WO2000056228A1 - Low profile anastomosis connector - Google Patents
Low profile anastomosis connector Download PDFInfo
- Publication number
- WO2000056228A1 WO2000056228A1 PCT/IB2000/000310 IB0000310W WO0056228A1 WO 2000056228 A1 WO2000056228 A1 WO 2000056228A1 IB 0000310 W IB0000310 W IB 0000310W WO 0056228 A1 WO0056228 A1 WO 0056228A1
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- WO
- WIPO (PCT)
- Prior art keywords
- connector
- connector according
- spike
- pivot bar
- ring
- 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
- A61B17/11—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
- A61B17/064—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
- A61B17/064—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
- An aspect of some preferred embodiments of the invention relates to providing a pivot bar on which a spike of an anastomosis device is mounted.
- the pivot bar is not part of the mechanical structure of the connector, allowing the spike to deform independently of the deformation of the rest of the connector, even if the device deformation is not restricted by a mold.
- the pivot bar is used to provide apply sufficient force to the spike, without requiring a significant bending radius.
- a device whose profile conforms to the blood vessels being connected can be provided.
- Such a pivot bar can be provided for spikes that engage one blood vessel or both blood vessels.
- a low profile is useful in a forward spike of the anastomosis connector, for example to reduce tension at the connection and/or reduce blood-connector contact.
- a low profile is useful in the backward spike of the connector, for example to minimally impact graft flexibility and/or to prevent inadvertent damaging of nearby structures.
- a low profile device may also be more easily provided by flexible means, such as a catheter.
- a low profile device does not restrict the motion of the graft relative to the target vessel.
- the graft can move, and, especially, the graft can assume a non-perpendicular orientation relative to the vessel.
- restriction of the graft motion and/or extension direction may be desired, so an extended connector may be provided.
- At least some of the pivot bars are not straight, optionally allowing for greater force application at some bending positions of the pivot bars.
- a spike (mounted on a pivot bar) is cut out of the material from which an opposing spike is formed.
- a connector comprises a ring with a plurality of radially displaced spikes on pivot bars.
- the pivot bar heights are staggered and/or the pivot bars are angled, allowing a better radial compression of the connector, during insertion of the connector into the side vessel.
- An aspect of some preferred embodiments of the invention relates to an anastomosis connector for a side to end anastomosis, in which at least some of the backward (or forward) spikes do not penetrate the "side” vessel. Rather, the spikes press against the vessels and prevent the "end” vessel from advancing too far (or retracting) into the side vessel.
- these pressing spikes are mounted on pivot bars, to allow a large force to be applied, without requiring a significant bend area.
- a pressing spike can be substantially parallel to the surface of the "side" vessel, reducing vessel motion at the connection area and/or allowing a better spreading out of pressure.
- an aspect of some preferred embodiments of the invention relates to the design of a ring-part of an anastomosis device.
- the anastomosis device comprises a plurality of ring segments arranged in a ring, with spike elements between the ring segments.
- the ring segments comprises arcs, for example each such ring segment comprising two, three or four parallel arcs interconnecting two neighboring spike elements.
- all the ring segments have their arcs in the same direction, however, this is not required.
- a ring segment may comprise one or more zigzag elements, for example including two or more bends.
- the arc or zigzag thickness may vary along a single ring segment.
- a strengthening or a loop is provided at the point of connection between the arc (or other ring segment) and the spike element.
- the strengthening or the loop serves to distribute strain caused by radially contracting the connector and/or to prevent over-straining at the point of connection.
- an aspect of some preferred embodiment of the invention relates to a graft eversion mechanism.
- the eversion mechanism comprises a graft holder and a plurality of forceps like devices.
- the forceps like devices can be operated in tandem, to grasp the ends of the graft, evert it and then pull the everted part back over the rest of the graft.
- the different forceps pull the graft back different amounts, forming an uneven eversion.
- An aspect of some preferred embodiments of the invention relates to performing an oblique eversion.
- an obliquely everted graft especially a vein, tends to form an oblique anastomosis connection and the graft tends to bend back to relieve the strain caused by the oblique eversion.
- the degree of obliqueness is selected responsive to an expected bending of the graft after the anastomosis is completed.
- An aspect of some preferred embodiments of the invention relates to a method of forming an oblique-connection anastomosis device.
- a perpendicular-connection anastomosis device is formed and then bent out of shape, to provide an oblique device.
- the bent device is preferably heat treated to train it to its new geometry.
- An aspect of some preferred embodiments of the invention relates to an apparatus for delivering a graft to an anastomosis location.
- the apparatus comprises two parts, a handle, and a replaceable inner-tool, which can be, for example, a hole-puncher or a graft delivery and anastomosis performance tool.
- the inner tool is inserted into the handle from the side of the handle.
- the tool is inserted into the side of the handle and than slid axially a short distance to lock.
- a potential advantage of this method is that a vein can be mounted on the graft delivery tool prior to its being mounted o the handle and there is little danger of the vein being damage by the handle.
- An aspect of some preferred embodiments of the invention relates to a punch for punching holes in blood vessels.
- Such a punch may be used from outside the body, or form inside the body, for example being provided through an endoscope or a catheter.
- the punch comprises a pointed shaft having a circumferential depression with defined therein. At least the end of the depression near the tip is sloping.
- An outer tube is provided over the shaft.
- the tip of the tube has a smaller inner diameter than the rest of the tube.
- the tip is inserted into a side of a blood vessel until the vessel wall is engaged by the depression.
- the tube is then advanced.
- the vessel wall is cut between the inner diameter of the outer tube and the sloping edge of the depression.
