Device and method for creating a restriction in an organ of the digestive tract - Patent application

Abstract

1. An instrument for use in forming a restriction in an organ of the gastrointestinal tract, optionally in the stomach, configured for insertion into the organ and comprising at least two, optionally at least three, optionally all of: an engagement device (20) for engaging and manipulating organ wall tissue, optionally to displace the tissue by pulling and / or folding and / or rolling the tissue; a scarring device (30) for scarring the tissue, optionally the displaced tissue; a device for delivering spacers (40) and / or separators to the tissue of the organ wall, optionally to the displaced and / or engaged tissue, and / or to tissue within the range of operation of the scarring device; and a fixation device for inserting one or more tissue fixators, optionally into the scarred area of ​​the tissue.

Description

[Technical field]

[0001] In one non-limiting embodiment, the present invention relates to the formation of a restriction in an organ of the digestive tract. The organ may be the stomach. [Background technology]

[0002] Obesity is a major problem in today's society, with 13% of the world's population being obese and 39% being overweight. Bariatric surgery is one of the most promising means of treating these problematic diseases when other therapeutic processes have failed.

[0003] Despite considerable advances in the field of bariatric surgery, many complex issues still need to be addressed in order to provide patients with satisfactory and lasting results.

[0004] For example, gastric sleeve surgery is well known to help patients lose weight, however, said weight loss is in most cases only temporary due to the expandable nature of stomach tissue. Therefore, this only provides a temporary solution and in the long term, the patient may regain weight. Furthermore, gastric sleeve surgery is a highly invasive procedure in which a large portion of the stomach is surgically removed, resulting in a long recovery time. Minimally invasive endoscopic procedures have been proposed, but these are generally less durable and effective than surgical procedures.

[0005] US Patent Application Publication No. 2017 020 592 proposes a surgical procedure to be performed after a failed bariatric weight loss surgery and consisting of removing tissue at the surgical site of the previous surgery.

[0006] US Patent No. 2017 367 723 refers to a method for removing ghrelin-producing cells to reduce production of the hunger hormone ghrelin. More specifically, the method relates to cell death of type AX cells in the stomach of a patient. Summary of the Invention [Problem to be solved by the invention]

[0007] The present invention aims to improve patient outcomes and versatility in the treatments and devices available for sustained weight loss in obese patients. [Means for solving the problem]

[0008] A first aspect of the invention provides an apparatus for use in forming a restriction in an organ of the gastrointestinal tract. The organ may optionally be the stomach. The apparatus may be insertable into the organ, optionally through a natural body orifice.

[0009] The instrument may comprise a device for displacing a region of organ wall tissue from within the organ to alter the shape of the organ wall.

[0010] The instrument may further comprise a device for scarring tissue in the target area at or adjacent to the displaced tissue area to alter tissue wall properties in the target area to effect restriction and / or support restriction.

[0011] The term scarring is understood as the deliberate injury of tissue such that a scar or scars are formed or appear on the tissue after healing of the injury.

[0012] The engagement device may be configured for insertion into the patient, optionally through a natural orifice of the patient. The engagement device may carry a cicatrization device for scarring tissue in the target area.

[0013] Additionally, the engagement device may include one or more engagement ports to allow for operation of one or more engagement devices and / or scarring devices.

[0014] In some embodiments, the engagement device may be configured to engage a portion of the organ wall from within the organ to draw and / or restrict the portion of the organ wall inward and / or outward. Optionally, the engagement device may be configured to pull at least a portion of the organ wall, for example, inward and / or outward (e.g., toward the engagement device), to change the position of the portion of the wall.

[0015] The engagement device may allow the organ wall to space away from the surrounding tissue. It may further allow the organ to be manipulated into a desired configuration or shape. This advantage may further help to avoid damage to non-target tissue during the procedure. In some embodiments, a spacer may be optionally provided to space and / or separate the target tissue from the non-target tissue to help avoid damage to the non-target tissue. More details on such spacers are provided below.

[0016] In some embodiments, the engagement device can provide an engagement element or multiple engagement elements for displacing a portion of the organ wall. Optionally, the engagement element can operate through one or more engagement ports of the engagement device.

