WO2001041624A2 - Vessel lip attachment - Google Patents
Vessel lip attachment Download PDFInfo
- Publication number
- WO2001041624A2 WO2001041624A2 PCT/IL2000/000611 IL0000611W WO0141624A2 WO 2001041624 A2 WO2001041624 A2 WO 2001041624A2 IL 0000611 W IL0000611 W IL 0000611W WO 0141624 A2 WO0141624 A2 WO 0141624A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- clip
- lips
- puller
- seal
- lip
- Prior art date
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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
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- 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
-
- 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
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
- A61B17/3496—Protecting sleeves or inner probes; Retractable tips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
- A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
- A61B2017/00252—Making holes in the wall of the heart, e.g. laser Myocardial revascularization for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00637—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00646—Type of implements
- A61B2017/00668—Type of implements the implement being a tack or a staple
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
-
- 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
Definitions
- the present invention relates to the manipulation of vessel hole lips, especially for effecting anastomosis connections.
- An aspect of some embodiments of the invention relates to eversion of the lips of a hole in a blood vessel, for example so that they are engaged by an anastomotic connector or a hole closure device.
- a puller is used to retract the lips into the connector.
- the puller is removable, for example being part of a device deliver ⁇ ' system.
- the puller may remain in the connection.
- no puller is used, for example, a change in the device geometry causing the lips to be retracted.
- the retraction is into the delivery system, after which the anastomotic device is applied.
- the delivery system guides the retraction.
- the pullers may be used in various types of vascular devices, whereby the pullers bring the lips of the blood vessel into a desired location relative to another lip or a device, and optionally hold the lip in place, or move it, during an operation of the device. Where a plurality of pullers are provided, the pullers may, for example, act simultaneously or in sequence.
- the anastomotic device may have, for example, one part, two parts or may comprise a plurality of independent (or attached by a thread) clamping elements.
- the retracted lips may be pressed against each other to prevent blood leakage. Alternatively, they may be pressed against a part of the device.
- An aspect of some embodiments of the invention relates to a method of attaching two blood vessel using multiple clips.
- the lips of the two blood vessels are everted and the clips are closed onto the everted part, so that the clips remain outside the blood vessels and there is an intima-to-intima connection between the blood vessels.
- the lips are everted using hooks that transfix the lips. Alternatively, the hooks do not transfix the lips.
- a vascular attachment device for sealing an opening between two blood conduit lips, comprising: at least one clip element adapted for sealing at least a portion of an opening between two blood conduit lips; and at least one puller adapted for pulling, inside the body, at least one of said lips into said clip element.
- said puller is attached to said device.
- said puller is not attached to said device.
- said puller is adapted to remain in a body after use.
- said puller is adapted to be removed from a body after use.
- said puller is bio-absorbable.
- said puller is adapted to penetrate said lip.
- said puller is adapted to transfix said lip.
- said puller is adapted to not penetrate said lip.
- said puller is adapted to be distorted by said clip.
- said distortion assists in a removal of said puller from said seal
- said at least one puller comprises a single puller adapted to pull both of said lips.
- said at least one puller comprises two pullers, each adapted to pull one of said lips.
- said puller is attached to a thread, for retracting said puller.
- said puller is distorted by said retracting, while pulling said lip into said clip.
- said at least one clip comprises a plurality of clips cooperating to seal said opening.
- said plurality of clips are not connected to each other.
- said plurality of clips are interconnected.
- said plurality of clips are rigidly interconnected.
- said plurality of clips are flexibly interconnected.
- said clip does not distort to effect said seal.
- said clip distorts to effect said seal.
- said clip comprises two arms the bend towards each other to effect said seal.
- said clip distorts plastically.
- said device comprises a delivery system comprising a contra element and a pressure element, which two elements compress said clip between them.
- said clip self-distorts.
- said device comprises a deliver ⁇ ' system comprising a restraining element adapted to selectively release said clip, to self distort.
- said clip comprises barbs, for engaging said lips.
- said clip comprises protrusions, for engaging said lips.
- said clip comprises a slot, for engaging said lips.
- said clip is adapted to seal said lips against each other.
- said clip is adapted to seal said lips against a part of said clip.
