Devices and methods for retaining a gastro-esophageal implant
Various methods and devices are described for retaining a medical implant within a body cavity. According to one aspect, at least a portion of a medical implant is positioned within a body cavity, and a wall of the body cavity is re-shaped such that the re-shaped wall prevents migration of the medical implant out of the body cavity. The re-shaped body wall may form a tissue pocket, tunnel, or other barrier against migration of the implant.
This application claims the benefit of U.S. Provisional Application No. 60/510,268, filed Oct. 10, 2003.
Inventors: Richard S. Stack, MD; Dan Balbierz; John Lunsford; Kevin van Bladel; William S. Eubanks MD, William L. Athas, Richard A. Glenn, Richard Kouri
FIELD OF THE INVENTIONThe present invention relates generally to the field of gastro-esophageal implant devices, and specifically to devices and methods for retaining such implants within the gastro-esophageal junction region or stomach of a patient.
BACK GROUND OF THE INVENTIONAn anatomical view of a human stomach S and associated features is shown in FIG. IA. The esophagus E delivers food from the mouth to the proximal portion of the stomach S. The z-line or gastro-esophageal junction Z is the irregularly-shaped border between the thin tissue of the esophagus and the thicker tissue of the stomach wall. The gastro-esophageal junction region G is the region encompassing the distal portion of the esophagus E, the z-line, and the proximal portion of the stomach S.
Stomach S includes a fundus F at its proximal end and an antrum A at its distal end. Antrum A feeds into the pylorus P which attaches to the duodenum D, the proximal region of the small intestine. Within the pylorus P is a sphincter that prevents backflow of food from the duodenum D into the stomach. The middle region of the small intestine, positioned distally of the duodenum D, is the jejunum J.
Various types of implants are positionable within the esophagus or stomach. These include prosthetic valves implanted for treatment of gastro-esophageal reflux disease. Another category of stomach implants includes prosthetic implants for controlling obesity. These include space-occupying devices such as inflatable balloons tethered to the stomach interior. Other obesity-controlling implants are shown and described in U.S. application Ser. No. 09/940,110, filed Aug. 27, 2001 and U.S. application Ser. No. 10/118,211006 filed Apr. 8, 2002, and U.S. Provisional Application No. 60/379,306 filed May 10, 2002, U.S. application Ser. Nos. 10/345,666 and 10/345,1104 filed Jan. 16, 2003. These applications are owned by the assignee of the present application, and the disclosures of these applications are incorporated herein by reference. Certain forms of these devices involve positioning a restrictive device in the proximal stomach. For example, a prosthetic pouch 2 of the type shown in
This type of pouch 2 may include a proximal opening 4 and a smaller distal opening 6 and forms a small reservoir that collects masticated food from the esophagus—thereby limiting the amount of food that can be consumed at one time. Because of its small volume (which may be on the order of approximately 2 cc-300 cc in volume, but is preferably in the range of 10-30 cc), the pouch functions to limit the amount of food that can be consumed at one time. Over time the food within this reservoir descends into the stomach through the distal opening.
As the pouch fills with food, it may distend, imparting pressure against the upper stomach and lower esophageal sphincter causing the patient to experience sensations of fullness. Other types of restrictive devices are disclosed in the above-identified prior applications as well as in this application.
The pouch 2 or other restrictive implant may be formed of a flexible material. Examples of such materials include, but are not limited to polyesters (e.g. Dacron® polyester), ePTFE fabric (e.g. GoreTex® fabric or others), a polyurethane such as ChronoFlex® polyurethane, nylon fabrics, silicone, other polymeric materials, and bio-absorbable materials (e.g. PLLA, PGA, PCL, poly-amhydride etc). In the case of the pouch 2, it is optimal but not mandatory that the material prevents passage of food through the sides of the pouch. The material may be a composite of compliant, semi-compliant and/or non-compliant materials that give different regions of the pouch different degrees of compliance so as to allow/limit expansion of the pouch in various locations. For example, it may be desirable to provide a pouch with a fairly elastic exit port to as to prevent occlusion in the event a large piece of food is ingested and/or to control the exit pressure of food from the pouch, whereas the proximal end of the pouch may be stiffer to prevent bulging. Varying degrees of compliance may also be built into the pouch by varying the cross-sectional thickness in different regions of the pouch. The material may be coated with a lubricious, bio-compatible, chemically inert material, such as paraleyne, to reduce friction on the base material's surface which will help prevent sticking and food build up on the device.
The restrictive implant may be reinforced with, constructed of, or supported by supporting members, such as a soft mesh, a cage structure, ribs, rings etc. The supporting members may be formed of stainless steel, polymer, shape memory materials such as nitinol, shape memory alloys, or shape memory polymers, or thickened regions of material. The implant may be constructed so as to be self-expanding, so that it will spring radially open into an expanded condition upon ejection from a deployment device or catheter.
