Source: http://www.google.com/patents/US20050283188?dq=3723653
Timestamp: 2017-12-13 07:35:02
Document Index: 633422002

Matched Legal Cases: ['art 532', 'art 534', 'art 534', 'art 532', 'art 534', 'art 532']

Patent US20050283188 - Vascular closure device - Google Patents
A method of accessing a blood vessel, comprising: forming a hole in the blood vessel; mounting a hole closure device onto the blood vessel; accessing the blood vessel through the hole, while the hole closure device is mounted on the blood vessel; and closing the hole by the hole closure device, after...http://www.google.com/patents/US20050283188?utm_source=gb-gplus-sharePatent US20050283188 - Vascular closure device
Publication number US20050283188 A1
Application number US 11/210,554
Publication number 11210554, 210554, US 2005/0283188 A1, US 2005/283188 A1, US 20050283188 A1, US 20050283188A1, US 2005283188 A1, US 2005283188A1, US-A1-20050283188, US-A1-2005283188, US2005/0283188A1, US2005/283188A1, US20050283188 A1, US20050283188A1, US2005283188 A1, US2005283188A1
Patent Citations (79), Referenced by (334), Classifications (31)
US 20050283188 A1
A method of accessing a blood vessel, comprising: forming a hole in the blood vessel; mounting a hole closure device onto the blood vessel; accessing the blood vessel through the hole, while the hole closure device is mounted on the blood vessel; and closing the hole by the hole closure device, after accessing the blood vessel through the hole.
1. A method of accessing a blood vessel, comprising:
forming a hole in the blood vessel;
mounting a hole closure device onto the blood vessel;
accessing the blood vessel through the hole, while the hole closure device is mounted on the blood vessel; and
closing the hole by the hole closure device, after accessing the blood vessel through the hole.
2. A method according to claim 1, comprising opening the hole closure device and accessing the blood vessel a second time, after closing the hole by the device.
3. A method according to claim 1, wherein the hole closure device comprises one or more spikes and wherein mounting the hole closure device onto the blood vessel comprises inserting the spikes into a wall of the blood vessel.
4. A method according to claim 3, wherein closing the hole is performed while the spikes remain in the wall of the blood vessel.
5. A method according to claim 1, wherein accessing the blood vessel comprises inserting a medical tool into the blood vessel through the hole.
6. A method according to claim 1, wherein the hole closure device comprises a port which is connected to the blood vessel so that it surrounds the hole and wherein accessing the blood vessel through the hole comprises accessing through the port.
7. A method according to claim 6, wherein the port comprises a ring with a plurality of spikes extending therefrom.
8. A method according to claim 1, wherein forming the hole and mounting the hole closure device are performed together.
9. A method according to claim 1, wherein the hole closure device is mounted on the blood vessel after the hole is perforated.
10. A method according to claim 1, wherein the hole closure device remains in contact with blood in the blood vessel after closing the hole.
11. A method according to claim 1, wherein the hole closure device does not contact blood in the blood vessel after closing the hole.
12. A method according to claim 1, wherein the hole closure device is adapted for collapse and wherein closing the hole closure device comprises removing an obstruction which prevents collapse of the hole closure device.
13. A vascular access kit, comprising:
a sterile container for the kit;
a vascular port, adapted for mounting to a hole in a blood vessel and allowing passage of a medical tube through the port and into the hole; and
a suture-less hole closure device adapted to be coupled to the port for hole closing of a blood vessel, within the sterile container.
14. A kit according to claim 13, wherein the hole closure device includes at least a portion of the port.
15. A kit according to claim 13, wherein the hole closure device is adapted to fit over the port.
16. A kit according to claim 13, wherein the hole closure device is adapted to fit through the port.
17. A kit according to claim 13, comprising a device holder, within the sterile container, adapted to hold the hole closure device in an open position.
18. A kit according to claim 17, wherein the device holder is adapted to fit through said port.
19. A kit according to claim 17, wherein said device comprises a clip.
20. A kit according to claim 13, wherein the vascular port and the hole closure device comprise a ring shared by the port and the hole closure device.
21. A kit according to claim 20, wherein the hole closure device comprises spikes connected to the ring.
22. A kit according to claim 21, wherein the spikes are not evenly arranged around the circumference of said ring.
23. A method of closing a hole in a blood vessel, comprising:
providing a hole closure device including at least three arms adapted to engage tissue in a plurality of different points surrounding the hole;
bringing the hole closure device to the vicinity of the hole;
causing the arms to engage the tissue around the hole; and
closing the hole by movement of the arms.
