U.S. patent application number 11/792147 was filed with the patent office on 2008-10-09 for emergency electrode on medical tube.
This patent application is currently assigned to Vision - Sciences Inc.. Invention is credited to Ron Hadani.
Application Number | 20080249507 11/792147 |
Document ID | / |
Family ID | 36087635 |
Filed Date | 2008-10-09 |
United States Patent
Application |
20080249507 |
Kind Code |
A1 |
Hadani; Ron |
October 9, 2008 |
Emergency Electrode on Medical Tube
Abstract
A food administering apparatus including a feeding tube, having
a distal outlet and proximal inlet, adapted for insertion of the
distal outlet into the stomach of an adult patient while the
proximal inlet is outside the patient, the tube being suitable for
administering food or medicine from a proximal port to the distal
outlet and at least one electrode mounted on the tube.
Inventors: |
Hadani; Ron; (Cresskill,
NJ) |
Correspondence
Address: |
Martin D Moynihan;PRTSI, Inc.
P O Box 16446
Arlington
VA
22215
US
|
Assignee: |
Vision - Sciences Inc.
Orangeburg
NY
|
Family ID: |
36087635 |
Appl. No.: |
11/792147 |
Filed: |
December 1, 2005 |
PCT Filed: |
December 1, 2005 |
PCT NO: |
PCT/US05/43273 |
371 Date: |
May 27, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60632739 |
Dec 1, 2004 |
|
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60653135 |
Feb 16, 2005 |
|
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60669007 |
Apr 7, 2005 |
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Current U.S.
Class: |
604/523 |
Current CPC
Class: |
A61B 1/00105 20130101;
A61B 1/05 20130101; A61N 1/05 20130101; A61B 1/00135 20130101; A61B
1/00142 20130101; A61N 1/3918 20130101; A61B 2018/1495 20130101;
A61N 1/3625 20130101; A61N 1/0517 20130101; A61N 1/3621
20130101 |
Class at
Publication: |
604/523 |
International
Class: |
A61M 25/00 20060101
A61M025/00 |
Claims
1. A food administering apparatus, comprising: a feeding tube,
having a distal outlet and proximal inlet, adapted for insertion of
the distal outlet into the stomach of an adult patient while the
proximal inlet is outside the patient, the tube being suitable for
administering food or medicine from a proximal port to the distal
outlet; and at least one electrode mounted on the tube.
2. An apparatus according to claim 1, wherein the at least one
electrode mounted on the tube is embedded within the tube.
3. An apparatus according to claim 1, comprising an electrical port
coupled to the electrode, adapted to receive electrical power from
an electrical source outside a patient.
4. An apparatus according to claim 3, wherein the port is adapted
to receive electrical power from an electrical source outside the
patient, wirelessly.
5. An apparatus according to claim 3, wherein the port is adapted
to receive electrical power from an electrical source outside the
patient, through wires.
6. An apparatus according to claim 1, comprising at least one wire
leading from the at least one electrode to a distal area of the
tube.
7. An apparatus according to claim 1, wherein the distal outlet has
a size of at least 6 French.
8. An apparatus according to claim 1, wherein the distal outlet
comprises an opening substantially perpendicular to an axis of the
tube.
9. An apparatus according to claim 1, wherein the distal outlet has
an area greater than 70% of the cross-sectional area of the
tube.
10. An apparatus according to claim 1, wherein the at least one
electrode comprises a plurality of electrodes.
11. An apparatus according to claim 1, wherein the at least one
electrode comprises only a single electrode.
12. An apparatus according to claim 1, wherein the at least one
electrode is located within 2 centimeters from the distal end of
the tube.
13. An apparatus according to claim 1, wherein the at least one
electrode surrounds the tube substantially entirely.
14. An apparatus according to claim 1, wherein the at least one
electrode is located along the tube at a position close to an
average person's heart, when the distal end of the tube is within
the person's stomach.
15. An apparatus according to claim 1, wherein the tube is adapted
for being positioned within a patient for at least 24 hours.
16. An apparatus according to claim 1, wherein the tube comprises a
wall, having an inner side adapted for being in contact with
administered food or medicine and an outer side on which the at
least one electrode is mounted.
17. An apparatus according to claim 1, wherein the apparatus
includes only a single tube.
18. An apparatus according to claim 17, wherein the single tube
defines only a single channel.
19. An apparatus according to claim 1, wherein the tube has a
length of at least 60 centimeters.
20. An apparatus according to claim 1, wherein when the distal
outlet of the tube is in the stomach, the electrode is suitable to
stimulate a body organ of the patient or to sense electrical
signals from a body portion of the patient.
21. A method of treating a patient, comprising: providing a feeding
tube having an electrode mounted thereon; inserting a distal end of
the feeding tube into a stomach of a patient, to an orientation in
which the electrode may be used to electrically stimulate a body
organ of the patient; and administering food or medicine to the
patient's stomach through the tube.
22. A method according to claim 21, wherein providing the feeding
tube with an electrode mounted thereon comprises providing a tube
manufactured with an electrode thereon.
23. A method according to claim 21, wherein providing the feeding
tube with an electrode mounted thereon comprises mounting the
electrode on the tube shortly before inserting the distal end of
the tube into the stomach.
24. A method according to claim 21, wherein the feeding tube
defines only a single channel.
25. A method according to claim 21, wherein providing the feeding
tube comprises providing a tube with only a single electrode
mounted thereon.
26. A method of treating a patient, comprising: providing a medical
tube having an electrode mounted thereon; inserting at least a
distal end of the medical tube into a patient; and performing a
first of one or more heart stimulation procedures on the patient,
using the electrode mounted on the tube, at least one hour after
inserting the distal end of the tube into the patient.
