JP2010525844A - Anastomosis applier and anastomosis method for performing intraluminal and / or transluminal anastomosis - Google Patents

Abstract

  An anastomotic ring applier system (30) for deploying a first compression ring (36) and a second compression ring (39) includes a second ring configured to hold a second compression ring (39). A first part (42) connectable to an anastomosis applier (32) with a carrier (38) and an external first ring carrier (31) supporting a first compression ring (36); And a ring access device (37) with a second portion (43) connected to a second ring conveying device (38), the first portion (42) being a first thread (47). ) And the second part (43) forms a second thread (48) that meshes with the first thread (47). The rotary device (49) is configured to rotate the first and second parts (42, 43) relative to each other, the parts being translated relative to each other to provide compression rings (36, 39). ) Approach and interconnect.

Description

Disclosure details

  The present invention relates generally to devices and methods for surgically modifying organs and vessels, and more particularly, by attaching an anastomotic ring device including two snap-connectable rings, particularly in the GI tract. And / or surgical instruments and methods that perform transluminal anastomoses, such as gastrojejunostomy, jejunum jejunostomy, or similar interventions, such as colorectal anastomoses, jejunocolonic anastomoses, or anastomoses involving the bile duct.

  Known surgical methods and instruments for performing the aforementioned anastomosis by attaching an anastomotic ring device are traditionally open or abdominal, which are somewhat invasive and require the use of highly complex and cumbersome surgical devices. Requires mirror surgery techniques. As a result, the risk of complications after surgery is undesirably high.

  Furthermore, the known devices and methods are not suitable for performing anastomoses by pure endoscopic or endolumenal approaches, or at least partially endoscopic or intraluminal approaches.

  Such an intraluminal approach would significantly reduce the disadvantages of traditional open surgery and laparoscopic methods if supported by appropriate instrumentation. In particular, intraluminal surgery will reduce the invasiveness of the intervention, thereby reducing the risk of complications and shortening the patient's post-operative course.

  Even though endoscopic and intraluminal approaches to anastomosis are very promising, it is currently very difficult to actually use such an approach, for example to perform gastrointestinal anastomoses. For example, the instruments and methods are not well developed to ensure, for example, proper ring positioning, controlled tissue access, and reliable alignment and connection of the ring during deployment. Because. As a result, surgical complications and post-operative complications cannot be excluded.

  Accordingly, it is an object of the present invention to provide surgical instruments, in particular an anastomosis applier, specially developed and configured to perform intraluminal or transluminal anastomoses, particularly of the digestive tract, by an intraluminal approach It is to be.

  A further object of the present invention is to provide an intraluminal or endoscopic approach that is less invasive than currently used open surgery and laparoscopic approaches, particularly in the gastrointestinal tract, translumenal. It is to provide a surgical method for performing an anastomosis.

  These and other objects are achieved by an anastomotic compression ring applier system according to claim 1 and by the method described in the following description. Advantageous embodiments are claimed in the dependent claims.

  For a better understanding of the present invention and recognition of the associated advantages, a detailed, non-limiting description of embodiments is provided with reference to the accompanying drawings.

  For clarity and to better clarify the technical effects of the features of the anastomosis applier system according to the invention and the interaction of the system with the particular application environment, the following The detailed description will first discuss the surgical method devised by the inventors, followed by an anastomosis applier and surgical instrument for performing the method.

<General procedure for anastomosis>
Methods for performing intraluminal or transluminal anastomoses, such as gastrojejunostomy, jejunal jejunostomy, colorectal anastomosis, jejunocolonic anastomosis, or bile duct anastomosis, generally include the following:
A guide wire means 88 extends from the proximal end 88 'outside the body into the patient's body, where it is intended to be joined by anastomosis, a first proximal tissue portion 45 and a second distal tissue portion. Creating a guidewire means loop by placing the guidewire means 88 on the body so as to pass through 44 and extend out of the body to a distal end 88 '' outside the body;
(In the following, unless otherwise specified, the terms "proximal" and "distal" refer to the direction along the guidewire loop, as well as the proximal end 88 'and the distal end of the guidewire loop as defined above. Pointing to the end 88 ”)
Secure the first proximal ring 36 of the anastomosis ring device to the proximal end 88 ′ of the guidewire means 88 and guidewire means 88 until the first proximal ring 36 reaches the first proximal tissue portion 45. Carrying the first proximal ring 36 to the first proximal tissue portion 45 by pulling the extracorporeal distal end 88 "distally;
A second distal ring 39 of the anastomosis ring device is slidably connected to the distal end 88 ″ of the guidewire means 88 until the second distal ring 39 reaches the second distal tissue portion 44. Pushing the second distal ring 39 proximally along the guidewire means 88;
Pulling the first proximal compression ring 36 distally and simultaneously pushing the second distal compression ring 39 proximally brings the proximal and distal rings closer together, thereby in compression contact with each other Tearing the first tissue portion 45 and the second tissue portion 44 located on the guide wire means 88 between the first ring 36 and the second ring 39;
Spreading the tissue projecting inwardly over the anastomosis ring device to open the anastomosis lumen;
Connecting the first ring 36 and the second ring 39, thereby clamping the first and second tissue portions between the first ring 36 and the second ring 39;
Pulling the proximal end 88 'of the guidewire means 88 to remove the guidewire means 88 from the body;
including.

  The loop of the guide wire means 88 is at a natural orifice such as the mouth, nose, anus, or alternatively, an artificially created opening in the body, such as a colostomy, abdominal incision, wound or fistula In the beginning and end. Preferably, the guidewire means enters and exits the body through a natural tube (eg, mouth, FIGS. 13 and 14).

  The guidewire means may include one or more single flexible guidewires, but preferably only one single guidewire is provided that penetrates the proximal and distal tissue portions.

