1. Field of the Invention
The present invention relates to a vascular suction device, a dilator and a stapler for the closure of a puncture made in the wall of an artery or vein during a medical procedure. The present invention has particular utility for use in and around the femoral artery during and after coronary/cardiac procedures. Other utilities include soft-tissue anchoring, meniscal repair, thoracic lung closure, endoscopic procedures, esophageal repair, laparoscopy, skin/epidermal wound closure and general tissue closure.
2. Description of Related Art
Surgical stapling instruments, dilators and cannulas for diagnostic, interventional and/or therapeutic medical procedures are known. For example, U.S. Pat. No. 5,709,335 issued to Heck discloses a wholly distal surgical stapling instrument for stapling a tubular tissue structure to a luminal structure, such as a vascular lumen. This device can be used for anastomotic stapling of a tubular vessel having two untethered ends, and is especially useful for making the primary anastomotic connection of a bypass vein to a coronary artery or to the aorta. The device essentially includes a rod that is placed within the tubular vessel and an anvil that forces staples (associated with the rod) to bend outwardly against the vessel and a target (such as a coronary artery). Thus, this device requires that the stapler device be placed within the tubular vessel (e.g., vein or artery) for operation. While this device is useful when stapling a graft vein or the like, unfortunately, this device would be inappropriate when the entirety of the tubular tissue is not accessible, such as following percutaneous catheterization procedures.
Another example can be found in U.S. Pat. No. 5,403,333 issued to Kaster et al. This patent discloses a side-to-end anastomotic staple apparatus for use where the end of a blood vessel becomes connected to the side or wall of a second blood vessel or other structure, such as the heart. Similar to the previous discussion, this device requires that at least one end of the vessel be open, so that a stapling mechanism can be inserted therethrough. As noted above, many surgical procedures only access a portion of the vessel. Thus, this device would not be useful in these circumstances.
Yet another example, U.S. Pat. No. 5,695,504 issued to Gifford, III et al., discloses an end-to-side vascular anastomosis device to perform end-to-side anastomosis between a graft vessel and the wall of a target vessel. This device involves a procedure in which the end of a graft vessel is passed through an inner sleeve of the device until the end of the vessel extends from the distal end of the device. The distal end of the graft is then affixed to the wall of the target, using a staple and stapler which forces a staple into both tissues. Similar to the previous disclosures, this device is useful for the attachment of one tubular tissue onto another, however, is inadequate in sealing a puncture in an artery, vein or other tissue left by certain medical procedures.
Other examples can be found in the art. However, these devices are often complicated to manufacture and use, requiring expensive tooling and materials. It is often the case that staplers, cannulas and dilators are single application or procedure devices, which must be discarded after use. Thus, there is a need to provide an efficient stapler mechanism that is simple to use and relatively easy to manufacture, since the device is likely to be discarded after only one use. Moreover, the prior art has failed to provide a device that permits a doctor or clinician to gain access to a puncture site and remain centered on that site throughout the entire procedure, including closure of the puncture, or to ensure that the closure mechanism is delivered over and/or around the puncture site.
Thus, the present invention solves the aforementioned drawbacks by providing a suction cannula, dilator, stapler and staple that are simple to use and manufacture. In one aspect, the present invention provides a suction cannula that is concentrically aligned with a puncture site (e.g., puncture in an artery or vein) and provides vacuum about the periphery of the puncture site so that the puncture hole is always located during a medical procedure, and to thereby permit a surgeon to quickly and efficiently close the puncture using, for example, a stapling device. In the preferred embodiment the suction cannula has a tube-in-tube construction having an inner tube and an outer tube where a vacuum can be applied between the tubes.
In another aspect, the present invention provides a dilator, which can be placed within the inner tube of the suction cannula during insertion into the body. The dilator (and suction cannula) centers around a guide wire (that is already in place within the venous structure) and follows the path of the guide wire to the puncture site. Preferably, the dilator has a tapered tip on the distal end that follows the guide wire though the puncture hole made in the vein or artery. A blood indicator is provided on the proximal end to provide visual feedback when the surgeon is in the artery (i.e., pulsating blood indicates that the tip of the dilator is in the artery). In one preferred embodiment, the dilator includes a tapered tip on the distal end that is radially collapsible so that the dilator can be withdrawn from the artery and the suction cannula is thereby permitted to advance over the dilator to the artery wall. To that end, indicators on the external, proximal end of the dilator provide the user with a visual measurement as to the distance to the artery wall. Once the suction cannula makes contact with the vascular wall, and vacuum can be applied to the cannula so that the cannula remains concentrically aligned with the puncture in the vessel, and the dilator can be removed.