The pouch 2 or other implant in the stomach/esophagus may be fixed in place using sutures 8a, 8b or other means such as clips or suitable adhesives at anchor points around the perimeter of the proximal opening 4. The implant may include a reinforced section such as rim section 9 on pouch 2 for receiving the sutures 8a, 8b or other anchoring means. As illustrated in
Once secured within the stomach, the implant and associated anchoring means are subjected to significant forces caused by stomach motility and by forces imparted against the pouch by ingested food. Such forces may be imparted against restrictive devices such as pouch 2 as well as other forms of gastro-esophageal implants, such as prosthetic valves implanted within the esophagus for treatment of gastro-esophageal reflux disease or space-occupying implants for hunger control. Over time, such forces could cause the implant to become detached from the wall of the stomach or esophagus due to erosion of the stomach/esophageal tissue at the anchoring points. It is thus desirable to provide an anchoring mechanism that will retain an implant within the stomach and/or esophagus over an extended period of time.
SUMMARYVarious methods and devices are described for retaining a medical implant within a body cavity. According to one aspect, at least a portion of a medical implant is positioned within a body cavity, and a wall of the body cavity is re-shaped such that the re-shaped wall prevents migration of the medical implant out of the body cavity.
BRIEF DESCRIPTION OF THE DRAWINGS
The drawings show a number of methods and components that may be used individually or in combination with one another to facilitate retention of an implant in the stomach or esophagus, including in the gastro-esophageal junction region. These methods and components may facilitate retention by (1) re-shaping tissue or otherwise modifying the structure of the tissue at the implant location in a manner which allows a tissue structure to aid in retaining the implant either with or without a physical connection between the tissue and the implant; (2) anchoring the devices in place; and/or (3) facilitating even distribution of forces (e.g. forces resulting from food pressure or stomach motility) around the implant to minimize the chance of tissue erosion at points where the implant contacts or is anchored to tissue. This application also describes alternative embodiments to the restrictive device 2 of
For the purposes of this application, the terms “restrictive devices”, “satiation devices,” “obstructive devices” or “satiation pouches” will be used to mean devices or pouches intended to induce weight loss in one or more of a variety of ways. These include, but are not limited to, slowing the rate at which food passes from the esophagus into the stomach, physically restricting the amount of food that can be consumed, and/or imparting pressure against portions of the body (e.g. stomach, esophagus, esophageal sphincter, etc) causing the patient to experience sensations of fullness, and/or affecting levels of hormones or other substances in the body that control or affect feelings of hunger, and/or affecting the amount of ingested food absorbed by the body. The anchoring devices and methods described herein are useful for various types of satiation implants, including those not specifically described herein and including those positionable in the esophagus, the gastro-esophageal junction region and other portions of the stomach including the proximal stomach, fundus, antrum, etc.
It should be noted that although the embodiments are described in the context of satiation devices, the components and methods described for facilitating retention and/or promoting even distribution of forces may be equally suitable with other types of implants. These implants include, but are not limited to prosthetic valves for the treatment of gastro-esophageal reflux disease, gastric stimulators, pH monitors and drug eluting devices that release drugs, biologics or cells into the stomach or elsewhere in the GI tract. Such drug eluting devices might include those which release leptin (a hormone which creates feelings of satiety), Ghrelin (a hormone which creates feelings of hunger), octreotide (which reduces Ghrelin levels and thus reduces hunger), Insulin, chemotherapeutic agents, natural biologics (e.g. growth factor, cytokines) which aid in post surgery trauma, ulcers, lacerations etc. As yet another example, the implant may provide a platform to which specific cell types can adhere, grow and provide biologically-active gene products to the GI tract. As other alternatives, an implant may provide a platform for radiation sources that can provide a local source of radiation for therapeutic purposes, or provide a platform whereby diagnostic ligands are immobilized and used to sample the GI tract for evidence of specific normal or pathological conditions, or provide an anchor point for imaging the GI tract via cameras and other image collecting devices.
It should also be noted that the embodiments described herein have broad applicability for retaining implants in parts of the body outside the GI system. The term “implant” will thus be used to refer to satiation devices as well as other types of medical devices that may be implanted in the esophagus, gastro-esophageal junction, stomach, elsewhere within the GI tract, or in other hollow organs, vessels, and cavities of the body.
Retention Methods Utilizing Re-Shaping Techniques
The implant 10 includes leg members 16 that are retained within the pockets 14 of the plications 12. During implantation, the leg members may be inserted into the pockets 14, or the implant may be positioned before the plications are formed, in which case the plications 12 may be formed around the leg members 16.
