CN117157035A - Gastrointestinal tract and its anchoring - Google Patents

Abstract

An anchor (20) for anchoring a tube (10) relative to a pylorus of a patient. The tube (10) may be a bypass tube or a bypass conduit for bypassing a portion of the intestine. The anchor (20) may include a balloon (22) that is collapsible for introduction and optionally self-expanding to an operative state. The ball (22) may have an open structure with a low pressure chamber. The ball (22) may be configured to partially collapse in response to gastric contractions. This enables the ball to exhibit compliance with gastric contractions and absorb the contractions. Other embodiments of the tube, anchors, balloon, and staples are also described.

Description

Gastrointestinal tract and its anchoring

Technical Field

The present invention relates to the field of tubes for insertion into the gastrointestinal tract and anchors for such tubes. In some non-limiting aspects, the tube is a bypass tube for a bypass portion of the intestinal tract.

Background

Various surgical techniques and implants have been proposed to treat obesity and diabetes. Surgical techniques include the formation of a gastric pouch and gastric bypass of the stomach, duodenum and a portion of jejunum. Bypass tubes or cannulas have been proposed for insertion into the gastrointestinal tract to bypass the duodenum and optionally a portion of the jejunum.

Many of these techniques still face technical challenges. For example, endoscope placement and anchoring of bypass tubes remains challenging. One technique that has been proposed is to anchor the tube near the pylorus. However, the stomach and intestinal tract undergo significant movement during normal bodily functions. The contraction of the stomach muscles, including those at the antrum of the pylorus, complicates the holding of the catheter in place. For example, in the case of vomiting in a patient, muscle contraction may be extreme. Displacement into the duodenum or stomach may require medical intervention to correct position or retrieve the bypass tube. Many of the existing proposals suffer from the need for secure anchoring and atraumatic engagement with body tissue to avoid the obvious contradictory requirements of the device for tissue irritation.

It is desirable to address and/or mitigate one or more of the above problems.

Disclosure of Invention

Aspects of the invention are defined in the claims.

A first aspect of the invention provides an anchor for anchoring a tube relative to a pylorus of a patient. The tube may be a bypass tube or a bypass conduit bypassing a portion of the intestinal tract. The anchor may be defined independently of the tube or may be defined in combination with the tube.

The anchor may include a gastric ball coupled or coupleable to the proximal end of the tube. The balloon is expandable from a collapsed condition for introduction into the stomach to an operative condition within the stomach.

In some embodiments, the ball is configured such that in the expanded state, the pressure within the ball (22) is (i) no greater than atmospheric pressure and/or (ii) no greater than ambient pressure within the stomach. With such an arrangement, the ball is not permanently sufficiently pressurized compared to the ambient atmospheric pressure within the stomach.

The gastric balloon may be configured to partially collapse in response to gastric contractions. This enables the ball to exhibit compliance with gastric contractions and absorb the contractions without exerting significant tension on the tube, which would otherwise disengage the tube.

In some embodiments, the gastric balloon is self-expandable from a collapsed state to an operative state. The gastric ball may include a self-expanding structure, an optional frame structure (e.g., with ribs and/or struts) and/or a mesh structure.

The gastric balloon may be open and/or have communication openings that allow chyme to enter the interior of the balloon. For example, the ball may comprise an open frame or mesh.

Additionally or alternatively to the self-expanding structure, the ball may include a fluid-tight chamber. The chamber may have an inlet which may: (i) When the balloon is expanded to its operational state (e.g., in embodiments where the pressure within the balloon is intended to be no greater than atmospheric pressure and/or no greater than ambient pressure within the stomach), a fluid (e.g., a liquid such as saline; or a gas such as air) is allowed to be drawn into the chamber, and/or (ii) a fluid (e.g., a liquid such as saline; or a gas such as air) is allowed to enter the chamber to inflate the balloon (e.g., in embodiments where a pressurized balloon is used). The chamber may also be fluid-tight with respect to the type of fluid with which the chamber is configured to be used, e.g., substantially fluid-tight for liquid fluids, or substantially gas-tight for gaseous fluids.

In some embodiments including a self-expanding structure and a fluid-tight chamber (optionally with an inlet), the self-expanding structure and the fluid-tight chamber may be at least partially (optionally substantially entirely) nested within one another. For example, the fluid-tight chamber may be at least partially (optionally substantially entirely) sleeved within the self-expanding structure. The self-expanding structure may generally bias (e.g., pull) one or more walls of the fluid-tight chamber outwardly as the surrounding portion of the self-expanding structure self-expands. At least one wall of the fluid-tight chamber may be attached to and/or laminated with the self-expanding structure.

Additionally or alternatively to any of the above, the gastric balloon may be spaced from the proximal end of the tube. Optionally, the gastric ball is physically coupled to the tube by one or more struts or flexible tethers. Alternatively, the gastric ball is magnetically attracted or repelled by the tube such that there is a magnetic coupling or magnetic interaction between the gastric ball and the proximal end of the tube.

In the operational state, the ball may have any desired shape, such as a generally spherical shape, a teardrop shape, a diamond shape, a rugby shape, a bell shape (or a tulip shape). Thus, the term "balloon" encompasses any suitable shape and size (e.g., at least partially rounded shape and size) that is capable of performing an anchoring function to prevent migration of the anchor from the stomach through the pylorus.

Regardless of the shape of the ball used, the ball may include a passage, such as a central aperture, configured to allow chyme to pass through the ball (e.g., for exiting the stomach through the pylorus).

Additionally or alternatively to any of the above, in the second aspect, the anchor may comprise at least one resilient element expandable from a collapsed condition for introduction into the stomach and into an operative condition, wherein the resilient element has, at least in part, a helical shape in the operative condition.

The resilient member may optionally define a helical shape that gradually expands in a radial direction away from the proximal end of the tube. The spiral shape may include open spaces between adjacent turns or coils of the spiral.

Such a configuration facilitates easy collapse for introduction while also being expandable to a relatively large size in its operational state.

In addition or alternatively to any of the preceding, a third aspect of the invention provides an anchor for anchoring a tube relative to a pylorus of a patient, the anchor comprising a first loop for fitting against a gastric side of the pyloric sphincter and a second loop for fitting against a duodenal side of the pyloric sphincter. The first ring and the second ring are coupled to each other to clamp the pyloric sphincter between the rings, the first ring and the second ring having inner and/or outer diameters different from each other, optionally such that the inner diameter of one ring is greater than the outer diameter of the other ring.