[0017] The engagement elements can include, for example, one or more suction elements for drawing in a portion of the organ wall with negative pressure, one or more helical threads for screwing into the organ wall, and a selection of fasteners for fastening to the organ wall.

[0018] In some embodiments, the engagement device may be further configured to at least partially rotate to form the restriction of the organ.

[0019] Optionally, rotation of the engagement device may induce rotation of the engaging portion of the organ wall. The rotation may effect at least a partially rolled fold of the organ wall. Further optionally, the rotation may induce rolling of the organ wall around the engagement device. This may allow for limiting the size of the organ and / or spacing the organ or a portion of the organ from surrounding tissue.

[0020] The engagement device may rotate at least 180°, optionally at least 270°, optionally at least 360°, optionally at least 720°, for example, to wrap or coil the grasped portion of tissue. The engagement device can perform up to 720° or more rotations, for example, to reduce the size of an organ.

[0021] The device may be configured to displace at least a portion of an organ wall according to, but not limited to, any combination of the above embodiments.

[0022] The present invention may further provide an apparatus for scarring tissue in a target area to change tissue wall properties in the target area. The target area may be in the displaced tissue area or adjacent to the displaced tissue area. This may aid in the effect and / or aid in organ restriction.

[0023] The scarring device may be configured to damage the organ wall such that the formation of scar tissue may be promoted.

[0024] Scar tissue is generally defined as tissue that forms when a wound is repaired. Scar tissue is also defined as having different properties than normal tissue, for example, scar tissue is stiffer and more rigid than normal tissue, and scar tissue can also shrink over time.

[0025] Additionally or alternatively, the scarring device may scar multiple portions of an organ wall adjacent to one another, which may induce the formation of one or more adhesions between the multiple portions of the organ wall.

[0026] Adhesion is understood to be a band of scar-like tissue that forms between two surfaces in the body and attaches them to one another.

[0027] Thus, promoting the formation of scar tissue and / or organ wall adhesions may not only help to reduce organ wall motility, but also help to fix the organ in a restricted configuration.

[0028] In some embodiments, the scarring device may be configured to thermally damage the organ wall, for example, the scarring device may use caustic and / or cauterizing agents.

[0029] Optionally, the scarring device may induce thermal damage to the organ wall by laser and / or radio frequency treatment.

[0030] In some embodiments, the scarring device may be operated subsequent to and / or simultaneously with operation of the engagement device. Additionally or alternatively, the scarring device and the engagement device may be operated in an alternating manner.

[0031] In some embodiments, it may be desirable to scar one or more sections of the displaced tissue portion. Additionally or alternatively, it may be desirable to scar a different portion of the organ wall to a portion that may have been displaced.

[0032] Scarring one or more sections of the organ wall may reduce the motility of the organ. In addition, it may also promote contraction of the organ or fusion of multiple portions of the organ wall. By damaging the organ wall after the engagement device is manipulated, collateral damage to surrounding non-target tissue, for example, may be avoided.

[0033] In a second aspect, optionally in combination with the first aspect, the present invention provides a fixation device for placing one or more tissue engaging and / or tissue penetrating fasteners, optionally wherein the fasteners are placed in areas of tissue damaged by the tissue scarring device.

[0034] The fastener may be configured to secure the organ at a reduced size. Optionally, the fastener can secure the rolled folds of the organ. Placing the fastener in the damaged area of ​​the organ wall can avoid placing undue tension on the fastener, and thus may help avoid dislodging or breaking the fastener.

[0035] The fasteners may be any suitable means for securing the organ at a reduced size, for example the fasteners may be sutures, pledgets, staples.

[0036] Reducing scar tissue motility, optionally combined with placement of fixators, can avoid organ swelling following treatment and therefore allow for more sustained treatment to treat obesity.

[0037] According to some embodiments and any aspect of the invention, the engagement device may be further configured to disengage the engaged portion of the organ wall to facilitate extraction of the instrument from within the patient. For example, the engagement device may disengage the gripped portion of tissue by applying positive pressure. Optionally, the use of positive pressure may move the organ wall away from the device, thus facilitating extraction. Also, for example, the engagement device may disengage the portion of the organ wall by unscrewing a helical thread.

