The present invention relates to locating a blood vessel puncture. More particularly, the present invention relates to locating a blood vessel puncture using an enhanced visual bleed back system.
A large number of diagnostic and interventional procedures involve the percutaneous introduction of instrumentation into a vein or artery. For example, coronary angioplasty, angiography, atherectomy, stenting of arteries, and many other procedures often involve accessing the vasculature through a catheter placed in the femoral artery or other blood vessel. Once the procedure is completed and the catheter or other instrumentation is removed, bleeding from the punctured artery must be controlled.
Traditionally, external pressure is applied to the skin entry site to stem bleeding from a puncture wound in a blood vessel. Pressure is continued until hemostasis has occurred at the puncture site. In some instances, pressure must be applied for up to an hour or more during which time the patient is uncomfortably immobilized. In addition, a risk of hematoma exists since bleeding from the vessel may continue beneath the skin until sufficient clotting effects hemostasis. Further, external pressure to close the vascular puncture site works best when the vessel is close to the skin surface but may be unsuitable for patients with substantial amounts of subcutaneous adipose tissue since the skin surface may be a considerable distance from the vascular puncture site.
There are several prior art devices that try to overcome the disadvantages of the traditional external pressure application. For example, there are devices that place a hemostat within the bloodstream of the vessel, within the wall of the blood vessel, or adjacent to the wall of the blood vessel puncture site to close the puncture. However, reliance is on tactile sensation alone to indicate to the surgeon the proper placement of the puncture closing instrumentation. Other prior art references require a separate device for locating the blood vessel puncture site which is must then be removed for insertion of a second device to expel a hemostat. Still other prior art devices use bleed back ports to locate the blood vessel puncture site in conjunction with other devices such as a foot plate placed against the blood vessel wall or closure devices with anchors. However, in some of these prior art devices a surgeon is then required to use sutures and/or needles to close the blood vessel puncture. Moreover, in some of the prior art devices, external pressure applied at the surface of the skin may still be required.
Other devices utilize a dilator having a bleed back entrance port and a bleed back exit port. However, current dilators used today, as shown in
Thus, there is still a need for an apparatus and method to efficiently and easily locate a blood vessel puncture site.
The present invention provides for an apparatus to locate a blood vessel puncture having a bleed back entrance port near a first end, a bleed back exit port near a second end; and a lumen extending between the bleed back entrance port and the bleed back exit port, wherein said bleed back entrance port has a diameter substantially equal to or greater than the lumen diameter. The present invention further provides for a method for locating a blood vessel puncture by inserting a locator into a blood vessel lumen, the locator having a bleed back entrance port at a first end, a bleed back exit port at a second end, and a finger adjacent the bleed back entrance port, observing a blood flow out of the bleed back exit port, and withdrawing the locator out of the blood vessel lumen until the finger contacts the blood vessel wall.
The accompanying drawings, which are incorporated into and constitute a part of this specification, illustrate one or more embodiments of the present invention and, together with the detailed description, serve to explain the principles and implementations of the invention.
In the drawings:
Embodiments of the present invention are described herein in the context of an enhanced bleed back system. Those of ordinary skill in the art will realize that the following detailed description of the present invention is illustrative only and is not intended to be in any way limiting. Other embodiments of the present invention will readily suggest themselves to such skilled persons having the benefit of this disclosure. Reference will now be made in detail to implementations of the present invention as illustrated in the accompanying drawings. The same reference indicators will be used throughout the drawings and the following detailed description to refer to the same or like parts.
In the interest of clarity, not all of the routine features of the implementations described herein are shown and described. It will, of course, be appreciated that in the development of any such actual implementation, numerous implementation-specific decisions must be made in order to achieve the developer's specific goals, such as compliance with application- and business-related constraints, and that these specific goals will vary from one implementation to another and from one developer to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure.