27. A method according to claim 26, wherein providing the medical
tube comprises providing a tracheal tube.
28. A method according to claim 26, wherein providing the medical
tube comprises providing a feeding tube.
29. A method according to claim 26, wherein the electrode is not
electrically coupled to a source of electrical stimulation, not
even through one or more disconnected switches, at the time of
inserting the tube into the patient.
30. A method according to claim 26, wherein the patient has a risk
of less than 10% for requiring a heart stimulation procedure in the
following 24 hours, at the time of insertion of the medical
tube.
31. A method according to claim 26, wherein the patient has a risk
of less than 1% for requiring a heart stimulation procedure in the
following 24 hours, at the time of insertion of the medical
tube.
32. A medical tube apparatus, comprising: a tube, having a length
of at least 50 centimeters, for insertion into a patient, adapted
to carry fluids into or out of the patient in accordance with a
medical task; and a single electrode mounted on the tube in a
position and orientation selected such that when the tube is in the
patient in a manner which allows the tube to operate in accordance
with the medical task, the electrode may be used to stimulate a
body organ of the patient.
33. Apparatus according to claim 32, wherein the single electrode
is mounted on the tube in a position and orientation selected such
that when the tube is in the patient in a manner which allows the
tube to operate in accordance with the medical task, the electrode
may be used to stimulate the heart of the patient.
34. Apparatus according to claim 32, wherein the tube is adapted
for carrying air.
35. Apparatus according to claim 32, wherein the electrode is
mounted at a substantially closest position to the heart when the
tube is in its designated position.
36. A medical tube apparatus, comprising: a tube for insertion into
a patient, adapted to carry fluids into or out of the patient in
accordance with a medical task, the tube being suitable for being
located in the patient for more than 12 hours; and at least one
electrode mounted on the tube in a position and orientation
selected such that when the tube is in the patient in a manner
which allows the tube to operate in accordance with the medical
task, the electrode may be used to stimulate a body organ of the
patient.
37. Apparatus according to claim 36, wherein the tube is suitable
for being located in the patient for more than 24 hours.
38. Apparatus according to claim 36, wherein the tube comprises an
endotracheal tube.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit under 119(e) of U.S.
provisional patent application 60/632,739, titled "Add on Electrode
for Endoscope", filed Dec. 1, 2004, U.S. provisional patent
application 60/653,135, titled "Endoscopic Sheath with Illumination
System", filed Feb. 16, 2005, and U.S. provisional patent
application 60/669,007, filed Apr. 7, 2005, titled "Emergency
Electrode on Medical Tube". The disclosures of all of these
applications are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to cardioversion and
specifically to minimally invasive apparatus for tasks other than
cardioversion, which are designed to be useful also for
cardioversion, when necessary.
BACKGROUND OF THE INVENTION
[0003] Minimally invasive tools may be inserted through a patient's
throat to the patient's stomach or esophagus.
[0004] Nasogastric and gastric tubes are used for feeding patients
that have problems eating on their own. In addition, nasogastric
tubes are used for pumping liquids out of the stomach. The
nasogastric tube is passed through a patient's nose into the
stomach. In some cases, the nasogastric tube remains in the
patient's stomach for a few days.
[0005] U.S. Pat. No. 4,369,789 to Leveen et al., the disclosure of
which is incorporated herein by reference, describes an inflatable
oral-nasal gastric tube.
[0006] It is important to verify that the distal end of the
nasogastric tube is properly positioned in the patient's stomach
before passing food through the tube as the tube may move out of
the stomach, for example into the trachea, where administration of
food may be harmful to the patient.
[0007] U.S. Pat. No. 5,316,024 to Hirschi et al., the disclosure of
which is incorporated herein by reference, describes a resonance
circuit attached to a tube, for allowing determination of the
position of the end of the tube, by an external probe.
[0008] Other minimally invasive tools include catheters with
electrodes for electrical treatment and/or ultrasonic probes for
imaging. These tools are used for short term treatment of the
patient's heart.
[0009] U.S. Pat. No. 5,556,425 to Hewson et al., the disclosure of
which is incorporated herein by reference, describes an
esophageal/stomach electrode for electrically stimulating the
ventricle of the heart. Such stimulation may be required, for
example, for defibrillating and pacing the heart and/or stimulating
breathing. Internal stimulation from the esophagus is generally
more efficient and successful than external cardioversion. Internal
stimulation uses less power, and therefore is less likely to burn
the patient and/or pass dangerous current levels through sensitive
body organs that may be damaged by high currents.
[0010] U.S. Pat. No. 4,960,133 to Hewson, the disclosure of which
is incorporated herein by reference, suggests an esophageal
catheter with electrodes for heart defibrillating or pacing. The
catheter is in the form of a tube closed at its distal end, with
small suction ports near the electrodes, to allow application of
suction, for drawing the electrodes against the esophagus.
[0011] U.S. Pat. No. 5,179,952 to Buinevicius et al., the
disclosure of which is incorporated herein by reference, describes
an electrocardial stimulation probe which may carry a feeding tube
within it.
[0012] The insertion of the above described electrical stimulation
tools into the esophagus requires some expertise. In some cases,
the insertion of these tools must be performed in emergency
situations when the patient's heart has failed. It is important to
reduce the time required until electrical heart stimulation is
performed in such emergency situations.
[0013] U.S. Pat. No. 6,363,937 to Hovda et al. and U.S. Pat. No.