[0038] Additionally or alternatively, the engagement device may be at least partially collapsible to disengage from the organ wall, which can facilitate removal of the instrument from within the patient.

[0039] The engagement device can have a first, operative configuration for repositioning and / or damaging an organ wall and a second, collapsed configuration for insertion of an instrument and / or removal from within the patient.

[0040] The devices provided by the present invention may be configured to promote scarring of at least one section of an organ wall to reduce the size and / or motility of the organ.

[0041] In a third aspect, the present invention provides a method of forming a restriction in an organ of the gastrointestinal tract. The organ may optionally be the stomach. The method may optionally use the device described above.

[0042] The method may include inserting an engagement device into the patient's body, optionally through a natural body orifice.

[0043] The method can include a step consisting of actuating the engagement device to change the shape of the organ, for example, by displacing organ wall tissue. In some embodiments, actuating the engagement device can change the shape of the organ by pulling and / or pushing a portion of the organ wall. Optionally, the engagement device may be actuated to retract a portion of the organ wall inward.

[0044] Additionally or alternatively, the method may provide for actuating an engagement device to manipulate the organ wall tissue into a convoluted fold.

[0045] Additionally or alternatively, the method may provide for deploying a spacer in the region of the displaced organ wall tissue to space and / or separate the displaced organ wall tissue from surrounding tissue.

[0046] Additionally or alternatively, the method may provide for manipulating the scarring device to modify at least a region of the organ wall tissue, and optionally modify a target region adjacent the portion of the organ wall tissue engaged by the engagement device.

[0047] Optionally, actuating the engagement device and actuating the scarring device may be performed simultaneously with one another, or one after the other, or alternating.

[0048] Additionally or alternatively, the method may provide for actuating a fixation device to place one or more fixation elements at the damaged target area of ​​organ wall tissue.

[0049] A fourth aspect of the invention, optionally in combination with any of the preceding aspects, provides at least two, and optionally all three, of the following:

[0050] - an engagement device for engaging and manipulating organ wall tissue to displace the tissue (optionally by pulling and / or folding and / or rolling the tissue); - a scarring device for scarring tissue (optionally displaced tissue), - A fixation device for inserting one or more tissue fixators (optionally into the scarred area of ​​tissue).

[0051] The fourth embodiment specifically contemplates at least an engagement device and a scarring device in one form, and at least a scarring device and a fixation device in another form.

[0052] A fifth aspect of the invention provides a method comprising at least two, and optionally all three, of the following, optionally in combination with any of the preceding aspects:

[0053] - engaging and manipulating the organ wall tissue to displace the tissue (optionally by pulling and / or folding and / or rolling the tissue); - a scarring step of scarring the tissue (optionally the displaced tissue), - A fixation step of inserting one or more tissue fixators (optionally into the scarred area of ​​the tissue).

[0054] The fifth embodiment specifically contemplates at least the engaging and scarring steps in one embodiment, and at least the scarring and fixation steps in another embodiment.

[0055] In a sixth aspect of the invention, optionally in combination with any of the preceding aspects, the instrument may comprise or further comprise a device for delivering a spacer to the engaging and / or displacing portion of the organ wall. Optionally, the device for delivering the spacer may be integrated within the engaging device.

[0056] The spacer may be delivered such that it at least partially surrounds the engaged portion of the organ wall. For example, the spacer may be configured to be at least temporarily disposed around the engaged portion of the organ wall such that two sides of the engaged portion of the wall are at least partially approximated and / or maintained in proximity to one another.

[0057] The spacer may be any suitable means for creating separation between the target and non-target tissues such that application of the scarring device to the target tissue does not affect the non-target tissues. For example, the spacer may be a thermal isolator that prevents the transfer of thermal energy to the non-target tissues.

[0058] In some embodiments, the thermal separator may be delivered to the engaged portion of the organ wall through a port in the engagement device, or it may be delivered to the engaged portion of the organ wall within the engagement device, for example where a portion of the organ wall is pulled within the engagement device by the engagement element.

[0059] For example, a thermal separator may be placed prior to use of a scarring device, optionally a scarring device configured to thermally damage an organ wall.

