U.S. patent application number 11/255258 was filed with the patent office on 2006-02-23 for perorally removeable anti-reflux valve implantation.
This patent application is currently assigned to Reflux Corporation. Invention is credited to Thomas V. Taylor, Frank G. Weeden.
Application Number | 20060041319 11/255258 |
Document ID | / |
Family ID | 35115236 |
Filed Date | 2006-02-23 |
United States Patent
Application |
20060041319 |
Kind Code |
A1 |
Taylor; Thomas V. ; et
al. |
February 23, 2006 |
Perorally removeable anti-reflux valve implantation
Abstract
Disclosed are esophageal anti-reflux valve prostheses, and tools
and procedures for peroral implantation and extraction of the
prostheses. The prostheses disclosed have a semipermeable membrane
to allow retrograde passage of gas, magnets disposed at a distal
end of the sleeve to facilitate closure, and an outwardly bendable
array of spikes that are longitudinally aligned for peroral
insertion and lockable into a radially outwardly deployed
configuration to keep the prosthesis from dislocating after
implantation. The implantation tool has inner and outer concentric
tubes, the inner tube releasably threadably connected to the
prosthesis, the outer tube reverse threaded with the inner tube to
advance a distal headpiece to engage, deploy and lock the spikes
into the deployed configuration. A vacuum assist can be used to
help impact the lumen wall on the spikes. The extraction tool is
similar to the implantation tool with an inner tube for threadably
engaging the prosthesis, an outer tube with a distal crown with a
plurality of shoes to unseat and unlock the spikes, and an overtube
shield to receive the spikes and facilitate extraction of the
prosthesis.
Inventors: |
Taylor; Thomas V.; (Houston,
TX) ; Weeden; Frank G.; (Houston, TX) |
Correspondence
Address: |
LUNDEEN & DICKINSON, LLP
PO BOX 131144
HOUSTON
TX
77219-1144
US
|
Assignee: |
Reflux Corporation
Houston
TX
|
Family ID: |
35115236 |
Appl. No.: |
11/255258 |
Filed: |
October 21, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10064324 |
Jul 2, 2002 |
6958079 |
|
|
11255258 |
Oct 21, 2005 |
|
|
|
60302870 |
Jul 3, 2001 |
|
|
|
Current U.S.
Class: |
623/23.68 ;
606/108 |
Current CPC
Class: |
A61F 2/2476 20200501;
A61F 2/04 20130101; A61F 2002/044 20130101 |
Class at
Publication: |
623/023.68 ;
606/108 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Claims
1. (canceled)
2. (canceled)
3. (canceled)
4. (canceled)
5. (canceled)
6. (canceled)
7. (canceled)
8. (canceled)
9. (canceled)
10. (canceled)
11. (canceled)
12. (canceled)
13. The method of claim 36, wherein the prosthesis comprises: an
annular body; a valve depending from the annular body, said valve
allowing orthograde passage therethrough and inhibiting retrograde
passage of gastric contents; and wherein said plurality of
retractable spikes are spaced along a circumference of the annular
body adjacent one end thereof.
14. The method of claim 13 wherein said valve is a sleeve
valve.
15. (canceled)
16. (canceled)
17. (canceled)
18. The method of claim 13 wherein each of the spikes include a tip
at a free end thereof and a base attached to the annular body.
19. The method of claim 18 wherein a dog is formed between the base
and the tip of each of the spikes.
20. The method of claim 19 wherein a plurality of keepers are
positioned on an exterior surface of the annular body for receiving
the dogs and locking the spikes in a deployed alignment.
21. The method of claim 13 wherein each of the spikes is outwardly
bendable at the base between a retracted alignment during said
postioning and a deployed alignment following said deployment.
22. The method of claim 21 wherein said retracted alignment is
generally longitudinal.
23. The method of claim 21 wherein said deployed alignment is
generally radially outward.
24. (canceled)
25. (canceled)
26. The method of claim 14 wherein the annular body is internally
threaded.
27. The method of claim 13 wherein the valve is implanted to
relieve symptoms of a patient with Gastroesophageal reflux
disease.
28. The method of claim 27 wherein the patient does not suffer from
esophageal cancer.
29. The method of claim 36, wherein the prosthesis includes an
annular body and retractable radial spikes therefrom, and wherein
the tool comprises: an inner tube and an outer tube, said tubes
being generally concentrically aligned; a nipple secured to a
distal end of the inner tube, the nipple configured to be
releasably coupled with the annular body during said positioning;
and the headpiece secured to a distal end of the outer tube to
engage the retractable spikes and outwardly extend them into
position during said deployment by advancing the headpiece into
abutment with the nipple.
30. The method of claim 29 wherein the outer tube is configured to
be advanced or retracted as the outer tube is rotated with respect
to the inner tube.
31. The method of claim 30 said tool further comprising a handle,
said handle being secured adjacent to a proximal end of the inner
tube for manipulation thereof.
32. The method of claim 31 said tool further comprising a second
handle secured adjacent to a proximal end of the outer tube to
facilitate rotation of the outer tube with respect to the inner
tube.
33. The method of claim 29 further comprising viewing the esophagus
through a fiber optic cable disposed within a central longitudinal
passage of the inner tube.
34. The method of claim 29 wherein the headpiece includes a
plurality of transverse passages formed therein in communication
with a transverse bore in a wall of the inner tube and a central
longitudinal passage.
35. (canceled)
36. A method for using a tool to perorally implant an anti-reflux
prosthesis in an esophagus, the method comprising the steps of:
mounting the anti-reflux valve prosthesis onto a headpiece of the
tool; positioning the anti-reflux valve prosthesis in the
esophagus; deploying a plurality of radial spikes of the
prosthesis; pulling a vacuum across a longitudinal passage of the
tool; and drawing a lumen of the esophagus inwardly to facilitate
impaction of the spikes.
37. The method of claim 36 wherein the headpiece is configured to
be removable and replaced with a crown, the crown configured to
assist in the peroral removal of the prosthesis from the
esophagus.