<Loop production of guide wire means>
The loop of guide wire means 88 comprises the following treatment steps:
An elongate insertion device is introduced transluminally (eg, orally) through a proximal inlet port (eg, mouth) for a guidewire means, and proximal tissue portions (eg, jejunal anastomosis sites) distally from the outside of the body ) Pushing the insertion device towards
Through the one or more guidewire conduits formed in the insertion device, the distal end of the guidewire means is carried to the proximal tissue portion and a hole is drilled in the proximal tissue portion at the guidewire end or needle guidewire end. And (alternatively, the proximal tissue portion is insertable along the guidewire conduit and defines two or more internal conduits, one for the RF needle and one for the guidewire) , Drilled by a separate radio frequency needle device with a sheath)
(Thus, the distal end of the guidewire protrudes distally from the proximal tissue portion (eg, into the abdominal space previously infused with CO ₂ ).
Removing the insertion device from the body by pulling the insertion device proximally and out of the proximal entry port (e.g. mouth), leaving the guidewire means in place;
The grasping device is introduced transluminally through the distal inlet port for the guidewire means, which may coincide with the proximal inlet port (eg mouth), but not necessarily, from outside the body ( Pushing the grasping device proximally (with respect to the loop direction) towards a distal tissue portion, for example stomach wall tissue;
Widening the hole with a balloon catheter, which is preferably delivered to the distal tissue portion, preferably through a working channel of the grasping device, for example by a radio frequency needle or equivalent penetrating device;
Pass the grasping device through a pre-expanded hole (gastric incision) in the distal tissue portion, place it in the same space where the distal end of the guidewire is placed (eg, abdominal space previously blown with CO ₂ ) and grasp Pushing the device toward the distal end of the guidewire means;
Inserting the snare through a working conduit or instrument delivery conduit formed in the gripping device and advancing the snare proximally until the snare exits the gripping device and reaches the distal end of the guide wire;
To capture the guidewire means, push the snare over the guidewire distal end, close or tighten the snare around the guidewire means, and then through the punched hole in the distal tissue portion (eg, stomach wall) Pulling the snare distally with the distal end of the guidewire means, retracting the grasping device distally with the distal end of the guidewire through the distal inlet port (eg, orally) and exiting the body; ,
Can be made by.

  Advantageously, transluminal introduction of the grasping device and snare is performed by a pure endoscopic or endolumenal approach. Instead, this treatment step is performed under laparoscopic monitoring. In this case, the hole need not be widened, only the snare (preferably a high frequency snare configured to penetrate the stomach wall) will create a hole and enter the abdominal space through the hole. The guidewire distal end is then laparoscopically fed into the snare hole and captured by the snare hole.

  In the case of gastrojejunostomy, the insertion device must be orally advanced through the esophagus and stomach, across the pylorus and into the duodenum where it is not always easy to point. During this procedure step, a guide tube or protective tube may be pushed down the patient's mouth, down the esophagus and into the stomach, and the insertion device is advantageously inside the guide tube or protective tube to the pylorus. , Can also be guided across the pylorus.

<Delivery of the proximal ring of the anastomosis ring device to the anastomosis site and access of proximal and distal tissue parts>
The first proximal ring 36 has the following treatment steps:
Removably connecting the delivery member 33, preferably separate, outside the patient's body and the proximal ring;
For example, by inserting the carrier member 33 over a single guidewire and locking the carrier member to prevent the carrier member from sliding along the guidewire means, the proximal end 88 'of the guidewire means 88 is provided. Attaching the conveying member 33 (holding the proximal ring) to the outside of the body;
Is delivered to the anastomosis site. The transport member 33 is preferably locked by a locking element, such as a clip, that can be clamped around the guide wire and configured to provide an obstacle to the slide of the transport member. After connecting the delivery member to the proximal end of the guide wire, the delivery member is introduced into the proximal endoscope entry port and pulled distally to the anastomosis site, i.e., the guide wire distal end 88 ''. And pulled to the first proximal tissue portion (eg, intestinal wall 45).

  Alternatively, the locking of the conveying member to the guide wire can be obtained by a locking feature integrated in the conveying member, for example a clamping part. According to yet other embodiments, the delivery member is made and distributed with a guide wire, or after completion of the guide wire loop, the delivery member is pulled by pulling the guide wire distal end 88 'distally. The carrier member is guided in such a way that the guidewire loop is sufficient to be introduced with the proximal ring into the proximal inlet port (eg mouth and esophagus) and deliver the carrier member to the proximal tissue portion 45. Pre-connected to the wire.

  Alternatively, the delivery member may be slid along the guide wire to the proximal tissue layer, and the guide wire acts as a guide rail for the delivery member.

  Thereafter, the delivery member pushes the proximal ring, particularly its distal tissue contacting surface, against the proximal tissue portion and moves the proximal tissue portion distally toward the distal tissue portion to move the distal tissue portion. The proximal tissue portion 45 (eg, intestinal tissue) is pulled until the proximal tissue portion 45 and the distal tissue portion 44 are in intimate contact by pulling the guidewire distal end 88 "distally so as to contact the Can be approached towards the distal tissue portion 44 (eg, stomach wall).

