JP2004513670A - Vessel limbus coupler - Google Patents

Abstract

A conduit coupling device for sealing an opening between two vessel edges, wherein at least one clip element adapted to seal at least a portion of the opening between the two vessel edges And a device comprising at least one puller adapted to draw at least one of the edges into the clip element within the body.

Description

[0001]
[Related application]
This application is related to PCT applications filed by Applicants Bypass Inc., et al. / 00310. The present application also relates to an application filed with the PCT Israeli Receiving Office on the same day as the present application, entitled "Anastomosis Devices and Methods", Attorney Docket 088/01579. All of the above applications specify the United States, the disclosures of which are incorporated herein by reference.
[0002]
[Field of the Invention]
The present invention relates to the handling of the edge of a hole in a blood vessel, particularly for performing an anastomotic joint.
[0003]
[Background of the Invention]
Turning over the edges of blood vessels is generally performed extracorporeally, as described, for example, in US Pat. Nos. 5,366,462 or 5,695,504, the disclosures of which are incorporated herein by reference. Done. However, the edge of the hole in the artery cannot be handled in this way. This is because arteries must be left in the body.
[0004]
[Summary of the Invention]
An aspect of some embodiments of the present invention relates to turning over the edges of the holes in the blood vessel such that they are engaged with an anastomotic connector or a hole closure device. In an exemplary embodiment of the invention, a puller is used to pull the edge into the connector. Optionally, the puller is removable, for example, as part of a device delivery system. Alternatively, the puller may remain at the joint. Alternatively, no pulling tool is used, for example, a change in device shape pulls the edge. Instead of retracting into the device, retract into the delivery system and then attach the anastomotic device. The delivery system guides retraction in some embodiments of the present invention.
[0005]
The puller can be used with various types of vascular devices, where the puller carries the edge of a blood vessel to a desired position relative to other edges or devices and, optionally, during handling of the device. Hold the edge in place or move it. If multiple pullers are provided, the pullers can be activated, for example, simultaneously or sequentially.
[0006]
The anastomosis device may have, for example, one part, two parts, or a plurality of independent (or finely attached) clamping elements.
The retracted edges may be pressed together to prevent blood leakage. Alternatively, they may be pressed against a part of the device.
[0007]
An aspect of some embodiments of the invention relates to a method of connecting two blood vessels using a plurality of clips. In an exemplary embodiment of the invention, the edges of the two vessels were turned over, the clips were left outside the vessel, and the clips were turned over such that there was an intimal-intimal junction between the vessels. Closed on part. In some embodiments of the invention, the edges are turned over using hooks that penetrate the edges. Alternatively, the hook does not pierce the edge.
[0008]
Thus, according to an exemplary embodiment of the present invention, a conduit coupling device for sealing an opening between two vessel edges, comprising:
At least one clip element adapted to seal at least a portion of the opening between the two vessel edges; and
At least one puller adapted to draw at least one of the edges into the clip element within the body
There is provided a device comprising:
Optionally, said puller is attached to said device. Alternatively, the puller is not attached to the device.
[0009]
In an exemplary embodiment of the invention, the puller is adapted to remain in the body after use. Alternatively, the puller is adapted to be removed from the body after use.
In an exemplary embodiment of the invention, said puller is bioabsorbable.
In an exemplary embodiment of the invention, said puller is adapted to penetrate said edge. Alternatively or additionally, the puller is adapted to puncture the edge. Alternatively, the puller is adapted to not penetrate the edge.
[0010]
In an exemplary embodiment of the invention, said puller is adapted to be deformed by said clip. Optionally, the deformation facilitates removal of the puller from the closure.
In an exemplary embodiment of the invention, said at least one puller comprises a single puller adapted to pull both said edges. Alternatively, said at least one puller comprises two pullers, each adapted to pull one of said edges.
[0011]
In an exemplary embodiment of the present invention, the puller is attached to a thin wire for retracting the puller. Optionally, the puller is deformed by the retraction while retracting the edge into the clip.
[0012]
In an exemplary embodiment of the invention, said at least one clip comprises a plurality of clips cooperating to seal said opening. Further, the plurality of clips may be connected to each other. Alternatively, the plurality of clips are connected to each other. Further, the plurality of clips may be immovably connected to each other. Alternatively, the plurality of clips are flexibly connected to each other.
[0013]
In an exemplary embodiment of the invention, the clip does not deform to achieve the seal. Alternatively, the clip deforms to achieve the seal. The clip may further comprise two arms that bend toward each other to achieve the seal. Alternatively or additionally, the clip is plastically deformed. Further, the device may comprise a delivery system including a contra element and a pressure element, wherein the two elements press the clip between them.
