Transabdominal Gastric Device and Method

Abstract

Provided herein are trans-abdominal gastric systems and related methods that are useful in a range of applications for accessing internal regions of a patient. A cannula has internal and external anchors to reliably secure the anchor to an abdominal wall of the patient. An introducer with a capture element facilitates system placement by retrograde introduction. Upon completion, the system is removed and the gastric and abdominal wall incision and defect closed by sutures specially connected to the system that ensures reliable system removal and suture closure in a configuration that is outside the abdominal wall. The systems and methods are particularly suited for use with conventional laparoscopic or endoscopic medical instruments.

Claims

1. A surgical system comprising: a cannula having: an outer end; an inner end; a central portion having an outer-facing surface that extends between said inner end and said outer end and an inner-facing surface that defines a lumen configured to receive a portion of a medical instrument that traverses between said outer end and said inner end; an internal anchor connected to said inner end and having a surface shape configured to secure the system against an interior surface of an organ wall or peritoneal surface; and an external anchor removably and translationally connected to said cannula outer-facing surface and having a surface shape configured to secure said system against a skin surface.

2. The system of claim 1, wherein said internal anchor surface shape is adjustable, deployable, or both.

3. The system of claim 2, wherein said internal anchor is selected from the group consisting of: a balloon; a hinged umbrella; and a flexible bumper.

4. The system of claim 1, wherein said internal anchor encircles said cannula inner end and is configured to secure said system to an interior surface selected from the group consisting of; a stomach; upper GI tract; small intestine; liver, gall bladder, colon; spine, pancreas; kidney; a peritoneal cavity; and a retroperiteneal space.

5. The system of claim 1, wherein said internal anchor comprises a bumper and said bumper and said cannula are formed from a unitary material.

6. (canceled)

7. The system of claim 1, wherein said external anchor comprises a disc having an inner-facing surface that defines a passage for receiving said cannula.

8. The system of claim 7, wherein said translationally connected disc and cannula outer-facing surface comprises a matched internal thread and external thread pair on facing surfaces of said disc inner-facing surface and said cannula outer-facing surface, wherein rotation of said disc relative to said cannula outer-facing surface translates said disc along at least a portion of said cannula outer-facing surface.

9. The system of claim 7, wherein said disc comprises: a central body that defines said passage; and a flange connected to said central body, said flange comprising a plurality of passages extending there through.

10. The system of claim 9, wherein the plurality of passages are arranged in a circumferential offset pattern relative to a central body having a substantially circular shape.

11. The system of claim 10, wherein adjacent passages are separated by a separation distance that is greater than 1 mm and less than 4 mm and have alternating separation distances from said central body corresponding to a minimum separation distance and a maximum separation distance.

12. The system of claim 11, wherein said flange has an outer edge that is an octagon shape and the plurality of passages number eight, the plurality of passages comprising four corner-positioned passages and four side-positioned passages with adjacent corners separated by an individual side-positioned passage, with the corner-positioned passages separated from the central body by the maximum separation distance and the side-positioned passage separated from the central body by the minimum separation distance, wherein each of the plurality of passages is positioned adjacent to a corner region of the octagon shape flange outer edge.

13. The system of claim 9, further comprising a plurality of suture threads, wherein each individual suture thread traverses a pair of opposed passages.

14. The system of claim 1, further comprising a cap removably connected to said cannula outer end.

15. The system of claim 14, said cap comprising one or more instrument ports configured for introducing one or more medical instruments to said cannula lumen and out of said inner end and into a patient when the system is anchored to a wall by said internal anchor and a skin surface by said external anchor.

16. The system of claim 15, said cap comprising a plurality of instrument ports formed from a memory sealant, each instrument port having an independently selected size and introduction angle.

17. The system of claim 14, further comprising a pressure port operably connected to said cap for measuring or controlling pressure at said cannula inner end.

18. The system of claim 14, further comprising a stopcock connected to said cap for providing controlled access to said cannula lumen.

19. The system of claim 1, having an external anchor removed configuration for said external anchor removed from said cannula, the system further comprising an introducer removably connected to said cannula outer end in said external anchor removed configuration.

20. The system of claim 19, wherein said introducer comprises a receiving opening that removably receives said cannula outer end and at least a portion of said cannula central portion.

21. The system of claim 20, wherein said introducer comprises: a distal end; a proximal end through which said receiving opening traverses; a tapered central portion extending between said distal end and said proximal end; a capture element connected to said distal end; and wherein said tapered central portion is configured for introducing said system to a patient by retrograde introduction past a patient's oropharynx by pulling a guidewire connected to said capture element in a direction away from a patient surface.

22. The system of claim 19, wherein said introducer has a flexibility or bending moment selected so that said introducer is capable of deforming to follow contours of a patient oral-pharynx and esophagus during insertion in a patient.

23. The system of claim 19, having an introducer removed configuration, wherein in said introducer removed configuration, said external anchor is connected to said cannula outer surface in an external anchor deployed configuration.