- said clip compresses said lips, to effect said seal.
- said lips are lips of a same conduit.
- said lips are lips of two different conduits.
- At least one of said conduits is an in- vivo blood vessel.
- at least one of said conduits is a synthetic graft.
- a method of sealing an opening between two blood conduit lips comprising: providing a clip; first retracting a first lip into said clip; and second retracting a second lip into said clip.
- the method comprises closing said clip to seal said opening.
- closing comprises releasing said clip to self-deform.
- closing comprises plastically deforming said clip.
- said first and second retracting are performed simultaneously.
- said first and second retracting are performed using a single puller.
- said puller has a single lip engaging element.
- said puller has at least two lip engaging elements.
- said first and second retracting are performed using at least two pullers.
- the method comprises retracting said puller from said seal. Alternatively, the method comprises leaving said puller in said seal.
- the method comprises providing a pharmaceutical at said seal.
- said pharmaceutical comprises a clot prevention pharmaceutical.
- said pharmaceutical comprises a clot enhancing pharmaceutical.
- providing comprises providing a layer of material comprising said pharmaceutical.
- said layer is provided between said lips
- said two lips are lips of an opening in a single conduit.
- said two lips are lips of different conduits.
- at least one of the conduits comprises a blood vessel.
- FIGs. 1A-1D illustrate a blood vessel attachment method and apparatus, in accordance with an exemplary embodiment of the invention
- Fig. IE is a top view of a clip suitable for the method illustrated in Figs. 1A-1D;
- Figs. 2A-2B illustrate a blood vessel attachment method, in accordance with an alternative exemplary embodiment of the invention;
- Fig. 2C illustrates an alternative blood vessel attachment device, in accordance with an alternative exemplary embodiment of the invention
- Fig. 2D illustrates an alternative clip, in accordance with an exemplar ⁇ ' embodiment of the invention
- Figs. 3A-3D illustrate a hole-closure device based on a clip-puller combination, in accordance with an exemplary embodiment of the invention
- Fig. 4 illustrates a multi-clip connector, in accordance with an exemplary embodiment of the invention
- Figs. 5A-5F illustrate a method of deploying the clip of Fig. 4, in accordance with an exemplary embodiment of the invention
- Figs. 6A-6C illustrate an alternative method of deploying multiple clips in an anastomotic connection, in accordance with an exemplary embodiment of the invention.
- Figs. 7A-7C illustrate the deployment of other clip-devices for the attachment of two blood vessels, in accordance with exemplary embodiments of the invention.
- FIGs. 1A-1D illustrate a blood vessel attachment method, in accordance with an exemplary embodiment of the invention.
- an end-vessel 100 and a side vessel 102 are attached together using a clip 104.
- Clip 104 comprises a first arm 106 having a vessel engaging means, for example a barb 108, for engaging vessel 100, and a second arm 110, having a vessel engaging means such as a barb 112 for engaging vessel 102.
- the blood vessels and/or grafts may be part of the natural vasculature, synthetic, autologus, xenologus, cadaver grafts and/or any other type of blood conduit.
- Fig. 1 A the two vessels are engaged by the barbs, such that a lip 114 of vessel 100 is engaged by barb 108 and a lip 116 of vessel 102 is engaged by barb 112.
- the two lips may abut or there may be a space between them.
- clip 104 is folded so the intima portions of the two lips are pressed against each other by the two arms of the clip.
- the barbs prevent an inadvertent release of the vessel lips during the conformance change and/or provide stability after the connection is completed.
- the conformance change of the clip may be effect in various ways, for example elastically, super-elastically or using a shape memory clip, in which cases no external forces may be required.
- clip 104 is plastically deformed.
- Figs. IC and ID illustrate the use of a puller for retracting the vessel lips onto the barbs.
- Fig. IC shows a puller 120 including a curved tip 122 for pulling lip 114 of vessel 100 onto barb 108.
- Fig. ID shows a puller 124 including a curved tip 126 for pulling lip 116 of vessel 102 onto barb 112.
- other methods of mounting may be used, for example manual mounting.
- exemplary device for carrying out the method of Figs. 1C-1D is described below.
- tip 126 (and 122) is sharp.
