1. Field of the Invention
The invention relates to an anastomosis system and method, and more particularly, the invention relates to an anastomosis system for controlling a tissue site during an anastomosis procedure.
2. Brief 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 patients 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. In order to perform the suturing of the graft to a target vessel such as the coronary artery or the blood supplying artery the surgeon generally has an assistant hold the edges of the incision in the target vessel while the surgeon takes small stitches as close as possible to the edges of the incision. This suturing requires a high degree of precision and is quite time consuming. In addition, during conventional CABG procedures blood flow at the anastomosis site is stopped during suturing. This prevents bleeding from the incision site but also prevents blood from reaching a portion of the heart muscle served by the vessel.
Accordingly, it would be desirable to provide a vascular anastomosis system which allows the tissue at the anastomosis site to be controlled during suturing or other connection of the graft and target vessels. It would also be desirable to provide a vascular anastomosis system which allows the connection of a graft vessel to a target vessel prior to making an incision in the target vessel which allows blood flow between the target vessel and the graft vessel.
The present invention relates to an anastomosis system and method for controlling a blood vessel tissue site during an anastomosis procedure. The anastomosis system and method may be used on a pressurized vessel or on an unpressurized vessel. The anastomosis may be accomplished with sutures, staples, or other securing members.
In accordance with one aspect of the present invention, a method of controlling a tissue site during an anastomosis procedure includes the steps of inserting an anvil into a pressurized vessel at an intended anastomosis site, supporting a wall of the pressurized vessel at the intended anastomosis site with the anvil positioned adjacent an interior of the wall, performing anastomosis, and removing the anvil.
In accordance with another aspect of the invention, a method of controlling a tissue site during an anastomosis procedure includes the steps of inserting an anvil into a target vessel at an intended anastomosis site, supporting a wall of the target vessel at the intended anastomosis site with the anvil positioned adjacent an interior of the wall, performing anastomosis between a graft vessel and the target vessel, and making an incision in the wall of the target vessel to allow blood flow between the graft vessel and the target vessel.
In accordance with an additional aspect of the present invention, an anastomosis system for connecting a graft vessel to a target vessel includes an elongated anvil having substantially parallel staple bending features for bending the ends of staples, at least one staple with staple ends configured to be received by the staple bending features, and a staple holder for holding the at least one staple while puncturing tissue.
In accordance with a further aspect of the invention, an anvil for use in performing anastomosis between a graft vessel and a target vessel includes a handle, and an elongated anvil arm extending from the handle. The anvil arm has substantially parallel staple bending grooves or recesses for bending the ends of anastomosis staples. The elongated anvil arm is configured to be inserted into the target vessel beside an anastomosis site through a small incision which allows pressurization of the vessel to be maintained.
According to another aspect of the invention, a stapling system for use in performing anastomosis between a graft vessel and a target vessel includes a plurality of staples having ends configured to be inserted through tissue and bent over to secure the tissue, an expandable backbone supporting the plurality of staples for insertion. The backbone has an expandable configuration allowing a spacing between the plurality of staples to be changed.
In accordance with an additional aspect of the invention, a stapling system for use in performing anastomosis between a graft vessel and a target vessel includes a plurality of staples having ends configured to be inserted through tissue and bent over to secure the tissue, a staple strip holding the plurality of staples in a spaced arrangement for insertion into the tissue as a row of staples, and a frangible portion provided between each of the plurality of staples and the staple strip allowing the staples to be separated from the staple strip after insertion.
The 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:
The anastomosis system and method according to the present invention uses an anvil to control and support a tissue site during an anastomosis procedure. The anvil is particularly useful for supporting a wall of a coronary artery during attachment of a graft vessel to the coronary artery because the wall of the coronary artery is very thin, difficult to grasp, and susceptible to tearing. Although the present invention is particularly useful for controlling very thin tissues such as the walls of the coronary arteries, the anvil may also be used for controlling other tissue sites.
