U.S. patent application number 10/012929 was filed with the patent office on 2002-06-20 for temperature sensor adapter for foley catheters.
This patent application is currently assigned to Alsius. Invention is credited to Noda, Wayne A..
Application Number | 20020077680 10/012929 |
Document ID | / |
Family ID | 22971041 |
Filed Date | 2002-06-20 |
United States Patent
Application |
20020077680 |
Kind Code |
A1 |
Noda, Wayne A. |
June 20, 2002 |
Temperature sensor adapter for foley catheters
Abstract
The present invention includes an adapter for advancing a
temperature sensor through the drainage lumen of an operational
Foley catheter. The Foley catheter includes a catheter body having
proximal end, a distal end and a drainage lumen extending between
the ends. A balloon mounts on the distal end for holding the
catheter in the bladder of a patient. The adapter attaches to the
proximal end for inserting a temperature sensor via the catheter
drainage lumen to the distal end of the catheter. This adapter
enables a typical Foley catheter to achieve a temperature sensing
capability and provides collocated sensor elements in Foley
catheters having a single temperature sensor element. Such
temperature sensor measurements are useful, for example, in
conjunction with various heat exchange catheter systems.
Inventors: |
Noda, Wayne A.; (Mission
Viejo, CA) |
Correspondence
Address: |
ALSIUS CORPORATION
15770 LAGUNA CANYON ROAD, SUITE 150
IRVINE
CA
92618
US
|
Assignee: |
Alsius
|
Family ID: |
22971041 |
Appl. No.: |
10/012929 |
Filed: |
December 10, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60256083 |
Dec 15, 2000 |
|
|
|
Current U.S.
Class: |
607/105 ;
600/549; 604/317 |
Current CPC
Class: |
A61B 17/00 20130101;
A61B 2017/00115 20130101; A61B 2017/00084 20130101; A61B 2017/22068
20130101; A61B 2017/00292 20130101; A61B 2017/00119 20130101 |
Class at
Publication: |
607/105 ;
600/549; 604/317 |
International
Class: |
A61F 007/00; A61M
001/00; A61B 005/00 |
Claims
What is claimed is:
1. An adapter connectable with the drainage lumen of a Foley
catheter, comprising: a connector attachable to the drainage lumen
of a Foley catheter, the adapter having a drainage lumen, and a
temperature sensor lumen with a fitting; a temperature sensor
having a wire; a means for sealing the wire within the adapter; and
a means for selectively anchoring the wire within the adapter.
2. An adapter as set forth in claim 1, wherein the means for
sealing includes a cap and a seal attachable to the adapter, the
wire passes through the cap and seal.
3. An adapter as set forth in claim 2, wherein the fitting defines
an annular flange, the cap compresses the seal against the annular
flange to anchor the wire with respect to the adapter and for
sealing the wire within the adapter.
4. An adapter as set forth in claim 3, wherein the seal is
generally cylindrical in shape and circumscribes the wire.
5. An adapter as set forth in claim 3, wherein the adapter and the
cap are threaded.
6. An adapter as set forth in claim 3, wherein the adapter and the
cap are threaded, the cap rotatably attaches to the adapter so that
rotation of the cap compresses the seal.
7. An adapter as set forth in claim 3, wherein the cap includes an
axially disposed post, the post compresses the seal when the cap
rotates onto the fitting.
8. An adapter as set forth in claim 1, wherein the adapter attaches
to the drainage lumen of a Foley catheter having a catheter body
with a distal end, the temperature sensor includes a sensor element
disposed in the distal end.
9. An adapter connectable with the drainage lumen of a Foley
catheter, comprising: a connector attachable to the drainage lumen
of a Foley catheter, the adapter having a drainage lumen and a
temperature sensor lumen; a fitting attached to the temperature
sensor lumen; a temperature sensor having a wire, the temperature
sensor wire extending through the fitting; and a cap with a
threaded interior, the fitting being threaded to enable the threads
of the cap to join with the threads of the fitting, the cap
including an opening to enable the wire to pass through the
cap.