Such anchors can be firmly but atraumatically attached to the pyloric sphincter, providing good fixation even in the event of strong gastric contractions.

The first ring and/or the second ring may collapse to a collapsed state for introduction to the pylorus. The anchor may further include a connecting element between and coupled to the rings for selectively drawing the rings closer to each other to clamp the pyloric sphincter, the connecting element optionally being a suture.

In some embodiments, the anchor further comprises at least one inner ring for surrounding an inner circumference of the pyloric sphincter, optionally wherein the at least one inner ring comprises a first inner ring and a second inner ring.

The first ring and/or the second ring are made of or comprise any suitable material, such as one or more of the following: a metal; and/or a shape memory alloy, optionally nitinol; and/or plastic.

In addition or alternatively to any of the above, a fourth aspect of the invention provides a tube for insertion into at least the duodenum of a patient, and at least one gastric balloon that causes satiety via contact with the stomach wall. Various techniques are contemplated for configuring the ball to contact the stomach wall, such as one or any combination of the following:

The ball may optionally be inflated with, for example, air or gas, allowing the ball to float in the stomach.

A plurality of balls may be provided to at least partially fill the stomach while allowing normal stomach movement and contraction.

The ball is repelled relative to the tube in a direction towards the stomach wall, for example by magnetic repulsion.

In addition or alternatively to any of the above, a fifth aspect of the invention provides a tube for introduction into the gastro-intestinal tract of a patient, optionally a modified tract (e.g. following bypass surgery to modify the digestive tract). The tube may be configured for introduction at the anastomosis.

The tube is configured for allowing passage of gastric and/or intestinal contents therethrough in a first direction and for impeding passage of gastric and/or intestinal contents in a second, opposite direction.

For example, the tube may include at least one, optionally a plurality of valve elements configured to permit passage of gastric and/or intestinal contents therethrough in a first direction and to block passage of gastric and/or intestinal contents in a second direction. The valve element may comprise a flap that opens to allow passage of gastric and/or intestinal content through the tube in a first direction and closes to block passage of gastric and/or intestinal content in a second direction.

Such a tube may be advantageous in preventing reflux of digestive fluids to the stomach and/or esophagus. For example, the tube may prevent digestive fluids from the pancreas from passing through the anastomosis against the normal flow direction. This may reduce discomfort that the patient may experience after the surgery.

In addition or alternatively to any of the above, a sixth aspect of the invention provides a tube for introduction at the duodenum of a patient, the tube being made of plastic and comprising a suture-permeable and/or stapler-permeable woven or non-woven fabric layer near or at the proximal end. The fabric allows the tube to be anchored into body tissue near or at the pylorus by suturing or stapling through the fabric. The fabric may be laminated to or incorporated into the plastic of the tube. The fabric is used to prevent tear propagation in plastic materials, especially when stomach movements and contractions are encountered.

In addition or alternatively to any of the above, a seventh aspect of the invention provides a tube for introduction into the gastro-intestinal tract of a patient, the outer surface of the tube being provided with an open channel extending at least partially axially and/or longitudinally relative to the tube. This channel allows gastric secretions, such as pancreatic juice, to travel outside the tube and avoids entrapment of the secretions due to contact between the tube and the intestinal wall. Alternatively, the channel may have a spiral shape around the outside of the tube. Alternatively, the channels may be longitudinal grooves. More than one channel may be provided.

In addition or alternatively to any of the above, an eighth aspect of the invention provides techniques for treating diabetes or obesity by creating one or more folds (or artificial folds) in the stomach wall by applying at least one tissue penetrating fastener to reduce the natural volume of the stomach.

As used herein, the term "tissue penetrating fastener" includes any fastener that penetrates, optionally completely penetrates, tissue and includes (at least) sutures, staples or staples. The tissue penetrating fasteners may be placed, for example, by endoscopic or laparoscopic techniques.

One or more folds may extend generally in a direction (i) from the top to the bottom of the stomach and/or (ii) from the esophagus to the pylorus. Such folds may form a generally sleeve-shaped cavity or channel in the stomach.

The eighth aspect may optionally be used with a bypass tube and/or anastomosis for increasing the effectiveness of such devices by reducing gastric volume in an effective manner. For example, the eighth aspect may be particularly useful with any of the other devices described herein.

In addition or alternatively to any of the above, a ninth aspect of the invention provides a tissue penetrating fastener, optionally for attaching one or more loops to anatomical tissue, such as pyloric sphincter tissue. The fastener includes end pieces in the form of a head and a foot, the end pieces being interconnected by a connecting element. At least the head portion and optionally the foot portion may be placed in a generally undeployed configuration wherein the head portion (and optionally the foot portion) extends alongside the connecting element for introduction in a streamlined shape. In the deployed configuration, the head (and optionally the foot) is moved to protrude laterally on either side of the connecting member.

The end pieces may be made of any suitable material. The end piece may have a tubular form or a non-tubular form. The tubular form allows for introduction of the fastener onto the needle, for example in its undeployed configuration. In some embodiments, the head and/or foot of the fastener is made of a shape memory alloy, such as nitinol.

The connecting element may be generally flexible (e.g., suture) or generally inflexible (e.g., rigid wire). In some embodiments, the connecting element is formed as an extensible spring, but is biased to at least partially pull the end pieces toward each other.

In addition or alternatively to any of the preceding, a tenth aspect of the invention provides an apparatus for anchoring a device at a pylorus of a patient, the apparatus comprising:

-at least a first ring for attachment to the pyloric sphincter, said ring having a self-supporting shape, and

-a plurality of tissue penetrating fasteners insertable into and/or through the ring for attaching the ring to the face of the pyloric sphincter.

With a self-supporting ring, a firm attachment of the tissue of the pyloric sphincter is possible without the risk of attachment peristalsis caused by intestinal tissue regeneration, which would lead to displacement of the attachment position over time. The ring stabilizes the attachment point even if tissue regenerates. Gastrointestinal tissue has rapid repair and regeneration rates.

The tissue penetrating fastener may optionally comprise a fastener according to the ninth aspect of the invention.

The apparatus may further comprise a second self-supporting ring for placement and fixation on a face of the pyloric sphincter opposite the first ring, thereby clamping the pyloric sphincter. The fastener may be configured to pass through both loops.

In addition or alternatively to any of the above, an eleventh aspect of the invention provides a tool for attaching a device to body tissue at a pylorus of a patient, the tool comprising a plurality of first elongate supports for removable attachment to an annular portion of the device and a plurality of second elongate supports comprising penetrating elements for deploying tissue penetrating fasteners into the annular portion of the device.

