METHOD OF DEPLOYING AN INTRALUMINAL DEVICE AND INTRALUMINAL SYSTEM
20230277350 ยท 2023-09-07
Inventors
Cpc classification
A61F5/0076
HUMAN NECESSITIES
International classification
Abstract
A method of deploying an intraluminal device to the cardiac region of the stomach and an intraluminal system used to deploy an intraluminal device to the cardiac region of the stomach, wherein the intraluminal device has a wall defining a surface and an open portion of the surface that is adapted to be aligned with the gastroesophageal (GE) junction. The surface and the cardiac portion of the stomach are conformable with each other. The method includes deploying the intraluminal device trans-orally to the stomach with an endoscopic deployment device and retaining the device against the cardiac region of the stomach with the open portion generally aligned with the GE junction. The intraluminal device is fastened to the stomach from the abdominal cavity with at least one laparoscopic instrument while concurrently visualizing the device with an endoscope in the stomach while it is being fastened. The laparoscopic instrument is adapted to respond to the endoscope in order to adjust location between the laparoscopic instrument and intraluminal device while the laparoscopic instrument is fastening the intraluminal device.
Claims
1. A method of deploying an intraluminal device to the cardiac region of the stomach, the device comprising a wall defining a surface and an open portion said wall that is alignable with the gastroesophageal (GE) junction, said surface and the cardiac portion of the stomach conformable with each other, said method comprising: deploying the intraluminal device trans-orally to the stomach; retaining the intraluminal device in the stomach in contact with the cardiac portion of the stomach with the open portion generally aligned with the GE junction; fastening the intraluminal device to the cardiac portion of the stomach from within the abdominal cavity with at least one laparoscopic instrument; and visualizing the intraluminal device within the stomach with an endoscope during the fastening.
2. The method as claimed in claim 1 wherein said deploying comprises deploying the intraluminal device from a deployment device in the stomach and said retaining the intraluminal device comprises positioning the deployment device within the open portion of the wall in order to generally align the open portion with the GE junction.
3. The method as claimed in claim 2 wherein said retaining the device further comprises applying a proximal force on at least one retention filament connected with the wall and the retention filament passing through the esophagus.
4. The method as claim in claim 1 wherein said deployment device comprises said intraluminal device position at an exterior surface of the endoscope.
5. The method as claimed in claim 1 wherein said wall has a mean radius measured from said open portion and wherein said fastening is within a half of the radius closest to said open portion.
6. The method as claimed in claim 5 wherein said fastening is within a third of the radius closest to said open portion.
7. The method as claimed in claim 5 wherein said fastening is within a quarter of the radius closest to said open portion.
8. The method as claimed in claim 1 wherein said fastening comprises suturing with suture strands and reinforcing the suture strands at the abdominal side of each suture strand.
9. The method as claimed in claim 8 wherein said reinforcing comprises providing radial restraint to the suture strands.
10. The method as claimed in claim 9 wherein said providing radial restraint comprises engaging adjacent suture strands with each other.
11. The method as claimed in claim 8 wherein said reinforcing comprises producing scar material in the stomach tissue contacted by the suture strand.
12. The method as claimed in claim 11 wherein said producing scar material comprises positioning a biologically absorbable material between the suture strand and the stomach tissue.
13. The method as claimed in claim 12 wherein said suture stands are made from a non-absorbable material.
14. The method as claimed in claim 11 wherein said biologically absorbable material comprises multiple layers, each having a different rate of absorption.
15. The method as claimed in claim 14 wherein the layer with a highest rate of absorption is positioned against the stomach wall.
16. The method as claimed in claim 12 wherein said biologically absorbable material including a structural component that resists warping.
17. The method as claimed in claim 14 wherein the one of said layers furthest from the stomach tissue having an outer surface that is adapted to resist adhering to another surface.
18. The method as claimed in claim 12 including explanting the intraluminal device by severing the suture strands in the stomach and pulling the knots of the severed suture strands through the stomach wall into the stomach.
19. The method as claimed in claim 1 wherein said intraluminal device has a plurality of structural members and has a higher density of said structural members proximal said opening than distal said opening.
20. The method as claimed in claim 1 including a controller adjusting stress applied to the cardiac portion of the stomach with said intraluminal device.
21. The method as claimed in claim 20 including adjusting stress applied to the cardiac portion of the stomach with said intraluminal device.