10. An adapter as set forth in claim 9, wherein the fitting defines
an annular flange and the cap includes a seal, the cap presses the
seal against the annular flange when the cap rotates.
11. An adapter as set forth in claim 9, wherein the fitting defines
an annular flange and the cap includes a seal, the cap presses the
seal against the annular flange when the cap rotates, the seal
circumscribes the wire.
12. An adapter as set forth in claim 11, wherein the seal is
generally cylindrical in shape.
13. An adapter as set forth in claim 11, wherein the cap includes
an axially disposed post.
14. An adapter as set forth in claim 11, wherein the cap includes
an axially disposed post, the post defines an opening to enable the
wire to pass through the post.
15. An adapter as set forth in claim 14, wherein the post
compresses the seal when the cap rotates.
16. A Foley catheter having a temperature sensor adapter,
comprising: a catheter body with a proximal end and a distal end,
an inflatable balloon disposed near the distal end, an inflation
lumen extending from the proximal end to the balloon for inflating
and deflating the balloon; a drainage lumen extending from the
proximal end to the distal end; an adapter connectable with the
proximal end of the catheter body and in fluid communication with
the drainage lumen, the adapter includes a drainage lumen and a
temperature sensor lumen; a fitting attached to the adapter
temperature sensor lumen; and a temperature sensor having a wire
and a sensor element, the sensor element being disposed in the
distal end of the catheter body and the wire extending through the
catheter body drainage lumen and through the fitting.
17. A Foley catheter having a temperature sensor adapter as set
forth in claim 16, wherein the fitting defines an annular flange
and the adapter includes a cap and a seal, the cap presses the seal
against the annular flange to anchor the wire when the cap
rotates.
18. A Foley catheter having a temperature sensor adapter as set
forth in claim 16, wherein the fitting defines an annular flange
and the adapter includes a cap and a seal, the cap presses the seal
against the annular flange when the cap rotates, the seal defines a
opening to enable the wire to pass through the seal.
19. A Foley catheter having a temperature sensor adapter as set
forth in claim 16, wherein the fitting defines an annular flange
and the adapter includes a cap and a seal, the cap presses the seal
against the annular flange when the cap rotates, the seal
circumscribes the wire.
20. A Foley catheter having a temperature sensor adapter as set
forth in claim 19, wherein the seal is generally cylindrical in
shape.
21. A Foley catheter having a temperature sensor adapter as set
forth in claim 19, wherein the cap includes an axially disposed
post.
22. A Foley catheter having a temperature sensor adapter as set
forth in claim 19, wherein the cap includes an axially disposed
post, the post defines an opening to enable the wire to pass
through the post.
23. A method of using a temperature sensor adapter with a Foley
catheter, comprising: introducing a Foley catheter into the bladder
of a patient, the Foley catheter includes catheter body with a
proximal end, a distal end a drainage lumen extending between the
proximal end and the distal end for draining urine from the
bladder; draining urine from the bladder via the drainage lumen;
attaching an adapter having a temperature sensor to the proximal
end of the catheter body; and advancing the temperature sensor
towards the distal end of the catheter via the drainage lumen to
sense temperature within the bladder.
24. A method as set forth in claim 23, wherein the step of
advancing the temperature sensor includes sliding the temperature
sensor to the distal end of the catheter body.
25. A method as set forth in claim 23, wherein the step of
introducing precedes the steps of attaching and advancing.
26. A method as set forth in claim 23, wherein the step of
introducing includes: providing a Foley catheter with an integrated
temperature sensor; detecting failure of the integrated temperature
sensor; maintaining the catheter in the bladder; attaching the
adapter to the proximal end; and advancing the adapter temperature
sensor.