[0014]
In an exemplary embodiment of the invention, the clip deforms automatically. The device may further comprise a delivery system including a regulatory element adapted to selectively release the clip to automatically deform.
In an exemplary embodiment of the invention, said clip includes barbs for engaging said edge. Alternatively or additionally, the clip includes a protrusion for engaging the edge.
In an exemplary embodiment of the invention, said clip includes a slot for engaging said edge.
[0015]
In an exemplary embodiment of the invention, said clip is adapted to seal said edges. Alternatively or additionally, the clip is adapted to seal the edge with a portion of the clip.
In an exemplary embodiment of the present invention, the clip presses the edge to perform the sealing.
[0016]
In an exemplary embodiment of the invention, said edges are the edges of the same tube. Alternatively, the edge is the edge of two different tubes.
In an exemplary embodiment of the invention, at least one of said vessels is an in vivo blood vessel. Alternatively or additionally, at least one of the tubes is a synthetic implant.
[0017]
According to an exemplary embodiment of the present invention, a method for sealing an opening between vessel edges, comprising:
Supply of clips;
A first retraction of a first edge into the clip; and
Second retraction of a second edge into the clip
Are provided. The method may further include closing the clip to seal the opening. The closing may further include releasing the clip to automatically deform. Alternatively or additionally, the closing includes plastically deforming the clip.
[0018]
In an exemplary embodiment of the invention, said first and second retraction are performed simultaneously. Alternatively, the first and second retraction are performed using a single pulling tool. Further, the puller may have a single edge engaging element. Alternatively, the puller may have at least two edge engaging elements.
[0019]
In an exemplary embodiment of the invention, said first and second retraction are performed using at least two pullers.
In an exemplary embodiment of the invention, the method includes retracting the puller from the closure. Alternatively, the method includes leaving the puller in the enclosure.
In an exemplary embodiment of the invention, the method includes providing a drug to the closure. Further, the drug may include a clot preventing agent. Alternatively, the drug may include a clot promoting agent.
[0020]
In an exemplary embodiment of the invention, providing comprises providing a layer of the agent-containing material. Further, the layer may be provided between the edges.
In an exemplary embodiment of the invention, the two edges are edges of an opening in a single tube. Alternatively, the two edges are different tube edges.
In an exemplary embodiment of the invention, at least one of said tubes comprises a blood vessel.
[0021]
Non-limiting embodiments of the present invention will be described with reference to the following description of exemplary embodiments in conjunction with the drawings. The drawings are not usually shown to scale, and all values are exemplary and not necessarily limiting. In the figures, identical structures, elements or parts that appear in more than one figure are preferably numbered the same or similar in all the figures in which they appear.
[0022]
[Details of Preferred Embodiment]
1A-1D illustrate a vascular connection method according to an exemplary embodiment of the present invention. In FIG. 1A, a blood vessel end 100 and a blood vessel side 102 are connected to each other using a clip 104. The clip 104 includes a first arm 106 having a first engagement means, such as a barb 108 for engaging the blood vessel 100, and a vasculature such as a barb 112 for engaging the blood vessel 102. And a second arm 110 having a combining means. In this and other embodiments, the blood vessels and / or grafts may be natural blood vessels, synthetic, autologous, xenologus, cadaveric grafts, and / or any other type of blood vessel. Department.
[0023]
In FIG. 1A, the two blood vessels are engaged by the barbs such that the edge 114 of the blood vessel 100 is engaged by the barbs 108 and the edge 116 of the blood vessel 102 is engaged by the barbs 112. The two edges may abut or there may be a space between them.
[0024]
In FIG. 1B, the clip 104 is folded so that the two arms of the clip press the intimal portions of the two edges together. The barbs prevent inadvertent dislodgement of the vessel edges during conformal deformation and / or stabilize after joining is complete.
[0025]
Adaptive deformation of the clip can be performed in various ways, for example, elastically, superelastically, or using a shape memory clip, in which case no external force will be required. Alternatively, the clip 104 is plastically deformed.
[0026]
The clip 104 shown in FIG. 1A has an angle greater than 180 ° between the arms holding the barbs, but in some embodiments, pushes the clip with pliers or clamp scissors. The clip 104 is flat or has an angle of less than 180 ° so that it can be closed closed. The angle between the arms will affect the difficulty of attaching the edge of the vessel to the spine.
[0027]
1C and 1D illustrate the use of a puller to draw the edge of a blood vessel onto a barb. FIG. 1C shows a puller 120 including a curved tip 122 for pulling an edge 114 of the blood vessel 100 onto the barb 108. FIG. 1D shows a puller 124 having a curved tip 126 for pulling the edge 116 of the blood vessel 102 onto the barbs 112. Instead of the above, other attachment methods such as attachment by hand may be used. Exemplary devices for performing the methods of FIGS. 1C-1D are described below.
