US20060041319A1 - Perorally removeable anti-reflux valve implantation - Google Patents
Perorally removeable anti-reflux valve implantation Download PDFInfo
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- US20060041319A1 US20060041319A1 US11/255,258 US25525805A US2006041319A1 US 20060041319 A1 US20060041319 A1 US 20060041319A1 US 25525805 A US25525805 A US 25525805A US 2006041319 A1 US2006041319 A1 US 2006041319A1
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- spikes
- canceled
- prosthesis
- esophagus
- annular body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2476—Valves implantable in the body not otherwise provided for
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2002/044—Oesophagi or esophagi or gullets
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.
Description
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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FIG. 1 is a side sectional view of a preferred embodiment of the antivalve prosthesis according to the present invention. -
FIG. 2 is a top plan view of the prosthesis ofFIG. 1 showing the fixation spikes in a deployed configuration. -
FIG. 3 is a side sectional view of the annular body used in the prosthesis ofFIG. 2 showing the fixation spikes in a longitudinal, pre-deployment configuration. -
FIG. 4 is a top view of the annular body ofFIG. 3 . -
FIG. 5 is an enlarged sectional view of the upper end of the annular body showing a preferred embodiment of the outer edge profile. -
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 ofFIGS. 1-5 . -
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 ofFIGS. 1-5 . -
FIG. 8 is a simplified schematic of the crown of the extraction tool ofFIG. 7 showing the extraction foot detail. -
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 ofFIGS. 1-5 with the tool ofFIG. 6 . -
FIG. 10 is a side view, partly in section and partly cut away, of the distal end of the insertion tool-prosthesis assembly ofFIG. 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. -
FIG. 11 is a side view, partly in section and partly cut away, of the distal end of the extraction tool ofFIGS. 7-8 threaded into the prosthesis ofFIGS. 1-5 implanted in a patient″s esophagus in preparation for foot release extraction according to one embodiment of the present invention. -
FIG. 12 is a side view, partly in section and partly cut away, of the distal end of the extraction tool-prosthesis assembly ofFIG. 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. -
FIG. 13 is a side view, partly in section and partly cut away, of the distal end of the extraction tool-prosthesis assembly ofFIG. 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. -
FIG. 14 is a side view of an alternate embodiment of an antisleeve valve having embedded magnets for use with the annular body ofFIGS. 3-5 . -
FIG. 15 is an end sectional view of the valve ofFIG. 14 . -
FIG. 16 is a top view of the valve ofFIGS. 14-15 . -
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. -
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 ofFIGS. 17A and 17B coupled to the distal end of an insertion tool in preparation for peroral insertion. -
FIG. 19 is a side view, partly in section and partly cut away, of the assembly ofFIG. 18 following peroral placement of the prosthesis near the gastroesophageal junction and retraction of the overtube to deploy the fixation spikes. -
FIG. 20 is a side view, partly in section and partly cut away, of an assembly of the valve prosthesis inFIGS. 17-19 coupled to the distal end of a peroral extraction tool in preparation for removal. -
FIG. 21 is a side view, partly in section and partly cut away, of the assembly ofFIG. 20 following retraction of the fixation spikes within the overtube shield in preparation for peroral removal from the esophagus. - 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.
