U.S. patent application number 11/515181 was filed with the patent office on 2007-01-04 for occlusion device.
Invention is credited to Sabaratham Sabanathan, Thirumani Sabanathan.
Application Number | 20070005083 11/515181 |
Document ID | / |
Family ID | 10811536 |
Filed Date | 2007-01-04 |
United States Patent
Application |
20070005083 |
Kind Code |
A1 |
Sabanathan; Sabaratham ; et
al. |
January 4, 2007 |
Occlusion device
Abstract
An obturator for a bronchial tube or tubule of a human or animal
lung comprises a blocking element (92) and a securing element (90).
The blocking element serves to seal the tube or tubule against the
passage of fluid past the obturator when the obturator is disposed
in a bronchial tube or tubule. The securing element serves to
retain the blocking element in position. The blocking element
comprises a substantially cylindrical plug of biocompatible,
resiliently deformable closed-cell foamed plastics material, such
as PVC. The securing element comprises a stent having barbs (98) to
engage and retain the blocking element. The stent also has anchors
(100) to retain the stent in a bronchial tube or tubule. A method
of treatment of emphysema or other lung conditions or diseases in
human or animal patients comprises placing an obturator in a
bronchial tube or tubule of the patient so as to seal the tube or
tubule against the passage of fluid past the obturator.
Inventors: |
Sabanathan; Sabaratham;
(US) ; Sabanathan; Thirumani; (Leeds, GB) |
Correspondence
Address: |
FISH & RICHARDSON, PC
P.O. BOX 1022
MINNEAPOLIS
MN
55440-1022
US
|
Family ID: |
10811536 |
Appl. No.: |
11/515181 |
Filed: |
September 1, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09762692 |
Oct 31, 2005 |
|
|
|
PCT/GB98/00652 |
Mar 3, 1998 |
|
|
|
11515181 |
Sep 1, 2006 |
|
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|
Current U.S.
Class: |
606/157 ;
623/23.7 |
Current CPC
Class: |
A61F 2002/043 20130101;
A61B 17/12172 20130101; A61B 17/12136 20130101; A61B 17/12104
20130101; A61B 17/12177 20130101; A61B 17/12159 20130101; A61B
2017/1205 20130101; A61B 17/12022 20130101 |
Class at
Publication: |
606/157 ;
623/023.7 |
International
Class: |
A61B 17/24 20060101
A61B017/24; A61F 2/86 20060101 A61F002/86 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 30, 1997 |
GB |
9708681.3 |
Claims
1. A method of treating a lung, comprising: providing a flow
control device, the flow control device comprising a frame adapted
to self-expand from a contracted configuration to an expanded
configuration, the frame coupled to a membrane; inserting the flow
control device in a bronchial passageway such that the frame
self-expands within the bronchial passageway and the membrane seals
with a wall of the bronchial passageway so that the flow control
element prohibits air from flowing past the flow control element in
an inhalation direction within the bronchial passageway and also
prohibits air from flowing past the flow control element in an
exhalation direction within the bronchial passageway.
2. A method as in claim 1, wherein the flow control device has a
proximal end and a distal end, and wherein a transverse dimension
of the flow control device is greatest at a location in between the
proximal end and the distal end.
3. A method as in claim 1, wherein the flow control device has a
proximal end and a distal end, and wherein a diameter of the flow
control device at a location between the proximal and distal ends
is greater than the diameters at the proximal end and at the distal
end.
4. A method as in claim 1, wherein the flow control device has a
largest diameter at a location between proximal and distal ends of
the flow control device.
5. A method as in claim 1, wherein a diameter of the flow control
device undergoes an increase moving from a distal end of the flow
control device toward a proximal end of the flow control device,
and wherein the diameter also undergoes a decrease moving from the
distal end toward the proximal end.
6. The method of claim 1, wherein the membrane forms an air tight
seal with a wall of the bronchial passageway.
7. The method of claim 1, wherein the flow control device
self-expands in a manner such the flow control device has an
enlarged diameter at a location between proximal and distal ends of
the flow control device.
