U.S. patent application number 12/487308 was filed with the patent office on 2010-02-11 for valve.
This patent application is currently assigned to Vysera Biomedical Limited. Invention is credited to Niall BEHAN, Gabriel SOBRINO-SERRANO.
Application Number | 20100036504 12/487308 |
Document ID | / |
Family ID | 37905641 |
Filed Date | 2010-02-11 |
United States Patent
Application |
20100036504 |
Kind Code |
A1 |
SOBRINO-SERRANO; Gabriel ;
et al. |
February 11, 2010 |
VALVE
Abstract
An esophageal valve has a restriction to allow antegrade passage
of swallowed food and controlled retrograde passage of fluid. The
restriction comprises an iris having a number of folds.
Inventors: |
SOBRINO-SERRANO; Gabriel;
(Kinvara, IE) ; BEHAN; Niall; (Kilcolgan,
IE) |
Correspondence
Address: |
CHOATE, HALL & STEWART LLP
TWO INTERNATIONAL PLACE
BOSTON
MA
02110
US
|
Assignee: |
Vysera Biomedical Limited
Galway
IE
|
Family ID: |
37905641 |
Appl. No.: |
12/487308 |
Filed: |
June 18, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11643698 |
Dec 22, 2006 |
|
|
|
12487308 |
|
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|
|
60752881 |
Dec 23, 2005 |
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61074384 |
Jun 20, 2008 |
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Current U.S.
Class: |
623/23.68 |
Current CPC
Class: |
A61F 2/24 20130101; A61F
2/90 20130101; A61F 2002/044 20130101; A61F 2/91 20130101; A61F
2250/0067 20130101; A61F 2/2418 20130101; A61F 2/95 20130101; A61F
2/04 20130101; A61B 2017/00827 20130101; A61F 2250/0039
20130101 |
Class at
Publication: |
623/23.68 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Claims
1. An esophageal valve having a restriction to allow antegrade
passage of swallowed food and controlled retrograde passage of
fluid, the restriction comprising an iris having a number of
folds.
2. A valve as claimed in claim 1 wherein the valve is adapted to be
opened when different forces are applied in the antegrade and
retrograde directions.
3. A valve as claimed in claim 2 wherein the valve is adapted to
open in the antegrade direction in response to antegrade forces and
to open in the retrograde direction in response to retrograde
forces, the retrograde force required to open the valve being
substantially greater than the antegrade force required to open the
valve.
4. A valve as claimed in claim 1 wherein the iris is formed from a
tubular precursor, the ends of which are oppositely rotated.
5. A valve as claimed in claim 4 wherein the precursor is folded as
the ends are oppositely rotated.
6. A valve as claimed in claim 4 wherein the precursor is generally
cylindrical.
7. A valve as claimed in claim 4 wherein the precursor is generally
of hourglass shape.
8. A valve as claimed in claim 1 wherein the restriction comprises
at least three folds.
9. A valve as claimed in claim 1 wherein the valve has means to set
the differential forces required to open the valve.
10. A valve as claimed in claim 9 wherein the valve comprises a
stop to restrict the opening of the valve in one direction.
11. A valve as claimed in claim 9 comprising strengthening means to
restrict the opening of the valve in one direction.
12. A valve as claimed in claim 1 comprising a support for the
iris.
13. A valve as claimed in claim 12 wherein the tubular iris is
attached to the support.
14. A valve as claimed in claim 13 wherein a distal end of the
tubular iris is attached to the support and a proximal end of the
tubular iris is attached to the support.
15. A valve as claimed in claim 14 wherein the attachments are
arranged such that the valve will open in response to different
forces applied in the antegrade and in the retrograde directions.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application is a continuation-in-part of U.S.
patent application Ser. No. 11/643,698 filed Dec. 22, 2006 which
claims the benefit of U.S. Provisional Application No. 60/752,881
filed Dec. 23, 2005. The present application also claims the
benefit of U.S. Provisional Application No. 61/074,384 filed Jun.
20, 2008. The complete contents of all of these are incorporated
herein by reference.
INTRODUCTION
[0002] The invention relates to devices useful in the treatment of
GERD (Gastro Esophageal Reflux Disease)
[0003] GERD is often caused by a failure of the anti-reflux
mechanism. In healthy patients the anti-reflux mechanism is
comprised of the lower esophageal sphincter (LES) and the "Angle of
His," the angle at which the esophagus enters the stomach. These
create a valve that prevents duodenal bile, enzymes, and stomach
acid from traveling back into the esophagus where they can cause
burning and inflammation of sensitive esophageal tissue.