Restrictive implant 10 includes a restrictive component 18 which may be any configuration that slows the passage of food into the stomach, such as by reducing the effective cross-sectional area of the flow path between the esophagus and stomach or between one region of the stomach and another region of the stomach. For example, the restrictive component may be a pouch similar to see pouch 2 of
The leg members 16 may be long enough to be retained in tissue pockets formed well into the stomach, such as in the antrum, the fundus or other regions of the stomach while still positioning the restrictive orifice of the device in the proximal stomach. Alternatively, the leg members 16 may be shorter for retention by plications in the gastro-esophageal junction region or other proximal portions of the stomach. This concept of retaining the implant using tissue plications may be applied to implants positionable in other regions of the stomach (and throughout the body) as well, and is not limited to use with implants that provide restriction in the proximal stomach.
Implant 10a of
Formation of Pockets
The orientation of the pockets may be selected depending on the purpose to be achieved by the plications and/or the orientation of the implant to be retained. Referring again to
According to these methods, an endoscopic grasper 36 (
Over time, adhesions form between the tissue surfaces held in contact by the sutures, thereby creating a much stronger bond between the tissue surfaces than would be achieved using sutures alone. If desired, dissolvable or bioabsorbable sutures may be used to create the plications.
The procedure illustrated in
Referring to
Referring to
As yet another alternative, the
To form a structure of the type shown in
After the cuts 21 are formed, the areas of tissue surrounding the cuts 21 are folded downwardly as indicated by arrows in
Next, a line 234 of staples or sutures are applied across the tented tissue from the mucosal side of the stomach—thereby forming an enclosed pocket 236 on the exterior surface of the stomach as shown in
A collar 220 may be placed around the tented tissue 230 as shown in
The suture line 234 holds the serosal layers of tissue together as shown in
Because the tissue pocket 244 is formed of serosal tissue, it may be desirable to line the pocket 244 with a stent-like device 246 or another liner to both reinforce the pocket and protect the serosal surface from the acidic stomach environment.
As with the other embodiments, the procedure continues with formation of as many pockets as are needed to retain the desired implant in the stomach. Then, implants (or portions of implants) are fed into the pockets for retention within the stomach. As one example, legs 16 of a device such as device 10 (
As a third alternative, a member may be positioned in a pocket and tethered to a gastric balloon or other space-occupying device used in for inducing weight loss, or to another type of medical device such as a therapeutic or diagnostic device.
Tissue Surface Modification
As discussed in connection with
As one example, a single device may be used to modify regions of surface tissue and to join modified tissue surfaces.
Referring to
Referring to
A suture 62 is disposed within the suture lumen 56. The suture 62 has a suture catch 64 on its distal end, positioned adjacent to the opening of the lumen 56 into the recess 54. A suture needle 66 is slidable within the needle lumen 58. The needle lumen 58 and suture lumen 56 are oriented such that during operation needle 66 may be extended from the needle lumen 58, through tissue disposed within the recess and into engagement with the suture catch 64. As will be described in further detail below, subsequent retraction of the suture needle 66 carries the suture catch 64 and the end of suture 62 through the tissue and into needle lumen 58.
A cutting blade 68 is slidable within the cutting blade lumen 60 to shave a layer from tissue disposed within the recess 54. The handle 52 (
Use of the device 48 will next be described with reference to
First, the device 48 is introduced into the stomach under endoscopic visualization. The device 48 is placed into contact with the target stomach tissue, and tissue is drawn into the recess 54. This may be accomplished by pressing the recess 54 against the tissue surface, or by activating a vacuum source configured to draw tissue into the recess 54. As discussed previously and as indicated in
Once tissue has been drawn into recess 54, the cutting blade 68 is advanced (
Next (or simultaneously with advancement of the cutting blade 68), the suture needle 66 is driven through the tissue, engages with the suture catch 64 (
Next, the process is repeated at an adjacent location (preferably using the same unit of device 48 but alternatively using a second unit), thus creating a second exposed patch E2 of submucosa and placing a second suture 70 through the tissue as shown in
Referring to
Depending on the length of the leg members 16, only one or two such pockets 72 may be needed for retaining a leg member 16, or each leg member may be retained by an elongate array of pockets 72 as shown.
Other techniques may also be used for modifying the tissue surface to achieve optimal tissue adhesion between opposed tissue surfaces. Referring to
In another alternative shown in
Positioning Implants within Tissue Pockets
Laparoscopic incisions are next formed into the abdominal cavity, a trocar 84 is positioned in the incision, and the abdominal cavity is insufflated using procedures well known to those of skill in the art. Suture device 48 (or another type of device such as a laparoscopic stapler or clip applier) is passed through the trocar 84 and used under endoscopic visualization to plicate tissue pockets around the device leg members 16. The laparoscopic procedure is repeated for each of the leg members 16. Naturally, an open surgical procedure may be carried out in place of the laparoscopic procedure. In a less invasive procedure, the suture device 48 may be introduced through the esophagus into the stomach rather than through surgical or laparoscopic incisions.