24. An insertable trans abdominal gastric surgical system comprising: an introducer having a receiving passage and an outer tapered surface; a cannula having: an outer end removably connected to said introducer receiving passage; an inner end; a central portion having an outer-facing surface that extends between said outer end and said inner end and an inner-facing surface that defines a lumen configured to receive a portion of a medical instrument that traverses between said outer end and said inner end; an internal anchor connected to said inner end and having a surface shape configured to secure the system against an interior surface of an organ wall or peritoneal surface; wherein said introducer, cannula and internal anchor are configured for insertion into a patient by retrograde introduction past a patient's oropharynx and along an esophagus.

25. The system of claim 24, wherein said introducer comprises: a distal end; a proximal end through which said receiving passage traverses, wherein said receiving passage has an at least partially threaded inner-facing surface to rotationally and removably engage an at least partially threaded cannula outer facing surface.

26. The system of claim 25, further comprising a capture element connected to said distal end configured to connect to a guidewire to facilitate guided insertion in a direction through a patient's oropharynx and esophagus.

27. The system of claim 25, said outer tapered surface having: an angle of incidence at said distal end that is greater than or equal to 5 and less than or equal to 20; a total length that is greater than or equal to 2 cm and less than or equal to 15 CM; a tapered portion extending from said distal end and a substantially untapered portion extending between said proximal end and said tapered portion, having a tapered portion longitudinal length to untapered portion longitudinal length ratio (L.sub.T/L.sub.U) that is greater than or equal to 1 and less than or equal to 5; and wherein said introducer has a flexibility selected so that said introducer is capable of deforming to follow contours of a patient oral-pharynx and esophagus during insertion into a patient.

28. A method of inserting a surgical system in a patient, the method comprising the steps of: inserting a guidewire through a patient wall incision and into a patient organ or peritoneal space; guiding a portion of said inserted guidewire through an esophagus and mouth to provide an accessible portion of said guidewire; connecting a capture element of an introducer trans-abdominal gastric surgical system assembly to said accessible portion of said guidewire; pulling the guidewire connected to the capture element of the introducer surgical assembly in a direction away from the patient so the assembly is introduced into the patient organ or peritoneal space; continuing to pull the guidewire out through said wall incision to advance the introducer portion of said assembly out of the patient through said wall incision so that an internal anchor of said trans-abdominal gastric surgical system contacts an inner-facing organ wall or peritoneal surface of the patient; removing said introducer from said assembly to reveal an exposed end of said surgical system; connecting an external anchor to said exposed end of said surgical system; and moving said external anchor in a direction toward a skin surface of the patient to contact the skin surface in a position that faces said internal anchor to reliably secure said surgical system to the patient; thereby inserting said surgical system.

29. The method of claim 28, further comprising the step of attaching a cap to said exposed end of said inserted surgical system.

30. The method of claim 29, further comprising the step of introducing one or more than one surgical instruments through the surgical system for use in a procedure selected from the group consisting of: instrument triangulation; accessing a stomach lumen; accessing a retroperitoneal space; manipulating tissue; closing an incision; a gastric surgery; a gall bladder surgery; single or simultaneous access to an upper GI tract and small intestinal lumen; access of an intra-peritoneal space; and access of an extra-peritoneal space and associated organs.

31. The method of claim 28, further comprising the step of: placing a plurality of pre-sutures through the organ or peritoneal surface and an abdominal wall.

32. The method of claim 31, further comprising the step of temporally resting said internal anchor against a luminally-facing organ surface; pulling said internal anchor through the organ wall, thereby providing an open insertion through the organ wall with said plurality of pre-sutures around said gastric wall insertion; and securing said internal anchor to an inner-facing surface of the abdominal wall.

33. The method of claim 29, further comprising the step of removing the surgical system after procedure completion by: inserting at a start of or before the procedure a plurality of sutures by: introducing a cannulated-introducer needle through a first passage in the external anchor and through a first underlying tissue region comprising an abdominal and organ wall and into an organ environment; introducing a suture grasper through a second passage in the external anchor and through a second underlying tissue region comprising the abdominal and organ wall and into the organ environment, wherein the second passage is opposibly positioned relative to the first passage; placing a suture thread proximal portion through the cannulated-introducer needle; guiding a suture thread distal portion past an outer-facing surface of the internal anchor, wherein the suture thread distal portion longitudinally extends from the suture thread proximal portion; grasping at least a portion of said suture thread distal portion with said suture grasper; pulling the suture grasper and suture thread distal portion out of the organ environment and through the underlying abdominal and organ wall and the external anchor second passage, wherein the suture thread portion in the body is positioned around or beyond said internal anchor to avoid interference with an instrument introduced through a working channel formed by the surgical system; repeating the above steps with a second suture thread positioned through a third external anchor passage, fourth external anchor passage, and corresponding third and fourth underlying tissue regions comprising the abdominal and gastric wall; removing the cannulated-introducer needle and the suture grasper to reveal matched pairs of suture thread proximal and distal portions; loosening or removing the external anchor from said exposed end of said surgical system; removing the surgical system in a direction that pulls the internal anchor through the organ and abdominal wall and pulling the revealed matched pairs of suture thread proximal and distal portions in a direction away from the patient, thereby removing the surgical system from the patient; and suturing the suture threads in a position that is outside the abdominal wall thereby closing an abdominal and organ wall defect formed by the step of removing the gastric surgical system.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0043] FIG. 1A. Perspective view of a trans-abdominal gastric surgical system without an external anchor. FIG. 1B is a side view of FIG. 1A, illustrating the internal anchor interior surface that forms a hollow opening by the dashed lines. FIG. 1C is a different perspective view that better illustrates the internal anchor geometry and hollow interior volume. FIGS. 1D-1F are perspective views of the system in an external-anchor connected configuration.