[0004] A surgical treatment, which is often preferred over longtime
use of medication, is the Nissen fundoplication. In this procedure
the upper part of the stomach is wrapped around the LES (lower
esophageal sphincter) to strengthen the sphincter and prevent acid
reflux and to repair a hiatal hernia. The procedure is usually
carried out laparoscopically.
[0005] In 2000 the U.S. Food and Drug Administration (FDA) approved
two endoscopic devices to treat chronic heartburn. In one system
stitches are put in the LES to create pleats to strengthen the
muscle. Another, the Stretta Procedure, uses electrodes to apply
radio frequency energy to the LES. The long-term outcomes of both
procedures compared to a Nissen fundoplication are still being
determined.
[0006] The NDO Surgical Plicator is also used for endoscopic GERD
treatment. The Plicator creates a plication, or fold, of tissue
near the gastroesophageal junction, and fixates the plication with
a suture-based implant. The Plicator is currently marketed by NDO
Surgical, Inc.
STATEMENTS OF INVENTION
[0007] According to the invention there is provided an esophageal
valve having a restriction to allow antegrade passage of swallowed
food and controlled retrograde passage of fluid, the restriction
comprising a iris having a number of folds.
[0008] In one embodiment the valve is adapted to be opened when
different forces are applied in the antegrade and retrograde
directions.
[0009] In one case the valve is adapted to open in the antegrade
direction in response to antegrade forces and to open in the
retrograde direction in response to retrograde forces, the
retrograde force required to open the valve being substantially
greater than the antegrade force required to open the valve.
[0010] In one embodiment the iris is formed from a tubular
precursor, the ends of which are oppositely rotated. The precursor
may be folded as the ends are oppositely rotated. In one case the
precursor is generally cylindrical. In one case the precursor is
generally of hourglass shape.
[0011] In one embodiment the restriction comprises at least three
folds.
[0012] In one case the valve has means to set the differential
forces required to open the valve.
[0013] The valve may comprise a stop to restrict the opening of the
valve in one direction.
[0014] In one case the valve comprises strengthening means to
restrict the opening of the valve in one direction.
[0015] In one embodiment the valve comprises a support for the
iris.
[0016] In one case the tubular iris is attached to the support. The
attachments may be arranged such that the valve will open in
response to different forces applied in the antegrade and in the
retrograde directions.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The invention will be more clearly understood from the
following description thereof given by way of example only, in
which:
[0018] FIGS. 1 to 8 illustrate a valve of the invention in various
configurations;
[0019] FIG. 9 is an isometric view of a valve device according to
the invention;
[0020] FIG. 10 is a cross sectional view of the device of FIG.
9;
[0021] FIG. 11 is a plan view of a valve of with four folds;
[0022] FIG. 12 is a plan view of a valve with five folds;
[0023] FIG. 13 is a plan view illustrating the operation of the
valve;
[0024] FIGS. 14 and 15 are cross sectional views of the valve in
use; and
[0025] FIG. 16 is a cross sectional view of the valve in use.
DETAILED DESCRIPTION
[0026] The invention is a prosthetic esophageal valve, which
prevents reflux from entering into the esophagus. The valve is
specifically designed to allow swallowed food to pass distally
through it and also to allow retrograde flow of liquid and gasses
proximally during belching or vomiting.
[0027] FIGS. 1 to 8 illustrate a valve 1 in various configurations.
The valve 1 comprises a sleeve 5 which is twistable to move the
sleeve 5 between an open configuration (FIGS. 1 and 2) in which a
lumen 6 is open, and a sealed configuration (FIGS. 7 and 8) in
which the lumen is closed.
[0028] The implantable sleeve 5 could have an "hourglass" shape, as
illustrated in FIGS. 1 to 8. This shape would enable the device to
be located and secured at the oesophageal sphincter 25. In addition
the device can be twisted in-situ by the clinician to tailor the
elasticity of the orifice created. The sleeve 5 could be held in
place either by sutures or by an adhesive.
[0029] FIGS. 1 to 8 illustrate the sleeve 5 designed as a sphincter
implant with adjustable opening tightness.
[0030] Referring to FIGS. 9 to 16, in this case the middle of the
valve has a restriction 10 that controls flow in both directions.
The restriction 10 is formed through a series of folds 11 in the
lumen of the valve, which are created by simultaneously rotating
and folding a precursor as described above with reference to FIGS.
1 to 8.
[0031] The precursor component can be a straight tube or an
hourglass shaped tube with an open lumen.