22. The method as claimed in claim 20 wherein said adjusting stress comprises varying an amount of surface contact between the device wall and the stomach wall.
23. The method as claimed in claim 20 including adjusting stress applied to the cardiac portion of the stomach with said intraluminal device with at least one bladder connected with an external port.
24. The method as claimed in claim 1 wherein said intraluminal device is made at least in part from a bio-absorbable material.
25. The method as claimed in claim 1 wherein said wall includes an involute collar around said open portion.
26. The method as claimed in claim 1 wherein fastening the intraluminal device to the cardiac portion of the stomach from within the abdominal cavity comprises looping a suture strand around a structural member of the intraluminal device.
27. The method as claimed in claim 1 wherein said intraluminal device is used to treat at least one chosen from obesity, a metabolic disease, gastric reflux and hiatal hernia.
28. The method as claimed in claim 1 including explanting the intraluminal device including withdrawing the intraluminal device through the esophagus.
29. A system that is adapted to deploy an intraluminal device to the cardiac region of the stomach, the system comprising: an intraluminal device comprising a wall defining a surface and an open portion of said surface that is alignable with the gastroesophageal (GE) junction, said surface and the cardiac portion of the stomach being conformable with each other; an endoscopic deployment device that is adapted to deploying the intraluminal device trans-orally to the stomach; an endoscope that is adapted to visualize the intraluminal device in the stomach while the intraluminal device is being fastened to the cardiac portion of the stomach; and a laparoscopic instrument that is adapted to fasten the intraluminal device to the cardiac portion of the stomach from within the abdominal cavity, said laparoscopic instrument adapted to respond to said endoscope in order to adjust location between said laparoscopic instrument and said intraluminal device while said laparoscopic instrument is fastening the intraluminal device.
30. A kit that is adapted for use with an endoscope having a shaft to convert said endoscope into a combination endoscope and intraluminal device release device, said kit comprising: a holder having an inner diameter that is larger than an outer diameter of the shaft of said endoscope; an intraluminal device comprising a self-expandable wall positioned on said holder; a compression device comprising one chosen from a sleeve and a wrapped filament over said intraluminal device and adapted to keep said wall compressed to said holder; and a deploying filament adapted to extend external the patient, said deploying filament adapted to release said compression device to allow said intraluminal device to self-expand.
31. A method of converting an endoscope having a shaft to a combination endoscope and intraluminal device deploying device using the kit as claimed in claim 42, said method comprising: positioning the holder over the endoscope shaft; and positioning said intraluminal device and said compression device to said shaft by moving said intraluminal device and compression device from the holder to the endoscope shaft.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0041] The present invention will now be described with reference to the accompanying figures, wherein the numbered elements in the following written description correspond to like-numbered elements in the figures. A method 9 is provided for deploying an intraluminal device 10 to the cardiac region of the stomach. The intraluminal device 10 includes a wall 12 defining a surface 14 providing an open portion 16 that is alienable with the gastroesophageal (GE) junction of the patient. While open portion 16 is a generally central, through opening in wall 12 it could alternatively be a notch or other shape depending on the configuration of the intraluminal device. Wall 12 and the cardiac portion of the stomach are conformable to each other in order to stimulate baroreceptors in the wall of the cardiac portion of the stomach. This may be accomplished by the fastening of wall 12 to the stomach wall bringing the device wall and the stomach wall into physical contact in order to apply stress to the wall of the stomach. Alternatively, device wall 12 and the stomach wall may be more loosely joined so that the peristalsis of the stomach will bring the stomach wall into engagement will the device wall to stimulate baroreceptors. Detail operation of intraluminal device 10 is described in U.S. Pat. No. 7,846,174 and Patent Application Publication US 2016/0151233, the disclosures of which are hereby incorporated herein by reference in their entirely.