As discussed previously, it may be desirable to form the tissue pockets 72 before introducing the implant. The pre-formed tissue pockets 72 may be plicated as described in connection with
One method of delivering the legs 16 into the tissue pockets 72 is shown in
An articulating endoscopic grasper 88 is passed through the esophagus and into the stomach, and its distal end is fed into the distal end of a tissue pocket 72 until it exits the pocket's proximal end. The grasper 88 engages one of the guidewires 86 and pulls the guidewire through the tissue pocket such that the distal end of the guidewire extends out the pocket's distal end. The procedure is repeated for each guidewire. Outside the body, each leg 16 of the implant 10 is attached to the proximal end of one of the guidewires. The grasper 88 then engages the distal ends of the guidewires 86 and draws the distal ends 102 of the guidewires 86 out of the body, thereby towing the implant through the esophagus towards the stomach. As the implant 10 approaches the stomach, the distal ends of the guidewires 86 are individually manipulated to separately draw each leg 16 into a corresponding one of the tissue pockets 72.
Although anchoring of an implant using tissue pockets has been described with respect to implant 10, it should be kept in mind that other types of implants may also be retained using one or more tissue pockets. For example, a drug-eluting capsule may be positioned within a tissue pocket, or a drug-eluting device may include a capsule attached to one or more anchoring members that are retained within tissue pockets. Similar arrangements may be configured for other forms of diagnostic or therapeutic implants of the types mentioned above.
Alternative Methods
The configuration shown in
Referring to
A ring 94 is positioned on the exterior surface of the body wall surrounding the waist portion 92 of the hourglass liner 90, such that it causes the body wall tissue to conform to the hourglass shape of the liner 90, altering the shape of the stomach by creating a stricture as shown. If necessary, the ring 94 may be secured in place using partial or full thickness . sutures, barbs, clips etc. The ring 94 may have features similar to the collar 56 described in connection with
The relative positions of the ring 94, liner 90 and pouch 2 are such that the ring holds the liner 90 in position, and the liner in turn holds pouch 2 in position. Optional mounting studs 96 may be connected to the pouch 2 and sutured through the liner 90 to the body wall using partial or full thickness sutures. Further details of studs of this type are described in connection with
An optional feature in the
Another optional feature in the
Another configuration shown in
In the
As discussed in connection with
The ring 94 may also function as an anchor to which the implant may be attached using sutures, clips etc. In yet another alternative shown in
In
Referring to
In one embodiment, the circumferential ridge may finction as a physical barrier that prevents migration of the implant away from the proximal stomach, similar to the manner in which the wall re-shaped by ring 94 in
Attachment of the implant 246 may be performed during the same procedure in which the circumferential ridge is formed, or at a later date to permit the adhesions to form before the ridge is subjected to the stresses that will be imparted against it by the implant.
Referring to
Introduction of an implant may be performed immediately following formation of the plications, or at a later date after the opposed serosal tissue has adhered as described above. In one method of introducing the implant, a plurality of wires 252 having hooked distal ends are passed through a sheath 254 and used to hook the circumferential ridge 244a. Implant 246a, which has a plurality of small holes (not shown), is slipped over the wires by telescoping each of the small holes over a corresponding one of the wires 252. The implant 246a is compressed and passed into the sheath 254, and is then advanced through the sheath into contact with the ridge 244a while tension is maintained on the wires 252. The implant 246a may be physically connected to the ridge 244a using sutures, t-bars, or other fasteners as described in connection with
Although various types of implants may be retained using this method as well as the other methods described in this application, the implant 246a is shown in
Ring 247 may be formed of any of the materials described above in connection with pouch 2, including silicone, polyurethane, or one of a variety of types of polymers. A reinforcing element formed of an annular band of stainless steel, polymer, shape memory materials such as nitinol, shape memory alloys, or shape memory polymers may extend through the ring 247. The ring may be constructed so as to be self-expanding, so that it will spring radially open into an expanded condition upon ejection from a deployment sheath. Alternatively, the ring may be inflatable using an inflation medium such as a gas or liquid (e.g. saline), or using a photochemically or thermally curable polymer. As another alternative, the ring may be formed of a material that will degrade or erode within the body over a period of time.
The ring 247 may include an apron 256 having an annular groove 258 as shown in
Insert 260 includes a rim 262 that may be snapped into groove 258 to engage the ring and insert.
In one method of using this type of implant, the physician may implant the ring 247 and delay placement of the insert 260 until the patient has had several days to adjust to the presence of the implant. Later, the insert 260 may be endoscopically passed down the esophagus and into the stomach, and be snapped into place. On a later date, the physician may choose to remove the insert 260 and replace it with a more restrictive (i.e. one having a smaller exit orifice) or a less restrictive insert (i.e. one having a large exit orifice), depending on the needs of the patient. If desired, the insert may be formed of a material that degrades or erodes after a period of time, thereby eliminating the need for removal of the insert.
External Reinforcements
Several components described in this disclosure function as external reinforcement devices. As discussed in
Examples of external reinforcement devices include pledgets 130 (
During implantation of the pledgets 130, the implant such as pouch 2 (
During implantation of the t-bars, the end of the suture having the t-bar attached to it is endoscopically positioned adjacent the exterior wall of the stomach, and the free end is sewn through the stomach wall and the internally positioned implant wall.