The eleventh aspect is particularly, but not exclusively, suitable for use with the ninth and/or tenth aspects described above.

Each of the plurality of second elongate supports is axially movable relative to the plurality of first elongate supports. Each of the plurality of second supports is independently axially movable or is jointly movable with one or more other supports of the plurality of second supports. Each of the plurality of second elongate supports is movable between an extended position in which it extends substantially the same level as (optionally above) that reached by the plurality of first elongate supports and a retracted position in which it is retracted relative to the level reached by the plurality of first elongate supports.

The penetrating elements of each second elongate support may comprise, for example, pointed needles (optionally sharpened hypotubes), about which the tissue penetrating elements may be carried for deployment.

The tool may further include a multi-lumen catheter shaft having a plurality of lumens for the plurality of first elongate supports and the plurality of second elongate supports. The plurality of first elongate supports and the plurality of second elongate supports may be alternately arranged along a circumferential direction of the catheter shaft.

The tool may further include a constraining sheath slidable over the catheter shaft for constraining the first and second pluralities of elongate supports in the radially compressed configuration and allowing the elongate supports to diverge or splay away from one another, e.g., outwardly, when the constraining sheath is retracted.

Additionally or alternatively to any of the above, a twelfth aspect of the invention includes a method of attaching a device including a ring to a pylorus of a patient, the method comprising:

(a) Advancing a tool to the pylorus, the tool comprising a plurality of first elongate supports and a plurality of second elongate supports, the ring attached to the plurality of first supports, and the plurality of second elongate supports comprising a penetrating element and carrying fasteners for securing to tissue;

(b) Positioning the ring adjacent a first side of the pyloric sphincter and positioning the second elongate support on an opposite second side of the pyloric sphincter;

(c) Advancing each second elongate support individually or collectively such that the penetrating element penetrates the pyloric sphincter and into the loop on the first side;

(d) Partially withdrawing each second elongate support, individually or collectively, such that the first end piece of the fastener anchors the ring on the first side of the pyloric sphincter; and

(e) Each second elongate support is withdrawn, either individually or collectively, such that the second end of the fastener is anchored on the second side of the pyloric sphincter.

Steps (c) to (e) may be performed sequentially for one elongate support at a time, or each of steps (c) to (e) may be completed for a plurality of second elongate supports before proceeding to the next step.

The method of the twelfth aspect may optionally use the tool of the eleventh aspect described above and/or optionally use the instrument of the ninth and/or tenth aspect described above.

In all of the above aspects, the tube may be a bypass tube or a bypass conduit for bypassing a portion of the intestinal tract.

Drawings

Non-limiting embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

fig. 1 is a schematic side view of a first example of a gastric anchor for the duodenal tube.

Fig. 2 is a schematic cross-sectional view illustrating a first example in an implanted state.

FIG. 3 is a schematic side view of a second example of a gastric anchor similar to that of FIG. 1.

Fig. 4 is a schematic cross-sectional view illustrating other examples similar to the first example and the second example in an implanted state.

Fig. 5 is a schematic cross-sectional view illustrating other examples of at least one balloon in an implanted state.

Fig. 6 is a further schematic cross-sectional view illustrating the at least one balloon in an implanted state.

Fig. 7 is a schematic cross-sectional view illustrating other examples of a plurality of balloons in an implanted state.

Fig. 8 is a schematic cross-sectional view illustrating other examples of anchors for anchoring at the pylorus.

Fig. 9 is a schematic cross-sectional view illustrating a detail of fig. 8.

Fig. 10 is a schematic cross-sectional view illustrating other examples of anchors similar to those of fig. 8 and 9.

FIG. 11 is a schematic side view of other examples of tubes that may be attached by sutures and/or staples.

Fig. 12a to 12d are schematic cross-sectional views illustrating the steps of attaching the tube to the stomach wall with a spacer.

Fig. 13a and 13b are schematic perspective views of the outer profile of the tube in other examples.

Fig. 14 is a schematic view of a tube placed at a gastro-jejunal anastomosis.

Fig. 15 is a schematic cross-sectional view of the stand-alone tube of fig. 14.

Fig. 16 is a schematic cross-sectional view illustrating formation of folds to reduce stomach volume.

Fig. 17 is a schematic cross-sectional view illustrating a detail of fig. 16.

Fig. 18 is a schematic cross-sectional view illustrating a gastric plication in combination with other therapeutic devices for diverting the flow of gastric content.

Fig. 19 is a schematic side view of an example of a tissue penetrating fastener.

Fig. 20 is a schematic side view of a second example of a tissue penetrating fastener.

FIG. 21 is a schematic side view of a needle carrying a tissue penetrating fastener for deployment.

Fig. 22 is a schematic cross-sectional view showing the needle of fig. 21.

Fig. 23 is a schematic side cross-sectional view of the working end of the tool for attaching the duodenal tube to the pyloric sphincter using the tissue penetrating fastener of fig. 19 or 20.

Fig. 24 is a schematic perspective view of the working end of the tool of fig. 23.

Fig. 25-32 are schematic side views illustrating the sequence of placement and attachment of the bypass tube in the duodenum using the tools of fig. 23 and 24.

Fig. 33 is a schematic side view illustrating a second example of using two attachment rings.

Detailed Description

In the following description, the same reference numerals are used to designate similar or equivalent features, whether or not described in detail. Thus, the description of one embodiment may be combined with another embodiment. Where a tube is described, the tube may alternatively be a bypass tube or bypass conduit for bypassing a portion of the intestine to reduce nutrient intake.

Referring to fig. 1 and 2, a tube 10 for introduction into at least the duodenum D of a patient for use in treating diabetes or obesity is illustrated. The tube 10 may optionally extend to the jejunum. The proximal end 10a of the tube may be disposed in the duodenum D (as shown in fig. 2) proximate the pylorus P, or it may extend at least partially through the pylorus P. The tube 10 may optionally include a sheath or stent 12 for preventing displacement from the implantation site toward the stomach. The tube 10 may optionally include a reinforcement (not shown in fig. 1 and 2, but shown at 14 in later figures) to prevent twisting of the tube 10 at the pylorus that could cause occlusion.

The anchor 20 for the tube 10 includes a gastric ball 22 for placement in the stomach S. The balloon 22 has a collapsed condition adapted for introduction into the stomach, for example, through the mouth of a patient, and an operative condition in which the balloon 22 expands to define an anchor that prevents displacement through the pylorus P.