- tip 126 may be blunt, for example to prevent penetration of the tip into the blood vessel wall engaged by the tip.
- Tip 126 may also be forked, for example, to prevent over penetration of the tip into the blood vessel wall.
- Fig. IE is a top view of a clip suitable for the method illustrated in Figs. 1A-1D.
- clip 104 comprises an elliptical ring, one side of which is arm 106 and the other side of which is arm 110. The barbs are formed at the apexes of the ellipse.
- Two cross-bars 130 are provided to allow the clip itself to be used as a pivot for pullers 120 and 124.
- clip 140 is bar shaped. As will be described below, a complete anastomosis may require several such clips, or a multi-clip connector.
- Figs. 2A-2B illustrate a blood vessel attachment method, in accordance with an alternative exemplary embodiment of the invention.
- a clip 204 which may be the same as clip 104 of Fig. 1, is mounted on vessel 100 and 102.
- a single puller 220 including two barbs 222 and 226, one for each vessel is shown instead of two separate pullers. This puller is optionally used for mounting the vessels on clip 104 of Fig. 1.
- a contra element 232 comprising two spaced apart portions is placed behind clip 104, opposite from barbs 222 and 226. When puller 220 is retracted towards contra element 232, clip 204 is pulled between the contra element portions and bend, thus clamping the two blood vessel lips between the arms. The resulting completed connection is shown in Fig. 2B.
- Contra element 232 optionally includes an extension 236 on one or both portion, to prevent over retraction of clip 204.
- contra elements 232 are brought closer together, to further seal the anastomosis by bending clip 204. Contra elements 232 may be removed after the procedure is completed such that only clip 204 stays in the body.
- Puller 220 may be cut at point 234, thus keeping barbs 222 and 226 inside the anastomosis connection.
- the barbs are bio-absorbable.
- the barb includes a tissue bonding enhancing material.
- the barbs are pulled out of the vessels, possibly tearing the lips of the vessel, at portions outside of the connection area.
- the barbs are shorter than the thickness of the vessel wall, so the tear is not complete.
- barbs 222 and 226 soften at body temperature or in a liquid or electrolytic environment, allowing them to be pulled out.
- barbs 222 and 226 are bent back by bars 130 (Fig. IE) allowing them to be more easily retracted.
- barbs 222 and 226 are not sharp and do not penetrate the vessel wall, but merely pull it back and then can slide past the wall, possibly deforming, and out of the connector.
- puller 220 may be connected to the rest of the clip, for example, using a thread or wire.
- Fig. 2C illustrates an alternative blood vessel attachment device 240, in accordance with an alternative exemplary embodiment of the invention.
- Device 240 comprises a clip 242 and a puller 244, generally similar to clip 104 and clip 204.
- clip 242 is pre-bent.
- puller 244 is required to pull the tissue lips into a narrow space 246 formed between the two arms of clip 242.
- Barbs 248 can prevent retraction of the lips, once pulled into space 246.
- space 246 includes a wall (not shown) that divides the space into two spaces, one for each lip.
- a gauze, pad or bioabsorbable material may be provided as a layer between the two lips and/or between the lisp and the device.
- the layer elutes heparin or other blood coagulation promoters or antagonists, for example, to prevent clots or to promote clotting of leakage blood.
- Other pharmaceuticals may be provided as well. The pharmaceutical may be soaked in the layer, or, for example, it may be trapped in a matrix, so that it is slowly released over time.
- Fig. 2D illustrates an alternative clip 252, in accordance with an exemplary embodiment of the invention.
- the above described clips, for example that of Fig. IE have opposing arms. However, this is not required.
- Clip 252 has one arm 253 on one side of a base 256 and two arms 254 on an opposite side.
- a matching asymmetric puller 250 is also shown, that has two puller barbs 260 opposing a single puller barb 260, on a thread 262.
- Arms 253 and 254 may include barbs, as described above.
- the vascular tissue is pinched between the two arms 254, possibly being forced into the space between arms 254 by arm 253.
- the arms extend at an angle, so the space between the arms is more wedge shaped. Possibly, the distance between the arms is shorter than the combined width of the two target blood vessels.