<Delivery of distal ring of anastomosis ring device to anastomosis site and connection of distal and proximal rings>
The distal ring has the following treatment steps:
The second distal compression ring 39 is inserted over the guidewire distal end 88 "and the second distal compression ring 39 is directed toward the anastomosis site and thus to the first proximal compression ring 36. Pushing proximally along the guide wire means 88 (thanks to the guide wire loop and possibly further guide means, the first compression ring 36 and the second compression ring 39 are 45 and the second tissue portion 44, axially aligned at the anastomosis site)
(According to one embodiment, the distal compression ring provides angular positioning of the distal compression ring with respect to the proximal compression ring, if necessary, to allow interconnection of the proximal compression ring and the distal compression ring. Instead, the compression rings are pushed along the guidewire by suitable anastomotic appliers, which are advantageously configured such that the compression rings are at different angular positions or independent of each other. With connection features that allow the rings to be interconnected)
Clamp between the compression rings and thus the compression rings by pushing the distal compression ring proximally to engage the proximal compression ring or pulling the proximal compression ring distally to engage the distal compression ring A connected tissue part, and
Delivered to the anastomosis site. For this purpose, the anastomosis applier system includes a coupling device 1 and an access device 37. In this way (preferably at or near the surgical site) coupling the transport of the first compression ring to the access device 37 (connected to the second compression ring) and compression It is possible to apply opposing pushing or pulling forces on the ring.

  According to certain embodiments, the compression rings are configured to engage both compression rings and to maintain the compression rings connected at a desired reciprocal distance. Connected by applying a separate locking device.

  The method of connecting the compression ring to the other additionally includes the step of securing the tissue portion to the compression ring to effectively prevent the tissue from slipping radially and disengaging from the grip engagement with the compression ring. Can be included. This additional step may be performed before or simultaneously with the application of the locking device. This additional fixation step is performed by compressing the tissue portion between the distal ring device and the proximal ring device, and in the ring device and tissue portion so that the needle provides the aforementioned additional fixation. And preferably by driving a plurality of needles across them.

  According to one embodiment of this method, the locking device is inserted outside the body over the guidewire distal end 88 'as delivery of the locking device and needle group (if provided) to the anastomosis site is involved. , Pushed along guidewire 88 toward the anastomosis site and proximally toward the proximal compression ring. Preferably, both the distal compression ring and a separate locking device (and a group of needles, if provided) are connected to the distal end of the anastomosis applier (where the term “distal” is used in guidewire loops). (With reference to the surgeon's point of view) and is pushed to the anastomosis site by the anastomosis applier to engage the proximal compression ring.

  Instead, conversely to the previous embodiment, both the first proximal compression ring and a separate locking device (and needles, if provided) are secured to the proximal ring transport device 33. , Carried to the anastomosis site and engaged with the distal compression ring.

<Expanding the tissue at the anastomosis site>
The distal and proximal tissue portions that are to be joined by anastomosis are expanded by the following treatment steps:
After the tissue portions are in close contact with each other, but preferably before the distal and proximal compression rings are securely connected, the guides are cut or forced through the tissue extension. Widening the passage hole in the tissue section through which the wire means, preferably a single guidewire, passes. According to an advantageous embodiment, the passage opening of the tissue part is widened by a balloon dilator 11 which also acts as an expandable anchor head 4 (described further below) of the coupling device 1. be able to. Balloon dilator 11 can be inserted over guidewire 88 and delivered toward and at least partially across the passage opening in the tissue portion. Subsequently, the balloon dilator 11 is blown to the extent that it substantially fills the central hole of the distal compression ring, thereby expanding the anastomotic lumen to substantially the same extent, while at the same time anastomosing with the first ring carrier. The connecting operation is performed with the applier.

  According to an advantageous embodiment, the first proximal compression ring (locking device together with the needle group is preferably preassembled with one of the compression rings before or after inflation of the balloon dilator 11 of the coupling device 1. ) Is inserted over a portion of the balloon dilator 11 and the inflated balloon dilator provides a guide for subsequent access and alignment of the compression ring.

<Removal of instruments and guide wire means from patient's body>
After connection of the compression ring, the balloon dilator is deflated and removed from the capture portion 3 of the anastomosis applier. The anastomosis applier with the capture portion 3 is withdrawn from the patient's body. Also, the transport member 33 with the connecting portion 2 is removed from the first proximal compression ring and preferably removed with the guide wire 88 by pulling the guide wire proximal end 88 ′ proximally. Is done. When the first proximal ring is securely locked to the distal ring, during proximal traction of the guidewire 88, the conveying member (received the proximal ring by a weaker connection, eg, by a friction fit), is Separated from the distal compression ring, the proximal compression ring remains connected to the distal compression ring.

  Although the method of performing an anastomosis has been described and illustrated with respect to a gastrojejunostomy performed from the jejunum, such a gastrojejunostomy can also be performed starting from the stomach. In this case, it may be advantageous to introduce a protective device into the jejunum in order to prevent puncturing the intestinal wall opposite the intestinal wall to be anastomosed.

  Perhaps the tightness of the anastomosis can be tested with methylene blue.

  Said method may be advantageously performed during gastrojejunostomy, intracavity, or partially intracavity. If the method forms part of a procedure that creates a gastrointestinal bypass, it is probably similar to the above steps for further anastomoses involving the small intestine (eg, jejunal jejunostomy or ileo-jejunostomy). By applying in form, it is possible to proceed with the further anastomosis.

  From the above description of the general steps of the method and their specific application to gastrojejunostomy, the method determines the positioning of the single parts of the anastomosis ring device during deployment and in addition to those parts. One skilled in the art will recognize that it allows for continuous control of the applied force. This method further consents the performance of the anastomosis within the cavity, even if the laparoscopic or partially laparoscopic step of performing the anastomosis is not eliminated. .

  The described methods, particularly the use of an anastomosis applier with a connecting feature and a ring access feature, are not only advantageous for gastrojejunostomy and jejunostomy, but also for example, colorectal anastomosis, jejunocolonic anastomosis, or bile duct It is also advantageous to perform an anastomosis involving.

  The following describes an anastomotic ring applier system that has been specifically developed and configured to perform anastomoses according to the proposed method.

