JP2005525903A - Method and device for organizational reconfiguration - Google Patents

Abstract

An apparatus for reconstituting gastric tissue has a sealing member that seals the section of the tissue manipulator from contact with bodily fluids. The tissue manipulator has a first portion configured for removably coupling to the actuation member and a second portion configured for receiving an implant deployed within the patient. The tissue manipulator also has a rectangular member for receiving the coupler of the actuating member and a cavity. The tissue manipulator includes a first member having a tissue piercing element, and a second member having an engagement element for deflecting the tissue piercing element during relative movement of the first and second members. Have. The actuation member has a tissue piercing element support positioned to limit bending of the tissue manipulator. The instrument has an actuation mechanism configured to move at least one of the first and second portions of the tissue manipulator.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application refers to US Provisional Patent Application No. 60 / 459,996, filed Apr. 4, 2003, entitled “Methods and Devices for Tissue Reconstruction”, “Tissue Fixation Devices and Tissue Fixation”. US Provisional Patent Application No. 60 / 460,308, filed Apr. 4, 2003, referred to as "How to", and US Provisional Patent, filed May 17, 2002, referred to as "Actuator for Controlling Medical Devices". No. 60 / 381,539 is claimed and is hereby incorporated by reference in its entirety.

  This application is co-pending on July 18, 2002, entitled “Methods and Devices for Organizational Reorganization” claiming priority based on 60 / 306,652 filed July 18, 2001. US patent application Ser. No. 09 / 520,273, filed Mar. 7, 2000, which is a continuation-in-part of US patent application Ser. No. 10 / 197,574 and is referred to as “Methods and Devices for Tissue Reconstruction”. No. and US Provisional Patent Application No. 60 / 140,492, filed June 22, 1999, referred to as “Stomach Elevating Method and Device” United States patent application filed May 19, 2000, referred to as “tissue reconstruction,” which is a continuation-in-part of US patent application Ser. No. 09 / 519,945, filed Mar. 7, 2000, referred to as “devices and methods”. This is a continuation-in-part of US patent application Ser. No. 09 / 859,579, filed on May 18, 2001, which is a continuation-in-part of 09 / 574,424 and is referred to as “organizational reorganization”. It is included herein for reference in its entirety.

TECHNICAL FIELD This description relates to methods and devices for use in the treatment of gastroesophageal reflux disease.

Background Gastroesophageal reflux disease (GERD) is a common upper bowel disease in which the contents of the stomach improperly flow from the stomach into the esophagus. Reflux of gastric contents into the esophagus usually occurs when the gas pressure is sufficient to overcome the resistance to flow that exists at the gastroesophageal junction (GEJ) or when the gravity acting on the contents Occurs when enough to cause a flow through GEJ. Drug therapy, laparotomy, laparoscopic surgery, and endoscopy are known for treating GERD.

Overview In one general aspect, a medical device includes a tissue manipulator configured for introduction into a patient and a seal configured to substantially seal a section of the tissue manipulator from contact with bodily fluids. A stop member. The tissue manipulator has at least one movable member that is movable within the sealing member and has a portion that extends out of the sealing member.

  Implementations can include one or more of the following features. For example, the tissue manipulator has a second movable member that is movable and has a portion extending out of the sealing member. The tissue manipulator includes a pivot around which the movable member rotates in the opposite direction. The sealing member defines a hole for receiving a guide wire and utilizes the guide wire to advance the tissue manipulator into the patient. The sealing member is a flexible member.

  In the illustrated embodiment, the medical device has a flexible linkage coupled to the tissue manipulator and a sealing portion that covers the linkage. The sealing portion is in contact with the sealing member.

  In another general aspect, a medical device has an apparatus that is sized to be fully received within a patient's organ. The device has a first portion configured to removably couple to the actuating member and a second portion configured to receive an implant to be deployed in the patient, the device Define a through hole for receiving the guide wire and utilize the guide wire to allow advancement of the device into the patient.

  Implementations can include one or more of the following features. For example, the second portion is configured to be fragilely connected to the implant. The apparatus has a pair of jaw members configured to move in response to actuation by the actuation member. Each jaw member defines a through hole. The through holes overlap when the jaw members close and form a through hole that receives the guide wire. The jaw members each have a tissue manipulator and a shell on the tissue manipulator. Each tissue manipulator has a coupler that forms part of the first portion of the device. One tissue manipulator has a region that has a frangible connection with a portion of the implant, and the other tissue manipulator has a region that defines an opening for receiving another portion of the implant. The two areas form the second part of the device. Each shell defines a through hole that forms a portion of the through hole that receives the guide wire.

  In another general aspect, a medical device includes an apparatus sized to be fully received within a patient's organ. The device has a first portion configured to be removably coupled to the actuating member and a second portion configured to receive an implant to be deployed within the patient. The device is configured to be disconnected from the actuation member upon application of an overload to the actuation member within the patient.

  Implementations can include one or more of the following features. For example, the first part has a cage that moves under application of overload and disconnects the device from the actuating member. The cage is configured such that the overload applied to the actuating member is less than the load that penetrates the implant through the patient's muscle tissue. The cage is configured so that the overload applied to the actuating member is about 27 pounds or less.

  In another general aspect, a medical device includes a first member having at least two tissue piercing elements connected thereto by a frangible connection, deflecting the tissue piercing elements in opposite directions, And a second member having an engagement element that separates the tissue piercing element from the first member with a frangible connection during relative movement of the second member.

  Implementations can include one or more of the following features. For example, the engagement element defines an angled surface on which the tissue piercing element is pushed when the first and second members move together. The medical device has a flexible member connecting at least two tissue piercing elements.

  In another general aspect, a medical device includes an apparatus sized to be fully received within a patient's organ. The device has a first portion configured to be removably coupled to the actuating member and a second portion configured to receive an implant deployed within the patient. The apparatus includes a first member having a tissue piercing element and a second member having an engagement element configured to deflect the tissue piercing element in opposite directions upon relative movement of the first and second members. And having.

  Implementations can include one or more of the following features. For example, the engagement element defines an angled surface on which the tissue piercing element is pushed when the first and second members move together. The medical device has a flexible member that couples at least two tissue piercing elements.

  In another general aspect, a medical device includes an apparatus sized to be fully received within a patient's organ. The device has a first portion configured to be removably coupled to the actuating member and a second portion configured to receive an implant deployed within the patient. The first portion defines a rectangular opening for receiving the actuation member and a cavity for receiving the actuation member coupler and having a length of at least 0.7 inches.

  Implementations can include one or more of the following features. For example, the first portion has a shaped region configured to receive a corresponding shaped region of the actuating member and defines a slot shaped to receive the edge of the actuating member.

  In the illustrated embodiment, the device has a pair of jaw members. One of the jaw members has a tissue piercing element positioned against the cavity to be supported by the coupler. The other of the jaw members has an engagement element that is arranged against the cavity to be supported by the coupler.

  In another general aspect, a medical device has an actuation member and an end effector configured for detachable coupling to the actuation member. The end effector has a tissue piercing element. The actuating member has a tissue piercing element support disposed to limit bending of the end effector as the tissue piercing element pierces the tissue.

  Implementations can include one or more of the following features. For example, the medical device has a second end effector that includes a tip engagement element configured to deflect the tissue piercing element upon relative movement of the end effector. The actuating member has a tip engagement element support positioned to limit bending of the second end effector when the tip engagement element deflects the tissue piercing element. The actuating member includes two arms. One arm has a tissue piercing element support and the other arm has a tip engagement element support.

  In another general aspect, the medical assembly includes a cartridge configured for removable attachment to the medical device, such that the cartridge automatically aligns with the medical device during attachment of the cartridge to the medical device. A resilient holder configured to receive the cartridge.

  Embodiments have a resilient portion that is configured to bend upon attachment of the cartridge to the medical device if the cartridge is not aligned with the portion.

  In another general aspect, a medical device is disposed under tension with a tissue manipulator including first and second members and moves at least one of the first and second members toward the other member. And an actuating mechanism including a cable that engages the tissue. The actuation mechanism is configured to limit the over tension of the cable.

  Implementations can include one or more of the following features. For example, the actuation mechanism is configured to limit the application of tension to a cable of about 72 pounds or more. The actuating mechanism has a clutch configured to slip when over tension is applied to the cable.

  In another general aspect, a medical device is disposed under a tension by an external force with a tissue manipulator including first and second members, and at least one of the first and second members is directed toward the other member. An actuating mechanism including a cable moving to The actuation mechanism is configured to limit the loss of tension on the cable when an external force is removed during deployment.

  Implementations can include one or more of the following features. For example, the operating mechanism has a knob for applying an external force. The actuating mechanism has a pawl and a ratchet coupled to the knob that engage the pawl and limit the loss of tension on the cable when external forces are removed during deployment.

  Medical device and device aspects may include one or more of the following advantages. For example, medical devices and devices are designed to facilitate gastric tissue reconstitution. The sealing feature facilitates cleaning and allows reuse of the device. A guidewire received in the hole facilitates passage through the esophagus into the stomach and minimizes trauma. If the rescue mechanism does not allow the cartridge to be separated from the tissue, the device can be removed from the patient. The instrument advantageously deploys the implant using the same mechanism that closes the instrument arm. The device is adapted to limit cable breakage if something prevents the closure of the device, for example if the user attempts to deploy the implant over a previously deployed implant. The device also allows the user to deploy the implant with one hand. That is, when the user releases his hand from the deployment knob (repositions his hand and keeps turning the knob), the user does not need to hold the knob with another hand and avoid reversing the knob.

  Other features and advantages will be apparent from the description and drawings.

  Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION Referring to FIG. 1, gastric tissue, for example, gastric tissue near a gastroesophageal junction (GEJ) 702, such as a gastric sputum or tissue 704 in any part of the stomach within about 2 cm of GEJ. An apparatus 700 for reconfiguration is shown. GEJ is the area of transition from the esophagus and stomach. The stomach is a part of the stomach located beyond the GEJ. Device 700 includes an elongate shaft 710 sized to allow oral access to the stomach and a tissue manipulator 712 for manipulating stomach tissue. Within the lumen 714 defined by the shaft 710, a standard GI endoscope 715 is provided that provides gaze guidance for the reconstruction procedure. The device 700 is particularly adapted for treating GERD. By using the device 700, bulges, folds, or tissue wraps are formed near the gastroesophageal junction 702, as described below, to reduce gastric fluid reflux into the esophagus.

  The tissue manipulator 712 includes an elongate cable assembly 716 housed within the lumen 714 of the shaft 710 and a distal end effector 718 that is actuated to perform various steps in the tissue reconstruction procedure with the cable assembly 716. Have. End effector 718 has first and second jaw members 720, 722 that engage tissue 704. A cable assembly 716 includes first and second cable pairs 724a, 724b and 726a, 726b, respectively, for moving relative to and away from each other in a first plane; A third cable 728 for moving the end effector 718 relative to the shaft 710, generally transverse to the first plane and preferably perpendicular, as will be described further below. During insertion into the stomach, the end effector 718 is aligned with the shaft 710 (as shown in FIG. 3A). Once placed in the stomach, the cable 728 is actuated to move out of alignment with the shaft 710 (as shown in FIG. 1) and connect to the end effector 718.

  The cable assembly 716 includes a spring beam 784 that is formed of, for example, stainless steel or nitinol and extends into the shaft 710. A spring beam 784 is included. End effector 718 is attached to beam 784 at distal end 785 of beam 784. The beam 784 is deflected into a straight array in its resting state. Pulling cable 728 causes beam 784 to bend. When cable 728 is released, beam 784 returns to a straight array.

  Referring also to FIG. 2, the first jaw 720 is fitted with a tissue fixation member, such as the first portion 732 of the fixation device 730, and the second jaw 722 has a second portion of the tissue fixation device 730. No. 734 is attached. As will be described further below, after jaws 720, 722 engage tissue 704 and manipulate the tissue in a lapping motion, for example, to create a bulge 736 in a stomach fistula, tissue fixation device 730 is deployed ( Deployed) to secure the engaged tissue. The cable assembly 716 includes a fourth cable 737 for deploying the fixation device 730, as will be described further below.

  End effector 718 further includes a tube 738 and a third tissue engaging member or retractor, eg, a coil 740 received within tube 738 for purposes described below. Coil 740 is housed within overtube 742 and coil 740 and overtube 742 are moved axially proximal and distal relative to jaws 720, 722 along axis A of cable assembly 716. obtain. The coil 740 can be rotatably advanced into the tissue.

  Referring to FIG. 3A, instrument 700 has a handle 743 at its proximal end 745. The handle 743 includes a control knob 744 for controlling the cables 724a, 724b, 726a, 726b to close and open the jaws 720, 722, and a control knob 746 for controlling the cable 728 to move the end effector 718. Have. The handle 743 has a port 748 through which the coil 740 and overtube 742 can be introduced into the shaft lumen 714 and a pull knob 750 for deploying the tissue fixation device 730 as described below. As shown in FIG. 3B, handle 743 defines a channel 752 through which endoscope 715 is introduced into shaft lumen 714.

  1 and 3C show a working channel in shaft 710 for receiving various cables, overtube 742, and endoscope 715, but within jaws 720, 722 within lumen 714 of shaft 710. Cable housings 760a, 760b defining channels 762a, 762b for receiving cables 724a, 724b for receiving, and cable housings 764a, 766b defining channels 766a, 766b receiving cables 726a, 726b for opening the jaws 720, 722. 764b. Within the lumen 714, a cable housing 768 that defines a channel 770 in which a cable 728 for bending the end effector 718 is received and a cable housing 772 that defines a channel 774 in which the cable 737 for deploying the fixation device 730 is received. There is. Coil 740 and overtube 742 are received in channel 778 defined in coil housing 776 within lumen 714. Housing 776 extends from port 748 to tube 738. As shown in FIG. 3D, the coil 740 has a tissue piercing tip 741 and a distal section 740a having a coil wound more loosely than the remainder of the coil 740. The endoscope 715 is received in a channel 782 defined in the endoscope housing 780 within the lumen 715.

  The spring beam 784 is generally located between the cable housing 776 and the endoscope housing 780, and the beam 784 enters the shaft 710 from the distal end of the shaft that is attached to the shaft 710 by, for example, silicone adhesive / sealant. It extends about 4 inches. The various cable housings and spring beams 784 do not move relative to the shaft 710 and the handle 743. Actuating the end effector 718 is the movement of the cable within the cable housing. The shaft 710 is preferably formed of, for example, a heat shrinkable tube.

