WO2004028376A1 - Pince chirurgicale glissante - Google Patents

Pince chirurgicale glissante Download PDF

Info

Publication number
WO2004028376A1
WO2004028376A1 PCT/IL2003/000770 IL0300770W WO2004028376A1 WO 2004028376 A1 WO2004028376 A1 WO 2004028376A1 IL 0300770 W IL0300770 W IL 0300770W WO 2004028376 A1 WO2004028376 A1 WO 2004028376A1
Authority
WO
WIPO (PCT)
Prior art keywords
leg
sliding
clip according
rail
tip
Prior art date
Application number
PCT/IL2003/000770
Other languages
English (en)
Inventor
Amir Loshakove
Ido Kilemnik
Original Assignee
By-Pass, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from PCT/IL2002/000790 external-priority patent/WO2003026475A2/fr
Application filed by By-Pass, Inc. filed Critical By-Pass, Inc.
Priority to US10/529,125 priority Critical patent/US20060155309A1/en
Priority to AU2003264852A priority patent/AU2003264852A1/en
Publication of WO2004028376A1 publication Critical patent/WO2004028376A1/fr
Priority to US10/951,433 priority patent/US20050096674A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0643—Surgical staples, i.e. penetrating the tissue with separate closing member, e.g. for interlocking with staple
    • 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
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
    • 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
    • A61B2017/1135—End-to-side connections, e.g. T- or Y-connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter

Definitions

  • the present invention relates to surgical clips. BACKGROUND OF THE INVENTION
  • An aspect of some embodiments of the invention relates to a two part surgical clip comprising two legs.
  • a first leg slides along the other leg, which acts as a rail for guiding the first leg, when the clip changes from an open configuration to a closed configuration.
  • the sliding first leg is adapted to slide over the other leg and is locked in place by a locking mechanism.
  • the locking mechanism is a one-way lock which only prevent reverse sliding but not further sliding.
  • the sliding leg comprise a bent leg with an eye the encircles the other leg.
  • the two legs end in at least one sharp point, each said sharp points being adapted to pierce a blood vessel wall.
  • the other leg is contiguous with or coupled to a tearing mechanism which tears the other leg near the lock, after the two legs are locked.
  • an anastomosis clip delivery system in which a plurality of clips are arranged to surround a graft.
  • the delivery system is adapted to retract the plurality of rail legs.
  • the retracting and/or the tearing may be simultaneous for all rail legs.
  • the retracting and/or the tearing may be serial for some or all of the rail legs.
  • the tearing assists in locking the legs.
  • the tearing causes elongation of the torn section.
  • the elongated section is not exactly in the middle of a contiguous section of material (e.g., steel) or the tearing forces are not applied along the middle line, so the elongation is asymmetrical with respect to the middle and causes a bending of the torn end towards the middle line of the section.
  • locking is helped by bending towards the center of the leg.
  • the bending is away from a center of the leg.
  • the rail leg includes one or more thickenings or widenings and one or more corresponding slots, so that when the eye of the sliding leg slides over a thickening, the thickening is pushed into the slot so that its overall width fits within the eye.
  • Suitable design of the thickening for example for the thickening to be gradual in the sliding direction and abrupt in the other direction, allows such a thickening to function as a lock.
  • a plurality of such thickenings are used to provide multiple locking positions.
  • the sliding leg slides within the rail leg, rather than outside of it.
  • the sliding leg is adapted to not penetrate the blood vessel, for example by its being flat and not having a piercing point at its end.
  • one or both of the legs may be forked and/or may include a tissue stop to control a penetration depth thereof.
  • the sliding leg is not a planar element that lies on a surface of a blood vessel.
  • the sliding leg may be bent.
  • the sliding leg is formed of a planar material and then bent out of plane.
  • a base section of the sliding leg lies parallel to a main plane of the rail leg.
  • the base section is perpendicular to the main plane.
  • the base section is curved.
  • An aspect of some embodiments of the invention relates to a set of clips for an anastomotic connection, in which individual clips includes eyes for a suture which interconnects the clips.
  • the eye is provided on a section of a clip which is positioned so that it may fall into the blood stream. Such a suture is optionally removed after the anastomosis connection is completed.
  • a sliding surgical clip adapted to connect blood vessel tissue, comprising: an elongate rail leg having a main axis and terminating with a first tissue penetrating tip; and a sliding leg terminating with a second tip and configured to slide along said rail leg towards said first tissue penetrating tip, such that said two tips face each other and engage vascular tissue between them.
  • said second tip comprises a tissue penetrating tip.
  • the clip comprises a tissue stop on said sliding leg, which stop prevents over penetration of said leg into vascular tissue.
  • said second tip is forked.
  • said second tip has a section between 0.5 mm and 5 mm long adapted to enter a blood vessel.
  • said second tip has a section between 1 mm and 4 mm long adapted to enter a blood vessel.
  • said second tip has a section between 0.5 mm and 3 mm long adapted to enter a blood vessel.
  • said first tip has a section between 0.5 mm and 4 mm long adapted to enter a blood vessel. In an exemplary embodiment of the invention, said first tip is forked.
  • said first leg and said second leg are narrower than 1 mm, in a widest dimension thereof, for at least 3 mm adjacent their tips.
  • said first leg and said second leg are narrower than 0.7 mm, in a widest dimension thereof, for at least 2 mm adjacent their tips. In an exemplary embodiment of the invention, said first leg and said second leg are narrower than 1 mm, in a widest dimension thereof, for at least 20 mm adjacent their tips.
  • said clip is adapted for use with a blood vessel having a diameter of between 2mm and 40 mm.
  • said clip is provided as a set of connectors arranged in a generally circular array and adapted for use for attaching a blood vessel having a diameter of between 1 mm and 10 mm to a second blood vessel.