6,746,447 to Davison, the disclosures of which are incorporated
herein by reference, describe an electrosurgical catheter for
applying electrical energy to a target location in the
gastrointestinal track. The catheter includes electrodes and a
channel for delivering an electrically conducting fluid to the
electrode.
[0014] U.S. Pat. No. 4,735,206 to Hewson, the disclosure of which
is incorporated herein by reference, suggests inserting an
electrode catheter to the esophagus through a previously inserted
gastric tube.
[0015] U.S. Pat. No. 6,532,388 to Hill et al., the disclosure of
which is incorporated herein by reference, describes an esophageal
electrode device for use during surgery.
[0016] Electrical signals may be applied to the heart also from the
trachea.
[0017] U.S. Pat. No. 4,351,330 to Scarberry, the disclosure of
which is incorporated herein by reference, describes an emergency
resuscitation apparatus including an endotracheal and/or esophageal
tube.
[0018] U.S. Pat. No. 5,080,107 to Teves, the disclosure of which is
incorporated herein by reference, describes an endotracheal tube
with electrodes for atrial pacing, for use during surgery.
[0019] U.S. Pat. No. 5,125,406 to Goldstone et al., the disclosure
of which is incorporated herein by reference, describes an
electrode endotracheal tube, for detecting electro-myographic
signals in the laryngeal muscles.
[0020] PCT publication WO 01/32249 to Geddes et al., the disclosure
of which is incorporated herein by reference, describes a
tracheotrode and tracheal electro-ventilation system.
SUMMARY OF THE INVENTION
[0021] An aspect of some embodiments of the present invention
relates to inserting a feeding tube, such as a gastric tube or
nasogastric tube, into a patient, with at least one electrode
suitable for electrical stimulation of a body organ (e.g., heart)
and/or suitable for signal sensing from the body organ, mounted
thereon. In some embodiments of the invention, if an emergency
occurs and the patient needs, for example, electrical stimulation,
cardioversion or pacing, electrical signals may be applied
immediately using at least one electrode on the feeding tube. The
internal stimulation from within the esophagus may be performed
without requiring removal of the feeding tube and insertion of a
cardioversion catheter.
[0022] In some embodiments of the invention, a nasogastric tube is
produced with an electrode mounted toward its distal end and wires
connecting to the electrode running along the length of the tube,
for example embedded within the walls of the tube. Alternatively or
additionally, the electrode is coupled to a circuit for wirelessly
receiving power, for wirelessly receiving control signals and/or
wirelessly transmitting sensed signals. Further alternatively, an
add-on electrode may be added to a feeding tube before the tube is
inserted into the patient, for example into a patient having a high
risk for conditions requiring electrical stimulation.
[0023] The feeding tube is optionally adapted for long term use of
at least 3 hours, 6 hours, 12 hours or even 24 hours. In some
embodiments of the invention, the feeding tube is suitable for
placement in the patient for three or more days. Optionally, the
feeding tube is used in a patient at least partially not during
intensive medical treatment, such as surgery. The feeding tube
optionally comprises a simple tube, which is primarily directed for
feeding and does not include apparatus for surgery and/or emergency
handling, such as a pharyngeal cuff, laryngeal tube or a teeth
shield.
[0024] An aspect of some embodiments of the present invention
relates to inserting into a patient, an invasive probe adapted to
perform a medical task other than electrical stimulation of an
organ, with an electrode suitable for stimulation mounted thereon,
although the patient does not currently require a procedure using
the electrode. In some embodiments of the invention, the patient
has a risk of requiring an electrical stimulation procedure (e.g.,
cardioversion) of less than 10%, 5% or even 1%, at the time the
invasive probe is inserted.
[0025] In some embodiments of the invention, the electrodes are not
connected to an apparatus for generating electrical stimulation
signals at the time the invasive probe is inserted into the
patient. Possibly, apparatus for generating electrical signals is
not in the same room as the patient at the time that the invasive
probe is inserted into the patient.
[0026] An aspect of some embodiments of the present invention
relates to an invasive tube, which includes only a single
electrode, adapted for cardioversion, mounted thereon. The
placement of only a single electrode on an invasive tube is
considered, in accordance with an exemplary embodiment of the
invention, most cost effective for a tube that has a relatively low
chance for requiring the use of the electrode. The invasive tube
may include, for example, a tracheal tube or a feeding tube.
[0027] An aspect of some embodiments of the present invention
relates to an invasive tube suitable for placement within a patient
for at least 6 hours, not during surgery, which includes an
electrode mounted thereon. Optionally, the electrode is mounted on
the tube at a position best suitable for cardioversion and/or
closest the heart along the tube, when the tube is in its
designated position.
[0028] In some embodiments of the invention, the invasive tube
comprises an endotracheal tube which is adapted for intubation
and/or intensive care and not for surgery or for emergency patient
handling. In some embodiments of the invention, the endotracheal
tube is connected to a mechanical ventilation machine.
[0029] There is therefore provided in accordance with an exemplary
embodiment of the invention, a food administering apparatus,
comprising a feeding tube, having a distal outlet and proximal
inlet, adapted for insertion of the distal outlet into the stomach
of an adult patient while the proximal inlet is outside the
patient, the tube being suitable for administering food or medicine
from a proximal port to the distal outlet, and at least one
electrode mounted on the tube. Optionally, the at least one
electrode mounted on the tube is embedded within the tube.
Optionally, the apparatus includes an electrical port coupled to
the electrode, adapted to receive electrical power from an
electrical source outside a patient. Optionally, the port is
adapted to receive electrical power from an electrical source
outside the patient, wirelessly. Optionally, the port is adapted to
receive electrical power from an electrical source outside the
patient, through wires. Optionally, the apparatus includes at least
one wire leading from the at least one electrode to a distal area
of the tube. Optionally, the distal outlet has a size of at least 6
French.