- arms 254 can be elastically distorted, to accommodate a greater width of tissue.
- FIGs. 3A-3D illustrate a hole-closure device 300 based on a clip-puller combination, in accordance with an exemplary embodiment of the invention.
- Figs. 1 and 2 are described with reference to attaching two lips from different blood vessels, similar principles may be applied to vascular hole closure, in which the two lips that are sealed together are from a same blood vessel.
- Fig. 3A shows a hole closure device 300, in a layout view.
- device 300 is folded, such that it has a base 302 and two arms 304, each arm having one or more barbs 306 at its ends.
- Fig. 3C shows a device 300 being deployed.
- device 300 is held against a vessel 312, adjacent a hole 310 therein, by a contra-tube
- Hole 310 has lips 318 and 320, that can be pulled into device 300, by a puller 314. Possibly, puller 314 is pulled using a thread or wire 316, which optionally extends through tube 320.
- Fig. 3D shows hole 310 after puller 314 pulls lips 318 and 320 into device 300.
- Puller 314 (which may remain in the connection) is not shown, for example being retracted (possibly through the hole in base 302, optionally after being bent back by contact with base 302 itself) or being absorbed, as described above.
- Device 300 may be sized to fit various hole sizes and blood vessel thickness. Alternatively or additionally, a flat device, for example as shown in Fig. 3A is bent, on the spot, to match desired hole closure characteristics. Although device 300 is shown with two barbs 306 on each arm, a greater or smaller number of barbs may be provided, possibly not opposing barbs, or even protrusions (not sharp) instead of barbs.
- the length of the device may depend, for example on the size of hole 310.
- a plurality of devices 300 are applied size by side.
- the clips of Figs. 1-2 may be provided as individual clips, for example, one by one or using a multi-clip delivery system, for example for simultaneous delivery.
- several clips are required for connecting two blood vessels together, for example, 3, 4, 5, 6 or more clips.
- the clips may be connected together, for example using a thread or a ring, to form a single anastomosis connector (or hole closure device).
- previously described connectors and hole closure devices may be segmented to provide clips, for example each clip comprising two opposing spikes and an optional ring section.
- a torsion bar mechanism may be provided for rotation of the arms.
- FIG. 4 illustrates a multi-clip connector 400, in accordance with an exemplary embodiment of the invention.
- Connector 400 comprises a ring 402 having a plurality of "side” engaging clips arms 404 and an opposing plurality of "end” engaging clip arms 406. As shown, opposing clips arms do not need to have a same radial position, however, that is possible. Alternatively or additionally, the number of "side" and "end” clip arms may be different.
- the connector may be used for two "side” vessel or for two "end” vessels.
- the clip arms are not designed to penetrate the vessel walls, however, in some embodiments, at least some of the clip arms may penetrate the vessel walls, such arms may include a fork design or a protrusion distal from their tip, to prevent over penetration and/or motion of the vessel wall along the arm.
- the clip arms on opposing sides may have the same or a different general design.
- the clip arms on a same side of ring 402 may also be the same (as shown) or different, for example alternating clip arms having different designs.
- Figs. 5 A-5F illustrate a method of deploying the clip of Fig. 4, in accordance with an exemplary embodiment of the invention. In these figures, not all the repeating elements are shown, to reduce visual clutter.
- System 500 may be deployed, for example in open surgery, in endoscopic or throactoscopic surgery and/or in a transvascular approach.
- Fig. 5A illustrates a delivery system 500 having mounted therein a graft 502 and a connector 400.
- the view is a cross-sectional view selected so that the operation of one "side” arm 404 and one "end” arm 406 are clearly visible.
- System 500 includes an outer contra tube 506 and an inner pusher tube 504. Connector 400 is held, for example elastically or by friction, by outer contra tube 506.
- An outer base tube 508 is provided for closing the "side” arms, as will be described below.
- a plurality of "side” vessel pullers 512 are provided through apertures 514 formed in outer tube 506.
- a plurality of "end” vessel pullers 510 are provided through apertures 516 formed in outer tube 506.
- arms 504 and 506 are staggered, so that apertures 514 and 516 are staggered to match the arm locations.
