METHOD FOR SUTURING TWO PORTIONS OF A VESSEL TOGETHER

An endoscopic sleeve gastroplasty procedure comprises forming a gastric sleeve (5) through a stomach (1) by suturing a first portion (9) of a wall (3) of the stomach (1) to a second portion (11) of the wall (3). First and second rows (20, 22) of first and second mounds (18, 19) are formed in the first and second portions (9,11) by injecting a viscus bulking solution (25) into a submucosal layer (28) at sites (17) of the wall (3) to form pockets (27) therein to form the first and second mounds (18, 19). Sutures (15) are inserted into respective pairs (16) of the first and second mounds (18, 19) with anchor bars (38) of the sutures (15) located in the corresponding pockets (27). The sutures (15) are tightened for drawing the first and second mounds (18, 19) together to in turn draw the first and second portions (9, 11) of the wall (3) of the stomach (1) together to form the gastric sleeve (5).

FIELD OF THE INVENTION

The present invention relates to a method for suturing two portions of a wall of a vessel, lumen or organ together in the body of a human or animal subject. The invention also relates to a method for carrying out a sleeve gastroplasty procedure internally within the stomach of a human or animal subject.

The term “vessel” will hereinafter be used to include a vessel, a lumen or an organ, and the term “vessel wall” will be hereinafter used to refer to the wall of a vessel, a lumen or an organ.

BACKGROUND TO THE INVENTION

In minimally invasive surgical procedures, and in particular in endoscopic procedures, where it is required to suture a vessel internally within the vessel, in general, a suturing device is inserted through an instrument channel of an endoscope into the vessel, and the suturing of the parts of the vessel is carried out internally within the vessel. For example, where it is desired to evert a polyp in a vessel, for example, in a colon of a human or animal subject, the colon adjacent opposite sides of the polyp sutured together in order to urge the polyp to appear on the outside of the colon where it may be excised from the external side of the colon. Additionally, in a sleeve gastroplasty procedure being carried out endoscopically in the stomach of a human or animal subject, a suturing instrument is inserted into the stomach through an instrument channel of the endoscope, and opposite sides of the stomach wall are sutured together in order to form a gastric sleeve extending through the stomach. In general, in such cases of everting a polyp in a colon or forming a gastric sleeve in a sleeve gastroplasty procedure in the stomach of a human or animal subject, sutures are used of the type which comprise an elongated suture thread terminating in respective opposite ends thereof in anchor elements, and a cinch clip is slideably located on a loop formed by the suture thread between the anchor elements for tightening the suture. The anchor elements of the suture are typically located in a distal pointed end of a cannula of a suturing instrument, and during the suturing of the parts of the colon or stomach together, the cannula must be urged sequentially through the wall of the colon or the stomach to deposit the anchor elements on the outer surface of the colon or stomach with the suture thread extending from the anchor elements through the colon or stomach wall into the colon or stomach, so that as the suture is being tightened by urging the cinch clip of the suture along the loop of the suture thread towards the anchor elements, the anchor elements are drawn together, to in turn draw the parts of the colon or vessel wall together.

A particular disadvantage of such suturing methods for suturing parts of a vessel together where the pointed tip of the cannula must be urged through a vessel wall from the inner surface of the vessel to an outer surface thereof to deposit the anchor elements of the suture adjacent the outer surface of the vessel wall, is that there is a high risk of a vessel, lumen or organ adjacent the vessel in which the procedure is being carried out being punctured by the tip of the cannula. This is a particularly serious risk, in the event of, for example, an artery being located adjacent the vessel in which the procedure is being carried out, since the puncturing of such an artery could have fatal consequences.

There is therefore a need for a method for suturing two parts of a vessel together, particularly in a minimally invasive surgical procedure, for example, a procedure carried out endoscopically which addresses this problem. There is also a need for a method for carrying out a sleeve gastroplasty procedure which addresses this problem, and in particular, there is a need for a method for carrying out an endoscopic sleeve gastroplasty procedure which addresses the problem.

The present invention is directed towards providing a method for suturing two parts of a vessel together, and in particular, though not limited to a method for suturing two parts of a vessel together carried out endoscopically. The invention is also directed towards a method for carrying out a sleeve gastroplasty procedure, and in particular, though not limited to a method for carrying out an endoscopic sleeve gastroplasty procedure.

SUMMARY OF THE INVENTION

According to the invention there is provided a method for suturing a first portion of a wall of a vessel in a cavity in the body of a human or animal subject to a second portion of the wall of the vessel either interiorly in the interior of the vessel, or exteriorly of the vessel in the cavity, the method comprising:forming at least one first mound on a site of the first portion of the vessel wall,forming at least one second mound on a site of the second portion of the vessel wall,each one of the first and second mounds being formed by forming a pocket in a submucosal layer of the vessel wall or between the submucosal layer and a muscular layer of the vessel wall adjacent the site at which the corresponding one of the first and second mounds is to be formed,inserting at least one suture into or through a corresponding pair of the at least one first mound, and the at least one second mound, andtightening the suture to draw the corresponding pair of the first and second mounds together.