[0030] Optionally, the distal outlet comprises an opening
substantially perpendicular to an axis of the tube. Optionally, the
distal outlet has an area greater than 70% of the cross-sectional
area of the tube. Optionally, the at least one electrode comprises
a plurality of electrodes. Alternatively, the at least one
electrode comprises only a single electrode. Optionally, the at
least one electrode is located within 2 centimeters from the distal
end of the tube. Optionally, the at least one electrode surrounds
the tube substantially entirely. Optionally, the at least one
electrode is located along the tube at a position close to an
average person's heart, when the distal end of the tube is within
the person's stomach. Optionally, the tube is adapted for being
positioned within a patient for at least 24 hours.
[0031] Optionally, the tube comprises a wall, having an inner side
adapted for being in contact with administered food or medicine and
an outer side on which the at least one electrode is mounted.
Optionally, the apparatus includes only a single tube. Optionally,
the single tube defines only a single channel. Optionally, the tube
has a length of at least 60 centimeters.
[0032] Optionally, when the distal outlet of the tube is in the
stomach, the electrode is suitable to stimulate a body organ of the
patient or to sense electrical signals from a body portion of the
patient.
[0033] There is further provided in accordance with an exemplary
embodiment of the invention, a method of treating a patient,
comprising providing a feeding tube having an electrode mounted
thereon, inserting a distal end of the feeding tube into a stomach
of a patient, to an orientation in which the electrode may be used
to electrically stimulate a body organ of the patient, and
administering food or medicine to the patient's stomach through the
tube. Optionally, providing the feeding tube with an electrode
mounted thereon comprises providing a tube manufactured with an
electrode thereon. Optionally, providing the feeding tube with an
electrode mounted thereon comprises mounting the electrode on the
tube shortly before inserting the distal end of the tube into the
stomach. Optionally, the feeding tube defines only a single
channel. Optionally, providing the feeding tube comprises providing
a tube with only a single electrode mounted thereon.
[0034] There is further provided in accordance with an exemplary
embodiment of the invention, a method of treating a patient,
comprising providing a medical tube having an electrode mounted
thereon, inserting at least a distal end of the medical tube into a
patient, and performing a first of one or more heart stimulation
procedures on the patient, using the electrode mounted on the tube,
at least one hour after inserting the distal end of the tube into
the patient. Optionally, providing the medical tube comprises
providing a tracheal tube and/or a feeding tube. Optionally, the
electrode is not electrically coupled to a source of electrical
stimulation, not even through one or more disconnected switches, at
the time of inserting the tube into the patient. Optionally, the
patient has a risk of less than 10% or less than 1% for requiring a
heart stimulation procedure in the following 24 hours, at the time
of insertion of the medical tube.
[0035] There is further provided in accordance with an exemplary
embodiment of the invention, a medical tube apparatus, comprising a
tube, having a length of at least 50 centimeters, for insertion
into a patient, adapted to carry fluids into or out of the patient
in accordance with a medical task and a single electrode mounted on
the tube in a position and orientation selected such that when the
tube is in the patient in a manner which allows the tube to operate
in accordance with the medical task, the electrode may be used to
stimulate a body organ of the patient.
[0036] Optionally, the single electrode is mounted on the tube in a
position and orientation selected such that when the tube is in the
patient in a manner which allows the tube to operate in accordance
with the medical task, the electrode may be used to stimulate the
heart of the patient. Optionally, tube is adapted for carrying air.
Optionally, the electrode is mounted at a substantially closest
position to the heart when the tube is in its designated
position.
[0037] There is further provided in accordance with an exemplary
embodiment of the invention, a medical tube apparatus, comprising a
tube for insertion into a patient, adapted to carry fluids into or
out of the patient in accordance with a medical task, the tube
being suitable for being located in the patient for more than 12
hours and at least one electrode mounted on the tube in a position
and orientation selected such that when the tube is in the patient
in a manner which allows the tube to operate in accordance with the
medical task, the electrode may be used to stimulate a body organ
of the patient. Optionally, the tube is suitable for location in
the patient for more than 24 hours. Optionally, the tube is an
endotracheal tube.
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] Exemplary non-limiting embodiments of the invention will be
described with reference to the following description of the
embodiments, in conjunction with the figures. Identical structures,
elements or parts which appear in more than one figure are
preferably labeled with a same or similar number in all the figures
in which they appear, and in which:
[0039] FIG. 1 is a schematic illustration of a nasogastric tube
within a patient, in accordance with an exemplary embodiment of the
invention;
[0040] FIG. 2 is a schematic sectional view of a nasogastric tube,
in accordance with an exemplary embodiment of the invention;
[0041] FIG. 3 is a cross-sectional view of the nasogastric tube of
FIG. 2, in accordance with an exemplary embodiment of the
invention; and
[0042] FIG. 4 is a schematic illustration of an electrode carrier
band, in accordance with an exemplary embodiment of the
invention.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0043] FIG. 1 is a schematic illustration of a nasogastric tube 100
within a patient, in accordance with an exemplary embodiment of the
invention. Nasogastric tube 100 is shown passing through the
patient's nose 150 and the esophagus 152 into the patient's stomach
154. Along esophagus 152, tube 100 passes next to heart 156. It is
noted that tube 100 may be inserted to the patient through the
mouth rather than through the nose.