The instrumentation advantageously has the following components:
A first anastomosis ring 36 and a second anastomosis ring 39;
A fixed needle 81;
First ring carrying member 33;
Locking device 82;
Insertion device (not shown);
Gripping device (not shown);
Anastomosis applier 32; anchor head 14 / balloon dilator 11;
Guide wire 88;
Snare (not shown),
One or more of which will be described in more detail below by way of example embodiments.

<Outline of anastomosis ring applier system>
Referring to FIG. 12, an anastomotic ring applier system 30 includes a first compression ring transport device 31 (dashed line ---) and an anastomosis applier 32 (dashed line ---). The first compression ring transport device 31 is configured to hold the first compression ring 36 and is connected to or connected to the guide wire device 88, a first (eg jejunal) ring transport. Part 33 is included. The first ring carrier 33 may be connected to the balloon dilator 11, which is built around the guide wire, and the balloon dilator 11 is, for example, a fluid tube of the balloon dilator. Connects to the guide wire outside of the patient's body or near the inflatable head of the balloon dilator by a separate point of attachment (or more generally lock portion 35) that does not prevent fluid communication from the to the inflatable head Can be done.

  The first compression ring transporting device 31 is connected to the ring approaching device 37 (described below) of the anastomosis applier 32 by the connecting device 1 described above (the two-dot chain line in FIG. 12). It can be connected and removed from the ring access device 37.

  The anastomosis applier 32 further includes a second (gastric) ring transport portion 38 configured to hold the second compression ring 39, for example, by the ring connection portion 40, the ring connection portion 40 being snap fit or It is configured to engage the second (gastric) compression ring 39 by a friction fit or press fit.

  The anastomosis applier 32 is connected to the first ring carrier 31 by the coupling device 1 and the second part 43 connected to or connectable to the second ring carrier 38. And further includes a ring access device 37.

  The first portion 42 and the second portion 43 of the ring access device 37 are movable with respect to each other so as to bring the first ring transport device 31 and the second ring transport device 38 into close proximity, whereby 2 Two tissue layers (eg, stomach tissue layer 44 and jejunal tissue layer 45) held between the two compression rings 36, 39 are approximated and the compression rings 36, 39 are interconnected to complete the anastomosis.

  In accordance with the present invention, the ring access device 37 of the anastomosis applier 32 includes a screw drive 46, the first portion 42 forms a first thread 47, and the second portion 43 is a first A second thread 48 that meshes with the second thread 47 and a rotary device 49 cooperates with at least one of the first part 42 and the second part 43 to bring these parts into each other. Rotate. The relative rotation of the first part 42 and the second part 43 causes these parts to translate relative to each other, so that the first ring carrier 31 and the second ring carrier 38 and the two compressions Two tissue layers (eg, stomach tissue layer 44 and jejunal tissue layer 45) held between the rings 36, 39 are brought together to interconnect the compression rings 36, 39.

  As described above, the anastomotic ring applier system 30 can generally further include a coupling device 1, and thus the anastomotic applier 32 includes the coupling portion 2 or capture portion 3 of such a coupling device 1, At or near the surgical site, the anastomosis applier 32 can be reversibly coupled to the first ring delivery device 31 (compare FIG. 12).

<Description of Embodiment of Connecting Device 1 of Anastomosis Ring Applier System 30>
According to an embodiment, the coupling device 1 includes a coupling part 2 and a capture part 3 configured to capture and hold the coupling part 2. The coupling part 2 is a first connector 5 for connecting the coupling part 2 to the first ring transport device 31, an inflatable anchor head 4, and an actuating device 6 connected to the anchor head 4. And an actuating device suitable for deforming (blowing and contracting) the anchor head 4 so that the anchor head 4 can assume an expanded configuration (FIG. 10) and a contracted configuration (FIGS. 5 and 7). 6 is included.

  The capture portion 3 is connected to the anastomosis applier 32, in particular to a second ring transport device 38 intended to be coupled to the first ring transport device 31, a second connector 58 for connecting the capture portion 3. , 7 are included. The capture portion 3 further includes an anchor sheet 8 that defines a receiving space 9 for receiving at least a portion of the anchor head 4 and an access hole 10 through the access hole 10 through the anchor head. 4 can be inserted from outside the capture part 3 into the receiving space 9. The access hole 10 allows the anchor head 4 to be inserted and withdrawn when the anchor head 4 is contracted, and is at least partially inserted when the anchor head 4 is expanded. Is configured to lock onto the capture portion 3.

  According to an embodiment, the anchor head 4 comprises the balloon catheter or balloon dilator 11 described above, which is preferably in fluid communication with the balloon dilator 11 through a flexible pressure fluid tube 12. Can be actuated by a fluid pump device connected at. As shown in FIGS. 1, 5 and 10 respectively, the balloon dilator 11 may take a substantially elongated thread-like contracted shape, and when exposed to fluid pressure, a substantially elongated cylindrical expanded shape. You may take

  According to an embodiment, the balloon dilator 11 has an inflatable inner chamber 14 defined by a flexible but non-expandable wall 13 (in the sense of bending deformation), the balloon dilator 11 being Even if the balloon dilator 11 is only partially inserted into the receiving space 9 and only partially inserted, the shape of the anchor sheet 8 can be adapted. The balloon dilator 11 has a tapered distal (from the surgeon's point of view) insertion end 15, which is preferably substantially convex, e.g. towards the end of the ovive. In order to facilitate insertion of the anchor head through the tissue portion and into the access hole 10 of the capture portion 3, it may further include a central pin tip 16 or needle.

  According to an embodiment, the first connector of the connecting part 2 includes a longitudinal channel 17, which is configured to receive a guide wire 88 of the first ring transport device 31, for example. ing. The guide wire channel 17 is advantageously coaxial with the cylindrical expansion shape of the balloon dilator 11 and may be glued directly to the guide wire 88 or alternatively, the balloon dilator 11 may be The guide wire 88 can be latched by a clamping device such as a clip.