The anchor 20 is coupled or coupleable to the tube 10 by any suitable coupling means, such as by one or more struts or one or more flexible tethers 18. Alternatively, the anchor 20 is mounted directly on the tube 10.

In the illustrated example, the ball 22 is configured such that in the expanded state, the pressure within the ball is not (i) greater than atmospheric pressure and/or (ii) not greater than ambient pressure within the stomach. The ball 22 is not permanently sufficiently pressurized compared to the ambient atmospheric pressure within the stomach. This is in contrast to balloons or balloon types that are inflated and inflated from the inside by means of inflation pressure.

For example, because of the lack of positive pressure within the ball 22, the ball 22 can partially collapse in response to gastric contractions. This allows the ball 22 to at least partially exhibit compliance with gastric contractions and absorb such contractions without excessively pulling the tube 10, which would otherwise dislodge the tube 10 from the stomach. For example, if the patient vomits, the balloon 22 may be partially compressed to absorb or accommodate extremely transient gastric contractions. At the same time, the ball 22 is biased to its operative state in which the ball 22 is intended to prevent displacement in the distal direction, as the ball 22 will block the passage towards and through the pylorus.

In the illustrated example, the ball 22 self-expands from a collapsed condition to an operational condition. The gastric ball 22 may include a self-expanding structure 24 (partially shown schematically in fig. 2), an optional frame structure (e.g., with ribs and/or struts), and/or a mesh structure.

In one form, the gastric ball 22 may be open to the interior thereof and/or have communication openings that allow chyme to enter the interior of the gastric ball 22. For example, the ball 22 may include an open frame 24.

Alternatively, the ball 22 may include a fluid-tight chamber. The chamber may have an inlet 26 for allowing fluid to be drawn into the chamber when the balloon 22 expands to its operational state under the influence of, for example, the self-expanding characteristics provided by the self-expanding frame 24. The delivery device may include an inflow conduit (e.g., a vent passage) removably coupled to the inlet 26 to allow pressure equalization and/or expansion by allowing fluid to enter. For example, the fluid may be a liquid (e.g., saline) or a gas (e.g., air). After pressure equalization and/or expansion is completed, the inflow conduit may be disconnected from the inlet 26, thus sealing the chamber. The small amount of fluid in the chamber may provide a compliant pad that supplements self-expanding frame 24, thereby providing an atraumatic anchor with compliant features. Optionally, the fluid-tight chamber may include a central passage (not shown) for allowing chyme to pass to the pylorus and into the conduit 10.

Where a self-expanding structure and a fluid-tight chamber are provided, the self-expanding structure and the fluid-tight chamber may be at least partially (optionally substantially entirely) nested one within the other. For example, the fluid-tight chamber may be at least partially (optionally substantially entirely) sleeved with the self-expanding structure. The surface (e.g., outer surface) of the fluid-tight chamber may be in face-to-face contact (e.g., laminated) with the surface (e.g., inner surface) of the self-expanding structure.

The ball may include a fluid-tight chamber without a self-expanding structure, with or without self-expansion. The fluid-tight chamber may have an inlet allowing fluid to enter the chamber. Another alternative to self-expansion is a fluid-tight chamber made of an elastic material that self-expands, for example, toward a molded configuration of the fluid-tight chamber to a deployed configuration.

Fig. 3 shows a second example similar to the first example of fig. 1 and 2. The main difference in fig. 3 is the addition of an adjustment mechanism 28 for enabling the distance between the ball 22 and the proximal end 10a of the tube 10 to be set in situ prior to introduction into the stomach and/or during or after placement into the stomach. The adjustment mechanism 28 may, for example, include a threaded member and a rotatable nut. The adjustment mechanism 28 may be adjusted by manual rotation using a suitable tool or by magnetic rotation using a magnetic tool.

Referring to fig. 4, an alternative example of an anchor 20 is illustrated that includes at least one resilient element 29 that is expandable from a collapsed condition for introduction into the stomach and to an operative condition (fig. 4) in which the resilient element 30 has at least in part a helical shape.

The helical shape may diverge gradually in a radial direction away from the proximal end of the tube. The spiral shape may include open spaces between adjacent turns of the spiral or between coils.

Such a configuration may facilitate easy collapse for introduction while also being expandable to a relatively large size in its operational state. The helical shape may provide atraumatic compliant engagement that is capable of absorbing and accommodating gastric contractions, even strong transient contractions, without excessively pulling the tube 10. At the same time, the helical shape reliably anchors the tube 10 to prevent displacement past the pylorus. The anchor 20 may be collapsed by pulling on the helically shaped free end using a suitable retrieval tool, allowing the device to be removed when desired.

Fig. 5-7 illustrate other examples including one or more gastric balloons or balloons 22 configured to induce satiety by contact with the stomach wall. According to embodiments, the balloon may or may not be used as a gastric anchor. In place, the gastric anchor 20 is coupled to the proximal end of the tube 10.

The balloon or balloon 22 may optionally be inflated with a fluid (e.g., gas or liquid). A gas such as air may desirably float the balloon relative to the stomach contents. In fig. 5, at least one (optionally a plurality of) balloons 22 are tethered to the proximal end of the tube 10 to float upwardly relative to the stomach contents.

In fig. 6, at least one (optionally a plurality of) balloons 22 have magnetism, such as a magnetic coating or carry one or more magnetic elements 27. The magnetic repulsive force between the balloon 22 and the co-directional magnetic element (not shown) located at the proximal end of the tube 10 urges the balloon 22 away from the tube 10 and into contact with the stomach wall.

In fig. 7, a plurality of balloons 22 occupy a relatively large space in the stomach and bear against the stomach wall(s). The balloons 22 may be loose and/or constrained relative to each other. Balloon 22 may be loose and/or constrained relative to catheter 10.

In the above examples of fig. 5-7, the one or more balloons 22 are sized to allow movement and contraction of the stomach, and also to allow chyme to pass to the tube 10.

Referring to fig. 8-10, the anchor 20 includes a first ring 30 for fitting against the gastric side of the pyloric sphincter PS and a second ring 32 for fitting against the duodenal side of the pyloric sphincter PS. The first ring 30 and the second ring 32 are coupled to each other for clamping the pyloric sphincter PS between the rings 30 and 32. As can be seen in detail in fig. 9, the first ring 30 and the second ring 32 have inner and/or outer diameters that are different from each other. In the illustrated form, the inner diameter of one ring (e.g., first ring 30) is about greater than (or at least not substantially less than) the outer diameter of the other ring (e.g., second ring 32).

