U.S. patent application number 15/596620 was filed with the patent office on 2017-08-31 for devices for obstructing passage of air or other contaminants into a portion of a lung and methods of use.
This patent application is currently assigned to Boston Scientific Scimed, Inc.. The applicant listed for this patent is Boston Scientific Scimed, Inc.. Invention is credited to Aiden FLANAGAN, Torsten SCHEUERMANN, Jan WEBER.
Application Number | 20170245863 15/596620 |
Document ID | / |
Family ID | 50625212 |
Filed Date | 2017-08-31 |
United States Patent
Application |
20170245863 |
Kind Code |
A1 |
WEBER; Jan ; et al. |
August 31, 2017 |
DEVICES FOR OBSTRUCTING PASSAGE OF AIR OR OTHER CONTAMINANTS INTO A
PORTION OF A LUNG AND METHODS OF USE
Abstract
Provided are devices, systems and methods of selectively
controlling air flow into one or more section of a patient's lungs.
In particular, the devices may be valve devices having an inner
lumen configured to transition between a first diameter and a
second diameter smaller than the first diameter to control the
airflow through the valve.
Inventors: |
WEBER; Jan; (Maastricht,
NL) ; FLANAGAN; Aiden; (Kilcolgan, IE) ;
SCHEUERMANN; Torsten; (Munich, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Scimed, Inc. |
Maple Grove |
MN |
US |
|
|
Assignee: |
Boston Scientific Scimed,
Inc.
Maple Grove
MN
|
Family ID: |
50625212 |
Appl. No.: |
15/596620 |
Filed: |
May 16, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14229302 |
Mar 28, 2014 |
9681938 |
|
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15596620 |
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61816568 |
Apr 26, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/1204 20130101;
A61B 2017/00867 20130101; A61B 2090/3966 20160201; A61B 17/12036
20130101; A61F 2002/043 20130101; A61B 2017/00809 20130101; A61B
2017/00876 20130101; A61B 2017/1205 20130101; A61B 2017/00221
20130101; A61B 2017/00734 20130101; A61F 2/04 20130101; A61F
2002/482 20130101; A61F 2/86 20130101; A61B 17/12168 20130101; A61B
2017/00699 20130101; A61B 17/12177 20130101; A61B 2017/00411
20130101; A61B 17/12104 20130101; A61B 5/0816 20130101 |
International
Class: |
A61B 17/12 20060101
A61B017/12; A61F 2/04 20060101 A61F002/04; A61F 2/86 20060101
A61F002/86; A61B 5/08 20060101 A61B005/08 |
Claims
1-20. (canceled)
21. A device, comprising: a valve configured to move between a
first configuration and a second configuration, wherein air is
configured to encounter a greater resistance through the valve in
the second configuration than in the first configuration; and a
controller configured to send an output to the valve, the
controller being configured to: increase a frequency at which the
valve transitions between the first configuration and the second
configuration when a frequency of inhalation and exhalation of a
lung increases; and decrease the frequency at which the valve
transitions between the first configuration and the second
configuration when the frequency of inhalation and exhalation of
the lung decreases.
22. The device of claim 21, wherein the valve includes: a first
member having a proximal end, a distal end, and a lumen extending
therebetween; an inner member disposed about a portion of the
lumen, wherein the inner member defines a first diameter in the
first configuration, and defines a second diameter smaller than the
first diameter in the second configuration; and an actuation member
for transitioning the inner member between the first configuration
and the second configuration.
23. The device of claim 22, wherein the first member comprises a
wire frame having a plurality of interconnected wires.
24. The device of claim 23, wherein the wire frame comprises an
outer cover disposed about a portion of the wire frame.
25. The device of claim 22, wherein the actuation member is
configured to transition the valve from the first configuration to
the second configuration in response to a magnetic force.
26. The device of claim 22, wherein the actuation member includes
an electro-active polymer disposed on the inner member.
27. The device of claim 26, wherein the electro-active polymer is
connected to an electrical power source.
28. The device of claim 22, wherein the actuation member is
configured to transition the valve from the first configuration to
the second configuration in response to a stimulus.
29. The device of claim 21, wherein the valve is biased in one of
the first or second configurations.
30. The device of claim 21, further including a breathing sensor
operatively coupled to the controller, the breathing sensor
including an electrically conductive element, wherein the breathing
sensor is configured to detect the frequency of inhalation and
exhalation of the lung.
31. The device of claim 30, wherein the breathing sensor is
configured to detect the frequency of inhalation and exhalation of
the lung while the breathing sensor is coupled to a thorax.
32. A device, comprising: a plurality of valves each having a first
configuration and a second configuration, wherein air is configured
to encounter a greater resistance through each of the plurality of
valves in the second configuration than in the first configuration;
and a controller coupled to the plurality of valves, wherein the
controller is configured to transition each of the plurality of
valves between the first configuration and the second configuration
based on a respective location of each of the plurality of valves
in a lung.
33. The device of claim 32, wherein the plurality of valves
includes a first valve configured to be placed in a first airway of
the lung, and a second valve configured to be placed in a second
airway of the lung that is different than the first airway of the
lung, and wherein, over a period of one day, the controller is
configured to maintain the first valve in the first configuration
for a higher percentage of time than the second valve is maintained
in the first configuration based on respective locations of the
first airway and the second airway in the lung, and based on an
ability of the lung to expand in respective portions of the lung
adjacent to the first airway and the second airway.
34. The device of claim 32, wherein the controller is configured to
transition each of the plurality of valves between the first
configuration and the second configuration by changing a frequency
of energy supplied to the plurality of valves.
35. The device of claim 32, further including a breathing sensor
operatively coupled to the controller, the breathing sensor
including an electrically conductive element, wherein the breathing
sensor is configured to detect the breathing cycle of the lung
while the breathing sensor is coupled to a thorax of a patient.
36. The device of claim 35, further including a wireless output
operatively coupled to the breathing sensor, and a wireless
receiver operatively coupled to the controller, wherein the
wireless output is configured to send a wireless signal indicative
of the detected breathing cycle to the wireless receiver.
37. The device of claim 32, wherein the controller is configured to
increase a frequency at which at least one of the plurality of
valves transitions between the first configuration and the second
configuration when a frequency of inhalation and exhalation
increases in the lung.
38. A device, comprising: a first valve movable between a first
configuration and a second configuration; a breathing sensor
configured to detect a breathing cycle of a patient; and a
controller coupled to the first valve, the controller being
configured to transition the first valve between the first
configuration and the second configuration based on the detected
breathing cycle.
39. The device of claim 38, further including: a wireless receiver
operatively coupled to the controller; and a wireless output
operatively coupled to the breathing sensor, wherein the wireless
output is configured to send a wireless signal indicative of the
detected breathing cycle to the wireless receiver.
40. The device of claim 38, further including an energy supply
including an inductive coil configured to deliver energy to the
first valve, wherein the controller is configured to transition the
first valve between the first configuration and the second
configuration by changing a frequency of the energy delivered from
the energy supply to the first valve.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority from U.S.
Provisional Application No. 61/816,568, filed on Apr. 26, 2013, the
entirety of which is incorporated by reference herein.
FIELD
[0002] Embodiments of the disclosure relate generally to medical
devices and methods of treating medical conditions. In particular,
embodiments of the present disclosure relate to medical devices
having a valve. More specifically, embodiments of the present
disclosure relate to medical devices having a valve which may
selectively control air flow into sections of one or more lungs of
a patient.
BACKGROUND
[0003] Chronic obstructive pulmonary disease (COPD) is a disease of
the lungs in which the airways narrow over time limiting airflow
into and out of the lungs causing shortness of breath. In most
cases, advanced stages of COPD may lead to breathing difficulties
caused by the inability of the lungs to inflate/deflate due to
severe air trapping. One type of COPD is emphysema in which the
airways distal to the terminal non-respiratory bronchioles enlarge
due to the breakdown and destruction of the alveolar walls.
Emphysema can result in air trapping, hyperinflation, and dynamic
hyperinflation, each of which may reduce a patient's ability to
respire. This reduction in a patient's ability to respire may
ultimately lead to respiratory failure. In essence, in emphysema
patients, the residual volume of the airways distal to the terminal
non-respiratory bronchioles increases significantly, leaving little
remaining room in their thoracic cage to breath.