38. (canceled)
39. A method for implanting an anti-reflux valve prosthesis in an
esophagus, the method comprising the steps of: perorally inserting
and positioning the anti-reflux valve prosthesis into the
esophagus; deploying a plurality of spikes, the spikes depending
radially from the anti-reflux prosthesis; and impaling the
esophagus upon the spikes to hold the prosthesis in place.
40. The method of claim 39 further comprising using a vacuum to
assist in impaling the esophagus upon the spikes.
41. (canceled)
42. (canceled)
43. (canceled)
44. (canceled)
45. (canceled)
46. (canceled)
47. (canceled)
48. (canceled)
49. (canceled)
50. (canceled)
51. (canceled)
52. (canceled)
53. (canceled)
54. (canceled)
55. (canceled)
56. (canceled)
57. (canceled)
58. A method for using a tool for implanting an anti-reflux valve
prosthesis, wherein (A) the prosthesis comprises (1) an internally
threaded annular body comprising a biologically inert polymer, (2)
a valve depending from the annular body for allowing orthograde
passage therethrough and inhibiting retrograde passage of gastric
contents, and (3) a plurality of substantially rigid spikes spaced
along a circumference of the annular body adjacent a proximal end
thereof and extending radially outwardly from the annular body,
each spike comprising a tip at a free end thereof and a base at the
other end attached to the annular body, wherein each spike is
temporarily inwardly bendable for implantation and has memory to
return to the radially outwardly extending position, and (B) the
tool comprises (1) an inner tube, (2) a nipple secured to a distal
end of the inner tube for releasably threadably coupling the
annular body, (3) a handle secured adjacent to a proximal end of
the inner tube for manipulation thereof, (4) an overtube slideable
along and receiving the inner tube, (5) a handle secured to a
proximal end of the overtube for manipulation thereof, and (6) a
shield attached to a distal end of the overtube longitudinally
movable between a first position for receiving the fixation spikes
in the inwardly bent configuration during peroral insertion into
the esophagus, a second position for releasing the fixation spikes,
and a third position for facilitating return of the fixation spikes
to the memory position, comprising the steps of: threadably
engaging the nipple in the annular body; bending the spikes
inwardly and positioning the shield in the first position over the
spikes; perorally inserting the valve prosthesis into the esophagus
near the gastroesophageal junction; while holding the valve
prosthesis in place, moving the shield into the second position to
release the spikes to return to the memory position; optionally
moving the shield into the third position to facilitate return of
the spikes into the memory position to facilitate engagement of the
spikes in a wall of the esophagus; rotating the inner tube with
respect to the annular body to uncouple the nipple; and withdrawing
the tool from the esophagus.
59. The method of claim 58 further comprising moving the shield
into the third position to facilitate return of the spikes into the
memory position to facilitate engagement of the spikes in a wall of
the esophagus.
60. (canceled)
61. (canceled)
62. (canceled)
63. (canceled)
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims the benefit of U.S.
Provisional application Ser. No. 60/302,870, filed Jul. 3, 2001,
and entitled Perorally Insertable/Removable Anti-Reflux Valve,
which is hereby incorporated by reference in its entirety.
BACKGROUND OF INVENTION
[0002] This invention relates to a device and non-invasive surgical
method for treating gastroesophageal reflux disease. More
specifically, it relates to an anti-reflux valve prosthesis and
associated instrumentation for its peroral placement and in situ
fixing at the gastroesophageal junction, to prevent the reflux of
gastric contents into the esophagus. The invention further relates
to the instrumentation and methodology for peroral removal of such
a prosthesis.
[0003] Gastroesophageal reflux disease (GERD) is the commonest
cause of dyspepsia, affecting some 30% of the United States adult
population intermittently and some 10% on a continuous and
troublesome basis. Gastroesophageal reflux disease produces
heartburn, abdominal pain and regurgitation of acid-containing
gastric contents into the esophagus and pharynx. It may also lead
to alteration of the lining of the esophagus (Barrett''s
Esophagus), which may in turn lead to esophageal cancer. Current
methods of treating GERD include powerful antacid medication
therapies and surgical interventions.
[0004] Medication therapy with powerful antacids is directed at
treating the symptoms of GERD, and is necessarily not curative.
Furthermore, medication-based therapies are not always fully
effective, as reflux is not prevented and the esophagus may
continue to be exposed to gastric content.
[0005] Surgical intervention typically involves either open surgery
(performed through the abdomen or the chest) or laparoscopic
surgery (performed through one or more incision access ports
inserted through the abdominal wall), and the re-sectioning of
tissue or the implanting of a prosthetic device. Although surgical
interventions can be curative, these treatments are seriously
invasive and have the attendant risk of such procedures. Despite
the risk, the field has been motivated to provide solutions to the
GERD problem, which has resulted in the development of a number of
surgically implantable anti-reflux valve prosthetic devices. Prior
anti-reflux valve prostheses are essentially one-way valves
implanted at the gastroesophageal junction using open or
laparoscopic surgery. The implanted prosthesis allows normal
swallowing to take place in an orthograde manner while preventing
the reflux of gastric contents from the stomach into the
esophagus.
[0006] Examples of surgically implanted esophageal anti-reflux
valve prostheses include the devices of: Godin (U.S. Pat. No.
5,314,473) which discloses a one-way, antivalve comprising a
flattened tubular part associated with an annular fixing element;
and Reich (U.S. Pat. No. 4,846,836) which discloses a
bi-directional valve and housing for similar purposes. These
devices were developed to be inserted into the gastro-esophageal
junction via open or laparoscopic surgery and fixed there. The
purpose was to permit the unidirectional passage of ingested
materials into the stomach while preventing the reflux of gastric
content of the stomach into the esophagus. Typically, these devices
require suturing or other means to fix them to the tissue of the
esophagus.
[0007] Generally, all of these prior devices and methods require
surgical invasion of a body cavity and breach of the body membrane
in some fashion (e.g., open surgery or laparoscopy) in order to
accomplish their utility. Invasive surgical interventions are too
frequently complicated by problems such as stricture formation,
"gas bloat," or recurrent symptoms of reflux disease. Additionally,
the results obtained by gross surgical treatment can be
technique-dependent and vary significantly from surgeon to
surgeon.