  Referring again to FIG. 3A, the end effector 718 has a length L1 of about 2 inches, and the cable assembly 716 extends axially from the shaft 710 with a length L2 of about 2.5 inches. Has a length L3 of about 23.5 inches and the handle 743 has a length L4 of about 5 inches. Cable assembly 716, spring beam 784 and shaft 710 have the necessary flexibility to allow oral placement of device 700 in the stomach. The length L1 of the relatively rigid end effector 718 is minimized to ensure that the required flexibility of the instrument 700 is maintained. The distance that the cable assembly 716 extends axially from the shaft 710 is such that the cantilever beam 784 positions the end effector 718 relative to the shaft 710 such that the jaws 720, 722 are positioned against the inner surface of the stomach near GEJ. It is selected to allow the desired bending.

  The distal end effector 718 is sized to pass through a 12-16 mm diameter channel (corresponding to the diameter of the esophagus) and the shaft 710 has an outer diameter of about 12-16 mm and into the stomach. Allows the device 700 to pass through the oral cavity. The scope channel 782 has a diameter of about 8 mm or 10 mm. An 8 mm diameter scope channel allows passage of a 7.9 mm pediatric gastroscope, and a 10 mm diameter scope channel allows passage of a 9.8 mm adult gastroscope. Channel 778 has a diameter of about 2-3 mm for receiving cable 742.

  The distal end effector 718 is shown in greater detail in FIGS. 4A and 4B. End effector 718 has a central mount 800 that defines a slot 801. A pin 803 is supported by the mount 800 over the slot 801, and 720 and 722 are pivotally supported by the pin 803. Central mount 800 also houses two pulleys 802 on which cables 724a, 724b pass to close jaws 720, 722, respectively. Cables 724a and 724b terminate at points 804 and 806 on jaws 720 and 722, respectively. Cables 726a, 726b for opening the jaws 720, 722 end at points 808, 810 on the jaws 720, 722 proximal to the points 804, 806, respectively. End effector 718 tube 738 for receiving coil 740 and overtube 742 is attached to mount 800, and cable 728 for bending end effector 718 terminates at point 811 on tube 738.

  By pulling the cables 724a, 724b proximally, the jaws 720, 722 generally move in opposite directions in the first plane (the plane of the paper in FIG. 4A). By pulling cables 726a, 726b proximally, jaws 720, 722 generally move away from each other in the first plane. Pulling cable 728 proximally causes beam 784 to bend and move end effector 718 to a second plane (out of the paper plane of FIG. 4A) that is generally perpendicular to the first plane.

  Referring also to FIG. 5, the jaw 720 includes two guide tubes 816a and 816b and a slider 812 including two push rods 814a and 814b guided into the tubes 816a and 816b, respectively. The slider 812 is attached to the jaw 720 and slides relative to the jaw 720. Tubes 816a, 816b bend around jaw 720 and terminate at tissue piercing tips 818a, 818b, respectively (FIG. 6B). Push rods 814a, 814b may be formed of molded plastic, such as polyethylene or polypropylene, or as a braided stainless steel cable to provide flexibility following the curve of tubes 816a, 816b. Cable housing 772 is attached to slider 812 and cable 737 terminates at a fixed point 739 on jaw 720. Actuation of cable 737 pushes the slider 812 distally, as described below.

  The first part 732 of the tissue fixation device 730 is shown in more detail in FIGS. 6A and 6B. The first part 732 of the tissue fixation device 730 defines through holes 820a, 820b (FIG. 6C), and the part 732 is attached to the jaw 720 with the tips 818a, 818b received in the through holes 820a, 820b, respectively. Connected to the part 732 with a suture 822 are two anchoring elements, such as bars 824a, 824b. Each bar 824a, 824b defines two through holes 826a, 826b. The suture 822 passes through the hole 826 a, 826 b in the bar and the hole 820 a, 820 b in the part 732 and is tied to form a knot 823, securing the bar 824 a, 824 b to the part 732. Tubes 818a, 818b each define a channel 827 for receiving one of bars 824a, 824b and a groove 828 communicating with channel 827 for receiving suture 822 therethrough.

  With particular reference to FIGS. 4B and 7, the jaw 722 has a distal member 830 that includes a slot 832 for receiving the second part 734 of the fixation device 730 and a tissue piercing. Slots 834a, 834b are defined for receiving the tips 818a, 818b. The second part 734 of the fixation device 730 defines through holes 836a, 836b for receiving the tips 818a, 818b. When jaws 720, 722 are closed, tips 818a, 818b pass through slots 834a, 834b and holes 836a, 836b. Actuation of the anchoring device deployment cable 737 after closure of the jaws 720, 722 pushes the slider 812 and push rods 814a, 814b distally and the bars 824a, 824b are advanced out of the tissue piercing tips 818a, 818b. 8, rods 824a, 824b are placed on the opposite side 838 of the second part 734 of the fixation device 730. As shown in FIG.

  With reference to FIGS. 9A-9F, during use under endoscopic guidance, the physician advances device 700 orally and places end effector 718 into the stomach. During advancement into the stomach, the end effector 718 is generally aligned along the axis of the shaft 710, as shown in FIG. 9A. The physician then rotates control knob 746 and pulls cable 728 proximally, thereby bending beam 784 and moving end effector 718 out of alignment with shaft 710 to the position shown in FIG. 9B. . The jaws 720, 722 are then pivoted about the pin 803 to the open position shown in FIG. 9C by rotating the control knob 744 and pulling the cables 726a, 726b.

  The physician then advances coil 740 and overtube 742 by pushing the coil and overtube distal to channel 778, advances coil 740 and overtube 742 out of tube 738, and stomach tissue, preferably, As shown in FIG. 1, contact is made with gastric tissue beyond the gastroesophageal junction. Using an overtube 742 that pushes the tissue and stabilizes it, the physician rotates the coil 740 and simultaneously applies a slight distal pressure to move the coil into the tissue, as shown in FIG. 9D. Move forward. The coil 740 and overtube 742 are then pulled proximally to draw tissue between the jaws 720,722. The jaws 720, 722 are then closed as shown in FIG. 9E by rotating the control knob 744 and pulling the cables 724a, 724b proximally. Rotation of the control knob can also be a procedure that pulls the coil 740 and overtube 742 proximally and is arranged to ensure that the coil 740 and overtube 742 do not interfere with jaw closure. If the coil 740 and overtube 742 are not in their proximal positions, a lockout can be incorporated to prevent jaw closure.

  The closure of the jaws causes the parts 732, 734 of the fixation device 730 to contact two tissue sections, for example, against two separate tissue surfaces in the stomach, and allow the tissue piercing tips 818a, 818b to pierce through the tissue. , Into the holes 836a, 836b of the second part 734 of the fixation device 730. To deploy the fixation device 730, the physician pulls the cable 737 proximally and removes the slack from the cable 737. The cable housing 772 has a fixed length and is non-movably attached to the handle, so removing the slack from the cable 737 causes the cable housing 772 to move away as shown in FIG. 9F. The slider 812 is moved forward, and the t-shaped bars 824a and 824b are pushed out from the tissue piercing tips 818a and 818b.

  The physician then opens the jaws, separates the jaws 722 from the second part 734, returns the distal end effector to its initial position, generally aligned with the shaft 710, closes the jaws, and removes the device 700. FIG. 10 shows a cross-section of the tissue with an anchoring device 730 that secures the bulge 736 in place.

  Other embodiments are within the scope of the following claims.

  For example, instead of the coil 740, another tissue piercing or grasping element such as a T-shaped suture or two small grasping jaws can be used. The device 700 can be used without a third tissue engaging member.

  Referring to FIGS. 11A and 11B, the end effector 718 'includes another cable that routes to actuate the jaws 720,722. The end effector 718 ′ includes cables 726 a, 726 b for opening the jaws 720, 722, a single cable 724 ′ for closing the jaws 720, 722, and a cable 737 for advancing the slider 812. Have. The end effector 718 'also has a pivot 803 around which the cable routes and a series of pulleys 850a, 850b, 850c, 850d, 850e.

  A cable 724 ′ includes a first portion 852a that routes under the pulley 850a (as seen in FIGS. 11A and 11B) and over the pulley 850c, and a second portion that extends between the pulleys 850c and 850b. 852b and a third portion 852c that routes below and above pulley 850b. Cable 726a has a first portion 854a that extends to pulley 850d and a second portion 854b that extends between pulley 850d and anchor 851a secured to central mount 800. Cable 726b has a first portion 856a that extends to pulley 850e and a second portion 856b that extends between pulley 850d and anchor 851b secured to central mount 800.

  To open jaws 720 and 722, the user applies tension F1 to cables 726a and 726b (by rotating control knob 744). Tension F1 pulls first portions 854a and 856a of cables 726a and 726b proximally in the same direction as tension F1 and pulls second portions 854b and 856b of cables 726a and 726b away from pulleys 850e and 850d, respectively. Pull to the place. Rotating the knob 744 also causes slack in the cable 724 '. As a result, a true force F3 is generated, and the jaws 720 and 722 are opened.

  To close the jaws 720, 722, the user tensions the portions 852a and 852b of the cable 724 '(although rotating the control knob 744 in the opposite direction thereby also reducing the tension on the cables 726a, 726b). Multiply F2. The tension F2 acts to shorten the portion 852b of the cable 724 ', thereby pulling the pulleys 850c and 850b and closing the jaws 720, 722.

  Referring to FIG. 12A, in another embodiment, the third tissue engaging member 740 ′ is hooked by a tissue engaging coil 860 with a tissue penetrating end 860 a, a helical drive shaft 862, and a drive shaft 862. And a connecting member 864 for transferring the generated torque to the coil 860. The helical drive shaft 862 is preferably wound in the opposite direction to the tissue engaging coil 860 for reasons described below. Located on the connecting member 864 and axially movable relative thereto is a spring-loaded sheath 866. Tissue engaging member 740 'can be used alone or as a substitute for tissue engaging member 740 of FIG. The coil 860 has, for example, six loops having a pitch of 1.5 mm from loop to loop and a diameter of 2 mm. Other configurations can be used, for example, one or more loops where the number of loops is a multiple of the pitch corresponding to the desired penetration depth into the tissue.

  Referring to FIG. 12B, the tissue engaging member 740 ′ is shown without a spring-loaded sheath 866, and the connecting member 864 includes a distal most first section 864a having a diameter D1 and a diameter D2 that is larger than D1. A second section 864b having a diameter D3 between D1 and D2, a third section 864c having a diameter D4 substantially equal to D2, and a second section 864d having a diameter D5 greater than D4. And five segments 864e and a most proximal segment 864f having a diameter D6 approximately equal to D1. Diameters D1-D6 are, for example, about 0.04 inch, 0.09 inch, 0.06 inch, 0.09 inch, 0.12 inch, and 0.04 inch, respectively. It is shelf 867a that is defined between sections 864a and 864b, and shelf 867b that is defined between sections 864b and 864c, which is defined between sections 864c and 864d. Is a shelf 867c, defined between sections 864d and 864e is shelf 867d, and is defined between sections 864e and 864f is shelf 867e. Drive shaft 862 is received in connecting member section 864f and coil 860 is received in connecting member section 864a. The drive shaft 862 and the coil 869 are attached to the connecting member 864 by soldering, for example. The coil 860, for example, has a coil length L of about 0.25 inches and extends beyond the distal end 868 of the section 864a. Disposed on connecting member section 864c between shelves 867b and 867c is a spring 870 that deflects spring-loaded sheath 866 distally.

  Referring to FIG. 12C, the spring-loaded sheath 866 defines a lumen 872, and has a first section 866a having an inner diameter d1, a second hub section 866b having an inner diameter d2 smaller than d1, and approximately d1. A third section 866c having an equal inner diameter d3. Coil 860 is received within lumen 872 of sheath section 866a. The spring 870 is located radially within the lumen 872 between the connecting member section 864c of the sheath 866 and the section 866c of the sheath 866. The shelf hub 866b is deflected with respect to the shelf 867b by a spring 870. The spacing between the coupling member shelf 867d and the proximal end 874b of the sheath 866 allows for axial proximal movement of the sheath 866 relative to the action of the spring 870.

  To facilitate assembly of the tissue engaging member 740 ', the connecting member 864 is formed of two parts 876a, 876b, which have mating fingers 878 joined by, for example, crimping. According to this configuration, the sheath 866 allows sliding over the part 876a before joining 876b to 876a.

  Referring also to FIG. 12D, during operation, the user positions the distal end 874a of the sheath 866 relative to the tissue T that is penetrated to stabilize the tissue. The user then applies distal and rotational forces to the drive shaft 862, causing the connecting member 864 and coil 860 to move distally and rotate into the tissue, eg, the mucosal layer of the tissue. The coil 860 is advanced into the tissue, the distal end 874a of the sheath 866 remains on the surface of the tissue, the spring 870 is compressed, and the shelf 867b is advanced toward the proximal sheath end 874a. When the coil 860 is firmly secured to the tissue, eg, the mucosal layer of the tissue underlying the mucosal layer (this requires approximately 3 or 4 turns of the coil into the tissue), the user can The tissue can be manipulated with the joint member 740 '. By engaging multiple tissue layers, member 740 'provides a secure grasp on the tissue.

  Spring-loaded sheath 866 acts to stabilize both tissue and coil 860 as coil 860 is advanced into the tissue. The sheath 866 compresses the tissue, promotes initial penetration of the coil into the tissue, and helps prevent the tissue from twisting as the coil rotates. In addition, the coil 860 tends to move off-axis as it rotates into the tissue. The spring-loaded sheath 866 provides sufficient force against the tissue and has sufficient friction against the tissue surface to limit the movement of the sheath 866 as the coil 860 is advanced into the tissue. This hinders the tendency of the coil to go off-axis.

  Due to the opposing rotation of the drive shaft 862 and the coil 860, the rotational force applied to the drive shaft 862 causes a decrease in the diameter of the drive shaft 862 at the same time it encounters torsional resistance. This reduction in the diameter of the drive shaft 862 limits the contact of the drive shaft 862 with the walls of the associated work channel where the drive shaft 862 is located and can therefore be disturbed in the work channel.

