Apparatus and method for creating folds in internal organs - Patents.com

Abstract

An apparatus (10) for forming a plication (64) in a wall of an internal tissue of a patient. The apparatus (10) comprises an elongate instrument (11) for insertion into the patient proximate the tissue wall, optionally through a natural body orifice. The apparatus (10) comprises one or more of: (a) a retraction device (20) configured to engage tissue of the wall and tension the tissue of the wall to create a protrusion in the wall tissue, (b) a ligation device (30) configured to at least partially circumscribe the protrusion in the tissue of the wall to form a plication (64) in the tissue wall, and (c) a fixation device (40) for fixing the plication (64) in the tissue wall.

Description

[Technical field]

[0001] The present invention relates to the field of medical interventions involving the formation of folds in the walls of internal tissues. Some non-limiting aspects relate to interventions on the digestive system, e.g. the gastrointestinal tract, and optionally internal organs such as the stomach. Other non-limiting aspects relate to interventions on tissues including the parietal plates of muscle tissue. Summary of the Invention [Problem to be solved by the invention]

[0002] Creating plications in the stomach wall can be one technique for treating certain diseases related to the digestive system, but performing such procedures, especially from within the stomach itself, remains technically challenging. [Means for solving the problem]

[0003] Broadly speaking, a first aspect of the invention provides an apparatus for forming a plication in an internal tissue wall of a patient. The apparatus includes an elongate instrument for insertion into the patient proximate the tissue wall, optionally through a natural body orifice. The apparatus includes: (a) a retraction device configured to engage the wall tissue and pull the wall tissue to create a wall tissue protrusion; and / or (b) a ligation device configured to at least partially circumscribe a protrusion in the tissue of the wall to define and / or form a plication in the tissue wall; and / or (c) A fixation device for fixing the plication within the tissue wall. The present invention includes one or more of the following:

[0004] Certain embodiments of the invention provide combinations of (a) and (b), and / or combinations of (b) and (c), and / or combinations of (a) and (c), and / or combinations of (a), (b) and (c).

[0005] The wall may be a wall of an internal organ of a patient, and references to the wall may be to an organ wall. Additionally or alternatively, the wall may be a tissue wall of the digestive system, e.g., the gastrointestinal tract. Additionally or alternatively, the wall may be a wall of a body cavity. Additionally or alternatively, the wall may be a wall comprising muscle tissue. An example of all of the above is the wall of the stomach, and references to the wall may be to the stomach wall.

[0006] When used, the retraction device may comprise a suction or suction device for pulling the wall tissue by application of negative pressure, or may comprise a mechanical engagement device, such as gripper jaws for gripping the wall tissue, or a helical penetrating device that can be removably screwed into the wall tissue.

[0007] The retraction device may be extendable and / or retractable (eg, relative to the body of the instrument and / or relative to the ligation device) to engage wall tissue and perform a pulling action to create a wall tissue protrusion.

[0008] In addition to or in lieu of any of the above, the ligation device, when used, may comprise a ligation element, e.g., a ligature. The ligation element may have a retractable loop. The loop may be a closed loop, or the ligation element may comprise a loop region of an elongate element. The ligation device and / or element may include a lasso or snare. The ligation device optionally does not penetrate tissue.

[0009] The ligating device may act to at least partially immobilize the wall tissue protrusion and / or to laterally retract the wall tissue protrusion.

[0010] In some embodiments, the ligation element circumscribes the traction device in a circumferential direction, at least in one operating state of the ligation device and / or the traction device. Additionally or alternatively, the traction device may extend through a loop of the ligation device, at least in one operating state of the ligation device and / or the traction device.

[0011] In addition to or instead of any of the above, the fixation device, if used, may comprise a tissue-penetrating fixation element and / or an insertion device for inserting the fixation element, the fixation element being preferably configured to extend through the wall tissue at the fold. The insertion device may include a tubular needle having a sharp end for penetrating the wall tissue to create a passage for the fixation element. The fixation element may be at least partially contained within the cavity of the tubular needle, for example in a non-deployed configuration. The fixation element may be deployable (e.g., self-deployable and / or self-expandable) by expelling the fixation element from the needle and / or by retracting the needle to expose the fixation element. The insertion device may optionally incorporate multiple fixation elements for sequential deployment to allow multiple fixation elements to be deployed, for example at multiple locations, without the need to remove the device from the body each time.

[0012] In some embodiments, the insertion device and the ligation device are carried on the same carrier. The ligation device and the insertion device may be placed on the carrier adjacent to each other to interact with the same or adjacent areas of the wall tissue. The carrier may be a moving part of the instrument. Furthermore, the carrier may be a tube different from the retraction device. The tube may be expandable and / or contractible. Additionally or alternatively, the tube may be shaped at an angle to the retraction device, for example at an angle that presents the ligation device and / or the insertion device at an angle approximately perpendicular to the retraction device and / or approximately perpendicular to the retraction direction of the retraction device.

[0013] Additionally or alternatively to any of the above, the instrument may further comprise an elongate body having a working end for contacting a tissue wall and a manipulation end along which one or more of the retraction device, ligation device, and / or insertion device may be operated (and / or manipulated and / or actuated). In some embodiments, the body includes a first channel for housing the retraction device and / or through which the retraction device may be manipulated. The body further includes a second channel for housing a carrier tube for the ligation device and / or insertion device.