[0008] More recently, perorally implantable valve prostheses were
disclosed for fixation in the esophageal lumen near the
gatroesophageal junction in patent applications by one of the
present co-inventors, Dr. Thomas V. Taylor, U.S. Ser. No.
08/987,693, filed Dec. 9, 1997, U.S. Pat. No. 6,254,642; U.S. Ser.
No. 09/681,364, filed Mar. 26, 2001, U.S. Pat. No. ______; and U.S.
Ser. No. 09/681,364, filed Mar. 26, 2001, U.S. Pat. No. ______;
each of which is hereby incorporated herein by reference in its
entirety.
SUMMARY OF INVENTION
[0009] The present invention relates to an anti-reflux valve
prosthesis system for treating gastroesophageal reflux disease
(GERD) in a patient, which does not require open or laparoscopic
surgery to implant. The present invention provides for perorally
inserting a removable sutureless anti-reflux valve prosthesis down
the lumen of the esophagus, to the gastroesophageal junction, where
it is fixed in place. The advantage of this system is that peroral
insertion of such a valve eliminates the need for either open
formal laparotomy, thoracotomy or a laparoscopic approach using
multiple access ports. In the event it is later desired to remove
or replace the prosthesis, the valve can be removed using a peroral
extraction tool, again generally without the need for laparotomy,
thoracotomy, laparoscopy, or any other surgically invasive
technique.
[0010] In one aspect, the present invention provides an anti-reflux
valve prosthesis. The prosthesis has an annular fixation element
for fixing the prosthesis in an esophagus, and a one-way valve
depending from the annular fixation element for allowing orthograde
passage therethrough and inhibiting retrograde passage of gastric
contents. The valve includes a semipermeable membrane that is
essentially liquid impermeable, but gas permeable to allow
retrograde permeation of gas through the valve. The prosthesis can
be configured to be perorally installed or perorally removable. The
one-way valve of the prosthesis can be a sleeve valve. The
prosthesis can be made of a biologically inert material, including
but not limited to, a fluorinated polymer. The prosthesis is
configured to be implanted in the esophagus of a patient with
gastroesophageal reflux disease (GERD), preferably when that
patient''s esophagus is cancer free.
[0011] In another aspect, the present invention provides another
embodiment of an anti-reflux valve prosthesis that has an annular
fixation element for fixing the prosthesis in the esophagus and a
sleeve valve depending from the annular fixation element for
allowing orthograde passage therethrough and inhibiting retrograde
passage of gastric contents. The sleeve valve has a plurality of
magnets secured at a distal end thereof to facilitate closure of
the valve. Additionally, the prosthesis may contain a gas permeable
membrane to allow retrograde permeation of gas therethrough, where
the membrane is preferably liquid impermeable.
[0012] In still another aspect, the present invention provides an
anti-reflux valve prosthesis for peroral implantation in the
esophagus. The prosthesis in this embodiment includes an annular
body and a valve depending from the annular body for allowing
orthograde passage therethrough and inhibiting retrograde passage
of gastric contents. A plurality of substantially rigid spikes are
spaced along a circumference of the annular body adjacent one end
thereof, preferably the proximal end. The valve depending from the
annular body can be a sleeve valve which may include a plurality of
magnets secured at a distal end to facilitate closure of the valve.
The prosthesis may also include a gas permeable, and preferably
liquid impermeable, membrane to allow retrograde permeation of gas
therethrough. Each spike has a tip at a free end thereof and a base
at the other end attached to the annular body. A dog is formed on
each spike between the base and the tip. Each spike is outwardly
bendable at the base between a retracted generally longitudinal
alignment for insertion and a radially outwardly deployed alignment
for fixation. Preferably, the spikes can include a chamfer at the
base to facilitate the bending. A keeper is positioned on an
exterior surface of the annular body for receiving the dogs and
locking the respective spike in the deployed alignment. The annular
body of the prosthesis can be threaded to allow engagement with a
tool to perorally insert and/or remove the prosthesis from the
esophagus. The prosthesis is configured to be implanted in the
esophagus of a patient with gastroesophageal reflux disease (GERD),
preferably when that patient''s esophagus is cancer free.
[0013] In a further aspect, the present invention provides a tool
for implanting the perorally implantable prosthesis. In this
embodiment, the annular body is internally threaded and the spikes
are attached to a proximal end of the annular body. The tool
includes inner and outer tubes, a nipple secured to a distal end of
the inner tube for releasably coupling the annular body, and a
handle secured adjacent to a proximal end of the inner tube for
manipulation of the tool. The inner tube and the outer tube are
configured for advancement of the outer tube by rotating the outer
tube with respect to the inner tube. A headpiece is secured to a
distal end of the outer tube for bending the spikes outwardly into
the deployed alignment by advancement of the headpiece into
abutment with the nipple. A handle is preferably secured adjacent
to a proximal end of the outer tube to facilitate rotation of the
outer tube with respect to the first tube. Optionally, a plurality
of transverse passages are formed in the headpiece in fluid
communication with an annular space defined by an inner diameter of
the headpiece, an outer diameter of the inner tube and annular
seals on each end thereof. If present, the annular space is in turn
in fluid communication with a vacuum source via a transverse bore
in a wall of the inner tube and a central longitudinal passage
through the inner tube, for drawing a lumen of the esophagus
inwardly to facilitate penetration of the spikes. Optionally, a
fiber optic cable is disposed within a central longitudinal passage
of the inner tube for viewing the esophagus.
[0014] In still another aspect of the invention, there is provided
a method of using a tool to perorally implant an anti-reflux
prosthesis in an esophagus. The method includes: (a) mounting the
anti reflux valve prosthesis onto a headpiece of the tool; (b)
positioning the anti-reflux valve prosthesis in the esophagus; (c)
deploying a plurality of radial spikes of the prosthesis; (d)
pulling a vacuum across a longitudinal passage of the tool; and (e)
drawing a lumen of the esophagus inwardly to facilitate impaction
of the spikes. Optionally the headpiece of the tool can be
configured to be removable and replaced with a crown. The crown
would be configured to assist in the peroral removal of the
prosthesis from the esophagus.
