Anastomosis system utilizing an access port
A tool used in the performance of an anastomosis procedure between a graft vessel and a target vessel, where that anastomosis procedure utilizes at least one surgical tool, may include an access system that has a port and a seal connected to the port. The seal may substantially prevent loss of fluid from the target vessel.
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This application is a divisional of U.S. patent application Ser. No. 09/967,684, filed on Sep. 28, 2001, which is hereby incorporated by reference in its entirety.
FIELD OF THE INVENTIONThe invention relates to an anastomosis system, and more particularly, to an system utilizing an access port for a vascular anastomosis procedure.
Description of the Related Art
Vascular anastomosis is a procedure by which two blood vessels within a patient are surgically joined together. Vascular anastomosis is performed during treatment of a variety of conditions including coronary artery disease, diseases of the great and peripheral vessels, organ transplantation, and trauma. In coronary artery disease (CAD), an occlusion or stenosis in a coronary artery interferes with blood flow to the heart muscle. Treatment of CAD involves the grafting of a vessel in the form of a prosthesis or harvested artery or vein to reroute blood flow around the occlusion and restore adequate blood flow to the heart muscle. This treatment is known as coronary artery bypass grafting (CABG).
In the conventional CABG, a large incision is made in the chest and the sternum is sawed in half to allow access to the heart. In addition, a heart-lung machine is used to circulate the patient's blood so that the heart can be stopped and the anastomosis can be performed. In order to minimize the trauma to the patient induced by conventional CABG, less invasive techniques have been developed in which the surgery is performed through small incisions in the patient's chest with the aid of visualizing scopes. Less invasive CABG can be performed on a beating or stopped heart and thus may avoid the need for cardiopulmonary bypass.
In both conventional and less invasive CABG procedures, the surgeon has to suture one end of the graft vessel to the coronary artery and the other end of the graft vessel to a blood supplying vein or artery, such as the aorta. The suturing process is a time consuming and difficult procedure requiring a high level of surgical skill. Automated anastomosis systems are being developed to replace the suturing process in which one or more automated connecting members connect a graft vessel and a target vessel without suturing. However, when these automated anastomosis systems are deployed it is often difficult to properly align the graft vessel to the hole which is formed in the target vessel. In addition, there is often a problem of blood loss through the hole in the target vessel after the hole is formed and before the anastomosis procedure is completed. Blood loss may be prevented by clamping off the target vessel. However, clamping is undesirable because it may cause plaque to be dislodged and may cause neurological complications.
Accordingly, it would be desirable to provide an access port system for a sutureless vascular anastomosis device which assists in axial alignment, depth registration, and sealing to prevent blood loss when inserting tools into a target vessel.
SUMMARY OF THE INVENTIONThe present invention relates to an access port system for a vascular anastomosis procedure.
In accordance with one aspect of the present invention, a system for performing a vascular anastomosis procedure between a graft vessel and a target vessel includes a sealing element configured to substantially seal to a target vessel, a port connected to the sealing element and configured to allow passage of one or more instruments through the port and into the target vessel when the sealing element is substantially sealed to the exterior surface of the target vessel, a tissue cutter configured to be inserted through the port to form an opening in a side wall of the target vessel, an instrument configured to be inserted through the port to connect a graft vessel to the target vessel, and a seal configured to provide a seal between the port and the tissue cutter, and to provide a seal between the port and the instrument.
In accordance with an additional aspect of the present invention, a method of performing a vascular anastomosis procedure includes: substantially sealing an access port system to a target vessel; inserting a tissue cutter through the access port system, while providing a seal between the access port system and the tissue cutter; forming an opening in a side wall of the target vessel with the tissue cutter; removing the tissue cutter from the access port system; inserting an anastomosis instrument through the access port system, while providing a seal between the access port system and the anastomosis instrument; and performing a vascular anastomosis between a graft vessel and the target vessel with the anastomosis instrument.