Other types of external reinforcement devices are shown in
As another alternative to the pledget 130, a pledget may be formed in situ by injecting a drop of gel onto the exterior surface of the stomach, where the gel is a type that will solidify on the tissue surface. The gel may be delivered laparoscopically by approaching the stomach wall from outside the stomach, or it may be delivered endoscopically by injecting the gel using a needle passed through the wall of stomach from the stomach interior. Once the gel hardens into a pledget, the implant may be anchored to the hardened gel pledget using sutures, clips, etc. passed through the stomach wall. As yet another alternative, the gel may be injected in between the serosal and mucosal layers of stomach wall tissue to form the gel pledget within the stomach wall.
Naturally, each of the external reinforcement devices described above must in some way be connected to the implant located in the interior of the stomach.
As shown in
Referring to
Referring to
Collars
Another form of external reinforcement device is an external collar encircling the exterior of the stomach.
For other configurations, the collar is not physically connected to the implant, but may be positioned to restrict movement of the device.
The collar embodiments of
Similar properties are found in the
Referring to
Because the collar is intended to be wrapped around the stomach, its design must be such that it can be introduced into the stomach cavity in an elongate configuration, and then have its free ends attached to form it into a loop around the stomach. As illustrated in
As an alternative shown in
Alternative Restrictive Devices
The flexible nature of the pouch 2 allows it to move in response to stomach movement, thereby producing little or no stress on the sutures or anchors holding the pouch in place. This is believed desirable towards minimizing the chance that the implant will detach from the stomach wall. Other restrictive devices and methods of retaining them are shown in
Ring 194 includes a flow-restrictive orifice 196 through which food passes. If desired, the ring 194 may include a circumferential region surround the orifice 196 that is independently inflatable or deflatable to adjust the diameter of the exit orifice.
Restrictive device 208 of
Tissue Modification to Increase Tissue Strength
If desired, the tissue of the stomach, esophagus, or gastro-esophageal junction may be treated using techniques such as mechanical abrasion, RF ablation/coagulation, laser ablation, or chemical abrasion that can strengthen the tissue such as by forming a layer of scar tissue. Cyanoacrylate coatings or growth inhibitors may also be applied to the tissue to strengthen it. These forms of tissue modification may be used in embodiments in which implant devices are physically connected to the tissue using sutures, staples, etc, or in embodiments in which there is no such physical connection but in which increased tissue strength is desired for prevention of erosion.
Various components and methods have been described herein. These embodiments are given by way of example and are not intended to limit the scope of the present invention. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Also, while various materials, dimensions, shapes, implantation locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the invention. For example, the retention methods and devices are not limited to use within the gastrointestinal system and may be used for implants placed elsewhere in the body.
Claims
1. A method of retaining a medical implant within a body cavity, the method comprising the steps of:
- providing a medical implant;
- forming a tissue pocket on a wall of a body cavity, said tissue pocket having a first opening exposed to the interior of the body cavity; and
- retaining at least a portion of the medical implant within the tissue pocket.
2. The method according to claim 1, wherein the forming step includes the step of attaching regions of body tissue on the wall of the body cavity.
3. The method according to claim 1 wherein the method includes forming the tissue pocket and then inserting the portion of the medical implant into the tissue pocket.
4. The method according to claim 1 wherein the method includes placing the portion of the medical implant into contact with the wall and forming the tissue pocket around the portion of the medical implant.
5. The method according to claim 1 wherein:
- the tissue pocket includes a second opening;
- the retaining step includes positioning the medical implant such that a first portion of the medical implant extends from the first opening and a second portion of the medical implant extends from the second opening; and
- the second portion of the medical implant includes a retention element proportioned to resist passage of the retention element through the second opening during the retaining step.
6. The method according to claim 5 wherein the positioning step includes expanding the retention element to prevent release of the medical implant from the tissue pocket.
7. The method according to claim 6 wherein the expanding step includes inflating the retention element.
8. The method according to claim 5 wherein the positioning step includes deforming the retention element to prevent release of the medical implant from the tissue pocket.
9. The method according to claim 5 wherein:
- the method provides the medical implant to include a leg member retainable within the tissue pocket, wherein the retention element is positioned on the leg member.
10. The method according to claim 5 wherein the retention element is a clip and the positioning step positions the clip to extend through the first and second openings.
11. The method according to claim 1 wherein the medical implant is retained within the tissue pocket without the use of a fastener that both physically penetrates body tissue and is physically connected to the medical implant.
12. The method of claim 2, further including the step of causing the attached regions of tissue to adhere to one another.
13. The method according to claim 2 wherein the body cavity is a stomach having an interior and an exterior, and wherein the attaching step attaches regions of tissue such that serosal tissue from a first region and serosal tissue from a second region are in contact with one another.
