is
capable of displacing the seal when the body receives the
member.
[0018] In an embodiment, the disinfectant disperses between an
outer wall of the fluid communication member and an inner wall of
the body when the seal is displaced.
[0019] In an embodiment, the body defines outer threads.
[0020] In an embodiment, the outer threads engage mating threads of
a shell and enable the shell to translate with respect to the body.
The translating shell causes a sealed end of the body to be
pierced.
[0021] In an embodiment, the body defines inner threads.
[0022] In an embodiment, the inner threads engage mating threads of
a fluid communication member and enable the member to translate
with respect to the body. The translating member causes the seal to
be displaced.
[0023] In an embodiment, the seal is moveable.
[0024] In an embodiment, the body includes a tube portion that
defines the fluid flow passage. The disinfectant receptacle resides
about the tube portion.
[0025] In an embodiment, a portion of the passage is sized to house
a member that deforms to seal about a tube.
[0026] In an embodiment, the member automatically closes when the
tube is removed from the member.
[0027] In still another embodiment of the present invention, a
connector for making a resealable fluid path is provided. The
connector includes a cap that defines a fluid flow passage. The cap
seals an amount of disinfectant, such as a continuous quantity
thereof. A shell moveably engages the cap. The shell includes a
fluid communication member. The fluid communication member is
capable of piercing a sealed end of the cap and fluidly
communicating with the fluid flow passage when the shell moves with
respect to the cap.
[0028] In an embodiment, the disinfectant includes povidone
iodine.
[0029] In an embodiment, the connector includes a tip protector
that engages the shell.
[0030] In an embodiment, the shell attaches to a fluid line running
to a dialysate container and the cap attaches to a fluid line
running to a patient.
[0031] In an embodiment, the sealed end of the cap includes a slit
septum.
[0032] In an embodiment, the connector includes an elastomeric seal
that seals the disinfectant about the fluid flow passage.
[0033] In still another embodiment of the present invention, a
method for providing a sterile connection of a dialysate line is
provided. The method includes providing a cap that has a passage
and maintains a seal that houses a disinfectant. A first member
connects to a first end of the cap. The first member then fluidly
communicates with a first dialysate line. A second member connects
to a second end of the cap so as to displace the seal and the
disinfectant. The second member then fluidly communicates with a
second dialysate line.
[0034] In an embodiment, connecting the first member includes
moving the first member so as to pierce a sealed end of the cap,
which places the first member in fluid communication with the
second member.
[0035] In an embodiment, the sealed end of the cap seals about the
first member when the first member pierces the sealed end.
[0036] In an embodiment, the sealed end of the cap reseals when the
first member is removed from the cap.
[0037] In an embodiment, rupturing the seal includes threading the
second member into the cap and exerting pressure on the seal.
[0038] In an embodiment, connecting the second member includes
displacing the disinfectant between the cap and the second
member.
[0039] In an embodiment, the method further includes maintaining
the disinfectant between the cap and the second member after the
seal is displaced.
[0040] In an embodiment, the method includes removing the first
member from the cap such that the sterile connection between the
cap and the second member is maintained
[0041] In an embodiment, the method includes removing a tip
protector and connecting the second member in place of the tip
protector.
[0042] In still another embodiment of the present invention, a
method for providing PD is provided. The method includes the steps
of providing a first member in fluid communication with a dialysate
container, a second member in fluid communication with a peritoneal
cavity of a patient, and a cap that has a sealed first end, a
second end, a passage and maintains a seal that houses a
disinfectant; connecting the first member to the sealed first end
of the cap; connecting the second member to the second end of the
cap so as to displace the seal and the disinfectant thereby causing
the first member to pierce the sealed first end of the cap; filling
the peritoneal cavity with an amount of fresh dialysate fluid; and
removing the first member to automatically reseal the first end of
the cap.
[0043] In an embodiment, the method includes removing an amount of
spent dialysate fluid from the peritoneal cavity prior to filling
the peritoneal cavity with the fresh dialysate fluid.
[0044] In an embodiment, the method includes connecting another
first member to the first end, removing spent dialysate fluid from
the peritoneal cavity and refilling the peritoneal cavity with
fresh dialysate fluid.
[0045] In different embodiments, the filling and removing steps are
performed manually or automatically.
[0046] It is therefore an advantage of the present invention to
provide a dialysis connector that eliminates the need for the use
and therefore handling of an additional cap to seal a catheter
subsequent to use.