[0015] In still another aspect of the invention, there is provided
a tool to perorally implant an anti-reflux prosthesis in an
esophagus. The tool includes: (a) a means for mounting the anti
reflux valve prosthesis onto a headpiece of the tool; (b) a means
for positioning the anti-reflux valve prosthesis in the esophagus;
(c) a means for deploying a plurality of radial spikes of the
prosthesis; (d) a means for pulling a vacuum across a longitudinal
passage of the tool; and (e) a means for drawing a lumen of the
esophagus inwardly to facilitate impaction of the spikes.
[0016] In still another aspect of the invention, there is provided
a method of using a tool for implanting the anti-reflux valve
prosthesis. The method includes: (a) perorally inserting and
positioning the anti-reflux valve prosthesis into the esophagus;
(b) deploying a plurality of spikes, the spikes depending radially
from the anti-reflux prosthesis; and (c) impaling the esophagus
upon the spikes to hold the prosthesis in place. Optionally, the
method can include using a vacuum to assist in impaling the
esophagus upon the spikes.
[0017] Furthermore, another aspect of the invention provides for a
tool to implant an anti-reflux prosthesis. The tool includes: (a) a
means for perorally inserting and positioning the anti-reflux valve
prosthesis into the esophagus; (b) a means for deploying a
plurality of spikes, the spikes depending radially from the
anti-reflux prosthesis; and (c) a means for penetrating the
esophagus with the spikes to hold the prosthesis in place.
[0018] In still another aspect of the invention, there is provided
a method of using a tool for implanting an anti-reflux valve
prosthesis. The method includes: (a) releasably engaging a nipple
of the tool with an annular body of the prosthesis, the prosthesis
having a plurality of retractable embedment spikes; (b) perorally
inserting the valve prosthesis into the esophagus near the
gastroesophageal junction; (c) extending the spikes fully outwardly
into a deployed alignment for engagement with a lumen of the
esophagus; (d) uncoupling the nipple from the prosthesis; and (e)
withdrawing the tool from the esophagus. Furthermore, the method
can optionally include actuating a vacuum source to draw the wall
of the lumen inwardly and facilitate engagement of the spikes.
[0019] In still another aspect of the invention, there is provided
a tool for implanting an anti-reflux valve prosthesis. The tool
includes: (a) a means for releasably engaging a nipple of the tool
with an annular body of the prosthesis, the prosthesis having a
plurality of retractable embedment spikes; (b) a means for
perorally inserting the valve prosthesis into the esophagus near
the gastroesophageal junction; (c) a means for extending the spikes
fully outwardly into a deployed alignment for engagement with a
lumen of the esophagus; (d) a means for uncoupling the nipple from
the prosthesis; and (e) a means for withdrawing the tool from the
esophagus.
[0020] A further aspect is the provision of a tool for extracting
the anti-reflux prosthesis wherein the prosthesis includes an
annular body and extended radial spikes therefrom. The tool
includes an inner tube and an outer tube, with the tubes being
generally concentrically aligned, an nipple secured to a distal end
of the inner tube, the nipple configured to be releasably coupled
with the annular body, and a crown secured to a distal end of the
outer tube, the crown having a plurality of tangentially projecting
shoes to receive and retract the extended radial spikes.
Optionally, the outer tube of the tool can be configured to be
advanced or retracted as the outer tube is rotated with respect to
the inner tube. The tool can also comprise a handle secured to a
proximal end of the inner tube for manipulation thereof. The tool
can also include a second handle secured adjacent to a proximal end
of the outer tube to facilitate movement of the outer tube with
respect to the inner tube. The tool can optionally include a fiber
optic cable disposed within a central longitudinal passage of the
inner tube for viewing the esophagus. The tool can optionally
include an overtube having a shield of enlarged diameter at a
distal end thereof, wherein the overtube is slidable over the outer
tube to receive the plurality of spikes to facilitate removal of
the prosthesis from the esophagus. The shield may optionally be
tapered from a larger diameter at a distal end to a smaller
diameter at a proximal end. The crown may optionally be configured
to be removable and replaced with a headpiece that is configured to
assist in reinstalling the prosthesis into the esophagus.
[0021] A further aspect of the invention involves a method for
using a tool to extract an anti-reflux valve prosthesis from an
esophagus. The method includes: (a) perorally inserting the tool
into the esophagus, wherein the tool comprises a nipple and a
crown; (b) engaging the nipple into an annular body of the
prosthesis, wherein the prosthesis includes a plurality of extended
embedment spikes; (c) advancing the crown with respect to the
nipple, the crown configured to retract the embedment spikes; and
(d) removing the tool and engaged prosthesis from the esophagus.
Optionally, the method can include advancing a shield over the
spikes to place the spikes into a retracted position.
[0022] A further aspect of the invention involves a tool to extract
an anti-reflux valve prosthesis from an esophagus. The tool
includes: (a) a means for perorally inserting the tool into the
esophagus, wherein the tool comprises a nipple and a crown; (b) a
mens for engaging the nipple into an annular body of the
prosthesis, wherein the prosthesis includes a plurality of extended
embedment spikes; (c) a means for advancing the crown with respect
to the nipple, the crown configured to retract the embedment
spikes; and (d) a means for removing the tool and prosthesis from
the esophagus. Optionally, the tool can include means for advancing
a shield over the spikes to place the spikes into a retracted
position.
[0023] An alternate embodiment of the invention is an anti-reflux
valve prosthesis for peroral implantation in the esophagus,
comprising an annular body preferably made of a biologically inert
polymer, a valve depending from the annular body for allowing
orthograde passage therethrough and inhibiting retrograde passage
of gastric contents, and a plurality of substantially rigid spikes
spaced along a circumference of the annular body adjacent one end
thereof and extending radially outwardly from the annular body.
Each spike has a tip at a free end thereof and a base at the other
end attached to the annular body. Each spike is temporarily
inwardly bendable for implantation and has memory to return to the
radially outwardly extending position.