[0004] COPD is most commonly caused by noxious particles or gas,
often from tobacco smoking, which triggers an abnormal inflammatory
response in the lung and which may damage or destroy lung tissue.
Conventionally, Lung Volume Reduction Surgery (LVRS) has been used
to remove diseased and/or emphysematous lung tissue, thereby
allowing the expansion of the remaining (e.g. healthier) portions
of the lung tissue. This procedure is possible because the lungs
are divided up into relatively independent functional units.
Specifically, the lungs are divided up by fissures into a
predictable arrangement of lobes. For example, a human right lung
includes three lobes--a superior lobe, a middle lobe, and an
inferior lobe. A human left lung includes two lobes--a superior
lobe and an inferior lobe. The lobes are characterized by a
discrete connection with the first subdivision of the bronchial
tree after the level of the principal bronchi to both lungs--the
lobar bronchi. In a similar manner, the vascular, nerve, and
lymphatic supply from the hila to each lobe has minimal connection
with other lobes. This makes the lobes relatively independent
functional units within the lung. Indeed, pathology may be confined
to one lobe and corrective surgery may be facilitated by the clear
demarcation between lobes produced by the fissures.
[0005] Contrary to intuition, LVRS has been shown to help improve
breathing ability, lung capacity and overall quality of life. The
healthy alveoli are able to inflate more fully and dead space is
reduced. LVRS, however, may cause extensive discomfort to patients,
and may pose serious health risks due to the invasive nature of the
procedure. Lung transplantation is another surgical treatment for
homogeneous (diffuse) emphysema. However, lung transplantation
suffers from similar drawbacks as LVRS and may be an unrealistic
option for most patients as lung transplant eligibility is limited
both by stringent patient selection criteria and the scarcity of
donor lungs.
[0006] Therefore, a need exists for a minimally invasive treatment
that selectively controls air flow into the lungs to allow
expansion of healthier portions of the lungs.
SUMMARY
[0007] Embodiments of the present disclosure relate to a devices
for selectively controlling air flow.
[0008] In accordance with an aspect of the present disclosure, a
device for selectively controlling air flow may include an elongate
member having a proximal end, a distal end, and a lumen extending
therebetween; an inner member disposed about a portion of the
lumen, the inner member may be configured to transition between a
first configuration and a second configuration, in the first
configuration, the portion of the lumen including the inner member
may define a first diameter, and, in the second configuration, the
portion of the lumen including the inner member may define a second
diameter smaller than the first diameter; and an actuation member
for transitioning the inner member between the first configuration
and the second configuration.
[0009] Various embodiments of the device may include one or more of
the following features: the elongate member may include a wire
frame having a plurality of interconnected wires, the wire frame
may include an outer cover disposed about a portion of the wire
frame, the actuation member may be configured to transition the
inner member from the first configuration to the second
configuration in response to a magnetic force, the actuation member
may include an electro-active polymer disposed on the inner member,
the electro-active polymer may be connected to an electrical power
source, the actuation member may be configured to transition the
inner member from the first configuration to the second
configuration in response to a stimulus, the inner member may be
biased in one of the first or second configurations.
[0010] In accordance with another aspect, is a system for
controlling air flow in parts of a lung that may include a
plurality of valve devices; and a controller coupled to the
plurality of valve devices configured to control power supplied to
the plurality of valve devices, each of the plurality of valve
devices may include an elongate member having a proximal end, a
distal end, and a lumen extending therebetween, an inner member
disposed about a portion of the lumen, the inner member may be
configured to transition between a first configuration and a second
configuration, in the first configuration, the portion of the lumen
including the inner member may define a first diameter, and in the
second configuration, the portion of the lumen including the inner
member may define a second diameter smaller than the first
diameter, and may include an actuation member for transitioning the
inner member between the first configuration and the second
configuration, the actuation member may be disposed on a portion of
the inner membrane.
[0011] Various embodiments of system may include one or more of the
following features: the elongate member may include a wire frame,
the actuation member may include a plurality of magnets, the wire
frame may include an outer cover disposed about a portion of the
wire frame, the actuation member may include an electro-active
member disposed on the inner member, the electro-active polymer may
be deposited in one or more parallel stripes, the actuation may be
configured to transition the inner member from the first
configuration to the second configuration, the inner member may be
biased in one of the first or second configurations.
[0012] Another aspect of the present disclosure includes a method
of controlling air flow in a patient, and may include steps of
implanting a plurality of valve devices in a lung, in which each of
the plurality of valve devices may include an elongate member
having a proximal end, a distal end, and a lumen extending
therebetween, an inner member disposed about a portion of the
lumen, in which the inner member is configured to transition
between a first configuration and a second configuration, in the
first configuration, the portion of the lumen including the inner
member may define a first diameter, and in the second
configuration, the portion of the lumen including the inner member
may define a second diameter smaller than the first diameter, and
an actuation member that may transition the inner member between
the first configuration and the second configuration; and actuating
the actuation member to transition the inner member from the first
configuration to the second configuration so as to reduce a
dimension of the lumen.
[0013] Various embodiments of the method may include one or more of
the following features: the elongate member may include a wire
frame, the actuation member may include a plurality of magnets,
providing a magnetic force to actuate the actuating member and
transition the inner member from the first configuration to the
second configuration.
[0014] Additional objects and advantages of the present disclosure
will be set forth in part in the description which follows, and in
part will be obvious from the description, or may be learned by
practice of the claimed invention. The objects and advantages of
the claimed invention will be realized and attained by means of the
elements and combinations particularly pointed out in the appended
claims.
[0015] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory only and are not restrictive of the invention, as
claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate exemplary
embodiments of the present disclosure and together with the
description, serve to explain the principles of the disclosure.
[0017] FIGS. 1A and 1B are side views of an implanted valve device,
according to an embodiment of the present disclosure, showing
relaxed and contracted positions of the valve device.
[0018] FIGS. 2A and 2B are side views of an implanted valve device,
according to another embodiment of the present disclosure, showing
relaxed and contracted positions of the valve device.
[0019] FIGS. 3A and 3B are perspective views of a valve device,
according to another embodiment of the present disclosure.
[0020] FIG. 4A illustrates exemplary regions of a lung into which
exemplary embodiments of valve devices disclosed herein may be
placed, according to an embodiment of the present disclosure.
[0021] FIGS. 4B and 4C are views of a delivery device, according to
another embodiment of the present disclosure.
[0022] FIGS. 5A and 5B are views of a valve device, according to
another embodiment of the present disclosure.
[0023] FIG. 6 illustrates an exemplary circuit diagram for
controlling valve devices, according to an embodiment of the
present disclosure.
[0024] FIG. 7 is a graph showing relaxed and closed positions of
valve devices synchronized with inhalation frequency, according to
an embodiment of the present disclosure.
[0025] FIG. 8 illustrates a flow control device according to
another embodiment of the present disclosure.
DESCRIPTION OF THE EMBODIMENTS
[0026] Reference will now be made in detail to embodiments of the
present disclosure, examples of which are illustrated in the
accompanying drawings. Wherever possible, the same reference
numbers will be used throughout the drawings to refer to the same
or like parts. The term "distal" refers to the end farthest away
from a medical professional when introducing a device in a patient.
By contrast, "proximal" refers to the end closest to the medical
professional when placing a device in the patient.
[0027] Overview
[0028] Embodiments of the present disclosure relate to devices,
systems, and methods for controlling air flow. In particular,
embodiments of the present disclosure relate to devices, systems,
and methods which may selectively restrict air from entering
certain portions of the lungs or other organs. For example, when
placed in a portion of one or more lungs, the devices disclosed
herein may allow air to enter a section of the lungs at one time
and restrict air from entering at another time. In another example,
multiple valve devices may be implanted at different sections of
the lungs to allow air to enter a first section of the lungs while
restricting air from entering other parts of the lungs, thereby
allowing the first section of the lungs more space to expand during
inhalation.