27. A method as set forth in claim 23, wherein the Foley catheter
includes a balloon positioned at the distal end and an inflation
lumen, the method includes inflating the balloon via the inflation
lumen to hold the catheter in the bladder.
28. A method as set forth in claim 23, wherein the temperature
sensor includes a wire that extends through the drainage lumen of
the catheter and the adapter when the sensor advances, the method
further comprises sealing the wire.
29. A method as set forth in claim 23, wherein the temperature
sensor includes a wire and the method includes lubricating the
wire.
30. A method as set forth in claim 23, wherein the temperature
sensor includes a wire, the method further comprises anchoring the
wire to hold the temperature sensor in the drainage lumen.
31. A method as set forth in claim 30, wherein the adapter includes
a cap, a seal, a fitting with an annular flange and a temperature
sensor lumen, the fitting being integrated with the temperature
sensor lumen of the adapter, the seal seats against the annular
flange when the cap attaches to the adapter, the seal defines a
channel to enable the wire to pass through the seal, the wire
passes through the seal wherein, the step of anchoring the wire
includes attaching the cap to the adapter.
32. A method as set forth in claim 30, wherein the adapter includes
a cap with a seal, a fitting with an annular flange and a
temperature sensor lumen, the fitting being integrated with the
temperature sensor lumen of the adapter, the cap and the
temperature sensor lumen are threaded; the method includes seating
the seal against the annular flange when the cap attaches to the
adapter; defining an channel within the seal to enable the wire to
pass through the seal; passing the wire through the seal; and the
step of anchoring the wire includes threading the cap to the
adapter and rotating the cap with respect to the adapter to deform
the seal and anchor the wire.
33. A method for measuring and regulating patient temperature
comprising: introducing a heat exchange catheter into the
vasculature of a patient; introducing a Foley catheter into the
bladder of the patient; draining urine from the bladder via the
drainage lumen; attaching an adapter having a temperature sensor to
the proximal end of the Foley catheter; and advancing the
temperature sensor towards the distal end of the catheter to sense
temperature within the bladder.
34. The method as set forth in claim 33, further comprising
establishing a feedback loop between the temperature sensor and the
heat exchange catheter for regulating patient core body
temperature.
Description
PRIORITY
[0001] Priority of application Ser. No. 60/256,083 filed on Dec.
15, 2000 in the United States of America with the USPTO is claimed
under 35 U.S.C. .sctn. 119(e).
FIELD
[0002] This invention relates to Foley Catheters, and particularly
Foley Catheters having temperature sensors.
INCORPORATION BY REFERENCE
[0003] The disclosures of U.S. Pat. No. 6,019,783, issued Feb. 1,
2000, U.S. Pat. No. 6,126,684, issued Oct. 3,2000, and U.S. Pat.
No. 6,146,411, issued Nov. 14, 2000, are incorporated herein by
reference.
BACKGROUND
[0004] Foley catheters typically include a soft, thin rubber tube
with a balloon on one end. The catheter is threaded through the
urinary duct (urethra) and into the bladder to drain urine from the
bladder. A Foley catheter is typically used when normal urination
is disrupted by an infection, a swollen prostate gland, bladder
stones, or, sometimes, an injury. In very sick people, a catheter
may be used to keep track of urine production.
[0005] A typical Foley catheter has drainage lumen, and an
inflation lumen for inflating and deflating the balloon. The
balloon is normally deflated until properly positioned in a
patient's bladder. Once the catheter is properly positioned, the
inflation lumen delivers fluid to inflate the balloon. The inflated
balloon holds the catheter in place.
[0006] There are risks associated with the use of a Foley catheter.
For example, the bladder or urethra could be injured when the Foley
catheter is inserted. Infection is also possible. Patients may find
the process of insertion of a Foley catheter unpleasant and
sometimes painful.
[0007] The bladder is an accepted situs for core body temperature
measurements. Accordingly, some Foley catheters include a
temperature sensor included on the end of the catheter. A wire
connects the sensor, via the catheter, to externally located
monitoring devices.