  • said set is sutured together at their rail sections.
  • said second tip is adapted to penetrate vascular tissue without tearing the tissue.
  • said elongate rail leg comprises a lock which prevents reverse sliding of said sliding leg.
  • said elongate rail leg comprises multiple lock locations which prevents reverse sliding of said sliding leg.
  • said lock comprises a transaxial extension of said elongate rail which is configured to elastically move out of the way when said sliding leg slides towards said first tip.
  • said rail includes a slot adjacent said extension, to support said elastic motion.
  • said transaxial extension is robust enough to withstand a force of at least lKg on said extension.
  • said elongate rail leg comprises a lock which prevents forward sliding of said sliding leg after being locked.
  • the clip comprises a tissue stop on said rail leg to prevent over-penetration of said leg into vascular tissue.
  • said rail leg defines a weakened location adapted to be selectively torn when sufficient force is applied to opposite sides of said weakened location.
  • said rail leg defines a temporary locking location distanced from said tip, configured to hold said sliding leg prior to said sliding.
  • said sliding leg engages said rail leg from its outside.
  • said rail leg defines a slot along its length and wherein said sliding leg engages said rail leg from said slot.
  • said rail leg shares an elongate section with an adjacent rail leg, on an opposite side of a tearing location from said tip.
  • said sliding leg includes a base section coupled to said rail leg.
  • said base section defines an aperture, which aperture fits around said rail leg.
  • said fit is snug.
  • said base section lies in a plane, which plane lies parallel to said main axis.
  • said base section lies in a plane, which plane is substantially perpendicular to said main axis.
  • said base section is curved and lies on either side of said main axis.
  • said base section contacts said rail section at least three points, an axially middle one of said points being on an opposite side of said main axis than the other two of said points.
  • said rail leg defines an aperture adapted to receive a suture.
  • a method of deploying a clip comprising: engaging vascular tissue using a hooked section of a rail leg; sliding a hooked sliding leg along said rail leg until it engages said tissue; locking said sliding leg to said rail leg; and tearing a section of said rail leg off adjacent a locked location of said sliding leg.
  • Fig. 1 is a plan view of a rail leg of a sliding clip in accordance with an exemplary embodiment of the invention
  • Fig. 2 is a plan view of a sliding leg of a sliding clip in accordance with an exemplary embodiment of the invention
  • Fig. 3 is a perspective view of the rail leg of Fig. 1, bent in accordance with an exemplary embodiment of the invention
  • Fig. 4 is a perspective view of the sliding leg of Fig. 1, bent in accordance with an exemplary embodiment of the invention
  • Fig. 5 is a perspective view of an assembled sliding clip, in accordance with an exemplary embodiment of the invention.
  • Fig. 6 is a perspective view of a locked sliding clip, in accordance with an exemplary embodiment of the invention.
  • Fig. 7 is a perspective view of a locked sliding clip having a sliding leg mounted in parallel to a rail leg, in accordance with an exemplary embodiment of the invention
  • Fig. 8 is a perspective view of a locked sliding clip having a sliding leg mounted using a curved mount onto to a rail leg, in accordance with an exemplary embodiment of the invention
  • Fig. 9 is a perspective back view of a locked sliding clip similar to that of Fig. 8, in which a sliding leg has a forked spike, in accordance with an exemplary embodiment of the invention
  • Fig. 10 is a perspective view of a sliding clip in which a sliding leg slides along a rail leg, and not coupled thereto, in accordance with an exemplary embodiment of the invention
  • Fig. 11 is a perspective view of a sliding clip in which a sliding leg slides in a slot formed in a rail leg, in accordance with an exemplary embodiment of the invention
  • Fig. 12A is a perspective view of an alternative sliding clip in which a sliding leg slides in a slot formed in a rail leg, in accordance with an exemplary embodiment of the invention
  • Fig. 12B is a plan view of a sliding leg section of the clip of Fig. 12 A
  • Fig. 13 is a side view of a delivery system with only one clip shown, in accordance with an exemplary embodiment of the invention
  • Fig. 14 shows a leg tearing mechanism, in accordance with an exemplary embodiment of the invention.
  • Figs. 1-6 show a sliding clip in plan view, in parts and assembled, in accordance with an exemplary embodiment of the invention.
  • a clip 100 comprising a rail leg 102 and a sliding leg 104, which slides along rail leg 102.
  • clip 100 is open and in Fig. 6, clip 100 has been slid shut, so that it is locked in position.
  • Fig. 1 shows a plan view of rail leg 102.