[0024] Another aspect of the invention is the provision of a tool
for implanting the anti-reflux valve prosthesis of this alternate
embodiment wherein the annular body is internally threaded and the
spikes are attached to a proximal end of the annular body. The tool
includes an inner tube, a nipple secured to a distal end of the
inner tube for releasably threadably coupling the annular body, and
a handle secured adjacent to a proximal end of the inner tube for
manipulation thereof. An overtube is slidable along and receives
the inner tube. A handle is secured to a proximal end of the
overtube for manipulation. A shield is attached to a distal end of
the overtube. The shield is longitudinally movable between a first
position for receiving the fixation spikes in the inwardly bent
configuration during peroral insertion into the esophagus, a second
position for releasing the fixation spikes, and a third position
for facilitating return of the fixation spikes to the memory
position.
[0025] Another aspect of the invention is a method of using the
tool just described for implanting the anti-reflux valve
prosthesis. The method comprises: (a) threadably engaging the
nipple in the annular body; (b) bending the spikes inwardly and
positioning the shield in the first position over the spikes; (c)
perorally inserting the valve prosthesis into the esophagus near
the gastroesophageal junction; (d) while holding the valve
prosthesis in place, moving the shield into the second position to
release the spikes to return to the memory position; (e) optionally
moving the shield into the third position to facilitate return of
the spikes into the memory position to facilitate engagement of the
spikes in a wall of the esophagus; (f) rotating the inner tube with
respect to the annular body to uncouple the nipple; and (g)
withdrawing the tool from the esophagus.
[0026] A further aspect of the invention is a tool for extracting
the anti-reflux valve prosthesis of the alternate embodiment
wherein the annular body is internally threaded and the spikes are
attached to a proximal end of the annular body. The tool includes
inner and outer concentric tubes, a nipple secured to a distal end
of the inner tube for threadably coupling the annular body, and a
handle secured adjacent to a proximal end of the inner tube for
manipulation thereof. The inner tube and the outer tube are in
threaded interengagement for advancement of the outer tube by
rotating the outer tube with respect to the inner tube. A crown is
secured to a distal end of the outer tube and has a plurality of
tangentially projecting shoes disposed on a distal end of
respective longitudinal arms spaced along a circumference of the
crown in correspondence with the spikes for bending the fixation
spikes inwardly. An overtube has a shield of enlarged diameter at a
distal end. The overtube is slidable over the outer tube to receive
the plurality of inwardly bent spikes within the shield to inhibit
laceration of the esophagus during movement of the prosthesis.
[0027] A still further aspect of the invention is a method of using
the tool just described for extracting the anti-reflux valve
prosthesis. The method includes: (a) perorally inserting the tool
into the esophagus and threadably engaging the nipple in the
annular body of the prosthesis; (b) while holding the inner tube in
place, rotating the outer tube with respect to the inner tube to
advance the crown with respect to the nipple, engage the spikes
with the shoes and bend the fixation spikes radially inwardly; (c)
advancing the overtube to position the shield over the inwardly
bent spikes; and (d) withdrawing the tool and the prosthesis from
the esophagus.
BRIEF DESCRIPTION OF DRAWINGS
[0028] FIG. 1 is a side sectional view of a preferred embodiment of
the antivalve prosthesis according to the present invention.
[0029] FIG. 2 is a top plan view of the prosthesis of FIG. 1
showing the fixation spikes in a deployed configuration.
[0030] FIG. 3 is a side sectional view of the annular body used in
the prosthesis of FIG. 2 showing the fixation spikes in a
longitudinal, pre-deployment configuration.
[0031] FIG. 4 is a top view of the annular body of FIG. 3.
[0032] FIG. 5 is an enlarged sectional view of the upper end of the
annular body showing a preferred embodiment of the outer edge
profile.
[0033] FIG. 6 is a side view, partly in section and partly cut
away, of an insertion tool according to the present invention for
peroral implantation of the anti-reflux valve prosthesis of FIGS.
1-5.
[0034] FIG. 7 is a side view, partly in section and partly cut
away, of an extraction tool according to the present invention for
peroral removal of the anti-reflux valve prosthesis of FIGS.
1-5.
[0035] FIG. 8 is a simplified schematic of the crown of the
extraction tool of FIG. 7 showing the extraction foot detail.
[0036] FIG. 9 is an exploded side view, partly in section and
partly cut away, of an insertion tool-prosthesis assembly in
preparation for implantation of the anti-reflux valve prosthesis of
FIGS. 1-5 with the tool of FIG. 6.
[0037] FIG. 10 is a side view, partly in section and partly cut
away, of the distal end of the insertion tool-prosthesis assembly
of FIG. 9 showing implantation of the prosthesis in the esophageal
lumen following deployment of the fixation spikes and application
of the vacuum source prior to disengagement of the tool from the
prosthesis.
[0038] FIG. 11 is a side view, partly in section and partly cut
away, of the distal end of the extraction tool of FIGS. 7-8
threaded into the prosthesis of FIGS. 1-5 implanted in a patient''s
esophagus in preparation for foot release extraction according to
one embodiment of the present invention.
[0039] FIG. 12 is a side view, partly in section and partly cut
away, of the distal end of the extraction tool-prosthesis assembly
of FIG. 11 in a patient''s esophagus with the overtube shield
positioned in preparation for foot release extraction according to
one embodiment of the present invention.
[0040] FIG. 13 is a side view, partly in section and partly cut
away, of the distal end of the extraction tool-prosthesis assembly
of FIG. 12 with the overtube shield advanced in position over the
fixation spikes following the foot release extraction step and the
assembly being removed from the patient''s esophagus according to
one embodiment of the present invention.
[0041] FIG. 14 is a side view of an alternate embodiment of an
antisleeve valve having embedded magnets for use with the annular
body of FIGS. 3-5.
[0042] FIG. 15 is an end sectional view of the valve of FIG.
14.
[0043] FIG. 16 is a top view of the valve of FIGS. 14-15.