[0047] Moreover, an advantage of the present invention is to
provide a dialysis connector that reduces the likelihood of
peritonitis.
[0048] Another advantage of the present invention is to provide a
dialysis cap that remains attached to a catheter set after use.
[0049] Still another advantage of the present invention is to
provide a connector and a cap therefore having a septum that
automatically reseals upon removal of the cap from a shell that
couples to the dialysate container.
[0050] A further advantage of the present invention is to provide a
dialysis connector employing a sealed disinfectant in conjunction
with a releasable and resealable cap, which effectively minimizes
the spread of microbial contamination to a catheter transfer set,
and thus to the patient, during dialysis therapy.
[0051] Yet another advantage of the present invention is to provide
a cap for use in PD, including CAPD and APD that contains a
disinfectant and that cannot spill the disinfectant when a tip
protector is removed.
[0052] Yet a further advantage of the present invention is to
provide a cap for use in CAPD and APD that contains a continuous
amount of a disinfectant and does not require an absorbent material
to hold the disinfectant.
[0053] Still further, an advantage of the present invention is to
provide a resealable cap enclosed within a protective shell prior
to insertion of a catheter set.
[0054] Additionally, it is an advantage of the present invention to
provide a resealable cap having a sealed disinfectant that
displaces across threads of the cap and the transfer set.
[0055] Additional features and advantages of the present invention
are described in, and will be apparent from, the following Detailed
Description of the Invention and the Figures.
BRIEF DESCRIPTION OF THE FIGURES
[0056] FIG. 1A is a perspective view of one embodiment of the
dialysis connector and cap therefore of the present invention.
[0057] FIG. 1B is a schematic sectional view showing an embodiment
of an interface between the shell and the tip protector.
[0058] FIG. 1C is a schematic sectional view showing another
embodiment of an interface between the shell and the tip
protector.
[0059] FIG. 2 is a perspective view illustrating a part of the
process for connecting the connector and cap of the present
invention to a transfer set, which connects a catheter to a
patient.
[0060] FIG. 3 is a perspective view illustrating another part of
the process for connecting the connector and cap of the present
invention to a transfer set, which connects a catheter to a
patient.
[0061] FIG. 4 is an elevation view illustrating one step for using
the connector and cap of the present invention to insert and/or
remove a medical fluid into/from a patient.
[0062] FIG. 5 is an elevation view illustrating another step for
using the connector and cap of the present invention to insert
and/or remove a medical fluid into/from a patient.
[0063] FIG. 6 is an elevation view illustrating a further step for
using the connector and cap of the present invention to insert
and/or remove a medical fluid into/from a patient.
[0064] FIG. 7 is an elevation view illustrating still another step
for using the connector and cap of the present invention to insert
and/or remove a medical fluid into/from a patient.
DETAILED DESCRIPTION OF THE INVENTION
[0065] The present invention provides a connector and a cap
therefore that includes a disinfectant for any system requiring a
connection, such as a connection of a first length of tubing or
other conduit to a second length of tubing or other conduit, such
as for PD. The present invention provides a safe and easy
connection and method for introducing a disinfectant for a
user/patient. The connector and cap therefore do not create a mess
and do not make the user/patient perform special handling in order
not to spill the disinfectant contained therein.
[0066] The method and apparatus for the present invention can be
used to perform Continuous Ambulatory Peritoneal Dialysis ("CAPD")
and Automated Peritoneal Dialysis ("APD"), collectively referred to
herein as Peritoneal Dialysis ("PD"). It should be appreciated,
however, that the connector and cap and method for using same can
be used in a variety of other applications, particularly
applications that insert a medical fluid into the body of a
patient.
[0067] Referring now to the figures, and in particular to FIGS. 1A
to 1C, a connector 10 of the present invention is illustrated. FIG.
1A illustrates that the connector 10 includes a cap 12. Generally,
the components of the present invention, including the cap 12, are
made of a plastic material such as polyethylene, polypropylene,
nylon, polystyrene, polyester, PVC, a blend of various plastics or
any other plastic or synthetic material that is capable of being
washed and sterilized or substantially sterilized. As is
illustrated below, certain components of the connector 10 seal to
other components. These sealing components are generally made from
compressible materials such as compressible rubber, e.g., silicone
or the like.