14. The method according to claim 13, further including the step of causing the attached regions of serosal tissue to adhere to one together to form a tissue adhesion.
15. The method according to claim 2 wherein the body cavity is a stomach having an interior and an exterior, and wherein the attaching step attaches interior regions of tissue.
16. The method according to claim 15 wherein the attached interior regions of tissue comprise mucosal tissue.
17. The method according to claim 1, wherein the body cavity is a stomach and the method forms the tissue pocket accessible from the stomach interior.
18. The method according to claim 2, wherein the body cavity is a stomach and the regions of body tissue are on the exterior surface of the stomach.
19. The method according to claim 18 wherein the attaching step includes attaching the regions to form a fully-enclosed tissue pocket, and forming the at least one opening in the tissue pocket.
20. The method according to claim 18 wherein:
- the method includes drawing exterior stomach tissue into apposition to form a tissue fold;
- the method includes forming a cut in the tissue fold to create a window therein; and
- the attaching step includes attaching opposed layers of tissue surrounding the window, wherein the tissue pocket extends between the opposed layers of tissue bordered by the cut.
21. The method according to claim 18, wherein:
- the method includes drawing exterior stomach tissue into apposition to form a stomach fold;
- the attaching step includes forming a hole extending through the stomach fold and attaching opposed layers of tissue in the region surrounding the hole; and
- the tissue pocket comprises the hole extending through the opposed layers of tissue.
22. The method according to claim 2 wherein the attaching step attaches the regions of body tissue together using suture.
23. The method according to claim 2 wherein the attaching step attaches the regions of body tissue together using staples.
24. The method according to claim 2 wherein the attaching step attaches the regions of body tissue together using clips.
25. The method according to claim 2 wherein the attaching step attaches the regions of body tissue together using adhesives.
26. The method according to claim 2 wherein the method includes modifying at least one of the regions of body tissue prior to attaching the regions into contact with one another.
27. The method of claim 26 wherein the modifying step includes ablating at least one of the regions of body tissue.
28. The method of claim 26 wherein the modifying step includes cutting at least one of the spaced apart regions of body tissue.
29. The method of claim 28 wherein the cutting step includes shaving a tissue layer from at least one of the regions of body tissue.
30. The method according to claim 26 further including the step of causing the regions of body tissue to adhere to one another.
31. The method according to claim 26 wherein at least one of the regions of body tissue is mucosal tissue, and wherein the modifying step includes removing a portion of the mucosal tissue to expose underlying tissue layers.
32. The method according to claim 31 wherein the modifying step exposes a submucosal tissue layer.
33. The method according to claim 31 wherein the modifying step exposes a serosal tissue layer.
34. The method according to claim 31 wherein the modifying step exposes a muscularis tissue layer.
35. The method according to claim 1 wherein the medical implant is a drug delivery device.
36. The method according to claim 1 wherein the medical implant is a diagnostic device.
37. The method according to claim 1 wherein the medical implant is an anti-reflux device.
38. The method according to claim 1 wherein the body cavity is the stomach and wherein the medical implant is a device for inducing weight loss.
39. The method according to claim 38, wherein the medical implant is an expandable space-occupier and wherein the method includes expanding the space-occupier within the stomach to decrease the effective volume of the stomach.
40. The method according to claim 38, wherein the medical implant is a flow-restrictive device and wherein the method includes positioning the flow-restrictive device to restrict the rate of flow of food into the stomach.
41. The method according to claim 1, further including the step of retaining the medical implant using a plurality of tissue pockets formed in the body cavity.
42. The method according to claim 41 wherein the medical implant includes a plurality of leg members, and wherein the method includes the step of forming a plurality of tissue pockets in the body cavity and retaining the leg members within the tissue pockets.
43. The method according to claim 1 wherein the body cavity is a stomach and wherein the tissue pocket is formed using instruments passed into the stomach through the esophagus.
44. The method according to claim 43 wherein the body cavity is a stomach and wherein the tissue pocket is formed only using instruments passed into the stomach through the esophagus.
45. The method according to claim 1 wherein the body cavity is a stomach and wherein the tissue pocket is formed using instruments passed through the abdominal wall.
46. An obesity-controlling apparatus retainable in at least one tissue pocket formed on a wall of a human stomach, the apparatus comprising:
- a member proportioned to be retained within a tissue pocket formed on a wall of a human stomach; and
- a weight-loss component attached to the member.
47. The apparatus according to claim 46 wherein the weight-loss component includes a restrictive device proportioned to effectively narrow a passage from the esophagus into the stomach to thereby restrict the rate at which food flows into the stomach.
48. The apparatus according to claim 46 wherein the weight-loss component includes an expandable space-occupier device proportioned to reduce the effective volume of the stomach.
49. The apparatus according to claim 46 wherein the weight-loss component includes a drug-eluting device containing a hunger-controlling agent.