[0044] FIGS. 2A-2D. Views of a trans-abdominal gastric surgical system with external anchor and cap showing the interior volume of the internal anchor (FIG. 2A), the instrument port (FIG. 2B), a side view (FIG. 2C) and cross-section showing internal surfaces (FIG. 2D).

[0045] FIG. 3A. A trans-abdominal gastric surgical system and connector element ready to receive a guidewire for insertion into a patient (left panel). The right panel is a close-up view of the capture element connected to the introducer distal end. FIG. 3B shows the introducer connected to the trans-abdominal gastric surgical system with a side view with (left panel) and without (middle panel) the capture element, and a perspective view showing the internal surfaces (right panel). FIG. 3C shows the introducer portion only from a perspective view (left panel), a side view (middle panel) and through cross-sectional line E-E (right panel).

[0046] FIG. 4. Flow chart summary of system introduction to a patient and corresponding to illustrations in FIGS. 5-7 for an insertion method to form a working channel to the stomach lumen and FIG. 24 (element 10A providing a working channel to the peritoneal cavity for medical instrument 12A).

[0047] FIG. 5. Guidewire insertion through the abdominal and gastric wall, up the esophagus and out of the patient mouth.

[0048] FIG. 6. Guidewire connection to a capture element of an introducer-system that is ready for retrograde introduction.

[0049] FIG. 7 Retrograde introduction of the introducer-system to the gastric environment, by pulling the guidewire away from the abdominal incision, thereby forcing the introducer through the abdominal wall incision.

[0050] FIG. 8. Internal anchor in position against the gastric wall, introducer removed, external anchor and cap connected, and positioning of the external anchor against an outer surface of the patient to provide reliable positioning of the system and a reliable working channel through the abdominal wall and the gastric lumen. Also illustrated is an endoscope having a fiber optic light source.

[0051] FIG. 9. Flow chart summary of a method of removing the system; and as schematically illustrated in FIGS. 10-13.

[0052] FIG. 10. Cross-section of the system through the first and second external anchor flange passages to illustrate suture thread introduction.

[0053] FIG. 11. The suture thread of FIG. 11 is grasped and pulled out of the patient with a grasper that traverses a second external anchor passage that is opposibly positioned relative to the first external anchor passage.

[0054] FIG. 12. The steps outlined in FIGS. 10-11 are repeated for a second suture thread.

[0055] FIG. 13. The system and accessible suture threads are pulled so that all suture threads and the internal anchor are pulled outside the abdominal wall, thereby suturing the incision closed.

[0056] FIG. 14. Stomach incision for accessing intra-peritoneal space made by trans-abdominal gastric system placement with internal bumper pulled thru the gastric wall and positioned against the peritoneal surface (not shown, but see FIG. 16).

[0057] FIG. 15 Triangulation with two trans-abdominal gastric systems and an endoscope.

[0058] FIG. 16. Use of the system illustrating a cannula anchored to the gastric surface and a second cannula anchored to the peritoneal surface for simultaneous intra- and extra-luminal access, such as for gall bladder drainage.

[0059] FIG. 17 illustrates a side view of the system in use and spanning from outside the patient through to the gastric environment, with a working channel defined by a cannula of the system disposed therebetween.

[0060] FIG. 18. Top and side view of the external anchor (top left and right panels) and a cross-sectional view of the cannula and internal anchor portion (bottom panel).

[0061] FIG. 19 illustrates an external anchor: A perspective, B top, and C side views. The right panel in view B has an octagon flange edge shape compared to the circular flange edge shape in the left panel.

[0062] FIG. 20 shows a detailed view of the use of suture threads through the external anchor passages to facilitate system removal. A shows one suture thread. B shows two suture threads.

[0063] FIG. 21 provides examples of various caps and instrument ports, including A cap side view; B hinged cap top view open configuration; C hinged cap side view; D cap with a plurality of instrument ports and a pressure port.