[0068] The components of the connector 10 are constructed into
desired shapes via any known method for producing plastic or rubber
pieces, such as a molding process, e.g., an injection molding
process. The compressible or rubber pieces may alternatively be cut
and/or stamped from a larger piece of the compressible or rubber
material. In alternative embodiments, one or more of the
components, i.e., the plastic components, may alternatively be
constructed from a metal, e.g., a noncorrosive metal such as
stainless steel or aluminum, and may be formed via any known method
of forming or stamping same.
[0069] The cap 12 includes a body 14 that is injection molded or
blow molded to define a desired shape. Although FIG. 1A shows one
embodiment of the connector 10 and the cap 12, the body 14 of the
cap 12 may be made in a variety of different shapes and sizes to
mate with and/or work with various systems for introducing medical
fluids into a patient. The various systems can be provided by other
manufacturers or by the assignee of this invention. In one
embodiment, the body 14 defines the following components or
features.
[0070] The body 14 defines at least one receptacle 16. The
receptacle 16 is a well or other liquid containing shape that
encompasses a void except for a sealable side. The body 14 can
define a variety of different receptacles 16; however, FIG. 1A
shows an embodiment wherein the body 14 defines a single receptacle
16. A seal 18 encloses or caps off the receptacle 16. The seal 18
in an embodiment is a crosslinked elastomeric seal made from
silicone. The seal may alternatively be made from any other type of
rubber or compressible material such as neoprene, vinyl, viton,
buna-n, butyl, EPDM, latex or the like.
[0071] The seal 18 can be made from solid or sponge rubber. In an
embodiment, the seal 18 may be clear so that the user or patient
can see a disinfectant 20 housed between the seal and the
receptacle 16. In an embodiment, the seal 18 is coated with or
impregnated with a disinfectant, which acts to further sterilize
the connector 10.
[0072] In an embodiment, the seal 18 compresses against the walls
of the receptacle 16, so that the disinfectant 20 residing within
the receptacle 16 in any suitable form and/or manner cannot
initially escape, even if the cap 12 of the connector 10 is turned
so that the seal 18 faces downward and even if the patient or user
moves, manipulates, shakes or otherwise causes the disinfectant 20
to move within the receptacle 16.
[0073] In an embodiment, the seal 18, compressed within the walls
of the receptacle 16, is translatable so that the seal 18 can move
towards an end of the receptacle 16. The method for translating the
seal 18 is set forth in detail below in connection with FIGS. 3 to
7. In an alternative embodiment, the seal 18 is thin or otherwise
frangible, e.g., is constructed from a thin plastic or metal-coated
plastic sheet. The sheet is designed to rip when the patient or
user applies pressure to the sheet, wherein the disinfectant flows
through the ruptured sheet of the seal 18. In the alternative
embodiment, the seal 18 would not compress against the walls of the
receptacle 16; rather, a suitable adhesive would be used to secure
the seal 18 to the receptacle 16, or the seal 18 could be adhered
to the receptacle 16 via a known heat-shrinking or heating
process.
[0074] The disinfectant 20 is adaptable to be any suitable type,
form and/or amount of disinfectant that can sterilize or
substantially sterilize plastic, rubber, metal or other like
materials. In an embodiment, the disinfectant 20 is composed of
povidone iodine. It should be appreciated that the povidone iodine
can be provided in any suitable form and/or amount thereof. In an
embodiment, a povidone iodine gel may have been subjected to gamma
irradiation, steam sterilization and/or ethylene oxide.
[0075] In another embodiment, the disinfectant is or includes
iodine-containing antimicrobials. In a further embodiment, the
disinfectant uses or includes a povidone iodine (not in gel form)
that is or may be subjected to gamma irradiation and/or steam
sterilization. In still another embodiment, the disinfectant is or
includes betadine. It should be appreciated that the disinfectant
20 of the present invention can alternatively be any desired
disinfectant known to those of skill in the art.
[0076] The body 14 of the cap 12 also in an embodiment defines
internal threads 22 and external threads 24. In the illustrated
embodiment, the internal threads 22 and external threads 24 reside
on the same end of the cap 12. The purpose of the inner and outer
threads will be shown below. It is important to note, however, that
the relative relationship between the internal threads 22 and the
external threads 24 is not important to the operation of the
present invention. In general, the body 14 of the cap 12 enables
the first member to move along the central axis of the body 14 via
one of the set of threads. The body 14 of the cap 12 also enables a
second member to move along the central axis of the body 14. It is
not important which member moves by engaging the internal threads
22 and which member moves in the other direction by engaging the
external threads 24. An important aspect of the present invention,
rather, is that two separate members may move inward and outward
relative to the body 14 of the cap 12.