- the cut out portion is preferably contained in the depression.
- An aspect of some preferred embodiments of the invention relates to a device for measuring and preferably pre-stretching a graft before an anastomosis procedure.
- the device comprises two bars, a first one connected to a handle and a second one connected to a weak spring and a scale.
- the graft is mounted on the two bars.
- the motion of the first bar is coupled to the second bar via the graft.
- the motion of the second bar is limited by the spring.
- the scale shows the relative distance between the two bars, allowing a suitable anastomosis connector to be selected. Further pulling on the handle can be used to pre-stretch the vein in preparation for eversion and/or mounting of the anastomosis connector on it.
- an anastomosis connector comprising: a plurality of ring segments, together defining a radially expandable ring-like shape having a lumen; at least one pivot bar coupled to at least one of said ring segments; and at least one spike mounted on said pivot bar and rotatable around said pivot bar, where radial deformation of said ring-like shape does not substantially directly affect said spike rotational position.
- rotation of the pivot bar is mechanically decoupled from radial deformation of ring-like shape.
- said at least one pivot bar comprises at leas two pivot bars, where said at least one spike is mounted on a first one of said pivot bars and said first pivot bar is mounted on the other pivot bar.
- said at least one spike is pointed towards said ring-like shape.
- said at least one spike is pointed away from said ring-like shape.
- said at least one spike comprises at least two spikes, each mounted on a separate pivot bar, where said spikes point in opposite directions along an axis of said connector.
- said connector is designed such that said at least one spike remains outside of a side vessel in an end-to-side anastomosis.
- said connector is designed such that said at least one spike enters a side vessel in an end-to-side anastomosis.
- said pivot bar is comprised in a spike element.
- said spike element comprises two opposing spikes.
- said spike element interconnects two adjacent ring segments.
- said spike element is attached to only a single ring element.
- said at least one spike has a tip adapted to penetrate a blood vessel.
- said at least one spike has a tip adapted to lay against a blood vessel without penetrating it.
- said connector is heat-treated to have said at least one spike perpendicular to said ring.
- said connector is heat-treated to have said at least one spike parallel to said ring.
- said connector is heat-treated to have said at least one spike bend.
- said connector is heat-treated such that said at least one spike does not bend.
- said connector is heat-treated such that said pivot bar is twisted.
- said connector is heat-treated such that said pivot bar is not twisted.
- said pivot bar is within an axial extent of said ring-like shape.
- said pivot bar is substantially centered relative to said ring like shape.
- said pivot bar is outside an axial extent of said ring- like shape.
- said pivot bar is comprised in a pivot mechanism.
- said pivot mechanism is directly mounted onto at least one of said ring elements Alternatively, said pivot mechanism is coupled via a single extension to at least one of said ring elements. Alternatively, said pivot mechanism is coupled via at least two extensions to at least one of said ring elements.
- said pivot bar is coupled to said pivot mechanism via a hinge at each end of said pivot bar.
- said hinge comprises a thickening of said mechanism relative to said pivot bar.
- said connector comprises a plurality of alternating ring segments and pivot bar mechanism and said pivot bar mechanisms are axially staggered, to allow a greater radial compression of said ring-like shape.
- said pivot bar is straight.
- said pivot bar is piece-wise straight, alternatively, said pivot bar is curved.
- said connector is packaged.
- said packaging indicates a particular vessel type for said connector and for which said connector is adapted.
- said vessel type comprises a femoral artery.
- said vessel type comprises an aorta.
- said packaging indicates a particular vessel size for said connector and for which said connector is adapted.
- said packaging indicates a particular vessel wall thickness for said connector and for which said connector is adapted.
- said ring-like shape has an axial extent smaller than said wall thickness.
- said packaging indicates a particular connection geometry for said connector and for which said connector is adapted.
- said geometry is a side-to-end geometry.
- said packaging indicates a particular oblique angle geometry for said connector and for which said connector is adapted.
- said at least one spike is cut out of an opposing spike of said connector.
- At least one of said ring segments comprises a plurality of axially spaced elements.
- said plurality of elements comprises at least three elements.
- said plurality of elements comprises at least four elements.
- said plurality of elements comprises at least five elements.
- all of said plurality of elements have a same geometry.
- at least two of said plurality of elements have mirrored geometries.
- At least one of said plurality of elements has a single curve geometry.
- at least one of said plurality of elements has a dual curve geometry.
- at least one of said plurality of elements has at least three curves defined thereby.
- the connector comprises a strain dissipation element at a point of connection of at least one of said elements and a spike element to which said ring segment is attached.
- said strain dissipation element comprises a thickening of said axially spaced element.
- said thickening defines an aperture.
- a method of everting a blood vessel comprising: engaging a tip of said vessel at a plurality of points around its circumference; inverting said tip by inverting said points; and pulling said inverted points towards a distal end of said blood vessel.
- said plurality comprises four points.
- said engaging comprises engaging using forceps and where said inverting comprises rotating said forceps.
- said pulling comprises pulling different ones of said points different amounts.
- apparatus for graft eversion of a graft over a shaft having a tip comprising: a handle for engaging said shaft; a plurality of forceps arranged to engage a tip of said graft where it protrudes form said shaft; and a plurality of joints, each one associated with one of said forceps, for rotating said forceps pulling a tip of each of said forceps axially along said shaft.
- a method of measuring a graft size comprising: mounting a tip of said graft on two extensions, one extension coupled to a spring and one extension coupled to a handle; manipulating said handle such that said extensions separate; reading a measurement on a scale coupled to said spring; and selecting an anastomosis connector responsive to said read measurement.