- the tips of the pullers may or may not be aligned with the arms into which they pull vascular tissue. In some embodiments, at least some of the pullers may be non-planar.
- "end" pullers 510 are retracted, pulling the lips of graft 502 against clip device 400. This step may be performed inside the body or outside of it.
- Fig. 5C shows system 500 near a target side vessel 520.
- Target vessel 520 may be, for example, a coronary artery, a synthetic or biological graft, an aorta, a LIMA, a coronary vein, an aorta or a peripheral blood vessel, such as a femoral artery or a leg vein, or any other known blood conduit.
- graft 502 may be any known blood conduit.
- Pullers 512 are extended forward so that they enter an opening in vessel 520. In some embodiments of the invention, the insertion of pullers 512 is manual. In others, it is facilitated by an alignment of system 500 and the hole in the target vessel.
- a punch for forming the opening may be provided through outer base tube 508 and then replaced with the graft deliver ⁇ ' portion.
- a punch may be provided through graft 502.
- a separate punching tool is used.
- an incision is made using a knife.
- Fig. 5D pullers 512 are retracted, pulling the lips of the incision of vessel 520 into the clip, so that the lips of the two vessels are near, touching or overlapping each other.
- Fig. 5E a proximal inwards pointing portion 522 of base 508 is pushed inwards, causing arms 404 to close on the lips of vessel 520, and in the process possibly also everting them further.
- Portions 522 may include an inclined portion 526 for guiding the arms to close in a desired fashion.
- One exemplary method of moving portions 522 is advancing an outside tube 524 over base outer tube 508, causing it to radially compress.
- inner pusher tube 504 is advanced, closing arms 406 of clip 404.
- Base tube 508 may serve as a contra for the pressure.
- the blood vessels are thus held securely between arms 404 and 406, preferably preventing blood leakage.
- the steps of Figs. 5E and 5F are performed simultaneously or in an a opposite order. Although simultaneous performance for all the arms on a side is preferred, in some embodiments, not all the arms on a single side are closed together.
- pullers 512 and 510 may be retracted and base tube 508 can be radially expanded, to release clip 400.
- Inner tube 504 may be advanced further to release clip 400 from outer tube 506.
- the pullers may be dealt with as described above, for example, cut and left in the body, possibly to be absorbed.
- base tube 508 may include barbs or an inner lip for maintaining arms 404 open (until base tube 508 is advanced) and inner tube 504 may include an extension for preventing arms 406 from closing (until inner tube 504 is retracted).
- ring 402 may be elastic, for example to allow radial compression for deployment and/or for being held by outer tube 506.
- the vessel may be aligned in a non-axial manned to the rest of delivery system 500, for example, be provided through a lumen that is perpendicular to the system axis.
- the general working of the pullers remains the same.
- system 500 is a split system (into two, three or more lengthwise parts), so that it can be more easily removed from graft 502.
- FIGs. 6A-6C illustrate an alternative method of deploying multiple clips in an anastomotic connection, in accordance with an exemplary embodiment of the invention.
- Fig. 6A shows a graft 602, having a lip 604 transfixed on a puller 606.
- a delivery system 600, mounted on the graft includes an inner tube 620 on which an anastomotic connector 608 is mounted.
- Connector 608 may comprise, for example, a ring 616 and a plurality of clip arms 618.
- connector 608 is super-elastic, elastic or shape memory, with arms 618 prevented from folding in by a restraint 626.
- an inwardly pointing extension 610 of restraint 626 includes a circumferencially pointed (e.g., out of the figure plane) bump 612 (or restraint 626 is slotted) that prevents arm 618 from radial motion.
- a circumferencially pointed (e.g., out of the figure plane) bump 612 or restraint 626 is slotted) that prevents arm 618 from radial motion.
- Delivery system 600 further comprises a retracting tube 624 for retracting pullers 606 and a contra tube 622 which prevents retraction of connector 608.
- pullers 606 are extended into an incision 634, having lips 632 in a "side" vessel 630.