24. A method according to claim 23, wherein the hole closure device includes at least six arms.
25. A method according to claim 23, wherein the arms comprise spikes.
26. A method according to claim 23, wherein the hole closure device is adapted for collapse.
27. A method according to claim 26, wherein causing the arms to engage the tissue comprises removing an obstruction which prevents collapse of the hole closure device.
28. A method according to claim 26, wherein closing the hole comprises removing an obstruction which prevents collapse of the hole closure device.
29. A method of controlling a super-elastic device using a wire, comprising:
engaging said device between a loop in a wire and a holding surface;
applying a force away from said holding surface to distort said device;
deploying said device in a desired location; and
releasing at least one end of said wire thereby freeing said device.
30. A method according to claim 29, comprising ceasing said force, thereby allowing said device to relax.
31. A method according to claim 29, wherein said device comprises a clip.
32. A method of accessing a blood vessel, comprising:
mounting a hole closure device onto the blood vessel in an open configuration allowing access to the blood vessel through the hole;
accessing the blood vessel through the hole; and
33. A method according to claim 32, wherein mounting the hole closure device is performed before accessing the blood vessel.
34. A method according to claim 32, wherein mounting the hole closure device is performed after accessing the blood vessel.
35. A method according to claim 32, wherein the hole closure device is adapted for collapse and wherein closing the hole closure device comprises removing an obstruction which prevents collapse of the hole closure device.
This application is a divisional of U.S. application Ser. No. 09/936,789 filed Sep. 17, 2001 which is a U.S. national phase of PCT application No. PCT/IL99/00674, filed Dec. 9, 1999, which is a continuation-in-part of PCT application No. PCT/IL99/000284, now U.S. application Ser. No. 09/701,531, PCT application No. PCT/IL99/00285, now U.S. application Ser. No. 09/701,523, and PCT application No. PCT/IL99/00670 all of which designate the U.S. the disclosures of which are incorporated herein by reference.
a plurality of spikes extending from said ring, towards a center of said ring and to first direction along an axis of said ring, said spikes being adapted for engaging a blood vessel;
wherein rotating said tabs around said ring distorts said ring such that said spikes are rotated in a same direction as said tabs. Preferably, said device is comprised of a super-elastic material. Alternatively or additionally, said spikes are curved.
In a preferred embodiment of the invention, said tabs and said spikes are attached in pairs of one spike and one tab at a plurality of locations along the circumference of said ring. Alternatively, said tabs and said spikes are not attached at same locations along the circumference of said ring.
In a preferred embodiment of the invention, said spikes are evenly arranged around the circumference of said ring. Alternatively or additionally, said ring has a resting state in a shape of a circle. Alternatively, said ring has a resting state in a shape of an ellipse with a large ratio between the length of its two axes. The ring may be smooth or it may be undulating, for example in the form of a sine wave. Preferably, said spikes are arranged on opposing sides of said ellipse
a vascular port; and
a suture-less hole closure device adapted to fit over said port. Preferably, said hole closure device is as described above.
a suture-less hole closure device adapted to fit through said port. Preferably, the kit comprises a device holder adapted to fit through said port and adapted for holding said device. Optionally, said device comprises a clip.
In a preferred embodiment of the invention, the kit comprises:
an outer element adapted to mount over said port; and
a base for a hole closure device adapted to cooperate with said hole closure device to seal a hole remaining in said vessel when said port is removed.
There is also provided in accordance with a preferred embodiment of the invention, a set of a hole closure device and a delivery system, comprising:
at least one peg extending from said rod and axially movable relative to said rod;
a curved spike extending from said base in a same general direction,
wherein, said peg is engaged by said device, in a resting configuration, between said base and said curved spikes and wherein said curved spikes are configured such that when said peg is retracted from said base, said peg causes said spikes to rotate, around a line perpendicular to said retraction. Preferably, said system comprises a tube adapted to pass over said inner rod and advance to apply force against said spikes in a direction that causes them to rotate opposite from said peg retraction. Alternatively or additionally, said device is plastically deformed by said retraction of said peg. Alternatively or additionally, said spikes are mounted on protrusions from said base.
There is also provided in accordance with a preferred embodiment of the invention, a two part hole closure device for a blood vessel, comprising:
a skeleton; and
a plurality of spike receptacles disposed around said skeleton;
a spike part adapted for contact with blood flow comprising:
a plurality of spikes having tips and adapted for fitting in said plurality of receptacles, wherein said spikes are curved such that when said spike part is inserted in said base part, said spike tips are in a plane substantially parallel to said base part.
