Abstract
Apparatus for endoscopic anastomosis of the stomach and the bowel of a patient to allow food to bypass the duodenum and optionally a portion of the jejunum comprising a tube, surgical apparatus and at least one operating element. The tube is insertable into the stomach and has a proximal end and a distal end. The surgical apparatus is at least partially, preferably completely, insertable through the tube. The operating element, for operating the surgical apparatus from the proximal end, is connected or connectable to the surgical apparatus. The surgical apparatus is configured for establishing anastomosis between a first area of the stomach and a second area of the bowel.
Claims
1-28. (canceled)
29. An apparatus for endoscopic anastomosis of the stomach and the bowel of a patient to allow food to bypass the duodenum, comprising: a tube insertable into the stomach, the tube having a proximal end and a distal end; surgical apparatus which is deployable at the distal end of the tube and is at least partially insertable through the tube; and at least one operating element connected or connectable to the surgical apparatus for operating the surgical apparatus from the proximal end; wherein the surgical apparatus is configured for establishing anastomosis between a first area of the stomach and a second area of the bowel.
30. The apparatus according to claim 29, wherein the surgical apparatus comprises a cutting device for cutting tissue.
31. The apparatus according to claim 30, wherein the cutting device is rotatable in the direction along the circumference of the tube.
32. The apparatus according to claim 30, wherein the cutting device is convertible between (i) a stowed configuration for introduction to the first and/or second area, the stowed configuration having a first lateral profile about an axis of the tube; and (ii) a deployed configuration for operative cutting of tissue, the deployed configuration having a second lateral profile about an axis of the tube larger than the first lateral profile.
33. The apparatus according to claim 32, wherein the second lateral profile has a predetermined size, and the cutting device is configured to cut tissue when in the deployed configuration.
34. The apparatus according to claim 30, wherein the cutting device is mounted on a shaft, wherein the cutting device is configured for cutting a closed-loop shape aperture in tissue, the closed loop shape extending around an axis of the shaft.
35. The apparatus according to claim 30, wherein the cutting device, when deployed for cutting, has a cutting element and/or cutting surface facing towards the distal end of the tube.
36. The apparatus according to claim 30, wherein the cutting device, when deployed, is configured for cutting tissue in a cutting direction towards the distal end of the tube.
37. Apparatus according to claim 30, wherein the cutting device is configured for cutting tissue from a first side, and the apparatus further comprises a counter element deployable on an opposite second side of the tissue.
38. The apparatus according to claim 37, wherein the cutting device is positioned distally of the counter element, at least in the deployed configuration of the cutting device.
39. The apparatus according to claim 36, wherein the counter element is configured to (i) protect surrounding tissue on the second side from the cutting device, and/or (ii) provide a cutting board for the cutting device, and/or (iii) co-operate with the cutting device to capture cut-out tissue for removal through the tube.
40. The apparatus according to claim 37, wherein the counter element is convertible between (i) a stowed configuration for introduction to the first and/or second area, the stowed configuration having a first lateral profile about an axis of the tube; and (ii) a deployed configuration having a second lateral profile about an axis of the tube larger than the first lateral profile.
41. The apparatus according to claim 30, wherein the cutting device comprises at least one selected from: a blade element, a piercing element, and an electrical or optical ablation element.
42. The apparatus according to claim 30, wherein the cutting device is movable during cutting, in a rotary direction following a curve and/or in an axial direction.
43. The apparatus according to claim 37, wherein the apparatus comprises at least one insertable element insertable through a tissue wall at the first and/or second area, the insertable element having a stowed configuration for introduction through the tissue wall, and being expandable to a deployed configuration for overlapping, at least partially, tissue of the tissue wall.
44. The apparatus according to claim 43, wherein the insertable element is movable relative to the tube up to 20 cm from a distal end of the tube.
45. The apparatus according to claim 43, wherein the distal region of the insertable element in the stowed configuration comprises a second cutting device for piercing and/or cutting tissue.
46. The apparatus according to claim 43, wherein at least two of: the insertable element in the deployed configuration; the counter element in the deployed configuration; or the cutting device, are adapted to form an interface to enclose tissue, especially the first area and/or second area.
47. The device according to claim 43, wherein the insertable element is foldable radially outward from the longitudinal axis of the tube from the stowed configuration into the deployed configuration.
48. The apparatus according to claim 29, wherein the apparatus comprises an implantable stent comprising a non-return mechanism convertible between an open state and a closed state, wherein the closed state prevents passage of fluid and an open state enables crossing of fluid or a non-return valve enabling only one-directional passage of fluid.