[0014] The instrument may be insertable, for example, inside a body organ, and the protrusion of the organ wall tissue may be an inward protrusion. In some embodiments, the organ is an organ of the digestive system, for example an organ of the gastrointestinal tract. The organ may be the stomach, and the instrument may be insertable through the patient's mouth to access the stomach wall.

[0015] The tissue penetrating fixation element may comprise a first shoulder for fixation against a first side of tissue (e.g., a double tissue wall of a fold), a second shoulder for fixation against a second side of tissue, and a connecting element extending between the first and second shoulders. In use, the connecting element extends through one or more penetrating openings from the first side to the second side of the tissue fold. The first shoulder resists movement of the anchor from the first side to the second side, and the second shoulder resists movement of the anchor from the second side to the first side.

[0016] The connecting element can be, for example, elastic and / or pseudoelastic. The connecting element can be biased to a first length but longitudinally stretchable. The connecting element can maintain a bias tending to draw the double tissue walls into a face-to-face relationship to secure the plication. Elastic and / or pseudoelastic stretching can also accommodate varying tissue wall thicknesses in the plication and reduce the risk of tissue damage or breakage of the fixation element in the event of accidental excessive force and / or muscle contraction occurring in the plication.

[0017] The fixation element may be inserted in a non-deployed configuration in which the first and second shoulders have a smaller outer diameter, in particular by rotating or folding substantially flat and / or into alignment with the connecting element. The shoulders may be subsequently deployed, for example to their protruding positions.

[0018] In a closely related second aspect, the invention provides a method of operating an apparatus for forming a plication in an internal tissue wall of a patient, the apparatus comprising an elongate instrument for insertion into the patient, optionally according to the first aspect and optionally including any of the features described above. The method comprises: (a) operating a retraction device to engage and pull the wall tissue to create a wall tissue protrusion; and / or (b) operating the ligation device to circumscribe a protrusion in the tissue of the wall to define and / or form a plication in the wall; and / or (c) operating the fixation device to fix the plication in place; Includes one or more of:

[0019] Certain embodiments of the method provide a combination of (a) and (b), and / or a combination of (b) and (c), and / or a combination of (a) and (c), and / or a combination of (a), (b) and (c).

[0020] In a closely related third aspect, the present invention provides a method for creating a plication in a wall of an internal tissue of a patient, optionally using an apparatus according to the first aspect, optionally using any of the features of the first aspect described above, and / or optionally using a method of operation according to the second aspect, optionally using any of the features of the second aspect described above, the method comprising: (i) inserting an instrument into a tissue wall of a patient through a natural or non-natural orifice and (ii) engaging wall tissue and pulling the tissue to create a wall tissue protrusion; and / or (iii) ligating the tissue wall protrusion to circumscribe the tissue wall protrusion and define and / or form a plication; and / or (iv) securing the plication using tissue penetrating fixation elements; and one or more of Including or further including:

[0021] Certain embodiments of the method provide a combination of (ii) and (iii), and / or a combination of (iii) and (iv), and / or a combination of (ii) and (iv), and / or a combination of (ii), (iii) and (iv).

[0022] As with the first embodiment, in the method of the second and / or third embodiment, the wall may be a wall of an internal organ of a patient, and references to the wall may be to an organ wall. Additionally or alternatively, the wall may be a tissue wall of the digestive system, for example the gastrointestinal tract. Additionally or alternatively, the wall may be a body cavity wall. Additionally or alternatively, the wall may be a wall comprising muscle tissue. An example of all of the above is the wall of the stomach, and references to the wall may be to the stomach wall.

[0023] The methods of the second and third aspects may optionally further comprise releasing the retraction device from the tissue wall once the tissue protrusion has been ligated at least once (optionally, e.g., before or after fixation of the plication with the tissue-penetrating fixation elements). Additionally or alternatively, the methods of the second and third aspects may optionally further comprise releasing the ligation device once the plication has been fixed at least once, e.g., using the tissue-penetrating fixation elements.

[0024] Closely related fourth, fifth and sixth aspects of the invention relate to fixing a functional device to a patient's stomach, optionally for the treatment of diabetes or obesity. The functional device may be configured to occupy and / or reduce stomach volume and / or affect food digestion. The functional device may be or comprise, for example, a bypass sleeve.

[0025] A fourth aspect provides a method of placing a functional device in a stomach of a patient, the method comprising: (i) forming a plication in stomach wall tissue, the plication serving as an attachment site for a functional device; (ii) positioning the functional device such that the functional device is attached to the stomach at least in part using plications; Includes.

[0026] The plications may define one or more of a sheet, a dock, a reinforced section of tissue wall to act as an attachment site for a functional device. The plications may extend in a line, optionally a continuous line, e.g., a circular configuration that provides a closed loop shape for the attachment site. By using the stomach wall tissue itself to form the attachment site, the functional device may be securely attached within the stomach and easily positioned and / or removed without the need to insert a separate large dock member to define the attachment site within the stomach wall.

[0027] The step of forming the plication may optionally include the method of the second and / or third aspects above.

[0028] A fifth aspect similarly provides an apparatus for placing a functional device, such as a bypass sleeve, in a patient's stomach, the apparatus comprising: (i) a first apparatus for forming a plication in stomach wall tissue, the plication serving as an attachment site for a functional device; (ii) a second apparatus for positioning the functional device such that the functional device is attached to the stomach at least in part using plications; and Equipped with.