Such an anchor 20 is firmly but atraumatically attached to the pyloric sphincter PS, providing good fixation even in the event of a strong gastric contraction. In particular, the offset of one ring relative to the other ring may reduce the risk of tissue necrosis that may be caused by compression between two rings of the same diameter with the same clamping force.

The first ring 30 and/or the second ring 32 may be deflated to a deflated state for introduction to the pylorus. The anchor 20 further includes one or more connecting elements 34 located between the rings 30 and 32 and coupled to the rings 30 and 32 for selectively drawing the two rings closer to each other for gripping the pyloric sphincter PS. In the illustrated form, the connecting element 34 comprises filaments (e.g., sutures). The filaments engage loops 30 and 32 such that pulling on the filaments pulls at least one loop toward the other.

If desired, at least one of the rings 30, 32 may also be directly attached to the pylorus, such as by one or more tissue penetrating fasteners (similar to that shown in FIG. 10, described below).

A tube (not shown) may be attached to one or more of the first ring 30 and the second ring 32. The tube may be permanently attached or attached via a connector, such as a magnetic connector.

Referring to fig. 10, in addition to the first ring 32 and the second ring 32, the anchor 20 includes at least one inner ring 38 for surrounding the inner circumference of the pyloric sphincter PS. In the illustrated embodiment, a first inner ring 38a and a second inner ring 38b are used. One of a plurality of connecting elements 40 located between the inner rings 38a and 38b and coupled to the rings 38a and 38b selectively pulls the rings closer to each other for surrounding the inner edge of the pyloric sphincter PS. In the illustrated form, the connecting element 40 comprises filaments (e.g., sutures). The filaments engage loops 38a and 38b such that pulling on the filaments pulls at least one loop toward the other.

In use, after placement of the second ring 32, the inner rings 38a and 38b can be placed in spaced relation to the pyloric sphincter PS. The inner rings 38a and 38b are pulled together to enclose the inner edge, and then the first ring 30 is placed and/or pulled to clamp the pylorus between the first ring 30 and the second ring 32. If desired, one (or both) of the first and second rings 30, 32 may be attached directly to the tissue of the pyloric sphincter, such as by one or more tissue penetrating fasteners 42. In one example, fastener 42 is a stapler, for example, having a U-shaped form, with each leg of the U piercing tissue and being held captive by a lateral stop 42a (e.g., defining a T-shape). Alternatively, the fastener 42 may be a gang nail inserted from one side of the tissue and have self-expanding lateral stops or wings extending from the central shaft to retain the fastener on the opposite side of the tissue, thereby preventing withdrawal from the first side.

The tube 10 may optionally be attached (e.g., permanently or via an assemblable connection) to one of the rings, e.g., one of the inner rings 38a, 38b, as shown.

Referring to fig. 11, other examples of the tube 10 are illustrated. The tube 10 is configured to extend from the proximal end 10a at the pylorus into the duodenum, and optionally at least partially into the jejunum. The tube 10 may be made of plastic, such as silicone or polyurethane. Proximal end 10a is configured to be directly attached to body tissue by means of a suture or stapler 42 that pierces the material of tube 10. To prevent tearing of the plastic material, the proximal end includes a layer of suture-permeable and/or stapler-permeable reinforcing fabric 46, optionally laminated to and/or incorporated into the plastic material. The fabric 46 may be a woven or nonwoven material. The fabric 46 may be a polymeric material such as PET. The natural openings or spaces in the fabric material 46 allow sutures or fasteners to pass therethrough without damaging the fibers or filaments of the fabric itself. Thus, the fabric may prevent the tear from propagating in the plastic of the tube 10.

The proximal end 10a of the tube 10 may be flared to facilitate placement and attachment of the proximal end 10 a.

Optionally, the tube 10 includes a duodenal anchor 12 (such as a stent) and/or a reinforcement 14 across the pylorus to avoid the risk of twisting of the tube 10 due to gastric movement.

In use, the tube 10 may be placed in the duodenum, and optionally in the jejunum. The surgical stapling instrument can be used to staple the proximal end to tissue, such as the tissue that forms the pyloric sphincter, in a manner similar to that shown in fig. 10.

Fig. 12 a-12 d illustrate other techniques for securing a tube 10, such as the tube of fig. 11. Referring to fig. 12a, the tube 10 is introduced through the patient's mouth and placed at least into the duodenum, with the proximal end 10a of the tube 10 being proximal to the pylorus. The tube 10 may be temporarily held in place by mechanical means (not shown).

Referring to fig. 12b, the tool 70 is guided through the mouth to the pyloric antrum. Tool 70 includes a hypotube needle for piercing the region of the tube with fabric 46 and piercing the stomach wall. A small bolster 72 with attached seam lines is inserted through the fabric 46 and the stomach wall via a hypotube needle and deployed outside the stomach wall, leaving a seam line passing together through the stomach wall and the fabric 46.

Referring to fig. 12c and 12d, the hypotube needle is withdrawn to the inside of the stomach and the second spacer 74 is dropped over the same suture via the hypotube and deployed on the inner surface of the stomach wall. The suture is tightened to tightly clamp the stomach wall and the fabric 46 at the proximal end of the tube between the two bolsters 72 and 74. The suture is tied and severed, leaving pads 72 and 74 to form individual fasteners. The same process is repeated at several different points around the circumference of the proximal end of the tube 10 to firmly anchor the tube 10 to the stomach wall. The spacer may provide a secure attachment of the tube 10 and avoid irritation due to friction during gastric contractions, as the proximal end of the tube is attached to move tightly with the stomach wall. When it is subsequently desired to remove the tube 10 from the stomach, a tool may be inserted into the stomach to sever the suture and release the pads 74 on the inner surface of the stomach wall, thereby releasing the tube 10.

Referring to fig. 13a and 13b, a tube 10 for insertion into the gastrointestinal tract (optionally the duodenum) has an outer surface defining at least one channel 46 extending at least partially in the axial direction of the tube. In one form, the channel 46 may be substantially axial, for example in the form of a fluted surface (fig. 13 b). Alternatively, the channel may be in the form of a threaded surface (fig. 13 a) that is helical. The channel 46 allows intestinal fluid (e.g., pancreatic fluid) to flow along the exterior of the tube 10 as in the output section of intestine and may avoid that intestinal fluid is trapped by contact between the tube 10 and the intestinal tissue.