[0028]
In some embodiments of the present invention, the tips 126 (and 122) are pointed. Alternatively, the tip 126 may be blunt, for example, to prevent the tip from penetrating the vessel wall with which the tip is engaged. The tip 126 may be, for example, forked so that the tip does not excessively pierce the vessel wall.
[0029]
Although the clip is shown utilized for a side-to-end anastomotic joint, it can also be used for other types of joints, such as end-to-end and side-to-side joints. it can.
[0030]
FIG. 1E is a top view of a clip suitable for the method illustrated in FIGS. 1A-1D. In this exemplary embodiment, clip 104 includes an elliptical ring with arm 106 on one side and arm 110 on the other. The barbs are formed at the top of the ellipse. Two crossbars 130 are provided so that the clip itself can be used as a pivot for the pullers 120 and 124. In another embodiment, clip 104 is rod-shaped. A complete anastomosis, as described below, would require multiple such clips, ie, a multi-clip connector.
[0031]
2A-2B illustrate a vascular connection method according to another exemplary embodiment of the present invention. A clip 204 (which may be the same as clip 104 in FIG. 1) is attached to blood vessels 100 and 102. Instead of two separate pullers, one puller 220 is shown that includes two barbs 222 and 226 (one for each vessel). This puller can optionally be used to attach a blood vessel to the clip 104 of FIG. Opposite the barbs 222 and 226, and after the clip 104, is a reaction element 232 with two portions spaced therebetween. As the puller 220 is retracted toward the reaction element 232, the clip 204 is pulled and bent between the reaction element portions, thereby pinching the edges of the two vessels between the arms. The resulting completed joint is shown in FIG. 2B. The reaction element 232 can optionally have a protrusion 236 on one or both portions to prevent the clip 204 from retreating excessively. A further pulling of the reaction elements together may be performed so that bending the clip 204 further seals the anastomosis. The reaction element 232 will be removed after processing is complete so that only the clip 204 remains in the body.
[0032]
The puller 220 can be cut at the location 234, thereby leaving the barbs 222 and 226 in the anastomotic joint. Typically, the spines are bioabsorbable. Alternatively or additionally, the spines contain a tissue binding promoter. Alternatively or additionally, the barbs are pulled out of the blood vessel, usually tearing the edge of the blood vessel at the outer portion of the junction area. In certain embodiments of the invention, the barbs are shorter than the thickness of the vessel wall so that they do not tear completely. Usually, the spines soften and pull out at body temperature or in a liquid or electrolyte environment. Alternatively, the barbs 222 and 226 are bent back by the bar 130 (FIG. 1E), allowing them to be more easily pulled. Alternatively or additionally, the barbs 222 and 226 are not sharp and do not pierce the vessel wall, but merely pulling it down, usually sliding past the wall while deforming, outside the connector Get out. Alternatively or additionally, puller 220 may be coupled to other portions of the clip, for example, using a thread or wire.
[0033]
FIG. 2C illustrates another vascular coupling device 240 according to another exemplary embodiment of the present invention. Device 240 includes a clip 242 and a puller 244 substantially similar to clip 104 and clip 204. However, the clip 242 is bent in advance. Accordingly, the puller 244 needs to draw the edge of the tissue into the narrow space 246 formed between the two arms of the clip 242. The barbs 248 can prevent the edge once retracted into the space 246 from retreating. In some embodiments of the present invention, space 246 includes a wall (not shown) that divides the space into two spaces (one on each edge). Instead of or in addition to the wall, gauze, pad or bioabsorbable material can be provided as a layer between the two edges and / or between the edge and the device. In an exemplary embodiment of the invention, the layer elutes heparin or other procoagulant or competitive inhibitor, for example, to promote coagulation or prevent clots in leaked blood. Other drugs may be supplied as well. The drug may be immersed in the layer so that it is released slowly over time, or may be retained, for example, in a matrix.
[0034]
FIG. 2D illustrates another clip 252 according to an exemplary embodiment of the present invention. The clips described above, such as the clip of FIG. 1E, have opposing arms. However, this is not required. The clip 252 has one arm 253 on one side of the base 256 and two arms 254 on the opposite side. A corresponding asymmetric puller 250 is also shown, which has a single pulling barb 260 on the thread 262 and two opposing pulling barbs 260. Arms 253 and 254 may have barbs as described above. However, in an exemplary embodiment of the invention, vascular tissue is pushed into the space between arms 254, typically by arms 253, and is sandwiched between two arms 254. Optionally, the arms may extend at an angle so that the space between the arms is more wedge shaped. The distance between the arms is typically shorter than the combined thickness of the two targeted blood vessels. Alternatively or additionally, the arms may be elastically deformed to accommodate thicker tissue.