In accordance with a further aspect of the present invention, a system for performing a vascular anastomosis procedure between a graft vessel and a target vessel includes an access port configured to provide hemostasis for a side hole in a target vessel for the placement of an anastomosis device without the need to clamp the target vessel.
In accordance with another aspect of the present invention, a method of performing a vascular anastomosis procedure includes the steps of: substantially sealing to a target vessel; inserting a tissue cutter through the access port system; forming an opening in a side wall of the target vessel with the tissue cutter; removing the tissue cutter from the access port system; providing a seal in the access port system to substantially prevent blood loss from the opening in the target vessel; inserting an anastomosis instrument through the access port system; and performing a vascular anastomosis between a graft vessel and the target vessel with the anastomosis instrument.
In accordance with an additional aspect of the present invention, a method of performing a vascular anastomosis procedure includes the steps of: positioning an access port system at a target vessel; inserting a tissue cutter through the access port system, while providing registration of a position of the tissue cutter with the access port system; forming an opening in a side wall of the target vessel with the tissue cutter; removing the tissue cutter from the access port system; inserting an anastomosis instrument through the access port system, while providing registration of a position of the anastomosis instrument with the access port system; and performing vascular anastomosis between a graft vessel and the target vessel with the anastomosis instrument.
BRIEF DESCRIPTION OF THE DRAWING FIGURESThe invention will now be described in greater detail with reference to the preferred embodiments illustrated in the accompanying drawings, in which like elements bear like reference numerals, and wherein:
An access port system 10, as shown in
The access port system 10 includes a sealing element or sealing plate 12 which is configured to conform to and substantially seal to an exterior wall of a target blood vessel 100, such as the aorta. A port 14 is connected to the sealing plate 12 and is configured to allow passage of instruments through the port and into the target vessel 100. The port 14 is a tubular member which provides axial and longitudinal alignment or registration of instruments inserted into the target vessel 100. A proximal end of the port 14 is provided with a seal 16 in the form of a flapper valve, an elastomeric valve, or other valve. The seal 16 provides hemostasis while moving instruments into and out of the port 14. In particular, the seal 16 prevents blood loss from an opening formed in the target vessel by completely sealing the lumen of the port 14 when no instrument is in use and by sealing around a instrument when the instrument is inserted into the port.
The access port system 10 of
Once the access port system 10 is positioned on the target vessel, a tissue cutter is inserted through the lumen of the port 14 and forms an opening in the target vessel. The term “tissue cutter,” as used herein, is intended to mean any instrument which forms an opening in a target vessel, including tissue punches which cut a plug of tissue and tissue cutters which form an incision. The tissue cutter is then removed and an instrument for performing anastomosis is inserted through the port 14. The anastomosis procedure is then performed.
The instrument for performing anastomosis may be any of the known automated anastomosis systems such as those that use staples, sutures, one piece devices, or multi-piece devices to connect an end of a graft vessel to an opening in a side wall of a target vessel. Examples of anastomosis instruments are described in U.S. Pat. Nos. 6,179,849 and 6,206,913 and in WO 00/69343 and WO 01/08601.
Axial alignment of the instruments with the opening in the target vessel is provided by the port 14. In addition, depth registration of the instruments may be provided by features, such as protrusions within the port 14 or a proximal end of the port. An actuator handle 18 may also be provided to register the tissue cutter and/or other instruments within the port 14.
Once the anastomosis procedure has been completed, the instrument and the access port system 10 are removed from the target vessel leaving the graft vessel connected to the target vessel. The access port system 10 and instrument may be removed together or separately.
As shown in
The seal 46 illustrated in
Although the illustrated embodiments of the access port system according to the present invention include a port which is substantially perpendicular to the wall of the blood vessel, it may be desirable to provide a port arranged at a predefined angle with respect to the blood vessel. For example, when forming an anastomosis between a graft vessel and a coronary artery it is desirable to position the graft at an angle so that blood flow from the graft passes into the coronary with minimal turbulence and associate thrombosis.