In one embodiment of the invention each pocket is formed by injecting an injectable fluid into the submucosal layer of the vessel wall or between the submucosal layer and the muscular layer of the vessel wall where the pocket is to be formed.

In one embodiment of the invention the injectable fluid comprises an injectable liquid.

In another embodiment of the invention the injectable fluid comprises a viscous liquid, and preferably, an injectable viscous solution.

In another embodiment of the invention the viscous solution comprises a viscous bulking solution, and preferably, the viscous bulking solution comprises an injectable viscous bulking solution, and ideally, the viscous solution comprises a viscous gel.

In another embodiment of the invention the injectable fluid comprises a liquid of low viscosity.

In another embodiment of the invention the liquid of low viscosity comprises water ora waterbased solution, and preferably, a saline solution.

In another embodiment of the invention, the viscosity of the injectable fluid is sufficient to minimise dispersal of the injectable fluid from the corresponding pocket for a predefined time period at least sufficient to allow the suture to be inserted into the mound, and preferably, for a time period of at least 5 minutes, and advantageously, for a time period of at least 10 minutes, and preferably, for a time period of at least 15 minutes, and more preferably, for a time period of at least 20 minutes, and ideally for a time period of approximately 30 minutes.

In one embodiment of the invention the injectable fluid comprises a lifting agent.

In another embodiment of the invention the lifting agent comprises a lifting agent sold under the trade mark ORISE gel by Boston Scientific.

In another embodiment of the invention the injectable fluid comprises a lifting agent sold under the trade mark ELEVIEW by Aries Pharmaceutical.

In another embodiment of the invention the injectable fluid comprises a non-toxic fluid, and preferably, the injectable fluid comprises a biocompatible fluid.

In another embodiment of the invention the quantity of the injectable fluid injected into the submucosal layer or between the submucosal layer and the muscular layer of the corresponding one of the first and second portions of the vessel wall is sufficient to form the pocket of a size to form the corresponding one of the first and second mounds of the desired size.

In one embodiment of the invention the quantity of the injectable fluid injected into the submucosal layer or between the submucosal layer and the muscular layer of the corresponding one of the first and second portions of the vessel wall to form the pocket of the corresponding one of the first and second mounds lies in the range of 1 ml to 10 ml, and preferably, lies in the range of 1 ml to 5 ml, and more preferably, lies in the range of 1 ml to 2 ml.

In some embodiments of the invention when one or a pair of the mounds is formed as an elongated mound extending longitudinally along the one or both of the first and second portions of the wall of the vessel to be sutured together, the quantity of the injectable fluid injected into the submucosal layer or between the submucosal layer and the muscular layer to form each one of the corresponding pockets may be as much as 10 ml and greater.

In one embodiment of the invention a plurality of the first mounds are formed on the respective sites on the first portion of the vessel wall, and a plurality of the second mounds are formed on the respective sites on the second portion of the vessel wall.

Preferably, the first mounds are spaced apart on the first portion of the vessel wall, and advantageously, the second mounds are spaced apart on the second portion of the vessel wall.

In one embodiment of the invention the first mounds are equi-spaced apart on the first portion of the vessel wall, and preferably, the second mounds are equi-spaced apart on the second portion of the vessel wall.

Advantageously, the first mounds are formed in a first row on the first portion of the vessel wall, and preferably, the second mounds are formed in a second row on the second portion of the vessel wall. Preferably, the first and second mounds are spaced apart along the respective first and second rows.

In one embodiment of the invention the spacing between the first mounds is similar to the spacing of the second mounds.

In one embodiment of the invention the first and second mounds are formed sequentially on the first and second portions of the vessel wall.

In one embodiment of the invention each one of the first and second mounds comprises a substantially circular mound when viewed in plan, and preferably, each one of the first and second mounds is of diameter in the range of 3 mm to 25 mm, and advantageously, in the range of 5 mm to 20 mm, and more preferably, the diameter of each one of the first and second mounds lies in the range of 5 mm to 10 mm, and ideally, the diameter of each one of the first and second mounds is approximately 8 mm.

In an alternative embodiment of the invention each one of the first and second mounds comprises an elongated mound extending along the corresponding one of the first and second portions of the vessel wall, and preferably, each elongated first and second mound is formed by an elongated pocket formed in the submucosal layer or between the submucosal layer and the muscular layer of the vessel wall and extending along the corresponding one of the first portion and the second portion adjacent the site at which the elongated mound is to be formed.

In one embodiment of the invention the elongated pocket of the corresponding elongated mound is of tubular cross-section.