  Referring to FIGS. 13A and 13B, a torque generator 882 and a torque generator 882 held by a user are removably attached to apply distal and rotational force to the drive shaft 862, A drive rod 880 extending through the handle 743 is connected to the drive shaft 862. The drive rod 880 travels most of the length of the instrument 700 to provide high torque, and the drive shaft 862 extends to the extent of the inversion region to provide high flexibility. Drive rod 880 and drive shaft 862 are coupled, for example, by soldering. The torque generator 882 includes a handle 883, a collet 885, and a spring loaded cap 887. Collet 885 includes a peripheral section 885 'and four legs 885a extending from section 885' and each having an enlarged end 885b. Each leg 885a has a flat inner facing surface 885c that together define a square opening 886. The drive rod 880 has a connecting member 889 with four flat side surfaces 889a. The coupling member 889 is received in the opening 886 having a flat side 889a aligned with the surface 885c so that when closed, the torque generator 882 and the drive rod 880 are rotationally locked.

  Handle 883 defines a hole 881 'in which pin 882' is received and a large diameter hole 883 'in which pin 882, collet 885 and spring 887' are received. Cap 887 is biased (biased) distally by spring 887 '. The pin 882 'is press fit into the hole 881' and into the peripheral section 885 'of the collet 885. To attach the drive rod 880 to the torque generator 882, the cap 887 is moved proximally with respect to the force of the spring 887 ', thereby bending the legs 885a outwardly and placing the connecting member 889 in the opening 886. Can do. When the cap 887 is removed by the user, the spring 887 'moves the cap 887 distally and the leg 885a around the connecting member 889 closes. The distal movement of the cap 887 is limited by the contact of the shelf 880 'of the cap 887 with the enlarged leg end 885b.

  Tissue engaging member 740 'is preferably a single use disposable product supplied aseptically to the user. Member 740 'is mounted into the instrument from the distal end of the instrument and then attached to torque generator 882. This maintains the sterility of the distal end of member 740 '.

  Referring to FIG. 14A, in another embodiment, it is the solid needle 881a that is disposed within the coil 860 rather than the tissue stabilization by the spring-loaded sheath 866 of FIG. 12A. The needle 881a extends from the connecting member 864. Needle 881a facilitates initial engagement of coil 860 with tissue, and is particularly applicable to situations where coil 860 approaches the tissue surface at an angle. Referring to FIGS. 14B and 14C, it is the substance injection needle 881b that is disposed within the coil 860 and extends to the proximal end of the tissue engaging member, rather than a solid needle, through the coil 860. Can be advanced. The substance injection needle 881b has a metal tip 881c on a flexible plastic tube 881d. Connecting member 864, connecting member 889, pin 882 'and hand grip 883 define aligned through-holes that slidably receive needle 881b. The needle 881b is a substitute for the drive rod 880. The drive shaft 862 extends the length of the instrument.

  The substance injection needle 881b is used in a “bulking” procedure and is described, for example, in US Pat. No. 5,336,263 to Ersek et al., Which is incorporated herein by reference in its entirety. By injecting such biocompatible material, the tissue of the selected area can be enhanced. In use, the coil 860 acts to antagonize the pressure generated by the injection of the substance, which tends to secure the needle 881b to the tissue and tend to push the needle 881b out of the tissue. For substance injection, the tissue engaging device can be used through the working channel of the endoscope or can be used with the device 700. Alternatively, the wire forming the coil 860 can define the lumen and the material to be injected through the lumen of the wire.

  As shown in FIGS. 15A and 15B, another third tissue engaging member 740 ′ ″ pivots at the pivot 895 to an elongated member 892 that passes through the working channel of the instrument 700 and the distal end 892 a of the elongated member 892. A pair of worn scissors 893a and 893b. Scissors 893a and 893b each include a respective scissor tip 891a and 891b suitable for penetrating tissue. Scissors 893a and 893b are, for example, one or more as described in US Pat. No. 5,613,499 to Palmer et al., Which is incorporated herein by reference in its entirety. It is operated by the above guide wire (not shown).

  Scissors 893a and 893b are generally arcuate in shape and have scissor tips 891a and 891b oriented substantially perpendicular to the pivot point 895 and the lines L1, L2 defined by the ends of the respective scissor tips. . Scissors 893a and 893b are made of a rigid sterilizable material capable of puncturing tissue and maintaining scissor tips 891a and 891b suitable for withstanding at least short term exposure to a surgical environment such as the stomach. As such, scissors 893a and 893b can be made of stainless steel and Co—Cr alloy.

  Referring to FIGS. 15C and 15D, during operation, with the scissors 893a and 893b in their open positions, the user advances the tissue engaging member 740 '' 'to the mucosa on the muscle layer 895 in the stomach. Contact with a tissue surface such as layer 894. The user then closes the scissors 893a and 893b so that the scissor tips 891a and 891b penetrate the mucosal layer 894 and into the muscle layer 895. Once the scissor tips 891a and 891b are pulled together, the user uses the elongated member 892 to retract the scissors 893a and 893b from the engaging tissue. Retraction tissue fold formation and / or bulking can then occur as described elsewhere herein.

  Due to the arcuate shape of the scissors 893a and 893b, the initial closure of the scissors results in a substantially distal movement of the scissors tips 891a, 891b, and the subsequent closure of the scissors substantially results in the scissors tips 891a, 891b. Cause lateral movement. This distributes the retraction load imposed by the scissors 893a and 893b for fold formation over a relatively large area of tissue, reducing the possibility of tearing the tissue during retraction.

  Referring to FIGS. 16A and 16B, according to another embodiment of the present invention, an instrument 900 for reconstructing stomach tissue includes a handle 902, an elongated instrument shaft 904, a distal actuation assembly 905, Have As will be described below, the configuration of assembly 905 and the means of attachment of assembly 905 to instrument shaft 904 substantially seal the lumen of shaft 904 containing the actuation cable from contact with bodily fluids. As a result, only the disposable portion of assembly 905 needs to be supplied to the user in a sterile manner. The rest of the instrument can be easily disinfected by manual cleaning and immersion in disinfecting liquid between procedures.

  As in the embodiments described above, the device 900 receives a gastroscope 715 and a tissue engaging member 908 (such as the coil 740 or 740 'described above). The assembly 905 has a reversing portion 910 that is manipulated by the user to orient the assembly 905 (as shown in FIG. 16B). The handle 902 has control knobs 912, 914 that actuate the assembly 905, as well as a switch 915 that separates the locking mechanism, as described below.

  Referring to FIGS. 17A and 17B, shaft 904 defines a lumen 916 through which the end of gastroscope 715 projects. The inversion portion 910 has an inclined curved wall section 918 and the end of the gastroscope 715 is received relative thereto. When the reversing part 910 is bent, it is bent in a direction away from the section 918 (arrow A). The assembly 905 further includes a connecting member 919 and an end effector 906. The connecting member 919 includes a first portion 923 attached to the reversing unit 910 and a mount 924 on which the end effector 906 is pivotally attached. The end effector 906 has jaw members 920 and 922, each having tissue manipulation cartridges 960a and 960b, and the tissue manipulation cartridges 960a and 960b are detachably attached to the respective operating arms 962a and 962b.

  Covering the reversing portion 910 and the connecting member portion 923 is a cover 910 ', and covering the mount 924 and the end effector 906 is a hood 1220, as will be described further below. The hood 1220 provides an atraumatic distal end for oral placement of the device, and the cover 910 'seals the inversion 910 and connecting member portion 923 from contact with bodily fluids.

  In use, the end of the gastroscope 715 in the device lumen 916 and the gastroscope 715 in the section 918 allows the user to advance the device 900 orally into the stomach. Once in the stomach, the gastroscope 715 is operated alone to obtain the desired field of view. The user (as shown in FIG. 16B) bends the device 900, opens the jaws 920, 922, advances the tissue engaging member to engage the tissue, stabilizes the tissue, The 922 is closed and the cartridge 960a, 960b is manipulated to place the tissue into the bulge and the implant is deployed as described further below.

  Referring to FIG. 17C (coupling member 919 has been partially removed from FIG. 17C for clarity), actuating arms 962a, 962b are pivotally attached to mount 924 by pivots 963a, 963b, respectively. . A pair of cables for opening and closing the jaws 920 and 922, which will be described later, are connected to these jaws by a yoke 964. The yoke 964 has a generally H-shaped section 965, which includes two legs 966a that straddle the arm 962a and two legs 966b that straddle the arm 962b. Each arm 962a, 962b defines a slot 968a, 968b, and each leg 966a, 966b defines a through hole 970a, 970b. Pins 972a are received in slots 968a and 970a, and pins 972b are received in slots 968b and 970b. Slots 968a, 968b have first and second sections 974, 975, respectively. The slot section 974 is oriented at an angle greater than that of the slot section 975 with respect to the instrument axis for purposes described below. The yoke 964 has a post 978 extending proximally from section 965. Post 978 extends into connecting member 919. Attached to the post 978 is a first pulley 982, and attached to the connecting member 919 are two pulleys 984, 985, as will be described later, with a jaw closure cable over it. Route.

  The portion 923 of the connecting member 919 and the mount 924 have flat side surfaces 923a, 924a and rounded side surfaces 923b, 924b, as shown in FIG. 17D. The rounded sides 923b, 924b define a through hole 927 for passage of the tissue engaging member. Mount 923 also defines a hole 931 through which yoke 964 extends.

  Referring to FIGS. 17E and 17F, located in portion 923 is a lock arm 1250 pivotally attached at 1252. The lock arm 1250 has a ridge 1253 with a curved wall 1254 and the yoke 964 defines a notch 1256 with a correspondingly shaped curved wall 1258. After a predetermined amount of distal movement of the yoke 964, the curved wall 1254 of the ridge 1253 engages the curved wall 1258 of the notch 1256 to limit subsequent distal movement of the yoke 964. The lock arm 1250 is biased by the compression spring 1262 and rotates clockwise around the pivot 1252 (arrow Y), and when the notch 1256 passes under the lock arm 1250, the lock arm 1250 It rotates downward to engage the curved walls 1254, 1258. Attached to the lock arm 1250 is a cable 1260 that moves the arm 1250 from engagement with the yoke 964 to further allow distal movement of the yoke 964.

  FIG. 17G illustrates the interchangeable nature of cartridges 960a, 960b. Each of the arms 962 a and 962 b includes a flat rectangular member 1050 and a clip 1052. The member 1050 includes structures 1051 and 1053 extending from either side of the member 1050. The structure 1051 has a thin distal section 1051a that slopes to a wider proximal section 1051b for purposes described below with reference to FIG. Each of the cartridges 960a, 960b has a first pair of side walls 1054, a second pair of side walls 1056 defining a slot 1056a, an opening 1058, and a head 1059. The opening 1058 is rectangular in shape and is shown here as a square, but other shapes with mating contours with a flat proximal edge 1058a are suitable. Instead of the opening 1058, a recess in the cartridge corresponding to the shape of the clip 1052 can be used. The side walls 1054, 1056 are separated by a thin section 1057 that allows the cartridge to bend.

  To attach the cartridges 960a, 960b to the arms 962a, 962b, respectively, the cartridges slide over the arms with side walls 1054 that align the cartridge with the arms. A rectangular member 1050 is received in the slot 1056a, but the cartridge bends over the clip 1052 so that the clip 1052 is received in the opening 1058 and locks the cartridge to the arm. To remove the cartridge, the user pushes the side wall 1054 to bend the cartridge away from the clip 1052, and then the cartridge slides off the arm.

  Referring to the exploded view of FIG. 17H, the inversion portion 910 includes, for example, a proximal mount 1060 that is affixed to the end of the shaft 904 and a distal mount 1062 that is received in the slot 933 of the mount 923. Have. The mounts 1062 and 923 are attached by screws, for example. The mount 1062 is preferably metal, and the connecting member 919 is preferably plastic.

  Referring to FIG. 17I, the only member of the instrument 900 that extends from the inversion region 910 through the sealed section formed by the cover 910 'is a yoke 964. In order to restrict body fluid access to the reversal portion 910, the connecting member portion 923 defines a space 1070 in which the O-ring 1072 is disposed to seal the through hole 931.

  18-20, in order to control the reversing portion 910 and the end effector 906, the knobs 912, 914 are connected to a series of cables 925a, 925a ′ via a gear block mount 926 located in the handle 902. , 925b, 925c (FIG. 20). The block mount 926 defines through holes 928a, 928a ', 928b, 928c, in which racks 930a, 930a', 930b, 930c are respectively disposed. Each rack 930a, 930a ', 930b, 930c is connected to a respective cable 925a, 925a' 925b, 925c and has a flat side 932 that defines a gear 934, as described below. With particular reference to FIGS. 21A and 21B, the pinions 936a mesh with the racks 930a, 930a ', and the pinions 936b, 936c mesh with the racks 930b, 930c. Racks 930a, 930a 'are on the opposite side of pinion 936a, and racks 930b, 930c are on the opposite side of pinion 936b, 936c. The pinion 936b is preferably twice the diameter of the pinion 936c for reasons described later. The pinion 936a is driven by reduction gear sets 937 and 939. The gear 939 is attached to a shaft 942 that is integral with the reversing knob 912. The pinions 936 b and 936 c are attached to a shaft 944 that is integral with the jaw actuating knob 914 and passes through the shaft 942.

  When the user turns the knob 912 to operate the reversing unit 910, the shaft 942 and the pinion 936a rotate. Since the racks 930a, 930a ′ are on the opposite side of the shaft 942, the rotation of the pinion 936a causes the racks 930a, 930a ′ to move in reverse, thereby moving the cables 925a, 925a ′ and reversing as described below. The part 910 is bent or straightened. When the user turns knob 914 to manipulate the jaws, this causes shaft 944 and pinions 936b, 936c to rotate. Since the racks 930b and 930c are on the opposite side of the shaft 944, the rotation of the pinions 936b and 936c causes the racks 930b and 930c to move in a reverse linear motion, thereby moving the cables 925b and 925c, and the jaws as described below. Open and close. As is well known in the art, knob 912 is connected to tension adjustment lever 912a and knob 914 is connected to tension adjustment knob 914a.

  Referring to FIGS. 20 and 22, on each cable 925a, 925a ′, 925b, 925c, cable housing 947a, 947a ′, 947b, 947c, and cable housing adjustment screws 948a, 948a ′, 948b, 948c, respectively. And are provided. Cable housing adjustment screws 948a, 948a ', 948b, 948c are threadably received within respective block through holes 928a, 928a', 928b, 928c (as shown in FIG. 19). Rotation of the screws 948a, 948a ′, 948b, 948c causes the cable housings 947a, 947a ′, 947b, 947c to move distally and proximally along the respective cables 925a, 925a ′, 925b, 925c, resulting in an actuation force. Provides an optimal working length for transmission. Cables 925a, 925a ', 925b, 925c move freely through their respective housings and screws.