[0064] FIG. 22 includes examples of different internal anchor mechanisms, including: A bumper; B balloon; C hinge; and D hinged umbrella.

[0065] FIG. 23 illustrates an application using two trans-abdominal gastric systems and an endoscope, to provide medical instrument triangulation on a specific lumen gastric region.

[0066] FIG. 24 illustrates access to the peritoneal space with a system that is anchored to the peritoneal surface, such as by a transabdominal gastric system that is pulled through the gastric wall and positioned against the peritoneal surface, with a resultant incision through the gastric wall and available, as desired for access by medical instruments, either intra-luminally or trans-luminally. With this configuration of systems, a tissue may be approached, extralumenally, intralumenally, or both. An endoscope may be used, such as for intra- and/or extra-luminal visualization

DETAILED DESCRIPTION OF THE INVENTION

[0067] In general, the terms and phrases used herein have their art-recognized meaning, which can be found by reference to standard texts, journal references and contexts known to those skilled in the art. The following definitions are provided to clarify their specific use in the context of the invention.

[0068] Bumper refers to a shape of the internal anchor outer surface that is substantially curved and configured to provide reliable contact with an inner surface of a biological tissue, such as the stomach wall or peritoneal surface.

[0069] An internal anchor of the present invention is the element that is positioned in the body and that anchors the device to an inner surface of the body, in combination with the external anchor. The internal anchor may be shaped and configured so as to facilitate controlled transit through an incision in a wall, such as a gastric and/or an abdominal wall. For example, the internal anchor may be a relatively thin-walled bumper shaped to provide an exit volume on an inner-facing surface with the outer-facing surface providing a reliable connection to a luminal-facing surface of a wall, such as a gastric wall, a peritoneal wall, or an abdominal wall. In this manner the bumper may secure the system to a wall under a securing force. As desired, a removal force that is greater than the securing force may be used to controllably pull the internal anchor through the gastric wall and/or abdominal wall. Adjustable or deployable internal anchor surface shape refers to an internal anchor that can be adjusted or actuated from a first state or shape to a second state or shape. For example, a balloon-type internal anchor can have a surface shape that is adjustable by varying the pressure in the internal volume encompassed by the balloon surface or deployable by inflating from an uninflated state. An umbrella-type mechanism may be adjusted to provide surface shape adjustability in curvature. This aspect also facilitates control of the total surface contact area between the internal anchor surface and the corresponding biological surface, including the stomach or peritoneal wall.

[0070] Flexible refers to shape deformation under an applied force. Accordingly, a flexible anchor or flexible bumper refers to an anchor or bumper whose shape can at least partially conform to increase the magnitude and reliability of the contact area between the anchor and the corresponding biological surface. A flexible introducer, refers to the ability to deform in order to navigate the contour of a patient's anatomy for system introduction. One quantitative indication of flexibility is Young's modulus (defined as stress/strain). In an aspect, the introducer and/or cannula is formed of a polymer material having a Young's modulus that is less than or equal to 10 GPa, less than or equal to 10 MPa, or less than about 1 MPa, or any other range that provides the desired functional outcome of system flexibility during introduction along the esophagus. Similarly, the material durometer is selected to ensure the system and cannula is relatively soft to further reduce irritation during introduction or passage through a biological tissue.

[0071] Similarly, the dimensions and geometry of the introducer and cannula in combination with the material properties may provide a bending moment useful for system introduction to the gastric environment via the esophagus. Bending moment refers to the force on a portion of the introducer and cannula that generates a corresponding deflection of the introducer and cannula. The bending moment may be quantified based on a cantilever approximation, with an introducer having one end fixed, such as the proximal end that is connected to the cannula, and the other end such as the distal end that is free to move. The bending moment is selected so that a typical force experienced when introducing the system into a patient allows the system to follow contours of the oral-pharynx and esophagus, the system correspondingly bends or deflects to follow the contours and facilitate introduction and minimize unwanted forces on the oral-pharynx and esophageal wall.

[0072] Removably connected refers to a configuration of elements, wherein the elements can be temporarily connected to each other and, as desired, removed from each other without adversely impacting the functionality of other elements of the device. Translationally connected refers to a configuration of elements, wherein motion of one element is substantially unidirectional and parallel with respect to another element, wherein movement of one element does not affect each element's functionality. Operably connected refers to a configuration of elements, wherein an action or reaction of one element affects another element, but in a manner that preserves each element's functionality. For example, a pressure port operably connected to a cap refers to the ability to monitor or effect pressure change without impacting the functionality of the cap, including having other ports for introduction of medical instruments.

[0073] Unitary material refers to two elements that are integrally connected, such as an internal anchor and cannula that are formed from one piece. This is in contrast to identical material that may have separate elements that permanently connected, such as by an adhesive or bond, or removably connected such as by a threaded connection.