  • rail leg 102 comprises a forward section or tip 106, which is optionally bent into a hook as shown in Figs. 5 and 6, a body section 108, whose length optionally corresponds to an anastomosis thickness, a locking position area 110 for sliding leg 104, a shaft 112, an unlock position area
  • Tip 106 is optionally formed to have a single sharp tip 118, adapted to penetrate blood vessel tissue.
  • other tip designs can be used, for example, a tip with a tissue stop to prevent over penetration.
  • more than one tip 106 are provided, or a forking is provided in tip 106 near its base, such that each such tip is substantially free to penetrate tissue.
  • tip 118 is adapted to not penetrate tissue, for example to lie flat against an inside wall of a blood vessel.
  • tip 106 is bent so that sharp tip 118 is curved back and distanced a short distance from the rest of tip 106 and leg 102, for example to prevent tearing by piercing too close to an aperture lip.
  • sliding leg 104 may also include a tip.
  • the tips are configured to meet inside the tissue.
  • the tips are configured to slide past one another.
  • the tips are configured to not reach one another.
  • a tissue stop 121 is provided on rail leg 102, to prevent over penetration in tissue and/or later migration or rotation of the locked clip.
  • tissue stop 121 is used to position an end of a graft vessel which is transfixed by tip 118.
  • Body 108 is shown as being a solid section 120.
  • section 120 is elongatabale in an elastic manner, which allows the clip to conform to various tissue thicknesses (e.g., by elongation) and/or to prevent over tightening of the tissue connection.
  • section 120 may be cut in the form of a folded ribbon or a cell structure.
  • An aperture 124 is optionally provided through body 120. This aperture may be used, for example, to allow suturing by hand over an existing clip.
  • the aperture is used for attaching multiple clips using a suture, which prevents them from drifting too far apart and/or for safety, to prevent a clip from falling into a blood stream.
  • the suture is removed after the anastomosis is complete and/or is bio- absorbable.
  • a permanent suture is used.
  • the suture is elastic, to allow for some relative movement.
  • tissue stop (not shown), further from tip 118 than stop 121, is provided in body 120 to position a graft vessel wall in a desired position.
  • Locking position area 110 is where sliding leg 104 rests when locked.
  • a plurality of axially displaced such positions are provided.
  • a sliding stop 122 is optionally provided to prevent further sliding of leg 104. Alternatively the presence of tissue between the sharp tips prevents such sliding.
  • One or more optional locking tabs 128 resist reverse sliding of leg 104 after it reaches area 110.
  • the distance between stop 122 and tab 128 may be designed to match a thickness of sliding leg 104, so that sliding leg 104 is locked in a fixed position. Alternatively, some amount of freedom of motion is provided by increasing the distance.
  • the length of area 110 takes into account the presence of a wall of a graft vessel between stop 122 and sliding leg 104, when deployed.
  • a slot 126 is provided between tabs 128, so that when sliding leg 104 is first advanced over rail leg 102, it pushes the tabs inwards towards the slot and thus fits by. Reverse motion is prevented, for example, either by lack of sufficient force or by a shape of tabs 128 which is inclined towards end 116 and flat towards tip 106.
  • slot 126 is widened adjacent tabs 128 so that a thinner area 127 is provided in area 110. In an exemplary embodiment of the invention, this thinner area is torn when end 116 of leg 102 is pulled away from stop 122.
  • one or more tear-assisting slots or weakenings 129 are provided after tabs 128.
  • weakened areas 127 are configured to assist in locking using tabs 128. For example, during tearing, weakened sections 127 elongate, along with material connected to them and forming an inner side of tabs 128. The outer sides of tabs 128 do not elongate, or at least do not elongate as much, causing tabs 128 to bend outwards.
  • Shaft 112 is optionally uniform, to prevent inadvertent locking of leg 104 on leg 102 and/or distortion thereof.
  • an intermediate semi-locked position for sliding leg 104 is provided near area 110, to allow the clip to be in a semi locked position, during an anastomosis process.
  • shaft 112 narrows towards area 110.
  • sliding leg 104 Prior to closing of clip 100, sliding leg 104 optionally rests at unlock position area 114. In an exemplary embodiment of the invention, inadvertent motion of sliding leg 104 is prevented by providing one or more tabs 130 with a corresponding slot 132. Tab 130, as shown, is designed to allow both forward and reverse motion of sliding leg 104 over rail leg 102.
  • rail leg 102 is retracted by a retraction mechanism.
  • rail leg 102 is engaged at a notch 134 defined therein.
  • an aperture may be used for such engaging.
  • Fig. 2 is a plan view of a sliding leg 104 in accordance with an exemplary embodiment of the invention.
  • An eye section 140 includes an aperture 146 adapted to pass shaft 112 therethrough, so that the plane of 140 is perpendicular to the plane of shaft 112.