  On the opposite side of the racks 930a, 930a ', 930b, 930c from the screws 948a, 948a', 948b, 948c, the stops 949a, 949a ', 949b, 949c have respective block through holes 928a, 928a', 928b, 928c. Accepted within. The stoppers 949a, 949a ', 949b, and 949c restrict the movement of the racks 930a, 930a', 930b, and 930c, respectively.

  With particular reference to FIG. 22, the cable 925 a is received in a hole 950 defined in the rack 930. Cable 925a extends into hole 950 through hole 952 defined in end wall 954 of rack 930a. A spring 956 is disposed in the hole 950. Cable 925 a has an enlarged end 957 that extends through spring 956 and maintains the position of cable 925 a relative to spring 956. The spring 956 acts to continuously apply a slight tension to the cable 925a and keeps the cable tight. Similarly, the cables 925b and 925c are connected to the racks 930b and 930c, respectively.

  Referring to FIG. 19 again, a slide lever 1400 provided in the bracket 1402 is attached to the block mount 926. Switch 915 is received in opening 1404 in lever 1400 such that movement of switch 915 moves lever 1400. Lever end 1406 defines an oblique slot 1408 in which pin 1410 is received. The pin 1410 is attached to a stop member 1412 that contacts the stop 1414 after the jaw closure rack 930b has moved a predetermined distance. Movement of lever 1400 in the direction of arrow X causes pin 1410 and stop member 1412 to rotate about the axis of stop member 1412, separating stop member 1412 from stop 1414 and allowing further movement of rack 930b. . A cable 1260 attached to the lock arm 1250 is attached to the switch 915 at its opposite end. As switch 915 moves in the direction of arrow X, cable 1260 moves lock arm 1250 and separates lock arm 1250 (FIG. 17E) from yoke 964 (further described below with reference to FIG. 23). The bracket 1402 can be adjusted to fine tune the positioning of the switch 915 relative to the pin 1410 and the lock arm 1250.

  As shown in FIGS. 23A-23D, the jaw closure cable 925b is wrapped around pulleys 984, 985 and 982 and terminates at a fixation point 986 connected to the distal mount 1062 (FIG. 17E). . The jaw opening cable 925c is connected to the post 978 in a fixed relationship. When the user turns knob 914 in the direction of arrow A to close jaws 920, 922 (FIG. 20), this causes cable 925b to move in the direction of arrow B, allowing cable 925c to sag, 964 is moved distally in the direction of arrow C. Due to the 2: 1 ratio between pinions 936b and 936c, cable 925b travels twice the distance of cable 925c. (This is required by routing the cable 925b around the pulleys 982, 984 and 985.) The pins 972a, 972b slide along the slots 968a, 968b and close the jaws 920, 922. To open the jaws, the user turns the knob 914 in the direction of the opposite arrow A, which tensions the cable 925c and allows the cable 925b to slack. The tension on the cable 925c moves the yoke 964 proximally (opposite arrow C) and opens the jaws 920, 922.

  Due to the orientation of the slot sections 974, 975, during the initial stage of jaw closure when the yoke slides along the slot section 974 (FIG. 23B), the yoke follows the slot section 975. A greater ratio of jaw closure is observed for the distance traveled by the piston than during the subsequent latter stage when sliding (FIG. 23C). Such a configuration provides a quicker jaw closure with less mechanical advantage when less closure force is needed (since the jaws are not yet in contact with the tissue), but because the jaws grasp and penetrate the tissue In addition, when more closing force is required, it provides a slow jaw closure with a high mechanical advantage. After the jaws reach the position of FIG. 23C, the pin 1410 hits a stop 1414 on the handle 902 and the lock arm notch 1254 and yoke notch 1256 engage to restrict the subsequent closure of the jaws. The user then pushes the switch 915 proximally to move the stop member 1412 out of the way and disengage the locking arm 1250 from the yoke 964, which causes the knob 914 to further rotate, completely closing the jaws, An implant is deployed (FIG. 23D).

  Referring to FIGS. 24A-24D, the reversing portion 910 includes a series of links 990 that are hinged together with pins 991. Each link 990 has a generally U-shaped body 992, wherein the generally U-shaped body 992 defines a first section 992a that defines a U-shaped opening and a second that defines a larger U-shaped opening. Section 992b. Extending from the body 992 are two mating protrusions 994. The body 992 defines two side holes 996 (only one hole 996 is shown in FIG. 24B), and each protrusion 994 defines a side hole 998. When the two links 990 are mated, the protrusion 994 is in the U-shaped opening defined by section 992b. The holes 996, 998 are aligned and the pin 991 passes through the holes 996, 998 to join the two links. The body 992 has a side wall 1000 with a side wall portion 1001 fixed at an angle to allow bending of the joining link. Link 990 also defines axial holes 1002, 1003 for receiving cables 924a ', 924a, respectively. Cables 924a, 924a 'terminate on mount 1062. Pulling cable 924a causes portion 910 to bend and pulling cable 924a 'straightens portion 910. A cover 910 '(FIG. 17A) covers the link.

  Referring also to FIG. 25, in addition to lumen 916 for receiving gastroscope 715, shaft 904 and mount 1060 include lumen 1010 for receiving tissue engaging member 908, lumen 1012 for receiving bent cable 924a. A lumen 1014 for receiving a straight cable 924a ′, a lumen 1016 for receiving a closure cable 925b, a lumen 1018 for receiving an open cable 925c, and a lumen 1020 for receiving a locking cable 1260. And an extra lumen 1022 as necessary. Mount 1062 has respective holes 1024 and 1026 for passage of cables 925b, 925c, a hole 1028 where closure cable 925b terminates, and a passage hole 1030 for locking cable 1260.

  The tissue engaging member 908 is disposed in a U-shaped opening defined by the U-shaped body 992 in the reversing portion 910. The pin 991 is centrally disposed along the central axis of the tissue engaging member 908, and the tissue engaging member 908 is bent along the central axis when bent. Tissue engaging member 908 is surrounded by sheath 927a (FIGS. 17D and 18). The sheath 927a extends from the handle inlet 1002 to the proximal end of the through hole 927 in the connecting member 919. The sheath 927a has one end sealed by the handle 902 and the other end sealed by the connecting member 919. This effectively seals the remainder of the device from contact with the fluid flowing into the tissue engaging member 908. The shaft lumen 916 is similarly surrounded by a sheath 916 ′ that seals the remainder of the device from contact with bodily fluid entering the lumen 916.

  Referring to FIGS. 26 and 27, the end effector 906 is configured to deploy the tissue fixation member simultaneously with the closure of the jaws 920, 922 without requiring further actuation. The cartridge 960b of the jaw 922 has tissue passage tubes 1120a and 1120b. Tissue fixing rods 824a and 824b having a tip 1122 for tissue piercing are detachably attached to the tubes 1120a and 1120b. Each tube 1120 a, 1120 b defines a through hole 1124, and each rod 824 a, 824 b has a hub 1126 that fits within the hole 1124. Tubes 1120a, 1120b and rods 824a, 824b have the same outer diameter to facilitate tissue piercing. The rods 824a, 824b each define, for example, a through hole 1128 for receiving a suture (not shown) that passes through both holes and is tied to itself. Bars 824a, 824b may be coupled to tubes 1120a, 1120b, respectively, by press fitting, crimping, or spot laser welding. Crimping can be performed around the entire circumference of the bar, at two (opposite) sides of the bar, or at a single point along the circumference of the bar.

  The bars 824a, 824b are configured to be removed from the tubes 1120a, 1120b under the force applied by the closure of the jaws 920, 922. Referring to FIGS. 26 and 28A-28C, cartridge 960a defines two arcuate walls 1130 on which rods 824a, 824b are disposed upon closure of jaws 920, 922. As shown in FIG. 28, upon closure of the jaws 920, 922, the arcuate wall 1130 applies lateral force (ie, substantially perpendicular to the long axis of the tube) to the bars 824a, 824b, This removes the rod from each tube. When the jaws 920, 922 are opened and the instrument is pulled proximally, the bars 824a, 824b and the tissue fixation member parts 732, 734 (described above with reference to FIG. 8) are removed from the jaws 920, 922.

  With reference to FIGS. 29A and 29B, the jaws 920, 922 are connected by a region 1226 and each half is covered with a hood 1220 formed by halves 1222 and 1224 defining a seam 1228 therebetween. Portions 1222 and 1224 cover the jaws 920 and 922, respectively. As shown in FIG. 29A, when the jaws are closed, the hood 1220 provides an atraumatic distal end for delivery through the esophagus. As shown in FIG. 29B, when the jaws are opened, the halves 1222, 1224 separate at the seam 1228. The hood 1220 regulates trauma to the tissue during oral insertion of the device and eliminates the need for an outer sheath that extends the length of the device.

  Referring to FIG. 30, handle 902 defines an inlet 1002 through which gastroscope 715 is inserted. A seal 1004 is provided at the entrance 1002 for hermetically sealing between the handle 902 and the gastroscope 715. The seal 1004 has a narrow diameter sealing region 1006 and a narrow diameter alignment region 1008 spaced about 10 mm from the region 1006. Region 1006 has a diameter of about 9 mm, which is about the same as or slightly smaller than the diameter of gastroscope 715 (typically about 10 mm) (about 90%). Region 1008 has a diameter of about 11 mm, which is about the same as or slightly larger than the diameter of gastroscope 715 (about 110%). The alignment region 1008 provides support for the gastroscope 715 to maintain a hermetic seal at the sealing region during operation of the gastroscope. The seal 1004 is made of, for example, rubber or other deformable material.

  Other embodiments are within the scope of the following claims.

  For example, referring to FIG. 31, instead of the curved surface 1130 of FIG. 28, the cartridge 960a 'has a spring member 1130'. When rods 824a, 824b contact member 1130 ', member 1130' deflects and forms a curved surface, resulting in a lateral force applied to rods 824a, 824b, which removes the rod from tubes 1120a, 1120b. Works.

  Referring to FIG. 32, in another embodiment, the tube 1120 'has a pair of radially opposed slots 1132 that provide flexibility to the tube end 1133 and aid in the removal of the rod from the tube. The rod 824 'may have a pair of guide protrusions 1134 that are received in slots 1132 that radially orient the rod 824' relative to the tube 1120 '. Referring to FIG. 33, the rod 824 "has a ridge or relief groove 1136 that determines the force required to remove the rod from the tube. The tube can be formed of plastic and molded as an integral component of the cartridge, and the rod can be insert molded into the tube. Referring to FIG. 34, the rod 824 ′ ″ is connected to the tube 1120 ″ by a reduced diameter, weakly breakable region 1137 that breaks upon application of a lateral force to the rod 824 ′ ″. Yes.

  Referring to FIGS. 35A and 35B, instead of a bar attached by suturing, the tissue fixation member has a bar 1150 connected by a flexible spanning member 1152. The rod 1150 defines a through hole 1154 and is received on a member 1156 having a tissue piercing tip 1158. The member 1156 is a substitute for the tube 1120.

  Referring to FIG. 36A, the end effector 906 and the inversion 910 are partially covered with an atraumatic hood 1100 to help insert the device 900 through the esophagus. The hood 1100 has a tapered distal end 1102 that terminates in a small diameter head 1104. The hood 1100 has an opening 1106 through which the end effector 906 and the inversion portion 910 are disposed in the direction of arrow D after insertion of the device 900 through the esophagus. The distal end 1102 defines a channel 1105 that extends from the leading portion 1104 to the slot 1107. The device 900 can be introduced orally by using a guide wire (not shown) and inserting the guide wire through the channel 1105 entering at the leading portion 1104 and exiting at the slot 1107. The hood 1100 is made of an elastomeric material such as metal, plastic, rubber, polyurethane, or silicone, for example.

  As shown in FIG. 36B, a pair of flaps 1109 are provided over the assembly 905 to more reliably avoid tissue trauma when the device is introduced orally. These flaps are separated when the inversion unit 910 is deployed.

  Referring to FIG. 37, a relatively smooth surface is created between the jaws 920, 922, rather than the hood that covers the end effector 906, at the distal end of the instrument to facilitate insertion of the instrument into the patient. A volume filling burette 1200 is disposed. The burette 1200 defines a through hole 1200a for feeding over the guide wire. The volume fill burette 1200 is soluble in the operating environment, can be recovered from the operating environment, or can be discarded in the operating environment. For example, the guidewire may have a tip with a larger diameter than the hole 1200a so that the burette 1200 is retained on the guidewire and can be removed at the same time.

  Referring to FIG. 38, in another embodiment, the hood 1220 ′ has halves 1222 ′, 1224 ′ that are connected to the mount 924 by a pivot 1230. When the jaws are open, the halves 1222 ', 1224' pivot about the pivot 1230 and separate at the seam 1228 '. In FIG. 39, the halves 1222 ", 1224" of the hood 1220 "include a spring beam 1240 joined at a region 1226 '. When the jaws are open, the halves 1222 ", 1224" are separated by the seam 1228 "and the spring beam 1240 is deformed.

  Alternatively, an end cap 1242 is placed on the jaws to provide an atraumatic distal end, as shown in FIG. The end cap 1242 is removed by using a tissue engaging member and pushing it away distally, is soluble (eg, made of starch or gelatin), or “when the jaws are released”. It can be demolished. Providing perforations along the length of the cap 1242 can aid in demolition. After removal, the cap 1242 can be discarded in the operating environment when it is dissolved or discharged, or it can be retained by a guide wire and recovered when the device is withdrawn.

  Referring to FIGS. 41A and 41B, in another embodiment, the end effector 906 includes jaw members 920 ′, 922 ′, each removably attached to a respective actuation arm 962a ′, 962b ′. Tissue manipulation cartridges 960a ′ and 960b ′. The jaw 922 'houses push rods 814a, 814b for deploying the rods 824a, 824b described above with reference to FIG. However, push rods 814a, 814b are actuated by yoke 964 without using a separate mechanism for actuating push rods 814a, 814b. Each arm 962a ', 962b' defines a first arcuate section 974 ', a second generally linear angled section 975', and a third generally linear parallel section 976 '. Movement of the yoke 964 along the slot sections 974 'and 975' closes the jaws 920 ', 922'. To deploy tissue fixation device 730 (FIG. 2), movement of yoke 964 along section 976 ′ of slots 968a, 968b causes push rods 814a, 814b to move distally and causes rods 824a, 824b to move tissue. Advance from the piercing tips 818a, 818b and deploy the fixation device 730 as described above with reference to FIGS. 4A and 4B.