- pullers 606 are retracted, everting lips 632 and pulling both lips 632 and lips 604 into connector 608. Restraint 626 then releases arms 618, allowing the connector to close, sealing the connection between graft 602 and vessel 630. Pullers 606 are thus generally not required any more, at least not for holding vessel 630. Pullers 606 can then be further retracted, possibly causing no damage to the blood vessels, as the pullers are straightened by the retraction. Connector 608 can be released, for example by advancing contra tube 622. In a plastically deformed embodiment, restraint 626 acts as a anvil, to radially compress arms 618. Arms 618 may have sharp tips, as shown, for example to penetrate one or both of lips
- Figs. 5 and 6 illustrate anastomotic connectors
- the connector instead of being a ring as shown in Fig. 4, may be a line connector or a circular connector with arms only on its bottom part, pointing in.
- Figs. 7A-7C illustrate the deployment of other clip-devices for the attachment of two blood vessels, in accordance with exemplary embodiments of the invention.
- a clip 700 is elastic, super-elastic of shape memory, so that it desires to reach a folded shape (i.e., is self-closing).
- Another arm 710 of clip 700 may be held in another slot (or bump) 714.
- clip 700 is part of a single connector including a plurality of clips attached to a ring 716, here shown being held by a holder 718.
- a graft 702 is transfixed by arm 708 of clip 700.
- Arm 708 is inserted into an incision in a vessel 704 (only one side shown).
- the clip closes, sealing together graft 702 and vessel 704.
- a retraction of restraint 706 may fold arm 708 against arm 710.
- Fig. 7B shows an alternative embodiment of the invention, in which a self-closing clip
- clip 720 transfixes a graft 702 and a vessel 704.
- the clip maybe inserted, for example, manually, into an incision in vessel 704 and then embedded in the vessel wall by pulling it back.
- clip 720 is free to fold.
- clip 720 may be part of a multi-clip connector, in some embodiments of the invention.
- Fig. 7C shows an alternative embodiment of the invention, in which a clip 730 has the lips of graft 702 and vessel 704 inserted into it, for example manually or using a puller (not shown).
- Clip 730 comprises two arms 732 and 734 connected by a base 736.
- clip 730 is pre-stressed so that arms 732 and 734 desire to fold inwards.
- Arms 732 and 734 extend past base 736 as extensions 742 and 744, respectively.
- a restraint comprising two opposing restraint elements 738 and 740 engage and maintain in position, clip 730, via extensions 742 and 744.
- Clip 730 is a self-closing clip, in which arms 732 and 734 close towards each other.
- arms 732 and 734 advance towards each other and engage and seal together the lips of graft 702 and vessel 704.
- restraints 738 and 740 are brought together in order to enlarge the distance between arms 732 and 734 and make it easier to insert the lips of vessel 704 and graft 702 into the clip.
- clip 730 is laid against the vessel and the graft and as the restraints are let apart, the tips of arms 732 and 734 engage and advance the lips into the clip.
- a device is packaged and/or sold with an instruction leaflet, describing the device dimensions and/or situations for which the device should be applied.
- One or more of the following parameters of a device may be varied, for example:
- Various shapes may be provided, for example, rectangular, triangular, arcuate, circular and piecewise linear or curved.
- the arms may be planar or may extend outside of a plane, for example being curved.
- the barbs may be long enough to transfix the vessel walls. Alternatively, they may be made shorter, for example penetrating only some of the layers of the blood vessel. It is noted that different barbs on a same device may have different lengths or other properties, for example, depending on the properties of the target vessels. Exemplary lengths include, 0.1 mm, 0.5 mm, 1 mm, 2 mm and larger, smaller and intermediate sizes. Other parameters of the barb design may vary as well, for example the degree of sharpness (sharp vs. blunt).
- the length of the arms may also depend on the properties of the target vessels and the geometry of the connection. Exemplary lengths include, 1 mm, 3 mm, 5 mm, 7 mm and larger, smaller and intermediate sizes.
- the device may have a continuous surface, in some embodiments of the invention, for example as shown in Figs. 3A and IE, one or more holes may be formed in the surface of the device. This may reduce the total amount of foreign material in the body. It is noted, however, that the total amount of material in the blood flow may be very low or even zero, in some embodiments of the invention.