There is also provided in accordance with a preferred embodiment of the invention, a device for implanting a clip having a base and at least two spikes inside a blood vessel, comprising:
an elongate rod adapted to engage said base of said clip at its end;
a tube fitted over said rod and slideable with respect to said rod,
wherein said rod and said tube are deigned to cooperate with a particular clip, such that when said clip is engaged by said rod and said tube is advanced towards said clip, said spikes of said clip are spread apart. Preferably, said rod includes at least one cable guide and wherein a cable is provided through said cable guide to maintain said clip in place. Preferably, said cable guide comprises a lumen in said rod. Alternatively, said cable guide comprises a groove along said rod.
In a preferred embodiment of the invention, said tube comprises at least one notch for engaging said clip.
providing a clip having at least two spikes inside the blood vessel;
spreading apart the spikes and maintaining them in said spread configuration;
retracting said clip such that said clip engages said blood vessel on either side of a hole in said vessel; and
releasing said clip. Preferably, releasing said clip comprises releasing at least one end of a thin cable that holds said clip in a loop of said cable. Alternatively or additionally, said method includes releasing said spikes from said spread configuration after said retracting.
There is also provided in accordance with a preferred embodiment of the invention, a method of controlling a super-elastic device using a wire, comprising:
releasing at least one end of said wire thereby freeing said device. Preferably, the method comprises ceasing said force, thereby allowing said device to relax. Alternatively or additionally, said device comprises a clip.
There is also provided in accordance with a preferred embodiment of the invention, a device for sealing a hole, comprising:
a plurality of spikes, wherein said spikes extend towards a center of said ring from portions of said ring intermediate said inwards and said outwards pointing portions. Preferably, said device is formed of a single piece of sheet metal, without heat treatment after forming. Alternatively or additionally, said device is super-elastic.
FIGS. 10A-10E illustrate an aortic hole closure device having a flat profile and deployment thereof, in accordance with a preferred embodiment of the invention;
FIGS. 11A-11E illustrate a femoral hole closure device and deployment thereof, in accordance with a preferred embodiment of the invention;
FIGS. 12A-12F illustrate a two part hole closure device and deployment thereof, in accordance with a preferred embodiment of the invention;
FIGS. 13A-13E illustrate a one part hole closure device and deployment thereof from inside a blood vessel, in accordance with a preferred embodiment of the invention;
FIGS. 14A-14C illustrate a hole close device and a delivery system for the device in accordance with a preferred embodiment of the invention;
FIGS. 15A-15G illustrate a method of deploying the hole closer of FIGS. 14A-14C; and
FIGS. 16A-16E illustrate additional embodiments of hole closure devices, in accordance with preferred embodiments of the invention.
FIGS. 1A-1D illustrate a self-sealing vascular port 100 in a vessel 102, in accordance with a preferred embodiment of the invention. FIGS. 1A and 1B illustrate a top view and a side cross-sectional view (respectively) of port 100, in an open configuration and FIGS. 1C and 1D illustrate port 100 in a sealed configuration. In the following figures, some changes have been made for clarity. For example, some of the “seals” are shown partly open, the degree of eversion is exaggerated in some figures, the length of spikes is sometimes exaggerated and the amount the spikes protrude from blood vessels is sometimes exaggerated. In particular, although a 90° eversion is shown, for example in FIG. 1B, a smaller eversion or no eversion can also be accomplished. In the exemplary embodiment of FIG. 1, port 100 comprises a ring 110 having a plurality of spikes 104 to engage vessel 102. FIG. 1B shows port 100 being open and a tube 108 (dotted line) inserted in the opening of the port. In FIG. 1D, tube 108 is removed and port 100 changes configuration to become sealed, so no blood can exit from vessel 100. In the embodiments of FIG. 1A-1D, ring 110 rotates around its median axis, which axis is generally completely enclosed by the body of the ring, so that spikes 104, which engage vessel 102, urge portions of vessel 102 against each other. In this type of distortion, the ring does not move or rotate relative to the main axis (which is perpendicular to the blood vessel), but each circular cross-section of the ring rotates around the center of the cross-section. Preferably, an intima-to intima seal is achieved, however, this is not required in all preferred embodiments of the invention. In a preferred embodiment of the invention, once the port is sealed, the port remains in the body, possibly indefinitely.