Referring to fig. 14 and 15, a tube 10 for supplementing an anastomosis 50 (e.g., anastomosis of the stomach-jejunum) is illustrated. For example, the anastomosis may be between the fundus of the stomach and the jejunum or it may be between the incised stomach and jejunum (as shown in fig. 14). Tube 10 may optionally include an anchor 20 for anchoring at anastomosis 50. The anchor may include any of the features described above; alternatively, the anchor may include any of the features of fig. 8-10.

Tube 10 may be used to prevent or reduce backflow of pancreatic juice (as indicated by arrow 58) from pancreas 60 through anastomosis 50. For example, the catheter 10 is placed in the portion of the jejunum leading to the large intestine. The stomach contents (arrow 60) passing through the anastomosis are directed in the normal flow direction toward the large intestine. Pancreatic juice reaching (arrow 58) from upstream of the jejunum is directed outside of tube 10, thus away from anastomosis 59 and also toward the large intestine, thereby reducing the likelihood of such pancreatic juice flowing back through anastomosis 50.

The tube 10 may also be configured with directional flow characteristics to allow gastric content (e.g., chyme) to flow through the tube 10 in a first direction away from the stomach (arrow 62) and to impede flow through the tube 10 in a second, opposite direction. The unidirectional nature may also prevent intestinal fluid (e.g., pancreatic fluid) in jejunal circuit 54 from flowing back through anastomosis 50 to the stomach, thereby reducing patient's stomach discomfort.

The unidirectional nature of the tube may be implemented by at least one, optionally a plurality of valve flaps 56 (fig. 15) provided inside the tube 10. The valve flap may have a flexible and/or loose annular shape or comprise separate arcuate segments. The flap 56 is directed towards the outlet. Flow in a first direction (arrow 62) pushes the valve flap 56 against the wall of the tube 10 to allow flow. The flow in the opposite direction tends to push the valve flap 56 inwardly toward the center of the channel to narrow the channel in the tube 10 and thus impede the flow. Alternatively, the catheter 10 itself may be collapsible like a sock to perform the one-way valve function. The flow in the first direction opens and expands the tube 10. Flow in a second, opposite direction collapses the tube itself, preventing flow.

Referring to fig. 16 and 17, other illustrated techniques for treating diabetes or obesity include the application of at least one tissue penetrating fastener 80 to reduce the natural volume of the stomach by creating one or more folds 82 (or artificial folds) in the stomach wall. In the illustrated example, the fastener 80 is a stapler, optionally having a U-shaped profile with T-legs, as described above. The fastener may be placed, for example, endoscopically or laparoscopically.

One or more folds 82 may extend generally in the direction (i) from the top to the bottom of the stomach, and/or (ii) from the esophagus to the pylorus. Such folds 82 may form a generally sleeve-shaped cavity or channel in the stomach.

Referring to fig. 18, a gastric reduction fold 82 may also be used in conjunction with tube 10, and optionally with anastomosis 50 (e.g., stomach-jejunum anastomosis 50). The pylorus P may be closed or blocked by a closure device 84. The closure device 84 may, for example, include a ring similar to that described above with respect to fig. 8-10 for anchoring to the pyloric sphincter.

Fig. 19-33 illustrate other examples of securing the tube 10 to the pylorus P using a tissue penetrating fastener 100.

Referring to fig. 19 and 20, each fastener generally includes two end members in the form of a head 102 and a foot 104 coupled via a connecting element 106. The head 102 and foot 104 generally have atraumatic shapes, such as a round bar shape. In the example shown, the head 102 and foot 104 are tubular such that these pieces can be carried around a puncture needle 108 (fig. 21 and 22) for introduction and deployment. The head 102 and foot 104 may be rigid or semi-rigid elements optionally made of a shape memory alloy (e.g., nitinol).

The connecting element 106 may be rigid or flexible. In the example of fig. 19, the connecting element 106 is substantially linear. In the example of fig. 20, the connecting element 106 has the form of an elongated spring for generating a compressive load when the spring is elongated.

At least the head 102 and optional foot 104 may be placed in a generally undeployed configuration (fig. 21 and 22) in which the head (and optional foot) extends alongside the connecting element for streamlined introduction. In the deployed configuration (fig. 19 and 20), the head (and optionally the foot) is moved to protrude laterally on either side of the connecting member.

Referring to fig. 23 and 24, a tool 120 is illustrated for attaching a loop 122 of the duodenal tube 10 to a patient's pylorus P using the fastener 100.

The tool 120 includes a plurality (e.g., three in the illustrated form) of first elongate supports 124 attached to the ring 122 for introducing the ring into the pylorus and for retaining the ring during deployment of the fastener. For example, the first elongate support 124 may be attached to the inner core of the ring 122 by a suture loop 126. The suture loop 126 may be threaded within the elongate support and may be released from one end when it is desired to separate the elongate support 124 from the loop 122.

The tool 120 further includes a plurality (e.g., three in the illustrated form) of second elongate supports 128, each having a puncture needle 108 at a free end thereof. A safety suture 138 may be passed through the second elongate support and looped around the fastener 100 or around the fastener 100 to ensure that the fastener 100 does not prematurely disengage from the needle 108.

The tool 120 further includes a multi-lumen catheter shaft 132 having lumens for receiving the plurality of first and second elongate supports 214, 128. The first and second supports 124, 128 may be alternately distributed in the circumferential direction such that each first elongated support 124 is located between two adjacent second elongated supports 128, and vice versa. At least the second elongate support 128 is axially slidable between an axially extended position and an axially retracted position for penetrating tissue with the needle 108, as shown below. The first elongate support 124 may also be axially slidable if desired.

The tool 120 further includes a constraining sheath 134 slidable over the catheter shaft 132. The constraining sheath 132 may constrain the first and second elongate supports 124, 128 in a radially compressed configuration (fig. 23) for introduction through the stomach to the duodenum. Retraction of the constraining sheath 134 allows the first and second elongate supports 124, 128 to disperse or splay outwardly into a radially expanded configuration (fig. 24). The first elongate support 124 and/or the second elongate support 126 can be preformed to flare outwardly when the constraining action of the sheath 134 is removed. The constraining sheath may also be used to constrain the ring 122 in a radially compressed configuration for delivery. In a manner similar to that already described above, the ring can expand to its operative size when released from the sheath 134.