  Looking again at the capture portion 3, according to an embodiment of the invention, the capture portion 3 comprises a side wall 19 that is preferably cylindrical but not necessarily cylindrical, and a housing 18 with a distal end wall 20. Including, the side wall 19 and the distal end wall 20 together define at least a portion of the receiving space 9. The end wall 20 delimits the access hole 10, and the inflatable anchor head 4 can be introduced at least partially into the receiving space 9 through the access hole 10, and the edge of the access hole 10. The part tightens the anchor head 4 after the anchor head 4 is expanded.

  According to an embodiment, the end wall 20 has an internal locking surface 21 that faces into the receiving space 9 and is substantially perpendicular to the insertion direction (X) of the anchor head 4. There is or defines a circumferential shoulder inclined towards the inside of the receiving space 9, and the inner locking surface 21 is partly arranged to prevent the anchor head 4 from slipping once the anchor head 4 is subjected to traction. The anchor head 4 that has been introduced, expanded and tightened is locked.

  According to one embodiment, the inner locking surface 21 defines an undercut to prevent the blown anchor head 4 from slipping out of engagement with the capture portion 3.

  Preferably, the outer surface 22 of the distal end wall 20 defines a guide for facilitating insertion of the anchor head 4 into the anchor sheet 8.

<Detailed description of embodiment of anastomosis ring applier system>
According to the embodiment shown in FIGS. 1-9 (the terms “proximal” and “distal” relate to the surgeon's point of view), the first portion 42 of the access device 37 has an externally threaded outer housing Embodied as a rotor assembly 50 with an (externally threaded outer housing) 51, the outer housing 51 defines a distal opening 52 and a proximal connecting portion 53. A torque connector 54 connects the torsion cable or rotatable rod 55 to the proximal connection portion 53. A torsion cable or rotating rod 55 can pass through the working channel of an endoscope (eg, a gastroscope not shown) and has a proximal end that extends outside the patient's body and outside the patient's body. Appropriate torque and rotational motion can be applied to the rotating rod 55 by the surgeon. The torque connector 54 may include a connection cap or plug (FIGS. 2, 3) connected to the tubular ring wall 57 of the outer housing 51 by a radial connection pin 56, the torque connector 54 being a twisted cable or a rotary type. Torque and traction (possibly but not necessarily) can be transmitted from the rod 55 to the threaded outer housing 51.

  In this embodiment, the capture part 3 of the coupling device 1 is arranged inside the outer housing 51 and can rotate freely with respect to the outer housing 51. The access hole 10 of the capture portion 3 is aligned with the distal end surface and is preferably arranged coaxially with the distal opening 52 of the outer housing 51.

  In order to facilitate free rotation of the outer housing 51 of the rotor assembly with respect to the capture part 3 and hence with respect to the captured anchor head 4 of the coupling device 1, a rotary bearing 58 is provided with the outer housing 51 and the capture part. 3 can be placed between.

  According to an embodiment, the access hole 10 of the capture part 3 is defined by a short tubular, preferably cylindrical, collar having a diameter smaller than the diameter of the receiving space 9 or the transversal extension. . The tubular collar has a cylindrical outer surface that engages the inner surface of the rotary bearing 58, which is connected to the outer housing 51 near the distal opening 52 (compare FIGS. 1 and 3). )

  In this embodiment, the second portion 43 of the ring access device 37 is embodied as a screw jack device 59. The screw jack device 59 includes a tubular support structure 60, eg, a rigid, with a proximal ground portion 61, a distal ring connector portion 64, and an internal thread 48 configured to mate with an external thread 47 of the rotor assembly 50. Or at least partially flexible tubing.

  The ground portion 61 is configured to connect the support structure 60 to an endoscope (eg, a gastroscope not shown in the drawings), which provides pushing and / or pulling forces and torques to the support structure 60. Can tell. Alternatively, the support structure 60 can extend outside the patient's body and the grounding portion 61 can be twisted outside the body and held or grounded axially.

  The distal ring connector portion 64 can be provided by a crown of elastic teeth, as shown in FIGS. 4 and 7, for example, by a second (eg, stomach) by a snap fit, press fit or friction fit operation. Configured to hold the compression ring 39.

  The coupling device 1 partially inserts the anchor head 4 inside the capture part 3 and subsequently blows into the anchor head 4 to provide a cylindrical guide for the tissue expansion means and compression ring during the access and snap connection. By providing both (expanded anchor head-balloon dilator 11) simultaneously, it is possible to securely connect the rotor assembly 50 to the first ring transport device 33. After the first ring transport means is coupled to the rotor assembly, the outer housing of the rotor assembly rotates relative to the axially twisted and locked support structure 60 by the rotational movement of the torque cable. So that the rotor assembly 50 translates with the capture portion 3, thus bringing the anastomosis compression rings 36, 39 close together and interconnecting.

  According to a further embodiment, the tubular support structure 60 is at least partially, preferably completely transparent, to allow visualization by an endoscope (eg, a gastroscope) across the tubular wall of the support structure. .

  For complete disclosure, referring to FIG. 6, an exemplary embodiment of an anastomotic ring device and locking device that may be deployed by an anastomotic applier according to the present invention will be described.

  FIG. 6 is a perspective view of an anastomotic ring device comprising a first (jejunal) ring 36 and a second (stomach) ring 39, the anastomotic ring device according to the previously described method. It is not only specifically configured to perform an anastomosis. The first compression ring 36 (or “bowel ring” or “intestinal ring” 36) is configured to lean against the first tissue portion 45 (jejunum tissue) while the second compression ring 39. (Or “stomach ring” 39) is configured to lean against the first tissue portion 45 and the second tissue portion 44 (stomach tissue) opposite the first ring 36.