- Referring to
FIGS. 1-2 , in a preferred embodiment, the present invention provides avalve prosthesis 10 comprising avalve 12, preferably of the sleeve type, depending from anannular body 14. Thesleeve 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 theannular body 14 viarings 16, which can be made of a suitably inert material such as stainless steel or heat-shrink TEFLON tubing. The lower end of thesleeve 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 thevalve 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, thesleeve valve 10 can be designed to evert when excessive gastric pressures are present, as in regurgitation. - 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 thesleeve valve 12, carrying an array of fixation spikes 18, preferably at an upper or proximal end thereof. The main portion of thebody 14 can have a pair ofgrooves 20 formed in the exterior surface near the distal or lower end to facilitate retention of therings 16 and form a seal between thevalve 12 and thebody 14. Ashoulder 21 is formed in the exterior surface near the proximal end of the main body to serve as a keeper to lock thespikes 18 in position for fixation, as discussed in more detail below. - The main portion of the
annular body 14 can be internally threaded, for example, with special acmeright 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, thethreads 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 theannular 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 theannular body 14, especially at theshoulder 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. - The
spikes 18 are evenly spaced along the circumference of theannular body 14 as best seen inFIGS. 2-4 . Eachspike 18 has a pointed or sharpenedtip 24 and a flexible or hingedbase 26 secured to the main portion of theannular body 14. Thespikes 18 are preferably integrally formed with the main portion of thebody 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 thespikes 18, anotch 28 can be provided at thebase 26, preferably leaving sufficient thickness so that thespike 18 is biased upwardly to facilitate the extraction process. A downwardly slopedarm 30 disposed between thetip 24 andbase 26 extends radially outwardly from eachfixation spike 18 and functions as a dog to lock thespike 18 into place for fixation in the lumen wall. Thearm 30 and theshoulder 21 are complementarily dimensioned and positioned so that a lower surface of thearm 30 is securely retained against inwardly taperedshelf 32 formed in theshoulder 21. The proximal surface of theshoulder 21 is preferably at a right angle to an axis of thebody 14 to help position thespikes 18 at a corresponding right angle. The distal surface of theshoulder 21 can be sloped to generally correspond approximately to the angle of thearm 30. - With reference to
FIG. 6 , there is illustrated atool 100 that can be used to insert or implant theprosthesis 10. Thetool 100 has aninner tube 102 received within anouter tube 104. Thetubes inner tube 102 is provided with anipple 106 at the distal end and a manipulatinghandle 108 at the proximal end. Thenipple 106 is threaded on an exterior surface to threadably engage the prosthesis 10 (SeeFIG. 9 ) in preparation for peroral insertion. Thenipple 106 preferably has an elongateddistal end 110 of reduced outside diameter to facilitate engagement with theprosthesis 10, and aproximal end 112 of slightly enlarged outside diameter to slightly bias the fixation spikes 18 outwardly upon engagement of theprosthesis 10. If desired, theinner tube 102 is provided with acentral passage 113 for equipping anoptics package 114 including a light source and a fiber optic cable and/or a conventional endoscope. - The
outer tube 104 is provided with aproximal handle 116 and adistal headpiece 118. The outer tube is threadedly connected to theinner tube 102 at threadedsection 120, which preferably has left-handed or opposite-direction standard threads. Theheadpiece 118 has a relatively enlargedoutside diameter 122 so as to bend the fixation spikes 18 outwardly as the outer tube is advanced along theinner tube 102 by counterclockwise rotation of theouter tube 104 while theinner tube 102 is held stationary. The left-handed threads ensure that the rotation of theouter tube 104 does not tend to turn theprosthesis 10. The headpiece can have arecess 124 formed in a distal end surface to shoulder theproximal end 112 and ensure that the fixation spikes are fully deployed and locked in place. - 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 thespikes 18. Theheadpiece 118 is provided with a plurality oftransverse passages 126 in communication with an annulus defined by the inside diameter of theheadpiece 118, the outside diameter of theinner tube 102, and opposing O-ring seals 128 on either side thereof. Atransverse bore 130 is formed in theinner tube 102 in fluid communication between the annulus and thecentral passageway 113. Avacuum hose 132 connects the proximal end of thecentral passageway 113 to a conventional vacuum source. - With reference to