In another embodiment of the invention each elongated mound is of transverse width lying in the range of 3 mm to 25 mm, and preferably, lying in the range of 5 mm to 20 mm, and more preferably, lying in the range of 5 mm to 10 mm, and advantageously, each elongated mound is of transverse width of approximately 8 mm.

In another embodiment of the invention the height of each one of the first and second mounds from a surface of the vessel wall adjacent the site at which the mound is formed lies in the range of 5 mm to 10 mm, and preferably, the height of each one of the first and second mounds lies in the range of 6 mm to 8 mm, and preferably, the height of each one of the first and second mounds from the surface adjacent the site at which the mound is formed is approximately 7 mm.

In one embodiment of the invention one suture is inserted into or through each pair of the first and second mounds.

In an alternative embodiment of the invention plurality of the sutures are inserted into or through each pair of first and second mounds, and preferably, a plurality of the sutures are inserted into or through one of the first and second mounds when the one of the first or second mounds comprises an elongated mound.

In one embodiment of the invention each suture is urged into or through the first and second mounds of the corresponding pair thereof, and preferably, each suture is urged sequentially into or through the first and second mounds of the corresponding pair thereof.

In another embodiment of the invention each suture comprises a suture thread terminating at respective opposite ends thereof in respective anchor elements, the suture thread defining a loop formed by two legs of the suture thread extending from the respective anchor elements, the loop extending through a cinch clip, the cinch clip being urgeable along the loop towards the anchor elements for reducing the effective length of the suture thread extending between the anchor elements to tighten the suture.

In one embodiment of the invention the cinch clip of each structure is configured to be a tight sliding fit on the loop sufficient to resist movement of the cinch clip along the loop in a direction away from the anchor elements.

In one embodiment of the invention each anchor element comprises an anchor bar, and preferably, the suture thread extends from each anchor bar at a position intermediate the ends of the anchor bar, and preferably, the suture thread extends from each anchor bar at a location substantially midway between the ends of the bar.

In one embodiment of the invention each suture is inserted into the first and second mounds of the corresponding pair thereof by inserting the anchor elements into the pockets of the respective first and second mounds of the pair thereof with the legs of the suture thread extending from the anchor elements through the corresponding mounds.

In one embodiment of the invention the leg of the suture thread of each suture extending from the corresponding anchor element extends from the corresponding anchor element through the submucosal layer or a part thereof of the corresponding one of the first and second mounds of the corresponding pair thereof.

In one embodiment of the invention the anchor elements of each suture element are inserted sequentially into the pockets of the first and second mounds of the corresponding pair thereof.

In an alternative embodiment of the invention each suture is inserted into the first and second mounds of the corresponding pair thereof by urging the anchor elements of the suture through the respective ones of the first and second mounds from an entry side of the corresponding ones of the first and second mounds to an exit side thereof with the anchor elements located on the exit side of the corresponding ones of the first and second mounds and the legs of the suture thread extending from the anchor elements through the corresponding ones of the first and second mounds from the exit side thereof to and through the entry side thereof.

In another embodiment of the invention the anchor elements of each suture are inserted sequentially into or through the first and second mounds of the corresponding pair thereof.

In another embodiment of the invention on one or more of the sutures being inserted into or through the first and second mounds of the corresponding pair or pairs thereof, the or each suture is tightened by urging the cinch clip thereof along the loop thereof towards the anchor elements thereof for drawing the first and second mounds of the corresponding pair thereof together.

In another embodiment of the invention the sutures are inserted sequentially into or through the respective pairs of the first and second mounds.

Preferably, commencement of insertion of the sutures into or through the pairs of the first and second mounds is not commenced until all of the first and second mounds have been formed.

In another embodiment of the invention each suture is tightened by urging the cinch clip thereof along the loop formed by the suture thread thereof towards the anchor elements for drawing the first and second mounds of the corresponding pair thereof together.

In one embodiment of the invention each suture is tightened before the next suture to be inserted is inserted.

In another embodiment of the invention a plurality of the sutures are inserted into or through the corresponding pair or pairs of the first and second mounds before the sutures of the plurality thereof are tightened, and preferably, the sutures are tightened sequentially.

In a further embodiment of the invention the sutures are not tightened until all of the sutures have been inserted into or through the pair or pairs of the first and second mounds.

In another embodiment of the invention each suture is inserted into or through the first and second mounds of the pair thereof by inserting a cannula into or through each one of the first and second mounds of the pair thereof, and preferably, the suture is located in a bore of the cannula and the anchor elements of the suture are sequentially discharged from the cannula as the cannula is urged into or through the respective first and second mounds of the corresponding pair thereof.

In another embodiment of the invention the suturing of the first and second portions of the vessel is carried out endoscopically, and in one embodiment of the invention the suturing of the first and second portions of the vessel is carried out internally within the vessel, and advantageously, the endoscope is inserted into the vessel.