[0029] The device and system may also be used to selectively
control which parts of the lungs, or any other organ into which the
device is placed, are exposed to smoke. e.g. during inhalation of
cigarette smoke, and further may be used to control and maintain
air velocity for COPD patients. In addition, the device, system and
method may be used to reduce or prevent inhalation of other
contaminants from entering portions of the lung or any other organs
into which the device is placed. For example, the device may be
used to prevent or reduce inhalation of noxious and/or toxic fumes,
and/or gases by those working in an environment in which
potentially harmful or irritating gases or fumes are present. For
instance, the device may be used by workers in oil fields and
mines, workers handling waste products, fire-fighters to prevent
exposure to smoke, toxic fumes, odors, and other contaminants, and
anyone exposed to harmful contaminants.
[0030] The device may also be used to choke air flow above a
certain flow-rate, such that a flow-condition is created similar to
that achieved by applying the "Rescue Technique" in which a gentle
force is applied to a patient's chest to force expiration or air.
This technique helps correct dynamic hyperinflation by gently
forcing air out of the lungs, thereby reducing both the internal
chest pressure as well as the air velocity through the bronchial
tubes. The device may be placed downstream in larger bronchial
tubes such that air velocity remains under a certain threshold,
this is in contrast to COPD patients in whom the bronchial tube may
collapse above a certain flow rate. The device may limit air
velocity to remain under a value lower than the critical flow at
which most bronchioles may collapse. The device may include a
membrane which moves inwards when air flow in increased. This
configuration may allow flow resistance to increase gradually with
increasing air flow so that air flow may remain (choked) under a
certain maximum. The membrane may be configured to not fully close
so as to maintain an air-duct through the device, allowing a low
flow-rate to be maintained, similar to the flow rate achieved by
the Rescue Technique.
[0031] In the above overview, the lung is only used as an example
and the disclosed devices may be used in other organs of the body.
Various embodiments herein may include one or more features of
other disclosed embodiments.
Exemplary Embodiments
[0032] FIGS. 1A and 1B illustrate two side views of an exemplary
valve device 100 for controlling air flow according to embodiments
of the present disclosure. Particularly, FIG. 1A illustrates valve
device 100 in a relaxed position and FIG. 1B illustrates the valve
device 100 in a contracted position.
[0033] Valve device 100 may include a substantially circular
cross-section or it may have a cross-section similar to that of
body cavities such that it may occupy a desired space in the body.
Accordingly, where required by given applications, valve device 100
may include elliptical, semi-circular, rhombic, rectangular, or any
other suitable profile. Moreover, the diameter of valve device 100
may vary based on the size of the body lumens in which it operates.
In addition, the cross-sectional geometry of valve device 100 may
vary along its length. The valve device 100 may include a lumen 105
between the valve device 100 distal 170 and proximal 180 ends.
[0034] The lumen 105 may have any suitable size and shape,
including circular, elliptical, semi-circular, rhombic, or
rectangular. The size and shape of the lumen 105 may be constant or
may vary along its length.
[0035] The valve device 100 may include a wire frame 110 made of
any suitable material for implantation in the body. Such materials
may include metals, including, for example, stainless steel or
other alloys and/or may include any suitable shape-memory material,
including metal and/or polymeric materials, such as nitinol or
polyurethane based memory polymers. The wire frame 110 may be
capable of self-expanding. For example, the wire frame 110 may
include a plurality of wires having one or more shape memory
materials interconnected to form a stent-like configuration. This
may allow the wire frame 110 to be in a collapsed position during
placement of the valve device 100, and then subject to
self-expansion upon placement due to the shape memory properties of
the shape memory materials.
[0036] In another embodiment, the wire frame 110 may be
non-self-expanding. For example, the wire frame may include a
plurality of wires interconnected to form a stent-like
configuration in a compressed or crimped configuration and may be
expanded by any suitable mechanism upon delivery of the device or
any time thereafter. For example, the compressed non-self-expanding
wire frame 110 may be delivered to the desired location in the
compressed configuration using a delivery device. An expandable
member, such as a delivery device having an expandable portion may
be inserted into the wire frame 110 lumen 105 and expanded, thereby
expanding the wire frame 110 and then removed from the wire frame
110. For example, the delivery device may be a catheter having an
expandable portion, such as an expandable balloon and the wire
frame 110 may be placed over the unexpanded device. The expandable
device, such as a balloon catheter may be expanded, thereby
expanding the wire frame 110 to the desired diameter. The balloon
catheter may then be deflated and removed from the expanded wire
frame 110.
[0037] The wire frame 110 may include barbs, tines and/or other
protrusions to allow implantation, removal and/or anchoring of the
valve device 100 in the desired location. For example, the wire
frame 110 may include a tine or other suitable protrusion (e.g. a
hook or loop) that may engage with implantation and/or removal
tools so as to allow the wire frame 110 to be expanded or
collapsed, for example using a pull wire. In addition, an outer
surface of valve device 100 may include one or more barbs for
engaging adjacent tissue to facilitate retaining the valve device
100 in a desired location.
[0038] The wire frame 110 may include an outer cover 120 having a
sufficient rigidity to maintain a tubular configuration on the wire
frame 110. The outer cover 120 may extend along the entire length
or only along one or more portions of the wire frame 110. The outer
cover 120 may extend completely around or only partially around the
wire frame 110. The material used to manufacture the outer cover
120 may include a flexible material and exemplary embodiments may
include polytetrafluoroethylene (PTFE), polyethylene, FEP
(fluorinated ethylene propylene), ETFE (ethylene
tetrofluoroethylene), polypropylene, polysulfone, polyethylene,
polyethersulfone, silicone, silicon rubber, etc. The outer cover
120 may include a coating having, for example, lubricious, and/or
therapeutic properties (e.g. antibiotic, anti-inflammatory,
anesthetic), and may be porous. In addition, the outer cover 120
may be radiopaque and/or may include markings to allow
visualization under x-ray or fluoroscopy.
[0039] Valve device 100 may include an inner membrane 130 along at
least a portion of the inside of the wire frame 110. The inner
membrane 130 may have elastic properties. The material used to
manufacture the inner membrane 130 may include a flexible material
and exemplary embodiments may include polytetrafluoroethylene
(PTFE), polyethylene, FEP (fluorinated ethylene propylene), ETFE
(ethylene tetrofluoroethylene), polypropylene, polysulfone,
polyethylene, polyethersulfone, silicone, silicon rubber, etc. The
inner membrane 130 may have a uniform flexibility or have varying
flexibilities along the inner membrane 130. For example, the inner
membrane 130 may be more flexible at a central portion. The inner
membrane 130 may have the same or different flexibility as the
outer cover 120.
[0040] The inner membrane 130 may be provided at one or more
continuous or non-continuous portions of the valve device 100, for
example, at a distal end 170, and/or proximal end 180, or any other
portions or combination of portions inside the valve device 100.
For example, as shown in FIGS. 1A and 1B, inner membrane 130 may be
provided inside a proximal portion 180 of the valve device 100. The
inner membrane 130 and may have a round, triangular shape or any
other suitable shape, geometry, size or orientation.
[0041] The valve device 100 may include one or more actuation
components 140 that may change from a first non-actuated state to a
second actuated state. The actuation components 140 may be directly
or indirectly connected to a portion of the inner membrane 130 by
any suitable means, such that when actuated, the actuation
components 140 may cause a change in the amount of inner lumen 105
space the inner membrane 130 occupies, thereby transitioning the
inner lumen 105 from a first diameter to a second smaller diameter,
thereby narrowing at least a portion of the lumen 105. For example,
when actuated, the actuation component 140 may cause the inner
membrane 130 to expand and thereby increasing the amount of inner
lumen 105 space the inner membrane 130 occupies.
[0042] The actuation components 140 may take any suitable
composition, size shape, geometry or orientation. Adjacent
actuation components 140 may be uniformly or non-uniformly spaced
apart on the valve device 100. Any suitable means may be used to
dispose the actuation components 140 on the valve device 100,
including, but not limited to: printing, adhesive, or
embossing.
[0043] In the exemplary embodiment shown in FIGS. 1A and 1B,
portions of the inner membrane 130 may include or be connected to
actuation components 140 that may change from a first non-actuated
state (FIG. 1A) to a second actuated state (FIG. 1B), such that the
actuated state causes at least a portion of the inner membrane 130
having a flap-like form, to bias from a first configuration to a
second configuration. For example, the actuated state may cause the
inner membrane 130 to expand and occupy a greater portion of the
lumen 105 (FIG. 1B) than when in the non-actuated state, and narrow
at least a portion of the lumen 105.