- the method comprises further manipulating said handle to stretch said graft tip.
- a hole puncher comprising: a sharp tip for forming a puncture in a blood vessel; a shaft having a varying diameter and having a depression formed therein for engaging a wall of said blood vessel, said diameter substantially matching a diameter of said tip at one end of the shaft, said diameter increasing away from said tip for a first distance and said diameter then defining a slope of diminishing diameter towards said depression; and an outer tube mounted on said shaft and having a tip, said outer tube having an inner diameter of said tip that is in a range of diameters defined by said slope of diminishing diameters.
- said tip of said outer tube has a smaller outer diameter that a more proximal portion of said outer tube.
- a method of forming an oblique anastomosis connector comprising: providing a non-oblique anastomosis connector; mounting said connector in a restraint; manipulating said restraints to deform said connector to a desired degree of obliqueness; and heat-treating said connector after said manipulation, to maintain said distortion.
- the method comprises heat-treating said connector prior to said mounting, to train a deformation of a spike portion of said connector.
- a side mounted delivery system comprising: a handle including an opening in its side; a graft delivery tool adapted to fit through said opening; and a groove and projection mechanism slidably interconnecting said tool and said handle.
- the system comprises a snap-lock mechanism for axially fixing said handle relative to said tool.
- Fig. 1 is plan view of a part of a pivot-bar based anastomotic connector, in accordance with a preferred embodiment of the invention
- Figs. 2A-2E illustrate a deployment method for the connector of Fig. 1, in accordance with a preferred embodiment of the invention
- FIG. 3 is plan view of a part of another pivot-bar based anastomotic connector, in accordance with an alternative preferred embodiment of the invention
- Figs. 4A-4C illustrate a deployment method for the connector of Fig. 3, in accordance with a preferred embodiment of the invention
- Fig. 4D is a cut-sectional view of an heat-treating device suitable for pivot-bar based anastomosis connectors, in accordance with a preferred embodiment of the invention.
- Fig. 5 is plan view of a part of a pivot-bar based anastomotic connector, featuring spikes cut out of spikes in accordance with a preferred embodiment of the invention
- Figs. 6A-6C illustrate various spike designs utilizing a pivot-bar or a similar hinge, in accordance with preferred embodiments of the invention
- Figs. 6D-6E illustrate a spike design utilizing two pivot bars, in accordance with a preferred embodiment of the invention
- Figs. 7A-7B illustrate an oblique anastomosis connector utilizing a pivot bar design, in accordance with a preferred embodiment of the invention
- FIGS. 8A-8E illustrate various anastomosis connector designs, in accordance with preferred embodiments of the invention.
- Figs 9A and 9B illustrate a connector-bending device, in accordance with a preferred embodiment of the invention
- Fig. 10 illustrates an alternative connector-bending device, in accordance with a preferred embodiment of the invention
- Fig. 11 is a cross-sectional view of a graft measurement and/or stretching device in accordance with a preferred embodiment of the invention
- Figs. 12A-12C illustrates a side-mounted anastomosis delivery system, in accordance with a preferred embodiment of the invention
- Figs. 13A-13F illustrate a graft eversion tool, in accordance with a preferred embodiment of the invention
- Fig. 14 illustrates a tip of a hole-punching tool, in accordance with a preferred embodiment of the invention.
- Fig. 1 is plan view of a part of a pivot-bar based anastomotic connector 100, in accordance with a preferred embodiment of the invention.
- Connector 100 is generally ring shaped, formed of a plurality of ring segments 102 and a plurality of spike elements 104 interspersed between the ring segments. It is noted however, that other connector designs, can be used, for example, the spike elements being independent of the ring segments.
- each ring segment 106 forms part of the ring structure of the connector and is typically, but not always, radially compressed, to allow easier insertion into a blood vessel.
- each ring segment 106 comprises a- plurality of side-by-side elements 106, which are preferably elastic.
- a spike element supports one or more opposing spikes, for example spikes 118 and 108 as shown.
- Spike 108 is shown with a sharp tip 109, for penetrating a graft vessel, as will be explained below with respect to Fig. 2.
- a particular feature of connector 100 is that one or both of spikes 108 and 118 are mounted on a pivot bar 110 or 120, such that the spike can be extended into the figure plane without substantially bending the spike, only by twisting the pivot bar. Furthermore, the amount of distortion of the pivot bar is considerably smaller than that of a comparable in-line hinge, such as is formed by a bending of the spike. Thus, the deformation is less likely to cause hinge failure and/or a hinge can be configured to also apply greater force to the spike. Although the spikes are shown mounted at the center of their pivot bars, this is not essential.
- pivot bars 110 and 120 are shown are being axially spaced from the connector by extensions 114 and 116, respectively. However, as will be shown in alternative embodiments below, this is not required.
- a joint 112 attaches pivot bar 110 to extension 114.
- the spacer is made thicker than the pivot bar, to prevent undesirable twisting of the spacer or any part of the connector other than pivot bar 110.
- Other variations of joints will be described below. It is noted, that strengthened or weakened portions may be provided at other points along the pivot bars, besides at their ends, to control where deformation takes place.
- the pivot bar is not a load bearing structure or a radially expanding structure, so that the forces applied to the spike can be independent of the radial expansion forces.
- Another potential advantage of this separation is that the radial expansion of connector 100 as a whole does not have to affect the spike positions vis-a-vis extensions and/or the rest of the connector.
- pivot bars Another potential advantage of pivot bars, is that the profile (e.g., protrusions from the anastomosis location) of the connector can be reduced.