[0074] Capture element refers to the portion of the introducer on which a force is exerted so as to advance the system into the patient, such as past the oropharynx, down the esophagus, into the gastric environment and through the abdominal wall so that one end of the system remains in the patient and the opposite end is accessible from the environment that is outside a patient's body. The invention is compatible with a range of capture elements, so long as the ability to reliably introduce the system by retrograde introduction via the esophagus is not impacted. Specific examples include, but are not limited to, a wire loop, a suture, a connection mechanism such as snap-fit, magnets, threaded attachment, clamp or fasteners.

[0075] Fluid refers to a material that may be removed or introduced from a volume to effect a change in pressure, including a material that flows under an applied force. Depending on the application of interest, the fluid may be a gas, a liquid, a gel, or a combination thereof.

[0076] Unless defined otherwise, substantially refers to a value that is within at least 20%, within at least 10%, or within at least 5% of a desired or true value. Substantially, accordingly, includes a value that matches a desired value.

Example 1: Trans-Abdominal Gastric Surgical System

[0077] Referring to FIGS. 1-3, a trans-abdominal gastric surgical system, also interchangeably herein as trans-abdominal gastric cannula 10 or generally, system, has a cannula 20 with an outer end 22, an inner end 23 and a central portion 24. Central portion has an outer-facing surface 25 that extends between the inner end and the outer end and an inner-facing surface 26 that defines a lumen 27 configured to receive a portion of a medical instrument 12 (see, e.g., FIG. 24) that traverses between the cannula outer and inner ends, such as from outside the patient to inside the patient. An internal anchor 30 is connected to the inner end 23 and has a surface shape 32 configured to secure the system against an interior surface of a gastric wall or peritoneal surface. An external anchor 40 is removably and translationally connected to the cannula outer-facing surface and has a surface shape 42 configured to secure the system against a skin surface (FIGS. 1D-1F). Accordingly, FIGS. 1A-1C illustrates an external anchor removed configuration, because external anchor 40 is not connected. This is in contrast to FIGS. 1D-1F and FIGS. 2A-2D (also showing cap 50), where external anchor 40 is connected and is capable of being positioned at various longitudinal distances along cannula axis, as indicated by arrow 46 directed along the system longitudinal axis.

[0078] As illustrated, the internal anchor may correspond to a bumper having a curved outer surface 32 with a maximum diameter 33, a height 34, an open exit diameter 35, and a hollow interior volume 36 formed by a thin-wall 37 (see, e.g., FIGS. 1B-1C and FIG. 2C).

[0079] Referring to FIGS. 1D-1F (external anchor connected configuration), FIGS. 2A-2D (external anchor and cap connected) and FIG. 19 (external anchor removed), external anchor 40 may be a disc having an inner-facing surface 43 that defines a passage 44 for receiving a cannula, more specifically cannula central portion 24. The translational connection between external anchor 40 and cannula 20 may be a matched internal thread 28 and external thread 45, illustrated as being on the inner-facing surface 43 of external anchor 40 and outer-facing cannula surface 25 of cannula 20, respectively. In this manner, the external anchor may be positioned to have any desired separation distance from the internal anchor by moving along the cannula in a longitudinal direction, as indicated by arrow 46. Other translational connections may be employed, including a tight friction fit, clamp, snap-fit, fasteners, set screws, or the like. The external anchor 40 may have a central body 47 in which the passage 44 is disposed and a flange 48 connected thereto. A plurality of second passages 49 may extend through the flange, for facilitating suture placement and system removal.

[0080] To provide controlled access to the cannula from the outer end 23 a cap 50 may be removably connected to the cannula outer end (FIG. 2A-2D). The cap may have one or more instrument ports 51 through which one or more medical instruments 12 may be inserted. The instrument port 51 may be formed from a memory sealant material 52, including a multilayer sealant (FIG. 21A). A pressure port 53 may be connected to the cap 50 to control pressure, such as by removal or introduction of a fluid to cannula inner end 22, and thereby to the gastric environment. Controlled access to the cannula may also be provided by a stop-cock 54 type mechanism connected to the cap.

Example 2: Introducer for Introducing the Device to a Patient

[0081] To facilitate system introduction to a patient, an introducer 60 may be used. Referring to FIG. 3A-3C, introducer 60 is removably connected to the system, such as when the external anchor 40 is removed as shown in FIG. 1A-1C, so as to provide a system that may be introduced to the gastric environment by retrograde introduction past a patient's oropharynx and into the gastric environment. Accordingly, FIG. 1A-1C may be further described as in an introducer-removed configuration and FIG. 3A-3B in an introduction ready configuration that is ready to be inserted into the patient by retrograde introduction. The introducer may have a receiving opening 61 that removably receives the cannula outer end 22 and a portion of the cannula central portion 24. The introducer may have a tapered portion longitudinal length (L.sub.T) and an untapered portion longitudinal length (L.sub.U) and a corresponding ratio, L.sub.T/L.sub.U. The receiving passage may have a threaded portion, such as to removably engage with the cannula central portion, in a manner similar to that of the external anchor and cannula central portion. A distal end 62 may connect to a capture element 65, illustrated as a wire loop. A proximal end 63 may contain the receiving opening 61, and a tapered central portion 64 that extends between the distal 62 and proximal 63 ends. In this manner, a guidewire 68 (see, e.g., FIGS. 5-7) may be used to pull the introducer and system combination into the gastric environment. The tapered end of the introducer may then be pulled through the incision in the gastric wall and abdominal wall through which the guidewire passes to provide a reliable contact area between the internal anchor and the gastric wall, as well as gently expanding the abdominal opening to ensure a good fit in the abdominal wall. Similarly, reliable contact area between the internal anchor and an inner facing surface of the peritoneal cavity may be established for an equivalent incision for a guidewire provided therein.