[0044] The actuation components 140 may be configured to limit the
amount of space of the inner lumen 105 that the inner membrane 130
occupies when it is expanded by the actuated actuation components
140 so as to prevent the lumen 105 from being fully blocked by the
inner member 130.
[0045] Examples of actuation mechanisms that may actuate the
actuation components 140 may include, but are not limited to:
electro-active polymer (EAP) actuation, pneumatic actuation (e.g.,
compressed air/gas), electrical actuation, hydraulic actuation,
piezoelectric actuation, thermal actuation, electrostatic
actuation, magnetic actuation, inductive actuation, actuation by
the body's own forces (e.g. during breathing), and any other
suitable actuation methods.
[0046] The embodiments shown in FIGS. 2A and 2B may include any of
the components or features of the embodiments described in
reference to FIGS. 1A and 1B.
[0047] Valve device 200 may include a substantially circular
cross-section or it may have a cross-section similar to that of
body cavities such that it may occupy a desired space in the body.
Accordingly, where required by given applications, valve device 200
may include elliptical, semi-circular, rhombic, rectangular, or any
other suitable profile. Moreover, the diameter of valve device 200
may vary based on the size of the body lumens in which it operates.
In addition, the cross-sectional geometry of valve device 200 may
vary along its length.
[0048] The valve device 200 may include a wire frame 210 made of
any suitable material such as a metal, for example, stainless steel
or other alloy and/or may include any suitable shape-memory
material including metal and/or polymeric material, such as nitinol
or polyurethane based memory polymers. The wire frame 210 may be
capable of self-expanding. For example, the wire frame 210 may
include a plurality of wires interconnected to form a stent-like
configuration with a lumen 205. This may allow the wire frame 210
to be in a collapsed position during placement of the valve device,
and then subject to self-expansion upon placement.
[0049] In another embodiment, the wire frame 210 may be
non-self-expanding. For example, the wire frame may include a
plurality of wires interconnected to form a stent-like
configuration in a compressed or crimped configuration and may be
expanded by any suitable mechanism upon delivery of the device or
any time thereafter. For example, the compressed non-self-expanding
wire frame 210 may be delivered to the desired location in the
compressed configuration using a delivery device. A device having
an expandable portion, such as the delivery device or any other
device having an expandable portion may be inserted into the wire
frame 210 and expanded, thereby expanding the wire frame 210 and
then removed from the wire frame 210. For example, the delivery
device may be a catheter having an expandable portion, such as an
expandable balloon and the wire frame 210 may be placed over the
unexpanded balloon catheter. The expandable device, such as a
balloon catheter may be expanded, thereby expanding the wire frame
210 to the desired diameter. The balloon catheter may then be
deflated and removed from the wire frame 210.
[0050] The wire frame 210 may include barbs, tines and/or other
protrusions to allow implantation, removal and/or anchoring of the
valve device 200 in the desired location. For example, the wire
frame 210 may include a tine or other suitable protrusion (e.g. a
hook or loop) that may engage with implantation and/or removal
tools so as to allow the wire frame 210 to be expanded or
collapsed, for example using a pull wire. In addition, an outer
surface of valve device 200 may include one or more barbs for
engaging adjacent tissue to facilitate retaining the valve device
200 in a desired location.
[0051] The wire frame 210 may include an outer cover 220 having a
sufficient rigidity to maintain a tubular configuration on the wire
frame 210. The outer cover 220 may extend along the entire length
or only along one or more portions of the wire frame 210. The outer
cover 220 may extend completely around or only partially around the
wire frame 210. The material used to manufacture the outer cover
220 may include a flexible material and exemplary embodiments may
include polytetrafluoroethylene (PTFE), polyethylene, FEP
(fluorinated ethylene propylene), ETFE (ethylene
tetrofluoroethylene), polypropylene, polysulfone, polyethylene,
polyethersulfone, silicone, silicon rubber, etc. The outer cover
220 may include a coating having, for example, lubricious, and/or
therapeutic properties (e.g. antibiotic, anti-inflammatory,
anesthetic), and may be porous. In addition, the outer cover 220
may be radiopaque and/or may include markings to allow
visualization under x-ray or fluoroscopy.
[0052] Valve device 200 may include an inner membrane 230 along at
least a portion of the inside of the wire frame 210. The inner
membrane 230 may have elastic properties. The material used to
manufacture the inner membrane 230 may include a flexible material
and exemplary embodiments may include polytetrafluoroethylene
(PTFE), polyethylene, FEP (fluorinated ethylene propylene), ETFE
(ethylene tetrofluoroethylene), polypropylene, polysulfone,
polyethylene, polyethersulfone, silicone, silicon rubber, etc. The
inner membrane 230 may have a uniform flexibility or have varying
flexibilities. For example, the inner membrane 230 may be more
flexible at a central portion. The inner membrane 230 may have the
same or different flexibility as the outer cover 220.
[0053] The inner membrane 230 may be provided at one or more
continuous or non-continuous portions of the valve device 200. For
example, as shown in FIGS. 2A and 2B, inner membrane 230 may be
provided along the length of the valve device 200. The inner
membrane 230 and may have a round, triangular shape or any other
suitable shape, geometry, size or orientation.
[0054] The valve device 200 may include one or more stretchable
components 240 that may change from a first non-elongated state to
a second elongated state. The stretchable components 240 may be
directly or indirectly connected to a portion of the inner membrane
230 by any suitable means, such that when elongated, they may cause
a change in the amount of inner lumen 205 space the inner membrane
230 occupies, thereby narrowing at least a portion of the lumen
205. For example, when elongated, the stretchable components 240
may cause the inner membrane 230 to expand, thereby increasing the
amount of inner lumen 205 space the inner membrane 230 occupies. In
turn, the inner lumen 205 transitions from a first diameter to a
second diameter that is smaller than the first diameter.
[0055] The stretchable components 240 may take any suitable
composition shape, geometry or orientation. Adjacent components 240
may be uniformly or non-uniformly spaced apart on the valve device
200. Any suitable means may be used to dispose the components 240
on the valve device 100, including, but not limited to: printing,
using adhesive, or embossing.
[0056] As shown in FIGS. 2A and 2B, an example of stretchable
components 240 that may change from a non-elongated state (FIG. 2A)
to second elongated state (FIG. 2B) such that the elongated state
causes at least a portion of the inner membrane 230, which may be
formed along the valve device 200, to occupy the lumen 205 and
narrow at least a portion of the lumen 205, may be an elastic fiber
network 240 having various expansion amounts.
[0057] The stretchable components 240 may be manufactured from any
suitable material that may stretch from a non-elongated state to an
elongated state and may function in accordance with Bernoulli's
Principle. Bernoulli's Principle states that as the speed of a
moving fluid increases, the pressure within the fluid decreases. As
such, the lumen 205 of the valve device 200 may have a certain
pressure and if this pressure drops, the inner membrane 230 may
collapse inwards, thereby closing the lumen 205. The stretchable
components 240 may prevent the lumen 205 from being fully closed by
the inner membrane 230 by being configured to reach their elastic
limit, e.g. the maximum amount the stretchable components 240 may
elongate, before the lumen 205 is fully closed by the inner
membrane 230. For example, the stretchable components 240 may act
as strain limiting factors. For instance, the stretchable
components 240 may be manufactured by extrusion or a casting a tube
made of a flexible soft polymer, for example a very low durometer
polyurethane. Holes may then be made in the wall of the tube,
using, for example, an excimer laser, such that only thin walls
between the holes remain. A polymer sheath may then be adhered to
the inside this open structure. In a similar manner, a polymer
sheath may be adhered around the outside of the tube. In addition,
the outer and inner sheath may be adhered together at both ends to
make a closed construction. In addition, or alternatively, the
stretch component 240 may be formed by any other suitable method.
For example, a thin flexible polymer material may be formed into a
tube and folded in half, similar to a sock, and placed inside a
hole. A pin may then be inserted through the middle of the folded
flexible polymer material and a polymer foam may be injected in the
formed double layer that adheres to both surfaces, forming a
stretch component 240 network between two sides of an inner
membrane 230.