- spike 118 Another potential advantage, realized in spike 118, is that the spike does not need to penetrate the blood vessel at all. Rather, the force applied by the pivot bar is sufficient to hold the spike against the blood vessel (as shown below in Fig. 2), without penetrating it.
- Figs. 2A-2E illustrate an exemplary deployment method for connector 100, in accordance with a preferred embodiment of the invention.
- Connector 100 is preferably heat trained to have a resting configuration as shown in Fig. 2E, with spikes 108 and 118 extending pe ⁇ endicular to the connector surface.
- FIG. 2A shows a connector 100 with both spikes axially aligned, mounted between a holder 134 and a graft cover 136.
- a graft 132 is provided everted over graft cover 136 and connector 100, and inside an aperture in the wall of a "side" vessel 130.
- a base tube 138 maintains connector 100 in its axial position relative to the rest of the delivery system.
- tips 109 of spikes 108 transfix graft 132, at its eversion.
- the base tube 138 is advanced relative to holder 134 and cover 136, so that spike 108 advances into the aperture in vessel 130 and reverts to its resting configuration pe ⁇ endicular to connector 100. Since most, if not all of the bending is in pivot bar 118, the side profile of the extended spike can be substantially pe ⁇ endicular. Tips 109 may be trained to be slightly bent towards the near vessel wall, to prevent them from protruding into vessel 130.
- holder 134 is retracted, allowing connector 100 to expand radially, at its ring segments 102.
- holder 134 is retracted even more, releasing spikes 118 to bend pe ⁇ endicular to connector 100.
- vessel 130 is grasped between spikes 108 and spikes 118.
- spikes 118 do not penetrate and blood vessel, while spikes 108 only penetrate graft 132, not vessel 130.
- spikes 108 may extend directly into the side of vessel 130.
- the spikes and spike tips are designed to support vessel 130.
- the spikes are wide.
- the spikes are roughed on their inner surface where they contact vessel 130.
- the spike tip may be wider than the spike, for example to define a contact pad between the spike and vessel 130.
- Connector 100 is preferably formed of a elastic, super-elastic or shape-memory material, such as Nitinol. However, connector 100 may alternatively be plastically deformed.
- holder 134 engages spikes 108, when it is retracted, it bends spikes 108, by twisting pivot bar 110. Once spikes 108 are bent sufficiently, holder 134 may disengage the spikes.
- a suitable holder tip for engaging and disengaging is shown, for a different pu ⁇ ose, in Fig. 9B. When the tip is rotated, the engaged spike is released.
- Fig. 3 is plan view of a part of a pivot-bar based anastomotic connector 200, in accordance with an alternative prefe ⁇ ed embodiment of the invention.
- connector 200 comprises a plurality of ring segments 202, comprising two arcs 206 and a plurality of spike elements 204, each comprising a spike 208 and a spike 218. It is noted that a particular spike element 208 does not need to include two opposing spikes and may include one or more than one spike in each axial direction.
- This connector is selected to exemplify a plurality of design features.
- a connector in accordance with a preferred embodiment of the invention is not to be construed as being limited to the particular mix of features illustrated. Rather, the embodiments were chosen to illustrate several features in each embodiment, with the understanding that other embodiments within the scope of the invention can contain any selection of features from any of the embodiments shown.
- connector 200 When deployed, can have a smaller axial extent than connector 100.
- spike 208 which may be a forward spike, does not have a pivot bar and the spike itself is bent for deployment.
- connector 200 Another feature exemplified by connector 200, is that the pivot bars for two adjacent spike segments 204 and 204' are not at the same axial position. Thus, the pivot bars of adjacent spike elements do not contact during radial compression of connector 200.
- a pivot bar 220 of spike 218 is not straight.
- the pivot bar is V shaped, however, a sine shape or a zigzag shape could also be provided.
- Spike 218 is preferably, but not necessarily, attached at the bend in pivot bar 220.
- a potential advantage of the V shaped designed showed is that a greater force can be applied over part of the bending positions of spike 218, than can be with a similar straight pivot bar.
- the pivot bar may be tilted to provide space for axial compression, but remain straight.
- connector 200 Another feature of connector 200 is that the mechanism supporting the pivot bars forms substantially square corners that jut into the neighboring ring segments. Alternatively, these corners may be rounded.
- the pivot bar is bent to conform with the connector surface, however, this is not essential, especially in those connectors where the pivot bar is coupled to the connector at only a single point.
- spikes 218 include a forked tip 219, for spearing vessel 130.
- this spearing can be at an angle significantly shallower than 90°, for example 60° or 30°.
- FIGS. 4A-4C illustrate a deployment method for connector 200, in accordance with a preferred embodiment of the invention.
- Fig. 4A shows connector 200 after its forward spike 208 is released to engage vessel
- a method similar to that shown in Fig. 2 may be used for releasing the spikes (which may be super-elastic), or other methods, for example as described in the above referenced PCT applications, can be used.
- Spikes 218 are preferably held between a connector holder 238 and a outer tube 234, during and shortly following the engagement of vessel 130 by spikes 208.
- a connection positioner 240 may be provided to control the position of connector 200 relative to vessel 130 and provide a counter-force for retracting connector 200 so that spikes 209 engage vessel 130.
- outer tube 234 is retracted, freeing spike 218 to bend. As shown, both spike 218 and pivot bar 220 bend, with the result that spike tip 219 engages vessel 130.
- Fig. 4C an optional step of advancing outer tube 234 is illustrated, this advancing further bends spike 218 and strengthens the engagement of vessel 130.