Alternatively, the suturing of the first and second portions of the vessel together is carried out externally of the vessel, and in one embodiment of the invention is carried out in the cavity in the body of the human or animal subject in which the vessel is located.

In another embodiment of the invention the method is carried out endoscopically by inserting the endoscope into the vessel or the cavity orally, rectally or vaginally.

In a further embodiment of the invention the first and second portions of the vessel wall of the vessel are first and second portions of the wall of a stomach, and preferably, the first and second portions of the wall of the stomach are sutured together in the carrying out of a sleeve gastroplasty procedure, and preferably, the endoscope is inserted orally into the subject to the stomach through the oesophagus.

The invention also provides a method for carrying out a sleeve gastroplasty procedure in the stomach of a human or animal subject in which first and second portions of the wall of the stomach are sutured together to form a gastric sleeve by the method according to the invention.

Advantages of the Invention

The advantages of the invention are many. A particularly important advantage of the invention is that by injecting the injectable fluid solution at the respective sites for forming the first and second mounds, the first and second mounds are readily easily formed, and furthermore, all the first and second mounds may be formed prior to commencement of insertion of the sutures into the respective pairs of the first and second mounds. This has the advantage of minimising the number of times the various instruments must be withdrawn and re-entered into the stomach through an endoscope, and therefore, minimises the time required to carry out a sleeve gastroplasty procedure or any other procedure which requires suturing two parts of a wall of a vessel together.

By virtue of the fact that the first and second mounds are formed within the vessel on the inner surface of the wall thereof, the sutures are inserted into or through the first and second mounds, with the anchor elements located either in the pockets or on an exit side of the mounds. Thus, by tightening the sutures, the first and second mounds are drawn together, which in turn results in the first and second portions of the vessel similarly being drawn together in order to promote knitting of the first and second portions of the vessel together. Accordingly, there is no need for a cannula of a suturing instrument to be urged through the wall of the vessel adjacent the first and second portions thereof for depositing the anchor elements of the sutures on the respective outer sides of the wall of the vessel, which could result in the cannula as it exits the wall of the vessel puncturing an adjacent vessel, lumen or organ in the cavity within which the vessel is located, with potentially fatal consequences.

Another advantage of the invention is that before the commencement of suturing, the mounds may be formed along the respective portions of the vessel to be sutured together, thereby enabling a surgeon or a clinician to mark out the lines along which the portions of the vessel wall are to be sutured by the mounds before any suturing commences.

The invention will be more clearly understood from the following description of some non-limiting examples thereof which are given solely by way of example with reference to the accompanying drawings.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawings and initially toFIGS.1to13thereof, a method for suturing first and second portions of a wall of a vessel together in the body of a human or animal subject will now be described. In this embodiment of the invention the vessel comprises a stomach indicated generally by the reference numeral1of a human subject2, in which a sleeve gastroplasty procedure is to be carried out by the method according to the invention whereby two portions of the wall3of the stomach1are sutured together, to form a gastric sleeve5extending through the stomach1and a lower redundant portion7. The two portions of the stomach1which are sutured together are a first portion9of a front wall10of the stomach1and a second portion11of a rear wall12of the stomach1. The first and second portions9and11of the stomach wall3are secured together by a plurality of sutures15which are inserted into respective pairs16of first mounds18and second mounds19, formed at sites17on the respective first portion9and second portion11of the wall3, as will be described in detail below, seeFIGS.1to3.

In this embodiment of the invention the sleeve gastroplasty procedure is carried out endoscopically internally in the stomach1. An endoscope21is inserted into the subject2orally and through the oesophagus23into the stomach1of the subject2, seeFIG.13. The stomach1is insufflated through an insufflating channel (not shown) of the endoscope21, and instruments for carrying out the sleeve gastroplasty procedure are inserted into the stomach1through an instrument channel (also not shown) in the endoscope21, as will be described below. Such endoscopes as the endoscope21will be well known to those skilled in the art, and further description of the endoscope should not be required.

In carrying out the method according to the invention, the first and second mounds18and19are initially formed on the first and second portions9and11in the wall3of the stomach1. The first mounds18are formed spaced apart along a first row20on the first portion9of the front wall10of the stomach1, and the second mounds19are formed spaced apart in a second row22on the second portion11of the rear wall12, seeFIGS.1and2. The first mounds18are substantially equi-spaced apart in the first row20, and the second mounds19are substantially equi-spaced apart in the second row22. The spacing between the first mounds18in the first row20, and the spacing between the second mounds19in the second row22is substantially similar, so that each first mound18corresponds with one of the second mounds19to form a pair thereof for suturing together by a corresponding one of the sutures15.

The first and second rows20and22of the first and second mounds18and19are sequentially formed, and the first mounds18in the first row20are sequentially formed, and the second mounds19in the second row20are also sequentially formed. Although, in some embodiments of the invention the first and second mounds of each one of the pairs16thereof may be sequentially formed before the next pair16of first and second mounds are formed, and as each one of the first and second mounds of each pair16thereof is formed, the suture may be inserted into the just formed mound before the next mound of the pair16thereof is formed.