[0058] The embodiments shown in FIGS. 3A and 3B may include any of
the components or features of the embodiments described in
reference to FIGS. 1A, 1B, 2A and, 2B.
[0059] Valve device 300 may include a substantially circular
cross-section or it may have a cross-section similar to that of
body cavities such that it may occupy a desired space in the body.
Accordingly, where required by given applications, valve device 300
may include elliptical, semi-circular, rhombic, rectangular, or any
other suitable profile. Moreover, the diameter of valve device 300
may vary based on the size of the body lumens in which it operates.
In addition, the cross-sectional geometry of valve device 300 may
vary along its length.
[0060] The valve device 300 may include a wire frame 310 made of
any suitable material such as a metal, for example, stainless steel
or other alloy and/or may include any suitable shape-memory
material, including metal and/or polymeric materials, such as
nitinol or polyurethane based memory materials. The wire frame 310
may be capable of self-expanding. For example, the wire frame 310
may include a plurality of wires interconnected to form a
stent-like configuration with a lumen 305. This allows the wire
frame 310 to be in a collapsed position during placement of the
valve device, and then subject to self-expansion upon
placement.
[0061] In another embodiment, the wire frame 310 may be
non-self-expanding. For example, the wire frame may include a
plurality of wires interconnected to form a stent-like
configuration in a compressed or crimped configuration and may be
expanded by any suitable mechanism upon delivery of the device or
any time thereafter. For example, the compressed non-self-expanding
wire frame 310 may be delivered to the desired location in a
compressed configuration using a delivery device. A device having
an expandable portion, such as the delivery device may be inserted
into the wire frame 310 and expanded, thereby expanding the wire
frame 310 and then removed from the wire frame 310. For example,
the delivery device may be a catheter having an expandable portion,
such as an expandable balloon and the wire frame 310 may be placed
over the unexpanded balloon catheter. The expandable portion, such
as a balloon catheter may be expanded, thereby expanding the wire
frame 310 to the desired diameter. The balloon catheter may then be
deflated and removed from the wire frame 310.
[0062] The wire frame 310 may include barbs, tines and/or other
protrusions to allow implantation, removal and/or anchoring of the
valve device 300 in the desired location. For example, the wire
frame 310 may include a tine or other suitable protrusion (e.g. a
hook or loop) that may engage with implantation and/or removal
tools so as to allow the wire frame 310 to be expanded or
collapsed, for example using a pull wire. In addition, an outer
surface of valve device 300 may include one or more barbs for
engaging adjacent tissue to facilitate retaining the valve device
300 in a desired location.
[0063] The wire frame 310 may include an outer cover 320 having a
sufficient rigidity to maintain a tubular configuration on the wire
frame 310. The outer cover 320 may extend along the entire length
or only along one or more portions of the wire frame 310. The outer
cover 320 may extend completely around or only partially around the
wire frame 310. The material used to manufacture the outer cover
320 may include a flexible material and exemplary embodiments may
include a flexible material and exemplary embodiments may include
polytetrafluoroethylene (PTFE), polyethylene, FEP (fluorinated
ethylene propylene), ETFE (ethylene tetrofluoroethylene),
polypropylene, polysulfone, polyethylene, polyethersulfone,
silicone, silicon rubber, etc. The outer cover 320 may include a
coating having, for example, lubricious, and/or therapeutic
properties (e.g. antibiotic, anti-inflammatory, anesthetic), and
may be porous. In addition, the outer cover 320 may be radiopaque
and/or may include markings to allow visualization under x-ray or
fluoroscopy.
[0064] Valve device 300 may include an inner membrane 330 along at
least a portion of the inside of the wire frame 310. The inner
membrane 330 may have elastic properties. The material used to
manufacture the inner membrane 330 may include a flexible material
and exemplary embodiments may include a flexible material and
exemplary embodiments may include polytetrafluoroethylene (PTFE),
polyethylene, FEP (fluorinated ethylene propylene), ETFE (ethylene
tetrofluoroethylene), polypropylene, polysulfone, polyethylene,
polyethersulfone, silicone, silicon rubber, etc. The inner membrane
330 may have a uniform flexibility or have varying flexibilities.
For example, the inner membrane 330 may be more flexible at a
central portion. The inner membrane 330 may have the same or
different flexibility as the outer cover 320.
[0065] The valve device 300 may include one or more actuation
components 340 that may change from a first non-actuated state to a
second actuated state. The actuation components 340 may be directly
or indirectly connected to a portion of the inner membrane 330 by
any suitable means, such that when actuated, the actuation
components 340 may cause a change in the amount of inner lumen 305
space the inner membrane 330 occupies, thereby narrowing at least a
portion of the lumen 305. For example, when actuated, the actuation
component 340 may cause the inner membrane 330 to expand and
thereby increasing the amount of inner lumen 305 space the inner
membrane 330 occupies. In turn, the inner lumen 305 transitions
from a first diameter to a second diameter that is smaller than the
first diameter.
[0066] The actuation components 340 may take any suitable
composition shape, geometry or orientation. Adjacent actuation
components 340 may be uniformly or non-uniformly spaced apart on
the valve device 300. Any suitable means may be used to dispose the
actuation components 340 on the valve device 300, including, but
not limited to: printing, using adhesive, or embossing.
[0067] As described above, the actuation of the actuation
components 340 may be accomplished by any suitable mechanism.
Examples of such actuation mechanisms may include, but are not
limited to: electro-active polymer (EAP) actuation, pneumatic
actuation (e.g., compressed air/gas), electrical actuation,
hydraulic actuation, piezoelectric actuation, thermal actuation,
electrostatic actuation, magnetic actuation, inductive actuation,
the body's own forces, and any other suitable actuation
methods.
[0068] Adjacent actuation components 340 may be uniformly or
non-uniformly spaced apart on the valve device and may comprise a
material that exhibits a change in state, size, shape, geometry,
orientation or any other change when subjected to a stimulus.
[0069] For example, the actuation components 340 may include an EAP
component. The actuation components 340 may have any suitable
shape, size (length, thickness, width) orientation or geometry. For
example, as shown in FIGS. 3A and 3B, the actuation components 340
may include EAP material(s) having a stripe like shape or other
suitable shape, configuration, or geometry. The actuation
components 340 may be oriented in a vertical, horizontal, oblique
angle, acute angle, or any other orientation and may be spaced at
regular or irregular intervals along the inner membrane 330. The
number and amount of space between each of the actuation components
340 may be varied depending on the amount of bending and the shape
required of the contracted inner membrane 330. The actuation
components 340 may be disposed the around the entire length of the
valve device 300 or along portions of the valve device 300. The
actuation components 340 may be disposed all the way around the
valve device 300 or partially around the valve device 300.
[0070] The actuation components 340 may be disposed by any suitable
means on the valve device 300, for example, via printing, using
adhesive, or embossing. FIGS. 3A and 3B show an example of using an
actuation configuration in which the actuation components 340 may
be disposed on the inner membrane 330 of the valve device 300. In
an exemplary embodiment, actuation components 340 may be printed on
the inner membrane 330 using a inkjet or any other suitable type of
printing. The actuation components 340 may include an EAP and the
EAP may cycle at frequencies up to about 5 Hz, which may be well
beyond normal breathing frequencies.
[0071] When subjected to a power source, such as for example, an
electric field, the actuation components 340 may change (e.g. bend,
contract, stretch, expand, swell, harden, soften) due to ionic
absorption or molecular attraction.
[0072] The actuation components 340 may include electronic, ionic
and/or elecstrictive, or any other suitable type of EAP. Some
commonly known EAPs include, but are not limited to, polypyrroles,
polyanilines, polythiophenes, polyethylenedioxythiophenes,
poly(p-phenylene vinylene)s, polysulfones and polyacetylenes.
[0073] For example, the actuation components 340 may include an
ionic liquid EAP, for example polypyrole, which may have similar
strength properties to human muscle, and/or other conjugated
polymers, such as, polyaniline, poly(ethylenedioxythiopene). The
actuation components 340 may swell and may switch between an
actuated and non-actuated state within a desired time period, for
example, within 1-10 or 1-5 seconds. The power consumption of the
EAP may be low, such as less than 1 volt.