[0042] Wall 12 is constructed of a structural element 13 and a flexible membrane 15 between loops of the structural element. Structural element 13 can be made from any suitable material that can provide rigidity but be flexible, such as a metal such as nitinol, or a polymeric material or carbon filament of the type known in the art. Structure element 13 may take various shapes such as seen in
[0043] Method 9 begins by providing laparoscopic access, such as by incision, between the stomach and the diaphragm and insufflating the abdomen at 17 (
[0044] Deployment device 24, whose outer diameter is less than the diameter of opening, or open portion 16, is then positioned at 20 with its outer tube 64 within opening 16 while a proximal force is placed on retention filaments 30 which are looped around a proximal portion of the intraluminal device and extend out of the patient's mouth. The proximal force applied to the retention filaments brings intraluminal device 12 into contact with the cardiac portion of the stomach. Since the deployment device is positioned in the esophagus it generally aligns opening 16 with the GE junction so that ingested food passes through opening 16 not between wall 12 and the stomach wall. Such general alignment is also maintained with the deployment device during fastening of the intraluminal device to the stomach wall at 34.
[0045] Intraluminal device 10 is fastened at 34 from the abdominal cavity with at least one laparoscopic instrument 11, such as a laparoscopic needle or other fastening device, while visualizing the intraluminal device with endoscope 25 from within the stomach while it is being fastened at 34. The visualizing of the interaction between the laparoscopic instrument and the intraluminal device in the stomach guides further movement between the fastening device and the intraluminal device in order to properly carry out optimal fastening of the intraluminal device to the cardiac portion of the stomach. For example, if used with a surgical robot, one robot arm could operate laparoscopic instrument 11 in the form of an end of arm tool. Another robot arm could operate endoscope 25 as an end of arm tool. Images captured by the endoscope in the stomach could then be used by a common robot controller to guide movement of laparoscopic instrument 11 in order to endure proper engagement between attachment fasteners and the intraluminal device.
[0046] In the illustrated embodiment, the fastening is with sutures in the form of individual strands 36 that are arranged a generally circular pattern around the esophagus, which is generally aligned with opening 16 by release device 24, as best seen in
[0047] A reinforcement in the form of a radial restraint 40 is applied to the suture strands 36 in order avoid the suture material of the strands cutting through the stomach wall and releasing the fastening of the device. Such radial constraint 40 could be applied by interweaving, or overlapping, the strands of adjacent loops 36, as best seen in
[0048] Alternatively, or additionally, the reinforcement may be provided by the production of scar material, such as collagen, in the stomach tissue contacted by a pledget 44. This occurs in the illustrated embodiment, by making pledget 44 from a biologically absorbable, or re-sorbable, material of the type known in the art. Such scar material is formed concurrently with and as a result of the biological absorption of the absorbable material making up pledget 44. In the illustrated embodiment, suture stands 36 are non-absorbable. This allows intraluminal device 10 to be deployed for an extended period of time without losing strength of fastening over time from an absorbable suture. Pledget 44 may be made from multiple layers, each having a different rate of absorption. The layer with the highest rate of absorption could be positioned against the stomach wall and other layer(s) further away. The provision of an absorbable pledget thus provides two functions. It is absorbed by the patient so no laparoscopic access is needed to remove the pledget after use. Since the absorption of the reinforcement causes the formation of collagen or scar material, some reinforcement against penetration of the stomach tissue by the suture strands remains, even after the reinforcement is absorbed. However, after being severed in the stomach, the entire non-absorbed suture can be retracted to the stomach because its knots can pull through the collage in in the stomach wall.
[0049] Explantation of intraluminal device at 68, such as after weeks or months of use, or longer, as will be described in more detail below. The suture strands 36 are severed in the stomach such as with an endoscopically deployed scissors and knots 38 pulled through the stomach wall into the stomach to allow the suture strands to be removed endoscopically or pass through the intestines. While the knot would resist being pulled through a reinforcement made from a rigid material, the absorbable reinforcement should be at least mostly absorbed by the time of explantation, and replaced with scar tissue. Knots 38 can be pulled through such scar tissue yet the scar tissue is sufficiently rigid to provide reinforcement to the suture strand to resist their cutting of stomach tissue. Since the pledget 44 will have been all or mostly absorbed by the time of explantation of device 10, the device and all other components such as suture strands, can be removed endoscopically from the stomach. Therefore, no portion of the implanted device will remain behind in the patient after explanation and the explantation does not require any invasive procedure such as laparoscopic incisions. Alternatively, or additionally, radial reinforcement 40 could include making the pledget 44 with an adherence surface feature that abuts the outer surface of the stomach that causes adherence between the restraint and the stomach. That adherence further strengthens the reinforcement in order to resist buckling. The surface of the reinforcement facing away from the stomach may have a non-adherence surface to avoid adhesion with other surfaces in the abdomen.