[0044] In an exemplary embodiment of the invention, tube 100
includes, at a proximal end, a fluid inlet port 102 for connecting
to a syringe or other medical tool for inserting food or liquids
and/or for applying suction. A distal end of tube 100 includes an
outlet 114 through which fluids pass between tube 100 and stomach
154.
[0045] Along its length, tube 100 includes one or more electrodes
108, which can be used for trans-esophagus heart stimulation (such
as heart pacing or cardioversion), when required. In some
embodiments of the invention, tube 100 includes at least two
electrodes 108, so that heart pacing can be more efficiently
performed with two internal electrodes.
[0046] FIG. 2 is a schematic sectional view of tube 100, in
accordance with an exemplary embodiment of the invention. Tube 100
optionally comprises a wall 122 which defines a channel 124 adapted
for transfer of food and liquids.
[0047] Electrodes 108 are optionally positioned along the length of
tube 100, at positions expected to be closest to the heart 156
and/or expected to close a circuit through the heart (or a specific
portion of the heart) in a desired manner, when outlet 114 is in
stomach 154. In some embodiments of the invention, wires 110
connect electrodes 108 to a proximal electrical port 120 near or on
fluid port 102. If the patient requires electrical stimulation
while tube 100 is in the patient, a source of electrical energy can
be connected to port 120 and the stimulation is performed. Thus,
the time required to remove tube 100 and to insert an electrical
stimulation electrode, is avoided.
Electrodes
[0048] Electrodes 108 are optionally adapted to perform a
stimulation task. Alternatively or additionally, one or more of
electrodes 108 are suitable for sensing electrical signals from the
heart. In an exemplary embodiment of the invention, electrodes 108
have a width of between about 6-8 mm, along the length of tube 100,
although other widths may be used. Optionally, all the electrodes
have the same tissue contact area. Alternatively, different
electrodes have different tissue contact areas, for example in
order to accommodate for patients of different sizes. Possibly, the
proximal electrodes are larger, in order to accommodate for larger
patients, generally having a larger distance from the heart to the
stomach.
[0049] In some embodiments of the invention, electrodes 108 extend
over the entire 360.degree. of the circumference of tube 100.
Alternatively, some or all of electrodes 108 extend over less than
the entire circumference of tube 100, optionally over less than
270.degree.. This embodiment is optionally used when tube 100 has a
preferred orientation, such that the electrodes are aligned
correctly within the esophagus.
[0050] Electrodes 108 may have a structure as described in any of
U.S. Pat. No. 4,369,789 to Leveen et al., U.S. Pat. No. 4,574,807
to Hewson, U.S. Pat. No. 4,735,206 to Hewson, U.S. Pat. No.
5,191,886 to Bilof, U.S. Pat. No. 5,417,713 to Cohen, and/or U.S.
Pat. No. 5,343,860 to Metzger et al., the disclosures of all of
which are incorporated herein by reference. Alternatively or
additionally, any other electrodes may be used.
[0051] In some embodiments of the invention, tube 100 includes a
plurality of electrodes 108, for example at least 4 electrodes, as
shown in FIG. 2, or even more than 6 or 8 electrodes. Optionally,
tubes used on patients of a wide range of sizes, include at least
10 or even more than 12 electrodes. In some embodiments of the
invention, tube 100 includes only a limited number of electrodes,
optionally fewer than three electrodes, or even only a single
electrode. In many cases, tube 100 is used on patients that have
only a small chance of requiring use of the electrodes and
therefore it is more cost effective to use only a limited number of
electrodes, or even only a single electrode.
[0052] Alternatively to ring electrodes, other electrode
configurations may be used, such as axial or trans-axial
electrodes.
Wires
[0053] FIG. 3 is a cross-sectional view of tube 100, in accordance
with an exemplary embodiment of the invention. As mentioned above,
tube 100 includes an internal channel 124 defined by a wall 122. As
shown in FIG. 3, in some embodiments of the invention, a bundle 116
of wires 110, which connect electrodes 108 to electrical port 120,
run along wall 122. Optionally, each of the electrodes 108 has a
separate corresponding interface 130 (FIG. 2) on electrical port
120 and a separate leading wire 110. In some embodiments of the
invention, each of interfaces 130 on electrical port 120 is marked
as to the depth of its corresponding electrode 108 (indicating the
depth of the electrode within the patient's esophagus). According
to the extent to which tube 100 is pushed into the patient and the
size of the patient, i.e., the distance from the patient's mouth to
the heart, a specific interface 130 to which electrical power is
applied, is selected. Another external electrode, on the patient's
back or stomach, is used. Alternatively, electrical power is
applied to two or more of electrodes 108, for example when there is
not sufficient time to determine the exact locations of the
electrodes and/or when high power levels are required.
[0054] In some embodiments of the invention, the size of the
patient is estimated based on the age and/or height of the patient.
The extent to which tube 100 is pushed into the patient is
optionally estimated according to the length of the proximal
portion of the tube outside the patient. In some embodiments of the
invention, the proximal portion of tube 100 includes markings 132
(FIG. 2) that indicate which of interfaces 130 should be used for
different lengths of the proximal portion of tube 100 outside the
patient. Optionally, each marking indicates an interface to which
it corresponds, possibly depending on one or more parameters of the
patient. In selecting an interface 130, a physician optionally
identifies a closest marking to the patient's nose (or mouth) and
uses the interface 130 corresponding to the closest marking and the
patient's parameters.