[0008] One drawback to Foley catheters with a temperature sensor is
that the sensor may fail. When the sensor fails, the failed
catheter may have to be replaced. This not only compounds patient
discomfort, but also increases the risk of injury and infection for
the patient.
[0009] What is desired is a way to measure a patient's core body
temperature while minimizing patient discomfort and risk of injury.
What is also desired is a way of assuring redundancy and accuracy
in core body temperature measurements.
SUMMARY
[0010] The adapter of the present invention attaches to the
drainage lumen of a standard Foley catheters, including Foley
catheters having integrated temperature sensors. The adapter is
generally "Y" shaped, having a drainage lumen in communication with
the catheter drainage lumen, and a temperature sensor lumen with a
temperature sensor.
[0011] The adapter has a threaded fitting fixed on the adapter
temperature sensor lumen for sealing the temperature sensor lumen
and for anchoring the temperature sensor. The adapter has a
threaded cap and a seal. The seal seats in the adapter and the
threads of the cap join with the threads of the fitting to actuate
the seal.
[0012] The temperature sensor includes a sensor element disposed
distally on the temperature sensor, and a wire. The wire extends
from the sensor element through the fitting.
[0013] The cap compresses the seal against the fitting when the cap
attaches to the adapter. Accordingly, the fitting prevents leakage
and anchors the temperature sensor wire with respect to the
adapter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a perspective view of a Foley catheter and the
adapter in accordance with the present invention.
[0015] FIG. 2 is a perspective view of a Foley catheter inserted
into a patient and the adapter in accordance with the present
invention.
[0016] FIG. 3 is a cross-sectional view of the catheter body as
seen along the line 3-3 in FIG. 2.
[0017] FIG. 4 is an exploded cross-sectional view of the cap and
fitting in accordance with the present invention.
[0018] FIG. 5 is a cross-sectional view of the cap operatively
engaged with the fitting as seen along the line 4-4 of FIG. 2.
DESCRIPTION
[0019] FIG. 1 shows a Foley catheter generally designated with the
reference numeral 10. The catheter 10 includes a catheter body 12
with a proximal end 14 and a distal end 16. The catheter 10 also
includes a balloon 18, an inflation lumen 20, a drainage lumen 22,
and an adapter 24.
[0020] The balloon 18 is deflated for insertion into a patient. The
balloon 18 is disposed near the distal end 16. The inflation lumen
20 extends within the catheter body 12 from the proximal end 14 to
the balloon 18, in fluid communication with the balloon 18, for
inflating and deflating the balloon 18.
[0021] The catheter drainage lumen 22 extends from the proximal end
14 to the distal end 16. The distal end 16 includes an opening 26
in fluid communication with the drainage lumen 22 to facilitate
drainage of urine from the bladder of a patient.
[0022] The adapter 24 has a drainage lumen 30, a temperature sensor
lumen 32 and a connector 25. The connector 25 attaches to the
proximal end 14 of the catheter body 12. The connector 25
establishes fluid communication between the adapter drainage lumen
30 and the catheter drainage lumen 22. Preferably the connector 25
is tapered and includes ribs 27 for insertion and press-fit into
the proximal end 14 of the catheter body 12.
[0023] The adapter temperature sensor lumen 32 includes a fitting
34 and a cap 36. The temperature sensor 38 has a wire 40 and a
distally located sensor element 33 (FIG. 2). The fitting 34 is
fixed on the temperature sensor lumen 32 of the adapter 24.
Preferably the fitting 34 bonds to the temperature sensor lumen 32.
The fitting 34 receives the cap 36. The cap 36 and a portion of the
fitting 34 are threaded to enable the cap 36 to rotate onto the
fitting 34. The cap 36 is rotatable to adjustably torque the cap 36
onto the fitting 34.