8. The method of claim 1, wherein the frame includes at least one
anchor and wherein the at least one anchor attaches to the wall of
the bronchial passageway.
9. The method of claim 1, further comprising: inserting a delivery
tube into the bronchial passageway, the delivery tube loaded with
the flow control device; and guiding the delivery tube to a
location within the bronchial passageway prior to releasing the
flow control element.
Description
[0001] This application is a continuation of co-pending U.S. patent
application Ser. No. 09/762,692, entitled "Occlusion Device", filed
Oct. 31, 2005, which is the National Stage of International PCT
Application No. PCT/GB98/00652, entitled "Occlusion Device", filed
Mar. 3, 1998, which claims the benefit of priority to U.K. Patent
Application No. 9708681.3, entitled "Lung Treatment Device", filed
Apr. 30, 1997. Disclosures of the aforementioned patent
applications are hereby incorporated by reference in their
entirety.
SUMMARY
[0002] The present invention relates to a device useful in the
treatment of emphysema and other diseases or disorders of the human
or animal lung.
[0003] Emphysema is a disease of the lung caused primarily by
prolonged smoking, although not exclusively thereby. It is an
unrelentless, intractable and debilitating process. Emphysema is
defined as an abnormal permanent enlargement of the air spaces
distal to the terminal bronchioles, accompanied by destruction of
their walls without obvious fibrosis. In this context, destruction
means non-uniformity in the pattern of respiratory,airspace
enlargement; orderly appearance of the acinus is disturbed and may
be lost.
[0004] Emphysema causes a physiological loss of lung elastic
recoil, which decreases expiratory airflow by loss of driving
pressure and premature airway closure from reduced airway traction.
The effect of this is that the alveoli become hyper-inflated
without there being any real exchange of air with the outside.
Therefore the patient begins to feel starved of oxygen and so
attempts to breathe more deeply. In breathing more deeply, the
effects are exacerbated.
[0005] Not only are those individual alveoli which have a block in
their respective bronchial tubules affected, but also neighbouring
alveoli, perhaps in other regions of the lung, which may otherwise
be perfectly serviceable, become affected because the
hyper-inflated alveoli pressurise neighbouring alveoli and prevent
them from expanding fully. There is, of course, a relatively fixed
"exchange" volume of an individual's lung, that is to say, the
difference between the expanded volume and the deflated volume.
Emphysema reduces the exchange volume because undeflated alveoli
occupy that space. Consequently, the only recourse available to the
patient is to increase the expanded volume, thereby resulting in
the barrel chest symptomatic of emphysema sufferers.
[0006] The major therapeutic modalities currently available consist
of bronchodilator and anti-inflammatory drugs, directed at
decreasing airway resistance, and antibiotics to treat acute and
chronic infection. Supplemental oxygen therapy for the hypoxaemic
patient improves exercise performance and improves survival in
patients with cor pulmonale. Despite all available medical
therapies, the course of the disease is one of progressive
limitation, increasing dyspnoea and significant increase in overall
mortality.
[0007] It has long been realised that full lung volume is more than
enough for survival in most circumstances and that a person can
survive quite satisfactorily with only one lung, for example.
Heterogenous distribution of emphysema, together with the lack of
pulmonary blood flow to those areas have made lung volume reduction
surgery a logical option. Removal of parts of the lung affected by
emphysema permits unaffected areas to become operative again and so
enable a better quality of life for the patient. Clearly, however,
such invasive procedures are of a very serious nature and some
patients will not, in any event, be in a sufficiently strong
condition to accept the trauma of such procedures. Primarily, the
basic relief for emphysema sufferers is inactivity, on the one
hand, and breathing pure oxygen, on the other.
[0008] Emphysema is a distressing condition affecting a relatively
large proportion of the population, and a more effective and less
traumatic treatment is required.
[0009] On a different matter, other lung conditions sometimes lead
to bleeding into the lung. A patient having this condition feels
movement of the blood caused by airflow in the lung during
breathing, and perceives the blood as a foreign body and irritant.