[0060] The thermal separator can prevent damage to non-target tissue due to the use of caustic and / or cauterizing agents.

[0061] Additionally or alternatively, the thermal isolator can prevent the transmission of laser and / or radio frequency treatment to non-target tissue.

[0062] In some embodiments, the thermal isolator may be a cooling balloon configured to avoid dissipation of thermal energy to non-target tissue. The cooling balloon may be at least partially toroidal to surround the engaging and / or displacing portions of the organ wall. The balloon may be configured to contain and / or circulate a fluid, preferably a cooling fluid, to prevent transfer of thermal energy to non-target tissue.

[0063] Additionally or alternatively, the separator may be expandable to increase the physical separation distance when expanded. The expansion fluid may be, for example, a cooling fluid as described above.

[0064] Thermal isolators offer the advantage of providing insulating isolation between target and non-target tissue, and therefore may reduce the risk of unintended damage to surrounding tissue.

[0065] Although certain features and aspects have been outlined above, this is not intended to limit the scope of protection. Protection is claimed for any novel features and / or ideas disclosed in this specification and / or shown in the drawings, whether or not emphasis is placed on them.

[0066] Non-limiting embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0067] [Figure 1] 1 is a schematic perspective view of one embodiment of an instrument for damaging the digestive tract; [Figure 2a] 1A-1C are schematic diagrams illustrating the use of a first embodiment of an instrument for damaging the digestive tract. [Figure 2b] 1A-1C are schematic diagrams illustrating the use of a first embodiment of an instrument for damaging the digestive tract. [Figure 2c] 1A-1C are schematic diagrams illustrating the use of a first embodiment of an instrument for damaging the digestive tract. [Figure 2d]1A-1C are schematic diagrams illustrating the use of a first embodiment of an instrument for damaging the digestive tract. [Diagram 3] FIG. 1 is a schematic flow diagram of a first general method of use. [Figure 4] FIG. 11 is a schematic flow diagram of a second general method of use. [Diagram 5] FIG. 11 is a schematic flow diagram of a third general method of use. [Figure 6a] 11 is a schematic diagram showing the use of a second embodiment of an instrument for damaging the digestive tract. FIG. [Figure 6b] 11 is a schematic diagram showing the use of a second embodiment of an instrument for damaging the digestive tract. FIG. [Figure 6c] 11 is a schematic diagram showing the use of a second embodiment of an instrument for damaging the digestive tract. FIG. [Figure 6d] 11 is a schematic diagram showing the use of a second embodiment of an instrument for damaging the digestive tract. FIG. [Figure 6e] 11 is a schematic diagram showing the use of a second embodiment of an instrument for damaging the digestive tract. FIG. [Figure 6f] 11 is a schematic diagram showing the use of a second embodiment of an instrument for damaging the digestive tract. FIG. [Figure 6g] 11 is a schematic diagram showing the use of a second embodiment of an instrument for damaging the digestive tract. FIG. [Figure 6h] 11 is a schematic diagram showing the use of a second embodiment of an instrument for damaging the digestive tract. FIG. [Figure 7a] 11 is a schematic diagram showing the use of a third embodiment of an instrument for damaging the digestive tract. FIG. [Figure 7b] 11 is a schematic diagram showing the use of a third embodiment of an instrument for damaging the digestive tract. FIG. [Figure 7c] 11 is a schematic diagram showing the use of a third embodiment of an instrument for damaging the digestive tract. FIG. [Figure 7d] 11 is a schematic diagram showing the use of a third embodiment of an instrument for damaging the digestive tract. FIG. [Figure 7e] 11 is a schematic diagram showing the use of a third embodiment of an instrument for damaging the digestive tract. FIG. [Figure 7f]11 is a schematic diagram showing the use of a third embodiment of an instrument for damaging the digestive tract. FIG. [Figure 8] FIG. 11 is a schematic flow diagram of a fourth general method of use. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0068] Detailed description of the drawings: With reference to FIG. 1, the instrument 10 provides an instrument body 11 configured to be inserted into a patient and including an working area 20 (e.g., working end) provided with a plurality of engagement devices 21 and a scarring device 30. The engagement devices 21 are operable to cause engagement between the working end 20 and a portion of an organ wall. For example, the engagement devices 21 may be or include a suction port for applying negative pressure to draw tissue against the body 11 or other positive engagement device. The one or more engagement devices 21 may be provided entirely within the working end 20 or a portion of the one or more engagement devices 21 may be provided elsewhere. For example, a negative pressure generator may be provided on or coupled to the instrument outside the body.