  The first ring 36 and the second ring 39 are in at least one, preferably two or more, locked positions corresponding to different compression ratios acting on the tissue portions 44, 45 clamped between the rings. Both are configured to be latched.

  Both the first compression ring 36 and the second compression ring 39 are preferably closed circular and annular so that the compression rings can be aligned and connected to each other independently of their relative angular position. It has a shape (FIGS. 11 and 12).

  The pressure surfaces of the first ring 36 and the second ring 39 intended to contact and clamp the first tissue portion 45 and the second tissue portion 44 are substantially flat, or In order to increase the circumference of the anastomotic lumen relative to the outer circumference (not shown) of the ring, it is wavy in the circumferential direction. Advantageously, the pressure surface is roughened or locally profiled to prevent tissue 45, 44 from being radially squeezed out of the ring device in response to axial pressure. .

  According to a preferred embodiment, the second compression ring 39 (stomach ring) is engaged by the second ring carrier 38 (eg by snap-fit, friction fit, shape-fit or press fit). Including shapes or specific interaction parts suitable for use.

  Both compression rings are advantageously made partially or completely with a bioabsorbable or bio-fragmentable material.

  A group of needles 81 or staples are provided to provide additional fixation of the tissue portion to the compression rings 36, 39 to prevent the tissue from slipping out of engagement with the ring device. A group of needles or staples are configured to be secured to at least one of the compression rings and penetrate tissue clamped between the compression rings.

  The needles 81 may be fixed directly to the compression ring or to the ring locking device 82 or, as shown in FIG. 11, the group of needles 81 includes a self supporting needle ring 83; Needle ring 83 can be received, for example, by a suitable seat defined in locking device 82 to ensure that needle 81 is secured to the ring device during and after needle deployment.

  Both the needle and the needle ring are advantageously made of bioabsorbable or biodegradable materials, but this is not necessary.

  Turning now to the locking device itself, according to certain embodiments (eg, FIGS. 6 and 7), the locking device 82 is engaged with the proximal end surface of the first (jejunal) compression ring 36. An annular proximal shoulder 84 with a suitable distal engagement surface 85 and a tubular longitudinal portion 86 projecting distally from the proximal shoulder 84. The longitudinal portion 86 has a shape configured to be inserted through the central opening of both the first compression ring 36 and the second compression ring 39 to provide a second (gastric) compression ring. Forming one or more resiliently supported snapper teeth 87 configured to snap into 39 corresponding edges or surfaces (in the description of locking device 82, the term " “Proximal” and “distal” relate to the direction of deployment).

  By providing a separate locking device, the compression ring can be specifically designed to meet delivery and anastomosis requirements, thereby compromising between these requirements and compression ring connection requirements. ). The tubular shape of the locking device 82 stabilizes the shape of the anastomotic lumen and provides a protective lining that is fluid and content that passes through the anastomotic lumen at least during wound healing. Separate the tissue portions 45, 44 clamped between the compression rings from the object.

  The locking device 82 is advantageously made partially or completely from a bioabsorbable or biodegradable material.

  As can be appreciated from the foregoing description, the anastomotic ring applier system 30 has many advantages. The coupling device allows the first ring delivery device to be connected and disconnected in the cavity to or from the surgical site at or near the surgical site; Allows the compression ring to be approached in a well controlled manner without the need to apply push-pull forces from outside the patient's body along the entire instrument path to the anastomosis ring. Furthermore, the expandable anchor head of the coupling device can simultaneously act as a tissue expansion device and as a guide device for the compression ring.

  While preferred embodiments of the invention have been described in detail, it is not the intention of the applicant to limit the scope of the claims to such specific embodiments, and is intended to be within the scope of the invention. It is intended to cover modifications and alternative structures.

Embodiment
(1) In an anastomotic ring applier system (30) for deploying a first compression ring (36) and a second compression ring (39);
An anastomosis applier (32),
A second ring carrier (38) configured to hold the second compression ring (39);
A ring access device (37) for supporting the first compression ring (36), a first portion (42) connectable to an external first ring transport device (31), and the second A second part (43) connected to the ring conveying device (38) of the second part (43), the first part (42) forming a first thread (47) and the second part (43) a ring access device (37) that forms a second thread (48) that meshes with the first thread (47);
A rotary device (49) acting on at least one of the first and second parts (42, 43), for rotating the first and second parts (42, 43) relative to each other. A rotary device in which the first and second parts (42, 43) are translated relative to each other so that the compression rings (36, 39) are brought into close proximity and interact with each other (49),
An anastomosis applier (32), including
Including an anastomosis ring applier system.
(2) In the anastomotic ring applier system (30) according to embodiment 1,
The first compression ring conveying device (31) comprising a first ring conveying part (33) configured to hold the first compression ring (36), the anastomosis applier The first compression ring transport device (31), coupled to the ring access device (37) of (32) and capable of being separated from the ring access device (37);
An anastomosis ring applier system.
(3) In the anastomosis ring applier system (30) according to embodiment 1 or 2,
A coupling device (1) comprising:
A connecting portion (2) connected to the first ring carrier (33) and having an inflatable anchor head (4);
A capture portion (3) connected to the ring access device (37), defining a receiving space (9) for receiving at least a portion of the anchor head (4), and an access hole (10). The anchor head (4) can be inserted through the access hole (10) from outside the capture part (3) into the receiving space (9); ,
An actuator (6) connected to the anchor head (4), wherein the anchor head (4) is configured to deform so that the anchor head (4) can assume an expanded configuration and a contracted configuration. An actuating device (6);
A coupling device (1) comprising:
Further including
The access hole (10) is configured to allow the anchor head (4) to be inserted and withdrawn when the anchor head (4) is contracted, and to move the access device to the first ring carrier. The anchor head (4) is configured to lock the anchor head (4) at least partially inserted to the capture portion (3) when the anchor head (4) is expanded to be securely connected to a device. Anastomosis ring applier system.
(4) In the anastomosis ring applier system (30) according to embodiment 3,
The anchor head (4) includes a balloon dilator (11), and the actuating device (6) includes a fluid pump device connected in fluid communication with the balloon dilator (11). system.
(5) In the anastomosis ring applier system (30) according to embodiment 4,
The anastomotic ring applier system, wherein the anchor head (4) takes a substantially elongated thread-like contracted shape and can take a substantially elongated cylindrical expanded shape when exposed to fluid pressure.