[0024] The temperature sensor wire 40 normally slides through the
cap 36, the fitting 34, the connector 25, and the catheter drainage
lumen 22. The temperature sensor 38 includes a distally mounted
temperature sensor element 33 (FIG. 2) that seats in the distal end
16 of the catheter body 12. Rotating the cap 36 with respect to the
fitting 34 selectively anchors the wire 40 with respect to the
adapter 24 to prevent movement of the sensor element 33.
[0025] FIG.2 shows the Foley catheter 10 inserted into the bladder
42 of a patient. The Foley catheter 10 includes an integrated
temperature sensor 46 with an integrated sensor element 35 disposed
at the distal end 16 of the catheter body 12.
[0026] During normal operation of the Foley catheter 10, the
catheter 10 is introduced into the bladder 42 of a patient. The
balloon 18 inflates to hold the catheter 10 in the bladder 42.
Urine drains from the bladder 42 through the opening 26 and via the
catheter drainage lumen 22. The integrated sensor 46 with the
sensor element 35 senses the patient's bladder temperature.
[0027] The adapter 24 attaches to the proximal end 14 of the
catheter body 12. An operator manually advances the temperature
sensor wire 40 to slide the temperature sensor wire 40 and sensor
element 33 via the drainage lumen, towards the distal end 16 of the
catheter body 12. Preferably, the temperature sensor wire 40 slides
the temperature sensor element 33 fully to the distal end 16 of the
catheter body 12.
[0028] According to one method of using the invention, the
integrated temperature sensor 46 fails. This failure is detected.
The Foley catheter 10 remains in the bladder 42. The adapter 24 of
the present invention then attaches to the proximal end 14 of the
catheter and the sensor 38 with the sensor element 33 advances
through the drainage lumen of the Foley catheter 10 to position the
sensor element 33 in the distal end 16 of the catheter body 12.
[0029] The sensor element 35 and the sensor element 33 are
collocated for redundancy and improved accuracy. The sensor
elements 33 and 35 provide a primary and secondary measure,
respectively, of core body temperature. The secondary measure of
temperature is used in conjunction with primary temperature
measurements for improved temperature sensing accuracy and
reliability.
[0030] Collocated temperature sensor elements 33 and 35 are also
useful for communicating with discrete monitoring and data
compilation devices requiring temperature input, such as a discrete
patient data recorder and a medical device, for examples.
[0031] It can be appreciated that sensor collocation may not be
required in some systems. For example, when a patient normothermia
is desired, and an intravascular temperature regulator is used on
the patient, it may be desirable to have multiple temperature
sensors in various parts of the body (including the bladder) to
optimally determine the patient core body temperature and
communicate that body temperature to the intravascular temperature
regulator.
[0032] According to one aspect of the invention, the temperature
adapter 24 and Foley catheter 10 are used in conjunction with
vascular heat exchange catheter such as disclosed in copending U.S.
patent application Ser. No. 09/220,897, the disclosure of which is
incorporated herein by reference. It can be appreciated that core
body temperature measurements are important to facilitate proper
functioning of any system that regulates the core body temperature
of a patient. Accordingly, redundant bladder temperature
measurements with collocated sensor elements 33 and 35, is
desirable to minimize any risk or inconvenience associated with
temperature monitoring failure.
[0033] Foley catheters can be used to drain urine for several
weeks. An integrated temperature sensor 46, may fail during this
period. The method, thus, enables an introduced Foley catheter
having a failed integrated temperature sensor 46 to be used
continuously for draining urine notwithstanding failure of the
integrated temperature sensor 46. The steps of maintaining the
catheter 10 in the bladder 42 and attaching the adapter 24 to the
proximal end 14 and advancing the adapter temperature sensor 38
provides a secondary measure of temperature without requiring the
unpleasant steps of removal and replacement of the Foley catheter
10.