- Fig. 4D is a cut-sectional view of an heat-treating device 250 suitable for pivot-bar based anastomosis connectors, in accordance with a prefe ⁇ ed embodiment of the invention.
- connector 200 (or 100) is placed in device 250. This placement requires distorting the connector as shown.
- Device 250 is then heated to heat-treat the connector and make the new configuration its resting configuration to which the connector tends to return after distortion.
- a penetrating spike 218 is as shown in Fig. 3, and a contact spike 218' does not penetrate vessel 130.
- the contact spikes are distanced from the connector center, to allow more force to be applied to vessel 130 during deployment.
- a single connect may include both penetrating and contact spikes 218, as shown, or the connect may comprise only contact spikes 218' or only penetrating spikes 218.
- Fig. 5 is plan view of a part of a pivot-bar based anastomotic connector 300, featuring spikes cut out of larger spikes in accordance with a prefe ⁇ ed embodiment of the invention.
- connector 300 comprises a plurality of ring segments 302 each formed of a pair of arcs 306.
- a spike 308 is cut out of the body of a spike 318.
- a pivot bar 310 of spike 308 is mounted on optional extension tabs 314.
- connector 300 One feature of connector 300 is that the spikes bases are defined within the axial extent of ring segments 302.
- spikes 318 are hollow, so that a smaller amount of foreign material is present and better tissue adhesion, across the spike, can be provided.
- pivot bar 310 is mounted on extension tabs 314.
- the axial location of pivot bar 310 can be set after the connector manufacture, by bending tabs 314 a desired amount and then heat treating the device to finalize the tab location.
- graft 132 is typically transfixed by spikes 108, 208 or 308.
- no such transfixing is provided.
- ring segments 306 are provided inside of the everted part of graft 132. Tabs 314 are folded back past the edge of the eversion and then optionally again forward, so that spikes 308 and pivot bar 310 are on the outside of the everted section of graft 132.
- spikes 308 are defined in the center of ring segments 306, rather than between the segments, and the everted portion of graft 132 is held between ring segments 306 and pivot bar 310.
- Figs. 6A-6C illustrate various spike designs utilizing a pivot-bar or a similar hinge, in accordance with prefe ⁇ ed embodiments of the invention. As will be shown in the embodiment of Fig. 6D, these spikes may be extended differently from the spikes described above. In particular, these spikes may be pointed towards the ring of the connector, at least during manufacture.
- a spike mechanism 330 includes a pair of spikes 332 mounted on a base 336, which base includes an extension 334.
- Base 336 can serve as a pivot bar, inasmuch as the rotation of spikes 332 is supported by distortion of a significant length of base 336.
- Extension 334 may server for holding spike 332 during insertion.
- spike mechanism 340 features a spike 342, mounted on an extension portion 344 of a base 346, possibly allowing better control of the bending and a reduction in the volume taken up the rotation of the spike.
- a spike mechanism 350 features a spike 352 mounted directly on a base 356. It is noted that various spike lengths may be provided, within the scope of the invention, the spike lengths preferably being selected to penetrate vessel 130 only a desired amount.
- Figs. 6D-6E illustrate a spike mechanism 360 utilizing two pivot bars, in accordance with a prefe ⁇ ed embodiment of the invention.
- Fig. 6D is a plan view.
- Mechanism 360 has two spikes 362 mounted on a pivot bar 364.
- Pivot bar 364 is itself mounted, via two extensions 368 on a second pivot bar 366.
- a portion 370 connects mechanism 360 with the rest of a connector 372.
- Fig. 6E is a side view of a deployed connector 372.
- Mechanism 360 is bent twice, once at pivot bar 366 and once at pivot bar 364. This allows a substantially square profile to be produced, which conforms to the blood vessels taking part in the anastomosis.
- an opposing spike 374 which may be of any type. It should be noted that a single pivot bar can be used to provide a wide range of rotation angles, such as between 15° and 180°, or even over 180°. In some embodiments, a double pivot bar is provided for large angles of rotations, however, this is not required.
- Figs. 7A-7B illustrate an oblique anastomosis connector 400 utilizing a pivot bar design, in accordance with a prefe ⁇ ed embodiment of the invention.
- Fig. 7A is a plan view of a part of connector 400.
- Connector 400 comprises a plurality of ring segments 402, each comprises a plurality of arc sections 406.
- a forward bending spike 408 is provided, with a tip 409.
- a pair of backward spikes 418 are mounted on a pivot bar 420.
- Bar 420 is separated from connector 400 by a pair of extensions 414, however, a single extension or three or more extensions could be used.
- Fig. 7B is a side cross-sectional view of a deployed connector 400.
- spikes 418 and spikes 408 can be designed to push in opposite radial directions, for example spikes 408 pushing in and spikes 418 pushing away from the anastomosis connection.
- the wall of vessel 130 can be radially engaged by the spikes.
- the spikes apply a stretching force to the wall of vessel 130.
- the spike position and force application direction can be used to isolate the rest of vessel 130 from the forces applied by the anastomosis connection, optionally, while compressing a part of the wall of vessel 130 between at least some of the spikes (not necessarily all from the same axial set) and the ring-part of the spike.
- Figs. 8A-8E illustrate various anastomosis connector designs, in accordance with prefe ⁇ ed embodiments of the invention.
- Fig. 8A is a plan view of a portion of an anastomosis connector 500, in which each ring segment 502 is formed of a plurality of zigzag elements 506. Elements 506 may have a constant width or their width may vary.
- One expected benefit of using zigzag elements is that the connector is less likely than an arc-based device to distort in an unexpected manner.
- Another potential benefit of zigzag ring segments is that the force applied by the expanding ring can be better matched to the needs of the anastomosis.