  • the fit of the shaft in the aperture has a close tolerance.
  • a body section 142 of sliding leg 104 comprises a tip 144 which is optionally bent to penetrate a blood vessel wall, as shown in Fig. 6. While not shown, a tissue stop is optionally provided on body 142 to set the maximum penetration depth of tip 144. Optionally , tip 144 is forked, or more than one tip or body sections may be provided, to control penetration.
  • Body 142 can have other shapes, for example, be a spiral or include a spring section which compresses in a plane of body 142.
  • sliding leg 104 is bent as shown in Fig. 4, to lie substantially parallel to shaft 112 and be distanced at a desired distance, various angles, for example, between 90 degrees and 20 degrees may be provided.
  • Exemplary offsets are between 0.5 and 3 mm.
  • different ones of the clips in a set used for a single connection may have different angles and/or offsets.
  • eye section 140 is substantially perpendicular to shaft 112.
  • an angle may be desired, for example, an angle of between 80 and 20 degrees or an angle between 100 and 150 degrees. This can be provided, for example, by providing an aperture having an axis that is not perpendicular to the surface of the eye section.
  • Leg 104 is shown to be adapted to penetrate a target blood vessel.
  • this adaptation is provided by forming or polishing (e.g., by electro-polish) tip 144 (and/or tip 118), so that it merely penetrates vascular tissue and does not tear it or cut it.
  • leg 104 is flat, for example as shown in PCT publication WO 03/026475, the disclosure of which is incorporated herein by reference.
  • a bent body 142 is provided, but tip 144 is flattened so that it does not significantly penetrate tissue.
  • body 142 is made elastic enough to assist in conforming to variations in thickness of a blood vessel wall.
  • sliding leg 104 includes a tab that locks to an aperture in rail leg 102, for example, aperture 124.
  • tabs are described as extending to the sides.
  • such tabs comprise thickenings of the material, for example, if leg 102 is cut from a tube or a flat sheet.
  • Fig. 7 is a perspective view of a locked sliding clip 700 having a sliding leg 704 mounted in parallel to a rail leg 702, in accordance with an exemplary embodiment of the invention.
  • Sliding leg 704 has a base 741, enclosing an aperture 747.
  • base 741 lies on a same side of rail leg 702, as a pair of spikes 742 and 743, forming a fork.
  • Within aperture 747 a ring 740 is provided, with an aperture 746. Ring 140 and aperture 746 engage rail 702 as described above with reference to elements 140 and 146 in clip 100.
  • sliding leg 704 engages rail leg 702 in a stable manner, at least with respect to rotation in a plane including rail leg 702 and spikes 742 and 743.
  • This stability is provided by having two resting points on one side of leg 702 and one on the other side, between the other two.
  • the clips shown are very small, so that an aperture such as aperture 146 provides only a limited amount of resistance to rotation, especially if a relatively loose fit is provided.
  • rotational stability in a plane along the direction of sliding is provided by having two spaced apart rings 740.
  • ring 740 and 741 may be elastically pre-disposed towards each other, so aperture 746 need be exact only in a dimension where it locks to leg 702 (e.g., a width dimension relative to locking tabs 728, described below).
  • sliding leg 704 is mounted on a far side (not shown) of a body 712 of rail leg 704, which far side may have a same design as for clip 100.
  • a slot 726 lies between two tabs 728, so that ring 740 can slide over tabs 728, by compressing the tabs towards slot 726.
  • a forward tab (not shown) is provided to prevent over advance.
  • no such prevention is provided.
  • slot 726 is defined along body 712 and body 712 has a width greater than the opening of aperture 740. Ring 740 slides over body 712 only by compressing body 712 inwards towards slot 726.
  • sliding ring 740 is shown, in an alternative embodiment of the invention, an inner tab, is provided instead, which tab slides along slot 726, for example as described below for other embodiments. Tearing may be provided using slots as for clip 100, above, for example.
  • Clip 700 also shows a variation on the clip structure in that sliding leg 704 includes a forked tip having two extensions, 742 and 743, which may, for example, fit on either side of a tip 718 of leg 702. Alternatively or additionally, leg 702 has two or a higher number of tips.
  • Fig. 8 is a perspective view of a locked sliding clip 800 having a sliding leg 802 mounted using a curved mount 840 onto to a rail leg 804, in accordance with an exemplary embodiment of the invention.
  • the reference numbers generally correspond to those of fig. 7.
  • clip 800 has a three point locking mechanism A sliding leg section
  • a base ring 840 which is bent so that a front and a back end thereof are on one side of a rail leg 802 and a middle is on the other side.
  • a back bar 841 is provided to prevent ring 840 from slipping off.
  • a single slot 826 is provided.