(6) In the anastomotic ring applier system (30) according to any one of the embodiments 1 to 5,
The first part (42) of the access device (37)
A rotor assembly (50) with an externally threaded outer housing (51), which defines a distal opening (52) and a proximal connecting portion (53). When,
A torque connector (54) connecting a torsion cable (55) to the proximal connection portion (53);
Including
The capture portion (3) is rotatably received inside the outer housing (51), and the access hole (10) of the capture portion (3) is a distal end surface of the outer housing (51). An anastomosis ring applier system arranged in the vicinity.
(7) In the anastomotic ring applier system (30) according to embodiment 6,
The anastomotic ring applier system, wherein the torque connector (54) includes a connection cap connected to a tubular ring wall (57) of the outer housing (51) by a radial connection pin (56).
(8) In the anastomotic ring applier system (30) according to embodiment 6 or 7,
A rotating bearing (58) is arranged between the outer housing (51) and the capture part (3) to ensure that the outer housing (51) and the capture part (3) rotate relative to each other. An anastomosis ring applier system that makes it possible.
(9) In the anastomotic ring applier system (30) according to any one of embodiments 6 to 8,
The access hole (10) of the capture portion (3) is defined by a tubular collar having a smaller diameter than the transverse extension of the receiving space (9), the tubular collar being remote from the outer housing (51). An anastomotic ring applier system that engages the inner surface of the rotating bearing (58) connected to the outer housing (51) near a lateral opening (52).
(10) In the anastomotic ring applier system (30) according to any one of embodiments 6 to 9,
The second portion (43) of the ring access device (37) is a screw jack device (59) having a tubular support structure (60), wherein the tubular support structure (60) is a proximal ground. A screw jack apparatus (59) comprising a portion (61), a distal ring connector portion (64), and an internal thread (48) configured to mate with the external thread (47) of the rotor assembly (50). ) Including an anastomotic ring applier system.

(11) In the anastomotic ring applier system (30) according to embodiment 10,
The grounding portion (61) is configured to connect the support structure (60) to an endoscope, whereby the endoscope has a pushing and / or pulling force and torque, An anastomotic ring applier system that can be communicated to the support structure (60).
(12) In the anastomotic ring applier system (30) according to any one of embodiments 10 to 11,
The anastomotic ring applier system, wherein the distal ring connector portion (64) is configured to hold the second compression ring (39) by a friction fit.
(13) In the anastomotic ring applier system (30) according to any one of embodiments 10 to 12,
An anastomotic ring applier system, wherein the tubular support structure (60) is at least partially transparent.
(14) In a method for performing intraluminal or transluminal anastomosis, such as gastrojejunostomy, jejunal jejunostomy, colorectal anastomosis, jejunocolonic anastomosis, or bile duct anastomosis,
Creating a loop of guide wire means by placing the guide wire means (88) on the patient's body in a manner, said method comprising the step of the guide wire means (88) being located at the proximal end (88) outside the body. ') Into the body and within the body, through the proximal tissue portion (45) and the distal tissue portion (44) to be joined by anastomosis, and out of the body, the distal end outside the body Step extending to the section (88 "),
A first ring delivery device (31) with a first proximal ring (36) of the anastomosis ring device is secured to the proximal end (88 ') of the guidewire means (88) and the first Delivering one ring transporter (31) with the proximal ring (36) to the proximal tissue portion (45);
Attaching the distal ring (39) of the anastomotic ring device to the second ring carrying device (38) of the anastomotic applier system according to any of embodiments 1-13;
From the distal end (88 ″) of the guidewire means (88) proximally along the guidewire means (88) until the anastomotic applier reaches the distal tissue portion (44), Guiding the anastomosis applier; and
Coupling the first ring delivery device (31) across the proximal tissue portion (45) and the distal tissue portion (44) to a ring access device (37) of the anastomosis applier (32); ,
Actuating the ring access device (37) to approximate and snap-connect the distal ring (6) with the proximal ring (5), thereby the distal tissue portion and the proximal tissue portion Clamping between the distal ring (6) and the proximal ring (5);
Including a method.

1 is a cross-sectional view of an intraluminal anastomosis ring applier according to an embodiment of the present invention. FIG. 2 is a perspective view of details of the intraluminal anastomosis ring applier of FIG. 1. FIG. 3 is a cross-sectional view of the detail of FIG. FIG. 2 is a perspective view of additional details of the intraluminal anastomosis ring applier of FIG. FIG. 6 is a perspective view of an inflatable connection portion of the connection device of the intraluminal anastomosis ring delivery device according to an embodiment of the present invention. 1 is a perspective view of an anastomotic compression ring device intended to be deployed by an anastomotic applier according to the present invention. FIG. FIG. 7 illustrates steps of a method for performing a transluminal anastomosis with the anastomotic ring applier system of FIGS. 1-6 according to the present invention. FIG. 7 illustrates steps of a method for performing a transluminal anastomosis with the anastomotic ring applier system of FIGS. 1-6 according to the present invention. FIG. 7 illustrates steps of a method for performing a transluminal anastomosis with the anastomotic ring applier system of FIGS. 1-6 according to the present invention. FIG. 6 is a perspective view of an inflatable connection portion of a connection device of an anastomosis applier system in a disengaged configuration, according to an embodiment of the present invention. FIG. 11 is a cross-sectional perspective view of the coupling device of FIG. 10 in an engaged configuration. 1 is a schematic diagram of a general functional unit of an anastomotic compression ring deployment system according to the present invention. FIG. Fig. 4 shows the creation of a guidewire loop in preparation for an anastomosis (gastrojejunostomy). The production of an anastomosis (gastrojejunostomy) is shown.