- Fig. 8B is a plan view of a portion of an anastomosis connector 520, in which each ring segment 522 is formed of a plurality of arc elements 526.
- connector 520 five arc elements 526 are provided.
- a different number of arc-elements may be used, for example three or four.
- each element 506 need not be that of an arc of a circle, for example being a spline or a segment of an ellipse.
- the different elements may have different shapes and/or widths, for example the radius of curvature increasing in an axial direction.
- FIG. 8C is a plan view of a portion of an anastomosis connector 530, in which each ring segment 532 is formed of a plurality of arc elements 536.
- each ring segment 532 is formed of a plurality of arc elements 536.
- four arc elements are provided, a ⁇ anged in the form of two concentric near ellipses.
- a strengthening or a loop 538 is preferably provided, to prevent stress related damage from occurring at that point.
- FIG. 8D is a plan view of a portion of an anastomosis connector 540, in which each ring segment 542 is formed of a plurality of recurved elements 546.
- connector 540 two such recurved elements are provided.
- a plurality of forward spikes 548 have different lengths. These different lengths may be used for forming an oblique anastomosis connector and/or for oblique anastomosis connections, as described below, for example.
- the number of curves in the recurved element can be greater, for example, being three, four or more.
- Fig. 8E shows a connector 550 similar to connector 500 of fig. 8A, in which four, rather than three zigzag elements 556 are provided. It should be appreciated that the number, shape, thickness and mechanical working of the ring segments are determined based on a desired mechanical behavior. Typically, but not necessarily, the desired parameters are:
- the ring segment design may vary between elements in a single connector, for example being alternately arc elements and zigzag elements.
- structural elements are added to the connector to prevent to large an increase in radius, for example by providing struts or wires that interconnect neighboring spike elements and prevent them from separating too much.
- Oblique connectors may be formed by obliquely cutting metal tubes or sheet metal.
- an oblique connector is formed by manufacturing a pe ⁇ endicular connector and then distorting it to make it oblique.
- the above connectors may be formed by cutting a suitable Nitinol tube, for example having an outer diameter of 5.3 mm and having a material thickness of 0.18 mm.
- Figs 9A and 9B illustrate a connector-bending device 600, in accordance with a prefe ⁇ ed embodiment of the invention.
- Fig. 9 A is a side cross-sectional view of device 600.
- a connector 602 preferably after it is heat-treated to learn a new resting configuration of its spikes, is mounted on two tools 604, each of which engages the spikes of one side of connector 602.
- a screw 608 is used to fix one tool 604 to a bottom base 610 and another screw 608 is used to fix the other tool 604 to a top base 612.
- the two bases are moved relative to each other, such that connector 602 is distorted.
- the two bases are then attached to each other using screws 614 and the entire device is placed in an oven for additional heat-treating.
- Fig. 9B is a top view of tool 604, showing L shaped slots for engaging the spikes of connector 602 and an inner- threaded aperture for engaging screw 608.
- Fig. 10 illustrates an alternative connector bending device 630, in which a same base
- FIG. 1 1 is a cross-sectional view of a graft measurement device 700, in accordance with a prefe ⁇ ed embodiment of the invention.
- Device 700 comprises a body 701 having a handle
- a graft 132 is placed on two projections 704 and 710.
- Projection 704 is coupled to a piston 706 that is fixed to handle 702.
- Projection 710 is coupled to a piston 708, which is coupled to body 701 via a weak spring 714.
- a scale 712 is mounted on piston 708.
- an extension force applied to handle 702 is coupled to piston 708 via graft 132.
- the diameter of graft 132 affects the measurement shown on scale 712.
- other ways of coupling the diameter of the graft to the extension of a weak spring can also be used to the same effect.
- over-stretching of graft 132 can be prevented by selecting a spring that yields before the graft does or by selecting a spring that even when stretched to its maximum allowed length does not apply a force above a safety threshold.
- Figs. 12A-12C illustrates a side-mounted anastomosis delivery system, in accordance with a prefe ⁇ ed embodiment of the invention.
- a single handle 800 is used to provide various tools to the anastomosis location.
- Two exemplary tools are a graft delivery tool 802 and a hole puncher (not shown).
- the tools are loaded into handle 800 from the side of handle 800.
- a slide and snap mechanism is shown as an exemplary method of achieving side loading.
- Tool 802 has at least one rail 808 defined on it and handle 800 has a matching groove 810.
- a projection 814 on tool 802 matches a projection 812 in handle 800.
- the grooves and the projection may be switched between the handle and the tool.
- Fig. 12A shows handle 800 separated from tool 802.
- Fig. 12B groove 810 engages rail 808.
- tool 802 is advanced enough so that projections 814 and 812 interlock.
- Tool 802 may be removed by applying sufficient retraction force, to overcome the resistance of the projections, either bending them away or breaking them (for a one-time device).
- a graft 132 such as a vein
- a graft 132 is inserted into an opening 804 in tool 802 and exits at its open tip 806. Tip 806 with the graft on it is then inserted into an aperture in vessel 130 (e.g., Fig. 2).
- vessel 130 e.g., Fig. 2
- One potential advantage of side loading the graft holding tool 802 into handle 800, is that the vein is less likely to be damaged by passage through handle 800, if such passage is minimized.
- Another potential advantage is that it is easier to mount and navigate a short vein on a side-mounted tool. It is noted that graft mounting may be required to be performed even if the vein is still connected to the body, in which case, possibly, the vein cannot be removed from the body at all, or any significant distance.
- Tool 802 can co ⁇ espond, for example to the device used in Fig. 2, with tip 806 co ⁇ esponding to graft holder 136.