[0029] The fifth aspect may optionally use the apparatus of the first aspect above, and / or the method of one or more of the second, third and fourth aspects above. The first and second devices may optionally form part of the same unit (optionally using one or more parts in common), or they may be separate devices.

[0030] A sixth aspect provides a functional device for at least partial placement in a patient's stomach. The functional device may optionally be configured to occupy and / or reduce stomach volume and / or affect food digestion. In some embodiments, the functional device is or comprises a bypass sleeve.

[0031] The functional device comprises an attachment portion configured to be attached to a fold formed in the stomach wall tissue, whereby the functional device is attachable to the stomach at least partially using the fold.

[0032] The attachment portion may, for example, comprise an annular portion, eg, an annular aperture, for engaging an annular fold in the stomach wall tissue.

[0033] While certain ideas, features, and embodiments have been presented above, the invention may be broader and defined in other ways, and protection is claimed for any novel feature or idea described herein and / or shown in the drawings, whether or not emphasis is placed thereon. [Brief description of the drawings]

[0034] [Figure 1] 1 is a schematic longitudinal half-section and front view of a device for creating plications in a patient's internal organs; FIG. [Diagram 2] 1 is a schematic side view of an apparatus for creating plications in a patient's internal organs. [Diagram 3] 1 is a schematic internal view of an apparatus for creating plications in a patient's internal organs; [Figure 4] 1A-1D are schematic side and detailed views of elements from one embodiment of a device for creating plications in a patient's internal organs. [Diagram 5] 1 is a schematic perspective view of one embodiment of a device for creating plications in a patient's internal organs; [Figure 6a] 1A-1D are schematic diagrams illustrating the steps of an exemplary technique for forming plications in the stomach wall. [Figure 6b] 1A-1D are schematic diagrams illustrating the steps of an exemplary technique for forming plications in the stomach wall. [Figure 6c] 1A-1D are schematic diagrams illustrating the steps of an exemplary technique for forming plications in the stomach wall. [Figure 6d] 1A-1D are schematic diagrams illustrating the steps of an exemplary technique for forming plications in the stomach wall. [Figure 6e] 1A-1D are schematic diagrams illustrating the steps of an exemplary technique for forming plications in the stomach wall. [Figure 6f] 1A-1D are schematic diagrams illustrating the steps of an exemplary technique for forming plications in the stomach wall. [Figure 7] FIG. 2 is a schematic cross-sectional view showing a first example of an elongated fold formed in a stomach wall. [Figure 8] 11 is a schematic cross-sectional view illustrating a second example of an elongated fold formed in the stomach wall to define an attachment site for a functional device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] Next, non-limiting embodiments of the present invention will be described by way of example only. In the figures, the same reference numbers are used to denote the same or equivalent features in different embodiments and examples. Unless stated to the contrary, the description of a feature in one embodiment may also apply to the same or equivalent feature in an embodiment or example. Features may also be interchanged in the embodiments as desired.

[0036] A plication is, for example, a fold in an originally smooth tissue in which a first layer and a second layer of tissue are arranged to at least partially overlap one another while remaining attached to one another at the fold. The layers may be at least partially in contact with one another or they may be at least partially separated. The overlapping of the first and second layers of tissue forms a double tissue wall of the plication.

[0037] The term tissue is used to refer to the internal body structure of cells that form the body structure capable of folding, other terms that are considered equivalent could be, for example, organ wall, tissue wall, body cavity tissue, organ tissue, internal tissue, all of which may be used interchangeably for purposes of understanding the invention that follows.

[0038] 1-4, an apparatus 10 is configured to create a plication in the wall of a patient's internal organ. The apparatus 10 may comprise an instrument 11, and may further comprise or use one or any combination of a retraction device 20, a ligation device 30, and a fixation device 40.

[0039] A first aspect of the present invention provides an apparatus presenting a combination of a retraction device 20 and a ligation device 30, a combination of a retraction device 20 and a fixation device 40, a combination of a ligation device 30 and a fixation device 40, and a combination of a retraction device 20, a ligation device 30 and a fixation device 40.

[0040] In some embodiments, the apparatus 10 for creating plications is configured for insertion into the patient's body, and optionally, it may be suitable for insertion through a natural body orifice.

[0041] In some embodiments, the instrument 11 may provide an elongate body having a working end 11a for contacting a tissue wall and a manipulation end 11b configured to operate and optionally manipulate at least one or more of the retraction device 20, the ligation device 30, and the fixation device 40. The working end may be provided at the proximal end 11a of the instrument 11 and the manipulation end may be provided at the distal end 11b of the instrument 11. The manipulation end 11b may be configured for an operator to operate, manipulate, or actuate the working end 11a.

[0042] In other words, means may be provided for manipulating the apparatus 10, and optionally for manipulating the devices 20, 30, 40, to interact with the tissue wall at the proximal end 11a when the distal end 11b is actuated. The instrument 11 of the apparatus 10 may provide at least one internal channel 12 extending at least a portion of the length of the instrument 11 and may be configured to accommodate the retraction device 20, which may optionally be manipulated through the channel 12. The instrument 11 may further provide a second channel 13, which may be configured to accommodate a carrier tube 14, which may include a ligation device 30, which may additionally or alternatively accommodate a fixation device 40. The channel 12 may further be configured to accommodate the ligation device 30, and additionally or alternatively the fixation device 40. The instrument 11 may provide multiple channels for individually accommodating the devices 20, 30, 40.