[0069] The scarring device 30 is configured to damage and / or scar at least a section of an organ wall. For example, the scarring device may comprise a device for applying to tissue or for generating energy, e.g., heat, in tissue to thermally damage the tissue. The scarring device may comprise a laser and / or RF electrode and / or argon plasma. The laser and / or RF energy and / or argon plasma may be generated within a portion of the device within the body or may be delivered to the device working end 20 from outside the body. Although the scarring device 30 is shown as part of the same device as the engagement device 21, in other embodiments the scarring device 30 may be a separate or separately introduceable device.

[0070] 2a-2d, in one example method of use, working end 20 of device 10 is inserted into an organ 60, for example, of the gastrointestinal tract. Organ 60 may be the stomach. Device 10 may be inserted through a natural body orifice, for example the mouth, to access organ 60.

[0071] The instrument 10 is manipulated to engage the working end 20 with a portion of the organ wall tissue by one or more engagement devices 21 (see FIG. 2a). In a first rotation step, the working end 20 is rotated, for example, 360°, thereby rolling the engaged organ wall tissue (see FIG. 2b). In a further step, the working end 20 is rotated a further 720°, generating a rolled-up fold of the organ wall (see FIG. 2c). In the illustrated example, the tissue is rolled outward to form a fold or bulge on the exterior of the organ, although in other embodiments the tissue can be rolled inward to form a fold or bulge on the interior of the organ.

[0072] At any one or more stages during the rotating / rolling, the scarring device 30 may be operated to generate a scar in the tissue wall. For example, the scarring device 30 may be operated after a first rolling step and / or after a second rolling step. Alternatively, each rolling step may be performed as a sequence of multiple sub-steps, with the scarring device 30 being operated after each sub-step.

[0073] In Fig. 2d, the engagement device is disengaged and the working end 20 is removed from the wrapped and folded tissue. In one form, positive pressure can be applied through the port previously used as the suction port to ensure the working end 20 is released from the tissue wrapped around the working end. In another form, the working end 20 may be at least partially radially collapsible to provide additional space for the working end 20 to be released from the tissue wrapped around the working end.

[0074] The above methods provide many advantages for creating size restrictions in the organ 60. Scarring the tissue can cause the tissue to shrink and reduce the organ volume. Scarring can also reduce tissue motility. In the case of the gastric organ 60, scarring can also reduce the production of gastric juices by the damaged tissue, thus desirably contributing to reduced gastric function.

[0075] The one or more engagement devices 21 allow tissue to be rolled to reduce organ volume in addition to or in lieu of contraction through scarring. Additionally or alternatively, the one or more engagement devices allow organ wall tissue to be pulled away from other adjacent body organs, thereby significantly reducing the risk of accidental damage to other organs due to manipulation of the scarring device 30.

[0076] Although not explicitly shown, the instrument may further comprise a fixation device for applying one or more tissue penetrating fasteners to the rolled tissue. The fixation device may form part of the working end 20 of the instrument 11 or may be a separate device that can be introduced into the tissue after removal of the instrument working end 20. The tissue penetrating fasteners can secure the scar tissue in its rolled configuration. Examples of tissue penetrating fasteners include one or more sutures, or one or more pledgets, or one or more insertable anchors.

[0077] Scar tissue, with its reduced mobility and reduced regenerative capacity, can provide a stable environment for secure attachment of fasteners, and such tissue may be significantly less prone to release or expel fasteners embedded within the tissue, as compared to undamaged tissue.

[0078] By way of example, Figures 3-5 show the general methodology described herein. 3 shows a first exemplary method including a manipulating step 70 of engaging and manipulating organ wall tissue from within the organ to displace the tissue, for example, by pulling and / or rolling and / or folding the tissue. A scarring step 72 includes scarring the tissue using scarring device 30, for example, scarring the area of ​​displaced tissue or an area adjacent to it. This method can be repeated several times to gradually displace and scar the organ wall tissue.