49. The apparatus according to claim 29, wherein the apparatus comprises a pressure device for selectively applying a negative pressure to at least one area in the tube and/or a retaining element in an area at a distal end of the apparatus for retaining a distal end of the apparatus to tissue.
50. The apparatus according to claim 29, wherein, the apparatus comprises a fixation device, wherein the fixation device is designed to suture and/or staple the outer edges of the first area and the second area.
51. The apparatus according to claim 29, wherein the fixation device comprises fusing means, wherein the fusing means are designed to cause fusion of tissue of the first area of the stomach and the second area of the bowel, by applying a pressure and heating at least on the edges of the first area and the second area.
52. The apparatus according to claim 29, wherein the device comprises a second tube, wherein a distal end of the second tube is guidable from the stomach through the duodenum and connectable with the distal end of the tube across the stomach wall of the first area and the bowel wall of the second area.
53. The apparatus according to claim 52, wherein the apparatus comprises a guiding wire, wherein the tube and/or second tube can be guided along the guiding wire to enclose the first area and/or second area.
54. The apparatus according to claim 29, wherein the apparatus is configured to create the anastomosis by insertion of the apparatus into the body via a single orifice, the orifice being a natural body orifice.
55. A method of performing endoscopic anastomosis of the stomach and the bowel of a patient to allow food to bypass the duodenum, the method, characterized in the following steps: insertion of an apparatus into the stomach and attaching to the stomach wall in the first area; piercing and/or cutting through the stomach wall and deploying an insertable element outside of the stomach; advancing a counter element on the inside of the stomach to the first area; clamping the stomach wall of the first area between the insertable element and the counter element and cutting a hole into a section of the first area with the cutting device; advancing the apparatus through the hole and locating the target location making up the second area for the anastomosis; attaching to the outside of the bowel wall in the second area; piercing and/or cutting through the bowel wall and deploying the insertable element inside the bowel; pulling the insertable element to bring the first area into close contact with the second area; advancing the counter element with a fixation device and clamping the first and second area between the counter element and the insertable element; cutting a hole into a section of the second area with the cutting device and stapling and/or suturing the edges of the first area and second area together with the fixation device.
56. The method of claim 55, performed endoscopically through a single orifice into the body.
Description
[0168] Non-limiting embodiments of the invention are now described, by way of example only, with reference to the accompanying schematic drawings, in which:
[0169] FIG. 1: shows an illustration of an anastomosis of stomach and bowel;
[0170] FIG. 2a-2p: show an endoscopic anastomosis of the apparatus with an insertable element;
[0171] FIG. 3a-3b: show a schematic illustration of closing the pylorus;
[0172] FIG. 4a-4f: show the cutting device in the deployed and stowed configuration;
[0173] FIG. 5a-5h: show the use of the apparatus with an insertable element in the stowed and deployed configuration cutting tissue with the counter element;
[0174] FIG. 6a-6g: show an alternative embodiment of the apparatus with an insertable element in the stowed and deployed configuration cutting tissue with the counter element;
[0175] FIG. 7a-7g: show another alternative embodiment of the apparatus with an insertable element in the stowed and deployed configuration cutting tissue with the counter element;
[0176] FIG. 8a-8g: show a surgical anastomosis of the apparatus using a guiding wire;
[0177] FIG. 9a-9b: show fusing means that can ride over a guiding wire to fuse tissue through heating and pressure;
[0178] FIG. 10 is a schematic partial section showing a technique for reducing stomach volume; and
[0179] FIG. 11 is a schematic view showing a detail of FIG. 10 on an enlarged scale.
[0180] Referring to the drawings, FIG. 1 shows a schematic anastomosis 301 between the stomach 201 and the bowel 202. The anastomosis 301 allows food to bypass the duodenum and thus reduce the nutrient uptake. The anastomosis diameter can be in a range between 1 cm and 6 cm.
[0181] FIG. 2a shows the insertion of the apparatus 101 into the stomach over the mouth and oesophagus of a patient. After insertion the pressure device (not shown in the figures) a negative pressure can be applied in the tube 1 to attach the apparatus 101 at the distal end 3 of the tube 1 to the mucosa of the stomach 201 in the first area.