[0082] Once the system is positioned accordingly, the introducer may be removed to provide an introducer-removed configuration 67 that is ready to receive the external anchor 40, and illustrated in FIG. 8 as having already received external anchor 40 and cap 50 affixed thereto that in combination with internal anchor 30 secures the cannula to the abdominal wall.

Example 3: Closure System Removal

[0083] An important benefit of the instant systems and methods is the ability to simply, reliably and robustly close the gastric and abdominal incision or defect through which the system traverses and is pulled through. This is achieved, in part, by the plurality of passages 49 through the flange 48 of the external anchor 40 (FIGS. 2A-2B). Referring to the flow chart of FIG. 9 and corresponding diagrams of FIGS. 10-13 and schematic of FIG. 20, passages 49 facilitate guided insertion and removal of one or more suture threads 70 76 (FIG. 12). In particular, first thread 70 is inserted into first passage 71, such as by a cannulated-introducer needle 80 containing a suture thread proximal portion 74. A suture grasper 81 grabs a suture thread distal portion 75 and pulls the suture thread through second passage 72, that is geometrically opposed to first passage 71. Geometrically opposed in this aspect refers to a pair of passages wherein at least a portion of the external anchor central body 47 is disposed therebetween. Accordingly, with the illustrated configuration, the opposed passages may be 180 opposed (see inset of FIG. 13). The invention, however, is compatible with variations on the opposed configuration, so long as a portion of the suture thread traverses the outer-most facing surface of the internal anchor. As desired, a second suture thread 76 is similarly placed through third passage 77 and fourth passage 78 (FIG. 12 inset). In this manner, when the system is desired to be removed, the exposed suture threads are pulled away from the patient to remove the system and provide reliably sutures 82 that close the incision outside the abdominal wall. As desired, for a plurality of unique suture threads, different color threads are used to ensure the appropriate ends are tied together, such as red-to-red and blue-to-blue.

Example 4: System Introduction and Placement

[0084] Any one or more of the systems described herein is readily and reliably introduced to a patient. An example of one such method for introducing the system is summarized in the flow chart of FIG. 4 and corresponding illustrations FIG. 5-8.

[0085] Briefly, in steps 1000, 1010 and FIG. 5 a guidewire is inserted through an abdominal wall and into the stomach lumen, including using a standard or modified Seldinger technique. This guidewire may be directly inserted from the abdominal wall and into the stomach lumen. In step 1020, a capture element of the introducer is connected to the guidewire at one end. At the other end of the introducer the trans-abdominal gastric system is connected thereto (FIG. 6). The guidewire is then pulled in a retrograde direction, as shown in FIGS. 6-7 and step 1030 to introduce the system through the oral-pharynx, esophagus and into the stomach lumen, so that the internal anchor contacts the stomach wall (FIG. 8). In contrast, for a system that is to be anchored to the peritoneal wall, the system may be positioned with an internal anchor resting against the gastric wall, sutures prepositioned, and the internal anchor pulled entirely through the gastric wall and into position against the peritoneal surface (see, e.g., FIG. 25, illustrating one system 10 anchored to the gastric wall and a second system 10A anchored to the peritoneal surface), with similar steps thereafter. Sutures are pre-positioned through the gastric wall, via the abdominal wall, in step 1031, including by the various steps outlined in FIG. 9 jncluding steps 1161 of FIG. 9. In this manner, irrespective of the final end position of the internal anchor (e.g., internal anchor positioned against the inner-facing peritoneal surface 1035 or internal anchor positioned against the inner-facing stomach wall 1031), upon procedure completion, the defect in the gastric wall and abdominal wall are readily closed via the pre-positioned sutures. In step 1040, the introducer is removed. The external anchor and cap (FIG. 8) are connected to the system, so that the system is reliably anchored to the abdominal wall (step 1050), thereby providing a working channel to the stomach lumen 1060 for subsequent applications, as desired. As will be appreciated, an equivalent methodology is employed to provide system anchoring to the peritoneal surface to provide extra-luminal access relative to the stomach lumen. This is illustrated in step 1035, wherein the internal anchor is pulled through the stomach wall and subsequently secured to the inner-facing peritoneal surface, with equivalent steps 1040 and 1050 used to provide a working channel 1065 to the peritoneal space, and thereby providing extra-luminal access. This is explicitly illustrated with system 10A of FIG. 24, and opening 200 in the gastric wall formed by system 10A. As desired, pre-closure elements may be pre-positioned through the gastric wall and aligned with the abdominal wall in a manner equivalent to that summarized in FIGS. 9-13. This is an efficient and effective closure system that avoids the often time-consuming and laborious end-surgical routine of aligning the gastric wall incision with the abdominal wall incision before. FIG. 16 illustrates two pre-closure sutures passing through the abdominal and gastric walls, with the cannula system anchored to the perineal cavity to provide intra-peritoneal and extra-luminal access. In this manner, the pre-closure sutures ensure the defects in the gastric and abdominal walls are aligned and readily sutured upon surgical completion.