[0074] One or more portions of each of the actuation components 340
may be connected to an electrode 350 which in turn may be connected
to a power source. For example, portions adjacent both ends of each
actuation component 340 may be connected to an electrode 350.
Examples of the power source may include an internal or external
battery, or internal or external capacitor. The power source 360
may activate the actuation components 340, allowing them to change
states.
[0075] For example, as explained in Mirfakhrai et al., Polymer
artificial muscles. Mater. Today (Netherlands), vol. 10, no. 4, pp.
30-38, 2007, the contents of which are incorporated by reference
herein, according to a dielectric EAP (DEAP) principle, a voltage
may be applied to electrodes 350 connected to different portions of
an elastomer. The electrostatic forces generated by the voltage may
squeeze the elastomer. Since elastomers have a Poisson coefficient
close to about 0.5, the whole structure may stretch.
[0076] Each of the actuation components 340 may be actuated to
change states at any point or portion of the actuation component
340. For example, as shown in FIG. 3B, actuation members 340 may be
actuated and may bend at one or more points approximately half-way
between the distal end 370 and proximal end 380 of the valve device
300.
[0077] The shape, geometry and orientation of the inner membrane
330 formed by the actuated members 340 may vary depending on the
amount and location of the actuation or contracting of the actuated
members 340. For example, as shown in FIG. 3B, the inner membrane
330 may form an hour-glass like shape when the actuation components
340 are actuated.
[0078] Each of the actuation components 340 may comprise the same
or different type of composition. The amount that the actuation
components 340 may deflect/bend may be controlled by the amount of
power supplied, the composition of the actuation components and/or
the size (length, width, thickness).
[0079] In another example, the inner membrane 330 may be switched
between relaxed and contracted positions by using the body's own
forces e.g. by inhalation/expiration air-streams. Alternatively, an
external power source may be used to actuate the valve 300. For
example through an inductive system, an optical energy system or
any other suitable system. A coupling element, such as a receiver
or photovoltaic cell, or any other suitable coupling element may be
placed in an upper part of the trachea, by for example, placing an
implantable structure, such as a stent or any other suitable
implantable structure. The coupling element may have an
electrically conductive wire or other conductive element connected
to the valve device. The coupling element may receive power from an
external power source, such as a battery or capacitor.
[0080] A rechargeable element may be in close proximity to the
coupling element. For example, the rechargeable element may be worn
on or close to the neck, such as in the form of a necklace, neck
brace, or other form, so as to couple energy to the receiver.
Alternatively, or additionally, the receiver may be placed around
the patient's chest via a belt, or a pillow place under the
patient's head, or other suitable form.
[0081] The contracted state of the inner membrane 330, when the
actuation components 340 are actuated, may allow air to leave the
valve device 300 from the distal end 370, but prevent air from
entering from the proximal end 380. In this manner, inhaled air or
other inhaled contaminants may be prevented from entering a portion
of the lungs where the valve device 300 is placed.
[0082] As shown in FIG. 4A, the valve devices described herein may
be placed via any suitable minimally invasive method at e.g., a
bronchial inlet 410 to a lobe 420 of a lung. In an exemplary
embodiment, the valve devices may be in a collapsed state and may
be placed with a delivery mechanism, which may in turn be placed
into a steerable bronchoscope. The delivery mechanism may include a
hollow tube such as a catheter having a guide wire or any other
suitable delivery means.
[0083] The bronchoscope may be inserted into the airways, such as
through the nose or mouth, or through a tracheostomy. The valve
devices may be then pushed out of the carrier and into position via
any suitable means. For example, as shown in FIGS. 4B and 4C,
multiple valve devices may be deployed using a single delivery
device, such as a bronchoscope 450. The valve devices 455 may be in
a compressed form and may be inserted at a proximal end of the
bronchoscope 450 and pushed along the length of the bronchoscope
450 towards the distal end of the bronchoscope 450, from which end
the valve devices 455 may deploy. Each valve devices 455 may be
premounted (e.g. compressed) in a polymer housing tube 460 made of
any suitable material, such as PET or PTFE, so that the housing
tubes 460 may slide through the lumen of the bronchoscope 450 with
reduced friction.
[0084] The bronchoscope 450 may include a distal ring 465 in the
lumen of the bronchoscope 450 having the same inner diameter as the
inner diameter of the housing tubes 460 of the valve device 455.
The distal ring 465 may be configured to restrict or block the
housing tubes 460 from being pushed out of the bronchoscope 450.
Once the housing tubes 460 are at the distal end of the
bronchoscope 450, the housing tubes 460 may be pushed through the
lumen of the bronchoscope 450 with a push rod 470. The push rod 470
may have the same diameter as the inner diameter of the housing
tubes 460.
[0085] Alternatively, multiple valve devices 455, may be
pre-packaged in a single individual housing tube 460 and once the
bronchoscope is located, the single housing tube may be pushed
through the lumen of the bronchoscope 450 until the housing tube
460 reaches the distal inner ring 465. The pushrod 470 may then be
used to push a valve device 455 out of the distal end of the
bronchoscope 450, so that it may self-expand and this procedure may
be repeated multiple times for each valve device 455 loaded in the
housing tube.
[0086] The valve devices may contract as described above,
preventing inhaled air from entering the lobe 420. Multiple valve
devices may be placed near a common bronchial inlet 410 at the
inlets of adjacent lobes 420, 430 as desired. The multiple valve
devices serving the adjacent lobes 420 and 430 may be selectively
relaxed and closed in controlled manner, e.g. if the valve device
serving lobe 420 is relaxed, the valve device serving lobe 430 may
be closed. When the valve devices 400 are not supplied with a power
source (e.g. electrical, pneumatic, magnetic, fluidic, the body's
own forces), the relaxed or normal state, the valve devices may
allow both inhalation and exhalation.
[0087] The embodiments shown in FIGS. 5A and 5B may include any of
the components or features of the embodiments described in
reference to FIGS. 1A-3B.
[0088] Valve device 500 may include a substantially circular
cross-section or it may have a cross-section similar to that of
body cavities such that it may occupy a desired space in the body.
Accordingly, where required by given applications, valve device 500
may include elliptical, semi-circular, rhombic, rectangular, or any
other suitable profile. Moreover, the diameter of valve device 500
may vary based on the size of the body lumens in which it operates.
In addition, the cross-sectional geometry of valve device 500 may
vary along its length.
[0089] The valve device 500 may include a wire frame 510 made of
any suitable material such as a metal, for example, stainless steel
or other alloy and/or may include any suitable shape-memory
material, including metal and/or polymeric materials, such as
nitinol or polyurethane based memory polymers. The wire frame 510
may be capable of self-expanding. For example, the wire frame 510
may include a plurality of wires interconnected to form a
stent-like configuration with a lumen 505. This allows the wire
frame 510 to be in a collapsed position during placement of the
valve device, and then subject to self-expansion upon
placement.
[0090] In another embodiment, the wire frame 510 may be
non-self-expanding. For example, the wire frame may include a
plurality of wires interconnected to form a stent-like
configuration in a compressed or crimped configuration and may be
expanded by any suitable mechanism upon delivery of the valve
device or any time thereafter. For example, the compressed
non-self-expanding wire frame 510 may be delivered to the desired
location in the compressed configuration using a delivery device. A
device having an expandable portion, such as the delivery device,
may be inserted into the wire frame 510 lumen 505 and the
expandable portion may be expanded, thereby expanding the wire
frame 510. The device may then be removed from the expanded wire
frame 510. For example, the delivery device may be a catheter
having an expandable portion, such as an expandable balloon and the
wire frame 510 may be placed over the unexpanded balloon catheter.
The expandable device, such as a balloon catheter may be expanded,
thereby expanding the wire frame 510 to the desired diameter. The
balloon catheter may then be deflated and removed from the wire
frame 510.
[0091] The wire frame 510 may include barbs, tines and/or other
protrusions to allow implantation, removal and/or anchoring of the
valve device 500 in the desired location. For example, the wire
frame 510 may include a tine or other suitable protrusion (e.g. a
hook or loop) that may engage with implantation and/or removal
tools so as to allow the wire frame 510 to be expanded or
collapsed, for example using a pull wire. In addition, an outer
surface of valve device 500 may include one or more barbs for
engaging adjacent tissue to facilitate retaining the valve device
500 in a desired location.