  • a bar 829 separates the slot into to separate slots, for example, to prevent blood leakage along the slot or to control the elasticity of the slot.
  • bar 829 serves as a stop against which tearing forces may be applied.
  • Fig. 9 is a perspective back view of a similar clip 900 having a forked sliding leg, in which a back bar 941 is clearly visible.
  • a potential advantage of this design is that there are fewer sharp edges and/or bends, as compared to that of clip 700.
  • Fig. 10 is a perspective view of a sliding clip 1000 in which a sliding leg 1004 slides along a rail leg 1002, and not coupled thereto, in accordance with an exemplary embodiment of the invention.
  • sliding leg 1004 (or its corresponding legs in other embodiments) does not move relative to a base holding the leg. Instead leg 1002 is retracted.
  • sliding leg 1004 in such a delivery system, sliding leg 1004 is held in place by a fork having a tine on either side of the leg.
  • An exemplary tine 1005 is shown, and includes an optional step 1007 to prevent leg 1004 from moving away.
  • leg 1004 includes two apertures 1046 and 1047 in a base section 1040 thereof.
  • a pair of elastic tabs 1050 and 1052 are formed in rail leg 1002.
  • base 1040 slides over tabs 1050 and 1052, they elastically compress inwards.
  • tabs 1050 and 1052 spring back.
  • the presence of tissue in the clip generally pushes leg 1004 back, where it is locked by tabs 1050 and 1052.
  • one or both tabs is formed on sliding leg 1004 rather than on rail leg 1002.
  • only one tab or more than two tabs are used.
  • each tab can serve to define a locking station for the clip, for example, allowing multiple locking positions to be achieved by selectively advancing leg 1004 more along leg 1002.
  • Fig. 11 is a perspective view of a sliding clip 1100 in which a sliding leg 1104 slides in a slot 1126 formed in a rail leg 1102, in accordance with an exemplary embodiment of the invention.
  • a tab section 1141 of sliding leg 1104 fits in slot 1126, with a base section 1140 on an opposite side of leg 1102 than a pair of forked penetrating tips 1142 and 1143.
  • the sliding leg both engages the rail leg from outside and from a slot in the rail leg.
  • rail legs 1102 are mounted on extensions 1112. Unlike previous embodiments, where the extensions were each shown for a single rail leg, in Fig. 11, each extension 1112 bridges two rail legs 1102.
  • the coupling between extensions 1112 and legs 1102 optionally forms a weakening 1127, which is torn.
  • weakening 1127 is designed so that an inner side 1131 tears first and then an outer side 1129 tears.
  • inner side 1131 is urged into slot 1126, by outer side 1129 having been stretched more, and locks tab 1141.
  • a cut-out section 1133 may serve to control the tearing order.
  • Fig. 12A is a perspective view of an alternative sliding clip 1200 in which a sliding leg 1204 slides in a slot 1226 formed in a rail leg 1204, in accordance with an exemplary embodiment of the invention.
  • Fig. 12B is a plan view of sliding leg 1204, showing a tip 1242 thereof, which is curved in Fig. 12A.
  • sliding leg 1204 fits into slot 1126 in a perpendicular manner, with a tab 1241 fitting in slot 1126 and a stop 1245 and a second stop 1243 fitting on either side of rail leg 1204.
  • stops 1245 and 1243 are elastically urged towards the other stop, to better engage rail leg 1202 and/or stabilize sliding leg 1204.
  • one or more inner tabs 1228 are formed in slot 1226 to lock tab 1241 and thus leg 1204 in place.
  • a weakening 1227 is shown.
  • tearing of weakening 1227 is provided by pulling back on the rail legs relative to the sliding legs.
  • a similar mechanism may be used in the other embodiments as well. This may impose high strains on the sliding leg.
  • the sliding leg is backed by a ring (not shown) which prevents the sliding leg from distorting.
  • an extension of such a ring is provided in slot 1226, to hold the sliding leg in place and prevent its distortion.
  • the structure of the rail leg is optionally made strong enough to resist distortion except for weakenings 1227. For example, in Fig. 1, stop 122 is made robust.
  • the tearing force may be 0.5, 1, 5, 10 or 25 Kg, or intermediate or greater values.
  • a force of 25 Kg is used to tear 10 legs, so the force on a single leg is 2.5 Kg.
  • 6, 8 or 12 legs are torn.
  • the tearing force per leg can be, for example, between 0.5 and 3 Kg, depending on the leg design.
  • a staggered delivery system which tears fewer than all the legs at one time, thus reducing the total force required, for example, reducing the force which is applied by a human, a spring, a lever or an engine to less than 3Kg.
  • clips 100 themselves are designed to tear in a serial manner, rather than all together. For example, by varying the distance between tip 118 (or stop 121) and stop 122, or by varying the thickness of leg 104, even if all the legs are pulled back together, the force will be applied first to those legs whose stop 122 is closer to pulling section 116.
  • the clips are arranged so that opposing clips will tear together.
  • the clips are arranged to tear in a circle.
