Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-05-03
2001-07-17
Nguyen, Anhtuan T. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S057000, C604S904000
Reexamination Certificate
active
06261258
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention is directed to a device for promoting sealing of blood vessels, particularly for use in angioplasty.
Angioplasty is an increasingly common surgical procedure, particularly for treatment of circulatory and cardiovascular disorders. Angioplasty involves the insertion of arterial catheters (which range between 5 F and 9 F). This requires the advancement of appropriate catheters over guidewires (which are in the range of 0.035 inches or 0.089 cm in diameter). At the present time, following removal of the catheter, bleeding at the arterial insertion site is stopped by application of a 5 pound pressure bag, use of manual compression, or application of a clamp to the limb of the patient for a period of time. All of these procedures are inefficient and painful. Furthermore, these procedures risk the occurrence of hematoma in the patient.
Among the devices that have been used for sealing arterial punctures such as those made during angioplasty are those described in U.S. Pat. No. 5,830,130, to Janzen et al., U.S. Pat. No. 5,527,292 to Adams et al., U.S. Pat. No. 5,843,051 to Adams et al., U.S. Pat. No. 5,649,959 to Hannam et al., U.S. Pat. No. 5,540,715 to Katsaros et al., U.S. Pat. No. 5,129,822, to Weldon et al., U.S. Pat. No. 5,221,259 to Weldon et al., U.S. Pat. No. 5,292,332 to Lee, and U.S. Pat. No. 5,443,481 to Lee, the disclosures of which are herein incorporated in their entirety by this reference.
Although these patents disclose a variety of approaches for sealing puncture wounds in arteries such as those generated by angioplasty, there is still a need for an improved approach to seal such puncture wounds. There is a need for a device that is painless and is more effective than existing devices and procedures for sealing such wounds. There is further a need for improved procedures and devices that reduce the risk of hematoma formation in such devices and procedures.
SUMMARY
An improved device for promoting hemostasis subsequent to angioplasty or other procedures that requires the puncturing of a blood vessel meets these needs. In general, the device comprises:
(1) a barrel including:
(a) a cylindrical portion; and
(b) a terminal tapered portion, the terminal tapered portion being divided by at least one slot cut therein so that the tapered portion expands radially when force is applied to it; and
(c) an aperture at the narrow end of the terminal tapered portion;
(2) a proteinaceous powder in the cylindrical portion of the barrel, the proteinaceous powder including at least one protein that promotes hemostasis in a blood vessel, the aperture in the terminal tapered portion being for flow of the proteinaceous powder; and
(3) a plunger inserted into the barrel, the plunger including:
(a) a narrow portion including therein means for guiding a guidewire; and
(b) a conical portion extending from the narrow portion so that, when the plunger is inserted into the barrel, the large end of the conical portion is located closest to the tapered portion of the barrel.
Typically, the proteinaceous powder includes a protein selected from the group consisting of fibrinogen, fibrin, and thrombin.
Typically, the length of the barrel is about 1.5 cm and the diameter of the cylinder is about 0.3 cm. Typically, the means for guiding the guidewire is a channel in which the guidewire is inserted. Preferably, the channel has a diameter of about 0.5 mm.
Another aspect of the present invention is a method for sealing a blood vessel comprising:
(1) inserting the device of the present invention along a guidewire so that the terminal tapered portion enters the tissue in the vicinity of the blood vessel;
(2) pushing down the plunger to force the proteinaceous powder into the tissue in the vicinity of the blood vessel;
(3) removing the guidewire; and
(4) withdrawing the device from the tissue in the vicinity of the blood vessel to leave proteinaceous material in the tissue to assist hemostasis.
REFERENCES:
patent: 4056854 (1977-11-01), Boretos et al.
patent: 4309994 (1982-01-01), Grunwald
patent: 4324262 (1982-04-01), Hall
patent: 4986820 (1991-01-01), Fischer
patent: 5129882 (1992-07-01), Weldon et al.
patent: 5195980 (1993-03-01), Catlin
patent: 5221259 (1993-06-01), Weldon et al.
patent: 5275616 (1994-01-01), Fowler
patent: 5292332 (1994-03-01), Lee
patent: 5320639 (1994-06-01), Rudnick
patent: 5391183 (1995-02-01), Janzen et al.
patent: 5443481 (1995-08-01), Lee
patent: 5527292 (1996-06-01), Adams et al.
patent: 5540715 (1996-07-01), Katsaros et al.
patent: 5649959 (1997-07-01), Hannam et al.
patent: 5797899 (1998-08-01), Tilton, Jr.
patent: 5810810 (1998-09-01), Tay et al.
patent: 5830130 (1998-11-01), Janzen et al.
patent: 5843051 (1998-12-01), Adams et al.
patent: 5844087 (1998-12-01), Zimmermann
patent: 333 25 622 A1 (1985-01-01), None
patent: 1173433 (1969-12-01), None
“Tisseel® VH Fibrin Sealant”, published inContemporary Surgery, Dec., 1998 (Exhibit 19).
PCT Publication No. WO 95/08951 for PCT/US94/10993 by Hammerslag, published on Apr. 6, 1995.
Nguyen Anhtuan T.
Oppenheimer Wolff & Donnelly LLP
Sirmons Kevin C.
LandOfFree
Hemostatic device for angioplasty does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Hemostatic device for angioplasty, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Hemostatic device for angioplasty will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2486885