[0055] Alternatively or additionally, radio-opaque markings,
magnetic markings and/or any other internal markings which can be
relatively easily identified from outside the patient, are
positioned on or near one or more of the electrodes within the
patient. When electrification is required, a physician can use an
external sensor to determine the position of one or more of the
electrodes within the patient. Further alternatively or
additionally, an expanding element is located toward the distal end
of tube 100 at a predetermined distance from the electrodes on the
tube. When the electrodes are to be used, tube 100 is pulled back
until the expanding element touches the upper end of the stomach
and serves as a basis for indicating the position of the electrodes
along the esophagus.
[0056] Wires 110 of the electrodes 108 optionally pass along tube
100 in a single bundle 116 embedded in one side of the perimeter of
a wall 122 of tube 100. Alternatively, wires 110 are distributed
around wall 122, allowing wall 122 to be thinner than if the wires
are concentrated. In some embodiments of the invention, wires 110
are embedded within wall 122 in a manner which strengthens the wall
or at least does not weaken the wall. Alternatively, wires 110 are
laid within wall 122 even if they weaken the wall. In some
embodiments of the invention, for example in accordance with this
alternative, the interfaces of the wires are distributed around
fluid port 102 and are not located on a single electrical port 120,
such that in case the tube is damaged not all wires 110 are
disconnected. Alternatively or additionally, areas of wall 122 in
which wires 110 are embedded are thicker than other areas of wall
122. Further alternatively or additionally, to allow for cheaper
production, wires 110 pass within channel 124, fixed to the
internal side of wall 122 or extending freely within the channel.
Further alternatively or additionally, wires 110 extend outside of
tube 100, fixed to the external side of wall 122 or extending
freely.
[0057] Alternatively to each electrode 108 having a separate
leading wire 110, two or more of the electrodes 108 are connected
through a single wire to electrical port 120. In some embodiments
of the invention, all of electrodes 108 are connected to a single
wire 110.
[0058] In some embodiments of the invention, instead of, or in
addition to, wires 110, one or more of electrodes 108 is coupled to
a wireless power reception port 143 (FIG. 2). In some embodiments
of the invention, power reception port 143 includes a coil for
receiving electrical energy through magnetic coupling.
Alternatively or additionally, port 143 includes a flat surface
electrode, which is sufficiently large to allow inducing of
currents therein. The currents optionally pass through electrode
108 to stimulate body tissue. Further alternatively or
additionally, port 143 operates on any other wireless power
transfer method, such as any of the methods known in the field of
smart cards and/or any of the methods discussed in the above
mentioned U.S. provisional patent application 60/632,739, filed
Dec. 1, 2004.
[0059] In an exemplary embodiment of the invention, wires connect
electrodes 108 to a wireless port on the proximal end of tube 100.
Wireless transmission from the proximal end of the tube outside the
patient requires less transmission power, while still not requiring
connection of wires to the tube.
[0060] In still other embodiments of the invention, a battery 149
(FIG. 2) is embedded within wall 122, to provide electrical power
to one or more of electrodes 108. Optionally, battery 149 has
sufficient charge for a single stimulation procedure.
Alternatively, when necessary, a battery with a high charge,
sufficient for a plurality of stimulation procedures may be
used.
[0061] Batteries thin enough to be embedded in walls of a feeding
tube are known in the art of smart cards and any of such batteries
and methods of embedding may be used with a feeding tube, in
accordance with the present invention.
[0062] The embedded battery is optionally coupled to one or more of
electrodes 108 through a switch circuit, which is activated
wirelessly from outside the patient's body. Alternatively, any
other switching method may be used, for example a reed-switch means
adapted to be controlled by a magnet from outside the patient.
Tube
[0063] Wall 122 is optionally sufficiently durable to withstand
being placed in a patient for more than 24 hours, optionally for
more than 3 or even 7 days. Tube 100 optionally has a length of at
least 40 centimeters, 50 centimeters or even 60 centimeters, so
that its distal end can reach the patient's stomach. In some
embodiments of the invention, tube 100 has a length above 90
centimeters, for example, between about 110-140 centimeters, so as
to be usable even on full grown large patients. Alternatively, tube
100 may be of any other suitable length. Tube 100 optionally has a
diameter of at least 8 French, or even at least 14 French, so as to
allow easy passage of feeding fluids into the stomach. In some
embodiments of the invention, tube 100 has a diameter smaller than
20 French, or even smaller than 14 French, so as to allow easy
insertion of the tube into the patient. It is noted, however, that
other diameters may be used.
[0064] Outlet 114 is optionally of an area of at least 50%, 60% or
even at least 70% of the outer diameter cross-section area of tube
100, allowing easy passage of fluids into and/or out of the tube.
Optionally, outlet 114 is substantially of the size of the inner
diameter cross-section of tube 100 along at least most of its
length. In some embodiments of the invention, outlet 114 comprises
an opening in the distal end of tube 100. Optionally, a surface
containing outlet 114 is substantially perpendicular to an axis of
tube 100. Alternatively, outlet 114 is formed as an opening in wall
122 of tube 100, while the distal end of the tube is closed.
[0065] In some embodiments of the invention, tube 100 includes a
simple tube, which is as cheap as possible. Alternatively, tube 100
is more complex, for example having inflatable walls and/or a valve
preventing gastric juices from entering tube 100, on outlet 114.
Further alternatively or additionally, tube 100 includes an
inflatable member cuff or balloon for preventing gastric juices
from exiting the stomach outside of tube 100. Optionally, in
accordance with this alternative, at least some of electrodes 108
are mounted on the balloon or cuff, so that they are pushed against
the esophagus wall and hence form better contact with the
esophagus. Alternatively or additionally, any other device may be
used to push the electrodes 108 against the esophageal wall. It is
noted, however, that this alternative may add to the cost of tube
100 and therefore may optionally be used only for patients at high
risk of requiring cardioversion. In some embodiments of the
invention, tube 100 includes a fuse which prevents undesired
electrification of the patient.