The patient coughs in an attempt to dislodge the perceived foreign
body. Coughing blood, of course, is sometimes the first warning of
a more serious disease or condition, but once that is realised,
there is no benefit in such bleeding. Moreover, in such conditions
where the lung might heal itself and subsequently stop bleeding, or
indeed simply where the bleeding needs to be confined, the coughing
reaction, which is almost impossible to resist, does not help the
situation at all, and merely spreads the blood to other areas of
the lung.
[0010] U.S. Pat. No. 5,382,261 discloses a vessel occluder for
providing permanent occlusion of a vessel in a person by use of a
flexible closure member attached to at least one radially
expandable stent. The occluder does not have barbs or anchors or a
stent.
[0011] DE-U-9205797 discloses a self expanding `meshbasket` for the
occlusion of human hollow organs. The invention is directed to
female contraceptive devices and addresses the problem of remaining
in place. The device may also find application in embolism therapy
and vascular occlusion.
[0012] WO-A-9532018 discloses a body passageway closure for use in
the occlusion of various passageways within the body, with
particular application for the occlusion of blood vessels.
[0013] Therefore it is an object of the present invention to
provide a method of treatment of certain lung conditions or
diseases and to provide a device for such treatment.
[0014] In accordance with a first aspect of the present invention
there is provided a method of treatment of emphysema or other lung
conditions or diseases, the method comprising placing an obturator
in a bronchial tube or tubule so as to seal the tube or tubule
against the passage of fluid past the obturator.
[0015] In the case of emphysema, and by the simple expedient of
inserting an obturator in a bronchial tube, a section of a lung can
be isolated so that no air can be drawn into it. Thereafter, the
isolated part deflates in time as the air remaining in it becomes
absorbed, and so that part of the lung stops affecting other areas
of the lungs, which can thus perform normally. Such a procedure is
relatively simple, requiring only a delivery device for the
obturator, which device is inserted through the mouth and airway of
the patient until the proposed placement site is reached, whereupon
the device is activated to release the obturator from the
device.
[0016] In the case of bleeding into the lung, an obturator stops
the flow of blood. The lung is tamponated by the obturator and
blood merely collects in the isolated part of the lung and
ultimately, if the bleeding stops, will be reabsorbed.
Alternatively, in the case of some, perhaps terminal, conditions
such as some lung cancers, it at least provides temporary relief
for the patient.
[0017] In accordance with a second aspect of the invention there is
provided the use of a blocking element and a securing element in
the manufacture of an obturator for use in the treatment of a lung
condition in a human or animal by blocking a bronchial tube or
tubule. The condition may be emphysema.
[0018] Preferably the two elements are separate components, the
blocking element serving to seal the tube or tubule against the
passage of fluid past the obturator when the obturator is disposed
in a bronchial tube or tubule, and the securing element serving to
retain the blocking element in position in the tube or tubule.
[0019] The blocking element preferably comprises a substantially
cylindrical plug of biocompatible material. The plug may comprise
resiliently deformable closed-cell foamed plastics material, such
as PVC, so that it may be compressed to facilitate insertion into
the tube or tubule and thereafter expand to fill the cross-section
of the tube or tubule.
[0020] It is known to employ stents in medical fields to expand and
support collapsed blood vessels, and indeed bronchial tubes. A
stent is a compressible framework which, when inserted into a
vessel and released, expands and, within the limits of its
expansion, supports and possibly expands the walls of the
vessel.
[0021] Preferably, the securing element comprises a stent. The
stent may have barbs to engage and retain the blocking element. The
stent preferably also has anchors to retain the stent in a
bronchial tube or tubule.
[0022] In one embodiment, the stent comprises a crown of surgical
quality steel wire legs in zig-zag formation. Said barbs and
anchors may depend from points of the crown. Preferably the crown
is closed in its circumference, although this is not essential.
[0023] In another embodiment, the stent comprises a dome of
surgical quality steel wire legs. Said barbs and anchors may be
formed on the ends of said legs.