[0077] The inner threads 22 and the outer threads 24 may have any
thread pitch desired by the implementor of the present invention.
In the illustrated embodiment, the external threads 24 are slightly
tapered, for example, at about one degree. In an alternative
embodiment, the threads are straight, such as in a lead screw or
ball screw. In the illustrated embodiment, the external threads 24
enable one member to translate relative to another, wherein the
member eventually bottoms out or has a limited range of travel with
respect to the external threads 24. Likewise, the inner threads 22
may be straight threads that allow a member to rotate freely in and
out of the body 14 or the inner threads 22 may be tapered such that
the member bottoms out as it inserts into the body 14.
[0078] The body 14 defines a passage 26 that enables a medical
fluid such as a dialysate to move from one end of the cap 12 to
another. The passage 26 can alternatively be the opening defined by
the inner threads 22 and does not have to include the reduced
tubing piece illustrated as the passage 26 in FIG. 1A. The passage
26, however, is sized to have approximately the same inner diameter
as the tubes or catheters carrying the dialysate back and forth
from a dialysate container and the peritoneal cavity of the
patient.
[0079] In the illustrated embodiment, the body 14 defines a housing
28 at an end opposing the internal and external threads 22, 24. The
housing 28 is sized to hold a septum 30. The housing 28 is swaged
to the septum 30 or otherwise holds the septum 30 in a snug manner.
The septum 30 cannot move in either axial direction relative to the
body 14. The body 14 defines an end wall 32 having a smaller inner
diameter than that of the housing 28, which also holds the
compressible septum 30 in place. A suitable adhesive may also be
employed to hold the septum 30 within the housing 28.
[0080] In an embodiment, the septum 30 is cylindrical as is the
body 14 and the connector 10 in general. However, the septum 30,
the body 14, and the connector 10 can each have alternative shapes
such as being square or rectangular.
[0081] The septum 30 in an embodiment is made of a compressible or
rubber material. The septum can be made from any type of rubber,
including any of the above listed rubbers. As is well known in the
art, the septum 30 defines a slit (not illustrated) which enables a
tube or other type of fluid communication member to pass through a
back wall 34 of the septum 30. The septum 30 in the illustrated
embodiment generally defines a cap- or nut-shaped rubber or
otherwise compressible piece having the back wall 34 and a
cylindrical side wall 35 that extends from the back wall 34. The
nut-shaped or cap-shaped septum in an embodiment is made as one
piece, wherein the slit is made in the back wall 34. A tube or
fluid communication member then inserts and resides inside a hollow
chamber defined by the septum 30 and at some point is able to pass
through the back wall 34.
[0082] In the illustrated embodiment, the connector 10 is
configured so that the external threads 24 of the body 14 mate with
internal threads of a shell 36. The shell 36 is a plastic or metal
piece and may be of the same material as the body 14 of the cap 12.
The shell 36 defines the internal threads 38 that mate with the
external threads 24 of the body 14. The shell 36 can thus translate
in either axial direction relative to the body 14 by rotating in a
clockwise or counterclockwise direction about the body 14.
[0083] The shell 36 defines a tube or port 40, which in an
embodiment is integrally formed with the shell 36, e.g., through an
injection molding or blow molding process. The tube 40 extends
inwardly into a cavity defined by the shell 36 and into the body 14
of the cap 12 through an opening defined by the end wall 32 of the
body 14. The tube 40 also inserts into the cavity defined by the
septum 30. When the shell 36 rotates about the outer threads 24 of
the body 14 to a packaging position, an end 41 of the tube 40 abuts
or is directly adjacent to the back wall 34 of the septum 30. For
example, there may be a gap of about 0.010 in. (0.25 mm.) between
the end 41 of the tube 40 and the back wall 34 of the septum
30.
[0084] The tube or port 40 also extends outwardly from the shell
36. The tube or port 40 sealingly connects to a tube (not
illustrated) that runs to a dialysate container or a container
housing the medical fluid that transfers through the connector 10
of the present invention. In an embodiment, the tube connecting to
the dialysate bag press fits or sealingly fits over the port 40 in
such a way that the dialysate does not leak from the interface of
the flexible tube running to the dialysate container and the port
40. The tube of the dialysate bag can also connect to the port 40
via a solvent bond.
