Source: https://patents.google.com/patent/US20040193193A1/en
Timestamp: 2019-05-23 04:19:45
Document Index: 335432902

Matched Legal Cases: ['art 732', 'art 732', 'art 732', 'art 732', 'art 732', 'arts 876', 'art 876', 'art 876', 'arts 732']

US20040193193A1 - Tissue reconfiguration - Google Patents
US20040193193A1
US20040193193A1 US10/819,957 US81995704A US2004193193A1 US 20040193193 A1 US20040193193 A1 US 20040193193A1 US 81995704 A US81995704 A US 81995704A US 2004193193 A1 US2004193193 A1 US 2004193193A1
US10/819,957
US7722633B2 (en
2004-04-08 Priority to US10/819,957 priority patent/US7722633B2/en
2004-09-30 Publication of US20040193193A1 publication Critical patent/US20040193193A1/en
2010-05-25 Publication of US7722633B2 publication Critical patent/US7722633B2/en
This application is a continuation of U.S. application Ser. No. 09/859,579, filed May 18, 2001, which is a continuation-in-part of U.S. application Ser. No. 09/574,424, filed May 19, 2000, which is a continuation-in-part of U.S. application Ser. No. 09/520,273, filed Mar. 7, 2000, and U.S. application Ser. No. 09/5.19,945, filed Mar. 7, 2000, which claim priority from U.S. application Ser. No. 60/140,492, filed Jun. 22, 1999, all hereby incorporated by reference in their entirety.[0001]
Referring to FIGS. 1 and 3C, which shows the working channels in shaft [0085] 710 for receiving the various cables, overtube 742 and endoscope 715, within lumen 714 of shaft 710 are cable housings 760 a, 760 b defining channels 762 a, 762 b in which cables 724 a, 724 b for closing jaws 720, 722 are received, and cable housings 764 a, 764 b defining channels 766 a, 766 b in which cables 726 a, 726 b for opening jaws 720, 722 are received. Within lumen 714 are also a cable housing 768 defining a channel 770 in which cable 728 for bending end effector 718 is received, and a cable housing 772 defining a channel 774 in which cable 737 for deploying fixation device 730 is received. Coil 740 and overtube 742 are received in a channel 778 defined in a coil housing 776 in lumen 714. Housing 776 extends from port 748 to tube 738. As shown in FIG. 3D, coil 740 has a tissue penetrating tip 741 and a distal section 740a having a looser wound coil than the remainder of coil 740. Endoscope 715 is received in a channel 782 defined in an endoscope housing 780 in lumen 715.
First part [0092] 732 of tissue fixation device 730 is shown in more detail in FIGS. 6A and 6B. First part 732 of tissue fixation device 730 defines through holes 820 a, 820 b (FIG. 6A), and part 732 is loaded onto jaw 720 with tips 818 a, 818 b received in through holes 820 a, 820 b, respectively. Connected to part 732 with a suture 822 are two securing elements, e.g., bars 824 a, 824 b. Each bar 824 a, 824 b defines two through holes 826 a, 826 b. Suture 822 is threaded through holes 826 a, 826 b of the bars and through holes 820 a, 820b of part 732, and is tied together forming a knot 823 to secure bars 824 a, 824 b to part 732. Tubes 818 a, 818 b each define a channel 827 for receiving one of bars 824 a, 824 b, and a slot 828 communicating with channel 827 for receiving suture 822 therethrough.
Referring to FIGS. 11A and 11B, an end effector [0100] 718′ includes an alternative cable routing for actuating jaws 720, 722. End effector 718′ includes cables 726 a, 726 b for opening jaws720, 722, a single cable 724′ for closing jaws720, 722, and cable 737 for advancing slider 812. End effector 718′ also includes pivot 803 and a series of pulleys 850 a, 850 b, 850 c, 850 d, and 850 e around which the cables are routed.
Cable [0101] 724′ has a first portion 852a that is routed under (as viewed in FIGS. 11A and 11B) pulley 850 a and over pulley 850 c; a second portion 852 b that extends between pulleys 850 c and 850 b; and a third portion 852 c routed under pulley 850 b and over pulley 850 a. Cable 726 a has a first portion 854 a that extends to pulley 850 d and a second portion 854 b that extends between pulley 850 d and anchor 851 a fixed to central mount 800. Cable 726 b has a first portion 856 a that extends to pulley 850 e and a second portion 856 b that extends between pulley 850 d and anchor 851 b fixed to central mount 800.
Referring to FIG. 12B, in which tissue engagement member [0105] 740′ is shown without spring sheath 866, coupling member 864 includes a first, distal-most section 864a with a diameter, D1; a second section 864 b with a diameter D2 larger than D1; a third section 864 c with a diameter D3 between D1 and D2; a fourth section 864 d with a diameter D4 about equal to D2; a fifth section 864 e with a diameter D5 larger than D4; and a proximal-most section 864 f having a diameter D6 about equal to D1. Diameters D1-D6 are, for example, about 0.04″, 0.09″, 0.06″, 0.09″, 0.12″ and 0.04″, respectively. Defined between sections 864 a and 864 b is a shelf 867 a; defined between sections 864 b and 864 c is a shelf 867 b; defined between sections 864 c and 864 d is a shelf 867 c; defined between sections 864 d and 864 e is a shelf 867 d; and defined between sections 864 e and 864 f is a shelf 867 e. Drive shaft 862 is received over coupling member section 864 f and coil 860 is received over coupling member section 864 a. Drive shaft 862 and coil 869 are attached to coupling member 864 by, for example, soldering. Coil 860 has a coil length, L, of, for example, about 0.25″, extending beyond the distal end 868 of section 864 a. Positioned on coupling member section 864 c between shelves 867 b and 867 c is a spring 870 that biases sprung sheath 866 distally.
To facilitate assembly of tissue engaging member [0107] 740′, coupling member 864 is formed from two parts 876 a, 876 b having mating fingers 878 joined, for example, by compression fitting. This configuration permits sheath 866 to be slid over part 876 a prior to joining part 876 b to 876 a.
Handle [0112] 883 defines a bore 881 ′ in which a pin 882′ is received, and a larger diameter bore 883′ in which pin 882′, collet 885 and a spring 887′ are received. Cap 887 is biased distally by spring 887′. Pin 882′ is press fit into bore 881′ and into circumferential section 885′ of collet 885. To attach drive rod 880 to torque generator 882, cap 887 is moved proximally against the force of spring 887′, which allows legs 885 a to be flexed outward permitting coupling member 889 to be positioned in opening 886. The user releases cap 887, and spring 887′ acts to move cap 887 distally closing legs 885 a around coupling member 889. Distal motion of cap 887 is limited by contact of a shelf 880′ of cap 887 against enlarged leg ends 885 b.
In use, with gastroscope [0124] 715 in instrument lumen 916 and the end of the gastroscope residing in section 918, the user advances instrument 900 transorally into the stomach. Once in the stomach, gastroscope 715 is independently manipulated to obtain the desired view. The user flexes instrument 900 (as shown in FIG. 16B), opens jaws 920, 922, advances the tissue engagement member into engagement with the tissue to stabilize the tissue, closes jaws 920, 922 such that cartridges 960 a, 960 b manipulate the tissue into a bulge, and deploys an implant, as described further below.
Referring to FIG. 17C (coupling member [0125] 919 has been partially removed from FIG. 17C for clarity), actuating arms 962 a, 962 b are pivotally coupled to mount 924 at pivots 963 a, 963 b, respectively. A pair of cables, discussed below, for opening and closing jaws 920, 922 are coupled to the jaws via a yoke 964. Yoke 964 has a generally H-shaped section 965 with two legs 966 a straddling arm 962 a, and two legs 966 b straddling arm 962 b. Each arm 962 a, 962 b defines a slot 968 a, 968 b, and each leg 966 a, 966 b defines a through hole 970 a, 970 b. Received within slot 968 a and holes 970 a is a pin 972 a, and received within slot 968 b and holes 970 b is a pin 972 b. Slots 968 a, 968 b each have first and second sections 974, 975. Slot sections 974 are orientated at a greater angle relative to the axis of the instrument than that of slot sections 975, for purposes described below. Yoke 964 includes a post 978 extending proximally from section 965. Post 978 extends into coupling member 980. Mounted to post 978 is a first pulley 982, and mounted to coupling member 980 are two pulleys 984, 985, which a jaw closing cable is routed over, as described below.
Portion [0126] 923 and mount 924 of coupling member 919 have flat sides 923 a, 924 a and rounded sides 923 b, 924 b, as shown in FIG. 17D. Rounded sides 923 b, 924 b define a through bore 927 for passage of the tissue engagement member. Mount 923 also defines a through bore 931 through which yoke 964 extends.
Referring to FIGS. 17E and 17F, located in portion [0127] 923 is a lock arm 1250 pivotally mounted at 1252. Lock arm 1250 has a ridge 1253 with curved wall 1254 and yoke 964 defines a notch 1256 with a correspondingly shaped curved wall 1258. After a predetermined amount of distal travel of yoke 964, curved wall 1254 of ridge 1253 engages with curved wall 1258 of notch 1256 to limit further distal travel of yoke 964. Lock arm 1250 is biased by a compression spring 1262 to rotate clockwise about pivot 1252 (arrow Y) such that when notch 1256 passes under lock arm 1250, lock arm 1250 is rotated under the force of spring 1262 to engage curved walls 1254, 1258. Attached to lock arm 1250 is a cable 1260 for moving arm 1260 out of engagement with yoke 964 to allow further distal travel of yoke 964.
FIG. 17G illustrates the replaceable nature of cartridges [0128] 960 a, 960 b. Arms 962 a, 962 b each include a flat, rectangular member 1050 and a clip 1052. Member 1050 has formations 1051, 1053 extending from either side of member 1050. Formations 1051 have a thin distal section 1051 a that slopes to a wider proximal section 1051 b, for purposes described below with reference to FIGS. 46. Cartridges 960 a, 960 b each include a first pair of side walls 1054, a second pair of side walls 1056 defining slots 1056 a, an opening 1058, and a head 1059. Opening 1058 is rectangular in shape, here shown square, though other shapes are suitable that have a mating contour with a flat proximal edge 1058 a. Instead of an opening 1058, an indentation in the cartridge that corresponds to the shape of clip 1052 can be employed. Side walls 1054, 1056 are separated by a thin section 1057 which allows the cartridge to flex.
To attach cartridges [0129] 960 a, 960 b to arms 962 a, 962 b, respectively, the cartridge is slid over the arm with side walls 1054 aligning the cartridge to the arm. Rectangular member 1050 is received in slots 1056 a while the cartridge flexes over clip 1052 such that clip 1052 is received within opening 1058 to lock the cartridge to the arm. To remove the cartridge, the user pushes on side walls 1054 to flex the cartridge away from clip 1052, and the cartridge is then slid off the arm.
Referring to the exploded view of FIG. 17H, retroflex portion [0130] 910 has a proximal mount 1060 that is, e.g., glued onto the end of shaft 904, and a distal mount 1062 that is received within a slot 933 in mount 923. Mounts 1062, 923 are attached, e.g., by screws. Mount 1062 is preferably metal and coupling member 919 is preferably plastic.
Referring to FIG. 171, the only member of instrument [0131] 900 that extends from retroflex region 910 through the sealed section formed by cover 910′ is yoke 964. To limit access of bodily fluids to retroflex portion 910, coupling member portion 923 defines a space 1070 in which an o-ring 1072 is positioned to seal off through bore 931.
Referring to FIGS. 18-20, to control retroflex portion [0132] 910 and end effector 906, knobs 912, 914 interface with a series of cables 925 a, 925 a′, 925 b, 925 c (FIG. 20) through a gear block mount 926 located in handle 902. Block mount 926 defines through bores 928 a, 928 a′, 928 b, 928 c within each of which a rack 930 a, 930 a′, 930 b, 930 c, respectively, is located. Each rack 930 a, 930 a′, 930 b, 930 c is connected to a respective cable 925 a,925 a′, 925 b, 925 c, as described below, and has a flat side 932 defining teeth 934. Referring particularly to FIGS. 21A and 21B, associated with racks 930 a, 930 a′ is a pinion 936 a, and associated with each rack 930 b, 930 c is a respective pinion 936 b, 936 c. Racks 930 a, 930a′ are on opposite sides of pinion 936 a, and racks 930 b, 930 c are on opposite sides of pinions 936 b, 936 c. Pinion 936 c is preferably twice the diameter of pinion 936 b, for reasons discussed below. Pinion 936 a is driven by a reduction gear set 937, 939. Gear 939 is mounted to a shaft 942 that is integral with retroflex knob 912. Pinions 936 b, 936 c are mounted to a shaft 944 that is integral with jaw actuating knob 914, and passes through shaft 942.
To manipulate retroflex portion [0133] 910, the user turns knob 912, which causes shaft 942 and pinion 936 a to turn. Since racks 930 a, 930 a′ are on opposite sides of shaft 946, rotation of pinion 936 a causes opposed linear motion of racks 930 a, 930 a′, which moves cables 925 a, 925 a′ to flex and straighten retroflex portion 910, as described further below. To manipulate the jaws, the user turns knob 914, which causes shaft 946 and pinions 936 b, 936 c to rotate. Since racks 930 b, 930 c are on opposite sides of shaft 946, rotation of pinions 936 b, 936 c causes opposed linear motion of racks 930 b, 930 c, which moves cables 925 b, 925 c to open and close the jaws, as described further below. Associated with knob 912 is a tension adjustment knob 912 a, and associated with knot 914 is a tension adjustment lever 914 a, as is well known in the art.
Referring to FIGS. 20 and 22, mounted over each cable [0134] 925 a,925 a′, 925 b, 925 c is a cable housing 947 a, 947 a′, 947 b, 947 c, respectively, and a cable housing adjustment screw 948 a, 948 a′, 948 b, 948 c, respectively. Cable housing adjustment screws 948 a, 948 a′, 948 b, 948 c are threadably received within respective block through bores 928 a, 928 a′, 928 b, 928 c (as shown in FIG. 19). Rotation of screws 948 a, 948 a′, 948 b, 948 c translates cable housings 947 a, 947 a′, 947 b, 947 c distally and proximally along respective cables 925 a,925 a′, 925 b, 925 c to provide an optimal working length for transmitting actuating forces. Cables 925 a, 925 a′, 925 b, 925 c move freely through their respective housings and screws.
On the opposite side of racks [0135] 930 a, 930 a′, 930 b, 930 c from screws 948 a, 948 a′, 948 b, 948 c are stops 949 a, 949 a′, 949 b, 949 c received within respective block through bores 928 a, 928 a′, 928 b, 928 c. Stops 949 a, 949 a′, 949 b, 949 c limit the travel of racks 930 a, 930 a′, 930 b, 930 c, respectively.
Referring particularly to FIG. 22, cable [0136] 925 a is received within a bore 950 defined in rack 930 a. Cable 925 a extends through a hole 952 defined in an end wall 954 of rack 930 a into bore 950. Located within bore 950 is a spring 956. Cable 925 a extends through spring 956 and has an enlarged terminal end 957 that maintains the position of cable 925 a relative to spring 956. Spring 956 acts to continually exert a slight tensile force upon cable 925 a to keep the cable taught. Cables 925 b, 925 c are likewise coupled to racks 930 b, 930 c, respectively.
Referring again to FIG. 19, attached to block mount [0137] 926 is a slide lever 1400 mounted within a bracket 1402. Switch 915 is received within an opening 1404 in lever 1400 such that movement of switch 915 moves lever 1400. Lever end 1406 defines a diagonal slot 1408 in which a pin 1410 is received. Pin 1410 is attached to a stop member 1412 that contacts a stop 1414 after jaw closing rack 930 b has traveled a pre-set 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, disengaging stop member 1412 from stop 1414 to allow further movement of rack 930 b. Cable 1260 attached to lock arm 1250 is attached at its opposite end to switch 915. When switch 915 is moved in the direction of arrow X, cable 1260 moves lock arm 1250 to disengage lock arm 1250 (FIG. 17E) from yoke 964 (discussed further below with reference to FIGS. 23). Bracket 1402 can be adjusted to fine tune the positioning of switch 915 relative to pin 1410 and lock arm 1250.
As shown in FIGS. 23A-23D, jaw closing cable [0138] 925 b is wound around pulleys 984 and 982, and terminates at a fixed point 986 connected to distal mount 1062 (FIG. 17G). Jaw opening cable 935 c is connected in a fixed relationship to post 978. To close jaws 920, 922, the user turns knob 914 in the direction of arrow, A (FIG. 20), which moves cable 925 b in the direction of arrow, B, and permits slack in cable 925 c allowing yoke 965 to move distally, in the direction of arrow, C. Due to the 2:1 ratio between pinions 936 b and 936 c, cable 925 b moves twice the distance of cable 925 c. (This is required due to the routing of cable 925 b around pulleys 982, 984.) Pins 972 a, 972 b slide along slots 968 a, 968 b causing jaws 920, 922 to close. To open the jaws, the user turns knob 914 in the direction opposite arrow, A, which tensions cable 925 c and permits slack in cable 925 b. The tension on cable 925 c moves yoke 964 proximally, arrow, E, opening jaws 920, 922.
Due to the orientation of slot sections [0139] 974, 975, during the initial stage of jaw closing (FIG. 23B) when the yoke is sliding along slot section 974, there is a greater ratio of jaw closing for the distance the piston moves than during the later stage (FIG. 23C) when the yoke is sliding along slot section 975. There provides faster jaw closing with lower mechanical advantage when less closing force is needed (because the jaws are not yet contacting the tissue), and slower jaw closing with higher mechanical advantage when more closing force is needed as the jaws grasp the tissue and pierce through the tissue. After the jaws have reached the position of FIG. 23C, pin hits stop in handle and lock arm notch 1254 and yoke notch 1256 engage to limit further closing of the jaws. The user then pushes switch 915 proximally to move stop member out of the way and to disengage lock arm 1250 from yoke 964, this permits knob 914 to be further turned to completely close the jaws and deploy the implant (FIG. 23D).
Referring to FIGS. 24A-24D, retroflex portion [0140] 910 includes a series of links 990 that are hinged together with pins 991. Each link 990 includes a generally U-shaped body 992 with a first section 992 a defining a U-shaped opening and second section 992 b defining a larger U-shaped opening. Extending from body 992 are two mating prongs 994. Body 992 defines two transverse holes 996 (only one hole 996 being shown in FIG. 24B), and each prong 994 defines a transverse hole 998. When two links 990 are mated, prongs 994 lie within the U-shaped opening defined by section 992 b. Holes 996, 998 are aligned, and pin 991 is passed through holes 996, 998 to join the two links. Body 992 has a side wall 1000 with a portion 1001 of the side wall set at an angle to allow the joined links to flex. Links 990 also define axial holes 1003, 1004 for receiving cables 924 a, 924 a′. Cables 924 a, 924 a′ terminate on mount 1062. Pulling cable 924 a flexes portion 910, and pulling cable 924 a′ straightens portion 910. Cover 910′ (FIG. 17A) covers the links.
Referring also to FIG. 25, in addition to lumen [0141] 916 for receiving gastroscope 715, shaft 904 and mount 1060 define a lumen 1010 for receiving tissue engaging member 908, a lumen 1012 for receiving flexing cable 924 a, a lumen 1014 for receiving straightening cable 924 a′, a lumen 1016 for receiving closing cable 925 b, a lumen 1018 for receiving opening cable 925 c, a lumen 1020 for receiving locking cable 1260, and an extra lumen 1022 if needed. Mount 1062 includes holes 1024 and 1026 for passage of cables 925 b, 925 c, respectively, a hole 1028 at which the end of closing cable 925 b terminates, and a hole 1030 for passage of locking cable 1260.
Tissue engaging member [0142] 908 is located in the U-shaped openings defined by U-shaped bodies 992 in retroflex portion 910. Pins 991 are centered along the central axis of tissue engaging member 908 such that when flexed, tissue engaging member 908 is flexed along is central axis. Tissue engaging member 908 is surrounded by a sheath 927 a (FIGS. 17D and 18). Sheath 927 a runs from handle inlet 1002 to the proximal end of through bore 927 in coupling member 919. Sheath 927 a is sealed at one end to handle 902 and at the other end to coupling member 919. This effectively seals the remainder of the instrument from contact with fluid that enters tissue engaging member 908. Shaft lumen 906 likewise is lined with a sheath 906′ that seals the remainder of the instrument from contact with bodily fluids that enter lumen 906.
Referring to FIGS. 26 and 27, end effector [0143] 906 is configured for deployment of a tissue fixation member upon closing of jaws 920, 922 without requiring further actuation. Cartridge 960 b of jaw 922 includes tissue passing tubes 1120 a, 1120 b. Removably coupled to each tube 1120 a, 1120 b is a tissue fixation bar 824 a, 824 b having a pointed tip 1122 for penetrating tissue. Each tube 1120 a, 1120 b defines a through bore 1124, and each bar 824 a, 824 b has a hub 1126 that fits within bore 1124. Tubes 1120 a, 1120 b and bars 824 a, 824 b have the same outer diameter for ease of penetrating tissue. Bars 824 a, 824 b each define a through hole 1128 for receiving, for example, a suture (not shown), which is passed through both holes and tied off to itself. Bars 824 a, 824 b can be coupled to tubes 1120 a, 1120 b, respectively by a press fit, crimp, or spot laser welding. Crimping can be done around the entire perimeter of the bar, at two (opposing) sides of the bar, or at a single point along the perimeter of the bar.
Bars [0144] 824 a, 824 b are configured to detach from tubes 1120 a, 1120 b under the force applied by the closing of jaws 920, 922. Referring to FIGS. 26 and 28A-28C, cartridge 960 a defines two arcuate walls 1130 against which bars 824 a, 824 b are positioned upon closing of jaws 920, 922. As shown in FIG. 28C, upon closure of jaws 920, 922, the arcuate walls 1130 apply a lateral force (i.e., substantially normal to the long axis of the tubes) to bars 824 a, 824 b, which causes the bars to be released from the respective tubes. When jaws 920, 922 are opened, and instrument 900 pulled proximally, bars 824 a, 824 b and parts 732, 734 (discussed above with reference to FIG. 8) of the tissue fixation member are released from jaws 920, 922.
Referring to FIGS. 29A and 29B, jaws [0145] 920, 922 are covered with hood 1220 formed from halves 1222 and 1224 connected at a region 1226 and defining a seam 1228 therebetween. Each half 1222, 1224 covers a respective jaw 920, 922. When the jaws are closed, as shown in FIG. 29A, hood 1220 provides an atraumatic distal end for delivery through the esophagus. When the jaws are opened, as shown in FIG. 29B, halves 1222, 1224 separate at seam 1228. Hood 1220 limits trauma to the tissue during transoral insertion of the instrument and eliminates the need for an outer sheath extending the length of the instrument.
Referring to FIG. 30, handle [0146] 902 defines an inlet 1002 through which gastroscope 715 is introduced. Located at inlet 1002 is a seal 1004 for providing a hermetic seal between handle 902 and gastroscope 715. Seal 1004 has a sealing area 1006 of restricted diameter, and an alignment area 1008 of restricted diameter spaced about 10 mm from area 1006. Area 1006 has a diameter of about 9 mm, which is about the same or slightly smaller than (about 90% of) the diameter of gastroscope 715 (typically about 10 mm). Area 1008 has a diameter of about 11 mm, which is also about the same or slightly larger than (about 110% of) the diameter of gastroscope 715. Alignment area 1008 provides support for gastroscope 715 to maintain a hermetic seal at sealing area 1006 during motion of the gastroscope. Seal 1004 is made from, e.g., rubber or other deformable material.
Other embodiments are within the scope of the following claims. [0147]
For example, referring to FIG. 31, instead of curved surfaces [0148] 1130 of FIGS. 28, cartridge 960 a′ includes a spring member 1130′. When bars 824 a, 824 b contacts members 1130′, member 1130′ deflects forming a curved surface resulting in a lateral force being applied to bars 824 a, 824 b that acts to dislodge the bars from needles 1120 a, 1120 b.
Referring to FIGS. 32, in an alternative embodiment, tubes [0149] 1120′ include a pair of radially opposed slots 1132 that impart flexibility to end 1133 of the tube to aid in release of the bars from the tubes. Bars 824′ can include a pair of guide nubs 1134 received in slots 1132 to radially orients bars 824′ relative to tubes 1120′. Referring to FIG. 33, bars 824″ include a bump or undercut 1136 that determine the force needed to remove the bars from the tubes. The tubes can be formed from plastic and molded as an integral component of the cartridges, and the bars can be insert molded into the tubes. Referring to FIG. 34, bars 824′″ are connected to tubes 1120″ by a weak area 1137 of decreased diameter that breaks upon application of lateral force to bars 824′″.
Referring to FIGS. 35A and 35B, instead of bars attached by suture, the tissue fixation member includes bars [0150] 1150 connected by a flexible spanning member 1152. Bars 1150 define through bores 1154 and are received on members 1156 having tissue penetrating tips 1158. Members 1156 replace tubes 1120.
Referring to FIG. 36A, to aid in insertion of instrument [0151] 900 through the esophagus, end effector 906 and retroflex portion 910 are partially covered with an atraumatic hood 1100. Hood 1100 has a tapered distal end 1102 terminating in a small diameter lead portion 1104. Hood 1100 includes an opening 1106 through which end effector 906 and retroflex portion 910 are deployed, in the direction of arrow, D, after insertion of instrument 900 through the esophagus. Distal end 1102 defines a channel 1105 extending from lead portion 1104 to a slot 1107. Instrument 900 can be introduced transorally over a guidewire (not shown) by threading the guidewire through channel 1105 entering at lead portion 1104 to exiting at slot 1107. Hood 1100 is made from, e.g., metal, plastic, or elastomeric materials such as rubber, polyurethane or silicone.
As shown in FIG. 36B, to further ensure trauma to tissue as the instrument is introduced transorally is avoided, a pair of flaps [0152] 1109 are provided covering assembly 905. The flaps part when retroflex portion 910 is deployed.
Referring to FIG. 37, rather than a hood covering end effector [0153] 906, placed between jaws 920, 922 is volume-filling bullet 1200 that creates a relatively smooth surface at the distal end of the instrument to facilitate insertion of the instrument into a patient. Bullet 1200 defines a through hole 1200 a for delivery over a guidewire. Volume-filling bullet 1200 can be dissolvable in the operating environment, retrievable from the operating environment, or abandonable in the operating environment. For example, the guidewire can have a tip with a larger diameter than hole 1200 a such that bullet 1200 is retained on the guidewire and removable therewith.
Referring to FIG. 38, in another embodiment, a hood [0154] 1220′ includes halves 1222′, 1224′ that are connected to mount 924 at pivots 1230. When the jaws are opened, halves 1222′, 1224′ pivot about pivots 1230 to separate at seam 1228′. In FIG. 39, halves 1222″, 1224″ of a hood 1220″ include spring beams 1240 joined in a region 1226′. When the jaws are opened, halves 1222″, 1224″ separate at seam 1228″ and spring beams 1240 deform.
Alternatively, as shown in FIG. 40, to provide an atraumatic distal end, an end cap [0155] 1242 is placed over the jaws. End cap 1242 can be removed by pushing it off distally using the tissue engagement member, can be dissolvable (e.g., made out of starch or gelatin), or can “break-away.” when the jaws are opened. Providing a perforation along the length of cap 1242 can aid in break-away. After removal, cap 1242 can be abandoned in the operating environment, where it is dissolved or passed, or it can be retained by a guidewire so that it is withdrawn when the instrument is withdrawn.
Referring to FIGS. 41A and 41B, in an alternative embodiment, an end effector [0156] 906′ includes jaw members 920′, 922′, each of which includes a tissue manipulating cartridge 960 a′, 960 b′, respectively, releasable mounted to a respective actuating arm 962 a′, 962 b′. Jaw 922′ contains a pusher rods 814 a, 814 b for deploying bars 824 a, 824 b as described above with reference to FIG. 5. However, rather than employing a separate mechanism for actuating pusher rods 814 a, 814 b,pusher rods 814 a, 814 b are actuated by yoke 964. Each arm 962 a′, 962 b′ defines a slot 968 a′, 968 b″ having a first arcuate section 974′, a second generally linear, angled section 975′, and a third generally linear, parallel section 976′. Movement of yoke 964 along slot sections 974′ and 975′ closes jaws 920′, 922′. To deploy tissue fixation device 730 (FIG. 2), movement of yoke 964 along section 976′ of slots 968 a, 968 b moves pusher rods 814 a, 814 b distally advancing bars 824 a, 824 b out of tissue penetrating tips 818 a, 818 b to deploy fixation device 730, as described above with reference to FIGS. 4A and 4B.
Referring to FIG. 42, an alternative tissue fixation member for use with the embodiments of FIGS. 2 and 41, includes bars [0157] 1150′ connected by a flexible spanning member 1152.′ Bars 1150′ replace bars 824 a, 824 b.
The instruments embodied in FIGS. 43-45 are configured to allow one person to control both the gastroscope and the tissue reconfiguring instrument. Referring particularly to FIG. 43, an instrument [0158] 1300 for reconfiguring tissue includes a standard gastroscope 715 and a tissue manipulator 1304 mounted to gastroscope 715. Tissue manipulator 1304 includes a control mount 1306 which the user mounts to gastroscope tube 1307 by, e.g., a friction fit. Control mount 1306 includes knobs 912, 914, described above. End effector 906 and retroflex portion 910 of assembly 905 are mounted to a sleeve 1308 through which gastroscope tube 1307 extends. Sleeve 1308 defines conduits for the control cables as described above. Connecting control mount 1306 and sleeve 1308 is a flexible conduit 1310 enclosing the various cables for controlling end effector 906 and retroflex portion 910, as discussed above. Sleeve 1308 includes a hand grip 1312. Conduit 1310 permits axial movement of gastroscope 715 relative to tissue manipulator 1304. In use, the operator holds the gastroscope handle with one hand, and operates all the controls and manipulates grip 1312 with the other hand, permitting a single operator to control all functions.