[0024] It is known in medical fields to block blood vessels, for
example where a genetic or other defect has resulted in a hole
which needs blocking, or, for example, in the case of babies whose
aortic to pulmonary artery connection has not closed following
birth, a condition known as patent ductus arteriosus. In the case
of holes, it is well known to employ an "umbrella", where a
diaphragm of material forms the seal against the blood vessel wall,
the handle of the umbrella serving to keep the diaphragm across the
vessel. In the case of babies, it has also been known to employ a
plug of PVC foam to treat patent ductus arteriosus, the plug
encouraging clotting.
[0025] However, in the case of bronchial tubes and tubules a
diaphragm seal has not been used yet, although its application
cannot be entirely ruled out. For example, an umbrella device with
a larger surface area of contact with the bronchial mucosa might be
as effective.
[0026] In blood vessels a complete seal is seldom required because
any leak soon blocks by the formation of a clot; something that
would not happen in an airway of a lung. Secondly, airways are not
always absolutely circular in section, so a circular diaphragm may
not always make a good seal, at least around some parts of the
circumference, unless it has capacity to expand in all radial
directions and has a large contact area.
[0027] However, a complete seal is an absolute requirement of the
present invention (at least over the period of a single breath),
because without it, air can leak past during inhalation and
pressurise the lung in just the same way, and perhaps even to a
greater extent. More importantly, however, a patient with such an
obturator in place can only feel its presence if there is movement
of air around it to stimulate adjacent nerve endings. Once a
patient can feel the obturator, there will be irresistible
compulsion to cough which, if done excessively, may be sufficient
to dislodge the obturator.
[0028] Thus it has been found that a very effective seal is
achieved by the use of said cylindrical plug of foamed PVC (of the
type commonly employed as earplugs). The effectiveness of this
arrangement is probably due to the fact that any leakage path has
to be a long one and there are thus numerous opportunities for it
to close and seal about at least one closed circuit around the
plug. Another reason is that a plug can mould itself to the shape
of the tube or tubule, which is itself unlikely to be cylindrical,
or, indeed, circular in cross-section.
[0029] Preferably, the method of the present invention employs an
obturator of the type defined above.
[0030] The delivery device preferably comprises a delivery tube in
which the obturator is received in a compressed state at a distal
end thereof, a guide tube, which is capable of following a possibly
tortuous path under the guidance of a surgeon from entry into the
mouth of a patient, down the patient's trachea and one bronchus to
a proposed delivery site in a bronchial tube or tubule, and which
has a passage to receive the delivery tube therealong, and release
means to eject the obturator from the delivery tube and guide
tube.
[0031] The obturator needs to slide in the delivery tube during
ejection and the stent provides a low friction surface of the
obturator to facilitate such ejection.
[0032] It is feasible that the blocking and securing elements may
be integrally formed from plastics material, and wherein the
securing element comprises adhered or fused anchor elements on the
blocking element.
[0033] It is also feasible that the securing element may comprise a
memory metal which is released to its normal expanded shape by a
physical parameter, for example, the passage of an electric current
therethrough, once it has been inserted at the proposed location.
Otherwise it is in the same form as the above described steel stent
which relies on resilience for its expansion. The advantage of a
memory metal device is that it requires no compression during
insertion so that the delivery tube of the delivery device may be
replaced by a simple guide rod to which it is connected.
DESCRIPTION OF DRAWINGS
[0034] The invention will be better understood from the following
description of particular embodiments given as non-limiting
examples. The description refers to the accompanying drawings, in
which:
[0035] FIG. 1 shows a section through the human chest indicating
the location of bronchial obturators in the lungs;
[0036] FIG. 2 shows a bronchial obturator complete with delivery
system;
[0037] FIGS. 3a b and c show in perspective two embodiments of an
obturator according to the present invention, that of FIG. 3a
having a crown stent, and that of FIG. 3b having a dome stent, FIG.
3c being a crown stent in an open configuration prior to rolling
and, optionally, welding into a ring as in FIG. 3a;
[0038] FIGS. 4a and b show an internal barb and external anchor
respectively;
[0039] FIG. 5 is a perspective view of another embodiment of
obturator in accordance with the present invention; and,
[0040] FIG. 6 is a perspective view of yet another embodiment of
obturator also in accordance with the present invention.