- Figs. 13A-13F illustrate a graft eversion tool 900, in accordance with a prefe ⁇ ed embodiment of the invention.
- Tool 900 comprises a hollow shaft 902 for engaging a graft delivery tool, such as tool 802 (Fig. 8) and a plurality or forceps mounting points 904 (four shown in this exemplary embodiment, but other embodiments may have as few as one, two or three or more, such as five or six).
- a forceps 906 is mounted on each mounting point 904, using a forceps mechanism 908.
- the figures show only a single forceps in one forceps mounting mechanism.
- graft 132 is not shown.
- Fig. 13A shows device 900 prior to the provision of tool 802.
- tool 802 is provided in shaft 902.
- a graft is provided through opening 804 in tool 802 and out of its tip 806.
- a pe ⁇ endicular, rather than an oblique tip 806 is shown.
- an oblique tip for example as in Fig. 12, may be used instead, and the motion of forceps 906 is preferably matched to the obliqueness.
- an anastomosis connector (not shown) may already be mounted on tip 806, such that the vein everted over it.
- forceps 906 is brought over the tip of graft 132 and closed. It is noted that four pairs of forceps are thus closed on different parts of the graft tip.
- Fig. 13D all four forceps are rotated using their mechanism 908, so that the graft is everted.
- all the forceps are rotated simultaneously, alternatively, they are rotated in series.
- Many mechanism can be used to effect the simultaneous rotation.
- Fig. 13E the forceps are pulled down, elongating the eversion length.
- each forceps pulls down a different amount, thereby forming an oblique eversion.
- tip 806 has an oblique end, to support the oblique eversion. It is noted that many types of joint mechanisms can be used to effect the rotation and pulling down of the forceps tips.
- Fig. 13F the forceps are opened, releasing the graft and allowing tool 802 to be removed and inserted into handle 800 (if it is not already so inserted.
- the inventors have discovered that when a vein is everted obliquely, that is with the everted part having different lengths along the circumference of the eversion, the everted vein tends to bend after a while, in an attempt to release the strain caused by the uneven eversion.
- this mechanism is utilized when forming an eversion, even using a non-oblique anastomosis device, with the result that the graft curves after the anastomosis is completed.
- Fig. 14 illustrates a tip of a hole-punching tool 950, in accordance with a prefe ⁇ ed embodiment of the invention.
- the side of the figure to the left of the axis shows the tip prior to hole punching and the side of the figure to the right of the axis shows the tip after the punching is completed.
- Punch 950 comprises an anvil 954 and an outer cutting tube 952.
- a sha ⁇ inner tip 956 is used to form an initial hole in vessel 130 and then tip 956 is retracted.
- anvil 954 is advanced until vessel 130 is engaged by a depression 958 in anvil 954.
- Depression 958 preferably has an inclined side 962.
- Cutting tube 952 has a forward portion having a reduced inner diameter that is smaller than the outer diameter of the sides of depression 958.
- a benefit of this design is the relative laxity of tolerances, as long as the inner diameter of cutting tube 960 matches a diameter of some point of slope 962.
- Punch mechanism 950 can be used for both straight and oblique cuts, by varying the location and/or slope 962 of depression 958.
- a graft is attached to an aorta and then to a coronary vessel.
- a similar procedure may be used in other blood vessels, for example the femoral artery.
- a punch mechanism 950 can be used for both blood vessels.
- the graft may be, for example, a vein or artery from the same or a different patient. Alternatively, a xenograft or a synthetic graft may be used instead.
- end-to-side anastomosis connectors have focused on end-to-side anastomosis connectors.
- the above described features can also be applied to side-to-side and end-to-end anastomosis connections and connectors, for example replacing bending spikes with single or double pivot bending spikes.
- the above described spike and ring segment designs may also be applied to hole closure devices, that radially contract and seal a hole formed in a blood vessel. Such devices may include only "forward" spikes, to engage the blood vessel, at its side or at its end.
- the above described methods of vascular surgery 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 and/or which vessel is a "side" side and which vessel (or graft) is an "end" side of an end- to-side anastomosis.
- the location of various elements may be switched, without exceeding the sprit of the disclosure, for example, switching the anvil for the cutting edge in the hole-punching devices and 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”.