Each one of the first and second mounds18and19is formed by injecting an injectable fluid into a submucosal layer28of the wall3of the stomach1through an interior surface29of the wall3of the stomach1adjacent the site17, at which the corresponding one of the first or second mounds18or19is to be formed to form a pocket27therein, seeFIG.8. In this embodiment of the invention the injectable fluid comprises a viscous liquid, in this case a viscous bulking solution25. The viscous bulking solution25is injected into the submucosal layer28by a needle26entered into the stomach1through the instrument channel of the endoscope21. The viscous bulking solution25when injected into the submucosal layer28forms the pocket27beneath the site17at which the mound18or19is to be formed, seeFIG.8. The formation of the pocket27in the submucosal layer28deforms the submucosal layer28, thereby resulting in a portion24of the submucosal layer28rising above the pocket27to in turn form the corresponding mound18or19.

In embodiments of the invention where a viscous bulking solution is injected to form the pockets27, any suitable viscous bulking solution may be used. However, it is desirable that the viscous bulking solution25be of viscosity such that the viscous bulking solution25remains as a homogenous mass in the pocket27, with minimal dispersion from the pocket27, for a predefined time period sufficient to enable insertion of the suture15into the corresponding first or second mound18or19, and preferably, until all the sutures15have been inserted into the respective first and second mounds18and19of the corresponding pair thereof. In some embodiments of the invention it may be desirable that the viscous bulking solution25should remain in a homogenous mass in the pockets27until the sleeve gastroplasty procedure has been completed, which may be up to 30 minutes. Although, in general, it may be sufficient for the viscous bulking solution25to remain in the pocket27as a homogenous mass with minimal dispersion into the submucosal layer28for a predefined time period in the range of 5 minutes to 30 minutes. Suitable viscous bulking solutions are sometimes referred to as lifting agents. One such suitable lifting agent is a lifting agent sold under the trade mark ORISE gel by Boston Scientific, and another suitable lifting agent is that sold under the trade mark ELEVIEW byAriesPharmaceutical.

A sufficient amount of the viscous bulking solution25is injected into the submucosal layer28at each site17such as to form the pocket27of an appropriate size in order to form the corresponding one of the first and second mounds18or19of the desired size. In this embodiment of the invention the quantity of the viscous bulking solution25injected into the submucosal layer28at each site17is approximately 1 ml to 2 ml, which it has been found is sufficient to produce the first and second mounds18and19to be of substantially circular dome shape of diameter D when viewed in plan, in the range of 5 mm to 10 mm, and of height H above the interior surface29of the wall3adjacent the corresponding site17in the range of 5 mm to 10 mm, seeFIG.8, although in some embodiments of the invention up to 5 ml or more of the viscous bulking solution may be required to form each mound18or19.

In some embodiments of the invention, the viscous bulking solution25may be injected into the wall3of the stomach1adjacent a boundary between the submucosal layer28and an adjacent muscular layer30of the wall3in order to form the pockets27at the boundary between the submucosal layer28and the muscular layer30.

On the completion of the formation of the first and second mounds18and19in the first and second rows20and22, respectively, on the first and second portions9and11of the wall3of the stomach1, the needle26is withdrawn from the stomach1through the instrument channel of the endoscope21, and the sutures15are then sequentially inserted into the respective pairs16of the first and second mounds18and19, seeFIGS.3and4. The sutures15are then tightened for drawing the first and second mounds18and19of the respective pairs16tightly together, for in turn drawing the first and second portions9and11of the front and rear walls10and12together to promote knitting of the first and second portions9and11together adjacent the first and second rows20and22of the first and second mounds18and19, seeFIGS.1,5and7.

Before describing the insertion of the sutures15into the first and second mounds18and19of the respective pairs16thereof, one of the sutures15will first be described with reference toFIG.6. Each suture15comprises an elongated suture thread35terminating in respective opposite ends36thereof in anchor elements, in this embodiment of the invention anchor bars38. The suture thread35is secured to each anchor bar38adjacent a mid-point39of the anchor bar38. Legs37of the suture thread35extend from each anchor bar38to form a loop40. A cinch clip42having a loop accommodating bore43extending therethrough is located on the loop40with the loop40extending through the loop accommodating bore43. The cinch clip42engages the loop40with a tight sliding fit, and is urgeable along the loop40towards the anchor bars38to reduce the effective length of the suture thread35between the anchor bars38for tightening the suture15, to in turn draw the corresponding pair16of the first and second mounds18and19together. The tightness of the sliding fit of the cinch clip42on the legs37of the suture thread35forming the loop40is such as to permit sliding of the cinch clip42along the loop40towards the anchor bars38, but is tight enough to resist sliding of the cinch clip42in the reverse direction from the anchor bars38against any force induced in the suture thread35in the legs37thereof by the front and rear walls10and12of the stomach1tending to return to their original state.