DETAILED DESCRIPTION
[0041] In FIG. 1 of the drawings, a human chest cavity 10 includes
a pair of lungs 12 which each comprise upper and lower lobes 14,16.
A trachea 18 branches into two bronchi 20, which further branch
into bronchial tubes 22 and segmental bronchi 24. The bronchi 24,
after further branching, terminate in alveoli 26.
[0042] In the majority of patients suffering from emphysema, it
frequently effects mainly the upper lobes 14 of the lungs, leaving
the lower lobes 16 unaffected, or at least less affected. However,
if no treatment is given to a patient, the expansion effect of the
upper lobes as the condition develops presses on the lower lobes
and reduces their capacity to perform efficiently. Lower lobe
emphysema does occur in some patients, and in which event it is
then the upper lobes which are compressed.
[0043] Thus the present invention suggests placing an obturator 50
in a bronchial tube or tubule to isolate the region of the lung
supplied by that tube or tubule. Where the obturator is placed will
be decided by the surgeon and will depend on the how localised the
damaged region of lung is. That is to say, if the whole lobe is
badly affected, then the obturator is placed in the lobar bronchus
22 supplying that lobe (as shown at 50 in FIG. 1). On the other
hand, if the damage is more localised, then the obturator will be
placed in a smaller segmental bronchus 24, (as shown at 50' in FIG.
1). Thus more than one obturator may be employed in the same pair
of lungs isolating different regions of them. They will also be of
different sizes, depending where they are to be inserted.
[0044] The above considerations equally apply when the condition
being treated is not emphysema but some other condition which a
doctor considers can usefully be treated by the method of the
present invention. Such another condition is where a lung, or part
of it is bleeding into the airway and an obturator isolates the
bleeding region and inhibits coughing which may damage the lung
further, or at least cause further discomfort to the patient.
[0045] FIG. 2 shows an endo-bronchial obturator 50 complete with
delivery device 70. The delivery device comprises a handle 72 and
flexible guide tube 74. Slidably received in the guide tube is a
delivery tube 76 having the obturator 50 disposed at its distal end
78. A release means 80 is insertable in a proximal end 82 of the
delivery tube 76 and by means of which the obturator 50 may be
ejected from the end of the delivery tube. The guide tube is guided
down the trachea and into the appropriate bronchus by means of
guide lines (not shown) which enable the delivery system to be
turned to follow the desired course. Optical guidance means may be
included, or real-time X-ray or other monitoring methods may be
employed to guide the surgeon. Once the end of the guide tube
reaches the correct location, the delivery tube is inserted in the
handle end of the delivery device 70, and then the release means 80
is pushed down the tube 76 to eject the obturator. The obturator is
adapted to expand or be expanded, when ejected, to fill and block
the tube or tubule in which it is inserted.
[0046] As can be seen from FIG. 3a, the obturator 50a in its first
embodiment is comprised of two main components, a securing element
in the form of a stent 90, and a blocking element in the form of a
closed-cell, PVC foam plug 92.
[0047] The stent 90 is constructed from a plurality of legs 91 of
surgical grade stainless steel wire welded together such that when
extended the stent appears as a series 90b of connected `W`s, as
shown in an unconnected disposition in FIG. 3c. Indeed, it is not
essential that the final connection between ends 94,96 be made to
form a closed crown arrangement (as shown in FIG. 3a); it is
equally effective merely to roll the stent 90b as indicated by
arrows in FIG. 3c.
[0048] When the two ends of the stent are joined together, the
stent 90 folds into a circular frame or crown, capable of
encompassing the biocompatible block 92. The stent is constructed
so as to be of a size slightly smaller (in its unstressed
condition) than the block, so that its natural resilience squeezes
the block slightly. On the other hand, the stent should be larger
than the airway into which it is to be introduced so that it
presses outwardly against the wall of the airway, and is
incorporated into the mucosa of the air passage.
[0049] The legs 91 of the stent crown are fitted with both internal
barbs 98 and external anchors 100. The barbs 98 embed themselves in
the block 92 and secure the block to the stent 90. The anchors 100
are adapted to engage the walls of the patient's airways to hold
the stent in position.