FIGS. 1J and 1K illustrate a port closing device 300, in accordance with a preferred embodiment of the invention. the device comprises a ring 304 having a plurality of spikes 302 attached thereto. In FIG. 1J the port closer is in an expanded (open configuration). The port closer is advanced in this configuration until the spikes engage a blood vessel. Then, ring 304 is distorted (as shown in FIG. 1K), so that spikes 302 move towards each other and pinch between them portions of the blood vessel, sealing the lumen of the port closer. Ring 304 is preferably formed of an elastic, super elastic and/or shape memory material, so that it is pre-disposed to collapsing in the absence of a restraint (such as a tube 108 inside of it). However, as described herein, the method of collapsing can include plastic deformation of the device by an external force or a combination of plastic and other types of deformation.
FIGS. 10A-10E illustrate an aortic hole closure device 500 having a flat profile and deployment thereof, in accordance with a preferred embodiment of the invention. A similar device may also be used for other vascular structures.
FIGS. 11A-11E illustrate a femoral hole closure device 520 and deployment thereof, in accordance with a preferred embodiment of the invention. Device can be made similar to that of device 500, however, in a preferred embodiment of the invention, the device is adapted for oblique insertion, for example, the spikes being oblique and the ring being elliptical. Also, as will be explained below, fewer spikes may be used.
In device 520, two opposing spikes are shown. In an alternative embodiment there is one spike on one side and two spikes on the opposite side of the ring. Preferably, the aortic device 500 of FIGS. 10 is used to seal a hole in a manner that emulates a purse string suture. Device 520, on the other hand, preferably emulates sealing a linear cut by holding the cut ends together. Thus, fewer spikes may be used, and a distortion of the connector is useful. Also in FIG. 10, the connector may distort in some embodiments. Preferably in FIG. 10, ring 504 distorts (when released) so that it has a smaller radius, for example being formed of a coil or a wave-shape. Alternatively, the ring may distort to have a long radius aligned with the direction of the cut in the aorta and/or at a desired angle relative to the aorta axis. Preferably, guiding notch or groove is provided in the delivery system, to assist in aligning the connector orientation. An aorta-type connector may also be useful where the hole in the vessel is punched out or a “Y” shaped hole, and not a linear incision.
FIGS. 12A-12F illustrate a two part hole closure device 530 and a process of deployment thereof, in accordance with a preferred embodiment of the invention. In a preferred embodiment of the invention, device 530 comprises two parts, an outside base part 532 and an inside spike part 534. Spike part 534 is preferably provided from inside the vessel, while base part 532 is provided from outside the blood vessel, however, their positions and/or functions may be reversed with the receptacles being inside the vessel and the spikes coming from outside. Spike part 534 preferably comprises a base 536 and a plurality of spikes 538. Spikes 538 preferably flare out and are curved, rather than straight. Base part 532 preferably comprises a skeleton, for example a ring 540 and a plurality of receptacles 542 for spikes 538. Preferably the receptacles define circular apertures, however other shaped apertures may be provided instead. Alternatively, receptacles 542 may comprise a thin material punched through by spikes 538. Also a same number of spikes and receptacles is shown, In a preferred embodiment of the invention, a larger number of receptacles, for example surrounding skeleton 540 completely, is provided. A plurality of radial layers of receptacles may also be provided.
FIGS. 13A-13E illustrate a one part hole closure device 550 and a process of deployment from inside a blood vessel, in accordance with a preferred embodiment of the invention. In addition, this embodiment shows that a wire holding mechanism as described above can be used to deform a super-elastic connector it is holding in place.
FIGS. 14A-14C illustrate a hole close device 570 and a delivery system 580 for device 570 in accordance with a preferred embodiment of the invention. Device 570 is preferably plastically deformed, as will be described below.
FIGS. 15A-15G illustrate a method of deploying the hole closer of FIGS. 14A-14C.
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International Classification A61B17/08, A61B17/00, A61B17/122, A61B17/128
Cooperative Classification A61B17/11, A61B17/064, A61B2017/00668, A61B17/0644, A61B2017/1135, A61B17/0057, A61B2017/00663, A61B17/0643, A61B2017/1107, A61B2017/00637, A61B2017/00867, A61B17/1227, A61B17/068, A61B17/115, A61B17/128, A61B17/32053, A61B2017/0641, A61B17/083
European Classification A61B17/00P, A61B17/122S, A61B17/08C, A61B17/128, A61B17/115, A61B17/064D, A61B17/064, A61B17/11