FIG. 7 , there is illustrated atool 200 that can be used to remove or extract theprosthesis 10. This can be desirable if theprosthesis 10 is not functioning properly for the patient, e.g. if the lumen stretches and fails to seal against theprosthesis 10, thevalve 12 leaks, theprosthesis 10 irritates the patient, or the like. Thetool 200 has aninner tube 202 received within anouter tube 204, which in turn can be received within anovertube 205. Thetubes inner tube 202 is provided with anipple 206 at the distal end and a manipulatinghandle 208 at the proximal end. Thenipple 206 is threaded on an exterior surface to threadably engage theprosthesis 10 in preparation for extraction. Thenipple 206 preferably has an elongatedguide member 210 of reduced outside diameter at a distal end to facilitate engagement with theprosthesis 10, and aproximal end 212 of slightly enlarged outside diameter for shouldering upon threaded engagement of theprosthesis 10. If desired, theinner 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 (seeFIG. 6 ). - The
outer tube 204 is provided with aproximal handle 216 and adistal crown 218. Theouter tube 204 is threadedly connected to theinner tube 202 at threadedsection 220, which preferably has left-handed or opposite-direction standard threads. As best seen inFIG. 8 , thecrown 218 has a plurality of evenly spacedlongitudinal arms 222, each carrying atangential extraction shoe 224 along a circle in the proximal surface of theshoulder 21 of theprosthesis 10, in one-to-one correspondence between thespikes 18 and theshoes 224. Theshoes 224 are designed with a thickness increasing from a forward point to therespective arm 222, such that, upon advancement of theouter tube 204 by counterclockwise rotation, they catch between arespective spike 18 and theshoulder 21, and upon further counterclockwise rotation, they force thespikes 18 upwardly and disengage thearms 30 from theshelves 32, unlocking thespikes 18. - The
overtube 205 is slideabe over theouter tube 204, and is provided with aproximal handle 226 and adistal shield 228. Theshield 228 has afrustoconical section 230 flared outwardly from a small diameter adjacent theovertube 205 to a maximum diameter adjacent to a relatively shortcylindrical section 232 at a free distal end thereof. The diameter of thecylindrical section 232 is larger than the diameter of thecrown 218, but less than the diameter of the deployed spikes 18 to house thespikes 18 during retraction of theprosthesis 10 from the esophagus. - To use the
insertion tool 100 to implant theprosthesis 10, theprosthesis 10 is threaded onto thenipple 106 of theinsertion tool 100 as shown inFIG. 10 , shouldering theprosthesis 10 against theenlarged diameter 12 and pushing thespikes 18 slightly outwardly. Theouter tube 104 at this time is in a retracted position, with theheadpiece 118 spaced from thespikes 18. If desired, the headpiece 118 (seeFIG. 20 ) can be advanced along theinner tube 102 until the distal end just touches the tips 24 (seeFIG. 9 ) of thespikes 18 to ensure that further advancement of theheadpiece 118 will push the spikes outwardly. Then the assembly is inserted through the mouth and into the esophagus E to position theprosthesis 10 at the desired location of implantation, e.g. at the gastroesophageal junction. - Holding the
inner tube 102 and theprosthesis 10 in place, theheadpiece 118 is advanced by rotating theouter tube 104 counterclockwise to push thespikes 18 outwardly until theenlarged diameter 112 shoulders into therecess 124 and thearms 30 are locked into place in cooperation with theshoulders 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 thespikes 18, which preferably perforate the esophagus E. Theinner tube 102 is then rotated counterclockwise to release the threaded engagement with theprosthesis 10 and thetool 100 is retracted, leaving theprosthesis 10 in place. - As seen in
FIG. 11 , to remove theprosthesis 10 previously implanted in the esophagus, the distal end of thetool 200 is inserted through the mouth and down the esophagus E until it contacts theprosthesis 10. Thenipple 206 is threaded into theprosthesis 10 by rotating theinner tube 202 clockwise with thehandle 208, and then by turning theouter tube 204 counterclockwise, thecrown 218 is shouldered up against thespikes 18. Theovertube 205 can then be advanced to position theshield 228 near thespikes 18, as shown inFIG. 12 . This stretches the esophageal lumen outwardly to help retract thespikes 18. Further rotation of theouter tube 204 engages theextraction feet 224 between the base of thespikes 18 and the proximal surface of theshoulder 30, and dislodges thearms 30 to unlock thespikes 18. Thespikes 18 are biased or have some memory to return inwardly toward a longitudinal orientation, but if desired, thetool 200 can be advanced in the esophagus E to facilitate release of thespikes 18. Theovertube shield 228 is then advanced over theprosthesis 10 to hold thespikes 18 and minimize interference or catching on the lumen wall, as illustrated inFIG. 13 . Thetool 200 is then retracted, removing theprosthesis 10 from the esophagus. -