[0050] FIG. 4a shows an internal barb 98. The internal barb, also
constructed from surgical quality stainless steel, is substantially
straight and has a hook 99 at one end. The hooked end 99 is the
point and means by which the barb is secured to the biocompatible
block.
[0051] FIG. 4b shows an external anchor 100. The anchor, which is
also constructed from surgical quality stainless steel, is again
substantially straight and has a coil 101 at its end. A coil is
used so that damage is not caused to the tissue of the airway in
which the obturator is fitted, particularly if and when the
obturator is removed.
[0052] The barbs and anchors are joined to the stent crown by a
welded joint between two adjacent legs 91. Barbs can alternate with
anchors at the same end of the stent, or one end can have all
barbs, while the other end has all anchors. Both arrangements are
shown in FIGS. 3a and c respectively.
[0053] A different embodiment of obturator 50b, also in accordance
with the present invention, is shown in FIG. 3b in which surgical
quality stainless steel wires are all welded together at a point
104 to form a domed stent 90b. Legs 91b are alternately turned
inwards to form barbs 98b, or outwards to form anchors 100b.
Alternatively, all the legs could be anchors 100b, with
interspersed shorter barbs 98bb, as one is shown in dashed lines in
FIG. 3b.
[0054] The aforementioned obturators all rely on resilience of the
steel to return the stent to its original shape once released from
the delivery mechanism and so as to enable fitment in a narrower
tubule than the unstressed size of the stent would otherwise allow.
However, this requires prestressing the stent and keeping it
stressed during delivery. Thus the present invention may find
suitable application for memory metals, which only return to their
original shape when some physical condition changes, for example,
temperature rise or electrical current flow.
[0055] It is essential for the blocking device 92 to be comprised
of a resiliently deformable material such as PVC foam as mentioned
above. This enables the blocking device to be easily surrounded by
the stent 90 and deformed into a compact structure, thereby
enabling delivery of the block to its destination in the lung.
[0056] It is likewise essential that the block be capable of
expanding and reforming into its original shape once deposited in
the desired location in the lungs. It should be noted that the
block is deformed and reformed in both an axial and a radial
direction. It is the block 92 which seals a bronchial tube or
tubule; mucous surrounds the block and forms a fluid tight seal.
The presence of the stent around the block does not inhibit sealing
in any way since the stent is essentially incorporated into the
mucosa lining the airway.
[0057] Under compression, PVC foam has a high coefficient of
friction which would prevent ejection from the delivery device as
described above, if it was not surrounded by the stent 90, which
offers a relatively low friction surface to the inside of delivery
tube 76.
[0058] However, it is feasible that the block 92 could include a
low friction surface to enable such ejection without the stent.
Instead of the stent as described above, anchor means might be
moulded in biocompatible plastics material as a crown, for example,
on one end of the block, and either be adhered, fused or otherwise
bound thereto.
[0059] The effectiveness of the device depends, to some extent, on
the length of the block. Moreover, the block is required to be of a
size which is both comfortable to the patient once expanded in the
lung and which expands to completely obstruct the passage of air
into the affected portions of the lung. The extended size of the
block therefore ranges between 5 mm and 25 mm in length, and
between 5 and 11 mm in diameter, depending on the size of the tube
or tubule to be obturated.
[0060] Obturator 50c shown in FIG. 5, comprises a balloon 200,
which is inflated after insertion and then detached. The balloon is
captivated in an appropriate securing device such as stent 202. In
this case, the barbs would not be sharp, but would merely retain
ends of the balloon, or, as shown, would comprise turned-in points
204,206 at each end of the stent. Anchors 201 are provided.
[0061] Finally, as mentioned above, the obturator may be as shown
at 50d in FIG. 6, where it comprises a diaphragm 300 expanded by an
internal stent 302 having anchors 302. One end 306 of the diaphragm
is attached to the stent to retain it on the stent. The diaphragm
is also adhered to the stent.
[0062] While the obturator and method of the present invention has
been described with reference to human patients, animal patients
may in certain circumstances also benefit.
* * * * *