[0079] 4 illustrates a second exemplary method for intentionally damaging organ wall tissue that includes a scarring step 72. A fastening step 74 includes applying one or more tissue-penetrating fasteners to the scar tissue.

[0080] FIG. 5 shows a third exemplary method which includes a manipulation step 70 as described above, a scarring step 72 as described above, and a fixation step 74 as described above, and which combines all of the results and advantages of the first and second methods.

[0081] 6a-6h, in one example method of use, working end 20 of device 10 is inserted into an organ 60, for example, of the gastrointestinal tract. Optionally, device 10 is inserted through a natural body orifice, for example the mouth. Organ 60 may be the stomach.

[0082] In Figures 6b-6d, the instrument 10 is manipulated to engage the working end 20 with a portion of the organ wall tissue by one or more engagement devices 21. The instrument 10 is manipulated to tension the engaged tissue and form a bulge inside the organ. The delivery device is manipulated to deliver a spacer and / or separator 40 (hereafter referred to as a spacer / separator) to the engaged portion of the organ wall. The spacer / separator 40 is delivered to at least partially surround the engaged portion of the tissue and bring or maintain the two sides of the engaged tissue closer together.

[0083] The delivery device may form part of the working end 20 of the instrument 11 or may be a separate device that can be introduced into tissue.

[0084] As seen in Fig. 6e, the presence of the spacer / separator 40 maintains the engaged portion of the tissue in at least a partially spherical configuration. In the illustrated embodiment, the spacer / separator can be a thermal separator to provide a thermal barrier to protect the tissue behind the thermal separator from damage during the scarring procedure. The thermal separator may be provided, for example, by an insulating material, and / or a heat sink material, and / or a cooling device (e.g., cooled by circulation of a fluid coolant, also shown in the next embodiment).

[0085] In the illustrated embodiment, the spacer / separator 40 can remain in place on the tissue after the procedure, for example to function as a tissue fixation device, or (as will be shown in more detail in the next embodiment, the spacer / separator 40 can be removed after the procedure).

[0086] With reference to Figures 6f-6h, the scarring device 30 is manipulated to generate a scar in a tissue wall. The scarring device 30 is configured to conform to the configuration of the target tissue. For example, as seen in Figure 6f, the scarring device 30 adopts a spherical shape of the target tissue secured by the separator 40. The separator 40 limits damage from the scarring device 30 to the target tissue.

[0087] As seen in Figure 6h, the tissue damaged by the scarring device shrinks as it heals, resulting in organ restriction.

[0088] 7a-7f show a further example of a method of use similar to that of FIGS. 6a-6h, but using a spacer and / or separator (spacer / separator) 40. In this example, the spacer / separator 40 is temporarily placed and removed after the procedure. With reference to FIG. 7a, the spacer / separator 40 comprises a conduit 42 defining a loop. In one form, the conduit allows for circulating coolant fluid to actively cool adjacent tissue by absorbing and removing heat via circulating coolant. In another form, the conduit 42 allows for the expansion of the spacer to expand the conduit into a donut shape. In another form, the conduit can be actively cooled and expanded, for example, by using pressurized coolant fluid.

[0089] 7b, similar to the previous embodiment, the working end 20 of the instrument 10 is inserted into an organ 60, for example, of the gastrointestinal tract. Optionally, the instrument 10 is inserted through a natural body orifice, for example the mouth. The organ 60 may be the stomach. The instrument 10 is manipulated to engage the working end 20 with a portion of the organ wall tissue by one or more engagement devices 21.

[0090] With reference to Fig. 7c, the instrument 10 is manipulated to tension the engaged tissue and form a bulge inside the organ. With reference to Fig. 7d, the delivery device is manipulated to deliver a spacer / separator 40 to the engaged portion of the organ wall. The spacer / separator 40 is delivered to at least partially surround the engaged portion of the tissue and bring or maintain the sides of the engaged tissue closer together. The delivery device may form part of the working end 20 of the instrument 11 or may be a separate device that can be introduced into the tissue. The spacer / separator 40 may be telescopic relative to the delivery device to fit around the displaced tissue and contract the tissue to form a sphere.