[0050] While intraluminal device 10 is being fastening such as by suturing, a fold of stomach tissue may be made to wrap at least partially around pledget 44. An additional pledget 44a may be positioned in a traversing fashion over pledget 44 as shown in
[0051] The severing of suture strands 36, such as with an endoscopic scissors or the like, may be conveniently performed where the suture material crosses the structural member or members 13 thus spacing the suture material from the wall of device 10. The suture loops could be removed from the patient endoscopically or left in place loosely in the stomach to be passed on by peristalsis. The intraluminal device is removed trans-orally. The openings in the stomach wall left by the suture strands will heal. Wall 12 may include an involute collar or ring around opening 16 to provide additional stiffness to wall 12 and may be large enough to capture suture loops 36. While the fastening of intraluminal device 10 is illustrated using a laparoscopic needles to apply sutures, other laparoscopic fastening techniques could be used such as applying mechanical fasteners from the abdomen.
[0052] Wall 12 of device 10 in the illustrated embodiment has a generally circular shaped circumference but may have any shape that is conformable with the cardiac portion of the stomach. For example, although as shown as circular or elliptical, device 10 could have a flower-pedal shape, or the like. Wall 12 has a mean radius 32 measured from the center of opening 16 to the outer edge. Suture loops 36 are positioned within the half of radius 32 that is closest to opening 16. The suture loops may be within the third of the radius closest to said opening and may even be within the quarter of radius 32 closest to opening 16. This is advantageous because the portion of the stomach closest to the esophagus experiences the least amount of peristalsis because the portion of the stomach at the esophagus does not substantially move. So fastening wall 12 close to opening 16 minimizes movement of the sutures in response to peristalsis of the stomach.
[0053] In an alternative embodiment, an intraluminal device 110 is able to adjust stress applied to the cardiac portion of the stomach. Referring to
[0054] In another alternative embodiment, an intraluminal device 210 is able to adjust stress applied to the cardiac portion of the stomach. Referring to
[0055] The ability to adjust amount of stress applied by the intraluminal device allows the amount of satiety to be optimized to achieve desired weight loss. This may be accomplished by providing feedback to controller 150 of, for example, amount of weight loss. Controller 150 may then adjust mount of stress in order to optimize amount of satiety provided by the stress level.
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[0057] Other variations in the intraluminal device may be provided. For example, at least one magnet may be provided on the wall of the device that is used to fasten the device to the cardiac portion of the stomach by engaging at least one magnet positioned in the abdominal cavity of the patient. Alternatively, the wall or the intraluminal device may be no larger than required to engage with the suture loops in the stomach, such as a narrow ring shape or the like. While such configuration may not provide as much stimulus of the baroreceptors in the cardiac portion of the stomach, it may provide sufficient stimulus of the receptors. Intraluminal device 10, 110, 210 may have various uses. The intraluminal device may be used as a bariatric device. The intraluminal device may be used to treat a metabolic disease. Because the intraluminal device resists upward movement to the stomach wall it may be used to treat gastric reflux disease or hiatal hernia.
[0058] In an alternative embodiment illustrated in
[0059] Combination endoscope and deployment device 324 includes at least one filament guide 336 positioned on endoscope shaft 333 positioned proximal to intraluminal device 10 and adapted to guide movement of deploying filament 31. Filament guide 336 may also guide movement of retaining filaments 30. As best illustrated in
[0060] While combination endoscope and deployment device 324 may be supplied compete in the configuration illustrated in
[0061] A method 339 of converting an endoscope to a combination endoscope and intraluminal device is illustrated in
[0062] The filament guides and compression device may be removed from the endoscope shaft after the intraluminal device is affixed to the patient by reversing method 339. Alternatively, holder 332 could be retained to the endoscope's shaft during use so that it is available for use to remove kit 330 after the intraluminal device is deployed. This may be accomplished by having friction members, such as wide bands, extending from one or both end of holder 332 to grip the shaft, other variations will be apparent to the skilled artisan.
[0063] Illustrated in
[0064] Changes and modifications in the specifically described embodiments can be carried out without departing from the principles of the present invention which is intended to be limited only by the scope of the appended claims, as interpreted according to the principles of patent law including the doctrine of equivalents.