  • the clips are arranged to tear in accordance with an oblique connection or to tear at ends of an incision first or last.
  • lengths of shafts 112 are varied.
  • a ring holding areas 116 is modified so that it engages each area at a different point.
  • a ring pressing down on legs 104 is varied to have a different relative displacement for different clips.
  • Fig. 13 is a side view of a delivery system 1300 with only one clip shown, in accordance with an exemplary embodiment of the invention.
  • Delivery system 1300 has a front aperture 1306 through which a plurality of clips can extend. For clarity, only a single clip is shown and only a section of a graft 1302 is shown everted on a rail leg 102.
  • a sliding leg 104 is shown distanced from rail leg 102. In use, rail leg 102 is retracted, engaging a target vessel 1304. Then, sliding leg 104 is advanced, to enter the wall of vessel 1304 and then lock to rail 102. Then leg 102 is torn. In a simplest system, this is all achieved by retracting leg 102, effectively sliding leg 104 on it.
  • many of the systems described in earlier application by the instant applicant and by other applicants can be used.
  • Fig. 14 shows the inside of an exemplary delivery system 1400 for a clip 100.
  • Two sliding legs 104 are shown in temporary locking areas defined by tabs 130 and slot 132.
  • a back ring 1442 is provided to hold legs 104 in place and to serve as a backing while applying a the tearing force thereto.
  • An over tube 1440 is optionally provided to help maintain a proper orientation of the legs, for example while penetrating tissue.
  • legs 102 fit between an inner tube 1436 and a slot 1444 formed in ring 1442. In the embodiment shown, legs 102 are held by a slotted plate 1450.
  • a plurality of slots 1434 are shaped to each engage a notch 134 of a holding area 116.
  • a covering tube prevents holding areas 116 from falling out of the slots.
  • Plate 1450 is retracted by a mechanism ending in couplers 1452.
  • ring 1442 may be advanced past tube 1436.
  • one or more tabs 1438 engages and holds onto tube 1436 so that it moves with plate 1450.
  • Plate 1450 optionally comprises two plates, one on either side of the delivery system, to support splitting.
  • a clip may be manufactured of various materials, including for example, metals (e.g., stainless steel, NiTi alloys and titanium), plastics and bio-absorbable materials.
  • the clip is formed of a material that exhibits elastic, super elastic and/or shape memory properties.
  • the rail legs and/or the sliding legs may be interconnected before or after the anastomosis, for example, using a flexible element, such as a suture, or a rigid element, such as a metal bar.
  • the tips of the sliding leg and the rail leg are sharpened to minimize trauma to the blood vessels, during attaching, and especially to reduce tearing and/or dissection.
  • the tips may be formed to be needle like, so that they have no edges that can tear nearby tissue, except when inserted, tip first.
  • aorta is thicker, while a coronary vessel is thinner, thus suggesting different amounts of space in the clip.
  • an aorta may be 3 mm thick, while a coronary vessel may be less than 1 mm thick.
  • connector should be construed broadly to include various types of connectors, including one part, two part and multiple part connectors, some of which when deployed, result in a plurality of individual clip-like sections.
  • eversion where used means not only complete eversion of 180 degrees, but also partial eversion or flaring, for example of 90 degrees. Also, in some embodiments, mounting without eversion is provided.
  • Measurements are provided to serve only as exemplary measurements for particular cases. The exact measurements stated in the text may vary depending on the application, the type of vessel (e.g., artery, vein, xenograft, synthetic graft), size of connector, shape of hole
  • vessels involved e.g., 1mm, 2mm, 3mm, 5mm, aorta sized.
  • one or more of the devices are packaged and/or sold with an instruction leaflet, describing the device dimensions and/or situations for which the device should be applied.
  • surgical kits comprising sets of medical devices suitable for making anastomotic connections.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne une pince chirurgicale glissante conçue pour connecter des tissus de vaisseaux sanguins, comprenant: une jambe d'appui oblongue d'axe principal, se terminant par un premier embout de pénétration de tissu, et une jambe glissante se terminant par un second embout et conçue afin de glisser le long de la jambe d'appui vers le premier embout de pénétration de tissu, de façon que les deux embouts soient en face l'un de l'autre et engagent entre eux du tissu vasculaire.
PCT/IL2003/000770 2002-09-25 2003-09-25 Pince chirurgicale glissante WO2004028376A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US10/529,125 US20060155309A1 (en) 2002-09-25 2003-09-25 Sliding surgical clip
AU2003264852A AU2003264852A1 (en) 2002-09-25 2003-09-25 Sliding surgical clip
US10/951,433 US20050096674A1 (en) 2003-08-07 2004-09-27 Bypass punch anastomosis delivery system