As shown in
Also shown in
The anvil arm 14 has a sharp distal end 28 for puncturing the tissue of a target vessel to insert the anvil arm 14 into the target vessel. As illustrated in
Once the anvil arm 14 has been inserted into the target vessel 30, the anvil arm 14 is pulled against an inner wall of the target vessel causing tenting of the thin tissue of the vessel wall as illustrated in
As shown in
After stapling is complete, an incision is formed in the wall of the target vessel 30 to allow blood flow between the target vessel and the graft vessel 32. Some examples of methods and devices for forming the incision will be described in further detail below. After completion of the anastomosis, the anvil arm 14 is withdrawn from the target vessel 30 between adjacent staples 22. The withdrawal of the anvil arm 14 leaves a gap which is approximately the same as the spacing between adjacent staples. Accordingly, no blood leakage occurs at the location where the anvil arm has been withdrawn.
One example of an anvil arm 14 according to the present invention has a height and a width of about 2 mm or less, preferably about 1 mm or less, and a length of about 2 to 15 mm, preferably 5 to 12 mm. The length of the anvil will vary depending on the diameter of the graft vessel selected. Preferably, a length to width ratio of the anvil arm 14 is between 2:1 and 15:1.
The preferred staples 22 for use in the present invention have widths of about 0.2–3 mm, preferably about 2 mm or less and leg lengths of about 0.2–3 mm.
The expanding backbone 66 also includes two openings 76 at opposite ends which may be engaged by pins on an anastomosis system or staple holder. The opening 76 allow the backbone to be easily expanded by relative motion of holding pins.
The connecting diamond members 72 are configured to collapse inwardly toward the backbone when the staples 22a engage the staple bending surfaces 16a of the anvil. The collapsing of the diamond members 72 forces the staples 22a to separate from the diamond members at the connecting sections 74.
The examples of extendable cutting devices for use with the anvil according to the present invention which are shown in
As shown in
The operation of the system 140 of
Once the anvil has been inserted in the target vessel 30 as shown in
The invention has been described as including staple bending features provided on the anvil and staples provided at an exterior of the tissue. According to an alternative embodiment of the invention, the staples and/or staple holding strips may be positioned on the anvil and an exterior member with staple bending features may be moved toward the anvil to bend the ends of the staples and secure the graft and target vessels together.
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.
This application is a continuation of application Ser. No. 09/842,792, filed Apr. 27, 2001, now U.S. Pat. No. 6,478,804.
Number | Name | Date | Kind |
---|---|---|---|
3254650 | Collito | Jun 1966 | A |
3254651 | Collito | Jun 1966 | A |
3519187 | Kapitanov et al. | Jul 1970 | A |
3774615 | Lim et al. | Nov 1973 | A |
4214587 | Sakura, Jr. | Jul 1980 | A |
4244372 | Kapitanov et al. | Jan 1981 | A |
4248267 | Brandenberg | Feb 1981 | A |