Each suture15is inserted into the corresponding pair16of the first and second mounds18and19by a suturing instrument, for example, a suturing instrument of the type disclosed in PCT Published Specification No. WO 2021/165945, the disclosure of which is incorporated herein by reference. The suturing instrument is entered into the stomach1through the instrument channel of the endoscope21. Only a cannula45of the suturing instrument thereof is illustrated inFIG.9. The cannula45terminates in a pointed piercing tip47, and a bore46extends through the cannula45. The suture15is located in the bore46adjacent the pointed tip47, with the anchor bars38of the suture15sequentially located in the bore46, as described in PCT Published Specification No. WO 2021/165945, so that the anchor bars38of the suture15may be sequentially discharged from the cannula, and in turn sequentially inserted into the respective first and second mounds18and19of the corresponding pair16thereof.

Initially, the first mound18of the first pair16of the first and second mounds18and19is pierced by the pointed tip47of the cannula45of the suturing instrument, and the pointed tip47of the cannula45is urged into the pocket27of the first mound18. With the pointed tip47located in the pocket27, the suturing instrument is operated to discharge the first one of the two anchor bars38from the bore46of the cannula45through the pointed tip47thereof, thereby depositing the first one of the anchor bars38in the pocket27of the first mound18, seeFIG.9. The cannula45is withdrawn from the first mound18, with the leg37of the suture thread35, which is extending from the anchor bar38in the pocket27, through the portion24of the submucosal layer28forming the first mound18.

The second mound19of the pair16of the first and second mounds18and19is then pierced by the pointed tip47of the cannula45, and the pointed tip47thereof is urged into the pocket27of the second mound19. The second one of the two anchor bars38of the suture15is then discharged from the cannula45into the pocket27of the second mound19in a similar manner as the first anchor bar38is discharged into the pocket27of the first mound18. The cannula45is then withdrawn from the second mound19with the leg37of the suture thread35extending from the second one of the anchor bars38in the pocket27through the portion24of the second mound19.

As will be understood by those skilled in the art from the description of the suturing instrument in PCT Published Specification No. WO 2021/165945, the cinch clip42on the loop40of the suture thread35of the suture15will have been discharged into the stomach from the bore46of the cannula45, or from a distal end of a bore of a sleeve in which the cannula45is slideable, prior to the piercing of the first mound18of the pair16thereof. Once the cannula45has been withdrawn from the second mound19of the pair thereof, the cannula is withdrawn from the stomach through the instrument channel of the endoscope21to be recharged with the next suture. On being recharged with the next suture15, the cannula45of the suturing instrument is returned to the stomach1through the instrument channel of the endoscope21for inserting the next one of the sutures15into the next pair16of the first and second mounds18and19, and so on until the sutures15have been inserted into the first and second mounds18and19of all of the pairs16thereof.

On completion of insertion of the sutures15into the respective pairs16of the first and second mounds18and19thereof, the sutures15are sequentially tightened to draw the first and second mounds18and19of the respective pairs16thereof tightly together, for in turn drawing the first and second portions9and11of the front and rear walls10and12, respectively, of the stomach1tightly together along the first and second rows20and22of the first and second mounds18and19to promote knitting thereof. Each suture15is tightened by urging the cinch clip42along the loop40of the suture thread35of the suture15for drawing the anchor bars38of the suture15together, for in turn drawing the first and second mounds18and19of the corresponding pair16thereof tightly together.

Any suitable means for urging the cinch clips42along the loops40of the suture threads35of the respective sutures15may be used. In this embodiment of the invention the sutures15are tightened by the suturing instrument disclosed in PCT Specification No. WO 2021/165945. Only a distal part of the suturing instrument for tightening the sutures15is illustrated inFIGS.11and12. A hook48adjacent the distal end49of a pusher element50of the suturing instrument, which extends through the cannula bore46of the cannula45is urged outwardly of the cannula45and through a distal end51of a sleeve52within which the cannula45is slideable. The hook48is engaged with the loop40of the suture15which is to be tightened, seeFIG.11. With the hook48engaging the loop40of the corresponding suture15, the pusher element50along with the hook48is withdrawn with the cannula45into the outer sleeve52until the cinch clip42abuts the distal end51of the outer sleeve52, seeFIG.12. Further urging of the loop40into the outer sleeve52by the hook48, with the cinch clip42abutting the distal end51of the outer sleeve52results in the cinch clip42being urged along the loop40of the suture15towards the anchor bars38for tightening the suture15, see againFIG.12. The tightening of the suture15by urging the cinch clip42along the loop40of the suture thread35towards the anchor bars38for tightening a suture, similar to the suture15, is described in PCT Specification No. WO 2021/165945.