Precisely locating an artery is important for procedures such as puncture closure. Thus, the present invention is directed to a method and apparatus to accurately locate a blood vessel puncture site. Referring now to
The bleed back entrance port may be located away from the blood vessel puncture 26 or on the bottom surface of the apparatus 10 as shown in
Moreover, the finger 404 may be made to have a closed position as shown in
From the closed position, the finger 404 may extend radially outward, as shown in
To locate the blood vessel puncture 420, the apparatus 10 is placed within the blood vessel lumen 414. When the bleed back entrance port 402 enters the blood vessel lumen 414, blood will flow through the flash tube 418 in the direction of arrow 416 and out a bleed back exit port. The apparatus 10 is then withdrawn out of the blood vessel lumen 414. As the apparatus 10 is withdrawn and the bleed back entrance port 402 exits the blood vessel lumen 414, visual bleed back out of the bleed back exit port stops or lessens. At approximately the time when the bleed back entrance port 402 exits the blood vessel lumen 414, the finger 404 begins to engage the blood vessel wall 406. Additional tension applied to withdraw the apparatus 10 results in additional engagement and resistance by the finger 404.
It should be appreciated that the bleed back entrance port and finger each provide a benefit independently of each other and may be utilized separately in separate inventions. However, when combined as in the present invention shown in
Bleed back through the flash tube 606 that has a guidewire 600 residing within the flash tube 606 is often difficult to read when it exits the bleed back exit port 608. The guidewire 600 occupies a significant percentage of the available flash tube lumen 606 space which decreases the pressure out of the bleed back exit port 608. This causes a significantly less dramatic outflow of blood from the bleed back exit port 608. The result is an outflow of blood that appears like an ooze typically seen when the first end 610 of the apparatus enters the blood vessel lumen rather than a pulsatile appearance. Thus, a user is unable to determine whether the bleed back entrance port 604 is located within the blood vessel lumen which may result in an inaccurate determination of the location of the blood vessel puncture.
To correct for the disadvantage of the apparatus currently used,
Each of the embodiments described above are discussed with the use of a guidewire to assist in guiding the apparatus through the tissue tract and into the blood vessel lumen. However, the guidewire is not meant to be a limiting factor and may not be required.
Additionally, the first end of each embodiment may be made of any material that is dissolvable when positioned within the blood vessel puncture. Examples of such materials may include those made of absorbable polymers such as Collagen, Oxidized Cellulose, PGA, methyl cellulose, carboxymethyl cellulose, carbowaxes, gelatin (particularly pigskin gelatin), and sugar based compounds. Among the other suitable polymers are polylactic glycolic acids, polyvinyl pyrrolidone, polyvinyl alcohol, polyproline, and polyethylene oxide.
While embodiments and applications of this invention have been shown and described, it would be apparent to those skilled in the art having the benefit of this disclosure that many more modifications than mentioned above are possible without departing from the inventive cOncepts herein. The invention, therefore, is not to be restricted except in the spirit of the appended claims.
This application is a continuation-in-part of, and claims priority under 35 U.S.C. §120 to, and incorporates by reference herein in their entirety: 1. U.S. patent application Ser. No. 09/621,670 filed Jul. 24, 2000 by inventors Mark Ashby, Andrew Cragg, Luis Urquidi, Eduardo Chi Sing, and Eric Lee entitled “Depth and puncture control for system for hemostatis of blood vessel”, now U.S. Pat. Nos. 7,625,352 and 2. U.S. patent application Ser. No. 10/069,107 filed Dec. 16, 2002 by inventors Mark Ashby, Rodney Brenneman, Andrew Cragg, and Eduardo Chi Sing entitled “Device and Method for Determining a Depth of an Incision”, now Issued U.S. Pat. No. 7,201,725, which was a national stage filing of International Application No. PCT/US00/26367, filed Sep. 25, 2000, and which is the non-provisional application of provisional application Ser. No. 60/156,007 filed Sep. 23, 1999.