4331277 | Green | May 1982 | A |
4350160 | Kolesov | Sep 1982 | A |
4352358 | Angelchik | Oct 1982 | A |
4366819 | Kaster | Jan 1983 | A |
4368736 | Kaster | Jan 1983 | A |
4503568 | Madras | Mar 1985 | A |
4520817 | Green | Jun 1985 | A |
4523592 | Daniel | Jun 1985 | A |
4553542 | Schenck et al. | Nov 1985 | A |
4593396 | Anderson, Jr. | Jun 1986 | A |
4603693 | Conta et al. | Aug 1986 | A |
4605001 | Rothfuss et al. | Aug 1986 | A |
4607637 | Berggren et al. | Aug 1986 | A |
4617928 | Alfranca | Oct 1986 | A |
4624255 | Schenck et al. | Nov 1986 | A |
4624257 | Berggren et al. | Nov 1986 | A |
4657019 | Walsh et al. | Apr 1987 | A |
4665906 | Jervis | May 1987 | A |
4747407 | Liu et al. | May 1988 | A |
4752024 | Green et al. | Jun 1988 | A |
4773420 | Green | Sep 1988 | A |
4892098 | Sauer | Jan 1990 | A |
4907591 | Vasconcellos et al. | Mar 1990 | A |
4917087 | Walsh et al. | Apr 1990 | A |
4917090 | Berggren et al. | Apr 1990 | A |
4917091 | Berggren et al. | Apr 1990 | A |
4930674 | Barak | Jun 1990 | A |
4938408 | Bedi | Jul 1990 | A |
4951861 | Schulze et al. | Aug 1990 | A |
5005749 | Aranyi | Apr 1991 | A |
5018657 | Pedlick et al. | May 1991 | A |
5062842 | Tiffany | Nov 1991 | A |
5104025 | Main et al. | Apr 1992 | A |
5119983 | Green et al. | Jun 1992 | A |
5156310 | Biedenharn | Oct 1992 | A |
5156613 | Sawyer | Oct 1992 | A |
5156619 | Ehrenfeld | Oct 1992 | A |
5172845 | Tejeiro | Dec 1992 | A |
5178634 | Ramos Martinez | Jan 1993 | A |
5193731 | Aranyi | Mar 1993 | A |
5205459 | Brinkerhoff et al. | Apr 1993 | A |
5211683 | Maginot | May 1993 | A |
5234447 | Kaster et al. | Aug 1993 | A |
5250058 | Miller et al. | Oct 1993 | A |
5271544 | Fox et al. | Dec 1993 | A |
5275322 | Brinkerhoff et al. | Jan 1994 | A |
5285945 | Brinkerhoff et al. | Feb 1994 | A |
5292053 | Bilotti | Mar 1994 | A |
5300065 | Anderson | Apr 1994 | A |
5304220 | Maginot | Apr 1994 | A |
5314435 | Green et al. | May 1994 | A |
5314468 | Ramos Martinez | May 1994 | A |
5326013 | Green et al. | Jul 1994 | A |
5333773 | Main et al. | Aug 1994 | A |
5336233 | Chen | Aug 1994 | A |
5350104 | Main et al. | Sep 1994 | A |
5364389 | Anderson | Nov 1994 | A |
5366462 | Kaster et al. | Nov 1994 | A |
5392979 | Green et al. | Feb 1995 | A |
5395030 | Kuramoto et al. | Mar 1995 | A |
5417361 | Williamson, IV | May 1995 | A |
5431322 | Green et al. | Jul 1995 | A |
5443497 | Venbrux | Aug 1995 | A |
5447514 | Gerry et al. | Sep 1995 | A |
5452836 | Huitema et al. | Sep 1995 | A |
5454825 | Van Leeuwen | Oct 1995 | A |
5456712 | Maginot | Oct 1995 | A |
5456714 | Owen | Oct 1995 | A |
5464449 | Ryan et al. | Nov 1995 | A |
5465895 | Knodel | Nov 1995 | A |
5465896 | Allen et al. | Nov 1995 | A |
5478003 | Green et al. | Dec 1995 | A |
5478354 | Tovey et al. | Dec 1995 | A |
5489058 | Plyley et al. | Feb 1996 | A |
5522834 | Fonger et al. | Jun 1996 | A |
5533661 | Main et al. | Jul 1996 | A |
5535935 | Vidal et al. | Jul 1996 | A |
5540677 | Sinofsky | Jul 1996 | A |
5558667 | Yarborough et al. | Sep 1996 | A |
5562241 | Knodel et al. | Oct 1996 | A |
5571167 | Maginot | Nov 1996 | A |
5580067 | Hamblin et al. | Dec 1996 | A |
5586711 | Plyley et al. | Dec 1996 | A |