[0044] FIGS. 17A and 17B are side sectional and top plan views,
respectively, of an alternate embodiment of the annular body used
in the anti-reflux valve prosthesis of the invention wherein the
spikes are secured in a deployed configuration for implantation in
the lumen of the esophagus.
[0045] FIG. 18 is a side view, partly in section and partly cut
away, of an assembly of a valve prostheses made with the annular
body of FIGS. 17A and 17B coupled to the distal end of an insertion
tool in preparation for peroral insertion.
[0046] FIG. 19 is a side view, partly in section and partly cut
away, of the assembly of FIG. 18 following peroral placement of the
prosthesis near the gastroesophageal junction and retraction of the
overtube to deploy the fixation spikes.
[0047] FIG. 20 is a side view, partly in section and partly cut
away, of an assembly of the valve prosthesis in FIGS. 17-19 coupled
to the distal end of a peroral extraction tool in preparation for
removal.
[0048] FIG. 21 is a side view, partly in section and partly cut
away, of the assembly of FIG. 20 following retraction of the
fixation spikes within the overtube shield in preparation for
peroral removal from the esophagus.
DETAILED DESCRIPTION
[0049] As exemplified by the figures wherein like numerals refer to
like parts, the present invention provides a peroral prosthesis
system for treatment of gastroesophageal reflux disease (GERD) in a
patient comprising an anti-reflux valve prosthesis, a peroral
implantation tool for perorally inserting and positioning the valve
prosthesis at the distal end of the lumen of the esophagus and
implanting or fixing the valve prosthesis to the lumen wall, and a
peroral extraction tool for removing the prosthesis.
[0050] Referring to FIGS. 1-2, in a preferred embodiment, the
present invention provides a valve prosthesis 10 comprising a valve
12, preferably of the sleeve type, depending from an annular body
14. The sleeve valve 12 is made of a tubular membrane such as a
tube of silicone, latex, polyester, or preferably GORE-TEX or
TEADIT fluoropolymer, and has an upper end having a circular
cross-section for mounting to the annular body 14 via rings 16,
which can be made of a suitably inert material such as stainless
steel or heat-shrink TEFLON tubing. The lower end of the sleeve
valve 12 is preferably flat to facilitate closure upon exertion of
pressure from the gastric contents, thereby preventing reflux or
retrograde passage of gastric contents through the valve 12 under
normal conditions. In a preferred embodiment, the sleeve is a
semipermeable membrane that is essentially impervious to liquid but
allows gas permeation to facilitate relief and ease discomfort from
gas bloat, e.g. GORE-TEX film. If desired, the sleeve valve 10 can
be designed to evert when excessive gastric pressures are present,
as in regurgitation.
[0051] The annular body 14 is made from a biologically inert
material such as TEFLON, fluorinated ethylene-propylene copolymer
(FEP) or polytetrafluroethylene (PTFE), or the like, and serves as
a mounting ring for the sleeve valve 12, carrying an array of
fixation spikes 18, preferably at an upper or proximal end thereof.
The main portion of the body 14 can have a pair of grooves 20
formed in the exterior surface near the distal or lower end to
facilitate retention of the rings 16 and form a seal between the
valve 12 and the body 14. A shoulder 21 is formed in the exterior
surface near the proximal end of the main body to serve as a keeper
to lock the spikes 18 in position for fixation, as discussed in
more detail below.
[0052] The main portion of the annular body 14 can be internally
threaded, for example, with special acme right hand threads 22 that
are relatively large with a high pitch and rounded or contoured
bottoms to facilitate threaded engagement for implantation and
extraction, and also to inhibit the retention and accumulation of
swallowed material as it passes through. For example, the threads
22 are formed in one preferred embodiment with the dimensions given
for medium size threads (7 threads per inch) for rolled threads for
screw shells of electric sockets and lamp bases, American Standard,
in the Machinist''s Handbook. The inside diameter of the annular
body 14 should be large enough so as to facilitate the orthograde
passage of food and liquids through the esophagus, e.g. about 25
mm. The outside diameter of the annular body 14, especially at the
shoulder 21, should be sufficiently large to seat firmly in the
esophagus with some slight stretching of the lumen wall to
facilitate the formation of a fluid-tight seal therewith.
[0053] The spikes 18 are evenly spaced along the circumference of
the annular body 14 as best seen in FIGS. 2-4. Each spike 18 has a
pointed or sharpened tip 24 and a flexible or hinged base 26
secured to the main portion of the annular body 14. The spikes 18
are preferably integrally formed with the main portion of the body
14, but can have a smaller thickness than the wall of the main
body. For example, 1/16'' thick spikes may be utilized with a main
body thickness of 3/32''. To facilitate bending of the spikes 18, a
notch 28 can be provided at the base 26, preferably leaving
sufficient thickness so that the spike 18 is biased upwardly to
facilitate the extraction process. A downwardly sloped arm 30
disposed between the tip 24 and base 26 extends radially outwardly
from each fixation spike 18 and functions as a dog to lock the
spike 18 into place for fixation in the lumen wall. The arm 30 and
the shoulder 21 are complementarily dimensioned and positioned so
that a lower surface of the arm 30 is securely retained against
inwardly tapered shelf 32 formed in the shoulder 21. The proximal
surface of the shoulder 21 is preferably at a right angle to an
axis of the body 14 to help position the spikes 18 at a
corresponding right angle. The distal surface of the shoulder 21
can be sloped to generally correspond approximately to the angle of
the arm 30.
[0054] With reference to FIG. 6, there is illustrated a tool 100
that can be used to insert or implant the prosthesis 10. The tool
100 has an inner tube 102 received within an outer tube 104. The
tubes 102 and 104 can be rigid or flexible, as desired, preferably
made of autoclavable and/or sterilizable materials or combinations
of materials such as stainless steel, polypropylene or the like.
The inner tube 102 is provided with a nipple 106 at the distal end
and a manipulating handle 108 at the proximal end. The nipple 106
is threaded on an exterior surface to threadably engage the
prosthesis 10 (See FIG. 9) in preparation for peroral insertion.