The multi-lumen shaft 132 has a hollow interior passage 136 defining a receiving space for the tube 10. Tool 120 may also include a clamp 136 for releasably grasping and controlling the distal end of tube 10.

Fig. 25-32 illustrate the process of introducing and attaching tube 10 through the stomach using tool 120. In fig. 25, the tool 120 containing the tube 10 and ring 122 in a collapsed configuration is advanced through the stomach S and through the pylorus P into the duodenum D.

Referring to fig. 25, the distal end of the tube 10 is pushed out of the sheath 134 by pushing the clip 136 over the guidewire G into the duodenum.

Referring to fig. 27, constraining sheath 134 is retracted relative to shaft 132 to release ring 122 attached to the proximal end of tube 10 and allow ring 122 to expand toward its functionally operative size.

Referring to fig. 28, pulling slightly on the first elongate support 124 may urge the ring 122 against the first side (duodenal side) pyloric sphincter tissue. Further retraction of the sheath 134 allows the second elongate support 128 to expand to reveal the needle 108 carrying the fastener 100.

Referring to fig. 29, the fastener-carrying needle 108 is caused to penetrate the pyloric sphincter tissue and into the ring 122 by distally advancing or sliding the second elongate support 128. In the illustrated example, the needle 108 also penetrates the ring 122 until the head 102 of the fastener reaches the opposite side. As the needle 108 advances, the first elongate support may remain attached to the ring 122 to provide counter support for the ring 122.

Referring to fig. 30, the second elongate support 128 is partially retracted, allowing the head 102 of the fastener 100 to be deployed laterally and anchored distally to the ring 122.

Referring to fig. 31, the second elongate support 128 is fully retracted, allowing the foot 104 of the fastener to also be deployed laterally and anchored to the pyloric sphincter from the opposite side of the ring 122. The safety suture for fixation may be released by pulling on one end of the suture to allow the needle 108 to separate from the fastener 100.

Finally in fig. 32, the first elongate support 124 is released from the ring 122, thereby permanently and securely attaching the ring 122 to the pyloric sphincter. The constraining sheath 134 may be advanced to provide atraumatic coverage at the exposed ends of the first and second elongate supports 124, 128.

Fig. 33 illustrates a second example in which the pyloric sphincter is clamped from both sides using a second ring 122a in addition to the ring 122. The second ring 122a may be carried by the second elongate support 128 and/or attached to the second elongate support 128, allowing the second ring to be guided into contact with the pyloric sphincter as the second elongate support 128 is advanced. Further advancement of the second elongate support 128 causes the needle 108 to fully penetrate the second ring 122a. For example, the second ring 122a may be attached using a suture loop similar to the ring 126 already described for the first ring 122.

It is to be understood that the foregoing description is only illustrative of the invention and is not intended to limit the scope of protection. Any novel features or concepts described herein and/or shown in the accompanying drawings are claimed, whether or not emphasized.

Claims (39)

1. An anchor (20) for anchoring a tube (10) relative to a pylorus of a patient, the anchor comprising a gastric balloon (22) coupled or coupleable to a proximal end of the tube, the gastric balloon (22) being expandable from a collapsed state for introduction into the stomach to an operative state within the stomach.

2. The anchor of claim 1 configured such that in an expanded state, the pressure within the ball (22) is no greater than atmospheric pressure.

3. The anchor of claim 1 or 2, configured such that in the expanded state, the pressure within the ball (22) is no greater than the ambient pressure within the stomach.

4. An anchor according to claim 1, 2 or 3, wherein the gastric balloon (22) is configured to partially collapse in response to gastric contractions.

5. The anchor of any one of the preceding claims wherein the gastric ball (22) is self-expandable from a collapsed condition to an operative condition.

6. The anchor of claim 5 wherein the gastric ball (22) includes a self-expanding structure (24).

7. The anchor of claim 6 wherein the self-expanding structure comprises a frame structure and/or a mesh structure.

8. The anchor of claim 6 or 7 wherein the gastric ball (22) has a communication aperture allowing chyme to enter the interior of the ball.

9. The anchor of any one of claims 1 to 8 wherein the gastric ball (22) comprises a fluid-tight chamber and an inlet (26), the inlet (26) for (i) allowing fluid to be drawn into the chamber when the gastric ball is expanded to its operational state, and/or (ii) allowing fluid to enter the chamber to inflate the gastric ball.

10. The anchor of claim 6, 7 or 8 wherein the gastric ball further comprises a fluid-tight chamber and an inlet for allowing fluid into the chamber, wherein the self-expanding structure and the fluid-tight chamber are at least partially nested with one another.

11. The anchor of claim 10 wherein the fluid-tight chamber is at least partially nested within the self-expanding structure.

12. The anchor of any one of the preceding claims wherein the ball includes a channel configured to allow chyme to pass through the ball.

13. An anchor according to any one of the preceding claims, wherein the ball has or comprises at least one shape selected from the group consisting of: bell-shaped and tulip-shaped.

14. The anchor of any one of the preceding claims, wherein the gastric ball (22) is (i) coupled to the tube by one or more tethers (18) and/or struts, and/or (ii) mounted directly to the tube.

15. An anchor (20), optionally according to any of the preceding claims, for anchoring a tube relative to a pylorus of a patient, the anchor comprising a first ring (30) for fitting against a gastric side of the pyloric sphincter and a second ring (32) for fitting against a duodenal side of the pyloric sphincter, the first ring (30) and the second ring (32) being coupled to each other to clamp the pyloric sphincter between the rings, the first ring (30) and the second ring (32) having inner and/or outer diameters different from each other, optionally such that the inner diameter of one ring is greater than the outer diameter of the other ring.

16. The anchor of claim 15 wherein the first loop (30) and/or second loop (32) is collapsible to a collapsed state for guiding to a pylorus.

17. The anchor of claim 15 or 16, further comprising a connecting element (34), the connecting element (34) being located between and coupled to the rings for selectively drawing the rings closer to each other to clamp the pyloric sphincter, the connecting element (34) optionally being a filament or suture.

18. The anchor of claim 15, 16 or 17, further comprising at least one inner ring (38) for surrounding an inner circumference of the pyloric sphincter, optionally wherein the at least one inner ring comprises a first inner ring (38 a) and a second inner ring (38 b).

19. The anchor of claim 15, 16, 17 or 18 wherein the first loop and/or the second loop comprises one or more of: metal, and/or optionally a shape memory alloy of nitinol, and/or plastic.