5609285 | Grant et al. | Mar 1997 | A |
5611794 | Sauer et al. | Mar 1997 | A |
5632432 | Schulze et al. | May 1997 | A |
5632433 | Grant et al. | May 1997 | A |
5636780 | Green | Jun 1997 | A |
5643340 | Nunokawa | Jul 1997 | A |
5653373 | Green et al. | Aug 1997 | A |
5655698 | Yoon | Aug 1997 | A |
5657921 | Young et al. | Aug 1997 | A |
5662258 | Knodel et al. | Sep 1997 | A |
5669544 | Schulze et al. | Sep 1997 | A |
5669918 | Balazs et al. | Sep 1997 | A |
5669934 | Sawyer | Sep 1997 | A |
5676670 | Kim | Oct 1997 | A |
5693088 | Lazarus | Dec 1997 | A |
5695504 | Gifford, III et al. | Dec 1997 | A |
5702412 | Popov et al. | Dec 1997 | A |
5707362 | Yoon | Jan 1998 | A |
5707369 | Vaitekunas et al. | Jan 1998 | A |
5707380 | Hinchliffe et al. | Jan 1998 | A |
5709693 | Taylor | Jan 1998 | A |
5711472 | Bryan | Jan 1998 | A |
5725544 | Rygaard | Mar 1998 | A |
5749895 | Sawyer et al. | May 1998 | A |
5776130 | Buysse et al. | Jul 1998 | A |
5797920 | Kim | Aug 1998 | A |
5799857 | Robertson et al. | Sep 1998 | A |
5816471 | Plyley et al. | Oct 1998 | A |
5817113 | Gifford, III et al. | Oct 1998 | A |
5824015 | Sawyer | Oct 1998 | A |
5827265 | Glinsky et al. | Oct 1998 | A |
5827271 | Buysse et al. | Oct 1998 | A |
5833698 | Hinchliffe et al. | Nov 1998 | A |
5865730 | Fox et al. | Feb 1999 | A |
5878938 | Bittner et al. | Mar 1999 | A |
5879371 | Gardiner et al. | Mar 1999 | A |
5904697 | Gifford, III et al. | May 1999 | A |
5915616 | Viola et al. | Jun 1999 | A |
5918791 | Sorrentino et al. | Jul 1999 | A |
5921995 | Kleshinski | Jul 1999 | A |
5944730 | Nobles et al. | Aug 1999 | A |
5976159 | Bolduc | Nov 1999 | A |
5993464 | Knodel | Nov 1999 | A |
6004335 | Vaitekunas et al. | Dec 1999 | A |
6015416 | Stefanchik et al. | Jan 2000 | A |
6024748 | Manzo et al. | Feb 2000 | A |
6036700 | Stefanchik et al. | Mar 2000 | A |
6039733 | Buysse et al. | Mar 2000 | A |
6050472 | Shibata | Apr 2000 | A |
6053390 | Green et al. | Apr 2000 | A |
6066144 | Wolf et al. | May 2000 | A |
6066148 | Rygaard | May 2000 | A |
6071289 | Stefanchik et al. | Jun 2000 | A |
6083234 | Nicholas et al. | Jul 2000 | A |
6110187 | Donlon | Aug 2000 | A |
6117148 | Ravo et al. | Sep 2000 | A |
6176413 | Heck et al. | Jan 2001 | B1 |
6183486 | Snow et al. | Feb 2001 | B1 |
6187019 | Stefanchik | Feb 2001 | B1 |
6193129 | Bittner | Feb 2001 | B1 |
6193734 | Bolduc et al. | Feb 2001 | B1 |
6209773 | Bolduc et al. | Apr 2001 | B1 |
6248117 | Blatter | Jun 2001 | B1 |
6436097 | Nardella | Aug 2002 | B1 |
6514263 | Stefanchik | Feb 2003 | B1 |
6520973 | McGarry | Feb 2003 | B1 |
6530932 | Swayze | Mar 2003 | B1 |
Number | Date | Country |
---|---|---|
197 32 234 | Jan 1999 | DE |
1354559 | May 1995 | EP |
0885595 | Dec 1998 | EP |
0938870 | Sep 1999 | EP |
0820724 | Mar 2000 | EP |
0820725 | Mar 2000 | EP |
0990420 | Dec 2000 | EP |
2316910 | Jul 1996 | FR |
WO 9819625 | May 1998 | WO |
WO 9911178 | Mar 1999 | WO |
WO 9921491 | May 1999 | WO |
WO 0012013 | Mar 2000 | WO |
WO 0059380 | Oct 2000 | WO |
Number | Date | Country | |
---|---|---|---|
20030023253 A1 | Jan 2003 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 09842792 | Apr 2001 | US |
Child | 10253376 | US |