THREE-NEEDLE CLOSURE DEVICE
The present invention relates to a three-needle type vascular closure system. The closure system utilizes three needles in the form of a guiding device, an expandable needle, and a hooking device. The guiding device is used to make the initial opening in the vessel, where the opening provides access for a sheath through which a medical procedure is to be performed. The expandable needle is inserted into the vessel in which it expands radially from the needle to form a target. The hooking device is also inserted into the vessel and is used to hook the expandable needle so as to form an internal union between the hooking device and the expandable needle. The needles can then be retracted thereby extending a suture from the hooking device and forming an internal suture pass that can be used to approximate the tissue surrounding the initial opening in the vessel. In one embodiment, the suture is passed across the vessel opening prior to dilation of the vessel opening.
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This is a divisional of U.S. patent application Ser. No. 11/103,150 filed on 11 Apr. 2005, now pending, the disclosure of which is incorporated, in its entirety, by this reference, which is a divisional of U.S. patent application Ser. No. 10/791,097 filed on 2 Mar. 2004, now U.S. Pat. No. 6,932,824, the disclosure of which is incorporated, in its entirety, by this reference.
FIELD OF THE INVENTIONThis invention relates to suturing devices. More specifically, this invention relates to suturing devices for approximating tissue surrounding an opening in a corporeal vessel wall.
BACKGROUND OF THE INVENTIONVarious medical procedures, particularly cardiology procedures, involve accessing a corporeal vessel through a percutaneous sheath. The sheath necessarily requires the formation of a hole or opening in the vessel wall so that a medical procedure can be performed via the sheath. After the particular medical procedure has been performed, the sheath must eventually be removed from the vessel and the access hole in the vessel wall must be closed.
A number of prior vascular closure devices and methods have been developed in attempting to provide a solution for the problem of closing a hole in the vessel wall. Tissue approximation typically involves passing a length of suture into and through adjacent vessel and subcutaneous tissue, across the vessel opening, and back into and through adjacent vessel and subcutaneous tissue. Certain prior closure devices have involved relatively complicated methods and devices for extracting a length of suture from inside the vessel so that the physician can approximate tissue surrounding the hole in the vessel wall through use of the suture.
U.S. Pat. No. 5,643,292 and U.S. Pat. No. 6,059,800 disclose example prior suturing devices used for approximating tissue surrounding the opening in a vessel wall. Most prior closure devices enlarge the vessel opening thereby negating the benefits of using smaller or less invasive percutaneous products. Prior suturing devices are also relatively complicated and difficult to use. Furthermore, many suturing devices dilate the vessel opening and perform the medical procedure via the vessel opening before the suture is extended across the vessel opening for approximation tissue surrounding the vessel wall.
There remains a need, therefore, to provide a suture apparatus that is relatively simple in construction, is easy to use, and can effectively approximate tissue surrounding an opening in a vessel wall. There is further a need to provide a suturing device that minimizes the invasiveness of the suturing procedure.
SUMMARY OF THE INVENTIONThe present invention relates to a three-needle type pre-closure vascular suture device. The pre-closure system utilizes three needles in the form of a guiding device, an expandable needle, and a hooking device. The guiding device is used to align the vascular closure system with a vessel in which a vessel opening is to be first dilated and subsequently closed. The expandable needle is inserted into the vessel in which it expands radially from the needle to form a target. The hooking device is also inserted into the vessel and is used to hook the expandable needle so as to form an internal union between the hooking device and the expandable needle. The needles can then be retracted thereby extending a suture from the hooking device and forming an internal suture pass that can eventually be used to approximate the tissue surrounding the opening in the vessel. After the suture pass has been put in place across the opening, the vessel opening is then dilated by a sheath, or by some other suitable method, and a medical procedure would be performed through such a sheath. After the medical procedure, the already-in-place suture can be used to approximate tissue.
The foregoing and other features, utilities, and advantages of the invention will be apparent from the following detailed description of the invention with reference to the accompanying drawings.
The present invention relates to a three-needle type closure system. The closure system comprises a “pre-closure” system because it extends a suture across a vessel opening before the opening is dilated so that a medical procedure can be performed. The system utilizes three needles in the form of a guiding device, an expandable needle, and a hooking device. The guiding device is used to align the vascular closure system with a vessel in which an opening is to be dilated. The expandable needle is inserted into the vessel in which it expands radially from the needle to form a target. The hooking device is also inserted into the vessel and is used to hook the expandable needle so as to form an internal union between the hooking device and the expandable needle. The needles can then be retracted thereby extending a suture from the hooking device and forming an internal suture pass that can be used to approximate the tissue surrounding the vessel opening after a medical procedure has been performed. Also, while embodiments of the present invention are directed toward a vascular closure system for use in connection with a medical procedure, the teachings of the present invention are applicable in other areas as well.