[0092] The wire frame 510 may include an outer cover 20 having a
sufficient rigidity to maintain a tubular configuration on the wire
frame 510. The outer cover 520 may extend along the entire length
or only along one or more portions of the wire frame 510. The outer
cover 520 may extend completely around or only partially around the
wire frame 510. The material used to manufacture the outer cover
520 may include a flexible material and exemplary embodiments may
include a flexible material and exemplary embodiments may include
polytetrafluoroethylene (PTFE), polyethylene, FEP (fluorinated
ethylene propylene), ETFE (ethylene tetrofluoroethylene),
polypropylene, polysulfone, polyethylene, polyethersulfone,
silicone, silicon rubber, etc.
[0093] The outer cover 520 may include a coating having, for
example, lubricious, and/or therapeutic properties (e.g.
antibiotic, anti-inflammatory, anesthetic), and may be porous. In
addition, the outer cover 520 may be radiopaque and/or may include
markings to allow visualization under x-ray or fluoroscopy.
[0094] Valve device 500 may include an inner membrane 530 along at
least a portion of the inside of the wire frame 510. The inner
membrane 530 may have elastic properties. The material used to
manufacture the inner membrane 530 may include a flexible material
and exemplary embodiments may include a flexible material and
exemplary embodiments may include polytetrafluoroethylene (PTFE),
polyethylene, FEP (fluorinated ethylene propylene), ETFE (ethylene
tetrofluoroethylene), polypropylene, polysulfone, polyethylene,
polyethersulfone, silicone, silicon rubber, etc. The inner membrane
530 may have a uniform flexibility or have varying flexibilities.
For example, the inner membrane 530 may be more flexible at a
central portion. The inner membrane 530 may have the same or
different flexibility as the outer cover 520.
[0095] The valve device 500 may include one or more actuation
components 540 that may change from a first non-actuated state to a
second actuated state. The actuation components 540 may be directly
or indirectly connected to a portion of the inner membrane 530 by
any suitable means, such that when actuated, the actuation
components 540 may cause a change in the amount of inner lumen 505
space the inner membrane 530 occupies, thereby narrowing at least a
portion of the lumen 505. For example, when actuated, the actuation
component 540 may cause the inner membrane 530 to expand and
thereby increasing the amount of inner lumen 505 space the inner
membrane 130 occupies. In turn, the inner lumen 505 may transition
from a first diameter to a second diameter that is smaller than the
first diameter.
[0096] As shown on FIGS. 5A and 5B, an example of an actuation
component 540 that may change from a non-actuated stated (FIG. 5A)
to a second actuated state (FIG. 58) such that the actuated state
causes at least a portion of the Inner membrane 530 to increase the
amount of lumen 505 space it occupies and reduce the diameter of at
least a portion of the lumen 505, may be a material that exhibits a
change in size or shape when subject to a stimulus.
[0097] The actuation components 540 may take any suitable
composition shape, geometry and/or orientation. Adjacent actuation
components 540 may be uniformly or non-uniformly spaced apart on
the valve device 500. Any suitable means may be used to dispose the
actuation components 540 on the valve device 500, including, but
not limited to: printing, using adhesive, or embossing.
[0098] The actuation components 540 may be disposed on one or more
portions along the length of the valve device 500 to contract the
inner membrane 530 and thereby restrict or block air or any other
contaminant from entering through the valve device 500. The one or
more actuation components 540 may disposed on different positions
along the length of the valve device 500 and may be equal or
unequal in number and size on each side of the valve device 500.
For example, as shown in FIG. 5A, actuation components 540 disposed
on opposite sides of the valve device 500 may be equal in number
and size. The actuation components 540 may cause the inner membrane
530 to contract and transition the lumen 505 from a first diameter
to a second diameter smaller than the first, when actuated.
[0099] In the embodiment shown in FIG. 5A, the actuation components
540 may include one or more components having magnetic properties
having any suitable shape geometry, and orientation. For example,
the actuation components 540 having magnetic properties may be
permanent magnetic dots markers. These actuation components 540 may
be activated using a current source. For example, one or more
current conducting element 545 having any suitable shape, geometry,
and orientation may be placed on or adjacent to the outer cover 520
of the valve device 500 device at a proximity close to the
actuation component 540. In the example shown in FIGS. 5A and 58,
the current conducting element(s) 545 may be a wire coil. The wire
coil may be manufactured with any suitable material such as
stainless steel, copper, nitinol, or any other suitable
material.
[0100] The current conducting element(s) 545 may be connected to an
electrode 550, which in turn may be connected to a current
producing power source 560. The current conducting element(s) 545
may be activated by the power source 560 and cause a repulsive
magnetic force between the current conducting element(s) 545 and
the actuation component(s) 540, thereby causing the inner membrane
530 to contract. The current conducting element(s) 545 may attract
and repel the actuation component(s) 540 depending on the polarity
of the current conducting element(s) 545. A reverse current from
the power source 560 may cause an attractive magnetic force between
the current conducting element(s) 545 and the actuation
component(s) 540, thereby causing the inner membrane 530 to return
to a relaxed configuration.
[0101] In another embodiment, a current conducting element 545
having any suitable shape, geometry, and/or orientation may be
disposed on or adjacent to the outer cover 520 of the valve device
500 device at a proximity close another current conducting element
545 that may be disposed on the inner membrane 530. The current
conducting element 545 disposed on or adjacent to the outer cover
520 may be connected to an electrode 550, which in turn may be
connected to a power source 560. In addition, the current
conducting element 545 disposed on the inner membrane 530 may be
connected to a different electrode 550, which in turn may be
connected to a different power source 560. A single current may
flow through both coils, however, the current may flow in opposite
directions in each of the current conducting elements 545 disposed
on the inner membrane 530 and the outer cover 520 to cause
attractive or repulsive forces between the current conducting
elements 545 disposed on the inner membrane 530 and the outer cover
520. For example, the current in the current conducting element 545
disposed on the inner membrane 530 may be counter rotating to the
current conducting element 545 disposed on the outer cover 520 so
that an opposing magnetic field is generated. This may in turn
relax or contract the inner membrane 530.
[0102] The contracted state of the inner membrane 530 may allow air
to leave the valve device 500 from the distal end 570, but may
reduce or prevent air from entering from the proximal end 580. In
this manner, inhaled air may be reduced or prevented from entering
a portion of the lungs or other organ where the valve device 500 is
placed.
[0103] As shown in FIGS. 5A and 5B, power, may be provided via
electrodes 550 to the actuation components 540. The power may be of
any suitable types including, but not limited to, AC/DC electrical
power generated by any suitable means.
[0104] For example, multiple valve devices may share a combined
electrical source, such as a combined inductive coil for their
energy supply. The electrical source may be part of an electric
circuit to distribute power among multiple valves. The electric
circuit may include a bridge rectifier having a receiving portion
connected to the power source, such as the pickup portion of an
inductive coil. The bridge rectifier may transform the AC signal
from the power source, for example from inductive coils, into a DC
signal. For example, the distance between two inductive coils, one
that may be internal to the body and the other that may be external
to the body) that comprise a combined inductive coil power source
may change due to movement. This change in distance may impact the
height of the AC and thus the DC voltage. In order to alleviate
this impact, the voltage may be rectified. For example, the circuit
may include a precision voltage rectifier. In such a precision
voltage rectifier, when the input voltage is negative, no current
may flow through the load, and the output voltage may be zero. When
the input is positive, it may be amplified by an operational
amplifier and current may then flow through the load and, because
of the feedback, the output voltage may be equal to the input
voltage, and thereby rectified.
[0105] Once a constant DC voltage supply is established, for
example, using the precision voltage rectifier described above, the
circuit may include voltage distribution components to distribute
power to the multiple valves. For example, a flip-flop circuit
component which may switch between two stable states and can be
used to store state information. Such a flip-flop switch may
include a D-type flip-flop, which may change output on the rising
edge of a clock signal that oscillates between a high and a low
state.