[0043] In some embodiments, the instrument 11 may be configured to be inserted inside a body organ, and the created fold may be an inward protrusion of an internal tissue wall. The instrument may be at least partially flexible, for example to conform to a natural passageway for entering the patient through the digestive tract. In some embodiments, the tissue may be tissue of the digestive system, for example tissue of the gastrointestinal tract, and optionally an organ. The organ may be, for example, the stomach, and the instrument 11 may be inserted through the patient's mouth, for example, to access the stomach wall.

[0044] In some embodiments, the retraction device 20, if provided, may optionally extend along the channel 12 extending from the distal end 11b towards the proximal end 11a of the instrument 11, and may comprise means for engaging the tissue wall located at the proximal end 11a, for example a suction or suction device 21 configured to pull the tissue wall by applying negative pressure to the tissue wall. Optionally, the suction or suction device, if provided, may comprise a tapered profile 21a at the distal end of the instrument 11 and configured to insert a fold in the organ wall, further optionally the tapered profile of the suction or suction device is removable from the instrument 11.

[0045] Additionally or alternatively, the retraction device 20 can be provided with a mechanical device at its distal end for attachment to tissue of the organ wall. The mechanical device can be, for example, a grasping jaw configured to hook into the organ wall, or a helical penetrating device configured to removably screw into the organ wall.

[0046] Retraction device 20 may be configured to be extensible relative to the body of instrument 11 for engaging an organ wall. Optionally, it may be extensible relative to ligation device 30. Additionally or alternatively, retraction device 20 may be configured to be retractable relative to the body of instrument 11. Optionally, it may be configured to be retractable relative to ligation device 30. Retraction device 20 may be further configured to perform a retraction action, optionally to create a protrusion of the tissue it engages.

[0047] In other words, retraction device 20 may extend at least a portion of the length of instrument 11 and may be housed by channel 12, optionally channel 13, of instrument 11. Retraction device 20 may be operable by control means located at distal end 11b of instrument 11. Operation of the control means may direct one or more or all of the attachment or engagement of the retraction device to the tissue wall, longitudinal retraction of the tissue, creation or insertion of a protrusion in the wall, creation or insertion of a fold in the wall.

[0048] The retraction device 20 facilitates attachment of the apparatus 10 to the tissue wall and creation of a prominent fold in the tissue. The suction element, when provided, allows for controlled selection of tissue portions, thus allowing for at least partially homogenous or equal sized plications when multiple plications are performed.

[0049] In some embodiments, the device may comprise a carrier 14 configured to extend at least a portion of the length of the channels, e.g., 12, 13, optionally extending from the distal end 12b, 13b of the instrument 11 toward the proximal end 12a, 13a.

[0050] The carrier 14 may be configured to carry at least one, and optionally both, of the ligation device 30 and the fixation device 40. Additionally or alternatively, if both are provided, the ligation device 30 and the fixation device 40 may be generally adjacent to one another to interact with the same region of organ wall tissue, and optionally adjacent regions.

[0051] In some embodiments, the carrier 14 may be configured to be movable, and may further be a tube, optionally a different tube than the retraction device 20. The carrier may further be longitudinally extensible relative to the instrument 11.

[0052] Additionally or alternatively, the carrier 14 may be shaped at an angle relative to the retraction device 20, for example approximately perpendicular to the retraction device 20, additionally or alternatively, at an angle to present either or both of the ligation device 30 and the fixation device 40 approximately perpendicular to the retraction direction of the retraction device 20.

[0053] Additionally or optionally, in some embodiments, the carrier 14, optionally a tube of the carrier, may be at least partially flexible and / or configured to bend at least partially to perform an angle relative to the retraction device 20, such as approximately perpendicular to the retraction device, additionally or alternatively, to present either or both of the ligation device 30 and the fixation device 40 approximately perpendicular to the retraction direction of the retraction device 20.

[0054] The ligation device 30 may be configured to circumscribe the wall tissue protrusion. The ligation device 30 may extend at least a portion of the length of the instrument 11, optionally extending from the distal end 11b towards the proximal end 11a of the instrument 11, and further optionally extending from the distal end 13b towards the proximal end 13a of the channel 13. The channel 13 extends at least a portion of the length of the instrument 11. The ligation device 30 may provide a shaft 30' that may extend the length of the channel 12 or 13. The ligation device 30 may be further configured to be extendable relative to the body of the instrument 11, additionally or alternatively relative to the retraction device 20, and additionally or alternatively retractable.

[0055] The ligating device 30, when provided, may comprise a ligating element 31, e.g., a ligature, configured to at least partially circumscribe an internal tissue protrusion. The ligating element 31 may provide a loop, optionally a contractible or adjustable loop, further optionally a closed loop. Additionally or alternatively, the ligating element 31 may comprise a loop region of an elongate element. The ligating element 31, optionally the ligating device 30, may be, for example, a lasso or snare.

[0056] In some embodiments, the ligating element 31 is at least partially rigid and may additionally or alternatively be at least partially flexible, and optionally it may be made from any suitable material, such as a metal, optionally a metal alloy, etc. It may be made from Nitinol, for example.

[0057] Ligating device 30, when provided, may be further configured to at least partially immobilize the protrusion and / or to laterally retract the protrusion in the organ wall.