The nipple 106 preferably has an elongated distal end 110 of
reduced outside diameter to facilitate engagement with the
prosthesis 10, and a proximal end 112 of slightly enlarged outside
diameter to slightly bias the fixation spikes 18 outwardly upon
engagement of the prosthesis 10. If desired, the inner tube 102 is
provided with a central passage 113 for equipping an optics package
114 including a light source and a fiber optic cable and/or a
conventional endoscope.
[0055] The outer tube 104 is provided with a proximal handle 116
and a distal headpiece 118. The outer tube is threadedly connected
to the inner tube 102 at threaded section 120, which preferably has
left-handed or opposite-direction standard threads. The headpiece
118 has a relatively enlarged outside diameter 122 so as to bend
the fixation spikes 18 outwardly as the outer tube is advanced
along the inner tube 102 by counterclockwise rotation of the outer
tube 104 while the inner tube 102 is held stationary. The
left-handed threads ensure that the rotation of the outer tube 104
does not tend to turn the prosthesis 10. The headpiece can have a
recess 124 formed in a distal end surface to shoulder the proximal
end 112 and ensure that the fixation spikes are fully deployed and
locked in place.
[0056] If desired, the tool 100 can be provided with a passageway
to apply vacuum adjacent the prosthesis to draw the lumen wall
inwardly and facilitate penetration of the spikes 18. The headpiece
118 is provided with a plurality of transverse passages 126 in
communication with an annulus defined by the inside diameter of the
headpiece 118, the outside diameter of the inner tube 102, and
opposing O-ring seals 128 on either side thereof. A transverse bore
130 is formed in the inner tube 102 in fluid communication between
the annulus and the central passageway 113. A vacuum hose 132
connects the proximal end of the central passageway 113 to a
conventional vacuum source.
[0057] With reference to FIG. 7, there is illustrated a tool 200
that can be used to remove or extract the prosthesis 10. This can
be desirable if the prosthesis 10 is not functioning properly for
the patient, e.g. if the lumen stretches and fails to seal against
the prosthesis 10, the valve 12 leaks, the prosthesis 10 irritates
the patient, or the like. The tool 200 has an inner tube 202
received within an outer tube 204, which in turn can be received
within an overtube 205. The tubes 202, 204 and 205 can be rigid or
flexible, as desired, preferably made of autoclavable and/or
sterilizable materials or combinations of materials such as
stainless steel, polypropylene or the like. The inner tube 202 is
provided with a nipple 206 at the distal end and a manipulating
handle 208 at the proximal end. The nipple 206 is threaded on an
exterior surface to threadably engage the prosthesis 10 in
preparation for extraction. The nipple 206 preferably has an
elongated guide member 210 of reduced outside diameter at a distal
end to facilitate engagement with the prosthesis 10, and a proximal
end 212 of slightly enlarged outside diameter for shouldering upon
threaded engagement of the prosthesis 10. If desired, the inner
tube 202 can be provided with a central passage for equipping an
optics package including a light source and a fiber optic cable
and/or a conventional endoscope, as in the insertion tool 100 (see
FIG. 6).
[0058] The outer tube 204 is provided with a proximal handle 216
and a distal crown 218. The outer tube 204 is threadedly connected
to the inner tube 202 at threaded section 220, which preferably has
left-handed or opposite-direction standard threads. As best seen in
FIG. 8, the crown 218 has a plurality of evenly spaced longitudinal
arms 222, each carrying a tangential extraction shoe 224 along a
circle in the proximal surface of the shoulder 21 of the prosthesis
10, in one-to-one correspondence between the spikes 18 and the
shoes 224. The shoes 224 are designed with a thickness increasing
from a forward point to the respective arm 222, such that, upon
advancement of the outer tube 204 by counterclockwise rotation,
they catch between a respective spike 18 and the shoulder 21, and
upon further counterclockwise rotation, they force the spikes 18
upwardly and disengage the arms 30 from the shelves 32, unlocking
the spikes 18.
[0059] The overtube 205 is slideabe over the outer tube 204, and is
provided with a proximal handle 226 and a distal shield 228. The
shield 228 has a frustoconical section 230 flared outwardly from a
small diameter adjacent the overtube 205 to a maximum diameter
adjacent to a relatively short cylindrical section 232 at a free
distal end thereof. The diameter of the cylindrical section 232 is
larger than the diameter of the crown 218, but less than the
diameter of the deployed spikes 18 to house the spikes 18 during
retraction of the prosthesis 10 from the esophagus.
[0060] To use the insertion tool 100 to implant the prosthesis 10,
the prosthesis 10 is threaded onto the nipple 106 of the insertion
tool 100 as shown in FIG. 10, shouldering the prosthesis 10 against
the enlarged diameter 12 and pushing the spikes 18 slightly
outwardly. The outer tube 104 at this time is in a retracted
position, with the headpiece 118 spaced from the spikes 18. If
desired, the headpiece 118 (see FIG. 20) can be advanced along the
inner tube 102 until the distal end just touches the tips 24 (see
FIG. 9) of the spikes 18 to ensure that further advancement of the
headpiece 118 will push the spikes outwardly. Then the assembly is
inserted through the mouth and into the esophagus E to position the
prosthesis 10 at the desired location of implantation, e.g. at the
gastroesophageal junction.
[0061] Holding the inner tube 102 and the prosthesis 10 in place,
the headpiece 118 is advanced by rotating the outer tube 104
counterclockwise to push the spikes 18 outwardly until the enlarged
diameter 112 shoulders into the recess 124 and the arms 30 are
locked into place in cooperation with the shoulders 21. If desired,
the vacuum source can be connected and actuated for a brief period
to draw in the lumen of the esophagus and facilitate penetration of
the spikes 18, which preferably perforate the esophagus E. The
inner tube 102 is then rotated counterclockwise to release the
threaded engagement with the prosthesis 10 and the tool 100 is
retracted, leaving the prosthesis 10 in place.