In yet another aspect of the present invention, a stapler is provided which holds a multi-pronged staple on a shaft at the distal end. The distal portion of the stapler is constructed to fit within the suction cannula (i.e., the inner tube of the cannula) to approach the puncture in the wall of the artery (or other soft tissue), to permit the stapling of the artery. Preferably, the distal end of the stapler includes a T-flange that retains a staple, and a deploying mechanism that deploys the staple into the artery, thereby sealing the puncture. Deployment of the staple can include crimping of the staple through the vascular wall and/or partial insertion of the staple into the tissue. The T-flange permits the staple to be retained on the distal end of the stapler and deployed into the artery wall. An oval hub on the T-flange is provided that mates with an oval hole in the center of the staple. To hold a staple, a staple is placed on the hub and rotated 90 degrees, thereby affixing the staple to the stapler. Once the staple is crimped onto the artery wall, the shaft can be rotated 90 degrees, thereby aligning the oval hub and the oval hole, so that the stapler can be removed. Preferably, the staple includes a plurality of prongs that are inserted into the vascular wall.
Advantageously, the suction cannula of the present invention permits the surgeon to remain centrally located about a puncture site throughout the entire procedure, from incision to closing. The suction cannula permits a surgeon to enter an incision, and using a dilator as an artery indicator, secure the cannula to the artery wall, via vacuum force, about the puncture site. Also advantageously, this permits the surgeon to view and approach the puncture site (using a catheter, for example) throughout the entire procedure, without obstruction. In addition, a stapler and staple are provided which can be guided down the shaft of the cannula to quickly seal the puncture site.
It will be appreciated by those skilled in the art that although the following Detailed Description will proceed with reference being made to preferred embodiments, the present invention is not intended to be limited to these preferred embodiments. Other features and advantages of the present invention will become apparent as the following Detailed Description proceeds, and upon reference to the Drawings, wherein like numerals depict like parts, and wherein:
Referring to
Once the diagnostic, interventional, therapeutic, or other procedure (following the cannula to the puncture site) is complete, the puncture site is to be closed. As shown in
The preferred material used for the construction of the devices shown in all the figures can include plastic, stainless steel, titanium, and bioabsorbable material (where appropriate).
Modifications to the present invention are also possible. For example, instead of a stapling device 80, as described above, an appropriate suturing mechanism, laser suturing mechanism, or other closure system can be used to seal the puncture site. In any event, the suction cannula 10 provides unobstructed access to the puncture site during medical procedures, including closure of the wound. The driving mechanism 96 of the stapler could be appropriately modified with a push-button activated gear mechanism to slide the crimping member distally. Those skilled in the art will recognize that many modifications are possible to drive the crimping member, and all such modifications are deemed within the scope of the present invention.
The shape of the staple 70/flange 84 can also be modified. For example, the member 76 can modified and shaped as a rectangle, triangle, square, etc. Alternatively, the member 76 can include a circular shape which is friction fit over the flange member. Accordingly, the flange 84 would be appropriately modified to match the opening 74 defined by the member 76 to permit engagement and disengagement of the staple 70 and flange 84, as described above. The staple 70 can be further modified with barbs on the prongs 72, to provide a more secure fastening of the staple to the artery wall. The crimping member 82 can be modified to include a conforming portion 90 having a variety of shapes, provided that the overall functionality of the crimping member, as described herein, is not hindered.
The vacuum source applied to the cannula 10 can be any conventionally known automated vacuum supply. Of course, the cannula can be appropriately modified to include a manually activated vacuum using, for example, a bulb mechanism, when a vacuum supply is otherwise unavailable.