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/IL2002/000790 WO2003026475A2 (fr) 2001-09-25 2002-09-25 Systeme de distribution anastomotique
ILPCT/IL02/00790 2002-09-25

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US10/951,433 Continuation-In-Part US20050096674A1 (en) 2003-08-07 2004-09-27 Bypass punch anastomosis delivery system

Publications (1)

Publication Number Publication Date
WO2004028376A1 true WO2004028376A1 (fr) 2004-04-08

Family

ID=32040226

Family Applications (4)

Application Number Title Priority Date Filing Date
PCT/IL2003/000770 WO2004028376A1 (fr) 2002-09-25 2003-09-25 Pince chirurgicale glissante
PCT/IL2003/000769 WO2004028377A1 (fr) 2002-09-25 2003-09-25 Agencement de jambe anastomotique
PCT/IL2003/000774 WO2004028378A1 (fr) 2002-09-25 2003-09-25 Raccords anastomotiques
PCT/IL2003/000771 WO2004028380A1 (fr) 2002-09-25 2003-09-25 Dispositif de coupe pour vaisseau sanguin

Family Applications After (3)

Application Number Title Priority Date Filing Date
PCT/IL2003/000769 WO2004028377A1 (fr) 2002-09-25 2003-09-25 Agencement de jambe anastomotique
PCT/IL2003/000774 WO2004028378A1 (fr) 2002-09-25 2003-09-25 Raccords anastomotiques
PCT/IL2003/000771 WO2004028380A1 (fr) 2002-09-25 2003-09-25 Dispositif de coupe pour vaisseau sanguin

Country Status (2)

Country Link
AU (2) AU2003272045A1 (fr)
WO (4) WO2004028376A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110477985B (zh) * 2019-08-29 2024-08-27 北京华脉泰科医疗器械股份有限公司 血管吻合用免缝合扣环

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WO2001070090A2 (fr) 2000-03-20 2001-09-27 By-Pass, Inc. Mise en place d'une greffe et d'un connecteur
WO2002030172A2 (fr) 2000-09-28 2002-04-18 By-Pass, Inc. Systeme de connexion par anastomose
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WO2003026475A2 (fr) 2001-09-25 2003-04-03 By-Pass, Inc. Systeme de distribution anastomotique

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WO1995026170A1 (fr) * 1994-03-28 1995-10-05 Boris Petrovich Kruchinin Fixateur de microchirurgie
US6022351A (en) * 1999-02-23 2000-02-08 Bremer; Paul W. Skull closure device and procedure
US20020058955A1 (en) * 1999-12-14 2002-05-16 Blatter Duane D. Paired expandable anastomosis devices
WO2001070119A1 (fr) 2000-03-20 2001-09-27 By-Pass, Inc. Connecteur anastomotique et elargisseur de greffon pour le montage dudit greffon
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WO2002047561A1 (fr) 2000-03-20 2002-06-20 By-Pass, Inc. Procede et appareil permettant de former des ouvertures dans des vaisseaux sanguins
WO2002030172A2 (fr) 2000-09-28 2002-04-18 By-Pass, Inc. Systeme de connexion par anastomose
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WO2003026475A2 (fr) 2001-09-25 2003-04-03 By-Pass, Inc. Systeme de distribution anastomotique

Also Published As

Publication number Publication date
AU2003272045A1 (en) 2004-04-19
WO2004028378A1 (fr) 2004-04-08
WO2004028380A1 (fr) 2004-04-08
WO2004028377A1 (fr) 2004-04-08
AU2003264852A1 (en) 2004-04-19

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