[0035]
3A-3D illustrate a hole closure device 300 with a clip-puller combination, according to an exemplary embodiment of the present invention. Although FIGS. 1 and 2 have been described with reference to joining the edges of two different blood vessels, similar principles can be applied to a hole closure of a blood vessel where the two edges of the same blood vessel are sealed together.
[0036]
FIG. 3A is a layout diagram of the hole closure device 300. In FIG. 3B, the device 300 has been folded to have a base 302 and two arms 304. Each arm has one or more barbs 306 at its end.
[0037]
FIG. 3C shows the device 300 installed. In an exemplary embodiment of the invention, the device 300 is held by the contra-tube 320 in proximity to the hole 310 in the blood vessel while in contact with the blood vessel 312. Contra-tube 320 may be hollow. Alternatively, device 300 may be attached to tube 320. Hole 310 has edges 318 and 320 that can be pulled into device 300 by puller 314. Typically, puller 314 is pulled using a thread or wire 316. Thread or wire 316 may be further passed through tube 320.
[0038]
FIG. 3D shows hole 310 after puller 314 has drawn edges 318 and 320 into device 300. The puller 314 (which may be left at the joint) has been withdrawn, for example (typically after being bent back through holes in the base 302 and possibly contacting the base 302 itself), or Absorbed as described above, not shown. The device 300 can be sized to accommodate various hole sizes and vessel thicknesses. Alternatively or additionally, a flat device, such as that shown in FIG. 3A, is bent in place to meet the desired hole closure characteristics. Although device 300 is shown with two barbs 306 on each arm, it may have more or fewer barbs (typically barbs are not opposed), and Instead, the barbs may be provided with even (unsharp) projections. The length of the device will depend, for example, on the dimensions of the hole 310. Instead of or in addition to the above, a plurality of devices 300 are used side by side.
[0039]
Similarly, the clips of FIGS. 1-2 may be supplied as individual clips, for example, one at a time, or using, for example, a multi-clip delivery system for mass deployment. Generally, multiple clips, e.g., 3, 4, 5, 6, or more clips, are required to join two blood vessels. Alternatively, the clips can be joined together, for example, using a thread or ring, to form a single anastomotic connector (or hole closure device). Alternatively, the connector and hole closure device described earlier (eg, in the aforementioned PCT application) may be split to provide a clip, for example, each with two opposing spikes and an optional ring portion. .
[0040]
Instead of or in addition to the spike / arm bending, a torsion bar mechanism can be provided for rotation of the arm. In an exemplary embodiment of the invention, the base 256 of the clip 252 can be used as a torsion bar that twists instead of or in addition to bending the arms 254 and 253. This allows the clip 252 to simply be a pressure-based clip that makes strong contact with the two vascular tissues.
[0041]
FIG. 4 illustrates a multi-clip connector 400, according to an exemplary embodiment of the present invention. Connector 400 includes a ring 402 having a plurality of “side” engaging clip arms 404 and a plurality of opposite “end” engaging clip arms 406. As shown, the opposite clip arms need not be at the same radial position, but it is possible. Alternatively or additionally, the number of "side" and "end" clip arms may be different. Alternatively or additionally, the connector may be used for two blood vessels "sides" or for two blood vessels "ends". As shown, the clip arms are designed not to penetrate the vessel wall, however, in some embodiments, at least some clip arms can penetrate the vessel wall and such May include a fork-like design or projections distal from their tips to prevent penetration of the blood vessel and / or movement of the vessel wall along the arm. The clip arms on both sides can have the same or different schematic designs. Alternatively or additionally, the clip arms on the same side of the ring 402 may also be the same (as shown) or may be different such that the clip arms have alternately different designs. Is also good.
[0042]
5A-5F illustrate a method of installing the clip of FIG. 4, according to an exemplary embodiment of the present invention. In these figures, all repeating elements have not been shown to reduce visual confusion. The system 500 can be installed, for example, in open surgery, endoscopic or throscopic surgery, and / or a vascular approach.
[0043]
FIG. 5A illustrates a delivery system 500 having an implant 502 and a connector 400 mounted therein. This view is a cross-sectional view selected so that the operation of one “side” arm 404 and one “end” arm 406 can be clearly seen.