[0058] In other words, the ligation device 30 can facilitate fixation of the protrusions in the tissue wall relative to the surrounding tissue. The ligation device 30 may be further configured to retract a first layer of the tissue fold toward a second layer of the tissue fold, optionally, the two layers retracting into contact with one another.

[0059] In some embodiments, the ligating element 31 may be configured to circumscribe the retraction device 20, optionally in an operational state of the ligating device 30. Additionally or alternatively, the ligating element 31 may circumscribe the retraction device 20 in at least one operational state of the retraction device.

[0060] In some embodiments, the traction device 20, when provided, may be configured to extend through the loops of the ligation device 30 in at least one operational state of the ligation device 30, and additionally or alternatively in an operational state of the traction device 20.

[0061] In other words, ligation device 30 may extend at least a portion of the length of instrument 11 and may be housed by channel 13, and optionally channel 12, of instrument 11. Ligation device 30 may be operable by a control means located at a distal end of instrument 11. Operation of the control means may induce one or more or all of the following: circumscribing the protrusion within the body cavity tissue, fixation of the protrusion within the internal tissue, lateral retraction of the protrusion within the tissue wall.

[0062] The above-mentioned properties of the ligation device 30 allow for an improved apparatus for creating plications, for example, in the internal organs of a patient. Circumscribing and fixation of the area where the plication is desired may help to avoid tissue displacement during placement of the fixation element. Contacting the two layers forming the plication may allow for better fixation of the fixation means, thus reducing the chance of the fixation element becoming dislodged.

[0063] A fixation device 40 may be provided for fixing the plication to the organ wall. The fixation device 40 may be configured to extend at least a portion of the length of the channel 12 or 13. Optionally, extending from the distal end 12b, 13b towards the proximal end 12a, 13a of the respective channel 12 and 13. The channels 12 and 13 may optionally extend at least a portion of the length of the instrument 11, further optionally extending from the working distal end 11b towards the working proximal end 11a of the instrument 11. The fixation device 40 may be further configured to be extendable relative to the body of the instrument 11, additionally or alternatively relative to the retraction device 20, and additionally or alternatively retractable.

[0064] The fixation device 40 can provide an insertion device 41 that can be configured to insert at least one tissue-piercing element through the fold. The insertion device 41 can be positioned to create a passageway or through opening in the tissue wall for inserting the fixation element 42. The insertion device 41 can comprise a tubular needle, which can have a sharp end, configured to penetrate at least one layer of the fold and optionally configured to deliver the fixation element 42. The tubular needle can provide a hollow passageway for at least partially accommodating at least one, and optionally multiple, fixation elements 42, and further optionally, the fixation elements 42 within the cavity can be in an undeployed state.

[0065] In other words, fixation device 40 may extend at least a portion of the length of instrument 11 and may be housed by channel 13, and optionally channel 12, of instrument 11. Fixation device 40 may be operable by control means located at the distal working end 11b of instrument 11. Operation of the control means may guide one or more or all of the following: penetration of internal tissue creating a through opening, insertion of fixation element 42 by insertion device 41, ejection of the fixation element from within the insertion device, deployment of the fixation element by retracting the insertion device.

[0066] In some embodiments, the apparatus may be supplied pre-loaded with one or more fixation elements 42. Alternatively, at least one fixation element 42 may be loaded into the fixation device 40 prior to the intervention and / or at least one fixation element 42 may be loaded into the fixation device 40 during the intervention.

[0067] The fixation device 40 may be capable of fixing the protrusions within the tissue wall in the appropriate position relative to the surrounding tissue. The fixation device 40 may be configured to insert fixation elements 42 to fix a first layer of the tissue fold against a second layer of the tissue fold, optionally with the two layers secured in at least partial contact with one another.

[0068] The fixation element 42 may be any suitable means for fixing the plication, for example it may be an anchor, and additionally or alternatively it may be a suture, optionally secured with a pledget.

[0069] Providing multiple fixation elements can facilitate creating multiple plications without removing the device from within the patient, thus allowing for a quicker intervention as well as ease of use by the operator.

[0070] The fixation element 42 may have an undeployed state and a deployed state, for example, the fixation element 42 may be self-deployable, or additionally or alternatively, it may be self-expandable.

[0071] The undeployed configuration of the fixation element facilitates insertion and placement of the fixation element through the plication, which may further allow for a smaller insertion device.

[0072] As shown in FIG. 4, in some embodiments, the tissue penetrating fixation element 42 can optionally provide a first shoulder 42a for fixation against a first layer of the tissue fold and may further optionally include a second shoulder 42b for fixation against a second layer of the fold, the first and second shoulders being connected by a connecting element 42c extending between the two shoulders 42a and 42b.

[0073] In other words, the fixation element 42 may be configured to fix the double tissue walls of the fold and may include a first shoulder 42a and a second shoulder 42b, where the first shoulder 42a is configured to fix a first side of the tissue and the second shoulder 42b is configured to fix a second side of the tissue, and further, the first shoulder 42a and the second shoulder 42b of the fixation element 42 are connected by a connecting element 42c, e.g., elastic, optionally pseudo-elastic.