[0034] FIG. 3 shows the catheter body 12 having three lumens, the
inflation lumen 20, the drainage lumen 22, and an integrated
temperature sensor lumen 48. The temperature sensor lumen 48 houses
the wire 46 of the integrated temperature sensor 46. The wire 40 of
the adapter temperature sensor 38 is positioned freely in the
drainage lumen 22.
[0035] FIG. 4 shows the cap 36, the fitting 34 and a seal 56. The
cap 36 has internal threads 50 and the fitting 34 has external
threads 52. The cap 36 has an axis and includes an axially disposed
post 54. The seal 56 seats within the fitting 34. The post 54
defines a portion of a channel 58. The channel 58 extends axially
through the cap 36, the fitting 34 and the seal 56. The temperature
sensor wire 40 normally slides through the channel 58 when the cap
36 and the fitting 34 loosely engage, or disengage.
[0036] According to an aspect of the invention, the seal 56 is
generally cylindrical in shape and circumscribes the wire 40. The
wire 40 is lubricated to facilitate sliding when the cap 36 loosely
fits on the fitting 34.
[0037] The fitting 34 defines an annular flange 62 so that when the
cap 36 threads on to the fitting 34, the post 54 of the cap 36
presses the seal 56 against the annular flange 62. Rotation of the
cap 36 with respect to the fitting 34 deforms the seal 56, which
grips the wire 40 and thereby selectively anchors the wire 40 with
respect to the cap 36 and the fitting 34.
[0038] FIG. 5 shows the cap 36 engaging the fitting 34. The cap 36
rotates to compress the seal 56 against the flange 62. The seal 56
circumscribes the wire 40 so that compressing the seal 56 anchors
the wire 40.
[0039] In Use
[0040] An anticipated use for the invention described herein is in
conjunction with a patient temperature regulation system having a
heat exchange catheter. A system having a heat exchange catheter is
described generally in U.S. Pat. No. 6,019,783, the disclosure of
which is incorporated herein by reference. A feedback loop between
the temperature sensor of the Foley catheter and the patient
temperature regulation system is established.
[0041] A typical patient temperature regulation system includes an
venous catheter having a heating and/or cooling element. The
catheter inserts into a patient's central venous system to warm
and/or cool the blood. The warmed/cooled blood circulates within
the patient to effect the patient core body temperature. In
accordance with the present invention, the core body temperature is
measured using a Foley catheter and adaptor as described
herein.
[0042] A heat exchange catheter is described in U.S. Pat. Nos.
6,146,411 and 6,126,684, the disclosures of which are incorporated
herein by reference. One heat exchange catheter includes lumens for
circulating heat exchange fluid within the catheter. This creates a
closed system heat exchanger so that circulation of heat exchange
fluid within the catheter cools/warms the blood of the patient. A
system employing the heat exchange catheter has a temperature
measurement device and a control unit. The control unit regulates
the rate of flow of the heat exchange fluid as well as the
temperature of the fluid. A feedback loop established between the
Foley catheter-based temperature sensor elements of the present
invention is used to regulate the heat exchange fluid temperature
of the closed system, and the rate of heat exchange fluid flow.
[0043] While the present invention is anticipated to be used in
conjunction with a patient temperature regulation system, it can be
appreciated that it can be used in any of a number of systems. For
example, the present invention can be used in virtually any
surgical procedure requiring a measurement of a patient's core body
temperature.
[0044] It can also be appreciated that the seal 56 may take many
forms, including that of an o-ring. Notwithstanding the form of the
seal 56, the relative movement of the cap with respect to the seal
56 deforms the seal 56 to anchor the wire 40. It can be appreciated
that the seal 56 need not simply seat in the fitting 34, the seal
may also be formed as part of the fitting 34, or the cap 36. The
fitting 34 maybe discrete, or integrated with the temperature
sensor lumen 32 of the adapter 24. Accordingly, the present
invention should be limited only by the claims as set forth
below.
* * * * *