50. The apparatus according to claim 46 wherein the member is retainable within the tissue pocket in the absence of a fastener attached to the apparatus that physically penetrates body tissue.
51. The apparatus according to claim 46 wherein apparatus is positionable in a human stomach in which tissue pockets have been formed to include first and second openings, and wherein the member includes a retention element proportioned to prevent movement of the retention element through the second opening to prevent release of the member from the tissue pocket.
52. The apparatus according to claim 51 wherein the retention element is expandable to prevent release of the member from the tissue pocket.
53. The apparatus according to claim 52 wherein the retention element is inflatable.
54. The apparatus according to claim 52 wherein the retention element is compressible to a reduced-diameter position.
55. The apparatus according to claim 51 wherein the retention element is deformable to prevent release of the member from the tissue pocket.
56. The apparatus according to claim 51 wherein the retention element is a clip extendable through first and second openings of a tissue pocket.
57. The apparatus according to claim 47 wherein the restrictive device is a ring.
58. The apparatus according to claim 47 wherein the restrictive device is a mesh screen.
59. The apparatus according to claim 47 wherein the restrictive device is an inflatable balloon.
60. The apparatus according to claim 47 wherein the restrictive device is a pouch.
61. The apparatus according to claim 46, including a plurality of said members proportioned to be retained within a tissue pocket formed by attaching tissue surfaces of a human stomach.
62. The apparatus according to claim 46 including at least three of said members.
63. A medical implant system, comprising:
- an instrument insertable into a body for attaching regions of body tissue on the wall of a body cavity to form a tissue pocket; and
- a medical implant positionable within the body cavity, the medical implant including at least one portion proportioned for retention within a tissue pocket formed in the body cavity.
64. The implant system according to claim 63 wherein the medical implant is a drug delivery device.
65. The implant system according to claim 63 wherein the medical implant is a diagnostic device.
66. The implant system according to claim 63 wherein the medical implant is an anti-reflux device.
67. The implant system according to claim 63 wherein the medical implant is positionable within a stomach for inducing weight loss.
68. The implant system according to claim 63, wherein the medical implant is an expandable space-occupier positionable within a stomach to decrease the effective volume of the stomach.
69. The implant system according to claim 63, wherein the medical implant is a flow-restrictive device positionable within a stomach to restrict the rate of flow of food into the stomach.
70. The implant system according to claim 63 wherein the instrument is a suturing instrument.
71. The implant system according to claim 63 wherein the instrument is a stapling instrument.
72. The implant system according to claim 63 wherein the instrument is a clip-applier.
73. The implant system according to claim 63 wherein the medical implant includes a plurality of leg members proportioned to be retained within a plurality of tissue pockets formed using the instrument.
74. The implant system according to claim 63 wherein the medical implant is retainable within the tissue pocket without the use of a fastener that both physically penetrates body tissue and is physically connected to the medical implant.
75. A method of retaining a medical implant within a body cavity having a wall, comprising the steps of:
- positioning at least a portion of a medical implant within a body cavity; and
- re-shaping a wall of the body cavity such that the re-shaped wall prevents migration of the medical implant out of the body cavity.
76. The method according to claim 75 wherein the re-shaped wall prevents migration of the medical implant in the absence of a fastener attached to the medical implant and physically penetrating tissue of the wall.
77. The method according to claim 75 wherein the positioning step is carried out prior to the re-shaping step.
78. The method according to claim 75 wherein the positioning step is carried out after the re-shaping step.
79. The method according to claim 75 wherein the re-shaping step includes forming a tissue pocket on the wall, wherein at least a portion of the medical implant is retained within the tissue pocket.
80. The method according to claim 75 wherein the re-shaping step includes the step of positioning a re-shaping implant in contact with the wall.
81. The method according to claim 80 wherein the re-shaping step includes the step of positioning the re-shaping implant in contact with an exterior surface of the wall.
82. The method according to claim 80 wherein the re-shaping step includes the step of positioning the re-shaping device in contact with an interior surface of the wall.
83. The method according to claim 80 wherein the re-shaping step includes positioning a circumferential band in contact with the wall.
84. The method according to claim 83 wherein the body cavity is a stomach, and wherein the re-shaping step further includes the step of positioning a re-shaping liner on an interior surface of the stomach wall.
85. The method according to claim 84 wherein the liner includes a neck portion, and wherein the re-shaping step further includes positioning the circumferential band in contact with the wall such that wall tissue is disposed between the neck portion and the liner.
86. The method according to claim 75 wherein the re-shaping step includes attaching regions of tissue together.
87. The method according to claim 86 wherein the attaching step forms a tunnel and wherein the method includes positioning at least a portion of the implant within the tunnel.
88. The method according to claim 87 wherein the implant includes an expandable portion and wherein the positioning step includes positioning the expandable portion into contact with tissue surrounding the tunnel.