[0074] The first and second shoulders 42a, 42b may be, for example, anchors connecting the first and second tissue layers and may be further configured to resist migration from one to the other. The connecting element 42c may extend through a through opening from the first layer or side of tissue to the second layer or side of tissue. Additionally or alternatively, the connecting element 42c connecting the first and second shoulders, optionally an anchor, may enable fixation of the plication by maintaining a predetermined distance between the first and second shoulders 42a, 42b.

[0075] The above characteristics help secure the plication by facilitating a connection between shoulders 42a and 42b of fixation element 42 by connecting element 42c. The shoulders can help prevent migration of fixation element 42, and connecting element 42c can help prevent undoing of the plication by facilitating convergence of the first and second sides of the plication.

[0076] The connecting element 42c may be, for example, elastic, additionally or alternatively pseudoelastic. The connecting element 42c may be further biased to the first length, and optionally a bias may be maintained to urge the double tissue walls into at least a partial face-to-face relationship to secure the plication.

[0077] In some embodiments, the connecting element 42c may be longitudinally stretchable, optionally with elastic, additionally or alternatively pseudoelastic, stretching to accommodate varying tissue thicknesses in the plication. The longitudinal stretching may help to avoid tissue damage and may additionally or alternatively help to avoid breakage of the fixation element 42 if excessive forces are generated in the plication.

[0078] The longitudinal stretch of the connecting elements 42c can facilitate the accommodation of the folds during the motor functions of the organ, for example it can facilitate the accommodation of the gastric folds during the contractile movements associated with the digestive process.

[0079] In some embodiments, the fixation element 42 can provide a deployed state and a non-deployed state. In the non-deployed state, the first and second shoulders 42a and 42b can be rotated to lie substantially flat and optionally folded. Additionally or alternatively, the first and second shoulders 42a and 42b, respectively, can be rotated to align with the connecting element 42c and optionally folded.

[0080] 3, in some embodiments, the apparatus 10 can provide a support shaft 50 for supporting the ligating element 31 of the ligation device 30. The support shaft 50 can extend within, and optionally over, the instrument 11, and can further extend at least a portion of the length of the instrument 11, and optionally it can extend the length of the instrument 11. The support 50 can be configured to abut the ligation device 30. It can be configured to at least temporarily maintain the ligation element 31 of the ligation device 30 in a non-deployed state, and optionally the ligation element can circumscribe the retraction device 20.

[0081] Actuation of the operating end 11b can release the ligating element 31 from the support shaft 50, for example, for deployment around a plication.

[0082] Some embodiments, further shown in FIG. 3, may provide a retraction device 20 comprising a suction or aspiration shaft 21 and, additionally or alternatively, a tapered profile 21a configured to engage a tissue wall, for example by suction.

[0083] The tapered profile 21a of the suction device 21 allows a predetermined amount of tissue to be aspirated to form a plication. When aspirated, the aspirated tissue can conform to the tapered profile, thus forming folds in the tissue. When multiple plications are performed, the tapered channel can help promote uniformity of the plications by aspirating and folding the same amount of tissue per plication.

[0084] 5, some embodiments may provide an apparatus 10 comprising a first channel 12 for housing a ligation device 30 and a second channel 13 for housing a fixation device 40, the ligation device 30 and the fixation device 40 being at least partially adjacent to each other. The insertion device 41 may further provide a tissue penetrating element 41a for traversing the tissue, optionally the tissue fold, and additionally or alternatively, it may comprise a hollow channel 41b for housing at least one fixation element 42. The tissue penetrating element 41a may be, for example, a needle that may be at least partially flexible. The fixation device 41 may provide a plurality of fixation elements 42 housed within the insertion device 41 for insertion into the tissue to fix the fold.

[0085] In some embodiments, the apparatus can provide the retraction device 20 disclosed above in combination with the ligation device 30 disclosed above.

[0086] In some embodiments, the apparatus can provide the traction device 20 disclosed above in combination with the fixation device 40 disclosed above.

[0087] In some embodiments, the apparatus can provide the retraction device 20 disclosed above in combination with the ligation device 30 disclosed above, and further in combination with the fixation device 40 disclosed above.

[0088] In some embodiments, the apparatus can provide the ligation device 30 disclosed above in combination with the fixation device 40 disclosed above.

[0089] Figures 6a-6h illustrate a method of forming plications in a tissue wall, including a method of operation of the device 10. The figures show the formation of inward plications in the wall of a patient's stomach 60, but the same principles can be used in the walls of other organs or tissues.

[0090] Referring to FIG. 6a, working end 11a of instrument 11 is inserted through the patient's mouth and navigated into stomach 60 to contact a target site for forming a plication in the stomach wall.

[0091] 6b, the retraction device 20 operates to pull the wall tissue to form a stomach wall tissue protrusion 62. For example, the tissue wall can be held against the retraction device by applying negative pressure, and then the retraction device can be pulled away from the wall.

[0092] 6c and 6d, relative motion between (i) the folding device 30 and (ii) the retraction device 20 and / or tissue protrusion 62 advances the folding device over the tissue protrusion 62. For example, the retraction device 20 may retract, e.g., as part of the retraction to form the protrusion. Additionally or alternatively, the carrier 14 may advance to slide the ligating element 31 of the ligation device over the protrusion 62.

[0093] 6e, ligating device 30 operates to tighten ligating elements 31 around protrusions 62. For example, ligating elements 31 act to secure protrusions 62 and optionally allow retraction device 20 to disengage from the tissue. Also, for example, ligating elements 31 act to laterally compress protrusions 62 to form or define a plication in the tissue wall.