[0091] As seen in Fig. 7d, the presence of the spacer / separator 40 maintains the engaged portion of the tissue in an at least partially spherical configuration. In the illustrated embodiment, the spacer / separator may be a thermal separator to provide a thermal barrier to protect the tissue behind the thermal separator from damage during the scarring procedure. As discussed above, the loop shape allows for circulation of coolant fluid and / or expansion into a donut shape, increasing the physical spacing of the sphere from the tissue behind the spacer / separator 40, as shown in Fig. 7e.

[0092] Referring to FIG. 7f, the scarring device 30 is manipulated to generate a scar in the tissue wall. The scarring device 30 is configured to conform to the configuration of the target tissue. For example, as seen in FIG. 7f, the scarring device 30 adopts a spherical shape of the target tissue secured by the separator 40. The separator 40 limits damage from the scarring device 30 to the target tissue. The spacer / separator 40 may expand the size of the loop, for example, by stretching the loop relative to the delivery device, thereby allowing for unhindered removal from the tissue, and may be removed following the procedure.

[0093] FIG. 8 illustrates a fourth exemplary method including the manipulating step 70 described above, a delivering step 76 for delivering a spacer / separator to engage and / or displace tissue, and the scarring step 72 described above.

[0094] It will be understood that the foregoing is merely illustrative of examples of the invention and that many modifications and equivalents may be made within the scope and / or principles of the invention.

Claims

1. 1. An apparatus for use in forming a restriction in an organ of the gastrointestinal tract, optionally in the stomach, said apparatus configured to be insertable within said organ, said apparatus comprising: a device for displacing a region of organ wall tissue from within the organ to alter the shape of the organ wall; an apparatus for scarring tissue in the target area at or adjacent to the displaced tissue region to change tissue wall properties in the target area; An apparatus comprising:

2. The apparatus of claim 1 , wherein the device for scarring tissue is configured to scar tissue to provide and / or support the restriction.

3. The instrument of claim 1 or 2, wherein the engagement device is configured to tension at least a portion of the organ wall.

4. The apparatus of any of claims 1 to 3, further comprising a device for delivering a spacer and / or separator to the engaging and / or displacing portion of the organ wall, said spacer configured to protect adjacent tissue from said scarring device.

5. The apparatus of claim 4 , wherein the spacer is a thermal spacer.

6. a device adapted for use in forming a restriction in an organ of the gastrointestinal tract, optionally the stomach, and adapted to be insertable within said organ; 6. A device according to any of claims 1 to 5, optionally comprising a fixation device for placing one or more tissue engaging and / or tissue penetrating fasteners at the area of ​​scar tissue.

7. a device adapted for use in forming a restriction in an organ of the gastrointestinal tract, optionally the stomach, and adapted to be insertable within said organ; - an engagement device for engaging and manipulating organ wall tissue, optionally to displace said tissue by pulling and / or folding and / or rolling said tissue; - a scarring device for scarring the tissue, optionally the displaced tissue, - a device for delivering spacers and / or separators to tissue of said organ wall, optionally displacing and / or engaging tissue and / or to tissue within the working range of said cicatrization device; - a fixation device for inserting one or more tissue fixators, optionally into the scarred area of ​​tissue; 7. Apparatus, optionally according to any of claims 1 to 6, comprising at least two, optionally at least three, optionally all of:

8. A method for or for use in creating a restriction in an organ of the digestive tract, optionally in the stomach, optionally using a device according to any one of claims 1 to 7, - operating the engagement device to engage and manipulate organ wall tissue, optionally to displace said tissue by pulling and / or folding and / or rolling said tissue; - manipulating the scarring device to scar tissue, optionally the displaced tissue; - manipulating the device to deliver spacers and / or separators to tissue of said organ wall, optionally displacing and / or engaging tissue and / or to tissue within the working range of said scarring device; - manipulating the fixation device to optionally insert one or more tissue fasteners into the scarred area of ​​tissue; at least two, optionally at least three, optionally all of in any order.

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