20. An anchor (20), optionally according to any of the preceding claims (20), for anchoring a tube with respect to the pylorus of a patient, comprising at least one elastic element (29) expandable from a collapsed condition for introduction into the stomach and into an operative condition, the elastic element being at least partially helical in the operative condition.

21. An anchor according to claim 20, wherein (i) the resilient member (29) defines a helical shape that gradually expands in a radial direction away from the proximal end of the tube; and/or (ii) the spiral shape comprises open spaces between adjacent turns or coils of the spiral.

22. A tube configured for insertion into the gastro-intestinal tract, the tube comprising the anchor of any one of the preceding claims.

23. The tube of claim 22, wherein a portion of the tube configured for fitting at the pylorus comprises a reinforcement for preventing the tube from twisting.

24. A tube (10), optionally according to claim 22 or 23, or optionally comprising an anchor according to any of claims 1 to 21, configured for insertion into the gastrointestinal tract, configured for allowing passage of gastric and/or intestinal contents in a first direction and for preventing passage of gastric and/or intestinal contents in an opposite second direction.

25. The tube according to claim 24, comprising at least one, optionally a plurality of valve elements (56), the valve elements (56) being configured to allow passage of gastric and/or intestinal contents in a first direction and to prevent passage of gastric and/or intestinal contents in a second direction.

26. The tube according to claim 25, wherein the valve element (56) comprises a flap that opens to allow passage of gastric and/or intestinal contents through the tube in a first direction and closes to prevent passage of gastric and/or intestinal contents in a second direction.

27. A tube (10), optionally a tube (10) according to any of claims 22 to 26 and/or optionally comprising an anchor according to any of claims 1 to 21; the tube is for introduction to the duodenum of a patient, the tube is made of flexible plastic and comprises a layer of suture-and/or stapler-permeable woven or non-woven fabric (46) near or at the proximal end, the fabric (46) allowing anchoring of the tube into body tissue near or at the pylorus by suturing or stapling through the fabric, the fabric preventing tear propagation in the plastic.

28. A tube (10), optionally a tube (10) according to any of claims 22 to 27 and/or optionally comprising an anchor according to any of claims 1 to 21; the tube is for introduction into the gastro-intestinal tract of a patient, the outer surface of the tube being provided with at least one open channel (46) extending at least partially axially and/or longitudinally relative to the tube to allow gastric secretions to travel outside the tube, optionally wherein the channel has a shape selected from the group consisting of: a helical shape around the outside of the tube, and/or a longitudinal groove.

29. An instrument comprising a tube (10) optionally according to any one of claims 22 to 28 and/or optionally comprising an anchor according to any one of claims 1 to 21; the tube (10) is for introduction into the gastrointestinal tract of a patient, and the apparatus comprises or further comprises at least one gastric balloon (22), the at least one gastric balloon (22) being configured to abut a stomach wall distal from the pylorus, optionally for inducing satiety in the patient.

30. The apparatus of claim 29, wherein the balloon is inflated with a gas to float in the stomach and/or wherein the balloon is magnetically repelled relative to the tube; and/or wherein the balloon is tethered to the tube and/or wherein a plurality of space-occupying balloons are provided to be put together.

31. A tissue penetrating fastener for attaching one or more loops to pyloric sphincter tissue, the fastener comprising end members in the form of a head and a foot, the end members being interconnected by a connecting element, wherein at least the head is configured such that it can be placed in (i) a generally undeployed configuration in which the head extends alongside the connecting element for streamlined introduction, and (ii) a deployed configuration in which the head is moved to project laterally on either side of the connecting member.

32. A tissue penetrating fastener according to claim 31, wherein the foot is configured such that it can be placed in (i) a generally undeployed configuration in which the foot extends alongside the connecting element for streamlined introduction, and (ii) a deployed configuration in which the foot is moved to project laterally on either side of the connecting member.

33. An apparatus for anchoring a device to a pylorus of a patient, the apparatus comprising:

at least a first ring for attachment to the pyloric sphincter, the ring having a self-supporting shape, and

a plurality of tissue penetrating fasteners insertable into and/or through the ring for attaching the ring to a face of a pyloric sphincter, optionally wherein each tissue penetrating fastener is a fastener according to claim 31 or 32.

34. The apparatus of claim 33, further comprising a second self-supporting ring for placement and securement on a face of the pyloric sphincter opposite the first ring, thereby clamping the pyloric sphincter, the fastener optionally configured to pass through both rings.

35. A tool for attaching a device, optionally an instrument according to claim 33 or 34, to body tissue at a pylorus of a patient, the tool comprising a plurality of first elongate supports for removable attachment to an annular portion of the device and a plurality of second elongate supports comprising penetrating elements for deploying tissue penetrating fasteners into the annular portion of the device.

36. The tool of claim 35, wherein each of the plurality of second elongate supports is axially movable relative to the plurality of first elongate supports between an extended position in which the plurality of second elongate supports extends substantially at least to or beyond the extent reached by the plurality of first elongate supports and a retracted position in which the plurality of second elongate supports is retracted relative to the extent reached by the plurality of first elongate supports.

37. The tool of claim 35 or 36, wherein each penetrating element of each second elongate support comprises a pointed needle and is configured for carrying the tissue penetrating fastener around the penetrating element for deploying the tissue penetrating fastener.

38. The tool of claim 35, 36 or 37, further comprising a multi-lumen catheter shaft having a plurality of lumens for the plurality of first elongate supports and the plurality of second elongate supports, the plurality of first elongate supports and the plurality of second elongate supports being alternately arranged along a circumferential direction of the catheter shaft.

39. A method of attaching a device comprising a ring to a pylorus of a patient, the method comprising:

(a) Advancing a tool to the pylorus, the tool comprising a plurality of first elongate supports and a plurality of second elongate supports, the ring attached to the plurality of first supports, and the plurality of second elongate supports comprising a penetrating element and carrying fasteners for securing to tissue;

(b) Positioning the ring adjacent a first side of the pyloric sphincter and positioning the second elongate support on an opposite, second side of the pyloric sphincter;

(c) Advancing each second elongate support individually or collectively such that the penetrating element penetrates the pyloric sphincter and into the loop on the first side;

(d) Partially retracting each second elongate support, individually or collectively, such that the first end piece of the fastener anchors the ring to the first side of the pyloric sphincter; and

(e) Each second elongate support is withdrawn, either individually or collectively, such that the second end of the fastener is anchored to the second side of the pyloric sphincter.