  Referring to FIG. 42, another tissue fixation member used with the embodiment of FIGS. 2 and 41 has a bar 1150 'connected by a flexible spanning member 1152'. The bar 1150 'is a substitute for the bars 824a and 824b.

  The devices specifically shown in FIGS. 43-45 are configured to allow one person to control both the gastroscope and the tissue reconstruction device. With particular reference to FIG. 43, an apparatus 1300 for reconstituting tissue includes a standard gastroscope 715 and a tissue manipulator 1304 attached to the gastroscope 715. The tissue manipulator 1304 has a control mount 1306 that a user attaches to the gastroscope tube 1307 by, for example, a friction fit. The control mount 1306 has knobs 912, 914 as described above. The end effector 906 and the reversing part 910 of the assembly 905 are attached to the sleeve 1308, and the gastroscope tube 1307 extends through the sleeve 1308. Sleeve 1308 defines a conduit for the control cable, as described above. Connecting the control mount 1306 and the sleeve 1308 is a flexible conduit 1310 that encloses various cables for controlling the end effector 906 and the inversion portion 910, as described above. The sleeve 1308 has a hand grip 1312. Conduit 1310 allows for axial movement of gastroscope 1302 relative to tissue manipulator 1304. In use, the operator holds the gastroscope handle with one hand and operates any control and control grip 1312 with another hand, allowing one operator to control all functions.

  Referring to FIG. 44, the device 1320 for reconstituting tissue has a standard gastroscope 715, and the user wears an end effector 906 on the gastroscope 715. A cable for actuating the jaws is attached to the jaw control mount 1324. The cable is received in the standard biopsy channel 1332 'of the gastroscope. The reversing motion is provided by the gastroscope 715 and controlled by the gastroscope control. The jaw control mount 1324 has a knob 914 for actuating the jaw control cable. In the embodiment of FIG. 45, instead of attaching the tissue reconstructing device to a standard gastroscope, the integrated device 1330 has a knob 914 that attaches directly to the gastroscope 1330. A control cable for actuating the jaws is integrated with the gastroscope control cable. A tissue engaging member, such as member 740 'of FIG. 12, is introduced through gastroscope channel 1322'.

  Referring to FIGS. 46A and 46B, the cartridges 960a, 960b are supplied to the medical personnel in the holder 1450. The holder 1450 has a base section 1452 that has a first side 1453a for receiving the head 1059 of the cartridge 960a and a second side 1453b for receiving the head 1059 of the cartridge 960b. Base section 1452 defines an opening 1455 in which tubes 1120a, 1120b are disposed. Extending from both sides of the base section 1452 are two sets of detents 1454 located on both sides of the cartridge head 1059. Extending proximally from the base section 1452 are fins 1456 that have spring beams 1458 on either side of the fins 1456 on either side of the base section 1452. Guide rails 1460 are disposed on both sides of the spring beam 1458. There is a slot 1461 between the spring beams, and there is a slot 1463 between each spring beam 1458 and the guide rail 1460. The holder 1450 has a knob 1462 for easy handling. The hood 1220 is provided to the user along with the holder 1450. In order for the user to be able to hold the knob 1462, the knob 1462 is attached to the rest of the holder by a narrow section 1462a on which the hood slot is located.

  In order to mount the cartridges 960a, 960b in the holder 1450, each cartridge is placed on the base section 1452 in turn, with a narrow section 1057 of the cartridge aligned with the slot 1461. By depressing the cartridge, the spring beam 1458 is forced apart and the narrow section 1057 fits in place in the slot 1461 and the spring beam 1458 holds the cartridge in place. The cartridge head 1059 is located between the detents 1454 and the side wall 1056 is partially within the slot 1463 to align the cartridge and assist in holding the cartridge in place. With the base section 1452 disposed between the cartridges 960a, 960b, the cartridges are spaced so that the implant is not deployed (corresponding to the position shown in FIG. 23C).

  Referring also to FIG. 46C, in order to attach the cartridges 960a, 960b to the arms 962a, 962b, respectively, while holding the knob 1462, the user slides the cartridge over the arms (the arms are shown in FIG. 23C). To be arranged). Initially, the structure 1051 on the inner surface of the arm slides between the spring beams 1458 to force the spring beams apart. Further sliding on the cartridge arm positions the rectangular member 1050 below the arm 1056 and places the clip 1052 in the hole 1058. The cartridge is then attached to the arm. Since the spring beam 1458 is forcibly separated by the structure 1051, the holder 1450 can now be released from the cartridges 960a, 960b by opening the jaws, and the instrument is ready for use.

  Holder 1450 is preferably formed of plastic, and holder 1450 is supplied aseptically to surgical personnel along with cartridges 960a, 960b, hood 1220, and implant.

  47A-47F are various views of the handle 902. FIG.

  48 to 55, the device 2010 has a proximal end (not shown), a shaft 2012, an inversion portion 2014, and a distal end effector 2015. The distal end effector 2015 includes A movable arm 2016, a retractor 2020, and a graft 2022. The function of the instrument is controlled by the user by control at the proximal end, as disclosed herein.

  FIG. 48 shows the device 2010 in place in the esophagus 2030 and stomach 2032. The device is in a straight configuration that is inserted into the esophagus and stomach.

  FIG. 49 shows the device 2010 in place in the esophagus 2030 and stomach 2032, with the device 2010 in the inverted position. Inversion of the inversion portion 2014 is accomplished as disclosed in the cited patents and applications. In this position, the distal end of the movable arm 2016 of the end effector 2015 is located near the junction 2034 of the esophagus 2030 and the stomach 2032.

  FIG. 50 shows the device 2010 in place in the esophagus 2030 and stomach 2032 with the device 2010 in the inverted position and the movable arm 2016 in the open position showing the portion 2018 of the implant 2022 (FIG. 54). It is important to note that the movable arm 2016 is oriented relative to the inversion portion 2014 and grasps the tissue at the junction 2034 of the esophagus 2030 and stomach 2032. The movable arm 2016 opens and closes in the same plane on which the reversing unit 2014 moves. The actuation mechanism used to open the movable arm 2016 is substantially the same as the mechanism described herein, and the movable arm rotates at 90 ° with respect to the configuration described herein. The arm 2016 opens and closes in the same plane in which the reversing unit 2014 moves.

  51 shows the device 2010 in place in the esophagus 2030 and stomach 2032, where the device 2010 is in the inverted position, the movable arm 2016 is in the open position, and the retractor 2020 is at or at the junction 2034 of the esophagus 2030 and the stomach 2032. Engage with nearby tissue. Engagement of the retractor 2020 with tissue at or near the junction 2034 is accomplished as described herein.

  52 shows the device 2010 in place in the esophagus 2030 and stomach 2032, where the device 2010 is in the inverted position, the movable arm 2016 is in the open position, and the retractor 2020 is at the junction 2034 of the esophagus 2030 and stomach 2032, or The nearby tissue is drawn into the space between the movable arms 2016.

  FIG. 53 shows the device 2010 in place in the esophagus 2030 and stomach 2032, where the device 2010 is in the inverted position and the movable arm 2016 is closed, at or near the junction 2034 of the esophagus 2030 and stomach 2032. A fold 2036 of the organization is created. The mechanism for closing the movable arm is as described herein.

  FIG. 54 shows the device 2010 in place in the esophagus 2030 and stomach 2032, where the device 2010 is in the inverted position and the movable arm 2016 is open. The implant 2022 is placed through the tissue and maintains fixation of the tissue fold 2036. Implant placement is accomplished as described herein.

  FIG. 55 shows the device 2010 in place in the esophagus 2030 and stomach 2032, where the device 2010 is in a straight position and the movable arm 2016 is closed. A tissue fold 2036 is shown and secured by the implant 2022. The device 2010 is in place for removal from the patient.

  The device and method can be used to treat GERD by creating and securing tissue folds at or near the junction of the esophagus and stomach, thereby securing the stomach wall to the esophageal wall. . The pleats can be created and secured entirely by intraluminal methods. Two or more folds can be created at or near the junction of the esophagus and stomach. The movable arm is a method that allows the operator to rotate the position of the movable arm relative to the reversing part about the central axis of the movable arm and thus allows the operator to vary the orientation of the tissue folds. It can be attached to the reversing part.

  Referring to FIG. 56, the cable actuation mechanism 2100 is used to control the inversion and end effector of an oral medical device for treating GERD as described herein. The mechanism 2100 includes a knob assembly 2102, a gear assembly 2112 controlled by the knob assembly 2102, and a series of cables 2104, 2106 attached to the gear assembly 2112 to control the reversal of the medical device and the operation of the end effector. 2108, 2110. The mechanism 2100 includes a lever lock button assembly 2113 that is actuated to allow deployment of an implant coupled to the end effector of the medical device, and guides the cable to place the cable into the assembly for proper operation. And an adjustment block assembly 2114 used for adjustment. Cover 1200a is disposed on assembly 2114 when assembled.

  Referring to FIG. 57, knob assembly 2102 has a fixed central shaft 2116 that is surrounded by a rotatable shaft 2118, which is further surrounded by a rotatable shaft 2120. The shaft 2118 has a gear 2136 that engages the gear-to pulley 2150 of the gear assembly 2112. Cables 2106, 2110 are coupled to a gear-to-pulley 2150 and an end effector, and rotation of the gear-to- pulley 2150 controls the opening and closing of the end effector jaws. The shaft 2120 has a gear 2144 that engages a gear-pulley 2148 of the gear assembly 2112. Cables 2104 and 2108 are coupled to the gear-to-pull pulley 2114 and the reversing portion, and the rotation of the gear-to-pull pulley 2148 is adapted to control the bending and straightening of the reversing portion.

  Referring to FIG. 58, gear pulleys 2148, 2150 are mounted for rotation about fixed shaft 2146. The fixed shaft 2146 has a groove 2152 for receiving the clip 2154, and the clip 2154 is used to secure the gear pulleys 2148 and 2150 to the fixed shaft 2146. Gear pulley 2148 has a first groove 2160 for receiving cable 2108 and a second groove 2156 for receiving cable 2104. As shown in FIG. 57, the ends 2109, 2105 of the cables 2108, 2104, for example, include groove crimps 2161, 2157, respectively, by including ball crimps at the ends of the cables along with ball crimps received in the groove wall openings. As a result, rotation of the gear pulley 2148 in the direction of arrow B pulls the cable 2108 and bends the reversal, and rotation in the opposite direction pulls the cable 2104 and corrects the reversal. ing. The diameter of the groove wall 2161 is about twice the diameter of the wall 2157, and the movement of the cable 2108 is about twice the movement of the cable 2104. Also, the mechanical advantage is obtained by setting the gear ratio of gear 2148 to gear 2144 to about 2: 1.

  The gear pulley 2150 has a first groove 2168 for receiving the cable 2106 and a second groove 2164 for receiving the cable 2110. As shown in FIG. 57, the ends 2107, 2111 of cables 2106, 2110, for example, include groove crimps 2169, 2165 by including ball crimps at the ends of the cables together with ball crimps received in the groove wall openings, respectively. As a result, rotation of the gear pulley 2150 in the direction of arrow B pulls the cable 2106 and opens the end effector jaws, while rotation in the opposite direction pulls the cable 2106 and closes the jaws. The diameter of the groove wall 2169 is about twice the diameter of the wall 2165, and the movement of the cable 2106 is about twice the movement of the cable 2110. Also, the mechanical advantage can be obtained by setting the gear ratio between the gear 2150 and the gear 2136 to about 4: 1.

  Central shaft 2116 creates a seal between shaft 2116 and shaft 2118 for receiving a snap ring (not shown) for coupling shaft 2116 to a locking mechanism (not shown). A groove 2126 for receiving the O-ring 2128. Shaft 2118 includes a groove 2130 for receiving a snap ring (not shown) for coupling shaft 2118 to a knob (not shown) and an O for creating a seal between shaft 2118 and shaft 2120. A groove 2132 for receiving the ring 2134. The shaft 2120 provides a seal between the groove 2138 for receiving a snap ring (not shown) for coupling the shaft 2120 to a knob (not shown) and between the shaft 2120 and the handle housing (not shown). And a groove 2140 for receiving an O-ring 2142 for making.

  Referring to FIG. 59, the lever lock button assembly 2113 has a button assembly 2200 coupled to a slide 2216 and a locking mechanism 2214. Slide 2216 has a cable 2222 (FIG. 56) attached to it and activating a distal lock (not shown) of the end effector. The locking mechanism 2214 limits the rotation of the gear pulley 2150 and limits the extent of jaw closure until the user attempts to deploy the implant. To deploy the implant, the user presses the button assembly 2200, which simultaneously pulls the cable 2222 to release the distal lock and activates the locking mechanism 2214, allowing further rotation of the gear pulley 2150. In this way, it acts to allow further closure of the jaws.

  Button assembly 2200 is connected to lower plate 2122 and upper plate (not shown) by pins 2202. Referring also to FIGS. 60 and 61, the button assembly 2200 includes a button element 2203 that defines a hole 2204 into which a spring 2205 is inserted and a crossbar that receives a pin 2202 and from which two arms 2210 and 2212 extend. Branching element 2206 including 2208. The spring 2205 acts between the button element 2203 of the adjustment block 2114 (FIG. 56) and the housing 2215 to bias the button 2200 toward the locking position.

  The arm 2210 defines a slot 2219 for receiving the slide 2216 and a slot 2220 for receiving a pin 2218 attached to the slide 2216 for slidably connecting the slide 2216 to the arm 2210. When the user presses button element 2203, button assembly 2200 or arm 2210 pivots about pin 2202 in the direction of arrow E. This movement of arm 2210 causes slide 2216 to slide in the direction of arrow F, pin 2218 slides in slot 2220 (FIG. 61), and cable 2222 is pulled in the direction of arrow F to lock the distal lock. To release.