FIGS. 14-16 illustrate an alternate embodiment of asleeve valve 300 that usesmagnets 302 embedded within the tubing material near the distal end thereof. Thevalve 300 is in all respects otherwise similar to thevalve 12 illustrated in theprosthesis 10 ofFIG. 1 . Themagnets 302 are paired with opposite poles in an opposingmagnet 302″ in the opposing side of thevalve 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. Themagnets 302 also serve to facilitate detection by x-ray or other radiographic imaging techniques. -
FIGS. 17A, 17B , and 18-21 illustrate an alternate embodiment wherein theannular body 400 is formed withfixation spikes 402 that are in an outwardly radiating configuration with memory for positioning thespikes 402 in a deployed configuration, ready for implantation in the lumen of the esophagus. Theannular 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 (seeFIGS. 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. - As best seen in
FIG. 18 , to implant theprosthesis 410, it is threaded onto thenipple 414 on the distal end ofimplantation tool 416, which is generally similar to theimplantation tool 100 ofFIG. 6 . Theimplantation tool 416 has anovertube 418, which is longitudinally slideable over anouter tube 420. Ashield 422 of enlarged diameter is secured to the distal end of theovertube 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 thespikes 402 are received within theshield 422. The distal end of the assembly is then inserted perorally to position theprosthesis 410 near the esophageal junction or other location at which it is desired to be fixed, while retaining thespikes 402 within theshield 422 so as to avoid laceration by thespikes 402. - Once placed in the desired location within the esophagus, the
overtube 418 and shield 422 are retracted to release the spikes 402 (SeeFIG. 19 ). Thespikes 402 have memory to return to the outwardly disposed configuration and pierce the lumen wall to fix theprosthesis 410 in place. If desired, thespikes 402 can be mechanically assisted by sliding theshield 422 forward and pushing against the proximal surfaces of thespikes 402. Thetool 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 ofFIGS. 9-10 , or rapidly retracting theshield 422 to the position shown inFIG. 19 can also induce an impaction-facilitating localized vacuum. In addition, slightly retracting theprosthesis 410 with theimplantation tool 416 after the tips of the fixation spikes have caught on the lumen wall can also serve to facilitate impaction. Theimplantation tool 416 is then disconnected by rotating theinner tube 424 to unthread thenipple 414 from theprosthesis 410, and withdrawn from the esophagus to leave theprosthesis 410 fixed in place to inhibit reflux. - In the event that it is desired to remove the
prosthesis 410, theextraction tool 426 ofFIGS. 20-21 , which is generally similar to theextraction tool 200 ofFIGS. 7-8 , is inserted perorally and thenipple 428 on the distal end thereof is threaded into theannular body 400 until it shoulders as shown inFIG. 20 . Theouter tube 430 is then advanced by means of opposite-direction threads 432 so that theextraction shoes 224 on the distal end of the crown 218(seeFIG. 8 ) engage below the fixation spikes 402, and continued rotation of theouter tube 430 bends thespikes 402 upwardly or toward the proximal end of thetool 426 until they can be received within theshield 434 carried on the distal end of theovertube 436, which is slideable over theouter tube 430 into position as shown inFIG. 21 . Removal of thespikes 402 is facilitated by the localized expansion of the lumen by theshield 434, and also by advancing theprosthesis 410 slightly with thetool 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 theprosthesis 410. - 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.
Claims (63)
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)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/255,258 US20060041319A1 (en) | 2001-07-03 | 2005-10-21 | Perorally removeable anti-reflux valve implantation |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US30287001P | 2001-07-03 | 2001-07-03 | |
US10/064,324 US6958079B1 (en) | 2001-07-03 | 2002-07-02 | Perorally insertable/removable anti-reflux valve |
US11/255,258 US20060041319A1 (en) | 2001-07-03 | 2005-10-21 | Perorally removeable anti-reflux valve implantation |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US10/064,324 Division US6958079B1 (en) | 2001-07-03 | 2002-07-02 | Perorally insertable/removable anti-reflux valve |
Publications (1)
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US20060041319A1 true US20060041319A1 (en) | 2006-02-23 |
Family
ID=35115236
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US10/064,324 Expired - Fee Related US6958079B1 (en) | 2001-07-03 | 2002-07-02 | Perorally insertable/removable anti-reflux valve |
US11/255,258 Abandoned US20060041319A1 (en) | 2001-07-03 | 2005-10-21 | Perorally removeable anti-reflux valve implantation |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
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US10/064,324 Expired - Fee Related US6958079B1 (en) | 2001-07-03 | 2002-07-02 | Perorally insertable/removable anti-reflux valve |
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US (2) | US6958079B1 (en) |
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STCB | Information on status: application discontinuation |
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