[0066] In some embodiments of the invention, tube 100 includes only
a single internal channel 124 suitable for flow of fluids.
Electrodes 108 are optionally mounted on the outer surface of wall
122 of the single channel 124. Alternatively, the lumen defined by
the wall 122 on which electrodes 108 are mounted, is divided into a
plurality of channels, by an internal barrier connected to wall
122. Further alternatively, the lumen defined by wall 122, on which
electrodes 108 are mounted, includes a plurality of sub-tubes which
define sub-channels through which feed and/or suction are applied.
It is noted, however, that in this embodiment, tube 100 is
relatively complex.
Stimulation
[0067] In some embodiments of the invention, when the patient
requires emergency electrical stimulation, a stimulation generation
apparatus (e.g., a defibrillator) is connected to wires leading to
two or more of the electrodes 108 and the electrical stimulation is
applied accordingly. Alternatively, the stimulation is applied
through a single electrode on tube 100 and an external electrode on
the patient.
[0068] Optionally, if necessary, signals may be sensed through one
or more of the electrodes 108, for example in order to determine
whether electrical stimulation was effective and/or which of the
electrodes 108 should be used (e.g., which of the electrodes forms
best contact with the esophagus). Alternatively or additionally,
electrodes 108 are used to sense signals for determining whether
stimulation is required.
[0069] In an exemplary embodiment of the invention, when electrical
stimulation is required, a stimulation generation apparatus senses
the electrical impedance between each two electrodes 108 on tube
100 and accordingly automatically selects the electrodes 108
through which stimulation is to be applied (or a single electrode
to be used with an external electrode) and/or an amplitude or other
parameter (e.g., frequency) of the applied stimulation.
Alternatively or additionally to determining the electrodes to be
used and/or a stimulation parameter when the stimulation is
required, the most suitable electrodes and/or the stimulation
parameters are selected immediately after installation of feeding
tube 100 and/or at any other time before stimulation is required.
The results of the determination are optionally stored in the
stimulation generation apparatus for a time at which the
stimulation is required. Alternatively or additionally, a micro
memory chip is mounted on tube 100, optionally embedded within wall
122, and the determined information is stored on the micro memory
chip. The memory chip is optionally located at a proximal end of
the tube near electrical port 120. Alternatively, the memory chip
is located near electrodes 108. The memory chip communicates with
the stimulation generation apparatus through wires or
wirelessly.
[0070] In some embodiments of the invention, the stimulation
apparatus is only connected to the patient when it is determined
that the patient requires electrical stimulation. Alternatively,
for example in high risk patients, a stimulation apparatus is
continuously connected to electrodes 108 on tube 100. In some
embodiments of the invention, the stimulation apparatus includes or
is coupled to a monitor, which follows the state of the patient's
heart. When the monitor determines that electrical stimulation is
required, the stimulation apparatus automatically applies the
stimulation. Alternatively, when the monitor determines that
electrical stimulation is required, the stimulation apparatus
automatically determines a best electrode and power selection for
the stimulation. The monitor optionally, in parallel, generates a
warning to a physician to apply the electrical stimulation.
Distal end electrode
[0071] While in the above description electrodes 108 are used for
transesophageal stimulation, in some embodiments of the invention,
an electrode is placed close to the distal end of tube 100 near
outlet 114, for stimulation through the stomach. Such distal end
electrode may be placed on tube 100 instead of electrode 108 or in
addition to electrode 108. Optionally, tube 100 is deflectable in a
controlled manner, using any method known in the art, so that the
distal end electrode can be directed to a desired position within
the patient. Optionally, a deflection mechanism is embedded within
wall 122. Before applying the stimulation, the distal end of tube
100 is deflected so that it forms contact with a desired organ
wall, for example close to the heart.
[0072] The use of a distal end electrode may be employed also on
gastrostomy tubes.
[0073] In the above description, the nasogastric tube is provided
by the manufacturer with electrodes 108 mounted thereon. It is
assumed that although not required for the majority of the
patients, having the electrode on the nasogastric tube, for those
patients requiring electrical stimulation, is worth the small extra
cost involved in having the electrode on the many nasogastric tubes
on which it is not needed. In other embodiments of the invention,
one or more electrodes 108 are added at a later time, for example
by a physician inserting the nasogastric tube into the patient.
Thus, electrodes 108 may be added to the nasogastric tube only for
patients at a high risk of requiring stimulation. In addition,
electrodes 108 may be placed on the nasogastric tube at an axial
position adapted to the specific patient into which the tube is
inserted. This may reduce the number of electrodes required on the
tube.
[0074] FIG. 4 is a schematic illustration of an electrode carrier
band 144, in accordance with an exemplary embodiment of the
invention. Electrode carrier band 144 is a disposable band for
mounting an electrode onto an elongate medical invasive probe.
Carrier band 144 includes an electrode 137 and a wire 134 (or a
group of wires), which electrically connects the electrode to a
power generator, sensor, controller or other apparatus, at a
proximal end of a nasogastric tube on which electrode carrier band
144 is placed. Electrode 137 is optionally mounted on a substrate
136, which serves to attach the electrode to tube 100. In some
embodiments of the invention, substrate 136 is covered with an
adhesive on a surface opposite electrode 137, which surface is
attached to the nasogastric tube. Optionally, substrate 136 is
provided with a peel off sheet (not shown), which covers the
adhesive before attaching substrate 136 to the tube. Before using
the nasogastric tube, the peel off sheet is removed and substrate
136 is attached to tube 100. Alternatively or additionally other
fastening methods may be used to connect carrier band 144 to a
feeding tube. For example, the band may surround the feeding tube
entirely, with its ends connecting to each other using Velcro,
adhesive, snaps or any other connection mechanism.