[0085] It should be appreciated that the dialysate is generally
transferred back and forth, to and from, the dialysate container
under its own weight and generally does not require an external
pump or pressure system to drive the flow. Therefore, the fluid is
not under substantial pressure and the seal required for the port
40 is not difficult to achieve. In an alternative embodiment, a
hose clamp or other type of releasably fastenable device may be
used to bolster the seal made between the flexible tube running to
the dialysate bag and the port 40. Such interface is made readily
and without requiring the patient or user to have an excessive
amount of strength or to perform overly intricate operations.
[0086] A tip protector 42 fits over the shell 36 and at the same
time fits into the interior cavity defined by the internal threads
22 of the body 14. The tip protector 42 is made in an embodiment of
any of the plastic materials described above. The tip protector 42
defines a ring or handle 44 that enables the user or patient to
remove the tip protector 42 from the shell 36 to begin using the
connector 10. That is, the connector 10 is initially packaged with
the tip protector 42. The first time the user or patient uses the
tip protector 42, the user or patient removes the tip protector and
discards it.
[0087] The tip protector 42 serves a number of purposes in
protecting the connector 10 prior to use. The tip protector 42
provides a microbial barrier. The tip protector 42 disallows
bacteria and other harmful airborne agents from entering the body
14 of the cap 12 prior to use. Just before attaching the cap 12 to
a mating connector (see mating connector 60 in FIGS. 2 through 7),
the patient or operator removes the tip protector 42. In this way,
the inside of the body 14 of the cap 12 is only exposed to open air
for a very short amount of time.
[0088] In an embodiment, for example, when the connector 10 is to
be used for CAPD, the tip protector 42 also sets the shell 36 at
the appropriate distance relative to the body 14 for packaging the
connector 10. That is, the tip protector 42 helps to set the end 41
of the tube 40 of the shell 36 directly adjacent to the back wall
34 of the septum 30.
[0089] Prior to use, the tube 40 does not insert into or open up
the slit (not illustrated) in the back wall 34 of the septum 30.
However, it is desirable not to have the end of the tube or port 40
too far away from the back wall 34 of the septum 30 upon packaging
the connector 10 for a couple of reasons. First, it is desirable to
package the connector 10 in as small a space as possible. If the
connector 10 is packaged so that the end 41 resides away from the
back wall 34, then the connector 10 is longer in an axial direction
than it needs to be. Second, it is desirable not to make the user
or patient rotate the shell 36 more than is necessary to insert the
tube 40 through the slit of the back wall 34 of the septum 30 to
begin using the connector 10.
[0090] FIGS. 1A and 1B illustrate that the tip protector 42 in an
embodiment defines threads 46 that engage some of the internal
threads 38 of the shell 36. The shell 36 only threads into the tip
protector 42 so far before the shell 36 bottoms out against a
cylinder 48 defined by the tip protector 42. FIG. 1B illustrates
that in an embodiment, the outside of the shell 36 includes a taper
35 at the end of the portion of the shell 36 defining the threads
38. As the tip protector 42 threads into the shell 36, the taper 35
increasingly presses against the inside of the cylinder 48. In an
embodiment, the cylinder 48 of the tip protector 42 defines a
stepped portion 47 that facilitates the engagement between the
taper 35 of the shell 36 and the tip protector 42.
[0091] Thus, when the connector 10 is packaged, the tip protector
42 can be placed against or abutted against the body 14 of the cap
12 before the shell 36 threads onto the body 14 and onto the
threads 46 of the tip protector 42. The shell 36 threads over the
external threads 24 of the body 14 and passes or translates past
the body 14 a desired distance defined by the threads 46 of the tip
protector 42. It is at this point that the end 41 of the tube 40
abuts or is directly adjacent to the end wall 34 of the septum
30.
[0092] It should be appreciated that the cylinder 48 of the tip
protector 42 is not threaded and does not threadingly engage the
shell 36 so that the cylinder 48 simply slides over and translates
relative to the shell 36. It should also be appreciated that to
remove the tip connector 42, the user holds the shell 36 and
rotates the ring 44 a number of turns.