  Arm 2212 has a slot 2227 for receiving curved arm 2224 of locking mechanism 2214 and a slot for receiving pin 2266 attached to curved arm 2224 for slidably coupling curved arm 2224 to arm 2212. 2228. The curved arm 2224 is connected to the first portion 2230 of the L-shaped arm 2232 by a pin 2234. The L-shaped arm 2232 is coupled to the base plate 2122 by a post 2236 around which the arm 2232 can rotate. The L-shaped arm 2232 is coupled to the first end 2237 of the stop lever 2238 by a screw 2240 that is inserted into a slot 2242 defined by the second portion 2244 of the L-shaped arm 2232. Stop lever 2238 defines a slot 2239 about which lever 2238 receives post 2236 that rotates with arm 2232 (FIG. 61). Lever 2238 has a second end 2246 that is shaped to engage pin 2248 of gear pulley 2150.

  Engagement of lever 2238 with pin 2248 limits the extent to which the jaws can be closed so that the implant is not deployed until the button mechanism is activated to separate the lever and pin. When the user presses the button element 2203, the arm 2212 rotates about the pin 2202 in the direction of arrow E, moving the curved arm 2224 and the L-shaped arm 2232, and the L-shaped arm 2232 moves around the post 2236. Is rotated in the direction of arrow D (FIG. 61). This action rotates the stop lever 2238 around the post 2236 as well, separating the lever 2238 from the pin 2248 so that the gear pulley 2250 can be further rotated to deploy the implant. Stop lever slot 2242 facilitates assembly and calibration of cable actuating mechanism 2100 by allowing positioning of stop lever 2238 relative to jaw closure set during assembly.

  62-65, the adjustment block assembly 2114 has a housing 2215 that includes a front end 2800, a rear end 2802, a first side 2804, a second side 2806, an upper portion 2808, and a lower portion. 2810. The housing 2215 has five slots 2110E, 2108E, 2104E, 2106E, 2222E at the front end 2800, four holes 2110A, 2108A, 2104A, 2106A, and five holes 2110F, 2108F, 2104F at the rear end 2802, 2106F and 2222F. Holes 2110A, 2110F communicate with slots 2110E for receiving cables 2110 therethrough, holes 2108A, 2108F communicate with slots 2108E for receiving cables 2108 therethrough, and holes 2104A, 2104F through which In communication with slot 2104E for receiving cable 2104, holes 2106A, 2106F are in communication with slot 2106E for receiving cable 2106 therethrough. Slot 2222E opens at front end 2800 for receiving slide 2216 and communicates with hole 2222F at rear end 2802 for receiving cable 2222.

  Cable adjusters 2110D, 2108D, 2104D, 2106D, and 2222D are received in the respective holes 2110F, 2108F, 2104F, 2106F, and 2222F at the rear end 2802, respectively. Cables 2110, 2108, 2104, 2106, and 2222 each pass through one of the cable adjusters, which are used to set the length of the cables in the assembly. Within each hole 2110A, 2108A, 2104A, and 2106A at the front end 2800, a cable adjuster is optionally received, respectively, to help set the cable length.

  To facilitate assembly, each of cables 2110, 2108, 2104, and 2106 is preferably formed of two cables joined by connectors 2110C, 2108C, 2104C, and 2106C. Each cable end has a ball crimp 2110I, 2108I, 2104I, and 2106I (only one end of each cable and the ball crimp is shown in FIG. 63), which are the slots defined by the coupler. Removably received within 2110J, 2108J, 2104J, and 2106J. Couplers 2110C, 2108C, 2104C, and 2106C are received in slots 2110E, 2108E, 2104E, and 2106E, respectively. Slots 2110E, 2108E, 2104E, and 2106E have front stops 2110G, 2108G, 2104G, and 2106G, respectively, and rear stops 2110H, 2108H, 2104H, and 2106H, respectively. These stops limit the operation of couplers 2110C, 2108C, 2104C, and 2106C, respectively. The stop limits the operation of the coupler and thus limits the maximum amount of distance that the cables 2110, 2108, 2104, and 2106 can be pulled.

  Referring again to FIGS. 58 and 63, the knob assembly 2102 and gear assembly 2112 are encapsulated in a plate stack 2900, allowing cable 2110, 2108, 2104, and 2106 from grooves 2164, 2160, 2156, and 2168. Slip is limited. These plates have slots as required to allow the cable to exit the plate stack 2900 and connect to the adjustment block assembly 2114. Plate stack 2900 is aligned and connected to lower plate 2122 and upper plate (not shown) by posts 2902.

  Referring to FIG. 66, another embodiment using coupler contact with the slot ends in the housing 2215 that couples the cable operation is a concentric slot 1302a and slot 1302a in the plate stack plate 1300a. Providing pins 1304a and 1306a attached to an inwardly extending gear-pulley 2150. The slot 1302a has a first end 1308a and a second end 1310a. The rotation of the gear pulley 2150 is made by pins 1304a, 1306a that contact the ends 1308a, 1310a. Similarly, another concentric slot can be provided in another plate, a pin can be provided on the gear- pulley 2148, and the gear- pulley 2148 can be rotated.

  Referring to FIG. 67, the handle mechanism 3000 includes a gear 3002, and the gear 3002 is connected to the operation control knob 914 via a shaft 2118 (FIG. 57) that rotates at the same time. Gear 3002 drives transmission assembly 3004. The transmission assembly 3004 includes a drive gear 3006, a clutch 3008, a ring 3009, a pulley 3010, and a control arm 3012. When the gear 3002 rotates (as will be described later with reference to FIG. 96), the drive gear 3006, the clutch 3008, the ring 3009, and the pulley 3010 rotate. The various components of assembly 3004 interact to determine the fully open and closed positions of actuating arms 962a, 962b that are coupled to pulley 3010 (FIG. 17G), as described below. To determine a cartridge mounting position for providing a mechanism for holding the actuating arm in a fixed position for insertion through the esophagus and to keep the actuating arm open when no torque is applied to the knob 914 Provide the mechanism. Also, the ratchet formed on the pulley 3010 interacts with the control arm 3012 such that when the operator releases his hand from the knob 914, the arm is forcibly released by the tissue while the actuating arms 962a, 962b are closed. to continue. When the knob 914 is rotated to close the actuating arms 962a, 962b, as will be described further below, for example, the level at which tension applied to the cable can damage the cable, which can occur if something obstructs and separates the actuating arm. The clutch 3008 slips before reaching.

  Referring to FIG. 68, the ring 3009 has a ramp 3014 and the pulley 3010 has a first ramp 3015 and a second ramp 3016. A first recess 3018 is defined between the lamps 3015 and 3016, and a second recess 3020 is at the end of the lamp 3014. The position of the recess 3020 relative to the recess 3018 can be adjusted by rotating the ring 3009 relative to the pulley 3010 and is fixed by using a set screw 3021. The pulley 3010 also has a section of ratchet teeth 3022 and a stop pin 3024. As shown in FIGS. 67 and 69, the arm 3012 has a post 3030 that is rotatably mounted on the arm with a pin 3029. As the knob 914 rotates to close the working arm, the post 3030 moves over the ramp and enters the recess 3018. The position of this post 3030 sets the position of the working arm corresponding to the desired position for mounting the cartridge on the working arm and for passing the distal end of the instrument through the esophagus.

  Referring also to FIG. 70, the arm 3012 has a pawl 3032 attached to it that travels along the ratchet teeth 3022. When the operating arm is closed from the cartridge mounting position to the deployed position, the operator presses button 3034 (FIG. 67) on arm 3012 to rotate arm 3012 about pivot point 3036 and remove post 3030 from recess 3018. Continued rotation of the knob 914 advances the post 3030 along the ramps 3016 and 3014 so that the arm 3012 also pivots about the pivot point 3036 and the pawl 3032 engages the ratchet teeth 3022. Yes. The pawl 3032 has a torsion spring 3038 that biases it to engage the teeth 3022. The engagement of pawl 3032 and ratchet teeth 3022 when the actuating arm is closed may cause the user to move the hand from knob 914, such as when the user releases his hand from knob 914 during repeated rotation of the knob and closes the actuating arm. Release the movement arm limits the tendency of the working arm to be forced apart by the tissue located between them. When the actuating arm is fully deployed, i.e., when the arm is in the position where the implant has been deployed, the post 3030 falls into the recess 3020, moves the pawl 3032 away from the ratchet teeth 3022, and the button 3034 is lifted up. Provide visual, tactile and / or auditory feedback where the implant is deployed. To open the actuation arm, the operator rotates the knob 914 in the opposite direction. As post 3030 advances along the edge of ramp 3014, post 3030 pivots about pin 3029, engages upper ball plunger 3030a, arm 3012 remains in place, and pawl 3032 is in motion of the actuating arm. The ratchet teeth 3022 remain spaced apart.

  Referring to FIG. 71, the assembly 3004 has a deployment stop 3040 and an open stop 3042. Stops 3040 and 3042 are threaded and their position is adjustable. The pin 3024 of the ratchet 3010 hits the stop 3040 when the actuating arm is deployed (corresponding to the position where the post 3030 enters the recess 3020) and the pin 3024 stops when the actuating arm is in its fully open position. It hits the tool 3042. In the fully open position, pin 3024 interacts with detent 3044 and the actuating arm continues to open until torque is applied to knob 914. Also shown in FIG. 71 is a pair of spring loaded ball plungers 3030a which act on the post 3030 to limit movement of the post 3030 and bias the post 3030 to a neutral position. To do.

  92 and 93, the transmission assembly clutch 3008 has a clutch spring 4002 positioned between the gear 3006 and the pulley 3010, and the clutch spring 4002 is in the recess 4006 in the gear 3006 and in the pulley 3010. In the recess 4012. The clutch spring 4002 has a post 4004 that is shaped to fit within the recess 4006 of the gear 3006. The clutch spring 4002 defines a through hole 4007 that receives the post 4008 of the pulley 3010. The pulley recess 4012 is defined by a corrugated surface 4014 inside the wall 4016 that extends from the surface 4018 of the pulley 3010. The clutch spring 4002 has a leg 4010 that interacts with the undulating surface 4014 to form a one-way clutch. In this embodiment of the pulley 3010, the pulley 3010 has a protrusion 4020 formed at one end of a series of ratchet teeth and a stop 4021 formed by a surface 4018. As the ring 3009 slides over the wall 4016, the ramp 3014 fits snugly between the stop 4021 and the ramp 3016 (FIGS. 94 and 95).

  In FIG. 94, the transmission assembly 3004 is shown in a corresponding position when the jaw members 3102a, 3102b are closed but the implant is not deployed. This position is used during cartridge mounting and insertion of the device into the patient to prevent damage to surrounding tissue. When knob 914 is rotated and actuating arms 962a, 962b are closed, gear 3002 rotates gear 3006 in the direction of arrow 4022. Since the gear 3006 is input to the clutch spring 4002 at the contact surface between the recess 4006 and the post 4004, the spring 4002 rotates in the direction of 4022. Under normal operating conditions, rotation of the clutch spring 4002 causes the pulley 3010 to rotate due to the interaction of the leg 4010 with the undulating surface 4014, ie, the clutch spring 4002 does not slide relative to the pulley 3010. If the actuating arms 962a, 962b receive an abnormally high resistance to closure, the leg 4010 of the clutch spring 4002 bends inward as the clutch spring 4002 rotates, causing the clutch spring 4002 to slide relative to the pulley 3010, No additional tension can be placed on the actuating arm closure cable attached to the pulley 3010 that can damage the cable. For example, the clutch spring 4002 may begin to slip relative to the pulley 3010 when the cable is subjected to greater than 72 pounds of tension, at which point the cable will be overstressed.

  When the knob 914 is rotated to open the operating arms 962a and 962b, the gear 3002 rotates the gear 3006 in the direction of the arrow 4024, whereby the clutch spring 4002 and the pulley 3010 rotate in the direction of the arrow 4024. Due to the orientation of the leg 4010 relative to the undulating surface 4014, the clutch spring 4002 does not slide relative to the pulley 3010 when the clutch spring 4002 rotates in the direction of arrow 4024. Accordingly, greater torque can be exerted by the pulley 3010 in the opening direction (direction of arrow 4024) than in the closing direction (direction of arrow 4022).

  In the closed position, the pawl 3032 engages the protrusion 4020 of the pulley 3010 so that the pulley 3010 is held in its closed position and the post 3030 is biased to the position shown in FIG. When button 3034 is pressed (FIG. 95), arm 3012 rotates about pivot 3036 and post 3030 exposes ramp 3016 and rotates from the deflected position of FIG. 94 by the force of spring mounted ball plunger 3030a. Enter the neutral position. Since post 3030 is now pressed against ramp 3016, button 3034 remains in its pressed position and pawl 3032 engages ratchet teeth 3022. The knob 914 can now be rotated to further close the actuation arm. When the knob 914 is rotated to open the operating arms 962a and 962b beyond the position shown in FIG. 94, the pulley 3010 rotates in the opening direction (in the direction of the arrow 4024), and the force of the pulley 3010 is tensioned. Since it is large enough to overcome the deflection force exerted on the pawl 3032 by the spring 3038, the pawl 3032 slides over the protrusion 4020 and is pushed thereon.

  Referring also to FIG. 96, the cable actuation mechanism includes a knob assembly 5102 that is designed with a rotatable central shaft 5116 surrounded by a fixed shaft 5118 surrounded by a rotatable shaft 5120. Has been. The shaft 5120 has a gear 5144 that engages the gear pulley 2148 of the gear assembly 2112 (FIGS. 57 and 58). The shaft 5118 has a gear 3002 that engages the gear 3006 of the transmission assembly 3004 (FIGS. 67 and 92-95). Gear 3006 activates pulley 3010, which includes a first groove 5168 for receiving cable 2106 coupled to the end effector and a second groove for receiving cable 2110 coupled to the end effector. 5164.

  The central shaft 5116 has a groove 5126 for receiving an O-ring for creating a seal between the shaft 5116 and the shaft 5118. The shaft 5118 has a groove 5132 for receiving an O-ring for creating a seal between the shaft 5118 and the shaft 5120. The shaft 5120 has a groove 5140 for receiving an O-ring for creating a seal between the shaft 5120 and the shaft 5145. A lever 912a coupled to the reversing knob 912 rotates the shaft 5145, which, as is known in the art, causes the collar 5150 to engage and disengage the friction lock when rotated. Screwed. The shaft 5145 is disposed outside the shaft 5120 and is disposed in the collar 5150. The shaft 5145 is rotated by the lever 912a, which has an indentation 5155 that accepts an O-ring located between the shaft 5145 and the collar 5150 to seal the threaded area and the friction lock.