[0044]
System 500 includes an outer contra tube 506 and an inner push tube 504. The connector 400 is held by an external contra-tube 506, for example, resilient or frictional. An external base tube 508 is provided to close the "side" arm as described below. A plurality of “side” vessel pullers 512 are provided through holes 514 formed in the outer tube 506. A plurality of “end” vascular pullers 510 are provided through holes 516 formed in the outer tube 506. In an exemplary embodiment of the invention, the arms 404 and 406 are staggered, so that the holes 514 and 516 are also staggered to match the arm position. The tips of the pullers may or may not be aligned with the arms from which they draw the tubing. In some embodiments, at least some pullers are not flat.
[0045]
In FIG. 5B, the “end” puller 510 has been retracted, pulling the edge of the implant 502 toward the clip device 400. This step can be performed inside or outside the body.
[0046]
FIG. 5C shows the system 500 near the targeted vessel side 520. The target blood vessel 520 may be, for example, a circular artery, an artificial or biological graft, an aorta, a LIMA, a circular vein, an artery or a peripheral blood vessel, such as a femoral artery or a foot vein, or any other known blood vessel. Good. Implant 502 may also be any known blood vessel. The puller 512 is extended forward so as to enter the opening of the blood vessel 520. In some embodiments of the present invention, the insertion of the puller 512 is performed manually. In other embodiments, alignment is facilitated by the alignment of the system 500 with the hole in the target vessel. It should be noted that a punch for forming the opening can be supplied through the external base tube 508 and then replaced with the implant supply portion. Alternatively, a punch can be provided through the implant 502. Alternatively, a punch is provided through the implant 502. Alternatively, a separate drilling tool is used. Alternatively, an incision is made using a knife.
[0047]
In FIG. 5D, the puller 512 is retracted and pulls the edge of the incision in the blood vessel 520 into the clip so that the edges of the two blood vessels are closer and touch or overlap each other.
[0048]
In FIG. 5E, the proximal inward portion 522 of the base 508 is pushed inward, thereby closing the arms 404 toward the edge of the blood vessel 520, and also typically turning them back in the process. Portion 522 can include a ramped portion 526 that guides the arm to close in a desired manner. One typical method of moving section 522 is to advance outer barrel 524 along the outside of outer base tube 508 to compress it radially. While the puller 512 may deform while closing the arm 404, this is usually not important.
[0049]
In FIG. 5F, the internal pusher tube 504 advances and closes the arm 406 of the clip 400. The base tube 508 will serve as a counteracting pressure. In this way, the vessel is securely held between the arms 404 and 406, preferably preventing blood leakage.
[0050]
In some embodiments of the present invention, the steps of FIGS. 5E and 5F are performed simultaneously or in reverse order. While it is preferable to process all arms on the same side simultaneously, some embodiments do not close all arms on the same side together.
[0051]
Upon completion of the anastomosis, the pullers 512 and 510 can be retracted and the base tube 508 can be radially expanded to release the clip 400. The inner tube 504 may be advanced to further remove the clip 400 from the outer tube 506. Alternatively, the puller may be handled as described above, e.g., cut and left in the body, and is usually absorbed.
[0052]
The above has described the installation of a plastically deformable device. Similar delivery systems can be used with elastic, shape memory or superelastic devices. For example, the base tube 508 may include a barb or inner edge that keeps the arm 404 open (until the base tube 508 is advanced) and the inner tube 504 (until the inner tube 504 is retracted). ) An extension may be included to prevent the arm 406 from closing. Even in the plastically deformable device 400, the ring 402 may be resilient to allow radial compression during installation and / or to be retained by the outer tube 506.
[0053]
Although FIG. 5 above and FIG. 6 after describe a side-to-end anastomosis, it should be understood that similar structures can be used for diagonal, side-to-side and end-to-end joints. It is. In such a junction, the blood vessels can be positioned non-axially with respect to other portions of the delivery system 500, for example, by feeding through a lumen perpendicular to the axis of the system. However, the general operation of the puller remains the same.
[0054]
Alternatively or additionally, the system 500 is a split system (longitudinal, two, three or more parts) for easier removal from the implant 502.
[0055]
6A-6B illustrate another method of placing multiple clips at an anastomotic junction, according to an exemplary embodiment of the present invention.
[0056]
FIG. 6A shows an implant 602 having an edge 604 pierced by a puller 606. The delivery system 600 attached to the implant includes an inner tube 620 to which an anastomotic connector 608 is attached. The connector 608 can include, for example, a ring 616 and a plurality of arms 618. In an exemplary embodiment of the invention, connector 608 includes arms 618 that are superelastic, resilient, or shape memory and are prevented from folding in by restraining members 626. In an exemplary embodiment of the invention, the inward extension 610 of the regulating member 626 includes a circumferentially oriented (eg, out of the plane of the figure) protrusion 612 (or a slot provided in the regulating member 626). ), Which prevents radial movement of the arm 618. When the regulating member 626 rotates relative to the connector 608, or when the regulating member 626 expands in the radial direction, the arm 618 is released.