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Abstract
Description
Claims
Priority Applications (53)
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. |
BR0009172-3A BR0009172A (en) | 1999-03-19 | 1999-12-09 | Connector for anastomosis, process for reversing a blood vessel, apparatus for reversing a graft graft on a jaw has a tip, process for measuring a graft size, puncture hole, process for forming a connector for anastomosis, and distribution system mounted delate |
US09/936,805 US6979338B1 (en) | 1998-05-29 | 2000-03-20 | Low profile anastomosis connector |
CA002366708A CA2366708A1 (en) | 1999-03-19 | 2000-03-20 | Low profile anastomosis connector |
MXPA01009472A MXPA01009472A (en) | 1999-03-19 | 2000-03-20 | Low profile anastomosis connector. |
AU33138/00A AU769269B2 (en) | 1999-03-19 | 2000-03-20 | Low profile anastomosis connector |
KR1020017011866A KR20010113767A (en) | 1999-03-19 | 2000-03-20 | Low profile anastomosis connector |
JP2000606137A JP2002538926A (en) | 1999-03-19 | 2000-03-20 | Low profile connector |
NZ514745A NZ514745A (en) | 1999-03-19 | 2000-03-20 | Low profile anastomosis connector |
IL14543100A IL145431A0 (en) | 1999-03-19 | 2000-03-20 | Low profile anastomosis connector |
EP00911144A EP1171044A1 (en) | 1999-03-19 | 2000-03-20 | Low profile anastomosis connector |
IL15005100A IL150051A0 (en) | 1999-05-30 | 2000-09-28 | Blood vessel lip attachment |
BR0016247-7A BR0016247A (en) | 1999-12-08 | 2000-09-28 | Anastomotic devices and methods |
JP2001542802A JP2003515416A (en) | 1999-12-08 | 2000-09-28 | Anastomosis device and method |
PCT/IL2000/000611 WO2001041624A2 (en) | 1999-05-30 | 2000-09-28 | Vessel lip attachment |
PCT/IL2000/000609 WO2001041623A2 (en) | 1999-05-30 | 2000-09-28 | Anastomotic devices and methods |
EP00964605A EP1259169A2 (en) | 1999-12-08 | 2000-09-28 | Vessel lip attachment |
AU75525/00A AU7552500A (en) | 1999-12-08 | 2000-09-28 | Anastomotic devices and methods |
JP2001542803A JP2004513670A (en) | 1999-12-08 | 2000-09-28 | Vessel limbus coupler |
CA002393486A CA2393486A1 (en) | 1999-12-08 | 2000-09-28 | Vessel lip attachment |
EP00964603A EP1237485A2 (en) | 1999-12-08 | 2000-09-28 | Anastomotic devices and methods |
IL15000300A IL150003A0 (en) | 1999-12-08 | 2000-09-28 | Anastomotic devices and methods |
AU75527/00A AU7552700A (en) | 1999-12-08 | 2000-09-28 | Vessel lip attachment |
CA002393508A CA2393508A1 (en) | 1999-12-08 | 2000-09-28 | Anastomotic devices and methods |
CA002403119A CA2403119A1 (en) | 2000-03-20 | 2001-01-24 | Graft delivery system |
IL15159001A IL151590A0 (en) | 2000-03-20 | 2001-01-24 | Graft delivery system |
EP01959910A EP1265536A1 (en) | 2000-03-20 | 2001-01-24 | Graft delivery system |
AU2001228774A AU2001228774A1 (en) | 2000-03-20 | 2001-01-24 | Graft delivery system |
BR0109404-1A BR0109404A (en) | 2000-03-20 | 2001-01-24 | Medical graft delivery system, removable graft guide for a graft delivery system, and pot puller |
JP2001568319A JP2003527189A (en) | 2000-03-20 | 2001-01-24 | Graft transfer system |
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 |
CA002403506A CA2403506A1 (en) | 2000-03-20 | 2001-01-25 | An anastomotic connector and graft expander for mounting a graft |
IL15153901A IL151539A0 (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 |
AU28779/01A AU2877901A (en) | 2000-03-20 | 2001-01-25 | An anastomotic connector and graft expander for mounting a graft |
JP2001568320A JP2003532457A (en) | 2000-03-20 | 2001-01-25 | Anastomotic connector and graft expander for graph and attachment |
EP01959911A EP1289430A1 (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 |
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 |
JP2001568293A JP2004500209A (en) | 2000-03-20 | 2001-03-20 | Transfer of grafts and connectors |
CA002403289A CA2403289A1 (en) | 2000-03-20 | 2001-03-20 | Graft and connector delivery |
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 |
IL15169301A IL151693A0 (en) | 2000-03-20 | 2001-03-20 | Graft and connector delivery |
EP01917421A EP1265535A2 (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 |
PCT/IL2001/000266 WO2001070090A2 (en) | 2000-03-20 | 2001-03-20 | Graft and connector delivery |
US10/239,364 US20040097973A1 (en) | 2000-03-20 | 2001-03-20 | Transvascular bybass method and system |
PCT/IL2001/000600 WO2002047561A1 (en) | 2000-03-20 | 2001-06-28 | Method and apparatus for forming apertures in blood vessels |
HK02103911.8A HK1042030A1 (en) | 1999-03-19 | 2002-05-25 | Low profile anastomosis connector |
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 |
US10/668,059 US20050101983A1 (en) | 1998-05-29 | 2003-09-22 | Method and apparatus for forming apertures in blood vessels |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IL129067 | 1999-03-19 | ||
ILPCT/IL99/00284 | 1999-05-30 | ||
ILPCT/IL99/00285 | 1999-05-30 | ||
ILPCT/IL99/00670 | 1999-12-08 | ||
PCT/IL1999/000674 WO2000056223A1 (en) | 1999-03-19 | 1999-12-09 | Vascular closure device |
ILPCT/IL99/00674 | 1999-12-09 |
Related Child Applications (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/936,805 A-371-Of-International US6979338B1 (en) | 1998-05-29 | 2000-03-20 | Low profile anastomosis connector |
US10/459,373 Continuation-In-Part US20040049221A1 (en) | 1998-05-29 | 2003-06-11 | Method and apparatus for forming apertures in blood vessels |
US10/459,407 Continuation-In-Part US20040073247A1 (en) | 1998-05-29 | 2003-06-11 | Method and apparatus for forming apertures in blood vessels |
US10/668,059 Continuation-In-Part US20050101983A1 (en) | 1998-05-29 | 2003-09-22 | 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 (1)
Publication Number | Publication Date |
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WO2000056228A1 true WO2000056228A1 (en) | 2000-09-28 |
Family
ID=11062765
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/IB2000/000310 WO2000056228A1 (en) | 1998-05-29 | 2000-03-20 | Low profile anastomosis connector |
Country Status (1)
Country | Link |
---|---|
WO (1) | WO2000056228A1 (en) |
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