  Referring to FIGS. 72A and 72B, the end effector 3100 has jaw members 3102a, 3102b, each of which has tissue manipulation cartridges 3104a, 3104b covered by rubber shells 3106a, 3106b, respectively. The jaw members 3102a and 3102b are detachably attached to the operating arms 3108a and 3108b, respectively. Cartridges 3104a, 3104b are configured to receive a needle 3101a, which has a tissue piercing element 3101b having a tissue piercing tip 3101c. The portion of the actuation arm 3108a, 3108b received within each jaw member 3102a, 3102b is referred to as the actuation arm coupler.

  73-75, the rubber shell 3106b defines a hole 3110 for receiving a guide wire and two web members 3112, 3114 overlying the cartridge 3104b. Webs 3112, 3114 hold shell 3106b on cartridge 3104b, but allow tissue to push the shell back when compressing the tissue between the jaw members. The rubber shell 3106b has a rectangular end 3116 that fits uniformly around the mating region 3118 of the cartridge 3104b. The cartridge 3104b has a laterally extending post 3120 that folds over the cartridge needle 3101a and potentially limits the tendency of the rubber shell to be penetrated by the needle. When the cartridge 3104b is mounted on its respective actuation arm 3108b as described above, the metal actuation arm extends into the plastic cartridge and ends in the area behind the needle 3101a, and the needle Support. The cartridge 3104b has a chamfered inlet region 3121 that receives the actuation arm 3108b.

  Referring to FIGS. 76-78, the rubber shell 3106a defines a hole 3122 for receiving a guide wire and two web members 3124, 3126 over the cartridge 3104a. The rubber shell 3106a has a rectangular end 3128 that fits uniformly around the mating region 3130 of the cartridge 3104a. Cartridge 3104a has a post 3132 extending distally, and post 3132 folds over cartridge needle 3101b and the tendency of the rubber shell to be pierced by the needle when actuating arms 3108a, 3108b are closed Limit. The post 3132 extends from a metal clip 3133 protruding from the central U-shaped region 3129 of the cartridge 3104a. The U-shaped region 3129 defines a groove between the legs 3131 located on the opposite side of the clip 3133. The cartridge 3104a has a chamfered inlet region 3135 that receives the actuation arm 3108a.

  Referring also to FIG. 79, when the actuation arm is closed in its deployed position, element 3101b is pushed through a slot between legs 3131 (not shown in FIG. 79). The element 3101b is pushed toward the angled surface 3134 of the clip 3133, and the element 3101b tears out to the side, causing the breaking forces to face each other. The clip 3133 is formed as a metal protrusion extending from the cartridge 3104a. In particular, the inside of the element 3101b contacts the angled surface 3134 and at the same time the outside of the base of the needle 3101a contacts the surface of the leg 3131, thus the element 3101b is pushed against the angled surface 3134 and the needle 3101a is supported. The opposing breaking force helps the cartridge 3104a align with the cartridge 3104b and ensures that both needles are subjected to a force that ensures deployment of the implant. The metal clip 3133 controls the breakage applied by preventing the element 3101b from biting into the plastic body elsewhere in the cartridge 3104a, reducing friction, and setting the angle of the surface 3134. The load required to tear element 3101b is 2.5 pounds to 5.0 pounds and the angle at which element 3101b tears from cartridge 3104b is 10 ° to 14 °.

  Referring also to FIG. 80, in another embodiment, when the element 3101b is pushed through the slot between the legs 3131 and while contacting the angled surface 3134 of the metal clip 3133, the metal of the cartridge 3104a. The leg 3131 of the cartridge 3104a defines a conical section 3158 that serves to center the needle 3101a of the cartridge 3104b relative to the clip 3133.

  When the jaw members 3102a, 3102b are in a position to pass the distal end of the instrument through the esophagus, the holes 3110 and 3122 that receive the guidewire are aligned so that the guidewire can pass through the holes 3110 and 3122, And ensures that the actuation arms 3108a, 3108b remain closed during insertion.

  Referring to FIGS. 80-82, the actuating arm 3108a is preferably formed of steel and has a raised ramp 3140 that is received within the opening 3142 of the cartridge 3104a. Opening 3142 has a slot 3144 extending proximally, which extends to the end of cartridge 3104a. The cartridge 3104a has an instrument section 3146 that holds the cartridge in the actuating arm and forms a retainer that acts as a relief mechanism, ie when a predetermined load (ie, overload) is applied to the actuating arm 3108a. , Section 3146 bends or tears to allow the device to be removed from the patient. This is a safety feature built into both the cartridge and the account against the possibility of the cartridge becoming clogged with the implant after delivery of the implant in the tissue, or the arm being pinched in the tissue and closed position between the arms. In such a situation, the instrument arm can be removed from the cartridge by loading the instrument. Thus, the device can be removed from the patient under circumstances when the cartridge is not separated from the implant after deployment or when the arm is not open. The predetermined load is selected to be lower than the load pulling the graft through the muscle tissue, which is about 27 pounds. The portion of the cartridge 3104a, 3104b that is exposed proximal to the rubber shells 3106a, 3106b (see particularly FIG. 72) allows the operator to access and manipulate the section 3146 as needed to remove the cartridge from the actuation arm. Can be removed.

The actuating arm 3108a has a molding region 3150 that plugs into a corresponding molding region 3152 of the cartridge 3104a, a lip 3154 received in the slot 3156 of the cartridge 3104a, and a metal end 3159a (supported by the post 3132 to avoid bending of the cartridge 3104a. 72B and 82). The cavity length L _a in the cartridge 3104a that receives the coupling of the actuation arm 3108a is about 0.7 inches. Actuating arm 3108b has a metal end 3159b (FIG. 72B) that fits within the lumen of cartridge 3104b and extends to the base of needle 3101a. The length _{L b} of the cavity in the cartridge 3104a accept coupler actuating arm 3108a is approximately 0.6 inches.

  As described above with reference to FIGS. 46A and 46B, the cartridge is supplied to the healthcare professional in a holder. 83 and 84, the jaw members 3102a, 3102b are attached to the holder 3160 in the manner generally described above. The portion 3162 of the holder 3160 that attaches the cartridge to the holder (only one of which can be seen in FIG. 84) is flexible, allowing automatic alignment when the cartridge is mounted on the working arm. The holder 3160 may have a tab 3164 with a note such as “Remove before use” that indicates to the operator to remove the holder from the cartridge before use. The tab may be sized to make it clear to the user not to insert the cartridge into the patient with the holder in place.

  24A-24D show an inversion unit 910 having a series of links. Referring to FIG. 85, the inversion portion 910a is similarly formed of a series of links 3171 and has a proximal mount section 3170 that provides additional flexibility to the inversion portion to facilitate insertion. Referring also to FIG. 86, the section 3170 has a connecting portion 3174 with a protrusion 3176 for attaching the section 3170 to the remainder of the reversing portion 910a.

  Referring also to FIG. 87A, a flexible boot 3179 having a portion 3178 and a portion 3180 covers the inversion portion 910a. In particular, as shown in FIGS. 87B and 87C, portion 3178, except for protrusion 3176, covers link 3172 and coupling portion 3174 of proximal section 3170, and portion 3180 covers the remaining links of inversion portion 910a. . Portion 3178 has an inner tube end 3181 that seals to lumen 916 and an outer tube end 3182 that seals to shaft 904. Portion 3180 has a tube end 3183 that seals to the distal end 905a at the end region 905b (FIG. 85) of the inversion 910a.

  FIGS. 23A-23D show a closure cable 925b wound around pulleys 984, 982 and 985 and ending at a fixed point 986. FIG. Referring to FIG. 88a, the second jaw closure cable 3180 is wrapped around pulleys 984, 982 and 985 to reduce the loading on the cable 925 necessary to deploy the implant, Ends at 3182. This double pulley system achieves a closing force of about 35 pounds at the tip of the arm with less than about 15 pounds applied to each cable 925b and 3180. Referring to FIG. 88b, both cables 925b, 3180 end in a handle mechanism balancing pulley 3194. Balance pulley 3194 is connected to yoke 3196 which is connected to the closing pulley by a short cable 3198 as described above. When the arm is opened and closed, the pulley 3194 and the yoke 3196 move backward and forward. A balanced pulley ensures that both cables 925b and 3180 are pulled with the same force.

  Referring to FIGS. 89 and 90, the boot 3184 covers the distal end 905a of the inversion portion 910a except for the parts of the actuation arms 3108a, 3108b that engage the cartridge. The boot 3184 is flexible and allows the operating arms 3108a, 3108b to be opened and closed. The boot has a seal 3186 for sealing the actuation arm and a seal 3188 for sealing a port for a retractor (such as retractor 740 or 2020 as described above). Seals 3186 and 3188 are formed by first wrapping around a piece of boot 3184 adjacent to actuating arms 3108a, 3108b and binding with a thread and then applying an adhesive onto the thread. The seal 3188 has an interference ridge 3190 that acts to hold the distal end of the retractor within the boot 3184 during insertion. Boot 3184 defines a hole 3192 for receiving a guide wire. The boot prevents bodily fluids from contacting the cable and pulley during the procedure, and prevents cleaning fluid from contacting the cable and pulley during cleaning, providing for device reuse.

  Referring to FIG. 91, the end effector 3100 is connected to a reversing unit 910 a connected to the shaft 904. As shown, a boot 3184 covering the distal end 905a seals the actuation arms 3108a, 3108b (FIG. 72A) of the jaw members 3102a, 3102b. As described above, instrument 900 passes guidewire 4000 through straight shaft 904, lumen 916, boot 3184 hole 3192, and holes 3110 and 3122 that receive guidewire 4000. It can be introduced orally using a guidewire 4000.

  Other embodiments are within the scope of the following claims. Although the clutch spring 4002 is shown with three legs (FIGS. 92 and 93) and four legs (FIGS. 94 and 95), the clutch spring 4002 can be composed of any number of legs 4010. For example, the clutch spring 4002 may have one leg, two legs, or ten legs. Seals 3186 and 3188 may be formed using other methods, such as, for example, by an interference fit between the actuation arm and a portion of the boot adjacent to the actuation arm.

  The clip 3133 can be integrated with the cartridge 3104a, and the cartridge 3104a (and the clip 3133) can be formed of metal. Clip 3133 can be molded to the end of cartridge 3104a, which can be formed of plastic.