[0075] In some embodiments of the invention, substrate 136
comprises one or more protective layers, which protect the
nasogastric tube, from heat due to the electrical energy passed
through electrode 137. The protective layers include an
electrically isolative material, such as silicone,
polyvinylchloride, polyurethane or any other suitable isolative
material. The protective layer optionally has a thickness of at
least 0.1 mm or even 0.25 mm. In some embodiments of the invention,
the protective layer is thinner than 0.3 mm or even thinner than
0.15 mm, in order to limit the enlargement of the cross-section of
the nasogastric tube, due to the placement of electrode carrier
band 144 on the tube. Alternatively, a substrate 136 is not
included in carrier band 144, and electrode 137 is directly mounted
on the nasogastric tube (i.e., a portion of electrode 137 serves as
the substrate). The substrate together with the electrode are
optionally sufficiently flexible to take the form of the
nasogastric tube surface on which they are mounted. In some
embodiments of the invention, the substrate together with the
electrode is more flexible than the nasogastric tube, at least the
area of the tube on which substrate 136 is mounted.
[0076] Electrode 137, as well as electrodes 108, optionally
comprise a bio-compatible metal, such as titanium, silver,
stainless steel or gold. Alternatively, the electrode comprises an
alloy of metals, optionally including one or more of the above
materials. In some embodiments of the invention, electrode 137
includes a highly conductive outer film, of any suitable metal. The
conductive film is optionally used to cover a material base with a
lower electrical conductance.
[0077] Electrode 137 optionally covers most of the length of
substrate 136, so that the electrode covers a large percentage of
the circumference of the nasogastric tube. Thus, electrical
stimulation can be applied efficiently from many orientations of
tube 100.
[0078] In some embodiments of the invention, tube 100 is provided
in a sterile package along with the electrodes mounted thereon.
Alternatively, any of the add-on electrodes described in above
mentioned U.S. provisional application 60/632,739, is placed on a
nasogastric tube, before the tube is inserted into the patient.
Further alternatively, a thin sheath carrying the electrodes is
slid over the naso-gastric tube.
[0079] In some embodiments of the invention, tube 100 is adapted to
receive carrier band 144, for example by including a notch adapted
to receive the band, a fastening mechanism and/or a marking
indicating where to place the band. In some embodiments of the
invention, nasogastric tubes are produced with a marking indicating
where electrode carrier band 144 is to be placed along the length
of the tube. Possibly, the nasogastric tube includes a plurality of
markings corresponding to the positions for different patients
and/or for different types of expected stimulation situations.
[0080] Electrodes 108 and/or 137 may be used for various emergency
procedures, such as cardioversion, defibrillation and/or other
heart stimulation activities. Alternatively or additionally,
electrodes 108 and 137 may be used for sensing electrical signals
in both emergency and non-emergency procedures. Further
alternatively or additionally, electrodes 108 or 137 may be used
for long term pacing, for example in post-surgery patients. In
accordance with this alternative, the use of the electrodes is
optionally known in advance at the time of insertion of the feeding
tube, and hence a feeding tube with a larger number of electrodes
and/or more expensive electrodes may be used.
[0081] It is noted that the mounting of electrodes on feeding tubes
is not limited to a nasogastric tube, but rather may be used with
other feeding tubes (referred to also as food administering tubes),
such as gastric tubes inserted through a patient's mouth. In
addition, the mounting of electrodes for emergency situations may
be advantageous also on other tubes and invasive probes, such as
endotracheal tubes.
[0082] In one method of using feeding or endotracheal tubes with
electrodes suitable for cardioversion mounted thereon, a tube
having the electrode is inserted into a patient for a procedure
unrelated to cardioversion. The patient optionally has a low risk
of requiring cardioversion, optionally less that 10%, 5% or even
less than 1%. The tube is optionally inserted without the
electrodes being connected to a source of electrical power. If a
need for cardioversion arises, the electrodes are coupled to a
source of electrical power and cardioversion is performed.
Otherwise, the electrodes remain unused and are disposed with the
tube, when the tube is removed from the patient.
[0083] It will be appreciated that the above-described methods may
be varied in many ways, including, varying the type of nasogastric
tubes used. It should also be appreciated that the above described
description of methods and apparatus are to be interpreted as
including apparatus for carrying out the methods, and methods of
using the apparatus.
[0084] The present invention has been described using non-limiting
detailed descriptions of embodiments thereof that are provided by
way of example and are not intended to limit the scope of the
invention. It should be understood that features and/or steps
described with respect to one embodiment may be used with other
embodiments and that not all embodiments of the invention have all
of the features and/or steps shown in a particular figure or
described with respect to one of the embodiments. Variations of
embodiments described will occur to persons of the art.
Furthermore, the terms "comprise," "include," "have" and their
conjugates, shall mean, when used in the claims, "including but not
necessarily limited to."
[0085] It is noted that some of the above described embodiments may
describe the best mode contemplated by the inventors and therefore
may include structure, acts or details of structures and acts that
may not be essential to the invention and which are described as
examples. Structure and acts described herein are replaceable by
equivalents which perform the same function, even if the structure
or acts are different, as known in the art. Therefore, the scope of
the invention is limited only by the elements and limitations as
used in the claims.
* * * * *