Example 5: Removal Methods

[0086] An example of a method for removing the system in a safe and effective manner is summarized in the flow chart of FIG. 9 and corresponding illustrations FIG. 10-13. Passages 49 in the external anchor facilitate controlled suture positioning at the start of a surgical procedure. In steps 1100 and 1110, cannulated introducer needle 80 and suture grasper 81 are positioned through first passage 71 and second passage 72, respectively (FIG. 10) and underlying tissue into the gastric space. A suture thread is grasped and pulled through passage 71 and out of passage 72, thereby providing a threaded loop around the outermost portion of the internal anchor (FIG. 11 and steps 1120 1130 and 1140). As desired, steps 1100-1140 are repeated to obtain additional suture threads at different orientations from each other (FIG. 12 and repeating step 1150). The suture thread ends are pulled away from the patient to remove the system and internal and external anchors, thereby providing sutures 82 outside the abdominal wall 110 (FIG. 13 and steps 1160 1165 1170 1180). This method is simple and reliable, while minimizing the risk of infection or other complications associated with conventional trocar insertion methods. Box 1161 includes those steps that may be used to pre-position sutures during the introduction summarized in FIG. 4 at step 1031. The steps outside box 1161 are those that are used to tie the pre-positioned sutures to close the defects in all walls after procedure completion.

Example 6: Applications

[0087] Because the systems described herein provide reliable and complication-free access to the abdominal cavity, gastric lumen, or both (see, e.g., FIGS. 14-16, 23-24), the systems are compatible with a wide range of applications, including surgical applications. Any conventional endoscopic or laparoscopic instrument may be used with the instant transabdominal gastric surgical systems, including to achieve triangulation with either two or one systems. Various tissues and regions are similarly accessible, either directly or indirectly, with one or more medical instruments. For example, the system may be positioned through the skin and abdominal wall to provide access to the intraperitoneal or retroperitoneal space. Similarly, the system may be positioned through the skin, abdominal wall, and the stomach wall to provide intra-gastric or stomach lumen access. Similarly, use of two systems may provide simultaneous and independent access to both the intraperitoneal space and intra-gastric space. Such a platform is extremely versatile with respect to accessing various organs or regions of the body in an elegant and minimally disruptive manner. For example, from the gastric lumen, various surgical procedures on the stomach wall are performed. In addition, the esophagus and gastro-intestinal tract are readily accessed.

[0088] Furthermore, the intraperitoneal and retroperitoneal space can be accessed from the stomach lumen via an incision through the stomach wall by a trans-abdominal gastric system that has been pulled through the stomach wall (FIG. 14 or 16). Medical instruments in the stomach lumen, from outside the patient, can then pass through the stomach wall incision for an operative procedure in the intraperitoneal space, an organ or tissue surface associated therewith, or an organ moved into the gastric environment from the intraperitoneal or retroperitoneal space. Examples of tissues and organs that are particularly suited for surgical procedures with the systems and methods described herein includes all abdominal-pelvic organs, including the stomach, gall bladder, liver, pancreas, spleen, esophagus, small intestine, large intestine, pelvic organs and the thoracic cavity.

[0089] Examples of various applications are illustrated by the system placements summarized in FIGS. 14-16 and 23-24, and include, for example, endoscopic suturing/stapling, GI tract surgeries, surgery in the peritoneal, retroperitoneal and/or intragastric space, tissue manipulation such as grasping, lifting and incision, apposition of tissue edges, refractory GI bleed, resection of gastric gastrointestinal stromal tumors (GIST), hiatal hernia, fundoplication and gall bladder drainage.

[0090] FIGS. 17-24 describe, in further detail, other system embodiments and exemplary elements thereof. FIG. 17 is a side view of the system in use and traversing from outside a patient, through the skin 100, abdominal wall 110, and stomach wall 120, so that internal anchor 30 is positioned against an inner surface of the stomach wall 120. External anchor 40 is positioned against the skin 100 in an opposed configuration relative to the internal anchor 30. In this manner, the cannula 20 is reliably secured and ready for long term use. Instrument port 51 in cap 50 is ready to receive a medical device 12 (see, e.g., FIGS. 23-24).