[0057]
Delivery system 600 further includes a retraction tube 624 for retracting puller 606 and a contra tube 622 for preventing retraction of connector 608.
[0058]
In FIG. 6B, the puller 606 has been extended into the incision 634 (having an edge 632 on the vessel "side" 630).
[0059]
In FIG. 6C, the puller 606 is retracted, flipping over the edge 632, and drawing both the edge 632 and the edge 604 into the connector 608. Regulator 626 then releases arm 618, which closes the connector and seals the junction between graft 602 and blood vessel 630. The puller 606 is now typically no longer needed, at least to retain the blood vessel 630. The puller 606 can then be further retracted. The retraction causes the puller to be straightened, so that no damage to the blood vessels normally occurs. The connector 608 can be released, for example, by advancing the contratube 622. In the plastic deformation embodiment, the restricting member 626 acts as an anvil to radially compress the arm 618.
[0060]
The arm 618 can have a sharp tip as shown, for example, to penetrate one or both edges 632 and 604. Alternatively, the distal end of arm 618 may be blunt so that pressure is applied without stabbing. Alternatively, arm 618 may hold edge 604 to hit the top of the connector and edge 632 to hit the ring portion of the connector.
[0061]
It should be noted that while FIGS. 5 and 6 illustrate an anastomotic connector, a similar delivery system can be used to join two edges of a single blood vessel, for example, for a hole closure. . In such a case, instead of being a ring as shown in FIG. 4, the connector could be a line connector or an annular connector with arms only at the bottom and facing in.
[0062]
7A-7C illustrate the placement of another clip device for connecting two blood vessels, according to an exemplary embodiment of the present invention.
[0063]
In FIG. 7A, the clip 700 has elasticity, superelasticity, or shape memory that tends to assume a bent shape (i.e., automatically closes). The restricting member 706 has a slotted portion 712 that engages, for example, the arm 708 of the clip 700 to prevent the arm from closing. The other arm 710 of the clip 700 may be held in another slot (or bump). Alternatively, clip 700 is part of a single connector that includes a plurality of clips attached to ring 716, shown here as being held in holder 718.
[0064]
In use, the edge of the implant 702 is pierced into the arm 708 of the clip 700. Arm 708 is inserted into an incision in blood vessel 704 (only one side is shown). When the restriction member 706 releases the clip 700, the clip closes and seals the graft 702 and the blood vessel 704 together. In the plastic deformation type embodiment, the arm 708 can be bent toward the arm 710 by the retreat of the regulating member 706.
[0065]
FIG. 7B illustrates another embodiment of the present invention, wherein a self-closed clip 720 pierces the graft 702 and the blood vessel 704. The clip can be inserted into the incision in the blood vessel 704, for example, manually, and then retracted to embed it in the vessel wall. When the outer regulating tube 722 is retracted, the clip 720 can bend freely. In some embodiments of the invention, clip 720, like clip 700, can also be part of a multi-clip connector.
[0066]
FIG. 7C illustrates another embodiment of the present invention in which the edges of the graft 702 and the blood vessel 704 are inserted into the clip 730, for example, manually or using a puller (not shown). Have been. Clip 730 includes two arms 732 and 734 connected by a base 736. In an exemplary embodiment of the invention, clip 730 is pre-stressed such that arms 732 and 734 bend inward. Arms 732 and 734 extend beyond base 736 to provide extensions 742 and 744, respectively. A regulating member comprising two opposing regulating elements 738 and 740 engages and holds the clip 730 in place via the extensions 742 and 744. Clip 730 is a self-closed clip where arms 732 and 734 close toward each other. When the restriction elements 738 and 740 are released, the arms 732 and 734 advance toward each other, engaging and sealing the edges of the graft 702 and the blood vessel 704 together. In an exemplary embodiment of the invention, regulating elements 738 and 740 are attached so as to increase the distance between arms 732 and 734 and facilitate insertion of the vessel 704 and the edge of graft 702 into the clip. ing. Typically, the clip 730 is positioned to lean against the blood vessel and the graft, and when the restraining element is released, the tips of the arms 732 and 734 engage the edges and move into the clip.
[0067]
The device can be variously modified, such as to fit a particular type of blood vessel. In some embodiments of the invention, the device is packaged and / or sold with instructions describing the dimensions of the device and / or the circumstances under which the device is to be utilized.