[0182] FIG. 2b shows the piercing the stomach wall by a piercing element 11. The piercing element 11 can pierce a hole into the stomach wall with a sufficient lateral profile to insert a surgical apparatus 4 in form of an insertable element 12 in the stowed configuration 13 into the pierced opening as can be seen in FIG. 2c. The insertable element 12 can be converted into the deployed configuration 14 by expanding radially outward. The insertable element 12 is expanded laterally outward by folding radially outward around a fixed point in distal region of the insertable element 12 in an umbrella shape. The lateral profile of the insertable element 12 is thus overlapping the lateral profile of the cut into the tissue which introduced the insertable element 12. The insertable element 12 can be deployed outside the stomach wall and cover the cut made to introduce the insertable element 12 as seen in FIG. 2d.
[0183] FIG. 2e shows that the cutting device 6 can be advanced to the distal end 17 of the operating element 5 at the first area. The cutting device 6 can be operated by rotation of the operating element 5 but also a translational movement can be conceived. FIG. 2f shows that the stomach wall in the first area is clamped by the deployed insertable element 12 and counter element 9. A hole can be cut into the first area by operating the cutting device 6 with the control element. It is conceivable that the cutting device 6 is attached or attachable to the insertable element 12 or the counter element 9. It could also be conceived that the cutting device 6 can be deployed independently from the insertable element 12 or the counter element 9. In this embodiment the cutting device 6 is located on the internal surface of the stomach 201. After the hole was cut in FIG. 2g the cut-out tissue 26 is clamped between the insertable element 12 and the cutting device 6 as seen in FIG. 2h. The cut-out tissue 26 can be removed through the tube 1 with the insertable device in the stowed configuration 13.
[0184] As shown in FIG. 2i the operating element 5 can be advanced through the cut-out tissue to locate the target location of the second area of the bowel 202 as seen in FIG. 2j. For this purpose the apparatus 101 may optionally comprise a camera. The operating element 5 is movable relative to the distal end 3 of the tube 1 at least from the first area of the stomach 201 to the second area of the bowel 202.
[0185] Once the second area is located the operating element 5 can apply a negative pressure to attach the apparatus 101 to the second area and pierce it with a piercing element 11.
[0186] In FIG. 2l the insertable element 12 is introduced into the bowel through the pierced cut in the stowed configuration 13. It is also conceivable that the insertable element 12 comprises the piercing element 11 at its distal end in order to pierce tissue and being inserted at the same time.
[0187] In FIG. 2m the insertable element 12 is converted to the deployed configuration 14.
[0188] The operating element 5 and the insertable element 12 in the deployed configuration 14 can be pulled or retracted to bring the first area and second area into close contact. The insertable element 12 in the deployed configuration 14 serves to protect the enclosed and surrounding tissue and can prevent leakage. The cutting device 6 can be used to cut-out the clamped tissue between the insertable element 12 and the counter element 9. FIG. 2n and FIG. 20 show that the fixation device 15 can be advanced to fix, e.g. staple or suture, the bowel and stomach walls to create an anastomosis 301. In this embodiment the fixation device 15 is concentric to the operating element 5 and connected to the cutting device 6. However the fixation device 15 can be conceived to be connected or connectable to that counter element 9, the insertable element 12 and/or the operating element 5.
[0189] As seen in FIG. 20 the fixation device 15, the insertable element 12 and the cutting device 6 and can be retrieved through the tube 1. The cut-out tissue can be removed through the tube 1 with the insertable element in the stowed configuration 13. The anastomosis 301 can be inspected for size, shape and leaks as and the apparatus 101 consequently removed as seen in FIG. 2p.
[0190] FIG. 3a shows the pylorus 27 which can be closed after successful creation of a permanent anastomosis 301 of the stomach 201 and jejunum of the bowel 202. The closing of the pylorus could be carried out by attaching the apparatus 101 to the proximal opening of the pylorus 27 and deploying a fixation device (not shown in the figures). As shown in FIG. 3b the pylorus 27 is closed by multiple sutures and/or staples 37. It would also be conceivable that the pylorus 27 is closed by an implantable stent.