Number | Name | Date | Kind |
---|---|---|---|
581235 | Kenyon | Apr 1897 | A |
1578517 | Hein | Mar 1926 | A |
2086580 | Shirley | Jul 1937 | A |
2465357 | Correll | Mar 1949 | A |
2492458 | Bering, Jr. | Dec 1949 | A |
2507244 | Correll | May 1950 | A |
2558395 | Studer | Jun 1951 | A |
2597011 | MacMasters et al. | May 1952 | A |
2680442 | Linzmayer | Jun 1954 | A |
2761446 | Reed | Sep 1956 | A |
2814294 | Figge | Nov 1957 | A |
2824092 | Thompson | Feb 1958 | A |
2899362 | Sieger, Jr. et al. | Aug 1959 | A |
3157524 | Artandi | Nov 1964 | A |
3308819 | Arp | Mar 1967 | A |
3724465 | Duchane | Apr 1973 | A |
4000741 | Binard et al. | Jan 1977 | A |
4211323 | Olsen | Jul 1980 | A |
4218155 | Weidner | Aug 1980 | A |
4238480 | Sawyer | Dec 1980 | A |
4292972 | Pawelchak | Oct 1981 | A |
4323072 | Rosenbluth et al. | Apr 1982 | A |
4340066 | Shah | Jul 1982 | A |
4390018 | Zuloowski | Jun 1983 | A |
4404970 | Sawyer | Sep 1983 | A |
4515637 | Cioca | May 1985 | A |
4583968 | Mahurkar | Apr 1986 | A |
4587969 | Gillis | May 1986 | A |
4588395 | Lemelson | May 1986 | A |
4619261 | Guerriero | Oct 1986 | A |
4619913 | Luck et al. | Oct 1986 | A |
4645488 | Matukas | Feb 1987 | A |
4675004 | Hadford et al. | Jun 1987 | A |
4698056 | Ciannella | Oct 1987 | A |
4708718 | Daniels | Nov 1987 | A |
4744364 | Kensey | May 1988 | A |
4790819 | Li et al. | Dec 1988 | A |
4829994 | Kurth | May 1989 | A |
4850960 | Grayzel | Jul 1989 | A |
4852568 | Kensey | Aug 1989 | A |
4890612 | Kensey | Jan 1990 | A |
4900303 | Lemelson | Feb 1990 | A |
4929246 | Sinofaky | May 1990 | A |
4936835 | Haaga | Jun 1990 | A |
4950234 | Fujioka et al. | Aug 1990 | A |
5007895 | Burnett | Apr 1991 | A |
5021059 | Kensey et al. | Jun 1991 | A |
5049138 | Chevalier et al. | Sep 1991 | A |
5052998 | Zimmon | Oct 1991 | A |
5053046 | Janese | Oct 1991 | A |
5061274 | Kensey | Oct 1991 | A |
5080655 | Haaga | Jan 1992 | A |
5108421 | Fowler | Apr 1992 | A |
5163904 | Lampropoulous et al. | Nov 1992 | A |
5167624 | Butler et al. | Dec 1992 | A |
5192300 | Fowler | Mar 1993 | A |
5192301 | Kamiya et al. | Mar 1993 | A |
5195988 | Haaga | Mar 1993 | A |
5220926 | Jones | Jun 1993 | A |
5221259 | Weldon et al. | Jun 1993 | A |
5224938 | Fenton, Jr. | Jul 1993 | A |
5242683 | Klaveness | Sep 1993 | A |
5275616 | Fowler | Jan 1994 | A |
5282827 | Kensey et al. | Feb 1994 | A |
5304131 | Paskar | Apr 1994 | A |
5310407 | Casale | May 1994 | A |
5322515 | Karas et al. | Jun 1994 | A |
5325857 | Nabai et al. | Jul 1994 | A |
5334216 | Vidal et al. | Aug 1994 | A |
5360416 | Ausherman et al. | Nov 1994 | A |
5366480 | Corriveau et al. | Nov 1994 | A |
5370656 | Shevel | Dec 1994 | A |
5383896 | Gershony et al. | Jan 1995 | A |
5383899 | Hammersiag | Jan 1995 | A |
5385550 | Su et al. | Jan 1995 | A |
5388588 | Nabai et al. | Feb 1995 | A |
5391183 | Janzen et al. | Feb 1995 | A |
5403291 | Abrahamson | Apr 1995 | A |
5417699 | Klein | May 1995 | A |
5419765 | Weldon et al. | May 1995 | A |
5431639 | Shaw | Jul 1995 | A |
5437292 | Kipshidze | Aug 1995 | A |
5437631 | Janzen | Aug 1995 | A |