[0094] With reference to Fig. 6f, the fixation device 40 operates to begin to secure the plication within the wall tissue. For example, the insertion device 41 can extend from the carrier 14 to penetrate the overlapped tissue wall portions adjacent to and / or held by the ligation device 30. The insertion device 41 can be gradually retracted to controllably deploy the tissue-penetrating fixation elements 42 (Fig. 6g), at which point the fixation of the plication is completed. The ligation device 30 can then be disengaged, for example, by loosening the ligation elements 31 and pulling the carrier 14 away from the protrusions (Figs. 6g and 6h).

[0095] The process can be repeated as many times as necessary at one or more adjacent target sites to elongate or lengthen the plication in a particular direction. The fixation device 40 can incorporate multiple fixation elements 42 to allow the process to be repeated without the need to remove the instrument from the patient's stomach.

[0096] In general, therefore, the present invention may extend to a method of operation of an apparatus, optionally as described above, for forming at least one plication in the wall of a patient's internal organ, the apparatus may comprise an elongate instrument 11 for insertion into the patient.

[0097] The method may include a first step (a) for operating a retraction device 20 to engage tissue of the organ wall and tension said tissue of the organ wall to form a protrusion of the organ wall tissue.

[0098] Additionally or alternatively, the method may include a second step (b) of operating the ligation device 30 to optionally circumscribe the protrusion in the tissue wall to define, or additionally or alternatively form, a fold in the tissue wall.

[0099] Additionally or alternatively, the method may provide a third step (c) of operating the fixation device 40 to fix the plication in place.

[0100] Certain embodiments of the invention may provide a combination of steps (a) and (b), additionally or alternatively a combination of (b) and (c), additionally or alternatively a combination of (a) and (c), additionally or alternatively a combination of (a), (b) and (c).

[0101] In general, the invention may also extend to a method for forming plications in the wall of a patient's internal organ, optionally using the apparatus described above.

[0102] The method may include or further include a first step (i) of inserting an instrument 11 into the patient's organ through a natural or non-natural orifice, and at least one or more of the following steps:

[0103] A second step (ii) of engaging the organ wall tissue and pulling the tissue to create a protrusion of the organ wall tissue.

[0104] Additionally or alternatively, the method may optionally provide a third step (iii) of ligating the protrusion of the organ wall tissue to circumscribe the protrusion and additionally or alternatively form at least one fold in the organ wall.

[0105] Additionally or alternatively, the method may include a fourth step (iv) of securing the plication using tissue penetrating securement elements.

[0106] In a fourth aspect, the present invention may provide a method for creating a plication in a wall of a patient's internal organ, the method may optionally use an apparatus as described in any of the above aspects, and may provide an elongate instrument for insertion into the patient. The method may include one or more of the following steps (1) to (8):

[0107] The method may provide a first step (1) for inserting an elongated instrument 11 into a patient through an access site and inserting the instrument 11 into a desired location for plication.

[0108] Additionally or alternatively, a second step (2) for engaging the retraction device 20 with the organ wall and capturing a portion of the organ wall, for example by activating the suction element 21.

[0109] Additionally or alternatively, the method may include a further step (3) of tensioning the captured tissue to create a fold, for example by suctioning a portion of the tissue.

[0110] Additionally or alternatively, the method may provide a step (4) for deploying a ligation device 30 around the fold and tightening the ligation elements 31 to temporarily secure the fold.

[0111] The method may include an additional or alternative step (5) of releasing the retraction device 20 engaging the organ wall.

[0112] An additional or alternative step (6) may be provided by a method for delivering fixation element 42 to permanently or at least semi-permanently fixate the plication, where delivery of the fixation element may be facilitated by penetration of internal tissue by insertion device 41.

[0113] The method may further provide an additional or alternative step (7) of pivoting apparatus 10 and repeating steps (2)-(6), e.g., if multiple plications are required to create an elongated plication.

[0114] An additional or alternative final step (8) may be provided for retracting the device 10 from the patient's body.

[0115] 7 and 8 show examples of elongated folds in wall tissue, optionally created using the devices and / or methods described herein. The figures show stomach 60 folds for treating diabetes or obesity in a patient, for example, by modifying one or more of stomach volume, loss of appetite, and digestion by the body.

[0116] FIG. 7 shows plications 64 extending longitudinally within a stomach 60 to narrow the gastric cavity and / or reduce the stomach volume and / or change the shape of the stomach into a more streamlined sleeve shape in the direction from the gastric inlet 66 to the gastric outlet 68.

[0117] FIG. 8 shows an annular plication 64 that can define an attachment site, such as a sheet, and / or a dock, and / or a reinforced tissue fold, for a functional device 70 that can be at least partially inserted into the stomach 60. The functional device 70 can be, for example, a bypass sleeve. The sleeve can function, for example, to reduce the activity of the stomach 60 and direct digested or partially digested food into and / or at least partially through the small intestine. The sleeve 70 can extend at least partially into and / or through the duodenum, optionally at least partially into the jejunum. Additionally or alternatively, other functional devices 70, for example, functional devices for occupying stomach volume or functional devices for reducing stomach volume or affecting downstream digestion, can be attached using such plications 64 in the stomach wall.

[0118] It will be understood that the foregoing is merely illustrative of exemplary forms of the invention and that many modifications and equivalents may be used within the principles of the invention.