89. The method according to claim 87 wherein the body cavity is a stomach and the attaching step forms a tunnel in the proximal stomach, wherein the tunnel is at least partially contiguous with the esophagus.
90. The method according to claim 85 wherein the attaching step forms a barrier proportioned to obstruct passage of the implant from one region of the body cavity into another region of the body cavity.
91. The method according to claim 90 wherein the body cavity is a stomach, and wherein the barrier prevents migration of the implant towards the intestinal tract.
92. The method according claim 91 wherein the barrier is formed in the proximal portion of the stomach and the positioning step positions the implant between the barrier and the esophagus.
93. The method according to claim 74 wherein the medical implant is an obstructive device positionable within a stomach.
94. The method according to claim 74 wherein the medical implant is a restrictive device positionable within a stomach.
95. The method according to claim 74 wherein the medical implant is an anti-reflux device positionable within a stomach.
96. The method according to claim 74 wherein the medical implant is a drug-eluting device.
97. The method according to claim 75 wherein the medical implant is a diagnostic device.
98. The method according to claim 74 wherein the medical implant is a therapeutic device.
99. The method according to claim 19, further including the step of forming a second opening in the tissue pouch.
100. The method according to claim 1 wherein the retaining step retains the entire medical implant within the pocket.
101. The method according to claim 100, further including the step of closing the opening after positioning the medical implant within the pocket.
102. A method of attaching a medical implant to stomach tissue, including the steps of:
- positioning a medical implant within stomach having a wall; and
- attaching the medical implant to an external reinforcement device positioned in contact with the exterior surface of the wall using a connector extending through the wall from the implant to the external reinforcement device.
103. The method according to claim 102 wherein the external reinforcement device is a pledget.
104. The method according to claim 102 wherein the external reinforcement device is a t-bar.
105. The method according to claim 102 wherein the external reinforcement device is a band.
106. The method according to claim 102 wherein the external reinforcement device is a patch of reinforcing material.
107. A method of positioning an implant within the stomach, comprising the steps of:
- forming a plurality of plications in a wall of a stomach to form at least one tissue ridge;
- and positioning an implant in contact with the tissue ridge.
108. The method according to claim 107 wherein the forming step includes the step of attaching regions of body tissue on the wall of the stomach.
109. The method according to claim 108 wherein the attaching step is performed using sutures.
110. The method according to claim 108 wherein the attaching step is performed using t-bars.
111. The method according to claim 108 wherein the attaching step is performed using pledgets.
112. The method according to claim 108, wherein attaching step causes sections of serosal tissue to be positioned in apposition, and wherein the method further includes the step of causing the opposed sections of serosal tissue to adhere to one another.
113. The method according to claim 112 wherein the causing step is performed prior to the positioning step.
114. The method according to claim 107, wherein the positioning step includes fastening the implant to the tissue ridge.
115. The method according to claim 107 wherein the forming step is performed using endoscopic instruments passed through the esophagus into the stomach.
116. The method according to claim 115 wherein the forming step includes the steps of:
- extending a tissue-engaging device through the esophagus into the stomach;
- engaging tissue with the tissue-engaging device and drawing the engaged tissue in a proximal direction to form a plication; and
- during the drawing step, advancing a fastener through the plication.
117. The method according to claim 107 wherein the positioning step includes the steps of:
- extending tissue-engaging members through the esophagus into the stomach;
- engaging portions of the tissue ridge with the elements and drawing the engaged portions in a proximal direction; and
- during the engaging step, advancing the implant against the tissue ridge.
118. The method according to claim 117 wherein the tissue-engaging members including a plurality of elongate members having tissue-engaging distal ends, and wherein the advancing step includes slidably attaching the implant to the elongate members and sliding the implant along the members in a distal direction.
119. The method according to claim 107 wherein the implant is an obesity-controlling implant.
120. The method according to claim 107, further including the step of attaching a restrictive component to the implant, the restrictive component having an opening oriented such that food ingested by the patient flows through the opening and into the stomach, the opening proportioned such food flows through the opening at a rate that is slower than the rate at which food would flow into the stomach in the absence of the restrictive component.
121. The method according claim 120, wherein the restrictive component is a first restrictive component, and wherein the method further included the step of removing the first restrictive component and attaching a second restrictive component, the second restrictive component having an opening proportioned such food flows through the opening at a rate that is different than the rate at which food would flow into the stomach through the opening of the first restrictive component.
122. The method according to claim 107 wherein the implant is a device for controlling gastro-intestinal reflux disease.
Type: Application
Filed: May 11, 2004
Publication Date: Nov 10, 2005
Inventors: Richard Stack (Chapel Hill, NC), Dan Balbierz (Redwood City, CA), John Lunsford (San Carlos, CA), Kevin van Bladel (Livermore, CA), William Eubanks (Columbia, MO), William Athas (Chapel Hill, NC), Richard Glenn (Santa Rosa, CA), Richard Kouri (Raleigh, NC)
Application Number: 10/843,702