[0191] FIG. 4a and FIG. 4c show an embodiment of the cutting device 6 in the stowed configuration 7. FIG. 4b and FIG. 4d show the cutting device 6 in the deployed configuration 8. The cutting device 6 comprises a reversibly rollable or spirally furlable blade element 10 that is convertible between a stowed configuration 7 and a deployed configuration 8. The blade element 10 can be converted by rotation of the control element 28. However, also converting the cutting device 6 by relative movement of the control element 28 can be conceived. The blade element 10 in the deployed configuration 8 has a circular lateral profile as shown in FIG. 4b. The blade element 10 can preferably be rotated by a torsionally stiff control element 28 from the proximal end of the tube 1 (not shown in FIG. 4a-4d). The blade element 10 in this embodiment consists of only a single segment. The control element 28 is connected to the lateral distant regions 39 of the blade element 10 so that a reversible conversion between the deployed configuration 8 and the stowed configuration 7 can be carried out using the control element 28. FIG. 4e and FIG. 4f show the rollable blade element 10 completely unrolled. As shown in FIG. 4e and FIG. 4f the cutting device 6 comprises a holding device 29 in form of one or more releasable latches 30 to latch the blade element 10 in its deployed configuration (8). The latch 30 latches into latch opening 41 when the predetermined size of the cutting device 6 through radial expansion is reached.
[0192] FIG. 5a shows a schematic representation of an embodiment of the insertable element 12 in the stowed configuration 13 that is introduced through a tissue wall 25 by an operating element 5. As shown by the arrows in FIG. 5b the insertable element 12 can be converted into a deployed configuration 14 with a greater lateral profile. The lateral profile is larger than the lateral profile of the entry opening 31. In FIG. 5c the insertable element 12 is in the deployed configuration 14 and can form a protective cover of the tissue from the other side of the tissue wall 25. The tissue wall 25 can be clenched with the insertable element 12 and the counter element 9 forming an enclosing interface 40 and cut by the cutting device (not shown in the figures) in the process as schematically shown in FIG. 5e.
[0193] By clenching the tissue wall 25 before engaging in the cutting process the cutting can be performed non-traumatically for the surrounding tissue.
[0194] The cutting device 6 can be arranged on the proximal side of the insertable element 12 in the deployed configuration 14 or on the distal side of the counter element 9 in the deployed configuration (not shown in FIG. 5a-h).
[0195] In this embodiment the fixation (e.g. suturing and/or stapling) device 15 is located on the insertable element 12 and allows for suturing the tissue wall 25 in the deployed configuration 14. It would also be conceivable that the fixation device 15 is located on the distal end of the counter element 9. As illustrated in FIG. 5f the insertable element 12 and counter element 9 can be rotatable around the entry opening 31 in order to cut and fixation (e.g. suture and/or staple) the anastomosis 301. It would be conceivable that only the fixation device 15 is rotatable around the cut tissue wall 25.
[0196] FIGS. 5g and 5h show that the insertable element 12 can be converted to the stowed configuration 13 after cutting and fixation is complete. In the final step the insertable element 12 can be removed in the stowed configuration 13 through the tube 1 with the cut-out tissue (not shown in FIG. 5h).
[0197] FIGS. 6a to 6g show an alternative embodiment of the insertable element 12 in the stowed configuration 13 and deployed configuration 14 cutting tissue with the counter element 9. FIG. 6a shows the insertable element 12 in the stowed configuration 13 with a lateral profile corresponding to the entry opening 31 in the tissue. FIG. 6b shows that the lateral profile of the insertable element 12 is increased by folding radially outward mechanically. However, also an inflatable and/or a rotatable insertion element 12 would also be conceivable. FIGS. 6c and 6d show the formation of an enclosed interface 40 of tissue between the counter element 9 on the proximal side of the tissue and the insertable element 12 in the deployed configuration 14 on the distal side of the tissue. The cut-out tissue can be clenched in the interface 40 and removed through the tube (not shown in FIG. 6d-6g). The insertable element 12 and counter element 9 can be rotatable around the entry opening 31. A section of the tissue wall 25 can be cut and the edges of the interface 40 can be fixated (e.g. sutured and/or stapled) by the fixation device 15. FIG. 6e-6g show that the insertable element 12 in the stowed configuration 13 can be removed consequently. It is not shown explicitly in the FIGS. 5a-5g and 6a-6g but the tissue wall 25 can comprise in fact the tissue wall of the first area of the stomach 201 and the second area of the bowel 202. After creation of anastomosis 301 the insertable element 12 in the stowed configuration 13 can be removed by retracting the operating element 5.