[0068]
You can change one or more of the following parameters of the device, for example:
(A) Number of barbs on clip arm. Although only one barb is shown, two, three or more barbs may be provided.
(B) Position of the spine along the arm. Although barbs are shown at the tip of the arm, they may be located more inward. In devices with multiple barbs, the barbs may be arranged, for example, side by side or other anterior.
(C) Arm shape. A variety of shapes can be provided, such as square, triangular, arcuate, circular and partially straight or curved. The arms may be flat or may extend out of a plane, such as curved.
[0069]
(D) The length of the spine. The barbs may have a length sufficient to puncture the vessel wall. Alternatively, the barbs may be shorter, for example, to penetrate only some layers of the blood vessel. Note that different spines on the same device may have different lengths or other characteristics, for example, depending on the characteristics of the targeted blood vessel. Typical lengths include 0.1 mm, 0.5 mm, 1 mm, 2 mm and longer, shorter and intermediate sizes. Other parameters in the design of the barbs, such as the degree of sharpness (sharp or obtuse), are similarly varied.
[0070]
(E) Arm length. The length of the arm will also depend on the characteristics of the target vessel and the shape of the junction. Typical lengths include 1 mm, 3 mm, 5 mm, 7 mm and longer, shorter and intermediate sizes.
(F) The presence and dimensions of the base. Although not all devices include a base, the length of the base may be, for example, 1 mm, 3 mm, 5 mm, 7 mm and longer, shorter and intermediate sizes. The width of the base (between the two arms) may be, for example, 0.5 mm, 1 mm, 3 mm, 5 mm and larger, smaller and intermediate sizes.
[0071]
(G) The presence and shape of the lumen. In a device with a central lumen, the shape of the lumen and the drilled hole can be changed, for example, to a circle, ellipse or polygon.
(F) The solidity of the device. Although the device may have a continuous surface in some embodiments of the present invention, one or more holes may be formed in the surface of the device, for example, as shown in FIGS. 3A and 1A. Thereby, the total amount of foreign substances in the body can be reduced. However, the total amount of material in the bloodstream may be very low or even zero in some embodiments of the present invention.
[0072]
It should be understood that the above described method and apparatus for handling blood vessels can be modified in various ways. Deformation includes the order of steps performed inside and outside the body, the order of performing anastomotic joints, the order of steps within each anastomosis, the exact material used for the anastomotic connector, On the side, this involves changing which blood vessel (or graft) is lateral and / or whether the two edges to be joined are of the same or different vessels. Further, in mechanical embodiments, the location of various elements can be changed without departing from the spirit of the disclosure, such as changing a stationary element to a moving element where relative movement is required. Furthermore, the diversity of various features of both the method and the apparatus has been described. It should be understood that different combinations of different features are possible. In particular, not all features shown in a particular embodiment are required in each similar invention of the present invention. Furthermore, combinations of the features of the various embodiments described are also within the scope of some exemplary embodiments of the invention. Further, according to other exemplary embodiments of the present invention, certain features of the present invention described herein may be adapted for use with prior art devices. The specific shapes used to describe the invention should not be deemed to limit the broadest aspects of the invention to only those shapes. For example, where a circular lumen is shown, other embodiments may use an elliptical lumen.
[0073]
The scope of the present invention also includes a surgical kit that includes a set of medical devices suitable for performing single or a small number of anastomotic joints. The dimensions are shown only as exemplary dimensions for a particular case, the exact dimensions applied will depend on the application. Where the terms "comprise", "comprises", "includes", "includes" and the like are used in a claim, "including but not limited to" is meant.
[0074]
Those skilled in the art will appreciate that the present invention is not limited to what has been described. Rather, the scope of the present invention is limited only by the claims.
[Brief description of the drawings]
FIG. 1A-1D
1A-1D illustrate a vascular connection method and apparatus according to an exemplary embodiment of the present invention.
FIG. 1E
FIG. 1E is a top view of a clip suitable for the method illustrated in FIGS. 1A-1D.
FIG. 2A-2B
2A-2B illustrate a vascular connection method according to another exemplary embodiment of the present invention.
FIG. 2C
FIG. 2C illustrates another vascular connection device according to another exemplary embodiment of the present invention.
FIG. 2D
FIG. 2D illustrates another clip according to an exemplary embodiment of the present invention.
[FIG. 3A-3D]
3A-3D illustrate a hole closure device with a clip-puller combination according to an exemplary embodiment of the present invention.
FIG. 4
FIG. 4 illustrates a multi-clip connector according to an exemplary embodiment of the present invention.
FIG. 5A-5F
5A-5F illustrate a method of installing the clip of FIG. 4 according to an exemplary embodiment of the present invention.
6A to 6C.