Description of drawings
FIG. 3 is a diagrammatic representation of a device used to reconstruct tissue near the gastroesophageal junction of the stomach. FIG. 2 shows a tissue fixation device deployed by the apparatus of FIG. 1 in use to secure a bulge formed in tissue. It is a figure which shows the apparatus of FIG. FIG. 6 shows the proximal end of the device. FIG. 5 shows an operating channel in the shaft of the device. It is a figure which shows the coil assembly of an apparatus. FIG. 6 is a top view of the distal end of the instrument shown with the first and second jaw members in the open position. FIG. 6 shows the distal end of the instrument located off-axis with respect to the instrument shaft. FIG. 4B is a side view of the distal end of the instrument being rotated 90 degrees relative to FIG. 4A. FIG. 3 illustrates a first portion of the tissue fixation device of FIG. FIG. 3 shows a first jaw member with a first portion of a tissue fixation device attached to the jaw member. It is a figure which shows a 2nd jaw member. FIG. 3 illustrates the tissue fixation device of FIG. FIG. 2 shows the device of FIG. 1 in use. FIG. 2 shows the device of FIG. 1 in use. FIG. 2 shows the device of FIG. 1 in use. FIG. 2 shows the device of FIG. 1 in use. FIG. 2 shows the device of FIG. 1 in use. FIG. 2 shows the device of FIG. 1 in use. It is a figure which shows the structure | tissue fixed with the structure | tissue fixing device of FIG. FIG. 6 illustrates another cable routing for an end effector. FIG. 6 illustrates another cable routing for an end effector. FIG. 6 is an isometric view showing a tissue engaging member. FIG. 12B is an isometric view of the tissue engaging member of FIG. 12A shown with the outer sheath removed. FIG. 12B is a cross-sectional view of the tissue engaging member of FIG. 12A. FIG. 12B is a cross-sectional view of the tissue engaging member of FIG. 12A shown through tissue. FIG. 12B is an isometric view of the proximal end of the tissue engaging member and the torque generator of FIG. 12A. It is sectional drawing of the torque generator of FIG. 13A. It is a figure which shows another tissue engaging member. FIG. 6 shows another tissue engaging member including a tissue bulking needle. FIG. 14B is another view of the tissue engaging member of FIG. 14B. FIG. 5 is a diagram showing an additional tissue engaging member. FIG. 5 is a diagram showing an additional tissue engaging member. FIG. 5 is a diagram showing an additional tissue engaging member. FIG. 5 is a diagram showing an additional tissue engaging member. FIG. 3 is an isometric view for reconstructing an organization. FIG. 16B shows the device of FIG. 16A receiving a gastroscope. FIG. 16B is an isometric view of the proximal end of the device of FIG. 16A. FIG. 6 shows the distal end of the instrument with the removed hood member. FIG. 16B is a side view of the end effector of the device of FIG. 16A. FIG. 16B is a side view of the end effector of the device of FIG. 16A. FIG. 16B is a side view of the end effector of the device of FIG. 16A. It is the side view seen along line 17F-17F of FIG. 17E. It is a figure which shows the disposable component of the apparatus of FIG. 16A. FIG. 16B is an exploded view of the device of FIG. 16A. It is sectional drawing of the connection member of an end effector. FIG. 16B is a side view of the handle of the device of FIG. 16A shown with the cover removed. FIG. 19 is an isometric view of the gearbox located within the handle of FIG. 18. It is a figure which shows the mechanism inside the gear box of FIG. FIG. 21 is an end view of the mechanism of FIG. 20. It is a side view of the mechanism of FIG. It is sectional drawing of the rack of the mechanism of FIG. It is a figure which shows closure of the jaw member of an end effector. It is a figure which shows closure of the jaw member of an end effector. It is a figure which shows closure of the jaw member of an end effector. It is a figure which shows closure of the jaw member of an end effector. It is a figure which shows the distal end part in a bending position. FIG. 6 is an isometric view of the link at the inversion portion of the distal end. It is a figure which shows the bent inversion part. It is a figure which shows a straight inversion part. It is sectional drawing of the shaft of the apparatus of FIG. 16A. FIG. 6 is an isometric view of the distal end with an open jaw member. FIG. 5 shows a graft bar of a tissue fixation device shown coupled to a tube of a jaw member. FIG. 28 illustrates deployment of the graft rod of FIG. 27. FIG. 28 illustrates deployment of the graft rod of FIG. 27. FIG. 28 illustrates deployment of the graft rod of FIG. 27. It is a figure which shows a hood member with the closed jaw member. It is a figure which shows a hood member with the open jaw member. It is a figure which shows the seal | sticker on the handle | steering-wheel of FIG. It is a figure which shows another deployment mechanism. FIG. 10 shows another means for coupling a graft rod to a tube of a jaw member. FIG. 10 shows another means for coupling a graft rod to a tube of a jaw member. FIG. 10 shows another means for coupling a graft rod to a tube of a jaw member. FIG. 6 is an isometric view of another tissue fixation device. FIG. 6 is a cross-sectional view of another tissue fixation device. FIG. 16B shows another means for providing an atraumatic distal end on the device of FIG. 16A. FIG. 16B shows another means for providing an atraumatic distal end on the device of FIG. 16A. FIG. 16B shows another means for providing an atraumatic distal end on the device of FIG. 16A. FIG. 16B shows another means for providing an atraumatic distal end on the device of FIG. 16A. FIG. 16B shows another means for providing an atraumatic distal end on the device of FIG. 16A. FIG. 16B shows another means for providing an atraumatic distal end on the device of FIG. 16A. FIG. 6 is a partial cross-sectional isometric view of another embodiment of an end effector. FIG. 7 is a partial cross-sectional side view of another embodiment of an end effector. FIG. 42 illustrates a tissue fixation device for use with the end effector of FIG. 41. It is a figure which shows another structure of the apparatus for reorganizing an structure | tissue. It is a figure which shows another structure of the apparatus for reorganizing an structure | tissue. It is a figure which shows another structure of the apparatus for reorganizing an structure | tissue. FIG. 17F illustrates a cartridge assembly in which the disposable cartridge of FIG. 17F is mounted for operating and attaching to the instrument. FIG. 17F illustrates a cartridge assembly in which the disposable cartridge of FIG. 17F is mounted for operating and attaching to the instrument. FIG. 17F illustrates a cartridge assembly in which the disposable cartridge of FIG. 17F is mounted for operating and attaching to the instrument. FIG. 19 is an isometric view of the handle of FIG. FIG. 19 is a side view of the handle of FIG. 18. FIG. 19 is a side view of the handle of FIG. 18. FIG. 19 is a side view of the handle of FIG. 18. FIG. 19 is a side view of the handle of FIG. 18. FIG. 19 is an end view of the handle of FIG. 18. FIG. 5 is a side view of a device in place in the esophagus and stomach, as well as a vertical cross-sectional view of some esophagus and some stomach. In addition to a vertical cross-sectional view of some esophagus and some stomachs, it is a side view of devices in place in the esophagus and stomach, showing the device in the inverted position. FIG. 4 is a side view of a device in place in the esophagus and stomach, as well as a vertical cross-sectional view of some esophagus and some stomachs, showing the open movable arm. FIG. 5 is a side view of a device in place in the esophagus and stomach, as well as a vertical cross-sectional view of some esophagus and some stomach, showing retractor engaging tissue. FIG. 3 is a side view of a device in place in the esophagus and stomach, as well as a vertical cross-sectional view of some esophagus and some stomachs, showing a retractor that draws tissue. FIG. 4 is a side view of a device in place in the esophagus and stomach, as well as a vertical cross-sectional view of some esophagus and some stomachs, showing a closed movable arm forming a tissue fold. FIG. 2 is a side view of a device in place in the esophagus and stomach, as well as a vertical cross-sectional view of some esophagus and some stomachs, showing an open movable arm and graft that secures tissue folds. FIG. 4 is a side view of a device in place in the esophagus and stomach, as well as a vertical cross-sectional view of some esophagus and a portion of the stomach, showing the tissue folds along with the device in a straight configuration for removal from the patient. It is a figure which shows a cable operating mechanism. FIG. 57 illustrates the mechanism of FIG. 56 with the lever lock button assembly of the mechanism removed. FIG. 57 is a cross-sectional view of the mechanism of FIG. 56 with the lever lock button assembly of the mechanism removed. It is a figure which shows a lever lock button assembly. It is a figure which shows the button assembly of a lever lock button assembly. FIG. 60 illustrates the lever lock button assembly of FIG. 59 showing the actuated assembly. FIG. 57 illustrates the mechanism of FIG. 56 shown with a second set of optional cable adjustment devices. FIG. 63 shows the mechanism of FIG. 62 shown with the housing removed. FIG. 63 is an isometric view of the housing taken along line 9-9 of FIG. 62. FIG. 63 is an end view of the mechanism viewed along line 10-10 of FIG. 62. FIG. 6 shows a plate assembly used to couple cable movement. It is a figure which shows another embodiment of a handle mechanism. FIG. 68 illustrates a transmission assembly of the handle mechanism of FIG. 67. FIG. 68 is a view showing a part of the handle mechanism of FIG. 67 together with the removed gear. FIG. 70 is a view of the handle mechanism as viewed from the opposite side of the view of FIG. 69. FIG. 68 illustrates the handle mechanism of FIG. 67 with the transmission assembly of FIG. 68 removed. It is a figure which shows another embodiment of an end effector. FIG. 72B is a cross-sectional view of the end effector of FIG. 72A. FIG. 73 is a perspective view of a jaw member of the end effector of FIG. 72. FIG. 74 is a perspective view of a shell of a jaw member of FIG. 73. FIG. 74 is a perspective view of a cartridge of the jaw member of FIG. 73. FIG. 73 is a perspective view of a second jaw member of the end effector of FIG. 72. FIG. 77 is a perspective view of a shell of the jaw member of FIG. 76. FIG. 77 is a perspective view of a cartridge of the jaw member of FIG. 76. FIG. 73 is an end view of the end effector of FIG. 72. FIG. 79 shows the cartridge of FIG. 78 attached to an actuating arm. FIG. 81 is an additional view of the cartridge of FIGS. 78 and 80. It is a figure which shows the action | operation arm of FIG. It is a figure which shows the cartridge and shell which were attached to the holder. It is a figure which shows the holder for a cartridge and a shell. It is a figure which shows another embodiment of the inversion part of an apparatus. It is a figure which shows another embodiment of the inversion part of an apparatus. FIG. 87 is a view showing a boot for sealing the part of the reversal part of FIGS. 85 and 86; FIG. 87 is a view showing a boot for sealing the part of the reversal part of FIGS. 85 and 86; FIG. 87 is a view showing a boot for sealing the part of the reversal part of FIGS. 85 and 86; FIG. 6 shows another embodiment of a distal actuation mechanism of the instrument. FIG. 68B illustrates the handle mechanism of FIG. 67 shown with the two closure cables of FIG. 88A. FIG. 4 shows a boot for sealing a distal end portion of the instrument. FIG. 4 shows a boot for sealing a distal end portion of the instrument. FIG. 6 shows a distal portion of the device. FIG. 68 is an exploded perspective view of a clutch of the transmission assembly of FIG. 67. FIG. 68 is an exploded perspective view of a clutch of the transmission assembly of FIG. 67. FIG. 5 shows a portion of a transmission assembly with the removed gear. FIG. 5 shows a portion of a transmission assembly with the removed gear. FIG. 68 is a cross-sectional perspective view of the knob assembly of FIG. 67.

Claims (44)

A tissue manipulator configured for introduction into a patient and comprising at least one movable member;
A sealing member configured to substantially seal the tissue manipulator section from contact with bodily fluids;
The movable member is a medical device having a portion that is movable within the sealing member and that extends outward from the sealing member. The tissue manipulator includes a second movable member that is movable within the sealing member;
The medical device according to claim 1, wherein the second movable member has a portion extending outward from the sealing member.   The medical device according to claim 2, wherein the tissue manipulator includes a pivot in which the movable members rotate in opposite directions.   The medical device of claim 1, wherein the sealing member defines a hole for receiving a guide wire and allows the tissue manipulator to be advanced into the patient using the guide wire.   The medical device according to claim 1, wherein the sealing member is formed of a flexible member. A flexible linkage coupled to the tissue manipulator;
A sealing portion covering the linkage;
The medical device according to claim 1, further comprising:   The medical device according to claim 6, wherein the sealing portion is in contact with the sealing member. A device sized to be completely received within the patient's organ,
The device is
A first portion configured to be detachably coupled to the actuating member;
A second portion configured to receive an implant deployed within the patient;
The device defines a through hole for receiving a guide wire and utilizes the guide wire to allow advancement of the device into the patient.   The medical device of claim 8, wherein the second portion is configured to be fragilely connected to the implant.   The medical device according to claim 8, wherein the apparatus includes a pair of jaw members configured to move in response to an operation by the operation member. Each jaw member defines a through hole;
11. The medical device of claim 10, wherein the two through holes overlap when the jaw member closes to form a through hole that receives the guide wire.   The medical device according to claim 10, wherein the jaw members each include a tissue manipulator and a shell on the tissue manipulator.   13. The medical device of claim 12, wherein each tissue manipulator has a coupler that forms part of the first portion of the apparatus. One tissue manipulator comprises a region having a frangible connection with a portion of the implant,
The other tissue manipulator has a region defining an opening for receiving another portion of the implant;
The medical device of claim 12, wherein the two regions form the second portion of the apparatus.   13. The medical device of claim 12, wherein each shell defines a through hole that forms a portion of the through hole that receives the guide wire. A device sized to be completely received within the patient's organ,
The device is
A first portion configured to be detachably coupled to the actuating member;
A second portion configured to receive an implant deployed within the patient;
The medical device is configured to be disconnected from the actuation member when the actuation member is overloaded in the patient.   17. The medical device of claim 16, wherein the first portion includes a retainer that moves under application of an overload that disconnects the apparatus from the actuating member.   18. The medical device of claim 17, wherein the retainer is configured such that the overload applied to the actuating arm is less than a load that pulls the implant through the patient's muscle tissue.   The medical device of claim 17, wherein the retainer is configured such that the overload applied to the actuating member is about 27 pounds or less. A first member having at least two tissue piercing elements connected thereto by a frangible connection;
A second member having an engagement element;
The engaging element is configured to deflect the tissue piercing element in the opposite direction, and the first member at the easily breakable connecting portion during relative movement of the first member and the second member A medical device configured to separate the tissue piercing element from the device.   21. The medical device of claim 20, wherein the engagement element defines an angled surface against which the tissue piercing element is pushed when the first member and the second member move together.   21. The medical device of claim 20, further comprising a flexible member connecting the at least two tissue piercing elements. A device sized to be completely received within the patient's organ,
The device is
A first portion configured to be detachably coupled to the actuating member;
A second portion configured to receive an implant deployed within the patient;
The device is
A first member having a tissue piercing element;
A second member having an engagement element;
The medical device is configured to deflect the tissue piercing element in an opposite direction upon relative movement of the first member and the second member.   24. The medical device of claim 23, wherein the engagement element defines an angled surface against which the tissue piercing element is pushed when the first member and the second member move together.   24. The medical device of claim 23, further comprising a flexible member connecting the at least two tissue piercing elements. A device sized to be completely received within the patient's organ,
The device is
A first portion configured to be detachably coupled to the actuating member;
A second portion configured to receive an implant deployed within the patient;
The first part is
A rectangular opening for receiving the actuating member;
A medical device for receiving a coupler of the actuating member and defining a cavity having a length of at least 0.7 inches. The first portion has a molded region;
27. The medical device of claim 26, wherein the region is configured to receive a corresponding shaped region of the actuation member.   27. The medical device of claim 26, wherein the first portion defines a slot shaped to receive an edge of the actuating member.   27. The medical device of claim 26, wherein the apparatus has a pair of jaw members.   30. The medical device of claim 29, wherein one of the jaw members has a tissue piercing element disposed relative to the cavity supported by the coupler.   30. The medical device of claim 29, wherein one of the jaw members has an engagement element disposed against the cavity supported by the coupler. A device sized to be completely received within the patient's organ,
The device has a pair of jaw members,
Each jaw member
A first portion configured to be detachably coupled to the actuating member;
A second portion configured to receive an implant disposed within the patient;
The first part is
A rectangular opening for receiving the actuating member;
Receiving a coupling of the actuating member and defining a cavity having a length of at least 0.7 inches;
One of the jaw members has a tissue piercing element arranged to be supported by the coupler;
A medical device, wherein the other of the jaw members has an engagement element arranged to be supported by the coupler. An actuating member;
An end effector configured to be detachably coupled to the actuating member;
The end effector, having a tissue piercing element;
The medical device has a tissue piercing element support disposed to limit bending of the end effector when the tissue piercing element pierces tissue.   34. The medical device of claim 33, further comprising a second end effector having a tip engagement element configured to deflect the tissue piercing element during relative movement of the end effector.   35. The actuating member comprises a tip engaging element support disposed to limit bending of the second end effector when the tip engaging element deflects the tissue piercing element. The medical device described. The actuating member has two arms,
One arm has the tissue piercing element support material,
36. The medical device of claim 35, wherein the other arm has the tip engagement element support. A cartridge configured to be removably attached to a medical device;
A resilient holder configured to receive the cartridge such that the cartridge automatically aligns with the medical device during attachment of the cartridge to the medical device;
With medical assembly. The resilient holder has a resilient portion;
38. The medical assembly of claim 37, wherein the resilient portion is configured to bend during attachment of the cartridge to the medical device if the cartridge is not aligned with the portion. A tissue manipulator having a first member and a second member;
An actuating mechanism having a cable,
The cable is under tension and moves at least one of the first and second members toward the other member to engage tissue, and the actuation mechanism limits the excess tension of the cable Medical equipment that is configured to.   40. The medical device of claim 39, wherein the actuation mechanism is configured to limit the application of tension of about 72 pounds or more to the cable.   40. The medical device of claim 39, wherein the actuation mechanism includes a clutch configured to slip when excess tension is applied to the cable. A tissue manipulator having a first member and a second member;
An actuating mechanism having a cable,
The cable is under tension by an external force and moves at least one of the first and second members toward another member;
The medical device is configured to limit a loss of tension on the cable when the external force is removed during deployment.   The medical device according to claim 42, wherein the operating mechanism includes a knob for applying the external force. The actuating mechanism includes a pawl and a ratchet coupled to the knob;
44. The medical device of claim 43, wherein the pawl and the ratchet engage to limit a loss of tension on the cable when the external force is removed during deployment.

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