- the above described methods and devices of vascular manipulation may be varied in many ways, including, changing the order of steps, which steps are performed inside the body and which outside, the order of making the anastomosis connections, the order of steps inside each anastomosis, the exact materials used for the anastomotic connectors, which vessel is a "side" side and which vessel (or graft) is an "end" side of an end-to-side anastomosis and/or whether two lips that are connected are from a same vessel or from different vessels.
- the location of various elements may be switched, without exceeding the sprit of the disclosure, for example, switching the moving elements for non-moving elements where relative motion is required.
- surgical kits which include sets of medical devices suitable for making a single or a small number of anastomosis connections. Measurements are provided to serve only as exemplary measurements for particular cases, the exact measurements applied will vary depending on the application.
- the terms "comprises”, “comprising”, “includes”, “including” or the like means “including but not limited to”.
Abstract
Description
Claims
Priority Applications (35)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
BR0016251-5A BR0016251A (en) | 1999-12-08 | 1999-12-09 | Vascular connector for sealing an opening between two blood duct flanges, and method for sealing an opening between two blood duct flanges. |
CA002393486A CA2393486A1 (en) | 1999-12-08 | 2000-09-28 | Vessel lip attachment |
IL15005100A IL150051A0 (en) | 1999-05-30 | 2000-09-28 | Blood vessel lip attachment |
EP00964605A EP1259169A2 (en) | 1999-12-08 | 2000-09-28 | Vessel lip attachment |
JP2001542803A JP2004513670A (en) | 1999-12-08 | 2000-09-28 | Vessel limbus coupler |
AU75527/00A AU7552700A (en) | 1999-12-08 | 2000-09-28 | Vessel lip attachment |
AU28779/01A AU2877901A (en) | 2000-03-20 | 2001-01-25 | An anastomotic connector and graft expander for mounting a graft |
CA002403506A CA2403506A1 (en) | 2000-03-20 | 2001-01-25 | An anastomotic connector and graft expander for mounting a graft |
US10/239,365 US20030208214A1 (en) | 2000-03-20 | 2001-01-25 | Anastomotic connector and graft expander for mounting a graft |
BR0109397-5A BR0109397A (en) | 2000-03-20 | 2001-01-25 | Method for mounting a graft to a stud connector, method for mounting a graft to a connector having a plurality of studs arranged around a central opening, method of forming stud tips for an anastomotic connector, anastomotic connector, method for performing a anastomosis, method for twisting hooked nails in an anastomotic ring-type connector, method for selecting an anastomotic connector for a graft, medical graft dilator, and method for turning a graft |
JP2001568320A JP2003532457A (en) | 2000-03-20 | 2001-01-25 | Anastomotic connector and graft expander for graph and attachment |
IL15153901A IL151539A0 (en) | 2000-03-20 | 2001-01-25 | An anastomotic connector and graft expander for mounting a graft |
EP01959911A EP1289430A1 (en) | 2000-03-20 | 2001-01-25 | An anastomotic connector and graft expander for mounting a graft |
PCT/IL2001/000074 WO2001070119A1 (en) | 2000-03-20 | 2001-01-25 | An anastomotic connector and graft expander for mounting a graft |
JP2001568293A JP2004500209A (en) | 2000-03-20 | 2001-03-20 | Transfer of grafts and connectors |
BR0109396-7A BR0109396A (en) | 2000-03-20 | 2001-03-20 | Vascular connector for sealing an opening between two blood channel lips, connector placement system, pope method of pulling fingers back from a ring connector, and anastomosis apparatus |
AU2001244496A AU2001244496A1 (en) | 2000-03-20 | 2001-03-20 | Graft and connector delivery |
PCT/IL2001/000267 WO2001070091A2 (en) | 2000-03-20 | 2001-03-20 | Transvascular bypass method and system |
US10/239,364 US20040097973A1 (en) | 2000-03-20 | 2001-03-20 | Transvascular bybass method and system |