[0198] FIGS. 7a to 7g show an alternative embodiment of the apparatus with an insertable element 12 in the stowed configuration 13 and deployed configuration 14 cutting tissue with the counter element 9. FIG. 7a-7g are largely analogous to FIG. 5a-5h and/or FIG. 6a-6g and the same description applies respectively. As shown in FIG. 7a the counter element 9 can be arranged concentrically to the operating element 5. FIG. 7b shows that the distal region of the insertable element 12 in the stowed configuration 13 comprises a piercing element 11 which can be inserted in the entry opening 31. The operating element 5 comprises connection means 33 to the insertable element 12 which allow for a rotation of the insertable element 12 in the deployed configuration 14. In the deployed configuration 14 the lateral profile of the insertable element 12 is increased in relation to the stowed configuration 13. The insertable element 12 can rotate freely in order adapt to the surface conditions of a tissue surface but a rotation around a fixed angle would also be conceivable.
[0199] FIG. 7c-7f show that the connection means 33 can be moved relative to the counter element 9 in order to enclose the tissue wall 25 between the insertable element 12 in the deployed configuration 14 and the counter element 9.
[0200] The counter element 9 and the insertable element 12 are designed to enclose tissue concentrically around the entry opening 31. The cutting device can cut-out a section of the enclosed first and/or second area tissue walls 25 (not shown in the figures). The cut-out tissue 26 can be clenched between the insertable element 12 and the operating element 5 in order to be removed through the tube.
[0201] FIGS. 8a-8g show a surgical anastomosis 301 of the apparatus 101 using a guiding wire 24. The apparatus 101 comprises two guiding wires 24 which can be inserted into the stomach 201. FIG. 8b shows that one guiding wire 24 can be inserted at the first area in the stomach 201. The other guiding wire 24 can be inserted through the pylorus 27 and duodenum to the second area inside the bowel 202. FIG. 8c shows that distal ends of the two guiding wires 24 can be connected across the tissue wall of the stomach 201 and bowel 202. FIGS. 8d and 8e show that the tube 1 and the second tube 21 can be advanced along the guiding wire 24.
[0202] FIG. 8e further shows that the distal end 22 of the second tube and distal end 3 of the tube 1 can be connected across the tissue walls of the stomach 201 and bowel 202 across the first and second area. FIG. 8f shows that the apparatus 101 can be removed after successfully creating an anastomosis 301.
[0203] FIG. 8g shows that fusing means 20 which are illustrated in FIG. 9a and FIG. 9b can be advanced along the guiding wire 24. The fusing means 20 are designed to establish close contact of the first area and second area. For establishing close contact, the fusing means 20 can comprise a deployable balloon 34. However, fusing means 20 with deployable flanges 35 (shown in FIG. 9a and FIG. 9b) would also be conceivable. The fusing means 20 can be placed between the cut-out area in the first area and second area of by guiding the tube 1 or the second tube 21 along the guiding wire 24.
[0204] The fusing means 20 are designed to cause the fusion of tissue by applying a compressive force and heating.
[0205] FIG. 9a shows the fusing means 20 with closed flanges 35 and FIG. 9b shows the fusing means 20 with open flanges 35. In the embodiment in FIG. 9a and FIG. 9b the tissue can be clamped by flanges 35 and heated through radio-frequency heating. However, other means for heating could also be conceived. The distal end 38 of the fusing means 20 is shaped conical for easier insertion in the region of the first area and second area to create an anastomosis 301 by fusing the tissue edges. The lateral profile of the anastomosis 301 is determined by the lateral width 36 of the fusing means 20 in the region between the flanges 35. The anastomosis 301 using the fusing means 20 can establish permanent communication between the stomach 201 and the bowel 202. After the procedure the fusing means 20 can be retrieved and there is no need for a permanent implant, sutures and/or staples.
[0206] FIGS. 10 and 11, illustrate an optional technique to supplement an anastomosis, however formed (and not shown explicitly in FIG. 10). The technique involves application of at least one tissue-penetrating fixing 80 to reduce the natural volume of the stomach by creating one or more pleats 82 (or artificial folds) in the stomach wall. In the illustrated example, the fixing 80 is a staple, optionally having a U-shaped profile, with T-shaped limb ends. The fixing (s) may, for example, be placed by an endoscopic technique or a laparoscopic technique. Optionally, the fixing (s) may be placed using the same apparatus as that used for forming the anastomosis, or a different apparatus may be used.
[0207] The one or more pleats 82 may extend in a direction that is generally (i) from top to bottom of the stomach, and/or (ii) from the oesophagus to the pylorus. Such pleats 82 can form a generally sleeve shape cavity or passage in the stomach.
[0208] It will be appreciated that the foregoing description is merely a non-limiting description of illustrative examples of the invention, and does not limit the scope of protection. Protection is claimed for any novel feature and/or idea described herein and/or illustrated in the drawings, whether or not emphasis has been placed thereon.