Claims (13)

In an anastomosis ring applier system (30) for deploying a first compression ring (36) and a second compression ring (39):
An anastomosis applier (32),
A second ring carrier (38) configured to hold the second compression ring (39);
A ring access device (37) for supporting the first compression ring (36), a first portion (42) connectable to an external first ring transport device (31), and the second A second part (43) connected to the ring conveying device (38) of the second part (43), the first part (42) forming a first thread (47) and the second part (43) a ring access device (37) that forms a second thread (48) that meshes with the first thread (47);
A rotary device (49) acting on at least one of the first and second parts (42, 43), for rotating the first and second parts (42, 43) relative to each other. A rotary device in which the first and second parts (42, 43) are translated relative to each other so that the compression rings (36, 39) are brought into close proximity and interact with each other (49),
An anastomosis applier (32), including
Including an anastomosis ring applier system. An anastomotic ring applier system (30) according to claim 1,
The first compression ring conveying device (31) comprising a first ring conveying part (33) configured to hold the first compression ring (36), the anastomosis applier The first compression ring transport device (31), coupled to the ring access device (37) of (32) and capable of being separated from the ring access device (37);
An anastomosis ring applier system. In the anastomotic ring applier system (30) according to claim 1 or 2,
A coupling device (1) comprising:
A connecting portion (2) connected to the first ring carrier (33) and having an inflatable anchor head (4);
A capture portion (3) connected to the ring access device (37), defining a receiving space (9) for receiving at least a portion of the anchor head (4), and an access hole (10). The anchor head (4) can be inserted through the access hole (10) from outside the capture part (3) into the receiving space (9); ,
An actuator (6) connected to the anchor head (4), wherein the anchor head (4) is configured to deform so that the anchor head (4) can assume an expanded configuration and a contracted configuration. An actuating device (6);
A coupling device (1) comprising:
Further including
The access hole (10) is configured to allow the anchor head (4) to be inserted and withdrawn when the anchor head (4) is contracted, and to move the access device to the first ring carrier. The anchor head (4) is configured to lock the anchor head (4) inserted at least partially into the capture portion (3) when the anchor head (4) is expanded to be securely connected to a device. Anastomosis ring applier system. An anastomotic ring applier system (30) according to claim 3,
The anchor head (4) includes a balloon dilator (11), and the actuating device (6) includes a fluid pump device connected in fluid communication with the balloon dilator (11). system. An anastomotic ring applier system (30) according to claim 4,
The anastomotic ring applier system, wherein the anchor head (4) takes a substantially elongated thread-like contracted shape and can take a substantially elongated cylindrical expanded shape when exposed to fluid pressure. In the anastomotic ring applier system (30) according to any one of claims 1 to 5,
The first part (42) of the access device (37)
A rotor assembly (50) with an externally threaded outer housing (51), which defines a distal opening (52) and a proximal connecting portion (53). When,
A torque connector (54) connecting a torsion cable (55) to the proximal connection portion (53);
Including
The capture portion (3) is rotatably received inside the outer housing (51), and the access hole (10) of the capture portion (3) is a distal end surface of the outer housing (51). An anastomosis ring applier system arranged in the vicinity. An anastomotic ring applier system (30) according to claim 6,
The anastomotic ring applier system, wherein the torque connector (54) includes a connection cap connected to a tubular ring wall (57) of the outer housing (51) by a radial connection pin (56). An anastomotic ring applier system (30) according to claim 6 or 7,
A rotating bearing (58) is arranged between the outer housing (51) and the capture part (3) to ensure that the outer housing (51) and the capture part (3) rotate relative to each other. An anastomosis ring applier system that makes it possible. In the anastomotic ring applier system (30) according to any one of claims 6-8,
The access hole (10) of the capture portion (3) is defined by a tubular collar having a smaller diameter than the transverse extension of the receiving space (9), the tubular collar being remote from the outer housing (51). An anastomotic ring applier system that engages the inner surface of the rotating bearing (58) connected to the outer housing (51) near a lateral opening (52). In the anastomotic ring applier system (30) according to any one of claims 6-9,
The second portion (43) of the ring access device (37) is a screw jack device (59) having a tubular support structure (60), wherein the tubular support structure (60) is a proximal ground. A screw jack apparatus (59) comprising a portion (61), a distal ring connector portion (64), and an internal thread (48) configured to mate with the external thread (47) of the rotor assembly (50). ) Including an anastomotic ring applier system. The anastomotic ring applier system (30) according to claim 10,
The grounding portion (61) is configured to connect the support structure (60) to an endoscope, whereby the endoscope has a pushing and / or pulling force and torque, An anastomotic ring applier system that can be communicated to the support structure (60). In the anastomotic ring applier system (30) according to any one of claims 10 to 11,
The anastomotic ring applier system, wherein the distal ring connector portion (64) is configured to hold the second compression ring (39) by a friction fit. An anastomotic ring applier system (30) according to any one of claims 10 to 12,
An anastomotic ring applier system, wherein the tubular support structure (60) is at least partially transparent.

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