[0032] Additionally, the tube can have specific internal profiles
such as helical ribs or protrusions. The proximal and distal
opening forces can be varied by changing the internal profile of
the valve or the conical angle at either end of the valve. The
valve may be mounted to a semi-rigid support 20 such as a braided
plastic stent. In this case there is a proximal mounting 26 and a
distal mounting as illustrated particularly in FIG. 10. The degree
of attachment may be varied to influence the characteristics of the
valve. For example, the distal attachment 27 may be adapted to
facilitate opening in response to a pre-determined retrograde force
P.sub.2 which will facilitate belching or vomiting. Similarly, the
proximal attachment 26 may be adapted to facilitate opening in
response to a pre-determined antegrade force P.sub.1.
[0033] The restriction can be created by rotating the ends of the
tubular precursor contrary to each other either clockwise or
anticlockwise. This has the effect of creating an internal iris in
the centre of the rotated tube. The iris thus created has a number
of folds or wings, which are predetermined prior to rotation. The
angle of rotation can be between 15 and 200.degree.. The angle of
rotation can be used to vary the force to be applied to pass
through.
[0034] In addition, during the rotation of the tube it naturally
foreshortens. The foreshortening effect can be controlled by
applying longitudinal compression or tension.
[0035] When the target angle of rotation, number of folds and
degree of foreshortening is achieved the iris can be locked into
it's desired configuration by externally connecting it to a
supporting structure 20. The restriction can be made from three or
more folds. The helical angle of the internal ribs can be between
10 and 90.degree. to the vertical.
[0036] The valve functions as a conformable iris in which the
opening force can be predetermined through its geometric
properties.
[0037] It is possible to make the valve open with different forces
in the proximal and distal directions. For example, a re-inforcing
ring may be placed at one side of the valve. This functions as a
physical stop to reduce the freedom of movement of the iris wings
in one direction. Alternatively or additionally the opening
characteristics in response to antegrade and retrograde flow can be
altered by providing additional layers or thicknesses of material
at appropriate locations.
[0038] The conical sections 3, 4 act as a means to direct food
through the lumen rather than around the outside of the device
whereas the narrow restriction 2 in the middle of the valve
functions as a means of preventing flow.
[0039] The force provided by the valve to restrict flow is
dependent on a number of factors including:
[0040] the degree of restriction in the centre of the valve;
[0041] the angle or curvature between the end of the device and the
central restriction;
[0042] whether the angle (or curvature) of the proximal and distal
ends of the device are the same. Different angles will create
different degrees of restriction in the proximal and distal
directions;
[0043] the `pass through` force can also be manipulated by changing
the material properties from which the valve is made; and
[0044] the properties of the valve will also be influenced by the
external forces placed upon it by the natural movement and pressure
of the esophagus. This external force may augment the functioning
of the valve by contributing to the degree of restriction.
[0045] The angle that the proximal end of the device makes with the
restriction can be between 10 and 90.degree. to the horizontal.
[0046] The luminal diameter of the restriction in the centre of the
valve can be between 0 and 20 mm.
[0047] The elongation of the material used to construct the
restriction can be between 50 and 3000%
[0048] The tensile strength of the material used to construct the
restriction can be between 0.01 and 5 N/mm.sup.2.
[0049] In order to facilitate the normal passage of food in the
esophagus the restriction is capable of opening, in the proximal
direction, with an axial force of between 50 and 100 g.
[0050] In order to facilitate normal belching and vomiting the
restriction is capable of opening, in the distal direction, with a
pressure of between 200 and 500 mmH.sub.2O.
[0051] This design creates the optimum valve conditions while
positioned in the lumen of the esophagus. Previous approaches have
required devices to be placed either on the outside of the
esophagus or under the mucosal surface tissue of the esophagus.
Thus the current invention circumvents the need for invasive
procedures.
[0052] The valve allows retrograde opening at precisely defined
pressures.
[0053] Because the valve does not invert to facilitate belching and
vomiting it does not have to reorient itself periodically.
[0054] Many variations of valve can be produced to treat varying
severity of disease.
[0055] The device can also be made in a very low profile fashion to
facilitate its crimping and subsequent delivery.
[0056] The valve of the invention requires very low actuation
pressure. It can function asymmetrically to mimic the various
bodily functions in the esophagus.
[0057] The valve may be of any suitable biocompatible materials
that have characteristics as follows. The materials used for the
production of this valve should have a % elongation between 50% and
3000%. Additionally the material could have an antimicrobial action
to prevent colonisation when in-vivo. Additionally the material can
be elastic or viscoelastic and can optionally be an open cell foam.
The density of the material should be between 0.1 g/cm.sup.3 to 1.5
g/cm3.
[0058] The valve of the invention may be used to treat
gastroesophageal reflux disease.
[0059] The invention is not limited to the embodiments hereinbefore
described, which may be varied in detail.
* * * * *