Claims

1. 1. An apparatus (10) for forming a plication (64) in a wall of an internal tissue of a patient, said apparatus (10) comprising an elongate instrument (11) for insertion into the patient near said tissue wall, optionally through a natural body orifice, said apparatus (10) comprising: (a) a retraction device (20) configured to engage tissue of the wall and pull the tissue of the wall to create a protrusion of the wall tissue; (b) a ligation device (30) configured to at least partially circumscribe said protrusion in the tissue of said wall to form said plication (64) in said tissue wall; (c) a fixation device (40) for fixing the plication (64) within the tissue wall; An apparatus (10) comprising one or more of:

2. 2. The apparatus (10) according to claim 1, wherein the ligation device (30) comprises a ligation element (31) that preferably circumferentially circumscribes the traction device (20) in at least one operating state of the ligation device (30) and / or the traction device (20).

3. 2. The apparatus (10) according to claim 1, wherein the fixation device (40) comprises a tissue-penetrating fixation element (42) and / or an insertion device (41) for inserting the fixation element (42), the fixation element (42) being preferably configured to extend through the wall tissue at the fold (64).

4. 2. The apparatus (10) of claim 1, wherein the retraction device (20) extends through a loop of the ligation device (30) in at least one operating state of the ligation device (30) and / or the retraction device (20).

5. The apparatus (10) of claim 3, wherein the insertion device (41) and the ligation device (30) are carried on the same carrier (14).

6. 6. The apparatus (10) according to claim 5, wherein the ligation device (30) and the insertion device (41) are arranged on the carrier (14) adjacent to each other for interacting with the same or adjacent areas of tissue of the wall, the carrier (14) being optionally a movable part of the instrument (11).

7. 4. The apparatus (10) of claim 3, wherein the instrument (11) further comprises an elongate body having a working end (11a) for contacting the tissue wall and a manipulating end (11b) at which one or more of the retraction device (20), the ligation device (30), and / or the insertion device (41) can be manipulated.

8. 8. The apparatus (10) according to claim 7, wherein the body comprises a first channel (12) for accommodating the retraction device (20) and / or through which the retraction device (20) can be manipulated, and a second channel (13) for accommodating a carrier tube (14) for the ligation device (30) and / or the insertion device (41).

9. 9. The device (10) of claim 8, wherein the tissue-penetrating fixation element (42) comprises a first shoulder (42a) for fixation against a first side of tissue, a second shoulder (42b) for fixation against a second side of tissue, and a connecting element (42c) extending between the first shoulder (42a) and the second shoulder (42b).

10. 10. The device (10) of claim 9, wherein the connecting element (42c) is elastic and / or pseudoelastic.

11. 10. The device (10) of claim 9, wherein the fixation element (42) is insertable into the second channel (13) in an undeployed configuration configured by rotating or folding the first shoulder (42a) and the second shoulder (42b) to a position with a smaller outer diameter, in particular by being substantially flat and / or aligned with the connecting element (42c).

12. 1. A method of operating a device (10) for forming plications (64) in a wall of an internal tissue of a patient, said device (10) comprising an elongate instrument (11) for insertion into the patient, said method comprising: (a) operating a retraction device (20) to engage and tension said wall tissue to create a wall tissue protrusion (62); (b) operating the ligation device (30) to circumscribe the protrusion (62) in the wall and form the plication (64) in the wall; (c) operating the fixation device (40) to fix the plication (64) in place; A method comprising one or more of:

13. A method for forming plications (64) in a wall of an internal tissue of a patient, said method comprising: (i) inserting an instrument (11) into the tissue wall of the patient through a natural or non-natural orifice; (ii) engaging and tensioning said wall tissue to create a wall tissue protrusion (62); (iii) ligating said wall tissue protrusion (62) to circumscribe said tissue wall protrusion (62) and form said plication (64); (iv) securing said plication (64) using tissue-piercing fixation elements (42); A method comprising one or more of:

14. The method of claim 12 or 13, further comprising releasing a tensioning device, preferably said retraction device (20), from said tissue wall.

15. A method for placing a functional device (70) in a patient's stomach (60), said method comprising: (i) forming a plication (64) in the wall tissue of the stomach (60), preferably using a method according to claim 12 or 13, the plication (64) serving as an attachment site for the functional device (70); (ii) positioning the functional device (70) such that the functional device (70) is attached to the stomach (60) at least in part using the plication (64); A method comprising:

16. 1. An apparatus for placing a functional device (70) in a patient's stomach (60), said apparatus comprising: (i) a first apparatus for forming a plication (64) in the wall tissue of the stomach (60), preferably an apparatus (10) according to any one of claims 1 to 11, wherein the plication (64) serves as an attachment site for the functional device (70); (ii) a second apparatus for positioning the functional device (70) such that the functional device (70) is attached to the stomach (60) at least in part using the plication (64); An apparatus comprising:

17. A functional device (70) for placement at least partially within a patient's stomach (60), said functional device (70) comprising an attachment portion configured to be attached to a plication (64) formed in wall tissue of said stomach (60), preferably formed using an apparatus (10) according to any one of claims 1 to 11, whereby said functional device (70) is attachable to said stomach (60) at least partially using said plication (64).

18. The functional device (70) of claim 17, wherein the functional device (70) is or comprises a bypass sleeve.

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