Alternatively, the sutures15may be tightened by any suitable suture securing instrument of the type also disclosed in PCT Specification No. WO 2021/165945. Thereafter, the suturing instrument or the suture securing instrument, as the case may be, is withdrawn from the stomach1through the instrument channel of the endoscope21, and the insufflating gas is withdrawn from the stomach1.

In carrying out the endoscopic sleeve gastroplasty procedure the endoscope21is inserted orally through the oesophagus23into the stomach1. The stomach1is insufflated by a suitable insufflating gas delivered into the stomach1through an insufflating channel (not shown) of the endoscope21. With the stomach1insufflated, the injecting needle26connected to a source (not shown) of the viscous bulking solution25is inserted through the instrument channel (not shown) of the endoscope21into the stomach1. The injecting needle26is manoeuvred within the stomach1and moved sequentially from one site17to the next site17. At each site17, the appropriated amount of the viscous bulking solution25is injected through the interior surface29of the wall3of the stomach1into the submucosal layer28to form the corresponding pocket27, and in turn the corresponding one of the first and second mounds18and19in the corresponding one of the first and second portions9and11, respectively, of the wall3. On completion of the formation of the first and second mounds18and19, the injecting needle26is withdrawn through the instrument channel of the endoscope21.

The suturing instrument charged with one of the sutures15, is urged into the stomach1through the instrument channel (not shown) of the endoscope21. The suture15is then inserted sequentially into the first and second mounds18and19of the first pair16thereof by inserting the anchor bars38of the suture15into the pockets27of the respective first and second mounds18and19of the pair16thereof, as already described. The suturing instrument is then withdrawn through the instrument channel of the endoscope21and recharged with the next suture15. Thereafter, sutures15are inserted into the first and second mounds18and19of the respective pairs16thereof sequentially in a similar manner until sutures15have been inserted into all the pairs16of the first and second mounds18and19.

Once the sutures15have been inserted into the respective remaining pairs16of the first and second mounds18and19with the anchor bars38of the sutures15located within the pockets27of the first and second mounds18and19of the pairs16thereof, the suturing instrument is then used to tighten the sutures15of the respective pairs16of the first and second mounds18and19, in order to draw the first and second mounds18and19of the pairs16thereof together, and in turn the first and second portions9and11of the front and rear walls10and12, respectively, together, to promote knitting thereof, as already described.

Referring now toFIGS.14to19, a method for suturing first and second portions of a wall of a vessel together in the body of a human or animal subject according to another embodiment of the invention will now be described. In this embodiment of the invention, like the embodiment of the invention described with reference toFIGS.1to13, the vessel comprises a stomach indicated generally by the reference numeral60of a human subject, in which an endoscopic sleeve gastroplasty procedure is also to be carried out by the method according to this embodiment of the invention to form a gastric sleeve61extending through the stomach60. The method according to this embodiment of the invention is substantially similar to the method described with reference toFIGS.1to13in which a sleeve gastroplasty procedure has been described, and similar components are identified by the same reference numerals. The only difference between the method of this embodiment of the invention and that described with reference toFIGS.1to13is in the actual suturing of the front and rear walls62and63of the stomach60together.

In the method according to this embodiment of the invention first and second mounds18and19, which are similar to the first and second mounds18and19formed on the interior surface29of the front and rear walls10and12of the stomach1, are formed on first and second portions65and66, respectively, of the front and rear walls62and63, respectively, of the stomach60. The first and second mounds18and19formed on the first and second portions65and66of the front and rear walls62and63are formed in an identical manner as the first and second mounds18and19are formed on the interior surface29of the front and rear walls10and12of the stomach1. The first and second mounds18and19are formed by injecting the viscous bulking solution25into the submucosal layer28at sites17of the first and second portions65and66of the front and rear walls62and63of the stomach60in order to form respective pockets27adjacent the sites17at which the first and second mounds18and19are to be formed.

Once the first and second mounds18and19have been formed, the sutures15, described with reference toFIG.6are then inserted sequentially into the first and second mounds18and19of the respective pairs16thereof. However, in this embodiment of the invention instead of the anchor bars38of the respective sutures15being inserted into the pockets27of the corresponding ones of the first and second mounds18and19, the cannula45of the suturing instrument disclosed in PCT Specification No. WO 2021/165945 is urged to pierce transversely through the respective first and second mounds18and19of each pair16thereof from an entry side68thereof to an exit side69thereof as illustrated inFIG.18.