[0093] FIG. 1C illustrates an alternative embodiment that is used,
for example, when the connector 10 performs APD. The tip protector
42 simply slides and possibly slightly press fits onto or into the
body 14 of the cap 12. Here, the tip protector 42 does not define
the threads 46. The shell 36 may or may not be tapered and may
contain a stepped member 37, wherein the member 37 is intended to
slightly frictionally engage the inner wall of the cylinder 48. The
internal threads 38 of the shell 36 stop before reaching the inner
portion 39 of the shell 36 that abuts the tip protector 42.
[0094] When the connector is initially packaged, the body 14 cannot
move relative to the shell 36 until the tip connector 42 is
removed. This is important to ensure that the seal 18 is not
ruptured or displaced prior to using the connector 10. The tip
protector 42 also includes an inner extension 50 that extends into
the chamber created by the internal threads 22 of the body 14. The
extension 50 extends so that it abuts or is directly adjacent to
the seal 18. This ensures that prior to use, the seal 18 does not
loosen and move away from the receptacle 16 to thereby create a
leaky connector 10. Thus, it should be appreciated that the tip
connector 42 enables the connector 10 to be handled and shipped
without destroying the seal 18 and/or losing the disinfectant 20
maintained by the seal 18.
[0095] Referring now to FIGS. 2 and 3, one embodiment for
connecting the connector 10 of the present invention to a mating
connector 60 is illustrated. The connector 10 may be adapted to
operate with many different types of connectors or devices that
provide a catheter 62 that inserts into the peritoneal cavity of
the patient. In an embodiment, the connector 10 is adapted to
attach to a transfer set that is illustrated in FIG. 2 as the
connector 60. The transfer set in one embodiment is a MiniSet.TM.
manufactured by the BAXTER INTERNATIONAL INC. Although the
MiniSet.TM. 60 is one operable embodiment of the transfer set or
catheter device, the connector 10 can operate with any type of
device that couples to a tube or catheter, which inserts into the
patient's peritoneal cavity.
[0096] In FIG. 2, the tip protector 42 is unsecured or removed from
the shell 36 of the connector 10. The port 40 of the shell 36 of
the connector 10 is illustrated as sealingly connecting to a
flexible tube 64 that runs to the dialysate container or bag.
[0097] FIG. 3 illustrates that after inserting the connector 10
onto the connector or transfer set 60, the shell 36 connected to
the tube 64 threads off of and away from the cap 12. The connector
10 threads onto the connector or transfer set 60 using the internal
threads 22 defined by the body 14 of the cap 12, which are exposed
when the tip protector 42 is removed.
[0098] FIG. 3 illustrates a point in the process when the patient
has completed the transfer of the dialysate from the dialysate
container into the peritoneal cavity, or FIG. 3 illustrates a point
in the process when the patient or user has finished draining spent
dialysate from the peritoneal cavity into the dialysate container.
In either situation, when the shell 36 threads off of the container
10, the cap 12 of the container 10 remains fixed to the connector
or transfer set 60 and thereby caps off the transfer set 60. In
this manner, because the sterility of cap 12 is maintained and cap
12 remains functional, a separate cap which would normally have to
be taken off and re-placed onto the transfer set 60 before and
after each use is no longer necessary.
[0099] Referring now to FIGS. 4 to 7, one embodiment of a method
for removing spent dialysate and inserting new dialysate into a
patient in a substantially sterilized environment is illustrated.
FIG. 4 illustrates a point in the process when the tip protector 42
has been removed and the transfer set or connector 60 is ready to
be connected to the connector 10. At this point, the connector or
transfer set 60 has not engaged the seal 18 to thereby rupture or
displace the seal, which displaces the disinfectant 20. The
connector or transfer set 60 includes external threads 64 that
mates with the internally facing threads 22 of the body 14 of the
cap 12.
[0100] When the user or patient desires to connect the catheter
from the peritoneal cavity to the connector 10, the user or patient
threads the connector or transfer set 60 (connecting to the
catheter extending to the peritoneal cavity) into the body 14 of
the cap 12 so that ends 66 of the connector transfer set 60 engage
the seal 18 and either move it or rupture it (best seen in FIG. 5).
That is, the ends 66 apply a translational force to the seal 18
which causes the seal 18 to compress against the disinfectant 20.