5443481 | Lee | Aug 1995 | A |
5467780 | Nabai et al. | Nov 1995 | A |
5478352 | Fowler | Dec 1995 | A |
5479936 | Nabai et al. | Jan 1996 | A |
5486195 | Myers | Jan 1996 | A |
5490736 | Haber | Feb 1996 | A |
5522840 | Krajicek | Jun 1996 | A |
5522850 | Yomtov et al. | Jun 1996 | A |
5526822 | Burbank et al. | Jun 1996 | A |
5527332 | Clement | Jun 1996 | A |
5529577 | Hammershiag | Jun 1996 | A |
5540715 | Katseros et al. | Jul 1996 | A |
5542914 | Van Iten | Aug 1996 | A |
5545178 | Kensey et al. | Aug 1996 | A |
5558853 | Quay | Sep 1996 | A |
5591204 | Janzen et al. | Jan 1997 | A |
5591205 | Fowler | Jan 1997 | A |
5601602 | Fowler | Feb 1997 | A |
5601603 | Illi | Feb 1997 | A |
5645566 | Brennenman et al. | Jul 1997 | A |
5649547 | Ritchart et al. | Jul 1997 | A |
5653730 | Hammersiag | Aug 1997 | A |
5665107 | Hammersiag | Sep 1997 | A |
5676689 | Kensey | Oct 1997 | A |
5681279 | Roper et al. | Oct 1997 | A |
5716375 | Fowler | Feb 1998 | A |
5725498 | Janzen et al. | Mar 1998 | A |
5728132 | Van Tassel et al. | Mar 1998 | A |
5741223 | Janzen et al. | Apr 1998 | A |
5769086 | Ritchart et al. | Jun 1998 | A |
5775333 | Burbank et al. | Jul 1998 | A |
5782861 | Cragg et al. | Jul 1998 | A |
5800389 | Burney et al. | Sep 1998 | A |
5810806 | Ritchart et al. | Sep 1998 | A |
5830130 | Janzen et al. | Nov 1998 | A |
5858008 | Capaccio | Jan 1999 | A |
5868762 | Cragg et al. | Feb 1999 | A |
5902310 | Foerster et al. | May 1999 | A |
5984950 | Cragg et al. | Nov 1999 | A |
6007563 | Nash et al. | Dec 1999 | A |
6027471 | Fallon et al. | Feb 2000 | A |
6027482 | Imbert | Feb 2000 | A |
6027514 | Stine et al. | Feb 2000 | A |
6071300 | Brenneman et al. | Jun 2000 | A |
6071301 | Cragg et al. | Jun 2000 | A |
6086607 | Cragg et al. | Jul 2000 | A |
6161034 | Burbank et al. | Dec 2000 | A |
6162192 | Cragg et al. | Dec 2000 | A |
6183497 | Sing et al. | Feb 2001 | B1 |
6200328 | Cragg et al. | Mar 2001 | B1 |
6293958 | Berry et al. | Sep 2001 | B1 |
6315753 | Cragg et al. | Nov 2001 | B1 |
6709408 | Fisher | Mar 2004 | B2 |
6767339 | Reydel | Jul 2004 | B2 |
Number | Date | Country |
---|---|---|
0032826 | Jul 1981 | EP |
0476178 | Mar 1992 | EP |
0482350 | Apr 1992 | EP |
0557963 | Feb 1993 | EP |
0637431 | Nov 1994 | EP |
2641692 | Jul 1990 | FR |
1509023 | Apr 1978 | GB |
1569660 | Jun 1980 | GB |
782814 | Nov 1980 | SU |
1088709 | Apr 1984 | SU |
WO 9112847 | Sep 1991 | WO |
WO 9402072 | Feb 1994 | WO |
WO 9428800 | Dec 1994 | WO |
WO 9528124 | Oct 1995 | WO |
WO 9532669 | Dec 1995 | WO |
WO 9532671 | Dec 1995 | WO |
WO 9608208 | Mar 1996 | WO |
WO 9624290 | Aug 1996 | WO |
WO 9806346 | Feb 1998 | WO |
WO 9840016 | Sep 1998 | WO |
WO 9956692 | Nov 1999 | WO |
WO 9966834 | Dec 1999 | WO |
Number | Date | Country | |
---|---|---|---|
60156007 | Sep 1999 | US |
Number | Date | Country | |
---|---|---|---|
Parent | PCT/US00/26367 | Sep 2000 | US |
Child | 10069107 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 09621670 | Jul 2000 | US |
Child | 10462065 | US | |
Parent | 10069107 | Dec 2002 | US |
Child | 09621670 | US |