On the cannula45having completely pierced through the first one of the first and second mounds18and19of the corresponding pair16thereof, the first one of the anchor bars38of the suture15is discharged from the bore46of the cannula45on the exit side69of the first mound18, as illustrated inFIG.18. The cannula45is withdrawn from the first mound18with the suture thread35extending from the anchor bar38through the first mound18from the exit side69to the entry side68thereof, seeFIG.19. The suture15is then inserted in the second mound19of the pair16of the first and second mounds18and19by the cannula45, in a similar manner as described with reference to the first mound18, with the anchor bar38located on the exit side69of the second mound19, and the cannula45is withdrawn with the suture thread35extending from the anchor bar38through the second mound19from the exit side69to the entry side68thereof, seeFIG.15. With the suture15inserted in the first and second mounds18and19of the corresponding pair16thereof, the cannula45is withdrawn through the instrument channel of the endoscope21and recharged with the next suture15. The sutures15are sequentially inserted in the pairs16of the first and second mounds18and19until the sutures15have been inserted into the remaining pairs16of the first and second mounds18and19with the anchor bars38of the suture15located on the exit side69of the respective first and second mounds18and19of the pair16thereof, and with the legs37of the suture thread35extending from the respective anchor bars38through the corresponding ones of the first and second mounds18and19, seeFIG.15.

Once the sutures15have been inserted into the respective pairs16of the first and second mounds18and19, the sutures are tightened by urging the cinch clips42along the loops40of the suture thread35towards the anchor bars38in a similar manner as described with reference to the tightening of the sutures15with respect to the method described with reference toFIGS.1to13. As the sutures15of the respective pairs16of the first and second mounds18and19are tightened, the first and second mounds18and19are drawn together as illustrated inFIGS.14,16and17. By drawing the first and second mounds18and19of the pairs16thereof together, the first and second portions65and66of the front and rear walls62and63, respectively, are drawn together along the first and second rows20and22of the first and second mounds18and19, as illustrated inFIGS.14,16and17.

Otherwise, the suturing of the front and rear walls62and63of the stomach60together to form the gastric sleeve61in the endoscopic sleeve gastroplasty procedure is similar to the method for carrying out the endoscopic sleeve gastroplasty procedure described with reference toFIGS.1to13to form the gastric sleeve5.

While the method has been described for use in carrying out a sleeve gastroplasty procedure, it will be readily apparent to those skilled in the art that the method according to the invention may be used for suturing any two portions of a wall of any vessel, lumen or organ together, and furthermore, it will be readily apparent to those skilled in the art that the method according to the invention may be used for suturing two parts of a vessel, lumen or organ whereby the method is carried out within the vessel, lumen or organ, or is carried out externally of the vessel, lumen or organ. For example, the method may be used for suturing two portions of a wall of a vessel, lumen or organ together externally of the vessel, lumen or organ in, for example, a cavity in which the vessel, lumen or organ is located. For example, in the case of a vessel, lumen or organ which is located in the peritoneal cavity, it is envisaged that the method could be carried out laparoscopically in the peritoneal cavity in which the vessel, lumen or organ, the two portions of which are to be sutured together, is located.

It will be appreciated that while a specific suturing instrument has been described for suturing the two parts of the vessel wall together, any other suitable suturing instrument may be used. It will also be appreciated that while sutures of a specific type have been described for use in the method, any other suitable type of suture may be provided for inserting into the first and second mounds of each pair thereof, and for drawing the first and second mounds of the respective pairs together.

It will also be appreciated that while the method has been described whereby the first mounds of the first row have been formed sequentially, and the second mounds of the second row have been described as being formed sequentially before insertion of the sutures, it is envisaged that in some embodiments of the invention each time either a pair or one of a pair of the first and second mounds have been formed, the suture may be inserted into each one of the first and second mounds of the pair thereof as each mound has been formed, or the suture may be inserted into the first and second mounds of the corresponding pair thereof sequentially after the pair of the mounds have been formed before the next pair of first and second mounds are formed.

While in the embodiments of the invention described, the pockets have been described as being formed in the submucosal layer, in some embodiments of the invention it is envisaged that the pockets may be formed between the submucosal layer and a muscular layer of the wall of the vessel.

While the injectable fluid has been described as comprising a viscous bulking solution, while this is desirable, it is not essential. In some embodiments of the invention a less viscous fluid may be suitable. Indeed, in some embodiments of the invention the injectable fluid may be water or a saline solution. The choice of the injectable fluid will to some extent be dependent on the site at which the pocket is to be formed, the nature of the vessel wall, and the length of time between the formation of the mound, and the insertion of the suture into or through the mound. Since in general, it is believed that a less viscous injectable fluid will disperse into the submucosal layer or between the submucosal layer and the muscular layer of the vessel wall quicker than a more viscous injectable fluid would disperse, the viscosity of the injectable fluid, will most likely be dependent on the time between the formation of the mound and the insertion of the suture into or through the mound. It is believed that if the suture is to be inserted into or through a pair of the first and second mounds immediately after the formation of the mounds, a saline solution would be suitable for forming the pockets in the submucosal layer.

Additionally, while specific injectable viscous bulking solutions have been described, any other suitable viscous bulking solutions may be used.

While a specific type of suture has been described, it will be readily apparent to those skilled in the art that any other suitable suture may be used.