6A-6C illustrate another method of placing multiple clips in an anastomotic joint according to an exemplary embodiment of the present invention.
7A to 7C.
7A-7C illustrate the placement of another clip-device for connecting two blood vessels according to an exemplary embodiment of the present invention.
[Explanation of symbols]
104, 204, 252 clips
124, 220, 510, 512 Pulling tool
232 reaction element
300 hole closure device
400 multi-clip connector

Claims (56)

A vascular coupling device for sealing an opening between two vessel edges, comprising:
At least one clip element adapted to seal at least a portion of the opening between two vessel edges; and within the body to draw at least one of the edges into the clip element A device comprising at least one adapted puller. The puller is attached to the device;
The device of claim 1. The puller is not attached to the device;
The device of claim 1. The puller is adapted to remain in the body after use;
The device of claim 1. The puller is adapted to be removable from the body after use;
The device of claim 1. The puller has a bioabsorbable property,
The device of claim 1. The puller is adapted to penetrate the edge;
The device of claim 1. The puller is adapted to puncture the edge;
The device of claim 1. The puller is adapted to not penetrate the edge;
The device of claim 1. The puller is adapted to be deformed by the clip;
The device of claim 1. The device of claim 10, wherein the deformation facilitates removal of the puller from the closure. The at least one puller includes a single puller adapted to pull both of the edges;
The device of claim 1. The at least one puller includes two pullers each adapted to pull one of the edges;
The device of claim 1. The pulling device is attached to a thin wire for retracting the pulling device,
The device of claim 1. The retractor is deformed by the retraction while retracting the edge into the clip;
The device of claim 14. The at least one clip includes a plurality of clips cooperating to seal the opening.
The device of claim 1. 17. The device of claim 16, wherein the plurality of clips are not connected to each other. The plurality of clips are connected to each other;
The device of claim 16. The plurality of clips are immovably connected to each other;
The device of claim 18. The plurality of clips are flexibly connected to each other,
The device of claim 18. The clip does not deform to achieve the seal;
The device of claim 1. The clip deforms to achieve the seal;
The device of claim 1. 23. The device of claim 22, wherein the clip comprises two arms that bend toward each other to achieve the seal. The clip is plastically deformed,
23. The device of claim 22. Equipped with a delivery system including a reaction element and a pressure element,
25. The device of claim 24, wherein the two elements press the clip between them. Said clips deform automatically,
23. The device of claim 22. Providing a delivery system including a regulatory element adapted to selectively release said clip for automatic deformation.
27. The device of claim 26. The clip includes barbs for engaging the edge.
The device of claim 1. The clip includes a protrusion for engaging the edge.
The device of claim 1. The clip includes a slot for engaging the edge.
The device of claim 1. The clip is adapted to seal the edges together;
The device of claim 1. The clip is adapted to seal the edge with a portion of the clip;
The device of claim 1. The clip presses the edge to perform the sealing,
The device of claim 1. Said edges are the edges of the same tube,
A device according to any one of claims 1-33. The edge is the edge of two different tubes,
A device according to any one of claims 1-33. At least one of said vessels is an in vivo blood vessel;
34. The device of claim 1-33. At least one of the tubes is a synthetic implant;
34. The device of claim 1-33. A method of sealing an opening between vessel edges, comprising:
Supply of clips;
A method comprising: a first retraction of a first edge into the clip; and a second retraction of a second edge into the clip. Closing the clip to seal the opening,
39. The method of claim 38. The closing includes releasing the clip to deform automatically.
40. The method of claim 39. The closing includes plastically deforming the clip,
40. The method of claim 39. Said first and second retraction are performed simultaneously;
39. The method of claim 38. The first and second retraction are performed using a single pulling device;
39. The method of claim 38. The puller has a single edge engaging element;
44. The method of claim 43. The puller has at least two edge engaging elements;
44. The method of claim 43. The first and second retraction are performed using at least two pulling tools;
39. The method of claim 38. Including retracting the puller from the seal,
47. The method of claim 43 or claim 46. Including leaving the puller in the enclosure.
47. The method of claim 43 or claim 46. Including supplying a drug to the closure,
The method of any one of claims 38-46. The drug includes an anti-clot agent,
50. The method of claim 49. The drug includes a clot promoting agent,
50. The method of claim 49. Providing includes providing a layer of a substance comprising the drug;
50. The method of claim 49. The layer is provided between the edges;
53. The method of claim 52. The two edges are edges of an opening in a single tube;
The method of any one of claims 38-46. The two edges are edges of different tubes,
The method of any one of claims 38-46. At least one of the tubes includes a blood vessel;
47. The method of claims 38-46.

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