The access port systems according to the present invention may be used either in open chest or closed chest surgery and on a beating or stopped heart. The access port systems may be used for proximal or distal anastomosis, i.e. connection of a graft vessel to the aorta or coronary artery. The graft vessel may be a natural or synthetic graft, a mammary artery, or other vessel used for performing an anastomosis procedure. Although the invention is particulary designed for use in performing vascular anastomosis it may also be used for other non-vascular anastomosis.
While the invention has been described in detail with reference to the preferred embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made and equivalents employed, without departing from the present invention.
Claims
1. A system for performing a vascular anastomosis procedure between a graft vessel and a target vessel, the system comprising:
- a sealing element configured to substantially seal to the target vessel;
- a port connected to said sealing element;
- a tissue cutter insertable through said port to form an opening in a side wall of the target vessel;
- an anastomosis tool insertable through said port to connect the graft vessel to the target vessel; and
- a seal associated with said port, wherein said seal substantially provides a seal between said port and at least one of said tissue cutter and said instrument.
2. The system of claim 1, wherein said sealing element includes a plate contoured for placement against an exterior of the target vessel.
3. The system of claim 1, wherein said sealing element is configured to receive suction.
4. The system of claim 1, wherein said seal is a valve.
5. The system of claim 1, wherein said seal is fabricated from an elastomeric material.
6. The system of claim 1, further comprising a one-piece anastomosis device connected to said anastomosis tool, whereby said one-piece anastomosis device connects the graft vessel to the target vessel.
7. The system of claim 6, wherein said one-piece anastomosis device is superelastic.
8. The system of claim 1, wherein said port axially registers said tissue cutter and said anastomosis tool.
9. The system of claim 1, wherein said port is substantially cylindrical.
10. A system for use in performing vascular anastomosis between a graft vessel and the aorta with tools including a tissue cutter and an anastomosis tool, the system comprising:
- an access system including a port, and a seal connected to said port;
- wherein said seal is configured to sequentially admit the tissue cutter and the anastomosis tool therethrough; and
- wherein said seal provides substantial hemostasis when neither the tissue cutter nor the anastomosis tool are admitted through said seal, and also provides substantial hemostasis when either of the tissue cutter and the anastomosis tool are admitted through said seal.
11. The system of claim 10, wherein said access system substantially seals to an exterior surface of the target vessel.
12. The system of claim 10, wherein said seal is a valve configured to provide hemostasis.
13. The system of claim 10, wherein said seal is elastomeric.
14. The system of claim 10, wherein said port is substantially cylindrical.
15. The system of claim 10, wherein said port includes a lumen therethrough, and wherein said seal is located substantially at the proximal end of said port.
16. A tool used in the performance of an anastomosis procedure between a graft vessel and a target vessel, said procedure utilizing at least one surgical tool, the tool comprising:
- an access system including a port, and a seal connected to said port;
- wherein said seal is configured for transition between an open position and a closed position; and
- wherein in said closed position said seal substantially prevents loss of fluid from the target vessel through said seal, and wherein in said open position said seal admits at least one surgical tool and substantially prevents loss of fluid from the target vessel between said seal and the at least one surgical tool.
17. The tool of claim 16, wherein said access system further comprises an element connected to said port, wherein said element is shaped to contact the wall of the target vessel.
18. The tool of claim 16, wherein said seal is elastomeric.
19. The tool of claim 16, wherein said seal is a valve.
20. The tool of claim 16, wherein said seal is biased toward said closed position.
Type: Application
Filed: Apr 4, 2005
Publication Date: Aug 4, 2005
Applicant:
Inventors: Stephen Yencho (Menlo Park, CA), Bernard Hausen (Menlo Park, CA), Jaime Vargas (Menlo Park, CA)
Application Number: 11/098,350