[0106] The two outputs Q and not-Q of the flip-flop may be
connected to two operational amplifiers (Op-Amps), which may
produce an output voltage that may be larger than the voltage
difference between the input terminals. The Op-Amps may be
connected to the outputs (Q and not-Q) of the flip-flop in
non-inverting voltage following configuration connected directly to
the valves. The flip-flop may involve changing the output on the
clock signal which may be linked to the detected breathing
frequency via an input, such as an RF input. To transfer the clock
signal to the input of the flip-flop, a RF transmitter may be used
to separate from the inductive circuit as the energy requirement
may be low. In addition, the circuit may include a microcontroller
directly after the voltage rectifier, which may switch the current
between multiple valve devices with programmable relaxed/contracted
times for each valve device. The microcontroller may control
overlapping relaxed/contracted times for each valve device and may
include algorithms which may allow relaxed/contracted times for
each valve to be adjusted as a function of an observed effect. For
example, some healthier sections of may be used more than less
healthier sections of the lung. Therefore, the microcontroller may
adjust the relaxed/contracted times such that the valve device(s)
in the certain sections of the lungs remain relaxed at relatively
longer time periods than valve device(s) in other sections of the
lungs.
[0107] In an exemplary embodiment, as illustrated in FIG. 6,
multiple valve devices 640 may share a combined electrical power
source, for example, an inductive coil 610 for their energy supply
in a circuit system 600.
[0108] In an embodiment, the inductive coils 610 may act as an
electrical transformer to produce high-voltage pulses from a
low-voltage direct current (DC) supply. The inductive coils 610 may
be connected to a bridge rectifier 620 which may transform the AC
signal out of the coils 610 into a DC signal. The rectifier 620 may
rectify any changes in voltage due to movement which may alter the
distance between the two inductive coils 610 (external and internal
to the body). The voltage then may be distributed to the various
valve devices 640, for example, using a delayed (D-type) flip-flop
(or multi-stable vibrator configuration), which may change output
on the rising edge of a clock signal that oscillates between a high
and a low state.
[0109] The two outputs Q and not-Q of the flip-flop may be
connected to two Op-Amps in non-inverting voltage following
configuration connected directly to the valves 640. The flip-flop
may involve changing output on the clock signal which may be linked
to the breathing frequency via an input, such as an RF input
650.
[0110] The breathing frequency or breathing cycle may be detected
by a breathing sensor 680 connected to an external processor 670
and the breathing frequency may in turn be transmitted by a
transmitter, for example, an RF antenna 660 to the receiver, e.g.
RF input 650 connected to the microcontroller 630.
[0111] The breathing sensor 680 may be one similar to disclosed by
Marani, R, et al., A New System for Continuous Monitoring of
Breathing and Kinetic Activity Journal of Sensors, Volume 2010,
Article ID 43486, which includes an electrical conductive rubber
belt, worn around the thorax. Using this configuration, breathing
cycles may be identified. To transfer the clock signal to the input
of the flip-flop, a RF transmitter may be used that is separate
from the inductive circuit 600.
[0112] The microcontroller 630 may be placed directly after the
voltage rectifier 620 for switching the current between multiple
valves 640 with programmable relaxed/contracted times of each valve
640. The microcontroller 630 may be able to overlap between the
valves 640, and may include algorithms allowing the relaxing and
contracted times to be adjusted as a function of the effect seen
from sensing the breathing cycle of a patient. Accordingly,
actuation components (like 540) of one or more valve devices 500
may be switched between actuated and non-actuated states by
controlling the frequency of power supplied to the actuation
components. For example, the frequency of actuation of the
actuation components 540 of the valve devices 500 may be controlled
by the microcontroller 630 based on the breathing cycle of a
patient as detected by the breathing sensor 680 and transmitted to
the microcontroller 630 by the RF antenna 660 via the RF input
650.
[0113] In another embodiment, the power supply to the valves may be
stored at the valves itself using thin film capacitors charged by
low power RF energy. For example, if the valves are used
periodically, the capacitors may be charged during the long
intermediate time-frames. For instance, the capacitors may be used
to power valve devices used to block cigarette smoke from entering
portions of the lungs. In this example, the capacitors are charged
when the valves are not in use (e.g. when the patient is not
smoking). Any suitable source of RF energy may be used, for
example, Wi-Fi and other mobile base stations and handsets and
devices may be used. In addition, RF may be broadcasted from other
sources in unlicensed bands such as 868 MHz, 915 MHz, 2.4 GHz, and
5.8 GHz when more power or more predictable energy is needed than
what is available from ambient sources. In another example, the
same RF system may be used to switch the valve device, by signaling
a built in microprocessor to utilize the stored energy to close the
valve. A return signal can be given to the user that the valves are
closed and one can start smoking.
[0114] FIG. 7 shows an example of relaxed and contracted times of
various valves as a function of a breathing cycle. In this example,
some sections of the lung which are less affected by COPD may be
used more than severely affected. As such valves 1 and 2 which may
be in healthier lobes of the lung have longer relaxed times
compared to valve "I" in an affected lobe of the lung. These
relaxed and contracted times as controlled by the microcontroller
may be adjusted based on the breathing cycle.
[0115] The above discussed valve devices may also be used to
prevent exposure of parts of the lungs to cigarette smoke,
especially for patients with a severe stage of COPD including
patients with emphysema.
[0116] In another exemplary embodiment, as shown in FIG. 8, a tube
device 800 having a proximal end 810 that may be disposed in or
adjacent a tracheostomy orifice and a distal end 820. A tubular
member 830 having a lumen 850 may extend between the proximal end
810 and distal end 820. The tubular member 830 and lumen 850 may
have any suitable shape, diameter and/or size, which may vary along
the length of the tube device 800. The tubular member 830 may
include a coating on all or a portion that may have lubricious,
therapeutic and/or porous properties.
[0117] The distal end may include an expandable component 840, that
may be expanded via any suitable means, including, but not limited
to electro-active (EAP) polymer actuation, pneumatic actuation
(e.g., compressed air/gas such as a balloon), electrical actuation,
hydraulic actuation, piezoelectric actuation, thermal actuation,
electrostatic actuation, magnetic actuation, inductive actuation,
the body's own forces, and any other suitable actuation methods.
The expandable component 840 may take any suitable shape or
geometry, including an annular shape as shown in FIG. 8. The
material of the expandable component may be any suitable material
including polytetrafluoroethylene (PTFE), polyethylene, FEP
(fluorinated ethylene propylene), ETFE (ethylene
tetrofluoroethylene), polypropylene, polysulfone, polyethylene,
polyethersulfone, silicone, silicon rubber, etc. The expandable
component 840 may include a coating that may have lubricious,
therapeutic and/or porous properties.
[0118] The expandable member 840 may be inflated to seal the
bronchus so that only air entering from the tracheostomy may enter
the lung. In this manner, if it is determined that one lung has
less disease than the other, then the healthy lung may be isolated
so that it may not be exposed to further smoke and subsequently may
slow the rate of decline of lung function in that lung and oxygen
therapy may be administered directly. The tube device 800 may be
used to prevent smoke from enter the lung while allowing air from
the trachea opening to enter the lung.
[0119] One or more of the tubular member 800 and/or any of the
valve devices, and any combination thereof disclosed herein may be
placed in the body, such as in the second or third bifurcation of
the trachea. The tube device 800 and/or the valve devices may be
expanded (in the case of the tubular member 800)/contracted (in the
case of the valve devices) by the patient using an RF system as
describe above. The tube device 800 and/or the valve devices may
normally be in the non-expanded/relaxed state, but may be
temporarily switched to the expanded/contracted state upon
actuation. The power supply for the tube device 800 and/or valve
devices may be stored at the device itself using thin
film-capacitors charged by low power RF energy as described
above.
[0120] Embodiments of the present disclosure may be used in any
medical or non-medical procedure, including any medical procedure
where control of air into and out of the lungs is desired. In
addition, at least certain aspects of the aforementioned
embodiments may be combined with other aspects of the embodiments,
or removed, without departing from the scope of the disclosure.
[0121] Other embodiments of the present disclosure will be apparent
to those skilled in the art from consideration of the specification
and practice of the embodiments disclosed herein. It is intended
that the specification and examples be considered as exemplary
only, with a true scope and spirit of the invention being indicated
by the following claims.
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