CA002403289A CA2403289A1 (en) | 2000-03-20 | 2001-03-20 | Graft and connector delivery |
PCT/IL2001/000266 WO2001070090A2 (en) | 2000-03-20 | 2001-03-20 | Graft and connector delivery |
IL15169301A IL151693A0 (en) | 2000-03-20 | 2001-03-20 | Graft and connector delivery |
AU2001244497A AU2001244497A1 (en) | 2000-03-20 | 2001-03-20 | Transvascular bypass method and system |
EP01917421A EP1265535A2 (en) | 2000-03-20 | 2001-03-20 | Graft and connector delivery |
IL14405101A IL144051A0 (en) | 2000-09-28 | 2001-06-28 | Anastomotic connection system |
PCT/IL2001/000903 WO2002030172A2 (en) | 2000-09-28 | 2001-09-25 | Anastomotic connection system |
CA002425336A CA2425336A1 (en) | 2000-09-28 | 2001-09-25 | Anastomotic connection system |
BRPI0114275-5A BR0114275A (en) | 2000-09-28 | 2001-09-25 | anastomotic connector, supply system for an anastomotic connector, removal device on a connector, method for mounting a graft on a connector, template, and blood vessel cutter |
KR10-2003-7004275A KR20030068134A (en) | 2000-09-28 | 2001-09-25 | Anastomotic connection system |
AU2001295847A AU2001295847A1 (en) | 2000-09-28 | 2001-09-25 | Anastomotic connection system |
IL15513301A IL155133A0 (en) | 2000-09-28 | 2001-09-25 | Anastomotic connection system |
JP2002533625A JP2005506095A (en) | 2000-09-28 | 2001-09-25 | Anastomosis system |
EP01976583A EP1359850A2 (en) | 2000-09-28 | 2001-09-25 | Anastomotic connection system |
KR10-2002-7012407A KR20030017478A (en) | 2000-03-20 | 2002-09-19 | An anastomotic connector and graft expander for mounting a graft |
US10/459,407 US20040073247A1 (en) | 1998-05-29 | 2003-06-11 | Method and apparatus for forming apertures in blood vessels |
Applications Claiming Priority (10)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/IL1999/000285 WO1999062408A1 (en) | 1998-05-29 | 1999-05-30 | Vascular port device |
PCT/IL1999/000284 WO1999062415A1 (en) | 1998-05-29 | 1999-05-30 | Methods and devices for vascular surgery |
PCT/IL1999/000670 WO2000056226A1 (en) | 1999-03-19 | 1999-12-08 | Vascular surgery |
ILPCT/IL99/00670 | 1999-12-08 | ||
ILPCT/IL99/00674 | 1999-12-09 | ||
PCT/IL1999/000674 WO2000056223A1 (en) | 1999-03-19 | 1999-12-09 | Vascular closure device |
IBPCT/IB00/00302 | 2000-03-20 | ||
IBPCT/IB00/00310 | 2000-03-20 | ||
PCT/IB2000/000310 WO2000056228A1 (en) | 1999-03-19 | 2000-03-20 | Low profile anastomosis connector |
PCT/IB2000/000302 WO2000056227A1 (en) | 1999-03-19 | 2000-03-20 | Advanced closure device |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/459,407 Continuation-In-Part US20040073247A1 (en) | 1998-05-29 | 2003-06-11 | Method and apparatus for forming apertures in blood vessels |
US10/809,274 Continuation-In-Part US20050038454A1 (en) | 1998-05-29 | 2004-03-25 | Anastomotic delivery system |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2001041624A2 true WO2001041624A2 (en) | 2001-06-14 |
WO2001041624A3 WO2001041624A3 (en) | 2002-09-12 |
Family
ID=56289999
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/IB2000/000302 WO2000056227A1 (en) | 1998-05-29 | 2000-03-20 | Advanced closure device |
PCT/IL2000/000611 WO2001041624A2 (en) | 1998-05-29 | 2000-09-28 | Vessel lip attachment |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/IB2000/000302 WO2000056227A1 (en) | 1998-05-29 | 2000-03-20 | Advanced closure device |
Country Status (1)
Country | Link |
---|---|
WO (2) | WO2000056227A1 (en) |
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US10716559B2 (en) | 2012-08-10 | 2020-07-21 | W.L. Gore & Associates, Inc. | Devices and methods for securing medical devices with an anatomy |
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Also Published As
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WO2000056227A1 (en) | 2000-09-28 |
WO2001041624A3 (en) | 2002-09-12 |
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