[0091] The external anchor 40 is shown in more detail in FIGS. 18-20. In one embodiment, the external anchor flange is disc-shaped. In another embodiment the external anchor flange 48 outer edge comprises a plurality of straight edges 495, illustrated as an octagon. As shown by the middle right panel of FIG. 19, the passages may be defined by a passage separation distance 490, a minimum separation distance 491 and a maximum separation distance 492 from the central body 47 edge. In contrast to the left panel of FIG. 19B, the passages in the right panel form a circumferential offset pattern.

[0092] FIG. 20 shows a detailed view of the use of suture threads 70 76 through the external anchor passages 71 72 and 77 78, respectively, to facilitate system removal.

[0093] FIG. 21 provides examples of various caps and instrument ports. A is a cap side view showing the instrument port may be formed from a memory sealant 52 B is a hinged cap with a lid 250 connected via hinge 251 in an open configuration; C Shows a side view of B. A cap 50 having a plurality of instrument ports 51 and a pressure port 53 is shown in D.

[0094] Examples of different internal anchors are illustrated in FIG. 22, including A bumper. B balloon 260 that provide an adjustable and deployable anchor, via inflation tube 261. C Hinge anchor 262 and D hinged umbrella anchor 263 are examples of deployable internal anchors. Hinge 264 facilitates anchor end 265 movement from a stored to a deployed configuration.

[0095] FIG. 23 illustrates an application using two systems, to provide medical instrument triangulation on a specific internal or luminal gastric region, including with an endoscope.

[0096] FIG. 24 illustrates access to the peritoneal space 142 with a system 10A that is anchored to the peritoneal surface. Also illustrated is an incision 200 in the gastric wall formed by the trans-abdominal gastric system with the internal anchor pulled through the gastric wall and then positioned against the peritoneal surface, so that system 10A may be introduced via retrograde introduction in a manner similar to system 10. With this configuration of systems, tissue may be approached, extralumenally by device 12A via system 10A, intralumenally by device 12 via system 10, or both extralumenally and intralumenally. For simplification, pre-closure suture elements illustrated in FIG. 16 are not shown in FIGS. 23-24.

Statements Regarding Incorporation by Reference and Variations

[0097] All references throughout this application, for example patent documents including issued or granted patents or equivalents; patent application publications; and non-patent literature documents or other source material; are hereby incorporated by reference herein in their entireties, as though individually incorporated by reference, to the extent each reference is at least partially not inconsistent with the disclosure in this application (for example, a reference that is partially inconsistent is incorporated by reference except for the partially inconsistent portion of the reference).

[0098] The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed. Thus, it should be understood that although the present invention has been specifically disclosed by preferred embodiments, exemplary embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims. The specific embodiments provided herein are examples of useful embodiments of the present invention and it will be apparent to one skilled in the art that the present invention may be carried out using a large number of variations of the devices, device components, methods steps set forth in the present description. As will be obvious to one of skill in the art, methods and devices useful for the present methods can include a large number of optional composition and processing elements and steps.

[0099] When a group of substituents is disclosed herein, it is understood that all individual members of that group and all subgroups are disclosed separately. When a Markush group or other grouping is used herein, all individual members of the group and all combinations and subcombinations possible of the group are intended to be individually included in the disclosure.

[0100] Every formulation or combination of components described or exemplified herein can be used to practice the invention, unless otherwise stated.

[0101] Whenever a range is given in the specification, for example, a size range, a time range, or a composition or concentration range, all intermediate ranges and subranges, as well as all individual values included in the ranges given are intended to be included in the disclosure. It will be understood that any subranges or individual values in a range or subrange that are included in the description herein can be excluded from the claims herein.

[0102] All patents and publications mentioned in the specification are indicative of the levels of skill of those skilled in the art to which the invention pertains. References cited herein are incorporated by reference herein in their entirety to indicate the state of the art as of their publication or filing date and it is intended that this information can be employed herein, if needed, to exclude specific embodiments that are in the prior art.

[0103] As used herein, comprising is synonymous with including, containing, or characterized by, and is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. As used herein, consisting of excludes any element, step, or ingredient not specified in the claim element. As used herein, consisting essentially of does not exclude materials or steps that do not materially affect the basic and novel characteristics of the claim. In each instance herein any of the terms comprising, consisting essentially of and consisting of may be replaced with either of the other two terms. The invention illustratively described herein suitably may be practiced in the absence of any element or elements, limitation or limitations which is not specifically disclosed herein.

[0104] One of ordinary skill in the art will appreciate that materials, biological materials and methods other than those specifically exemplified can be employed in the practice of the invention without resort to undue experimentation. All art-known functional equivalents, of any such materials and methods are intended to be included in this invention. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed. Thus, it should be understood that although the present invention has been specifically disclosed by preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims.