US20130087596A1 - Surgical Stapling System - Google Patents
Surgical Stapling System Download PDFInfo
- Publication number
- US20130087596A1 US20130087596A1 US13/539,667 US201213539667A US2013087596A1 US 20130087596 A1 US20130087596 A1 US 20130087596A1 US 201213539667 A US201213539667 A US 201213539667A US 2013087596 A1 US2013087596 A1 US 2013087596A1
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- United States
- Prior art keywords
- loading unit
- graft
- shaft
- staples
- handle
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 0 CCCS(C(C)C)C(C)**C1C*(C2CCC2)C(C*)C1 Chemical compound CCCS(C(C)C)C(C)**C1C*(C2CCC2)C(C*)C1 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/115—Staplers for performing anastomosis in a single operation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/115—Staplers for performing anastomosis in a single operation
- A61B17/1155—Circular staplers comprising a plurality of staples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
- A61B17/12013—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot for use in minimally invasive surgery, e.g. endoscopic surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/115—Staplers for performing anastomosis in a single operation
- A61B2017/1157—Staplers for performing anastomosis in a single operation applying the staples radially
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/065—Y-shaped blood vessels
Definitions
- the present invention relates generally to a surgical stapling system, and more particularly to a system for joining two tubular structures using surgical staples. Still more particularly, the present invention relates to an apparatus and method for stapling together two tubular structures either through an open surgical procedure or laparoscopically.
- FIG. 1 is a perspective view of a first embodiment of prosthetic graft for use with the surgical stapling system of the present invention
- FIG. 2 is a perspective view of the prosthetic graft of FIG. 1 having optional sutures for closing the side port following deployment of the graft;
- FIG. 3 is a perspective view of a second embodiment of a prosthetic graft for use with the surgical stapling system of the present invention
- FIG. 4 is a perspective view of a loading unit in accordance with the present invention.
- FIG. 5 is a front perspective exploded view of the loading unit shown in FIG. 4 ;
- FIG. 6 is a rear perspective exploded view of the loading unit shown in FIG. 4 ;
- FIG. 7A is a longitudinal view, in partial cross-section of the loading unit in a state for loading a graft thereto;
- FIG. 7B is the same view as FIG. 7A , but showing the loading unit in a state for loading a prosthetic graft therein;
- FIG. 7C is the same view as FIG. 7A , but showing the loading unit with a graft loaded thereon;
- FIG. 8 is an elevational view of the loading unit showing a prosthetic graft loaded thereon;
- FIG. 9 is a perspective view of a placement wand in accordance with a first embodiment of the present invention.
- FIG. 10A is cross-sectional view of the handle of the wand of FIG. 9 in a locked condition
- FIG. 10B is the same view as FIG. 10A , but showing the wand handle in an unlocked condition
- FIG. 11 is a perspective view of a placement wand in accordance with a second embodiment of the present invention.
- FIG. 12A is a cross-sectional view of the handle of the wand of FIG. 11 in a locked condition
- FIG. 12B is the same view as FIG. 12A , but showing the wand handle in an unlocked condition
- FIG. 13 is a perspective view of a tourniquet for use in the present invention.
- FIG. 14A is a cross-sectional perspective view of the distal end of the tourniquet of FIG. 13 showing the band in an unlocked condition;
- FIG. 14B is the same view as FIG. 14A , but showing the band being inserted into the retaining block;
- FIG. 14C is the same view as FIG. 14A , but showing the band in a locked condition
- FIG. 15 is a perspective view of a surgical stapling instrument of the present invention.
- FIG. 16 is a front perspective exploded view of the head of the surgical stapling instrument shown in FIG. 15 ;
- FIG. 17 is a longitudinal cross-sectional view of the head of the surgical stapling instrument with the anvils in the open condition
- FIG. 18 is a longitudinal cross-sectional view of the head of the surgical stapling instrument with the anvils in the closed condition
- FIG. 19 is an enlarged cross-sectional view showing the male and female anvil locating members
- FIG. 20A is a longitudinal cross-sectional view of one embodiment of the actuating handle of the surgical stapling instrument in a condition in which the anvils are in the open condition and the stapling mechanism is not actuated;
- FIG. 20B is a longitudinal cross-sectional view of the head of the surgical stapling instrument having a loading unit mounted thereon, with the anvils of the surgical stapling instrument in the open condition;
- FIG. 21A is a longitudinal cross-sectional view of the actuating handle of FIG. 20A in a condition in which the anvils are in the closed condition and the stapling mechanism is not actuated;
- FIG. 21B is the same view as FIG. 20B , but showing the anvils of the surgical stapling instrument in the closed condition;
- FIG. 22A is a longitudinal cross-sectional view of the actuating handle of FIG. 20A in a condition in which the anvils are in the closed condition and the stapling mechanism has been actuated;
- FIG. 22B is the same view as FIG. 20B , but showing the loading unit in the position following staple deployment;
- FIG. 23 is a longitudinal cross-sectional view of another embodiment of the actuating handle of the surgical stapling instrument in a condition in which the anvils are in the open condition and the stapling mechanism is not actuated;
- FIG. 24 is a longitudinal cross-sectional view of the actuating handle of FIG. 23 in a condition in which the anvils are in the closed condition and the stapling mechanism is not actuated;
- FIG. 25 is a longitudinal cross-sectional view of the actuating handle of FIG. 23 in a condition in which the anvils are in the closed condition and the stapling mechanism has been actuated;
- FIG. 26 is an elevational view of a sizer in accordance with the present invention.
- FIG. 27 is a longitudinal cross-sectional view showing the loading unit and a prosthetic graft assembled to the head of the surgical stapling instrument prior to staple deployment;
- FIG. 28 is the same view as FIG. 26 , but showing partial deployment of the staples
- FIG. 29 is the same view as FIG. 26 , but showing the staples in a more advanced state of deployment;
- FIG. 30 is the same view as FIG. 26 , but showing the staples fully deployed;
- FIG. 31 is a partial cross-sectional view showing a deployed staple joining a graft to an aorta
- FIG. 32 is a highly schematic perspective view showing a transected aorta
- FIG. 33 is a highly schematic perspective view showing the use of a sizer to measure the transected aorta
- FIG. 34 is a highly schematic perspective view showing the use of a wand to position a loading unit and graft in the transected aorta;
- FIG. 35 is a highly schematic perspective view showing the use of a tourniquet to hold the loading unit and graft in place in the aorta;
- FIG. 36 is an end view showing the positioning of the stapling instrument relative to the tourniquet
- FIG. 37 is a highly schematic perspective view showing the use of a stapling instrument to staple the graft to the aorta.
- FIG. 38 is a highly schematic perspective view showing a circumferential line of staples joining the graft to the aorta.
- Graft 10 is a hollow generally Y-shaped structure formed by a tapered main body 12 , which branches into two legs 14 and 16 .
- Legs 14 and 16 may have a generally cylindrical shape with a substantially uniform diameter from their juncture with main body 12 to their respective free ends.
- main body 12 includes a cuff 18 having a substantially uniform diameter, the free end of which defines a blood flow inlet on one end of graft 10 , while the free ends of legs 14 and 16 define blood flow outlets from graft 10 .
- a generally cylindrical side port 20 is provided on one side of main body 12 , generally between legs 14 and 16 .
- Side port 20 provides a feature by which graft 10 may be inserted into a patient and held in place during a stapling procedure.
- side port 20 preferably projects from graft 10 at an acute angle relative to legs 14 and 16 to facilitate the insertion of a loading unit 100 (see FIG. 4 ) therein.
- loading unit 100 supports graft 10 and holds it in place relative to the aorta or other tubular body so that the graft may be connected to the body organ by stapling.
- FIG. 4 loading unit 100 supports graft 10 and holds it in place relative to the aorta or other tubular body so that the graft may be connected to the body organ by stapling.
- side port 20 may be provided with one or more sutures 22 adjacent the connection of the side port to main body 12 .
- Suture 22 may be threaded through side port 20 so as to provide a purse string tie by which the side port may be quickly and easily closed following deployment of graft 10 .
- side port 20 may be closed by stapling or by a conventional suturing procedure. Once side port 20 has been closed, any excess graft material may be removed by cutting.
- Graft 10 is preferably formed from a biocompatible material having sufficient strength to withstand the surgical implantation procedure described more fully below, as well as the blood flow and other biomechanical forces, which will be exerted on the graft.
- materials may include, for example, polyester materials, such as DACRON ⁇ , polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester materials coated with polytetrafluoroethylene, polyurethane, expanded polyurethane and silicone.
- Graft 10 may be provided in a range of sizes sufficient to accommodate the arterial morphology, which the surgeon is likely to face in the vast majority of patients.
- graft 10 may be provided with a cuff 18 having a diameter of approximately 16 m, 18 mm or 20 mm, although grafts 10 having larger or smaller diameters are also possible.
- FIG. 3 A second embodiment of a prosthetic graft 50 for use in the surgical stapling system of the present invention is shown in FIG. 3 .
- Graft 50 is substantially the same as graft 10 described above.
- graft 50 includes an elongated flap 52 projecting substantially perpendicularly from main body 12 . Flap 52 may be formed by sewing or otherwise connecting individual portions of graft material 54 and 56 in opposed relationship along a longitudinal slit formed in main body 12 . Following deployment of graft 50 , flap 52 may be closed by stapling or suturing. However, since flap 52 projects from main body 12 by a lesser amount than side port 20 , there may be no need to remove any excess material from the flap after it has been closed.
- Loading unit 100 for use in connection with the present invention is shown in FIGS. 4-8 .
- Loading unit 100 has a generally cylindrical body 102 extending in an axial direction, with a generally thin cap 104 at a proximal end thereof and a tapered cap 106 at a distal end thereof.
- proximal refers to the end of a component or device, which is closest to the actuating handle or surgeon
- distal refers to the end of a component or device that is farthest away from the actuating handle or surgeon.
- Cap 104 may have portions that protrude beyond the diameter of body 102 so as to define flanges 105 .
- cap 106 facilitates the assembly of a graft 10 onto loading unit 100 at one end, while flanges 105 act as a stop to prevent the graft from being pushed off the loading unit at the other end.
- a pair of fingers 108 projecting from cap 104 in the axial direction of body 102 but at a spaced distance therefrom help keep the graft in its assembled position on loading unit 100 and keep the legs 14 and 16 of the graft in a controlled position.
- a plurality of apertures 107 formed in cap 104 are sized and positioned to receive the fingers of a pusher 600 to be described below in connection with the stapling instrument.
- loading unit 100 includes a hollow, generally cylindrical cartridge 110 .
- Cartridge 110 is open at its proximal end for slidably receiving an actuator 170 , and has an end member 112 at its distal end.
- End member 112 has a central aperture 114 and a plurality of radially projecting slots 116 for receiving elongated fingers 176 provided on the distal end of actuator 170 .
- cartridge 110 mates with a second cylindrical cartridge 120 .
- Cartridge 120 has a central aperture 122 that aligns with aperture 114 of cartridge 110 , and a plurality of radially extending slots 124 , each of which aligns with a corresponding slot 116 in the distal end of cartridge 110 for receiving the elongated fingers 176 of actuator 170 .
- a plurality of projections (not shown) on the proximal surface of cartridge 120 mate with corresponding recesses (not shown) formed in the end member 112 of cartridge 110 so as to maintain cartridge 120 in registry with cartridge 110 .
- a plurality of staple pushers 130 are arranged between cartridge 110 and cartridge 120 for radial sliding movement between an inner staple holding position and an outer staple ejecting position.
- the number of staple pushers 130 utilized will depend on the number of staples to be simultaneously deployed during a stapling procedure.
- the preferred embodiment of the invention described herein includes ten staple pushers 130 for deploying twenty staples. It will be appreciated, however, that a greater or lesser number of staple pushers may be utilized depending on the number of staples to be deployed and physical constraints dictated by the size and operation of loading unit 100 .
- Each staple pusher 130 has a generally U-shaped profile consisting of first and second legs 132 and 134 connected by an intermediate portion 136 .
- Intermediate portion 136 has a first laterally projecting tab 138 that slidably engages in one of a plurality of recessed channels 140 formed in the end member 112 of cartridge 110 .
- Recessed channels 140 coincide with radially projecting slots 116 , but are larger in width and length.
- the opposite side of intermediate portion 136 has a second laterally projecting tab 142 that slidably engages in one of radial slots 124 formed in cartridge 120 .
- Tab 142 projects from intermediate portion 136 adjacent the inner end 144 of staple pusher 130 .
- Tab 138 projects from intermediate portion 136 at a spaced distance from end 144 of staple pusher 130 .
- a recessed slanted cam surface 146 is formed in intermediate portion 136 between tabs 138 and 142 , the purpose of which will be described below.
- loading unit 100 Prior to a stapling operation, with staple pushers 130 in their inner staple holding positions, loading unit 100 includes a plurality of surgical staples 150 . Staples 150 are loaded in loading unit 100 so that the crossmember 152 of each staple rests against the free end of one of legs 132 , 134 of staple pushers 130 , with staple legs 154 and 156 projecting radially outward. More particularly, the crossmember 152 of each staple rests in an elongated recess 148 formed in the free ends of the legs 132 and 134 of each staple pusher 130 .
- legs 154 and 156 of staples 150 reside within opposed radially extending guide channels 158 and 160 , respectively, guide channel 158 being formed in end member 112 of cartridge 100 , and guide channel 160 being formed in cartridge 120 .
- Recesses 148 locate the staples and hold them in place with respect to the free ends of legs 132 and 134 , while guide channels 158 and 160 guide the staples as they are deployed from loading unit 100 . It will be appreciated from the foregoing that a loading unit 100 having ten staple pushers 130 , and therefore twenty legs 132 , 134 , will be able to simultaneously deploy twenty staples 150 .
- Legs 132 , 134 of staple pushers 130 each include a pair of lateral ribs 162 positioned in linear alignment with recess 148 . Ribs 162 are aligned substantially collinearly with legs 154 and 156 of staples 150 so that, upon outward radial movement of staple pushers 130 , the force exerted by the staple pusher is distributed along the entire length of crossmember 152 , with a portion of the force being exerted in substantial linear alignment with the staple legs.
- any resistance to this outward movement as the free ends of staple legs 154 and 156 contact and pierce the aorta and graft 10 and strike the stapling anvils (to be described below) will not result in significant distortion to crossmember 152 .
- Staple pushers 130 are moved from their inner staple holding positions to their outer staple ejecting positions by actuator 170 .
- Actuator 170 has a generally tubular main body 172 with an annular flange 174 at the proximal end thereof, and a plurality of elongated fingers 176 at the distal end thereof. Fingers 176 are sized and shaped to be slidably received in the slots 116 of cartridge 110 and the slots 124 of cartridge 120 .
- Each of fingers 176 includes a tapered surface 178 , which cooperates with the cam surface 146 of a corresponding staple pusher 130 to move the staple pusher radially outward during a stapling operation, as will be described below.
- Actuator 170 is mounted on a tubular shaft 180 for sliding movement in the axial direction of loading unit 100 .
- Shaft 180 has an enlarged annular flange 182 at its proximal end to prevent cap 104 from sliding axially beyond the proximal end of the shaft.
- a retaining clip 184 is assembled over a pair of transverse slots 186 formed in the main body 172 of actuator 170 and cooperates with an annular groove 188 formed in shaft 180 to temporarily prevent actuator 170 from sliding on shaft 180 .
- the spring force of retaining clip 184 is only sufficient to prevent the unintended relative movement of actuator 170 on shaft 190 during shipping and handling of loading unit 100 .
- actuator 170 During a stapling operation, however, the force exerted axially on actuator 170 is sufficient to overcome the spring force of retaining clip 184 . That is, during a stapling operation, the axial force exerted on actuator 170 causes retaining clip 184 to spread open as it is pushed against the side of annular groove 188 until the retaining clip is pushed out of the groove, thereby enabling actuator 170 to slide axially along shaft 180 .
- a pair of cutouts 185 are formed on the opposite sides of shaft 180 near its proximal end, the purpose of which will be discussed below.
- loading unit 100 includes an assembly for gripping the distal edge of graft 10 and holding it in place during shipment of the stapling system of the present invention and during a stapling procedure.
- the assembly includes an external graft retainer 190 having a plurality of fingers 192 which may be extended radially outward from loading unit 100 to grip the outer distal edge of graft 10 , and an internal graft retainer 220 having a plurality of fingers 222 which may be extended radially outward from the loading unit to pierce the inner distal edge of graft 10 .
- Retainers 190 and 220 are assembled over the shaft of an elongated screw 200 which extends through an aperture in cap 106 , the central apertures in cartridges 110 and 120 , and actuator 170 , and which ultimately connects at its proximal end to the distal end of shaft 180 to hold all of the components of loading unit 100 in assembled relationship.
- Screw 200 may be joined to shaft 180 by any technique, including, for example, threaded engagement.
- External graft retainer 190 includes a generally flat, circular hub 194 having a central aperture 196 for receiving the shaft of crew 200 .
- Fingers 192 may be formed integrally with hub 194 and extend in a direction proximally and radially outward thereof.
- Each finger 192 terminates in a generally L-shaped tip 198 having a surface 198 a extending in a generally radial direction and a surface 198 b extending proximally therefrom in a generally axial direction.
- An angled cam surface 202 provided between tip 198 and hub 194 includes a protruding portion or bump 203 at the end of the cam surface farthest from tip 198 .
- Retainer 190 is preferably formed from spring steel or a similar material and shaped so that fingers 192 will be biased toward their rest positions when displaced radially outward therefrom.
- a cam ring 208 is mounted to hub 194 of retainer 190 by a plurality of screws or other known fastening technique, with a spring member 210 sandwiched therebetween.
- Cam ring 208 has an elongated central aperture 212 and a shaped surface 214 along its outer periphery. More particularly, the outer periphery of cam ring 208 includes a smaller diameter annular surface 208 a , a larger diameter annular surface 208 b , and a tapered surface 208 c therebetween, the purpose of which surfaces will be described below.
- Spring member 210 has a generally flat body portion 216 and a pair of tabs 218 bent in a proximal direction. Tabs 218 reside in an annular channel 201 formed in the shaft of screw 200 , thereby limiting the amount by which retainer 190 may move in the axial direction.
- Internal graft retainer 220 includes a generally flat circular hub 224 having an enlarged opening 226 . Opening 226 has enlarged regions that receive bosses 240 projecting from the interior of cap 106 . Bosses 240 are undercut so that retainer 220 may be rotated relative to cap 106 to lock it in place on the interior of the cap.
- Fingers 222 of retainer 220 may be formed integrally with hub 224 and extend in a direction proximally and radially outward thereof. Each finger 222 terminates in a needle-like tip 228 which projects radially outward.
- a radially inward projecting cam 230 formed on each finger 222 intermediate tip 228 and hub 224 has an angled distal cam surface 230 a , a cam surface 230 b which extends generally in the axial direction, and an angled proximal cam surface 230 c .
- Cam 230 is adapted to cooperate with the shaped peripheral surface 214 of cam ring 208 as will [sic] described further below.
- Retainer 220 is preferably formed from the same spring steel or similar material as retainer 190 and shaped so that fingers 222 will be biased toward their rest positions when displaced radially outward therefrom.
- retainers 190 and 220 are positioned relative to one another so that each finger 192 of retainer 190 lies adjacent a finger 222 of retainer 220 .
- Each pair of fingers 192 , 222 resides in one of a plurality of radial recesses 242 formed in the distal surface of cartridge 120 and continuing in the proximal surface of cap 106 .
- Each recess 242 includes a first surface 242 a extending generally in an axial direction, and a cam surface 242 b extending at an angle to surface 242 a .
- the surfaces 242 a and 242 b of each recess 242 are intended to interact with the cam surface 202 and bump 203 of the finger 192 residing in that recess, as will be explained further below.
- a guidewire 250 is connected at one end to loading unit 100 and projects outward from the proximal end thereof.
- Guidewire 250 has an enlarged end 252 formed in a conventional fashion. End 252 is receivable in a slot 254 having an enlarged end 256 formed in the shaft of screw 200 .
- the guidewire then extends through an axial bore (not shown) in the shaft of screw 200 , through the hollow center of shaft 180 and out the proximal end of loading unit 100 .
- the engagement of the enlarged end 252 of guidewire 250 in the enlarged end 256 of slot 254 locks the guidewire in place and prevents it from being pulled proximally out from loading unit 100 .
- FIG. 7A shows a cross-sectional view of loading unit 100 in an initial state for loading a graft thereto.
- fingers 192 on retainer 190 are positioned in recesses 242 spanning cartridge 120 and cap 106 so that bumps 203 on fingers 192 lie distally of the cartridge, i.e., they are not located on any cam surface.
- fingers 192 are positioned so that the tips 198 thereof lie below the outer surface of the loading unit.
- the cam ring 208 With retainer 190 positioned as described, the cam ring 208 will be positioned axially so that the cams 230 on the fingers 222 of retainer 220 are proximal of the cam ring, i.e., they are not supported by any of the surfaces of the cam ring. As a result, the tips 228 of fingers 222 are positioned below the outer surface of the loading unit.
- loading unit 100 may be inserted into side port 20 of graft 10 until the distal end of cartridge 110 protrudes from cuff 18 .
- an actuating tool T may be used to advance retainer 190 to the loading position shown in FIG. 7B .
- Actuating tool T has a series of pins P that may be inserted into corresponding apertures 106 a in cap 106 .
- pins P engage the hub 194 of retainer 190 , forcing the retainer in the proximal direction.
- retainer 190 moves proximally, cam surfaces 202 on fingers 192 engage the edge of cartridge 120 in the recesses 242 , thereby forcing fingers 192 radially outward.
- Continued movement of retainer 190 will cause bumps 203 on fingers 192 to travel across cam surface 242 a and to begin traveling up cam surface 242 b to the position shown in FIG. 7B , at which the tips 198 of the fingers are spaced outwardly from the loading unit.
- the movement of retainer 190 proximally also causes spring member 210 to move proximally, whereupon spring tabs 218 will enter channel 201 formed in the shaft of screw 200 .
- channel 201 has a width in the axial direction, which is sufficiently large that spring tabs do not contact the proximal wall of the channel before fingers 192 have moved radially outward by a far enough distance.
- the proximal movement of retainer 190 also causes cam ring 208 to proximally, whereupon the proximal edge of the cam ring will ride along the cam surfaces of the cams 230 on fingers 222 until cam surfaces 230 c slide down tapered surface 208 c on the cam ring and cam surfaces 230 b come to rest on smaller diameter annular surface 208 a .
- the tips 228 of fingers 222 will be positioned below the outer surface of loading unit 100 .
- graft 10 With fingers 192 and 222 in these positions, graft 10 can be positioned so that the free edge of cuff 18 rests against surface 198 a and below surface 198 b at the tip of each finger 192 .
- actuating tool T may be moved in the direction of arrows B shown in FIG. 7C and removed from loading unit 100 . With the actuating tool T no longer holding retainer 190 in place, the radially inward biasing force of fingers 192 , through the interaction of bumps 203 with cam surfaces 242 b , biases retainer 190 in the distal direction.
- the tapered surface 208 c on cam ring 208 will engage the cam surfaces 230 c on fingers 222 to push fingers 222 radially outward against the radially inward biasing force of the fingers.
- the biasing force exerted by fingers 192 preferably is deliberately designed to be greater than the biasing force exerted by fingers 222 so that retainer 190 moves in the distal direction.
- a spring element (not shown) may be assembled between cam ring 208 and cartridge 120 to assure that retainer 190 moves in the distal direction upon removal of actuating tool T from loading unit 100 . The distal movement of retainer 190 continues until spring tabs 218 strike the distal wall of annular channel 201 .
- retainer 190 may move distally until the surfaces 198 b at the tip of fingers 192 contact the graft, whereupon the graft prevents further inward movement of the fingers and, hence, further distal movement of retainer 190 .
- cam ring 208 moves distally with it.
- This movement causes the cam surfaces 230 c on fingers 222 to ride up the tapered surface 208 c on cam ring 208 , with cam surfaces 230 b ultimately coming to rest on larger diameter annular surface 208 b .
- This action causes fingers 222 to expand radially outward of loading unit 100 so that the tips 228 thereof pierce graft 10 from the inside.
- the interaction of the tips 198 of fingers 192 and the tips 228 of fingers 222 with graft 10 hold the graft securely on loading unit 100 .
- FIG. 8 An elevational view of the loading unit 100 having a graft 10 loaded thereon is shown in FIG. 8 .
- the pins P of actuating tool T may be provided with a feature which engages a corresponding feature in the hub 194 of retainer 190 so that actuating tool T may be used to manually pull retainer 190 distally to an appropriate position.
- loading unit 100 may be provided in a series of different diameters which correspond to the diameters in which graft 10 is provided.
- graft 10 and loading unit 100 are typically provided as a unit, with graft 10 mounted on a loading unit in condition for ready use by the surgeon.
- FIGS. 9-10 illustrate a placement wand 300 in accordance with one embodiment of the present invention.
- Wand 300 is a lightweight, maneuverable tool used to insert loading unit 100 and its associated graft into the proper surgical position and to hold them in place as the graft is temporarily secured to the aorta for a subsequent stapling procedure.
- Wand 300 includes a shaft 302 having a substantially straight elongated portion 304 and a distal end portion 306 , which is oriented at an angle relative to elongated portion 304 . End portion 306 may form an angle of between about 90° and about 180° with elongated portion 304 .
- end portion 306 forms an angle of between about 105° and about 125° with elongated portion 304 , with an angle of about 115° being most preferred.
- a bore 308 extending through the entire length of shaft 302 is sized to receive guidewire 250 as loading unit 100 is assembled to wand 300 .
- Attachment mechanism 314 is connected to the distal end of shaft 302 .
- Attachment mechanism 314 has a cylindrical end portion 316 having a counterbore sized for receiving the distal end of shaft 302 .
- a flat may be formed in the counterbore so as to mate with a corresponding flat formed on the distal end of shaft 302 , thereby defining the proper rotational relationship between attachment mechanism 314 and shaft 302 .
- Attachment mechanism 314 may be held in assembled relationship on shaft 302 by a set screw (not shown) or any other known fastening technique.
- Finger 320 Projecting distally from end portion 316 of attachment mechanism 314 is an elongated finger 320 .
- Finger 320 has a pair of flat side surfaces 322 , a curved upper surface 326 and a flat lower surface. The shapes of these surfaces coincide with the internal shape of shaft 180 of loading unit 100 so that the loading unit is unable to rotate once assembled to wand 300 .
- a bore (not shown) extending through attachment mechanism 314 aligns with bore 308 in shaft 302 when these components are assembled together.
- wand 300 includes an operating handle 330 having first and second handle portions 332 and 334 that may be assembled together using any conventional technique.
- Handle 330 may be assembled to the proximal end of shaft 302 by capturing a reduced diameter portion 336 of shaft 302 between the handle portions when they are assembled together.
- a pair of projections 338 and 340 formed in each of handle portions 332 and 334 engage a pair of grooves 342 and 344 , respectively, formed transversely in shaft 302 to locate shaft 302 in the proper rotational orientation relative to handle 330 and to prevent the shaft from sliding out of the handle when in the assembled position.
- Coiled guidewire tubing 346 is held in the proximal end of handle 330 by the assembly of handle portions 332 and 334 .
- Guidewire tubing 346 receives the excess length of guidewire 250 , which protrudes out from the proximal end of wand 300 and holds it in a manageable position.
- coiled tubing 346 may first be removed from handle 330 by pulling to expose guidewire 250 .
- guidewire tubing 346 may remain connected to handle 330 , and guidewire 250 may simply be pulled out from the tubing as wand 300 is removed from loading unit 100 .
- Handle 330 includes a locking mechanism 350 operable between a locked position for engaging guidewire 250 so as to prevent sliding movement between wand 300 and the guidewire, and an unlocked position for releasing the wand for movement relative to the guidewire.
- locking mechanism 350 may operate as a toggle.
- locking mechanism 350 may include a trigger lock 352 having a first operating button 354 and a second operating button 356 provided on either side of a pivot member (not shown). The ends of the pivot member are held by handle portions 332 and 334 so that trigger lock 352 is free to pivot between the locked and unlocked positions.
- a brake 360 having a pivot member (not shown) at one end thereof is pivotably mounted in handle 330 below trigger lock 352 , and a friction member 364 is mounted below brake 360 .
- Friction member 364 is preferably formed from a soft, resilient material which, when pressed with sufficient force against guidewire 250 , will prevent wand 300 from sliding relative to the guidewire.
- friction member 364 may be formed from a resilient plastic, rubber or like material.
- friction member 364 is formed from silicone rubber, and more preferably, is formed from a length of silicone rubber tubing.
- Brake 360 cooperates with friction member 364 to lock wand 300 to guidewire 250 in the locked position of locking mechanism 350 and to release wand 300 for movement relative to guidewire 250 in the unlocked position of locking mechanism 350 .
- button 354 is in the depressed position shown in FIG. 10A .
- an arcuate locking protrusion 366 formed on trigger lock 352 below its pivot member rests on a raised flat region 368 on the upper surface of brake 360 .
- brake 360 is forced downwardly against friction member 364 , forcing it tightly against guidewire 250 and preventing relative movement between the guidewire and wand 300 .
- friction member 364 has a tubular structure
- the downward force exerted by brake 360 causes the tubular structure to collapse, thereby engaging guidewire 250 between the opposed inner walls of the tube.
- Depressing button 356 to move trigger lock 352 to the unlocked position shown in FIG. 10B causes locking protrusion 366 to rotate about its pivot member until it lies over a recessed region 370 formed in the upper surface of brake 360 .
- the resiliency of the friction member pushes brake 360 upwardly until locking protrusion 366 rests within recessed region 370 .
- friction member 364 is no longer compressed against guidewire 250 , and the guidewire is released for sliding movement relative to wand 300 .
- FIGS. 11-12 A second embodiment of a placement wand 380 for use with the present invention is shown in FIGS. 11-12 .
- Wand 380 is substantially the same as wand 300 , but has a locking mechanism 382 which uses a slidable trigger lock 384 rather than the trigger lock 352 , which operates in a toggle, fashion.
- Trigger lock 384 slides between locked and unlocked positions in an elongated cavity 385 formed in first and second handle portions 386 and 388 of operating handle 390 .
- a locking protrusion 392 projects downwardly from trigger lock 384 at the proximal end thereof.
- a brake 394 having a pivot member (not shown) at one end thereof is pivotally mounted in handle 390 below locking protrusion 392 , and a friction member 398 is mounted below brake 394 .
- Friction member 398 is preferably formed from the same silicone rubber tubing as described above in connection with friction member 364 of wand 300 .
- the trigger lock 384 is slid to the distal position shown in FIG. 12A .
- locking protrusion 392 rests in a shallow depression formed in a raised region 397 on the upper surface of brake 394 .
- brake 394 is forced downwardly against friction member 398 , engaging guidewire 250 and preventing its movement relative to wand 380 .
- Sliding trigger lock 384 in the proximal direction to the unlocked position shown in FIG. 12B moves locking protrusion 392 to a position overlying a recessed region 399 formed in the upper surface of brake 394 .
- the resiliency of friction member 398 thus pushes brake 394 upwardly until locking protrusion 392 rests within recess region 399 .
- friction member 398 is no longer compressed against guidewire 250 and the guidewire is released for sliding movement relative to wand 380 .
- FIGS. 13-14 illustrate a tourniquet 400 for use in the present invention.
- Tourniquet 400 is used to temporarily hold the cuff 18 of graft 10 in an appropriate position within the exposed aorta so that a stapling operation may be performed. It will be appreciated, however, that tourniquet 400 may be used in any surgical procedure where there is a need to place a clamp around a tubular or cylindrical structure.
- Tourniquet 400 has a generally straight hollow shaft 402 with a handle 404 provided at a proximal end thereof.
- a button 406 is mounted in handle 404 for sliding movement in an axial direction along an elongated slot 408 .
- button 406 is connected to the proximal end of an elongated rod 410 , which is arranged for sliding movement within shaft 402 .
- band 416 is fixedly connected to the distal end of rod 410 , such as by a screw 417 or any other conventional connecting technique.
- band 416 has a rounded tip 418 and opposed notches 420 defining a narrowed neck spaced from tip 418 , the purpose of which will be described below.
- Band 416 preferably is wider than it is thick so as to define a rectangular cross-section that will hold an annular shape better than the round cross-section of a conventional suture.
- Band 416 may be formed from any material having sufficient flexibility to conform smoothly around loading unit 100 , graft 10 and the aorta, and sufficient tensile strength to securely hold graft 10 and the aorta in overlapping relationship during a stapling operation.
- particularly preferred materials for forming band 416 are nitinol or other shape memory materials, polypropylene, polyethylene, MylarTM polyester, nylon and other suitable materials.
- Nitinol or other shape memory materials are particularly preferred since they permit band 416 to be preformed with a curvature that will facilitate the maneuvering of band 416 around the graft and artery.
- a retaining block 422 is assembled in the distal end of shaft 402 for sliding movement in the axial direction between end plug 412 and one or more tangs 424 bent inwardly from shaft 402 .
- Retaining block 422 has an axial bore 428 , which is sized and shaped to receive the rounded tip 418 of band 416 .
- retaining block 422 has an axial slot 430 aligned with the through slot 414 in end plug 412 and sized and shaped to receive band 415 for sliding movement relative to the retaining block.
- the upper wall 432 of retaining block 422 has an axial slot 434 , which extends the length of the retaining block and communicates with axial bore 428 .
- a keyhole 436 is formed in the upper wall 432 of retaining block 422 in a direction transverse to slot 434 . Keyhole 436 is sized to receive tip 418 of band 416 and to permit its insertion into axial bore 428 .
- button 405 is initially pushed in the distal direction to deploy band 416 through the slot 414 in end plug 412 .
- band 416 When formed from a shape memory material, band 416 will form a curved shape so that tip 418 will approach the distal end of shaft 402 .
- band 416 When not formed from a shape memory material, band 416 may be manually manipulated to place tip 418 near the distal end of shaft 402 .
- Tourniquet 400 may then be operated to capture the tip 418 of band 416 . More particularly, button 406 may be pushed further in the distal direction so that the distal end of rod 410 contacts retaining block 422 . Further movement of button 406 in the distal direction will cause rod 410 to push retaining block 422 in the distal direction against the biasing force of spring 425 until the keyhole 436 in retaining block 422 is aligned with an aperture 438 in shaft 402 . At this point, tip 418 of band 416 may be inserted through aperture 438 and keyhole 436 until the tip resides within the axial bore 428 in retaining block 422 and notches 420 are aligned with the slot 434 in the upper wall 432 of the retaining block.
- button 406 is moved in the proximal direction so as to draw band 416 into shaft 402 .
- a plurality of teeth (not shown) provided on button 406 may engage with a similar plurality of teeth (not shown) provided on handle 404 .
- the engagement of the teeth on these respective components may act as a ratchet mechanism enabling button 406 to be retracted, but blocking it from movement relative to handle 404 in the distal direction. Therefore, as band 416 is progressively tightened, it will be locked in place and prevented from loosening at each step in the tightening process.
- the teeth on the respective components may be biased into engagement with one another by a spring (not shown) interposed between button 405 and handle 404 .
- a spring (not shown) interposed between button 405 and handle 404 .
- Instrument 500 includes a hollow outer shaft 502 having a substantially straight elongated portion 504 and a smoothly curved distal and portion 506 which terminates at an angle relative to elongated portion 504 .
- End portion 506 may terminate at an angle of between about 90° and about 180° relative to elongated portion 504 .
- end portion 506 terminates an angle of between about 105° and about 125° relative to elongated portion 504 , with an angle of about 115° being most preferred.
- An anvil assembly 510 is provided at the distal end of shaft 502 , while a handle 512 is provided at the proximal end thereof.
- a bushing 508 having a flange 509 at a proximal end thereof may be assembled over a reduced diameter portion at the proximal end of outer shaft 502 and held in place thereon by a retaining ring 507 so as to be rotatable relative to the shaft.
- Handle 512 may be assembled to shaft 502 by capturing flange 509 between handle portions 511 and 513 when they are assembled together.
- anvil assembly 510 includes a generally hollow anvil hub 514 having a cylindrical side wall 516 to which right anvil 518 a , left anvil 518 b , and center anvil 518 c are pivotably mounted.
- Each anvil includes an elongated arm 520 having a dog-leg configuration with a pair of laterally projecting guide pins 522 at the proximal end thereof and an arcuate-shaped bracket 524 at the distal end thereof.
- An anvil insert 526 having a plurality of spaced staple returns 528 may be mounted to each bracket 524 .
- Instrument 500 has a total of twenty staple returns 528 , six each on right anvil 518 a and left anvil 518 b , and eight on center anvil 518 c , which has a bracket 524 with a slightly larger arcuate length.
- Each staple return has depressions for guiding the free ends of a staple 150 into a bent configuration.
- staple return 528 may be formed directly in brackets 524 .
- brackets 524 on the ends of anvils 518 a , 518 b and 518 c each define an arc such that, in the closed position of anvil assembly 510 , these brackets collectively define a complete circle.
- Each bracket 524 includes a male locating member 530 at one end thereof and a female locating member 532 at the opposite end thereof, the male and female locating members on adjacent brackets 524 engaging with one another in the closed position of anvil assembly 510 so as to properly locate and align staple returns 528 relative to one another.
- male locating member 530 may have a conical portion 530 a with a rounded tip and a substantially flat ring 530 b formed around its base.
- Female locating member 532 may have a tapered recess 532 a shaped to mate with the tapered walls of portion 530 a , and a substantially flat ring 532 b formed around recess 532 a .
- An extended bore 532 c may be formed at the bottom of recess 532 a .
- the small area of surfaces 530 b and 532 b combined with the high compressive force developed on the closing of the anvils, cause any tissue which may be captured between surfaces 530 b and 532 b to be pulverized. Furthermore, any miscellaneous tissue, which may be captured between conical portion 530 a and tapered recess 532 a upon the closing of anvil assembly 510 , may be pushed into the extended bore 532 c at the bottom of recess 532 a .
- male locating member 530 and female locating member 532 helps assure that anvils 518 a , 518 b and 518 c achieve a fully closed condition and are not prevented from doing so by any extraneous tissue which may be present during the surgical procedure.
- Anvils 518 a , 518 b , and 518 c are pivotably mounted to anvil hub 514 by a series of yokes 534 formed at spaced distances on the outer surface of side wall 516 .
- Each yoke 534 includes a pair of supports 536 which project beyond the distal end 538 of anvil hub 514 , and which are spaced apart so as to receive one of anvil arms 520 therebetween.
- a barrel nut 540 may be inserted through a pair of axially aligned apertures 542 formed in supports 536 and through an aperture 544 provided at the dog leg in an anvil arm 520 and mate with a screw 541 for holding the anvil in assembled relationship to anvil hub 514 .
- anvils 518 may be held to yokes 534 through any other technique allowing pivoting of the anvil arms, such as through a pivot pin or the threaded engagement of one end of a shoulder bolt with threads formed in one of apertures 542 .
- Access openings 546 are formed in side wall 516 in the spaces between each pair of supports 536 in a yoke 534 , the access openings continuing radially inward by a predetermined amount in the distal end 538 of anvil hub 514 . Access openings 546 enable the proximal ends of anvil arms 520 to project into the interior of anvil hub 514 and provide clearance for the movement of anvils 518 between open and closed positions.
- the distal end 538 of anvil hub 514 includes a central aperture 545 having curved top and bottom surfaces and flat side surfaces, and a series of apertures 548 arranged substantially symmetrically around central aperture 545 for slidably receiving the fingers of a pusher 600 , the purpose of which will be described below.
- a cam element 550 is slidably assembled in the open proximal end of anvil hub 514 .
- Cam element 550 has a generally cylindrical structure with a series of ribs 554 projecting radially outward therefrom. Ribs 554 are oriented in the axial direction of anvil assembly 510 and engage in similarly oriented channels (not shown) formed in the interior of anvil hub 514 . Each channel is positioned so as to be radially inward of a corresponding yoke 534 .
- Ribs 554 are formed with a central slot 558 having a width sufficient to receive the proximal end of an anvil arm 520 , and an undercut 560 on each side of the slot for receiving the guide pins 522 on anvils 518 .
- the bottom surface of each slot 558 defines a tapered cam surface 562 so that axial movement of cam element 550 relative to anvil hub 514 causes anvils 518 to move between the open and closed positions.
- An arm 564 projects axially from the proximal end of cam element 550 .
- Arm 564 has a transverse aperture 566 at its free end for connection to a drive mechanism for effecting axial movement of cam element 550 , as will be explained below.
- Cam element 550 includes a central bore 568 having flat top and bottom surfaces and curved side surfaces, and a generally cylindrical counterbore 570 extending inwardly from the distal end of the cam element to an end wall 572 .
- a series of through openings 574 similar in size and shape to apertures 548 in anvil hub 514 , are arranged substantially symmetrically around central opening 568 for slidably receiving the fingers of pusher 600 .
- An anvil hub shaft 576 is mounted in anvil assembly 510 between anvil hub 514 and cam element 550 .
- Shaft 576 has a large intermediate portion 578 having a substantially cylindrical cross-section, and a proximal end portion 580 , which is smaller in cross-section so as to define a step 582 therebetween.
- shaft 576 has a distal end portion 584 , which is smaller in cross-section than intermediate portion 578 so as to define a step 586 therebetween.
- the intermediate portion 578 of shaft 576 has similar recesses 588 formed in its upper and lower surfaces, each of which is sized and shaped to receive a catch member 590 .
- Catch members 590 have a protruding transverse rib 591 so that the catch members rest in recesses 588 in a see-saw fashion.
- a spring catch 592 in the form of a split ring may be assembled in an annular groove 594 formed by the circumferential alignment of groove portions in the intermediate portion 578 of shaft 576 and in each of catch members 590 .
- the assembly of spring catch 592 around the catch members 590 and the intermediate portion 578 of shaft 576 holds the catch members in assembled relationship to shaft 576 so that the distal ends of the catch members are biased outwardly, while permitting the distal ends of the catch members to pivot inwardly upon the application of a radially inward compressive force thereto.
- catch members 590 each have a radially projecting prong 596 having a sharply tapered distal surface and a slightly tapered proximal catch surface. Prongs 596 secure loading unit 100 to instrument 500 , as will be explained below.
- the distal end portion 584 of shaft 576 has a shape similar to that of the elongated finger 320 at the end of wand 300 . That is, the distal end portion 584 of shaft 576 has flat side and lower surfaces and a curved upper surface for mating engagement within shaft 180 of loading unit 100 .
- An axial bore 599 is provided along the length of shaft 576 for receiving guidewire 250 , as will be explained below.
- Shaft 576 is assembled in anvil hub 514 so that the distal end portion 584 of shaft 576 extends through the central aperture 545 in the anvil hub, with step 586 abutting the inside wall of the distal end 538 of the anvil hub adjacent aperture 545 .
- the shape of the aperture 545 in anvil hub 514 assures that the anvil hub is assembled in the proper orientation on shaft 576 and is unable to rotate once assembled thereon. In this assembled position, the distal end portion 584 of shaft 576 extends outwardly from anvil hub 514 , as do the radially projecting prongs 596 on catch members 590 .
- Cam element 550 is assembled in anvil hub 514 so as to capture the intermediate portion 578 of shaft 576 therebetween. That is, cam element 550 is assembled over the proximal end portion 580 of shaft 576 until the end wall 572 of counterbore 570 is engaged with step 582 on shaft 576 .
- the corresponding shapes of the proximal end portion 580 of shaft corresponding shapes of the proximal end portion 580 of shaft 576 and the central bore 568 in cam element 550 assures that these elements are assembled in the proper orientation and that the cam element is unable to rotate once assembled on the shaft.
- a pusher 600 having a disk-shaped base member 602 and a plurality of axially extending fingers 604 is assembled in anvil assembly 510 so that fingers 604 extend through openings 574 in cam element 550 and apertures 548 in anvil hub 514 .
- Fingers 604 are of a sufficient length that when pusher 600 is displaced fully in the distal direction, the free ends of fingers 604 protrude outwardly from the distal end 538 of anvil hub 514 and into a loading unit 100 mounted on instrument 500 .
- pusher 600 acts on actuator 170 to deploy staples 150 during a stapling operation.
- a link 606 having a transverse aperture 608 is connected to the proximal and of base member 602 for joining pusher 600 to a drive mechanism for effecting axial movement of the pusher.
- Anvils 518 may be moved between the open and closed positions by an adjustment knob 610 provided at the handle end of instrument 500 .
- Adjustment knob 610 actuates a drive mechanism that transfers rotational movement of knob 610 into axial movement of cam element 550 , thereby displacing anvils 518 .
- the drive mechanism may include an elongated tube 612 slidably disposed within the hollow shaft 502 of instrument 500 .
- tube 612 may be connected to a link coupler 614 using any conventional arrangement.
- the distal end of tube 612 fits within a bore formed in the proximal end of link coupler 614 .
- These elements may be held together by an suitable means, including by sliding a retaining ring (not shown) into a slot 616 formed transversely in link coupler 614 and engaging it in an annular groove formed adjacent to the distal end of tube 612 .
- Link coupler 614 may be joined to arm 564 on cam element 550 by a plurality of links 620 .
- a pair of track inserts 622 assembled in the opposite sides of curved distal end portion 506 of shaft 502 may define first and second pairs of laterally spaced guide tracks 624 and 626 .
- Links 620 may ride in guide tracks 626 so that any axial movement of tube 612 is transferred along the curved portion of shaft 502 to cam element 550 .
- Links 620 may take any form capable of transmitting the compressive force exerted by tube 612 and link coupler 614 to cam element 550 as anvil assembly 510 is placed in a closed condition, and capable of transmitting the tensile force from tube 612 and link coupler 614 to cam element 550 as tube 612 is retracted to place anvil assembly 510 in an open condition.
- links 620 may consist of individual links joined together in a conventional fashion, or may be in the form of a solid band having periodic thinned sections defining a plurality of living hinges.
- links 620 may not be links at all, but may be a solid band having the requisite compressive and tensile strength, while at the same time having sufficient flexibility to bend smoothly and uniformly along the curved portion of shaft 502 .
- tube 612 may be connected to a coupling element 628 .
- the proximal end of tube 612 may be inserted into a bore formed in the distal end of coupling element 628 , and these elements may be held together in the same manner as tube 612 and link coupler 614 , that is, by sliding a retaining ring (not shown) into a slot 630 formed transversely in coupling element 628 and engaging it in an annular groove formed adjacent to the proximal end of tube 612 .
- the distal end of tube 612 may be joined to link coupler 614 and the proximal end of tube 612 may be joined to coupling element 628 by any other known connection techniques.
- Coupling element 628 may have a pair of elongated bosses (not shown) extending in the axial direction on either side of the coupling element. Each of the bosses may be slidably held in an elongated slot provided in each of handle portions 511 and 513 .
- the elongated slots have a predetermined length so as to define the extent of axial travel of coupling element 628 .
- coupling element 628 may be threadedly engaged with a shaft 642 .
- Shaft 642 has a stepped structure so as to define an intermediate portion 644 , which is smaller in diameter than a threaded distal portion 646 and larger in diameter than a proximal portion 648 .
- a bushing 650 may be assembled over intermediate portion 644 and may be held in place by the step between the intermediate portion 644 and distal portion 646 of shaft 642 and a retaining ring 652 assembled in an annular groove formed in the intermediate portion 644 proximally of the bushing.
- the outer circumference of bushing 650 may be formed with an annular groove 654 , which enables the bushing to be captured in a circular opening formed in the proximal end of handle 512 when handle portions 511 and 513 are assembled together.
- Adjustment knob 610 has an internal elongated annular boss 656 for receiving the proximal portion 648 of shaft 642 .
- a pair of diametrically opposed teeth 658 formed on the free end of boss 656 may engage recesses 660 formed in the intermediate portion 644 of shaft 642 so that any rotational movement of knob 610 results in a corresponding rotation of shaft 642 .
- a barrel nut 662 engages a threaded portion 664 formed on the proximal portion 648 of shaft 642 so as to hold knob 610 in assembled relationship to the shaft.
- Barrel nut 662 resides in a counterbore 666 formed in the proximal end of knob 610 so that it does protrude outwardly from the knob.
- a conventional clutch mechanism may be provided between knob 610 and shaft 642 to prevent the overloading of anvil assembly 510 .
- the clutch mechanism will enable knob 610 to rotate without further movement of the anvils, thereby preventing damage to instrument 500 or damage to tissue from the closing anvils.
- trigger mechanism 670 for actuating a stapling operation.
- trigger mechanism 670 may include a trigger 672 pivotably mounted between handle portions 511 and 513 by a pivot pin 674 .
- Trigger 672 has a generally hollow, molded construction including a pair of spaced side walls 676 .
- Trigger mechanism 670 may further include a linkage assembly 680 including a pair of links 682 and 684 joined together by a pivot pin 686 .
- One end 688 of linkage assembly 680 is pivotably held in a fixed position between handle portions 511 and 513 by a pivot pin 690 .
- linkage assembly 680 The opposite end 692 of linkage assembly 680 is pivotably joined to a coupling element 694 .
- An elongated tube 702 slidably disposed within outer shaft 502 of instrument 500 and over tube 612 may be connected at its proximal end to coupling element 694 . More particularly, the proximal end of tube 702 may be inserted in a bore formed in the distal end of coupling element 694 .
- This assembly may be maintained in the same manner as the assembly of tube 612 to link coupler 614 , that is, by sliding a retaining ring (not shown) into a slot 703 formed transversely in coupling element 694 and engaging it in an annular groove formed adjacent to the proximal end of tube 702 .
- tube 702 may be connected to a coupling link 704 .
- the distal end of tube 702 may be inserted in a bore formed in the proximal end of coupling link 704 and may be held in assembled relationship therein in the same fashion as the other tube/coupler connections described above, namely, by sliding a retaining ring (not shown) into a slot 706 formed transversely in coupling link 704 and engaging it in an annular groove formed adjacent to the distal end of tube 702 .
- any other known connection techniques may be used both to join the distal end of tube 702 to coupling link 704 , and to join the proximal end of tube 702 to coupling element 694 .
- Coupling link 704 preferably is assembled over tube 612 and proximally of link coupler 614 so as to not interfere with the axial movement thereof, and may be joined to link 606 on pusher 600 by a plurality of links 708 .
- Links 708 may ride in laterally spaced guide tracks 624 formed in track inserts 622 so that any axial movement of tube 702 is transferred along the curved portion of shaft 502 to pusher 600 .
- Links 708 may have any of the structures described above in connection with links 620 . Moreover, links 708 may have the same structure as links 620 or a structure different therefrom.
- trigger mechanism 670 may be actuated by pressing trigger 672 toward handle 512 .
- This movement of trigger 672 will cause engagement surface 700 to push against the apex 698 of linkage assembly 680 , thereby causing the angle between links 682 and 684 to be increased against the biasing force of spring 696 .
- the end 688 of linkage assembly 680 is fixed relative to handle 512 , the increased angle between links 682 and 684 will cause the other end 692 of linkage assembly 680 to move axially in the distal direction.
- Instrument 500 may further include a guidewire tube 709 , which is positioned within tube 612 . At its distal end, guidewire tube 709 protrudes out from tube 612 and has a curved portion whose distal end is inserted in a counterbore formed in the proximal end of anvil hub shaft 576 . At its proximal end, guidewire tube 709 extends out from tube 612 , through coupling element 628 and into shaft 642 . Guidewire tube 709 provides an uninterrupted channel for guidewire 250 from loading unit 100 through instrument 500 .
- Safety 710 may be in the form of an elongated pin (not shown) having a radially projecting tab 714 formed with an aperture 716 .
- a shaft (not shown) may be inserted through aperture 716 to mount safety 710 for sliding movement in a transverse direction between handle portions 511 and 513 .
- Safety 710 In this rest position, one end of the elongated pin projects outwardly through an aperture in handle portion 511 to define a first button, and the other end of the elongated pin projects outwardly through an aperture in handle portion 513 to define a second button.
- safety 710 With the ends of the elongated pin and the shaft constrained from movement by handle portions 511 and 513 , safety 710 is prevented from moving pivotably relative to handle 512 , but is free to move transversely with respect to the handle.
- Safety 710 further includes a pair of tangs 732 , which, in the rest position of the safety, align with and engage notches 734 formed in the side walls 676 , respectively, of trigger 672 .
- Such engagement prevents trigger 672 from being depressed to actuate a stapling operation. Pressing either the first or the second button toward handle 512 moves tangs 732 out of alignment with side walls 676 of trigger 672 , thereby clearing the path for the trigger to be depressed relative to handle 512 so that a stapling operation can be performed.
- FIGS. 23-25 A second embodiment of a handle and trigger mechanism for use with a stapling instrument 800 in accordance with the present invention is shown in FIGS. 23-25 .
- Stapling instrument 800 is substantially the same as stapling instrument 500 described above, with the exception of the handle and the trigger mechanism used to actuate a stapling procedure.
- the trigger mechanism 802 of instrument 800 includes a trigger 804 having an elongated grasping portion 806 spaced from handle 808 , and a drive portion 810 projecting laterally from one end of the grasping portion so as to define a generally L-shaped configuration.
- Trigger 804 is mounted between portions 812 of handle 808 for pivoting movement about a pivot pin 816 disposed at the intersection of grasping portion 806 and drive portion 810 .
- Instrument 800 includes the same tube 702 , coupling link 704 and links 708 as instrument 500 .
- the structure at the proximal end of tube 702 differs from that in instrument 500 .
- the proximal end of tube 702 may be connected to a coupling element 818 in any conventional manner, including that by which tube 612 is connected to coupling element 628 at its proximal end.
- Coupling element 818 may be assembled on tube 612 for sliding movement in the axial direction of the tube.
- a biasing spring 820 may be assembled over tube 702 between the distal end of coupling element 818 and an annular surface 822 formed transversely in handle 808 .
- Coupling element 818 may have a pari of elongated bosses (not shown) extending in the axial direction on either side of the coupling element. Each of these bosses may be slidably held in an elongated slot (not shown) provided in each of handle portions 812 .
- the elongated slots have a predetermined length so as to define the extent of axial travel of coupling element 818 .
- Drive portion 810 of trigger 804 may be formed with a pair of spaced walls 828 at the free end thereof.
- Each of walls 828 may include a curved cam surface 830 projecting in a distal direction therefrom.
- walls 828 reside on either side of tube 612 with cam surfaces 830 contacting the proximal end of coupling element 818 .
- the force exerted by spring 820 biases coupling element 818 in the proximal direction, thereby pivoting the grasping portion 806 of trigger 804 toward handle 808 .
- the counterclockwise movement of trigger 804 (as shown in FIG.
- Instrument 800 may further include a safety 840 to prevent the premature accidental deployment of staples 150 .
- Safety 840 may be pivotably connected between handle portions 812 by a pivot pin 842 so that safety 840 is positioned between handle 808 and the grasping portion 806 of trigger 804 .
- safety 840 has a recess 804 sized to receive the grasping portion of 806 of trigger 804 .
- Recess 844 may include a resilient member 846 adapted to engage within a shallow recess 848 in grasping portion 806 in the locked condition of trigger mechanism 802 .
- resilient member 846 may be in the form of an S-shaped member integrally molded with safety 840 .
- Resilient member 846 causes safety 840 to fit tightly between handle 808 and grasping portion 806 in the locked condition. Such engagement prevents trigger 804 from being depressed to actuate a stapling operation. Pivoting safety 840 away from grasping portion 806 , however, releases trigger 804 for movement toward handle 808 to actuate a stapling operation.
- FIG. 26 depicts a sizer 900 for use in the present invention.
- Sizer 900 has several functions, including (1) measuring the diameter of the aorta so that a graft 10 of a proper size may be connected thereto, (2) assuring that there is an adequate amount of transected aorta between the surgical clamp on the aorta and the point of transection for connecting graft 10 using the surgical stapling system of the present invention, and (3) identifying approximately where the staple line will be located on the aorta relative to the point of transection so that the surgeon can be sure that the staples will penetrate healthy aortic tissue.
- Sizer 900 includes a shaft 902 having a substantially straight elongated portion 904 and a distal end portion 906 , which is oriented at an angle relative to elongated portion 904 .
- End portion 906 may form an angle of between about 90° and about 180° with elongated portion 904 .
- end portion 906 forms an angle of between about 105° and about 125° with elongated portion 904 , with an angle of about 115° being most preferred.
- a handle 908 is provided at the proximal end of shaft 902
- a measuring bulb 910 is provided at the distal end of the shaft.
- Measuring bulb 910 has a cylindrical central portion 912 with a generally frusto-conical portion 914 formed on the distal end thereof and another generally frusto-conical portion 916 formed on the proximal end thereof adjacent shaft 902 .
- the frusto-conical shape of portions 914 and 916 facilitate the insertion and removal of sizer 900 through a surgical opening, as well as the insertion of sizer 900 into a transected aorta.
- bulb 910 has a diameter D at central portion 912 , and a length L from the proximal end of central portion 912 to the distal tip 918 of the bulb.
- the diameter D is used to select a graft 10 of an appropriate size for attachment to the aorta.
- a plurality of sizers 900 will be available, each with a bulb 910 having a different diameter D.
- bulbs 910 are provided having nominal diameters of approximately 16 mm, 18 mm, and 20 mm so as to accommodate the different sizes of aortas a surgeon may ordinarily encounter.
- the selected sizer If the bulb 910 of a sizer 900 fits too loosely within the transected end of the aorta, the selected sizer is too small, and a sizer having a larger diameter D should be tried. On the other hand, if the bulb 910 of a sizer 900 does not fit into the transected end of the aorta, the selected sizer is too large, and a sizer having a smaller diameter D should be tried. The proper size is indicated when the bulb 910 fits easily within the transected aorta without excess play.
- the length L dimension of bulb 910 is used to determine whether there is an adequate amount of transected aorta available between the surgical clamp on the aorta and the point of transection to perform a stapling procedure. Thus, if the bulb 910 of a sizer 900 can be inserted into the transected aorta so that the entirety of central portion 912 lies within the aorta, the length of aorta available will be sufficient to perform a stapling procedure.
- a length of central portion 912 remains exposed when bulb 910 has been inserted fully within the transected aorta (i.e., until the surgical clamp prevents further insertion of the bulb), there will not be a sufficient length of aorta available to perform the stapling procedure. In such event, the surgical clamp may be moved farther away from the point of transection to make more of the aorta available. If that is not possible, a conventional graft may be attached to the aorta using a conventional suturing technique. Since the length of the aorta available for a stapling procedure is independent of the diameter of the aorta, the length L is the same for each of bulbs 910 , regardless of their diameters.
- Bulb 910 is provided with a circumferential recess 920 in central portion 912 .
- Recess 920 is located in the length direction of the bulb so as to indicate the position at which the circumferential line of staples will be deployed.
- a surgeon may position bulb 910 of sizer 900 adjacent the aorta prior to transecting same to ensure that the staples will be deployed in healthy aortic tissue relative to the point of transection.
- the surgical stapling system may be provided in the form of one or more kits—a first kit consisting of a series of sizers 900 having different diameters; a second kit consisting of a stapling instrument 500 and a tourniquet 400 ; and a third kit consisting of a graft 10 , a loading unit 100 , and a wand 300 .
- kits may include ancillary tools and materials that may be needed to perform a stapling procedure.
- the graft 10 may be preloaded onto the loading unit 100 , which, in turn, may be assembled to the distal end of the wand 300 .
- the size of the graft and the loading unit may differ from kit to kit depending upon the size of the aorta to be repaired.
- the various components may be separated into multiple kits having the components noted above based on different levels of clean room requirements, which must be adhered to during manufacture, and packaging. Each of the components may be designed to be disposable after their use to perform a single surgical procedure.
- the surgeon may position a sizer 900 adjacent an aorta A to be repaired so as to determine, based on the anticipated point of transection, whether there will be healthy aortic tissue at the projected circumferential stapling line indicated by the circumferential recess 920 in the sizer.
- the surgeon may then clamp the aorta and form a transection as shown in FIG. 32 .
- sizer 900 of an appropriate diameter is then inserted into the transected aorta to determine the approximate diameter of the aorta as well as whether a sufficient length of transected aorta is available between the transection and the clamp to perform a stapling procedure.
- the surgeon uses wand 300 to insert a loading unit 100 and its associated graft 10 of the proper diameter into the transected aorta.
- graft 10 is inserted until the cuff 18 of the graft is positioned entirely within the aorta.
- tourniquet 400 is used to deploy band 416 around the aorta and the underlying graft 10 and loading unit 100 .
- Tourniquet 400 may be positioned so that the shaft 402 thereof is oriented at either the two o'clock or ten o'clock position, as can be seen in FIG.
- tourniquet 400 is used to deploy band 416 so that the band is positioned around the aorta in a region adjacent the point of transection. Tightening band 416 around the aorta holds the aorta and graft 10 in fixed overlapping relationship around loading unit 100 .
- wand 300 may be disconnected from loading unit 100 . This may be accomplished by first pulling guidewire tubing 346 from the proximal end of handle 330 and off of guidewire 250 , and then depressing button 356 on handle 330 to place locking mechanism 350 in the unlocked condition. As a result, wand 300 may be pulled proximally along guidewire 250 , whereupon finger 320 will be drawn out from shaft 180 of the loading unit 100 . Wand 300 may then be removed entirely from guidewire 250 . Alternatively, wand 300 may be removed from guidewire 250 with guidewire tubing 356 attached thereto.
- the surgeon may assemble instrument 500 to loading unit 100 as shown in FIG. 37 .
- guidewire 250 may be inserted into the axial bore 599 in shaft 576 , through guidewire tube 709 and out the proximal end of instrument 500 .
- Instrument 500 may then be slid along guidewire 250 until the distal end of shaft 576 is inserted into shaft 180 of loading unit 100 .
- the prongs 596 projecting radially outward from shaft 576 will encounter the cutouts 185 formed on the opposite sides of shaft 180 .
- prongs 596 will be biased radially outward and snap into place, thereby creating an audible click to assure that instrument 500 is fully assembled to loading unit 100 .
- guidewire 250 may be formed with a colored band or other marker, which will be visible outside of handle 512 when instrument 500 has been assembled fully to loading unit 100 .
- Anvil assembly 510 may then be placed in the closed condition shown in FIG. 18 by rotating adjustment knob 610 .
- adjustment knob 610 As adjustment knob 610 is rotated, shaft 642 is rotated in the same direction through the engagement of teeth 658 on the knob with recesses 660 on the shaft.
- the rotation of shaft 642 causes coupling element 628 to move distally as a result of its threaded engagement with shaft 642 .
- the distal movement of coupling element 628 pushes tube 612 distally, and with it link coupler 614 and links 620 .
- cam element 550 As a result of this distal movement, cam element 550 is also moved in the distal direction.
- trigger mechanism 670 may be actuated to deploy staples 150 .
- one of buttons 726 and 730 is depressed to release safety 710 from trigger 672 .
- Trigger 672 may then be squeezed toward handle 512 , whereupon engagement surface 700 within trigger 672 pushes against the apex 698 of linkage assembly 680 .
- This movement causes the end 692 of linkage assembly 680 to move axially in the distal direction, thereby moving coupling element 694 , tube 702 , coupling link 704 and links 708 distally.
- links 708 drives the fingers 604 of pusher 600 out through apertures 548 of anvil hub 514 , through apertures 105 in the cap 104 of loading unit 100 , and against the annular flange 174 at the proximal end of actuator 170 .
- the continued distal movement of pusher 600 drives actuator 170 distally, overcoming the spring force exerted by retaining clip 184 to hold actuator 170 in a fixed axial position relative to shaft 180 .
- the distal movement of actuator 170 causes the tapered surface 178 on each of the fingers 176 of the actuator to engage the cam surface 146 of a corresponding staple pusher 130 .
- the staple pushers are driven radially outward, pushing staples 150 ahead of them. Staples 150 move radially outward until the free ends of the legs 154 and 156 of the staples contact the staple returns 528 on anvils 518 .
- Staple returns 528 cause staple legs 154 and 156 to turn inwardly and back toward the crossmember 152 of the staple so as to form a “B” configuration, shown in FIG. 31 , when the stapling operation has been completed.
- Staples 150 are deployed so that one leg 156 of each staple pierces graft 10 and aorta A is then turned back through the aorta.
- the other leg 158 of each staple pierces aorta A directly and is then turned back through the aorta, forming a loop around the free edge of graft 10 to hold it tightly to the aorta.
- the tips of the staple legs may or may not pierce graft 10 from the opposite side.
- cam ring 208 will be moved distally relative to the cams 230 on the fingers 222 of retainer 220 until cam surface 230 a is riding on the outer periphery of the cam ring.
- cam ring 208 will cause fingers 222 to move inwardly of loading unit 100 as a result of the inward biasing force exerted by the fingers, thereby releasing the tips 228 of the fingers from graft 10 .
- the actuation of trigger mechanism 270 to deploy staples 150 simultaneously releases retainers 190 and 220 from the cuff 18 of the graft.
- trigger 672 may be released, whereupon the biasing force of spring 698 will cause the trigger to return to its rest position.
- the apex 698 of linkage assembly 680 will move away from handle 512 , with the end 692 of the linkage assembly moving in the proximal direction. This proximal movement will cause coupling element 694 , tube 702 , coupling link 704 , and links 708 to also move proximally, resulting in the withdrawal of the fingers 604 of pusher 600 from loading unit 100 .
- Anvil assembly 510 may then be placed in the open condition by rotating knob 610 in the opposite direction, and instrument 500 , with loading unit 100 connected thereto, may be removed from graft 10 , leaving the graft attached to the aorta by a circumferential line of staples 999 , as can be seen in FIG. 38 . Subsequently, the legs 14 and 16 of graft 10 may be sutured in a conventional fashion to the patient's iliac arteries. The procedure is completed by closing side port 20 of graft 10 through the use of suture 22 to form a purse string tie, through a conventional suturing operation, or by a surgical stapling technique, and, where appropriate, by removing any excess portion of side port 20 from the graft.
- the various components of the present invention may be used in a conventional open body surgical procedure.
- the instruments may also be used to perform a stapling operation laparascopically by providing the instruments with appropriate seals to prevent the escape of air used to expand the body cavity during a laparoscopic procedure.
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Abstract
A system is provided for joining two tubular structures by a surgical stapling procedure. The system includes a series of sizers, a specifically designed graft, a loading unit, a wand, a tourniquet, and a stapling instrument. As a result, a plurality of staples may be simultaneously deployed quickly and accurately in a circumferential pattern so as to join together two tubular structures. The system may be used in either an open surgical procedure or laparascopically.
Description
- This application claims the benefit of priority from and is a continuation of U.S. patent application Ser. No. 12/555,417, filed Sep. 8, 2009, which in turn claims the benefit of priority to and is a division of U.S. patent application Ser. No. 11/131,770, filed May 17, 2005, which in turn claims the benefit of priority of U.S. Provisional Patent Application Ser. No. 60/571,738 filed May 17, 2004. The disclosure of each of the aforementioned patent applications is incorporated by reference herein in its entirety for any purpose whatsoever.
- The present invention relates generally to a surgical stapling system, and more particularly to a system for joining two tubular structures using surgical staples. Still more particularly, the present invention relates to an apparatus and method for stapling together two tubular structures either through an open surgical procedure or laparoscopically.
- A more complete appreciation of the subject matter of the present invention and the various advantages thereof can be realized by reference to the following detailed description in which reference is made to the accompanying drawings in which:
-
FIG. 1 is a perspective view of a first embodiment of prosthetic graft for use with the surgical stapling system of the present invention; -
FIG. 2 is a perspective view of the prosthetic graft ofFIG. 1 having optional sutures for closing the side port following deployment of the graft; -
FIG. 3 is a perspective view of a second embodiment of a prosthetic graft for use with the surgical stapling system of the present invention; -
FIG. 4 is a perspective view of a loading unit in accordance with the present invention; -
FIG. 5 is a front perspective exploded view of the loading unit shown inFIG. 4 ; -
FIG. 6 is a rear perspective exploded view of the loading unit shown inFIG. 4 ; -
FIG. 7A is a longitudinal view, in partial cross-section of the loading unit in a state for loading a graft thereto; -
FIG. 7B is the same view asFIG. 7A , but showing the loading unit in a state for loading a prosthetic graft therein; -
FIG. 7C is the same view asFIG. 7A , but showing the loading unit with a graft loaded thereon; -
FIG. 8 is an elevational view of the loading unit showing a prosthetic graft loaded thereon; -
FIG. 9 is a perspective view of a placement wand in accordance with a first embodiment of the present invention; -
FIG. 10A is cross-sectional view of the handle of the wand ofFIG. 9 in a locked condition; -
FIG. 10B is the same view asFIG. 10A , but showing the wand handle in an unlocked condition; -
FIG. 11 is a perspective view of a placement wand in accordance with a second embodiment of the present invention; -
FIG. 12A is a cross-sectional view of the handle of the wand ofFIG. 11 in a locked condition; -
FIG. 12B is the same view asFIG. 12A , but showing the wand handle in an unlocked condition; -
FIG. 13 is a perspective view of a tourniquet for use in the present invention; -
FIG. 14A is a cross-sectional perspective view of the distal end of the tourniquet ofFIG. 13 showing the band in an unlocked condition; -
FIG. 14B is the same view asFIG. 14A , but showing the band being inserted into the retaining block; -
FIG. 14C is the same view asFIG. 14A , but showing the band in a locked condition; -
FIG. 15 is a perspective view of a surgical stapling instrument of the present invention; -
FIG. 16 is a front perspective exploded view of the head of the surgical stapling instrument shown inFIG. 15 ; -
FIG. 17 is a longitudinal cross-sectional view of the head of the surgical stapling instrument with the anvils in the open condition; -
FIG. 18 is a longitudinal cross-sectional view of the head of the surgical stapling instrument with the anvils in the closed condition; -
FIG. 19 is an enlarged cross-sectional view showing the male and female anvil locating members; -
FIG. 20A is a longitudinal cross-sectional view of one embodiment of the actuating handle of the surgical stapling instrument in a condition in which the anvils are in the open condition and the stapling mechanism is not actuated; -
FIG. 20B is a longitudinal cross-sectional view of the head of the surgical stapling instrument having a loading unit mounted thereon, with the anvils of the surgical stapling instrument in the open condition; -
FIG. 21A is a longitudinal cross-sectional view of the actuating handle ofFIG. 20A in a condition in which the anvils are in the closed condition and the stapling mechanism is not actuated; -
FIG. 21B is the same view asFIG. 20B , but showing the anvils of the surgical stapling instrument in the closed condition; -
FIG. 22A is a longitudinal cross-sectional view of the actuating handle ofFIG. 20A in a condition in which the anvils are in the closed condition and the stapling mechanism has been actuated; -
FIG. 22B is the same view asFIG. 20B , but showing the loading unit in the position following staple deployment; -
FIG. 23 is a longitudinal cross-sectional view of another embodiment of the actuating handle of the surgical stapling instrument in a condition in which the anvils are in the open condition and the stapling mechanism is not actuated; -
FIG. 24 is a longitudinal cross-sectional view of the actuating handle ofFIG. 23 in a condition in which the anvils are in the closed condition and the stapling mechanism is not actuated; -
FIG. 25 is a longitudinal cross-sectional view of the actuating handle ofFIG. 23 in a condition in which the anvils are in the closed condition and the stapling mechanism has been actuated; -
FIG. 26 is an elevational view of a sizer in accordance with the present invention; -
FIG. 27 is a longitudinal cross-sectional view showing the loading unit and a prosthetic graft assembled to the head of the surgical stapling instrument prior to staple deployment; -
FIG. 28 is the same view asFIG. 26 , but showing partial deployment of the staples; -
FIG. 29 is the same view asFIG. 26 , but showing the staples in a more advanced state of deployment; -
FIG. 30 is the same view asFIG. 26 , but showing the staples fully deployed; -
FIG. 31 is a partial cross-sectional view showing a deployed staple joining a graft to an aorta; -
FIG. 32 is a highly schematic perspective view showing a transected aorta; -
FIG. 33 is a highly schematic perspective view showing the use of a sizer to measure the transected aorta; -
FIG. 34 is a highly schematic perspective view showing the use of a wand to position a loading unit and graft in the transected aorta; -
FIG. 35 is a highly schematic perspective view showing the use of a tourniquet to hold the loading unit and graft in place in the aorta; -
FIG. 36 is an end view showing the positioning of the stapling instrument relative to the tourniquet; -
FIG. 37 is a highly schematic perspective view showing the use of a stapling instrument to staple the graft to the aorta; and -
FIG. 38 is a highly schematic perspective view showing a circumferential line of staples joining the graft to the aorta. - In the detailed description that follows, the features of the present invention will be described in connection with the anastomosis of a prosthetic graft to the aorta, such as may be performed in the repair of an abdominal aortic aneurysm. It will be appreciated, however, that the various features of the present invention may be readily utilized to connect a tubular prosthetic graft to any body lumen. Each of the various components of the surgical stapling system of the present invention is described in separate headings below.
- Referring to
FIG. 1 , there is illustrated one preferred embodiment of aprosthetic graft 10 for use in the present invention.Graft 10 is a hollow generally Y-shaped structure formed by a taperedmain body 12, which branches into twolegs Legs main body 12 to their respective free ends.Opposite legs main body 12 includes acuff 18 having a substantially uniform diameter, the free end of which defines a blood flow inlet on one end ofgraft 10, while the free ends oflegs graft 10. - A generally
cylindrical side port 20 is provided on one side ofmain body 12, generally betweenlegs Side port 20 provides a feature by whichgraft 10 may be inserted into a patient and held in place during a stapling procedure. In that regard,side port 20 preferably projects fromgraft 10 at an acute angle relative tolegs FIG. 4 ) therein. As will be explained below,loading unit 100 supportsgraft 10 and holds it in place relative to the aorta or other tubular body so that the graft may be connected to the body organ by stapling. Optionally, referring toFIG. 2 ,side port 20 may be provided with one ormore sutures 22 adjacent the connection of the side port tomain body 12.Suture 22 may be threaded throughside port 20 so as to provide a purse string tie by which the side port may be quickly and easily closed following deployment ofgraft 10. Wheregraft 10 is not provided with one ormore sutures 22,side port 20 may be closed by stapling or by a conventional suturing procedure. Onceside port 20 has been closed, any excess graft material may be removed by cutting. -
Graft 10 is preferably formed from a biocompatible material having sufficient strength to withstand the surgical implantation procedure described more fully below, as well as the blood flow and other biomechanical forces, which will be exerted on the graft. Such materials may include, for example, polyester materials, such as DACRON©, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester materials coated with polytetrafluoroethylene, polyurethane, expanded polyurethane and silicone. -
Graft 10 may be provided in a range of sizes sufficient to accommodate the arterial morphology, which the surgeon is likely to face in the vast majority of patients. In that regard,graft 10 may be provided with acuff 18 having a diameter of approximately 16 m, 18 mm or 20 mm, althoughgrafts 10 having larger or smaller diameters are also possible. - A second embodiment of a
prosthetic graft 50 for use in the surgical stapling system of the present invention is shown inFIG. 3 .Graft 50 is substantially the same asgraft 10 described above. However, rather thanside port 20,graft 50 includes anelongated flap 52 projecting substantially perpendicularly frommain body 12.Flap 52 may be formed by sewing or otherwise connecting individual portions ofgraft material main body 12. Following deployment ofgraft 50,flap 52 may be closed by stapling or suturing. However, sinceflap 52 projects frommain body 12 by a lesser amount thanside port 20, there may be no need to remove any excess material from the flap after it has been closed. - A
loading unit 100 for use in connection with the present invention is shown inFIGS. 4-8 .Loading unit 100 has a generallycylindrical body 102 extending in an axial direction, with a generallythin cap 104 at a proximal end thereof and atapered cap 106 at a distal end thereof. As used herein, the term “proximal” refers to the end of a component or device, which is closest to the actuating handle or surgeon, and the term “distal” refers to the end of a component or device that is farthest away from the actuating handle or surgeon.Cap 104 may have portions that protrude beyond the diameter ofbody 102 so as to defineflanges 105. The tapered portion ofcap 106 facilitates the assembly of agraft 10 ontoloading unit 100 at one end, whileflanges 105 act as a stop to prevent the graft from being pushed off the loading unit at the other end. A pair offingers 108 projecting fromcap 104 in the axial direction ofbody 102 but at a spaced distance therefrom help keep the graft in its assembled position onloading unit 100 and keep thelegs apertures 107 formed incap 104 are sized and positioned to receive the fingers of apusher 600 to be described below in connection with the stapling instrument. - Referring to the exploded views of
FIGS. 5 and 6 ,loading unit 100 includes a hollow, generallycylindrical cartridge 110.Cartridge 110 is open at its proximal end for slidably receiving anactuator 170, and has anend member 112 at its distal end.End member 112 has acentral aperture 114 and a plurality of radially projectingslots 116 for receivingelongated fingers 176 provided on the distal end ofactuator 170. - At its distal end,
cartridge 110 mates with a secondcylindrical cartridge 120.Cartridge 120 has acentral aperture 122 that aligns withaperture 114 ofcartridge 110, and a plurality of radially extendingslots 124, each of which aligns with acorresponding slot 116 in the distal end ofcartridge 110 for receiving theelongated fingers 176 ofactuator 170. A plurality of projections (not shown) on the proximal surface ofcartridge 120 mate with corresponding recesses (not shown) formed in theend member 112 ofcartridge 110 so as to maintaincartridge 120 in registry withcartridge 110. - A plurality of
staple pushers 130 are arranged betweencartridge 110 andcartridge 120 for radial sliding movement between an inner staple holding position and an outer staple ejecting position. The number ofstaple pushers 130 utilized will depend on the number of staples to be simultaneously deployed during a stapling procedure. The preferred embodiment of the invention described herein includes tenstaple pushers 130 for deploying twenty staples. It will be appreciated, however, that a greater or lesser number of staple pushers may be utilized depending on the number of staples to be deployed and physical constraints dictated by the size and operation ofloading unit 100. - Each
staple pusher 130 has a generally U-shaped profile consisting of first andsecond legs 132 and 134 connected by anintermediate portion 136.Intermediate portion 136 has a first laterally projectingtab 138 that slidably engages in one of a plurality of recessedchannels 140 formed in theend member 112 ofcartridge 110. Recessedchannels 140 coincide with radially projectingslots 116, but are larger in width and length. The opposite side ofintermediate portion 136 has a second laterally projecting tab 142 that slidably engages in one ofradial slots 124 formed incartridge 120. Tab 142 projects fromintermediate portion 136 adjacent theinner end 144 ofstaple pusher 130.Tab 138, on the other hand, projects fromintermediate portion 136 at a spaced distance fromend 144 ofstaple pusher 130. A recessed slanted cam surface 146 is formed inintermediate portion 136 betweentabs 138 and 142, the purpose of which will be described below. - Prior to a stapling operation, with
staple pushers 130 in their inner staple holding positions,loading unit 100 includes a plurality ofsurgical staples 150.Staples 150 are loaded inloading unit 100 so that thecrossmember 152 of each staple rests against the free end of one oflegs 132, 134 ofstaple pushers 130, withstaple legs 154 and 156 projecting radially outward. More particularly, thecrossmember 152 of each staple rests in anelongated recess 148 formed in the free ends of thelegs 132 and 134 of eachstaple pusher 130. Further, thelegs 154 and 156 ofstaples 150 reside within opposed radially extendingguide channels guide channel 158 being formed inend member 112 ofcartridge 100, and guidechannel 160 being formed incartridge 120.Recesses 148 locate the staples and hold them in place with respect to the free ends oflegs 132 and 134, whileguide channels loading unit 100. It will be appreciated from the foregoing that aloading unit 100 having tenstaple pushers 130, and therefore twentylegs 132, 134, will be able to simultaneously deploy twentystaples 150. -
Legs 132, 134 ofstaple pushers 130 each include a pair of lateral ribs 162 positioned in linear alignment withrecess 148. Ribs 162 are aligned substantially collinearly withlegs 154 and 156 ofstaples 150 so that, upon outward radial movement ofstaple pushers 130, the force exerted by the staple pusher is distributed along the entire length ofcrossmember 152, with a portion of the force being exerted in substantial linear alignment with the staple legs. As a result, any resistance to this outward movement as the free ends ofstaple legs 154 and 156 contact and pierce the aorta andgraft 10 and strike the stapling anvils (to be described below) will not result in significant distortion tocrossmember 152. -
Staple pushers 130 are moved from their inner staple holding positions to their outer staple ejecting positions byactuator 170.Actuator 170 has a generally tubularmain body 172 with anannular flange 174 at the proximal end thereof, and a plurality ofelongated fingers 176 at the distal end thereof.Fingers 176 are sized and shaped to be slidably received in theslots 116 ofcartridge 110 and theslots 124 ofcartridge 120. Each offingers 176 includes atapered surface 178, which cooperates with the cam surface 146 of acorresponding staple pusher 130 to move the staple pusher radially outward during a stapling operation, as will be described below. -
Actuator 170 is mounted on atubular shaft 180 for sliding movement in the axial direction ofloading unit 100.Shaft 180 has an enlargedannular flange 182 at its proximal end to preventcap 104 from sliding axially beyond the proximal end of the shaft. A retainingclip 184 is assembled over a pair oftransverse slots 186 formed in themain body 172 ofactuator 170 and cooperates with an annular groove 188 formed inshaft 180 to temporarily prevent actuator 170 from sliding onshaft 180. The spring force of retainingclip 184 is only sufficient to prevent the unintended relative movement ofactuator 170 onshaft 190 during shipping and handling ofloading unit 100. During a stapling operation, however, the force exerted axially onactuator 170 is sufficient to overcome the spring force of retainingclip 184. That is, during a stapling operation, the axial force exerted onactuator 170causes retaining clip 184 to spread open as it is pushed against the side of annular groove 188 until the retaining clip is pushed out of the groove, thereby enablingactuator 170 to slide axially alongshaft 180. A pair ofcutouts 185 are formed on the opposite sides ofshaft 180 near its proximal end, the purpose of which will be discussed below. - Between
cartridge 120 andcap 106,loading unit 100 includes an assembly for gripping the distal edge ofgraft 10 and holding it in place during shipment of the stapling system of the present invention and during a stapling procedure. The assembly includes anexternal graft retainer 190 having a plurality offingers 192 which may be extended radially outward fromloading unit 100 to grip the outer distal edge ofgraft 10, and aninternal graft retainer 220 having a plurality offingers 222 which may be extended radially outward from the loading unit to pierce the inner distal edge ofgraft 10.Retainers elongated screw 200 which extends through an aperture incap 106, the central apertures incartridges actuator 170, and which ultimately connects at its proximal end to the distal end ofshaft 180 to hold all of the components ofloading unit 100 in assembled relationship.Screw 200 may be joined toshaft 180 by any technique, including, for example, threaded engagement. -
External graft retainer 190 includes a generally flat,circular hub 194 having acentral aperture 196 for receiving the shaft ofcrew 200.Fingers 192 may be formed integrally withhub 194 and extend in a direction proximally and radially outward thereof. Eachfinger 192 terminates in a generally L-shapedtip 198 having a surface 198 a extending in a generally radial direction and asurface 198 b extending proximally therefrom in a generally axial direction. Anangled cam surface 202 provided betweentip 198 andhub 194 includes a protruding portion or bump 203 at the end of the cam surface farthest fromtip 198.Retainer 190 is preferably formed from spring steel or a similar material and shaped so thatfingers 192 will be biased toward their rest positions when displaced radially outward therefrom. - A
cam ring 208 is mounted tohub 194 ofretainer 190 by a plurality of screws or other known fastening technique, with aspring member 210 sandwiched therebetween.Cam ring 208 has an elongatedcentral aperture 212 and ashaped surface 214 along its outer periphery. More particularly, the outer periphery ofcam ring 208 includes a smaller diameter annular surface 208 a, a larger diameter annular surface 208 b, and atapered surface 208 c therebetween, the purpose of which surfaces will be described below.Spring member 210 has a generallyflat body portion 216 and a pair oftabs 218 bent in a proximal direction.Tabs 218 reside in anannular channel 201 formed in the shaft ofscrew 200, thereby limiting the amount by whichretainer 190 may move in the axial direction. -
Internal graft retainer 220 includes a generally flatcircular hub 224 having anenlarged opening 226.Opening 226 has enlarged regions that receivebosses 240 projecting from the interior ofcap 106.Bosses 240 are undercut so thatretainer 220 may be rotated relative to cap 106 to lock it in place on the interior of the cap. -
Fingers 222 ofretainer 220 may be formed integrally withhub 224 and extend in a direction proximally and radially outward thereof. Eachfinger 222 terminates in a needle-like tip 228 which projects radially outward. A radially inward projectingcam 230 formed on eachfinger 222intermediate tip 228 andhub 224 has an angled distal cam surface 230 a, a cam surface 230 b which extends generally in the axial direction, and an angled proximal cam surface 230 c.Cam 230 is adapted to cooperate with the shapedperipheral surface 214 ofcam ring 208 as will [sic] described further below.Retainer 220 is preferably formed from the same spring steel or similar material asretainer 190 and shaped so thatfingers 222 will be biased toward their rest positions when displaced radially outward therefrom. - In the assembled condition of
loading unit 100,retainers finger 192 ofretainer 190 lies adjacent afinger 222 ofretainer 220. Each pair offingers radial recesses 242 formed in the distal surface ofcartridge 120 and continuing in the proximal surface ofcap 106. Eachrecess 242 includes afirst surface 242 a extending generally in an axial direction, and acam surface 242 b extending at an angle to surface 242 a. Thesurfaces recess 242 are intended to interact with thecam surface 202 and bump 203 of thefinger 192 residing in that recess, as will be explained further below. - A
guidewire 250 is connected at one end toloading unit 100 and projects outward from the proximal end thereof.Guidewire 250 has anenlarged end 252 formed in a conventional fashion.End 252 is receivable in aslot 254 having an enlarged end 256 formed in the shaft ofscrew 200. The guidewire then extends through an axial bore (not shown) in the shaft ofscrew 200, through the hollow center ofshaft 180 and out the proximal end ofloading unit 100. The engagement of theenlarged end 252 ofguidewire 250 in the enlarged end 256 ofslot 254 locks the guidewire in place and prevents it from being pulled proximally out fromloading unit 100. - A procedure will now be described for mounting a
graft 10 ontoloading unit 100, which procedure is typically performed in a factory prior to shipment of the stapling system of the present invention.FIG. 7A shows a cross-sectional view ofloading unit 100 in an initial state for loading a graft thereto. In this position,fingers 192 onretainer 190 are positioned inrecesses 242 spanningcartridge 120 andcap 106 so thatbumps 203 onfingers 192 lie distally of the cartridge, i.e., they are not located on any cam surface. As a result,fingers 192 are positioned so that thetips 198 thereof lie below the outer surface of the loading unit. Withretainer 190 positioned as described, thecam ring 208 will be positioned axially so that thecams 230 on thefingers 222 ofretainer 220 are proximal of the cam ring, i.e., they are not supported by any of the surfaces of the cam ring. As a result, thetips 228 offingers 222 are positioned below the outer surface of the loading unit. - In this initial condition,
loading unit 100 may be inserted intoside port 20 ofgraft 10 until the distal end ofcartridge 110 protrudes fromcuff 18. Withgraft 10 being held in this position, an actuating tool T may be used to advanceretainer 190 to the loading position shown inFIG. 7B . Actuating tool T has a series of pins P that may be inserted into corresponding apertures 106 a incap 106. As actuating tool T is moved in the axial direction of arrow A shown inFIG. 7B , pins P engage thehub 194 ofretainer 190, forcing the retainer in the proximal direction. Asretainer 190 moves proximally, cam surfaces 202 onfingers 192 engage the edge ofcartridge 120 in therecesses 242, thereby forcingfingers 192 radially outward. Continued movement ofretainer 190 will causebumps 203 onfingers 192 to travel acrosscam surface 242 a and to begin traveling upcam surface 242 b to the position shown inFIG. 7B , at which thetips 198 of the fingers are spaced outwardly from the loading unit. The movement ofretainer 190 proximally also causesspring member 210 to move proximally, whereuponspring tabs 218 will enterchannel 201 formed in the shaft ofscrew 200. It should be noted thatchannel 201 has a width in the axial direction, which is sufficiently large that spring tabs do not contact the proximal wall of the channel beforefingers 192 have moved radially outward by a far enough distance. - The proximal movement of
retainer 190 also causescam ring 208 to proximally, whereupon the proximal edge of the cam ring will ride along the cam surfaces of thecams 230 onfingers 222 until cam surfaces 230 c slide down taperedsurface 208 c on the cam ring and cam surfaces 230 b come to rest on smaller diameter annular surface 208 a. As in the initial starting position, thetips 228 offingers 222 will be positioned below the outer surface ofloading unit 100. - With
fingers graft 10 can be positioned so that the free edge ofcuff 18 rests against surface 198 a and belowsurface 198 b at the tip of eachfinger 192. At this point, actuating tool T may be moved in the direction of arrows B shown inFIG. 7C and removed fromloading unit 100. With the actuating tool T no longer holdingretainer 190 in place, the radially inward biasing force offingers 192, through the interaction ofbumps 203 withcam surfaces 242 b,biases retainer 190 in the distal direction. At the same time, thetapered surface 208 c oncam ring 208 will engage the cam surfaces 230 c onfingers 222 to pushfingers 222 radially outward against the radially inward biasing force of the fingers. The biasing force exerted byfingers 192 preferably is deliberately designed to be greater than the biasing force exerted byfingers 222 so thatretainer 190 moves in the distal direction. Optionally, a spring element (not shown) may be assembled betweencam ring 208 andcartridge 120 to assure thatretainer 190 moves in the distal direction upon removal of actuating tool T fromloading unit 100. The distal movement ofretainer 190 continues untilspring tabs 218 strike the distal wall ofannular channel 201. Alternatively, wheregraft 10 has sufficient strength,retainer 190 may move distally until thesurfaces 198 b at the tip offingers 192 contact the graft, whereupon the graft prevents further inward movement of the fingers and, hence, further distal movement ofretainer 190. - In either event, as
retainer 190 moves distally,cam ring 208 moves distally with it. This movement causes the cam surfaces 230 c onfingers 222 to ride up the taperedsurface 208 c oncam ring 208, with cam surfaces 230 b ultimately coming to rest on larger diameter annular surface 208 b. This action causesfingers 222 to expand radially outward ofloading unit 100 so that thetips 228 thereof piercegraft 10 from the inside. The interaction of thetips 198 offingers 192 and thetips 228 offingers 222 withgraft 10 hold the graft securely onloading unit 100. That is, withtabs 218 ofspring member 210 abutting the distal wall ofannular channel 201,retainer 190 is prevented from moving further in the distal direction. Furthermore, the interaction of thebumps 203 onfingers 192 withcam surfaces 242 b preventsretainer 190 from moving proximally in the axial direction since any such movement would have to overcome the biasing force offingers 192. Withretainer 190 unable to move axially in either direction, thetips 198 offingers 192 and thetips 228 offingers 222 remain in fixed positions and holdgraft 10 securely in place. An elevational view of theloading unit 100 having agraft 10 loaded thereon is shown inFIG. 8 . - In a variant of
loading unit 100 described above, rather than relying upon the relative biasing forces exerted byfingers cam ring 208 andcartridge 120, the pins P of actuating tool T may be provided with a feature which engages a corresponding feature in thehub 194 ofretainer 190 so that actuating tool T may be used to manually pullretainer 190 distally to an appropriate position. - It will be appreciated that
loading unit 100 may be provided in a series of different diameters which correspond to the diameters in whichgraft 10 is provided. Thus,graft 10 andloading unit 100 are typically provided as a unit, withgraft 10 mounted on a loading unit in condition for ready use by the surgeon. -
FIGS. 9-10 illustrate aplacement wand 300 in accordance with one embodiment of the present invention.Wand 300 is a lightweight, maneuverable tool used to insertloading unit 100 and its associated graft into the proper surgical position and to hold them in place as the graft is temporarily secured to the aorta for a subsequent stapling procedure.Wand 300 includes ashaft 302 having a substantially straight elongated portion 304 and adistal end portion 306, which is oriented at an angle relative to elongated portion 304.End portion 306 may form an angle of between about 90° and about 180° with elongated portion 304. In preferred embodiments,end portion 306 forms an angle of between about 105° and about 125° with elongated portion 304, with an angle of about 115° being most preferred. Abore 308 extending through the entire length ofshaft 302 is sized to receiveguidewire 250 asloading unit 100 is assembled towand 300. - An
attachment mechanism 314 is connected to the distal end ofshaft 302.Attachment mechanism 314 has a cylindrical end portion 316 having a counterbore sized for receiving the distal end ofshaft 302. A flat may be formed in the counterbore so as to mate with a corresponding flat formed on the distal end ofshaft 302, thereby defining the proper rotational relationship betweenattachment mechanism 314 andshaft 302.Attachment mechanism 314 may be held in assembled relationship onshaft 302 by a set screw (not shown) or any other known fastening technique. - Projecting distally from end portion 316 of
attachment mechanism 314 is anelongated finger 320.Finger 320 has a pair of flat side surfaces 322, a curved upper surface 326 and a flat lower surface. The shapes of these surfaces coincide with the internal shape ofshaft 180 ofloading unit 100 so that the loading unit is unable to rotate once assembled towand 300. A bore (not shown) extending throughattachment mechanism 314 aligns withbore 308 inshaft 302 when these components are assembled together. - At its proximal end,
wand 300 includes anoperating handle 330 having first andsecond handle portions shaft 302 by capturing a reduceddiameter portion 336 ofshaft 302 between the handle portions when they are assembled together. A pair ofprojections handle portions grooves shaft 302 to locateshaft 302 in the proper rotational orientation relative to handle 330 and to prevent the shaft from sliding out of the handle when in the assembled position.Coiled guidewire tubing 346 is held in the proximal end ofhandle 330 by the assembly ofhandle portions Guidewire tubing 346 receives the excess length ofguidewire 250, which protrudes out from the proximal end ofwand 300 and holds it in a manageable position. Whenwand 300 is removed fromloading unit 100, as explained below,coiled tubing 346 may first be removed fromhandle 330 by pulling to exposeguidewire 250. Alternatively,guidewire tubing 346 may remain connected to handle 330, and guidewire 250 may simply be pulled out from the tubing aswand 300 is removed fromloading unit 100. - Handle 330 includes a
locking mechanism 350 operable between a locked position for engagingguidewire 250 so as to prevent sliding movement betweenwand 300 and the guidewire, and an unlocked position for releasing the wand for movement relative to the guidewire. In the embodiment shown inFIGS. 9-10 ,locking mechanism 350 may operate as a toggle. Thus,locking mechanism 350 may include atrigger lock 352 having afirst operating button 354 and asecond operating button 356 provided on either side of a pivot member (not shown). The ends of the pivot member are held byhandle portions trigger lock 352 is free to pivot between the locked and unlocked positions. Abrake 360 having a pivot member (not shown) at one end thereof is pivotably mounted inhandle 330 belowtrigger lock 352, and afriction member 364 is mounted belowbrake 360.Friction member 364 is preferably formed from a soft, resilient material which, when pressed with sufficient force againstguidewire 250, will preventwand 300 from sliding relative to the guidewire. In that regard,friction member 364 may be formed from a resilient plastic, rubber or like material. Preferably,friction member 364 is formed from silicone rubber, and more preferably, is formed from a length of silicone rubber tubing.Brake 360 cooperates withfriction member 364 to lockwand 300 to guidewire 250 in the locked position of lockingmechanism 350 and to releasewand 300 for movement relative to guidewire 250 in the unlocked position of lockingmechanism 350. - More particularly, in the locked condition of
locking mechanism 350,button 354 is in the depressed position shown inFIG. 10A . In this position, anarcuate locking protrusion 366 formed ontrigger lock 352 below its pivot member rests on a raisedflat region 368 on the upper surface ofbrake 360. As a result,brake 360 is forced downwardly againstfriction member 364, forcing it tightly againstguidewire 250 and preventing relative movement between the guidewire andwand 300. Wherefriction member 364 has a tubular structure, the downward force exerted bybrake 360 causes the tubular structure to collapse, thereby engagingguidewire 250 between the opposed inner walls of the tube. -
Depressing button 356 to movetrigger lock 352 to the unlocked position shown inFIG. 10B causes lockingprotrusion 366 to rotate about its pivot member until it lies over a recessedregion 370 formed in the upper surface ofbrake 360. Withbrake 360 no longer held tightly againstfriction member 364, the resiliency of the friction member pushesbrake 360 upwardly until lockingprotrusion 366 rests within recessedregion 370. As a result,friction member 364 is no longer compressed againstguidewire 250, and the guidewire is released for sliding movement relative towand 300. - A second embodiment of a
placement wand 380 for use with the present invention is shown inFIGS. 11-12 .Wand 380 is substantially the same aswand 300, but has alocking mechanism 382 which uses aslidable trigger lock 384 rather than thetrigger lock 352, which operates in a toggle, fashion.Trigger lock 384 slides between locked and unlocked positions in anelongated cavity 385 formed in first andsecond handle portions 386 and 388 of operatinghandle 390. A lockingprotrusion 392 projects downwardly fromtrigger lock 384 at the proximal end thereof. Abrake 394 having a pivot member (not shown) at one end thereof is pivotally mounted inhandle 390 below lockingprotrusion 392, and a friction member 398 is mounted belowbrake 394. Friction member 398 is preferably formed from the same silicone rubber tubing as described above in connection withfriction member 364 ofwand 300. - In the locked condition of
locking mechanism 382, thetrigger lock 384 is slid to the distal position shown inFIG. 12A . In this position, lockingprotrusion 392 rests in a shallow depression formed in a raisedregion 397 on the upper surface ofbrake 394. As a result,brake 394 is forced downwardly against friction member 398, engagingguidewire 250 and preventing its movement relative towand 380. - Sliding
trigger lock 384 in the proximal direction to the unlocked position shown inFIG. 12B moves lockingprotrusion 392 to a position overlying a recessedregion 399 formed in the upper surface ofbrake 394. The resiliency of friction member 398 thus pushesbrake 394 upwardly until lockingprotrusion 392 rests withinrecess region 399. As a result, friction member 398 is no longer compressed againstguidewire 250 and the guidewire is released for sliding movement relative towand 380. -
FIGS. 13-14 illustrate atourniquet 400 for use in the present invention.Tourniquet 400 is used to temporarily hold thecuff 18 ofgraft 10 in an appropriate position within the exposed aorta so that a stapling operation may be performed. It will be appreciated, however, thattourniquet 400 may be used in any surgical procedure where there is a need to place a clamp around a tubular or cylindrical structure. -
Tourniquet 400 has a generally straighthollow shaft 402 with ahandle 404 provided at a proximal end thereof. Abutton 406 is mounted inhandle 404 for sliding movement in an axial direction along anelongated slot 408. Withinhandle 404,button 406 is connected to the proximal end of anelongated rod 410, which is arranged for sliding movement withinshaft 402. - At its distal end,
shaft 402 is enclosed by anend plug 412 having a throughslot 414. Throughslot 414 is sized to slidably receive an elongatedflexible band 416. At one end,band 416 is fixedly connected to the distal end ofrod 410, such as by ascrew 417 or any other conventional connecting technique. At its other end,band 416 has a roundedtip 418 andopposed notches 420 defining a narrowed neck spaced fromtip 418, the purpose of which will be described below. Band 416 preferably is wider than it is thick so as to define a rectangular cross-section that will hold an annular shape better than the round cross-section of a conventional suture. Band 416 may be formed from any material having sufficient flexibility to conform smoothly aroundloading unit 100,graft 10 and the aorta, and sufficient tensile strength to securely holdgraft 10 and the aorta in overlapping relationship during a stapling operation. In that regard, particularly preferred materials for formingband 416 are nitinol or other shape memory materials, polypropylene, polyethylene, Mylar™ polyester, nylon and other suitable materials. Nitinol or other shape memory materials are particularly preferred since they permitband 416 to be preformed with a curvature that will facilitate the maneuvering ofband 416 around the graft and artery. - A retaining
block 422 is assembled in the distal end ofshaft 402 for sliding movement in the axial direction betweenend plug 412 and one ormore tangs 424 bent inwardly fromshaft 402. Aspring 426 disposed between retainingblock 422 and end plug 412 biases the retaining block in the proximal direction againsttangs 424. - Retaining
block 422 has anaxial bore 428, which is sized and shaped to receive therounded tip 418 ofband 416. Belowbore 428, retainingblock 422 has anaxial slot 430 aligned with the throughslot 414 inend plug 412 and sized and shaped to receive band 415 for sliding movement relative to the retaining block. The upper wall 432 of retainingblock 422 has anaxial slot 434, which extends the length of the retaining block and communicates withaxial bore 428. Akeyhole 436 is formed in the upper wall 432 of retainingblock 422 in a direction transverse to slot 434.Keyhole 436 is sized to receivetip 418 ofband 416 and to permit its insertion intoaxial bore 428. - To operate
tourniquet 400, button 405 is initially pushed in the distal direction to deployband 416 through theslot 414 inend plug 412. When formed from a shape memory material,band 416 will form a curved shape so thattip 418 will approach the distal end ofshaft 402. When not formed from a shape memory material,band 416 may be manually manipulated to placetip 418 near the distal end ofshaft 402. -
Tourniquet 400 may then be operated to capture thetip 418 ofband 416. More particularly,button 406 may be pushed further in the distal direction so that the distal end ofrod 410contacts retaining block 422. Further movement ofbutton 406 in the distal direction will causerod 410 to push retainingblock 422 in the distal direction against the biasing force ofspring 425 until thekeyhole 436 in retainingblock 422 is aligned with anaperture 438 inshaft 402. At this point, tip 418 ofband 416 may be inserted throughaperture 438 andkeyhole 436 until the tip resides within theaxial bore 428 in retainingblock 422 andnotches 420 are aligned with theslot 434 in the upper wall 432 of the retaining block. Asbutton 406 is released, the biasing force ofspring 426 will push retainingblock 422 proximally, whereuponnotches 420 will reside inslot 434,keyhole 436 will no longer be aligned withaperture 438, andtip 418 will be captured within thebore 428 in the retaining block. - To tighten
band 416 aroundloading unit 100,graft 10 and the aorta,button 406 is moved in the proximal direction so as to drawband 416 intoshaft 402. Asbutton 406 is retracted, a plurality of teeth (not shown) provided onbutton 406 may engage with a similar plurality of teeth (not shown) provided onhandle 404. The engagement of the teeth on these respective components may act as a ratchetmechanism enabling button 406 to be retracted, but blocking it from movement relative to handle 404 in the distal direction. Therefore, asband 416 is progressively tightened, it will be locked in place and prevented from loosening at each step in the tightening process. The teeth on the respective components may be biased into engagement with one another by a spring (not shown) interposed between button 405 and handle 404. Thus, by depressingbutton 406 to overcome the biasing force of the spring, the teeth may be separated from one another so thatbutton 406 may be moved distally to releaseband 416. - One embodiment of a
stapling instrument 500, which attaches toloading unit 100 and is operable to actuate a stapling procedure, is illustrated inFIGS. 15-22 .Instrument 500 includes a hollowouter shaft 502 having a substantially straightelongated portion 504 and a smoothly curved distal and portion 506 which terminates at an angle relative toelongated portion 504. End portion 506 may terminate at an angle of between about 90° and about 180° relative toelongated portion 504. Preferably, end portion 506 terminates an angle of between about 105° and about 125° relative toelongated portion 504, with an angle of about 115° being most preferred. Ananvil assembly 510 is provided at the distal end ofshaft 502, while ahandle 512 is provided at the proximal end thereof. Optionally, abushing 508 having aflange 509 at a proximal end thereof may be assembled over a reduced diameter portion at the proximal end ofouter shaft 502 and held in place thereon by a retainingring 507 so as to be rotatable relative to the shaft. Handle 512 may be assembled toshaft 502 by capturingflange 509 betweenhandle portions handle 512 tobushing 508, the handle is able to rotate without binding relative to the remainder ofinstrument 500, and therefore may be maneuvered by the surgeon to an appropriate position to effect a stapling procedure. - Referring specifically to
FIG. 16 ,anvil assembly 510 includes a generallyhollow anvil hub 514 having a cylindrical side wall 516 to whichright anvil 518 a,left anvil 518 b, andcenter anvil 518 c are pivotably mounted. Each anvil includes anelongated arm 520 having a dog-leg configuration with a pair of laterally projecting guide pins 522 at the proximal end thereof and an arcuate-shapedbracket 524 at the distal end thereof. Ananvil insert 526 having a plurality of spaced staple returns 528 may be mounted to eachbracket 524.Instrument 500 has a total of twenty staple returns 528, six each onright anvil 518 a andleft anvil 518 b, and eight oncenter anvil 518 c, which has abracket 524 with a slightly larger arcuate length. Each staple return has depressions for guiding the free ends of a staple 150 into a bent configuration. Alternatively,staple return 528 may be formed directly inbrackets 524. - The
brackets 524 on the ends ofanvils anvil assembly 510, these brackets collectively define a complete circle. Eachbracket 524 includes amale locating member 530 at one end thereof and afemale locating member 532 at the opposite end thereof, the male and female locating members onadjacent brackets 524 engaging with one another in the closed position ofanvil assembly 510 so as to properly locate and align staple returns 528 relative to one another. - In a preferred embodiment hereof shown in
FIG. 19 ,male locating member 530 may have aconical portion 530 a with a rounded tip and a substantially flat ring 530 b formed around its base. Female locatingmember 532 may have a taperedrecess 532 a shaped to mate with the tapered walls ofportion 530 a, and a substantiallyflat ring 532 b formed aroundrecess 532 a. Anextended bore 532 c may be formed at the bottom ofrecess 532 a. Whenanvil assembly 510 is closed,conical portion 530 a fits withinrecess 532 a and surfaces 530 b and 532 b are pressed tightly against one another. The small area ofsurfaces 530 b and 532 b, combined with the high compressive force developed on the closing of the anvils, cause any tissue which may be captured betweensurfaces 530 b and 532 b to be pulverized. Furthermore, any miscellaneous tissue, which may be captured betweenconical portion 530 a andtapered recess 532 a upon the closing ofanvil assembly 510, may be pushed into theextended bore 532 c at the bottom ofrecess 532 a. Hence, this structure ofmale locating member 530 and female locatingmember 532 helps assure thatanvils -
Anvils anvil hub 514 by a series of yokes 534 formed at spaced distances on the outer surface of side wall 516. Each yoke 534 includes a pair ofsupports 536 which project beyond thedistal end 538 ofanvil hub 514, and which are spaced apart so as to receive one ofanvil arms 520 therebetween. Abarrel nut 540 may be inserted through a pair of axially alignedapertures 542 formed insupports 536 and through anaperture 544 provided at the dog leg in ananvil arm 520 and mate with ascrew 541 for holding the anvil in assembled relationship toanvil hub 514. Alternatively,anvils 518 may be held to yokes 534 through any other technique allowing pivoting of the anvil arms, such as through a pivot pin or the threaded engagement of one end of a shoulder bolt with threads formed in one ofapertures 542. Access openings 546 are formed in side wall 516 in the spaces between each pair ofsupports 536 in a yoke 534, the access openings continuing radially inward by a predetermined amount in thedistal end 538 ofanvil hub 514. Access openings 546 enable the proximal ends ofanvil arms 520 to project into the interior ofanvil hub 514 and provide clearance for the movement ofanvils 518 between open and closed positions. Thedistal end 538 ofanvil hub 514 includes acentral aperture 545 having curved top and bottom surfaces and flat side surfaces, and a series of apertures 548 arranged substantially symmetrically aroundcentral aperture 545 for slidably receiving the fingers of apusher 600, the purpose of which will be described below. - A
cam element 550 is slidably assembled in the open proximal end ofanvil hub 514.Cam element 550 has a generally cylindrical structure with a series ofribs 554 projecting radially outward therefrom.Ribs 554 are oriented in the axial direction ofanvil assembly 510 and engage in similarly oriented channels (not shown) formed in the interior ofanvil hub 514. Each channel is positioned so as to be radially inward of a corresponding yoke 534. -
Ribs 554 are formed with a central slot 558 having a width sufficient to receive the proximal end of ananvil arm 520, and an undercut 560 on each side of the slot for receiving the guide pins 522 onanvils 518. The bottom surface of each slot 558, includingundercut portions 560, defines a taperedcam surface 562 so that axial movement ofcam element 550 relative toanvil hub 514 causesanvils 518 to move between the open and closed positions. Anarm 564 projects axially from the proximal end ofcam element 550.Arm 564 has atransverse aperture 566 at its free end for connection to a drive mechanism for effecting axial movement ofcam element 550, as will be explained below. -
Cam element 550 includes acentral bore 568 having flat top and bottom surfaces and curved side surfaces, and a generallycylindrical counterbore 570 extending inwardly from the distal end of the cam element to anend wall 572. A series of throughopenings 574, similar in size and shape to apertures 548 inanvil hub 514, are arranged substantially symmetrically aroundcentral opening 568 for slidably receiving the fingers ofpusher 600. - An
anvil hub shaft 576 is mounted inanvil assembly 510 betweenanvil hub 514 andcam element 550.Shaft 576 has a largeintermediate portion 578 having a substantially cylindrical cross-section, and aproximal end portion 580, which is smaller in cross-section so as to define astep 582 therebetween. Similarly,shaft 576 has adistal end portion 584, which is smaller in cross-section thanintermediate portion 578 so as to define astep 586 therebetween. Theintermediate portion 578 ofshaft 576 has similar recesses 588 formed in its upper and lower surfaces, each of which is sized and shaped to receive acatch member 590.Catch members 590 have a protrudingtransverse rib 591 so that the catch members rest in recesses 588 in a see-saw fashion. Aspring catch 592 in the form of a split ring may be assembled in an annular groove 594 formed by the circumferential alignment of groove portions in theintermediate portion 578 ofshaft 576 and in each ofcatch members 590. The assembly ofspring catch 592 around thecatch members 590 and theintermediate portion 578 ofshaft 576 holds the catch members in assembled relationship toshaft 576 so that the distal ends of the catch members are biased outwardly, while permitting the distal ends of the catch members to pivot inwardly upon the application of a radially inward compressive force thereto. At their distal ends, catchmembers 590 each have a radially projecting prong 596 having a sharply tapered distal surface and a slightly tapered proximal catch surface. Prongs 596secure loading unit 100 toinstrument 500, as will be explained below. - The
distal end portion 584 ofshaft 576 has a shape similar to that of theelongated finger 320 at the end ofwand 300. That is, thedistal end portion 584 ofshaft 576 has flat side and lower surfaces and a curved upper surface for mating engagement withinshaft 180 ofloading unit 100. Anaxial bore 599 is provided along the length ofshaft 576 for receivingguidewire 250, as will be explained below. -
Shaft 576 is assembled inanvil hub 514 so that thedistal end portion 584 ofshaft 576 extends through thecentral aperture 545 in the anvil hub, withstep 586 abutting the inside wall of thedistal end 538 of the anvil hubadjacent aperture 545. The shape of theaperture 545 inanvil hub 514 assures that the anvil hub is assembled in the proper orientation onshaft 576 and is unable to rotate once assembled thereon. In this assembled position, thedistal end portion 584 ofshaft 576 extends outwardly fromanvil hub 514, as do the radially projecting prongs 596 oncatch members 590. -
Cam element 550 is assembled inanvil hub 514 so as to capture theintermediate portion 578 ofshaft 576 therebetween. That is,cam element 550 is assembled over theproximal end portion 580 ofshaft 576 until theend wall 572 ofcounterbore 570 is engaged withstep 582 onshaft 576. The corresponding shapes of theproximal end portion 580 of shaft corresponding shapes of theproximal end portion 580 ofshaft 576 and thecentral bore 568 incam element 550 assures that these elements are assembled in the proper orientation and that the cam element is unable to rotate once assembled on the shaft. - A
pusher 600 having a disk-shapedbase member 602 and a plurality of axially extendingfingers 604 is assembled inanvil assembly 510 so thatfingers 604 extend throughopenings 574 incam element 550 and apertures 548 inanvil hub 514.Fingers 604 are of a sufficient length that whenpusher 600 is displaced fully in the distal direction, the free ends offingers 604 protrude outwardly from thedistal end 538 ofanvil hub 514 and into aloading unit 100 mounted oninstrument 500. As will be explained below,pusher 600 acts onactuator 170 to deploystaples 150 during a stapling operation. Alink 606 having atransverse aperture 608 is connected to the proximal and ofbase member 602 for joiningpusher 600 to a drive mechanism for effecting axial movement of the pusher. -
Anvils 518 may be moved between the open and closed positions by anadjustment knob 610 provided at the handle end ofinstrument 500.Adjustment knob 610 actuates a drive mechanism that transfers rotational movement ofknob 610 into axial movement ofcam element 550, thereby displacinganvils 518. Referring toFIGS. 17-22 , the drive mechanism may include anelongated tube 612 slidably disposed within thehollow shaft 502 ofinstrument 500. At its distal end,tube 612 may be connected to alink coupler 614 using any conventional arrangement. In a preferred arrangement, the distal end oftube 612 fits within a bore formed in the proximal end oflink coupler 614. These elements may be held together by an suitable means, including by sliding a retaining ring (not shown) into aslot 616 formed transversely inlink coupler 614 and engaging it in an annular groove formed adjacent to the distal end oftube 612. -
Link coupler 614 may be joined toarm 564 oncam element 550 by a plurality oflinks 620. A pair of track inserts 622 assembled in the opposite sides of curved distal end portion 506 ofshaft 502 may define first and second pairs of laterally spaced guide tracks 624 and 626.Links 620 may ride in guide tracks 626 so that any axial movement oftube 612 is transferred along the curved portion ofshaft 502 tocam element 550.Links 620 may take any form capable of transmitting the compressive force exerted bytube 612 andlink coupler 614 tocam element 550 asanvil assembly 510 is placed in a closed condition, and capable of transmitting the tensile force fromtube 612 andlink coupler 614 tocam element 550 astube 612 is retracted to placeanvil assembly 510 in an open condition. Thus,links 620 may consist of individual links joined together in a conventional fashion, or may be in the form of a solid band having periodic thinned sections defining a plurality of living hinges. Alternatively,links 620 may not be links at all, but may be a solid band having the requisite compressive and tensile strength, while at the same time having sufficient flexibility to bend smoothly and uniformly along the curved portion ofshaft 502. - At its proximal end,
tube 612 may be connected to acoupling element 628. In a preferred embodiment, the proximal end oftube 612 may be inserted into a bore formed in the distal end ofcoupling element 628, and these elements may be held together in the same manner astube 612 andlink coupler 614, that is, by sliding a retaining ring (not shown) into a slot 630 formed transversely incoupling element 628 and engaging it in an annular groove formed adjacent to the proximal end oftube 612. Alternatively, the distal end oftube 612 may be joined to linkcoupler 614 and the proximal end oftube 612 may be joined tocoupling element 628 by any other known connection techniques. Couplingelement 628 may have a pair of elongated bosses (not shown) extending in the axial direction on either side of the coupling element. Each of the bosses may be slidably held in an elongated slot provided in each ofhandle portions coupling element 628. - At its proximal end,
coupling element 628 may be threadedly engaged with ashaft 642.Shaft 642 has a stepped structure so as to define anintermediate portion 644, which is smaller in diameter than a threadeddistal portion 646 and larger in diameter than aproximal portion 648. Abushing 650 may be assembled overintermediate portion 644 and may be held in place by the step between theintermediate portion 644 anddistal portion 646 ofshaft 642 and a retainingring 652 assembled in an annular groove formed in theintermediate portion 644 proximally of the bushing. The outer circumference ofbushing 650 may be formed with anannular groove 654, which enables the bushing to be captured in a circular opening formed in the proximal end ofhandle 512 when handleportions -
Adjustment knob 610 has an internal elongatedannular boss 656 for receiving theproximal portion 648 ofshaft 642. A pair of diametricallyopposed teeth 658 formed on the free end ofboss 656 may engage recesses 660 formed in theintermediate portion 644 ofshaft 642 so that any rotational movement ofknob 610 results in a corresponding rotation ofshaft 642. Abarrel nut 662 engages a threaded portion 664 formed on theproximal portion 648 ofshaft 642 so as to holdknob 610 in assembled relationship to the shaft.Barrel nut 662 resides in a counterbore 666 formed in the proximal end ofknob 610 so that it does protrude outwardly from the knob. - Optionally, a conventional clutch mechanism (not shown) may be provided between
knob 610 andshaft 642 to prevent the overloading ofanvil assembly 510. Thus, once a threshold to the further closure ofanvils knob 610 to rotate without further movement of the anvils, thereby preventing damage toinstrument 500 or damage to tissue from the closing anvils. - Handle 512 of
instrument 500 is further provided with atrigger mechanism 670 for actuating a stapling operation. Referring toFIGS. 20A , 21A and 22A,trigger mechanism 670 may include atrigger 672 pivotably mounted betweenhandle portions pivot pin 674.Trigger 672 has a generally hollow, molded construction including a pair of spacedside walls 676.Trigger mechanism 670 may further include alinkage assembly 680 including a pair oflinks pivot pin 686. Oneend 688 oflinkage assembly 680 is pivotably held in a fixed position betweenhandle portions pivot pin 690. Theopposite end 692 oflinkage assembly 680 is pivotably joined to acoupling element 694. Aspring 696 connected betweenlinks bias linkage assembly 680 to the rest position shown inFIG. 20A . In this rest position, the distal end oflink 682 is relatively close to the proximal end oflink 684, such that the links form a relatively small angle therebetween. Furthermore, an apex 698 defined at the connection oflink 682 to link 684 is biased against anengagement surface 700 formed between theside walls 676 oftrigger 672. - An
elongated tube 702 slidably disposed withinouter shaft 502 ofinstrument 500 and overtube 612 may be connected at its proximal end tocoupling element 694. More particularly, the proximal end oftube 702 may be inserted in a bore formed in the distal end ofcoupling element 694. This assembly may be maintained in the same manner as the assembly oftube 612 to linkcoupler 614, that is, by sliding a retaining ring (not shown) into aslot 703 formed transversely incoupling element 694 and engaging it in an annular groove formed adjacent to the proximal end oftube 702. At its distal end,tube 702 may be connected to acoupling link 704. In a preferred arrangement, the distal end oftube 702 may be inserted in a bore formed in the proximal end ofcoupling link 704 and may be held in assembled relationship therein in the same fashion as the other tube/coupler connections described above, namely, by sliding a retaining ring (not shown) into aslot 706 formed transversely incoupling link 704 and engaging it in an annular groove formed adjacent to the distal end oftube 702. Alternatively, any other known connection techniques may be used both to join the distal end oftube 702 tocoupling link 704, and to join the proximal end oftube 702 tocoupling element 694.Coupling link 704 preferably is assembled overtube 612 and proximally oflink coupler 614 so as to not interfere with the axial movement thereof, and may be joined to link 606 onpusher 600 by a plurality oflinks 708.Links 708 may ride in laterally spaced guide tracks 624 formed in track inserts 622 so that any axial movement oftube 702 is transferred along the curved portion ofshaft 502 topusher 600.Links 708 may have any of the structures described above in connection withlinks 620. Moreover,links 708 may have the same structure aslinks 620 or a structure different therefrom. - As will be appreciated from the foregoing description,
trigger mechanism 670 may be actuated by pressingtrigger 672 towardhandle 512. This movement oftrigger 672 will causeengagement surface 700 to push against the apex 698 oflinkage assembly 680, thereby causing the angle betweenlinks spring 696. Since theend 688 oflinkage assembly 680 is fixed relative to handle 512, the increased angle betweenlinks other end 692 oflinkage assembly 680 to move axially in the distal direction. This axial movement will be transferred throughcoupling element 694,tube 702,coupling link 704, andlinks 708 topusher 600, resulting in the movement of thefingers 604 of the pusher intoloading unit 100, and the resultant deployment ofstaples 150. Following the deployment ofstaples 150, the biasing force ofspring 696 will causetrigger 672 to return to its rest position as the compressive force is released therefrom. -
Instrument 500 may further include aguidewire tube 709, which is positioned withintube 612. At its distal end,guidewire tube 709 protrudes out fromtube 612 and has a curved portion whose distal end is inserted in a counterbore formed in the proximal end ofanvil hub shaft 576. At its proximal end,guidewire tube 709 extends out fromtube 612, throughcoupling element 628 and intoshaft 642.Guidewire tube 709 provides an uninterrupted channel forguidewire 250 fromloading unit 100 throughinstrument 500. - To prevent the premature accidental deployment of
staples 150,trigger mechanism 670 may be provided with a safety 710. Safety 710 may be in the form of an elongated pin (not shown) having aradially projecting tab 714 formed with anaperture 716. A shaft (not shown) may be inserted throughaperture 716 to mount safety 710 for sliding movement in a transverse direction betweenhandle portions tab 714 and handleportion 511, and a second spring (not shown) mounted on the shaft betweentab 714 and handleportion 513 bias safety 710 to a rest position which is in a substantially central location between the handle portions. In this rest position, one end of the elongated pin projects outwardly through an aperture inhandle portion 511 to define a first button, and the other end of the elongated pin projects outwardly through an aperture inhandle portion 513 to define a second button. With the ends of the elongated pin and the shaft constrained from movement byhandle portions tangs 732, which, in the rest position of the safety, align with and engagenotches 734 formed in theside walls 676, respectively, oftrigger 672. Such engagement preventstrigger 672 from being depressed to actuate a stapling operation. Pressing either the first or the second button towardhandle 512moves tangs 732 out of alignment withside walls 676 oftrigger 672, thereby clearing the path for the trigger to be depressed relative to handle 512 so that a stapling operation can be performed. - A second embodiment of a handle and trigger mechanism for use with a
stapling instrument 800 in accordance with the present invention is shown inFIGS. 23-25 .Stapling instrument 800 is substantially the same as staplinginstrument 500 described above, with the exception of the handle and the trigger mechanism used to actuate a stapling procedure. Thus; referring toFIG. 23 , thetrigger mechanism 802 ofinstrument 800 includes atrigger 804 having an elongated graspingportion 806 spaced fromhandle 808, and adrive portion 810 projecting laterally from one end of the grasping portion so as to define a generally L-shaped configuration.Trigger 804 is mounted betweenportions 812 ofhandle 808 for pivoting movement about apivot pin 816 disposed at the intersection of graspingportion 806 and driveportion 810. -
Instrument 800 includes thesame tube 702,coupling link 704 andlinks 708 asinstrument 500. However, the structure at the proximal end oftube 702 differs from that ininstrument 500. More particularly, the proximal end oftube 702 may be connected to acoupling element 818 in any conventional manner, including that by whichtube 612 is connected tocoupling element 628 at its proximal end. Couplingelement 818 may be assembled ontube 612 for sliding movement in the axial direction of the tube. A biasingspring 820 may be assembled overtube 702 between the distal end ofcoupling element 818 and anannular surface 822 formed transversely inhandle 808. Couplingelement 818 may have a pari of elongated bosses (not shown) extending in the axial direction on either side of the coupling element. Each of these bosses may be slidably held in an elongated slot (not shown) provided in each ofhandle portions 812. The elongated slots have a predetermined length so as to define the extent of axial travel ofcoupling element 818. -
Drive portion 810 oftrigger 804 may be formed with a pair of spacedwalls 828 at the free end thereof. Each ofwalls 828 may include acurved cam surface 830 projecting in a distal direction therefrom. In the assembled position oftrigger mechanism 802,walls 828 reside on either side oftube 612 withcam surfaces 830 contacting the proximal end ofcoupling element 818. In the rest position oftrigger mechanism 802, shown inFIG. 23 , the force exerted byspring 820biases coupling element 818 in the proximal direction, thereby pivoting the graspingportion 806 oftrigger 804 towardhandle 808. The counterclockwise movement of trigger 804 (as shown inFIG. 25 ) will cause thedrive portion 810 of the trigger to exert a force oncoupling element 818 through cam surfaces 830, drivingcoupling element 818 in the distal direction against the biasing force ofspring 820. This axial movement ofcoupling element 818 will be transferred throughtube 702,coupling link 704 andlinks 708 topusher 600, thereby resulting in the deployment ofstaples 150 aspusher fingers 604 are driven intoloading unit 100. Following deployment ofstaples 150,spring 820 will again biascoupling element 818 proximally to returntrigger 804 to its rest position once the compressive force has been released therefrom. -
Instrument 800 may further include asafety 840 to prevent the premature accidental deployment ofstaples 150.Safety 840 may be pivotably connected betweenhandle portions 812 by apivot pin 842 so thatsafety 840 is positioned betweenhandle 808 and the graspingportion 806 oftrigger 804. At its free end,safety 840 has arecess 804 sized to receive the grasping portion of 806 oftrigger 804. Recess 844 may include aresilient member 846 adapted to engage within ashallow recess 848 in graspingportion 806 in the locked condition oftrigger mechanism 802. In a preferred embodiment,resilient member 846 may be in the form of an S-shaped member integrally molded withsafety 840.Resilient member 846 causessafety 840 to fit tightly betweenhandle 808 and graspingportion 806 in the locked condition. Such engagement preventstrigger 804 from being depressed to actuate a stapling operation. Pivotingsafety 840 away from graspingportion 806, however, releases trigger 804 for movement towardhandle 808 to actuate a stapling operation. -
FIG. 26 depicts asizer 900 for use in the present invention.Sizer 900 has several functions, including (1) measuring the diameter of the aorta so that agraft 10 of a proper size may be connected thereto, (2) assuring that there is an adequate amount of transected aorta between the surgical clamp on the aorta and the point of transection for connectinggraft 10 using the surgical stapling system of the present invention, and (3) identifying approximately where the staple line will be located on the aorta relative to the point of transection so that the surgeon can be sure that the staples will penetrate healthy aortic tissue. -
Sizer 900 includes ashaft 902 having a substantially straightelongated portion 904 and adistal end portion 906, which is oriented at an angle relative toelongated portion 904.End portion 906 may form an angle of between about 90° and about 180° withelongated portion 904. In preferred embodiments,end portion 906 forms an angle of between about 105° and about 125° withelongated portion 904, with an angle of about 115° being most preferred. - A
handle 908 is provided at the proximal end ofshaft 902, and a measuringbulb 910 is provided at the distal end of the shaft. Measuringbulb 910 has a cylindricalcentral portion 912 with a generally frusto-conical portion 914 formed on the distal end thereof and another generally frusto-conical portion 916 formed on the proximal end thereofadjacent shaft 902. The frusto-conical shape ofportions sizer 900 through a surgical opening, as well as the insertion ofsizer 900 into a transected aorta. - As shown in
FIG. 26 ,bulb 910 has a diameter D atcentral portion 912, and a length L from the proximal end ofcentral portion 912 to thedistal tip 918 of the bulb. The diameter D is used to select agraft 10 of an appropriate size for attachment to the aorta. Thus, in a typical arrangement, a plurality ofsizers 900 will be available, each with abulb 910 having a different diameter D. Typically,bulbs 910 are provided having nominal diameters of approximately 16 mm, 18 mm, and 20 mm so as to accommodate the different sizes of aortas a surgeon may ordinarily encounter. If thebulb 910 of asizer 900 fits too loosely within the transected end of the aorta, the selected sizer is too small, and a sizer having a larger diameter D should be tried. On the other hand, if thebulb 910 of asizer 900 does not fit into the transected end of the aorta, the selected sizer is too large, and a sizer having a smaller diameter D should be tried. The proper size is indicated when thebulb 910 fits easily within the transected aorta without excess play. - The length L dimension of
bulb 910 is used to determine whether there is an adequate amount of transected aorta available between the surgical clamp on the aorta and the point of transection to perform a stapling procedure. Thus, if thebulb 910 of asizer 900 can be inserted into the transected aorta so that the entirety ofcentral portion 912 lies within the aorta, the length of aorta available will be sufficient to perform a stapling procedure. However, if a length ofcentral portion 912 remains exposed whenbulb 910 has been inserted fully within the transected aorta (i.e., until the surgical clamp prevents further insertion of the bulb), there will not be a sufficient length of aorta available to perform the stapling procedure. In such event, the surgical clamp may be moved farther away from the point of transection to make more of the aorta available. If that is not possible, a conventional graft may be attached to the aorta using a conventional suturing technique. Since the length of the aorta available for a stapling procedure is independent of the diameter of the aorta, the length L is the same for each ofbulbs 910, regardless of their diameters. -
Bulb 910 is provided with acircumferential recess 920 incentral portion 912.Recess 920 is located in the length direction of the bulb so as to indicate the position at which the circumferential line of staples will be deployed. Hence, a surgeon may positionbulb 910 ofsizer 900 adjacent the aorta prior to transecting same to ensure that the staples will be deployed in healthy aortic tissue relative to the point of transection. - The use of the surgical stapling system of the present invention to attach a graft to a transected aorta will now be described with reference to
FIGS. 27-38 . The surgical stapling system may be provided in the form of one or more kits—a first kit consisting of a series ofsizers 900 having different diameters; a second kit consisting of astapling instrument 500 and atourniquet 400; and a third kit consisting of agraft 10, aloading unit 100, and awand 300. Each of the kits may include ancillary tools and materials that may be needed to perform a stapling procedure. In the third kit, thegraft 10 may be preloaded onto theloading unit 100, which, in turn, may be assembled to the distal end of thewand 300. The size of the graft and the loading unit may differ from kit to kit depending upon the size of the aorta to be repaired. The various components may be separated into multiple kits having the components noted above based on different levels of clean room requirements, which must be adhered to during manufacture, and packaging. Each of the components may be designed to be disposable after their use to perform a single surgical procedure. - As a first step of the procedure, the surgeon may position a
sizer 900 adjacent an aorta A to be repaired so as to determine, based on the anticipated point of transection, whether there will be healthy aortic tissue at the projected circumferential stapling line indicated by thecircumferential recess 920 in the sizer. The surgeon may then clamp the aorta and form a transection as shown inFIG. 32 . As shown inFIG. 33 ,sizer 900 of an appropriate diameter is then inserted into the transected aorta to determine the approximate diameter of the aorta as well as whether a sufficient length of transected aorta is available between the transection and the clamp to perform a stapling procedure. - Once the approximate size of the aorta has been determined, and assuming the availability of a sufficient length of transected aorta, the surgeon uses
wand 300 to insert aloading unit 100 and its associatedgraft 10 of the proper diameter into the transected aorta. Referring toFIG. 34 ,graft 10 is inserted until thecuff 18 of the graft is positioned entirely within the aorta. At this point,tourniquet 400 is used to deployband 416 around the aorta and theunderlying graft 10 andloading unit 100.Tourniquet 400 may be positioned so that theshaft 402 thereof is oriented at either the two o'clock or ten o'clock position, as can be seen inFIG. 36 , so that the tourniquet does not interfere with either the assembly ofinstrument 500 toloading unit 100 or the closing of theanvils 518 of the instrument. As shown inFIG. 35 ,tourniquet 400 is used to deployband 416 so that the band is positioned around the aorta in a region adjacent the point of transection. Tighteningband 416 around the aorta holds the aorta andgraft 10 in fixed overlapping relationship aroundloading unit 100. - Once
band 416 has been placed around the aorta and tightened,wand 300 may be disconnected fromloading unit 100. This may be accomplished by first pullingguidewire tubing 346 from the proximal end ofhandle 330 and off ofguidewire 250, and then depressingbutton 356 onhandle 330 to placelocking mechanism 350 in the unlocked condition. As a result,wand 300 may be pulled proximally alongguidewire 250, whereuponfinger 320 will be drawn out fromshaft 180 of theloading unit 100.Wand 300 may then be removed entirely fromguidewire 250. Alternatively,wand 300 may be removed fromguidewire 250 withguidewire tubing 356 attached thereto. - As the next step, the surgeon may assemble
instrument 500 toloading unit 100 as shown inFIG. 37 . Withanvils 518 in the opened condition (by appropriate rotation of knob 610),guidewire 250 may be inserted into theaxial bore 599 inshaft 576, throughguidewire tube 709 and out the proximal end ofinstrument 500.Instrument 500 may then be slid alongguidewire 250 until the distal end ofshaft 576 is inserted intoshaft 180 ofloading unit 100. Asinstrument 500 is advanced, the prongs 596 projecting radially outward fromshaft 576 will encounter thecutouts 185 formed on the opposite sides ofshaft 180. As they are received incutouts 185, prongs 596 will be biased radially outward and snap into place, thereby creating an audible click to assure thatinstrument 500 is fully assembled toloading unit 100. As a further assurance of complete assembly, guidewire 250 may be formed with a colored band or other marker, which will be visible outside ofhandle 512 wheninstrument 500 has been assembled fully toloading unit 100. -
Anvil assembly 510 may then be placed in the closed condition shown inFIG. 18 by rotatingadjustment knob 610. Asadjustment knob 610 is rotated,shaft 642 is rotated in the same direction through the engagement ofteeth 658 on the knob with recesses 660 on the shaft. The rotation ofshaft 642 causescoupling element 628 to move distally as a result of its threaded engagement withshaft 642. The distal movement ofcoupling element 628 pushestube 612 distally, and with it linkcoupler 614 and links 620. As a result of this distal movement,cam element 550 is also moved in the distal direction. The relative movement ofcam element 550 intoanvil bracket 514 causes the guide pins 522 onanvils 518 to move outwardly alongtapered cam surface 562, resulting in the inward movement ofbrackets 524 at the distal ends of the anvils.Knob 610 is rotated untilanvil assembly 510 is in the fully closed condition withbrackets 524 defining a complete circle. - With
anvil assembly 510 fully closed,trigger mechanism 670 may be actuated to deploystaples 150. As a first step, one of buttons 726 and 730 is depressed to release safety 710 fromtrigger 672.Trigger 672 may then be squeezed towardhandle 512, whereuponengagement surface 700 withintrigger 672 pushes against the apex 698 oflinkage assembly 680. This movement causes theend 692 oflinkage assembly 680 to move axially in the distal direction, thereby movingcoupling element 694,tube 702,coupling link 704 andlinks 708 distally. The distal movement oflinks 708 drives thefingers 604 ofpusher 600 out through apertures 548 ofanvil hub 514, throughapertures 105 in thecap 104 ofloading unit 100, and against theannular flange 174 at the proximal end ofactuator 170. - The continued distal movement of
pusher 600 drives actuator 170 distally, overcoming the spring force exerted by retainingclip 184 to holdactuator 170 in a fixed axial position relative toshaft 180. The distal movement ofactuator 170 causes the taperedsurface 178 on each of thefingers 176 of the actuator to engage the cam surface 146 of acorresponding staple pusher 130. As a result of the interaction of taperedsurfaces 178 withstaple pushers 130, the staple pushers are driven radially outward, pushingstaples 150 ahead of them.Staples 150 move radially outward until the free ends of thelegs 154 and 156 of the staples contact the staple returns 528 onanvils 518. Staple returns 528 causestaple legs 154 and 156 to turn inwardly and back toward thecrossmember 152 of the staple so as to form a “B” configuration, shown inFIG. 31 , when the stapling operation has been completed.Staples 150 are deployed so that oneleg 156 of each staple piercesgraft 10 and aorta A is then turned back through the aorta. Theother leg 158 of each staple pierces aorta A directly and is then turned back through the aorta, forming a loop around the free edge ofgraft 10 to hold it tightly to the aorta. The tips of the staple legs may or may not piercegraft 10 from the opposite side. - As the
fingers 176 ofactuator 170 progress distally, the tips of the fingers will engage the proximal surface ofcam ring 208, driving the cam ring andretainer 190 connected thereto towardcap 106, as shown inFIG. 29 . This movement will push thetips 198 of thefingers 192 ofretainer 190 off of thecuff 18 ofgraft 10. At the same time,cam ring 208 will be moved distally relative to thecams 230 on thefingers 222 ofretainer 220 until cam surface 230 a is riding on the outer periphery of the cam ring. Continued distal movement ofcam ring 208 will causefingers 222 to move inwardly ofloading unit 100 as a result of the inward biasing force exerted by the fingers, thereby releasing thetips 228 of the fingers fromgraft 10. Hence, the actuation of trigger mechanism 270 to deploystaples 150 simultaneously releasesretainers cuff 18 of the graft. - Following the deployment of
staples 150,trigger 672 may be released, whereupon the biasing force ofspring 698 will cause the trigger to return to its rest position. At the same time, theapex 698 oflinkage assembly 680 will move away fromhandle 512, with theend 692 of the linkage assembly moving in the proximal direction. This proximal movement will causecoupling element 694,tube 702,coupling link 704, andlinks 708 to also move proximally, resulting in the withdrawal of thefingers 604 ofpusher 600 fromloading unit 100.Anvil assembly 510 may then be placed in the open condition by rotatingknob 610 in the opposite direction, andinstrument 500, withloading unit 100 connected thereto, may be removed fromgraft 10, leaving the graft attached to the aorta by a circumferential line of staples 999, as can be seen inFIG. 38 . Subsequently, thelegs graft 10 may be sutured in a conventional fashion to the patient's iliac arteries. The procedure is completed by closingside port 20 ofgraft 10 through the use ofsuture 22 to form a purse string tie, through a conventional suturing operation, or by a surgical stapling technique, and, where appropriate, by removing any excess portion ofside port 20 from the graft. - The various components of the present invention may be used in a conventional open body surgical procedure. The instruments may also be used to perform a stapling operation laparascopically by providing the instruments with appropriate seals to prevent the escape of air used to expand the body cavity during a laparoscopic procedure.
- In addition to the several embodiments described above, the various components of the stapling system of the present invention may be varied in many ways. For example, it will be appreciated that, where appropriate, any of the features described in connection with a particular embodiment hereof may be incorporated in any other embodiment described herein.
- Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.
Claims (6)
1. A method of joining a graft and a tubular structure using surgical staples, said method comprising:
positioning a loading unit including a circumferential line of staples and a graft removably joined with said loading unit in a body within said transected length of said tubular structure adjacent an overlapping end of said tubular structure, said loading unit including a guidewire joined with an end of said loading unit and extending from an opposite end of said loading unit, said guidewire being configured to extend out of said graft and said body;
using said guidewire, moving a stapling instrument from a first position to a second position, said stapling instrument having a plurality of anvils and a trigger mechanism for firing said staples in said loading unit when said stapling instrument is connected to said loading unit in said second position, wherein said stapling instrument is not connected to said loading unit while in said first position, said stapling instrument is exterior to said body and said loading unit is located inside said body when in said first position, and said stapling instrument is connected to said loading unit and inside said body in said second position; and
actuating said trigger mechanism thereby firing said staples radially outwardly from said loading unit and through said graft and said tubular structure, thereby causing said staples to strike said anvils and bend inwardly.
2. A method according to claim 1 , further comprising:
determining diameters of said tubular structure and a transected length of said tubular structure.
3. A method according to claim 1 , further comprising:
holding said graft and said overlapping end in relative overlapping positions.
4. A method according to claim 1 , further comprising:
withdrawing said stapling unit and said loading unit through an opening in said graft and from said body; and
closing any said opening is said graft.
5. A method according to claim 1 , further comprising:
extending retractable fingers in said loading unit to temporarily join said graft with said loading unit; and
retracting said retractable fingers in said loading unit.
6. A method according to claim 1 , wherein said stapling instrument includes means for preventing accidental actuation of said trigger mechanism and firing of said staples in said loading unit.
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US13/539,667 US20130087596A1 (en) | 2004-05-17 | 2012-07-02 | Surgical Stapling System |
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US13/539,667 US20130087596A1 (en) | 2004-05-17 | 2012-07-02 | Surgical Stapling System |
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US12/555,417 Abandoned US20100224668A1 (en) | 2004-05-17 | 2009-09-08 | Surgical Stapling System |
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Also Published As
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US20100224668A1 (en) | 2010-09-09 |
US20060000869A1 (en) | 2006-01-05 |
WO2005115254A2 (en) | 2005-12-08 |
US7585307B2 (en) | 2009-09-08 |
EP1746940A2 (en) | 2007-01-31 |
WO2005115254A3 (en) | 2007-06-28 |
US20050283191A1 (en) | 2005-12-22 |
CA2566794A1 (en) | 2005-12-08 |
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