Eventually, as the user screws the connector 60 into the body 14,
the pressure becomes too much for the seal to handle, whereby the
seal either moves so that the disinfectant leaves the receptacle 16
and squirts out around the seal 18 and the ends 66 pierce, or the
seal ruptures (thin sheet seal embodiment described above) and the
disinfectant 20 runs out over the external threads 64 of connector
60.
[0101] In the illustrated embodiment, the seal 18 remains intact
but moves or displaces the disinfectant 20 to run out over the
outside of the threads 64 of the connector 60, so that
microorganisms contained thereon are substantially destroyed. The
seal 18 as illustrated may be made in a teardrop-type shape wherein
the blunt end of the teardrop has more sealing force than the
tapered or sharper end of the seal 18. In this manner, the sharper
or tapered end may slightly deform as the blunt end is dragged
along the surface of the receptacle 16.
[0102] The mating connector 60 in an embodiment is sized to engage
and slide along the passage 26 of the body 14. This also aids in
dispersing the disinfectant 20 onto the outside of the mating
connector 60 to disinfect the engaging threads. That is, the
disinfectant will take the path of least resistance and tend to
move into the open cavity defined between the outside of the
connector 60 and an inner wall of the body 14, rather than
squeezing through the friction fit between the inner opening of the
connector 60 and the passage 26.
[0103] Referring now to FIG. 6, after the mating connector or
transfer set 60 bottoms out against the body 14, i.e., pushes the
seal 18 all the way against the receptacle 16 of body 14. The
assembly of the connector 10 to the mating connector 60 is now
complete, so that the sealed end of the body 14 made by the slit
septum 30 can be unsealed or opened. To break the seal of the
septum 30, the user or patient rotates the shell or shell 36
relative to the body 14 wherein the threads of the shell 36 turn
against the threads of the body 14. The shell 36 thereby translates
towards the mating connector 60, so that the tube or port 40 of the
shell 36 pierces through the back wall 34 of the septum 30 and
through the slit defined by the back wall 34. At this point, fluid
communication exists between the peritoneal cavity of the patient
and the dialysate bag.
[0104] Thus, at the point illustrated in FIG. 6, the dialysate
fluid may flow in either direction. That is, if the patient is
removing spent dialysate from the peritoneal cavity, the dialysate
fluid can flow from the catheter in the cavity into the mating
connector 60, through the passage 26 of the body 14, out the port
40 and into the flexible tube 64 running to the dialysate container
or bag.
[0105] In CAPD, to remove the spent dialysate from the peritoneal
cavity, the user or patient typically opens a clamp on the upstream
side of the mating connector 60 or integrally formed with the
mating connector 60, wherein the spent dialysate runs into an
awaiting container. The flex tube 64 typically runs to a "Y"
connection, wherein one leg extends to the spent dialysate
container and another leg extends to a new dialysate bag. When the
old dialysate has been drained into the spent bag, the operator
opens a fill-bag clamp that enables the new dialysate to run from
the flexible tube 64, to the port 40, through the septum 30,
through the passage 26, into the internal diameter of the mating
connector 60 and into the catheter leading into the peritoneal
cavity. With APD, one or more pumps automatically pull the spent
dialysate from the patient's peritoneal cavity and places fresh
dialysate into same.
[0106] FIGS. 4, 5 and 6 illustrate one complete cycle of flushing
old or spent dialysate and replenishing new dialysate into the
peritoneal cavity. With both CAPD and APD, the cycle is repeated a
number of times. Obviously, many other different types of medical
fluids may be substituted for the dialysate described herein,
wherein a number of medical procedures may be performed using the
connector 10 having the cap 12 of the present invention.
[0107] Referring now to FIG. 7, when the transfer of fluids has
been exchanged, the user or patient removes the shell 36 from the
cap 12, so that the tube 40 of the shell 36 removes from the septum
30. When removed, the slit in the wall 34 of the septum 30 closes
and the end of the body 14 is once again sealed. The body 14
remains in the threaded position with respect to the mating
connector 60, so that the disinfectant 20 is maintained between the
mating threads and the open area between the mating connector 60
and the body 14.
[0108] It should be understood that various changes and
modifications to the presently preferred embodiments described
herein will be apparent to those skilled in the art. Such changes
and modifications can be made without departing from the spirit and
scope of the present invention and without diminishing its intended
advantages. It is therefore intended that such changes and
modifications be covered by the appended claims.
* * * * *