A guiding device 127 is disposed within the center lobe 110 of the sheath 100 as shown in
An expandable needle 142 is disposed within the left lobe 115 of the sheath as shown in
A hooking device 157 is disposed within the right lobe 105 of the sheath 100 as shown in
After a medical procedure has been performed via sheath 185, various techniques for approximating an opening can then be used to approximate tissue surrounding the vessel opening. For example, the two ends of the suture 175 could be joined to form a suitable knot that may be slidable down over an opening to create a sealing pressure on the opening. Alternatively, other vessel opening procedures can be utilized. In this manner the opening can efficiently be sealed thereby promoting rapid homeostasis.
While this invention has been described with reference to certain specific embodiments and examples, it will be recognized by those skilled in the art that many variations are possible without departing from the scope and spirit of this invention. The invention, as defined by the claims, is intended to cover all changes and modifications of the invention which do not depart from the spirit of the invention. The words “including” and “having,” as used in the specification, including the claims, shall have the same meaning as the word “comprising.”
Claims
1. A vascular closure system, comprising:
- a sheath including a plurality of hollow lobes;
- a guiding device disposed within one of the hollow lobes;
- an expandable needle disposed within a different one of the hollow lobes; and
- a hooking device disposed within yet another different one of the hollow lobes, wherein the hooking device is configured to hook the expandable needle.
2. The vascular closure system of claim 1 wherein the sheath includes three hollow cylindrical lobes.
3. The vascular closure system of claim 1 wherein the sheath comprises a distal profile capable of dilating tissue.
4. The vascular closure system of claim 1 wherein the guiding device further comprises:
- an access needle; and
- a guide wire configured to conform to the shape of the interior surface of a vessel.
5. The vascular closure system of claim 1 wherein the guiding device further comprises:
- an access needle; and
- a bent guide wire configured to conform to the shape of the interior surface of a vessel.
6. The vascular closure system of claim 1 wherein the guiding device comprises an expandable foot.
7. The vascular closure system of claim 1 wherein the guiding device is configured to be inserted into a first opening in a vessel, the expandable needle is configured to be inserted into a second opening in the vessel, and the hooking device is configured to be inserted into a third opening in the vessel.
8. The vascular closure system of claim 1 wherein the sheath includes three lobes, a left lobe, a center lobe and a right lobe, and wherein the guiding device is disposed within the center lobe, the expandable needle is disposed within the left lobe, and the hooking device is disposed within the right lobe.
9. The vascular closure system of claim 1 wherein the expandable needle further comprises:
- a needle tip configured to pierce the surface of a vessel;
- an expandable mesh that includes an expanded state and an extended state;
- an insertion rod configured to insert the expandable needle without expanding the expandable mesh; and
- an actuator configured to expand the expandable mesh into the expanded state.
10. The vascular closure system of claim 1 wherein the hooking device further comprises:
- a curved hollow needle configured to pierce the surface of a vessel;
- a suture extending through the curved hollow needle; and
- a piercing toggle connected to the suture and disposed on an end of the curved hollow needle such that a contiguous piercing surface is formed with the end of the curved hollow needle and the piercing toggle.
11. The vascular closure system of claim 1 wherein the hooking device further comprises:
- a tubular curved hollow needle configured to pierce the surface of a vessel;
- a degradable suture extending through the curved hollow needle; and
- a piercing toggle connected to the suture and disposed on an end of the curved hollow needle such that a contiguous piercing surface is formed with the end of the curved hollow needle and the piercing toggle, wherein the piercing toggle is shaped to provide an efficient hooking surface.
12. A vascular closure system, comprising:
- a sheath including three hollow lobes;
- a guiding device disposed within one of the hollow lobes, wherein the guiding device further includes: an access needle; a guide wire configured to conform to the shape of the interior surface of a vessel;
- an expandable needle disposed within a different one of the hollow lobes, wherein the expandable needle further includes: a needle tip configured to pierce the surface of a vessel; an expandable mesh that includes an expanded state and an extended state; an insertion rod configured to insert the expandable needle without expanding the expandable mesh; an actuator configured to expand the expandable mesh into the expanded state; a hooking device disposed within yet another different one of the hollow lobes, wherein the hooking device is configured to hook the expandable needle, wherein the hooking device further includes: a curved hollow needle configured to pierce the surface of a vessel; a suture extending through the curved hollow needle; and a suture extending through the curved hollow needle and a toggle connected to the suture and disposed on the end of the curved hollow needle.
13. A method of performing a medical procedure via a vessel opening, comprising:
- extending a suture across a vessel opening;
- pushing the suture to a side of the vessel opening;
- dilating the opening by inserting a sheath into the vessel opening;
- performing a medical procedure via the sheath subsequent to at least the step of extending a suture across a vessel opening;
- removing the sheath from the vessel opening;
- cinching the suture to approximate tissue surrounding the vessel opening.
Type: Application
Filed: Feb 18, 2010
Publication Date: Jun 10, 2010
Applicant: St. Jude Medical Puerto Rico LLC (Caguas, PR)
Inventors: John Avi Roop (Crystal, MN), Kedar R. Belhe (Minnetonka, MN), Catherine A. Pipenhagen (Chanhassen, MN)
Application Number: 12/708,412
International Classification: A61B 17/04 (20060101); A61B 17/06 (20060101);