[0062] As seen in FIG. 11, to remove the prosthesis 10 previously
implanted in the esophagus, the distal end of the tool 200 is
inserted through the mouth and down the esophagus E until it
contacts the prosthesis 10. The nipple 206 is threaded into the
prosthesis 10 by rotating the inner tube 202 clockwise with the
handle 208, and then by turning the outer tube 204
counterclockwise, the crown 218 is shouldered up against the spikes
18. The overtube 205 can then be advanced to position the shield
228 near the spikes 18, as shown in FIG. 12. This stretches the
esophageal lumen outwardly to help retract the spikes 18. Further
rotation of the outer tube 204 engages the extraction feet 224
between the base of the spikes 18 and the proximal surface of the
shoulder 30, and dislodges the arms 30 to unlock the spikes 18. The
spikes 18 are biased or have some memory to return inwardly toward
a longitudinal orientation, but if desired, the tool 200 can be
advanced in the esophagus E to facilitate release of the spikes 18.
The overtube shield 228 is then advanced over the prosthesis 10 to
hold the spikes 18 and minimize interference or catching on the
lumen wall, as illustrated in FIG. 13. The tool 200 is then
retracted, removing the prosthesis 10 from the esophagus.
[0063] FIGS. 14-16 illustrate an alternate embodiment of a sleeve
valve 300 that uses magnets 302 embedded within the tubing material
near the distal end thereof. The valve 300 is in all respects
otherwise similar to the valve 12 illustrated in the prosthesis 10
of FIG. 1. The magnets 302 are paired with opposite poles in an
opposing magnet 302'' in the opposing side of the valve 300 to
facilitate closure, yet the magnetic force is not so strong as to
inhibit opening of the valve for orthograde passage of food and
liquids. The magnets 302 also serve to facilitate detection by
x-ray or other radiographic imaging techniques.
[0064] FIGS. 17A, 17B, and 18-21 illustrate an alternate embodiment
wherein the annular body 400 is formed with fixation spikes 402
that are in an outwardly radiating configuration with memory for
positioning the spikes 402 in a deployed configuration, ready for
implantation in the lumen of the esophagus. The annular body 400
can be formed, for example, by injection molding or transfer
molding the fluorinated polymer in the shape of a blank having a
tubular section and a disk portion that extends radially outwardly
from one end of the tubular section. The fixation spikes 402,
internal threads 404 and external sleeve valve 406 (see FIGS.
18-20) retention grooves 408, are then formed by milling or
machining the blank. The fixation spikes 402 have some flexibility
so that they can be bent slightly to facilitate insertion and
removal, but also have memory to return to the outwardly radiating
configuration to facilitate implantation once the prosthesis is
properly positioned in the esophagus for implantation. It is not
necessary for the fixation spikes 402 to have immediate memory, and
can, if necessary, take several minutes to return to the memory
position (radial deployment), or if desired, can be assisted into
the memory position by mechanical and/or slight heating to body
temperature.
[0065] As best seen in FIG. 18, to implant the prosthesis 410, it
is threaded onto the nipple 414 on the distal end of implantation
tool 416, which is generally similar to the implantation tool 100
of FIG. 6. The implantation tool 416 has an overtube 418, which is
longitudinally slideable over an outer tube 420. A shield 422 of
enlarged diameter is secured to the distal end of the overtube 418.
To prepare the assembly for peroral implantation, the fixation
spikes 402 are bent upwardly toward the proximal end, and the
overtube 418 and shield 422 are moved forwardly so that the spikes
402 are received within the shield 422. The distal end of the
assembly is then inserted perorally to position the prosthesis 410
near the esophageal junction or other location at which it is
desired to be fixed, while retaining the spikes 402 within the
shield 422 so as to avoid laceration by the spikes 402.
[0066] Once placed in the desired location within the esophagus,
the overtube 418 and shield 422 are retracted to release the spikes
402 (See FIG. 19). The spikes 402 have memory to return to the
outwardly disposed configuration and pierce the lumen wall to fix
the prosthesis 410 in place. If desired, the spikes 402 can be
mechanically assisted by sliding the shield 422 forward and pushing
against the proximal surfaces of the spikes 402. The tool 416 can
also include modifications for applying a vacuum to the esophagus
to facilitate impaction of the fixation spikes 402 into the wall of
the esophagus, as in the embodiment of FIGS. 9-10, or rapidly
retracting the shield 422 to the position shown in FIG. 19 can also
induce an impaction-facilitating localized vacuum. In addition,
slightly retracting the prosthesis 410 with the implantation tool
416 after the tips of the fixation spikes have caught on the lumen
wall can also serve to facilitate impaction. The implantation tool
416 is then disconnected by rotating the inner tube 424 to unthread
the nipple 414 from the prosthesis 410, and withdrawn from the
esophagus to leave the prosthesis 410 fixed in place to inhibit
reflux.
[0067] In the event that it is desired to remove the prosthesis
410, the extraction tool 426 of FIGS. 20-21, which is generally
similar to the extraction tool 200 of FIGS. 7-8, is inserted
perorally and the nipple 428 on the distal end thereof is threaded
into the annular body 400 until it shoulders as shown in FIG. 20.
The outer tube 430 is then advanced by means of opposite-direction
threads 432 so that the extraction shoes 224 on the distal end of
the crown 218(see FIG. 8) engage below the fixation spikes 402, and
continued rotation of the outer tube 430 bends the spikes 402
upwardly or toward the proximal end of the tool 426 until they can
be received within the shield 434 carried on the distal end of the
overtube 436, which is slideable over the outer tube 430 into
position as shown in FIG. 21. Removal of the spikes 402 is
facilitated by the localized expansion of the lumen by the shield
434, and also by advancing the prosthesis 410 slightly with the
tool 426. Additionally, air or another inert gas can be injected
into the esophagus, or a balloon (not shown) could be inflated
around or just below the prosthesis 410.
[0068] While the above description contains many specifics, these
should not be construed as limitations on the scope of the
invention, but rather as exemplifications of preferred embodiments
thereof. Many other variations are possible, which would be obvious
to one skilled in the art. Accordingly, the scope of the invention
should be determined by the scope of the appended claims and their
equivalents, and not just by the illustrative embodiments.
* * * * *