Referring to FIG. 44, an instrument [0159] 1320 for reconfiguring tissue includes a standard gastroscope 715 to which the user mounts end effector 906. Cables for actuating the jaws are attached to a jaw control mount 1324. The cables are received in the standard biopsy channel 1322′ of the gastroscope. Retroflexing action is provided by gastroscope 715 and is controlled by the gastroscope controls. Jaw control mount 1324 includes knob 914 for actuating the jaw control cables. In the embodiment of FIG. 45, rather than mounting the tissue reconfiguring instrument to a standard gastroscope, an integral instrument 1330 includes a knob 914 mounted directly to gastroscope 1330. The control cables for actuating the jaws are integrated with the gastroscope control cables. The tissue engaging member, e.g., member 740′ of FIGS. 12, is introduced through the gastroscope channel 1322′.
Referring to FIGS. 46A and 46B, cartridges [0160] 960 a, 960 b are supplied to the medical personnel in a holder 1450. Holder 1450 includes a base section 1452 having a first side 1453 a for receiving head 1059 of cartridge 960 a, and a second side 1453 b for receiving head 1059 of cartridge 960 b. Base section 1452 defines an opening 1455 where tubes 1120 a, 1120 b are located. Extending from either side of base section 1452 are two sets of detents 1454 that are positioned on either side of the cartridge head 1059. Extending proximally from base section 1452 is a fin 1456 with spring beams 1458 on either side of fin 1456 on both sides of base section 1452. Located on either side of spring beams 1458 are guide rails 1460. Between the spring beams is a slot 1461 and between each spring beam 1458 and guide rail 1460 is a slot 1463. Holder 1450 includes finger grips 1462 for ease of handling. Hood 1220 is provided to the user with holder 1450. To allow the user to hold finger grips 1462, finger grips 1462 are attached to the remainder of the holder by a thin section 1462a over which the slot in the hood is positioned.
To load cartridges [0161] 960 a, 960 b in holder 1450, each cartridge is in turn positioned over base section 1452 with thin section 1057 of the cartridge aligned with slot 1461. By pushing down on the cartridge, spring beams 1458 are forced apart and thin section 1057 snaps into place in slot 1461, with spring beams 1458 holding the cartridge in place. Cartridge head 1059 is located between detents 1454, and side walls 1056 are partially within slots 1463 to align the cartridge and help hold the cartridge in position. With base section 1452 located between cartridges 960 a, 960 b, the cartridges are spaced such that the implant will not deploy (corresponding to the position shown in FIG. 23C).
Referring also to FIG. 46C, to attach cartridges [0162] 960 a, 960 b to arms 962 a, 962 b, respectively, while holding finger grips 1462, the user slides the cartridges over the arms (with the arms positioned as shown in FIG. 23C). Initially, formation 1051 on the inner surfaces of the arms slide between spring beams 1458 forcing the spring beams apart. Further sliding of the cartridge over the arms, positions rectangular member 1050 under arms 1056 and locates clip 1052 in hole 1058. The cartridges are now attached to the arms. Because spring beams 1458 have been forced apart by formation 1051, holder 1450 can now be released from cartridges 960 a, 960 b by opening the jaws and the instrument is ready for use.
Holder [0163] 1450 is preferably formed from plastic, and holder 1450 with cartridges 960 a, 960 b, hood 1220 and the implant are supplied to the surgical personnel in a sterile condition.
FIGS. 47A-47F are various views of handle [0164] 902.
US10/819,957 1999-06-22 2004-04-08 Tissue reconfiguration Active 2021-09-26 US7722633B2 (en)
US10/819,957 US7722633B2 (en) 1999-06-22 2004-04-08 Tissue reconfiguration
US20040193193A1 true US20040193193A1 (en) 2004-09-30
US7722633B2 US7722633B2 (en) 2010-05-25
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