Additional modifications are also possible. Referring to
Anther embodiment of the cannula 140 of the present invention is depicted in
Although the detailed description provided herein has largely been in reference to arterial procedures, the present invention is not so limited. The cannula of the present invention can also be used in other tissue environments, as may be required.
This application is a continuation application under 37 CFR §1.53(b) of application Ser. No. 09/486,185 filed Feb. 18, 2000 now abandoned, which claims priority to U.S. Provisional application No. 60/093,701 filed Jul. 22, 1998, and PCT application No. PCT/US99/16476 filed Jul. 21, 1999, all of which are hereby incorporated by reference in their entirety.
Number | Name | Date | Kind |
---|---|---|---|
2568566 | Sokolik | Sep 1951 | A |
4441497 | Paudler | Apr 1984 | A |
4469101 | Coleman et al. | Sep 1984 | A |
4648871 | Jacob | Mar 1987 | A |
4836205 | Barrett | Jun 1989 | A |
4932962 | Yoon et al. | Jun 1990 | A |
4950285 | Wilk | Aug 1990 | A |
4990153 | Richards | Feb 1991 | A |
5029580 | Radford et al. | Jul 1991 | A |
5037433 | Wilk et al. | Aug 1991 | A |
5053047 | Yoon | Oct 1991 | A |
5074874 | Yoon, Inbae et al. | Dec 1991 | A |
5104394 | Knoepfler | Apr 1992 | A |
5123913 | Wilk et al. | Jun 1992 | A |
5222976 | Yoon | Jun 1993 | A |
5234445 | Walker et al. | Aug 1993 | A |
5234447 | Kaster et al. | Aug 1993 | A |
5250053 | Snyder | Oct 1993 | A |
5279311 | Snyder | Jan 1994 | A |
5281237 | Gimpelson | Jan 1994 | A |
5282809 | Kammerer et al. | Feb 1994 | A |
5320629 | Noda et al. | Jun 1994 | A |
5330491 | Walker et al. | Jul 1994 | A |
5334198 | Hart et al. | Aug 1994 | A |
5342374 | Wan et al. | Aug 1994 | A |
5364407 | Poll | Nov 1994 | A |
5364408 | Gordon | Nov 1994 | A |
5370610 | Reynolds | Dec 1994 | A |
5374275 | Bradley et al. | Dec 1994 | A |
5391173 | Wilk | Feb 1995 | A |
5403333 | Kaster et al. | Apr 1995 | A |
5405354 | Sarrett | Apr 1995 | A |
5417699 | Klein et al. | May 1995 | A |
5423833 | Zauza | Jun 1995 | A |
5439467 | Benderev et al. | Aug 1995 | A |
5460613 | Ulrich et al. | Oct 1995 | A |
5462561 | Voda | Oct 1995 | A |
5462562 | Elkus | Oct 1995 | A |
5468251 | Buelna | Nov 1995 | A |
5490503 | Hollister | Feb 1996 | A |
5496335 | Thomason et al. | Mar 1996 | A |
5501690 | Measamer et al. | Mar 1996 | A |
5507758 | Thomason et al. | Apr 1996 | A |
5522821 | Brown | Jun 1996 | A |
5544664 | Benderev et al. | Aug 1996 | A |
5545170 | Hart | Aug 1996 | A |
5554162 | DeLange | Sep 1996 | A |
5569269 | Hart et al. | Oct 1996 | A |
5569271 | Hoel | Oct 1996 | A |
5571119 | Atala | Nov 1996 | A |
5573540 | Yoon | Nov 1996 | A |
5618290 | Toy et al. | Apr 1997 | A |
5695504 | Gifford et al. | Dec 1997 | A |
5709335 | Heck | Jan 1998 | A |
5713849 | Bosma et al. | Feb 1998 | A |
5715815 | Lorenzen et al. | Feb 1998 | A |
6001078 | Reekers | Dec 1999 | A |
6428498 | Uflacker | Aug 2002 | B2 |
Number | Date | Country |
---|---|---|
0455 626 | Nov 1991 | EP |
Number | Date | Country | |
---|---|---|---|
20040082906 A1 | Apr 2004 | US |
Number | Date | Country | |
---|---|---|---|
60093701 | Jul 1998 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 09486185 | US | |
Child | 10689358 | US |