USO0RE40863E

(19) United States (12) Reissued Patent

(10) Patent Number:

Tay et al. (54)

(45) Date of Reissued Patent:

APPARATUS AND METHOD FOR SEALING

(58)

Jul. 21, 2009

Field Of Classi?cation Search .................. .. 606/27,

VASCULAR PUNCTURES

606/32, 37, 38, 40, 41, 4552, 191, 192, 606/194, 195, 198, 216; 507/115; 128/DIG. 8,

(75) Inventors: Sew Wah Tay, Plymouth, MN (US); Kemal Schankereli, StillWater, MN (US); Thomas Holman, Princeton, MN (US); Hans Mische, St. Cloud, MN (US)

128/DIG. 22; 600/372i374, 453*455 See application ?le for complete search history. (56)

References Cited U.S. PATENT DOCUMENTS

(73) Assignee: Boston Scienti?c Scimed, Inc., Maple Grove, MN (US)

1,596,004 A *

(21) Appl. No.:

10/150,878

1,731,069 A 1,983,669 A

(22)

PCT Filed:

Oct. 22, 1993

(86)

PCT No.:

PCT/US93/10202

§ 371 (0X1)’ (2), (4) Date:

Oct. 23, 1995

(87)

US RE40,863 E

8/1926 De Bengoa

* 10/1929 Herman * 12/1934 Kimble

(Continued) FOREIGN PATENT DOCUMENTS DE EP EP

38 38840 A1 * 0 075 860 A2 * 0476 178 A1 *

5/1990 4/1983 3/1992

PCT Pub. No.: WO94/24948

(Continued)

PCT Pub. Date: Nov. 10, 1994

OTHER PUBLICATIONS Related US. Patent Documents

Article entitled “The Mechanism of Blood Vessel Closure

Reissue of:

By High Frequency Electrocoagulation” by Bernard Sigel

(64) Patent No.: Issued: Appl. No.:

6,063,085 May 16, 2000 08/537,902

Filed:

Oct. 23, 1995

and Marvin R. Dunn, Surgery Gynecology & Obstetrics, Oct. 1965, vol. 121, No. 4, pp. 823*831.*

(Continued) Primary Examinerisamuel G Gilbert

US. Applications: (63)

(74) Attorney, Agent, or FirmACrompton, Seager & Tufte

Continuation-in-pait of application No. 08/055,634, ?led on

LLC

Apr. 30, 1993, now Pat. No. 5,507,744, and a continuation

(57)

in-part ofapplication No. 07/873,955, ?led on Apr. 23, 1992,

ABSTRACT

now abandoned.

(51)

(52)

Int. Cl. A61B 18/18 A61B 17/00 A61B 17/34 A61B 18/04 A61B 18/14 A61B 18/08 A61B 19/00

An apparatus for closing and sealing a vascular puncture is connected to an energy supply such that heat is generated in, or thermally conducted to, the tissue, thereby thermally fus ing the vascular tissue together. The method for closing and sealing a vascular puncture comprises applying radio fre

(2006.01) (2006.01) (2006.01) (2006.01) (2006.01) (2006.01) (2006.01)

quency or other energy to the tissue, the energy being su?i

cient to thermally fuse the tissue together, thus sealing the

puncture. Embodiments of depth ?nding and guiding devices, as Well as blood vessel occluders, are also disclosed.

69 Claims, 20 Drawing Sheets

US. Cl. ....................................................... .. 606/50

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US RE40,863 E Page 2

US. PATENT DOCUMENTS

4,716,897 A * 4,717,381 A *

1/1988 Noguchi et al. 1/1988 Papantonakos

2,790,442 A : 4/1957 Donaldson

4,735,201 A * 4/l988 O,Reilly

5,533,223: * 134132; ggl‘ist

4,744,359 A * 5/1988 Hattaetal.

3’l76’n4 A * M965 Kniislyey

4,744,364 A * 5/1988 Kensey

3,301,258 A *

1/1967 Werneretal.

4760347 A *

8/1988 valnancpurt

3302 635 A

2/l967 Pittman

4,765,331 A

8/1988 PetruZZ1 et al.

Z1970 Peters

4,776,349 A * 10/1988 Nashefet al.

*

334943364 A * 3,532,095 3,613,682 3,636,943 3,699,967 3,794,040 3,801,766 3,801,800 3,825,004 3,858,586 3,874,388 3,886,944 3,920,021 3,929,137 3,938,527 3,963,030 3,978,863

A A A A A A A A A A A A A A A A

>1< >1< * * * * * * * * * * * * * *

10/1970 10/1971 1/1972 10/1972 2/1974 4/1974 4/1974 7/1974 1/1975 4/1975 6/1975 11/1975 12/1975 2/1976 6/1976 9/1976

Miller Naylor Balamuth Anderson Balamuth Morrison, Jr. Newton Durden,III Lessen King et al. Jamshidi Hiltebrandt Gonser RiouX et al. Newton Fettelet al.

4,790,819 4,801,293 4,832,688 4,834,725 4,836,204 4,848,339 4,848,352 4,850,960 4,852,568 4,854,320 4,860,745 4,890,612 4,900,303 4,917,089 4,920,980 4,921,478

A A A A A A A A A A A A A A A A

*

* 12/1988 Ll etal. * 1/1989 Jackson * 5/1989 Sagae et al. * 5/1989 Iwatschenko * 6/1989 Landymore et al. * 7/1989 Rink et al. * 7/1989 Pohndorfet al. * 7/1989 Grayzel * 8/1989 Kensey * 8/1989 Dew et a1. * 8/1989 Farin et al. * 1/1990 Kensey * 2/1990 Lemelson * 4/1990 Sideris * 5/1990 Jackowski * 5/1990 Solano et al.

3,980,085 A

*

9/1976 Ikuno

4,929,246 A

*

5/1990

4,003,380 A 4,007,743 A

* *

1/1977 Wien 2/1977 Blake

4,938,761 A 4,943,290 A

* *

7/1990 Ensslin 7/1990 Rexroth et al.

4,011,872 4,014,343 4,016,881 4,043,342 4,051,855 4,054,143 4,074,718 4,112,950 4,122,853 4,162,673 4,168,708 4,198,957 4,215,699 4,228,800 4,230,119 4,269,174 4,271,847 4,273,127 4,314,555 4,353,371 4,359,052

A A A A A A A A A A A A A A A A A A A A A

* * * * * * * * * * * * * * * * * * * * *

3/1977 3/1977 4/1977 8/1977 10/1977 10/1977 2/1978 9/1978 10/1978 7/1979 9/1979 4/1980 8/1980 10/1980 10/1980 5/1981 6/1981 6/1981 2/1982 10/1982 11/1982

Komiya Esty RiouX etal. Morrison, Jr. Schneiderrnan Bauer Morrison, Jr. Pike Smith Patel Lepley, Jr. et al. Cage et al. Patel Degler, Jr. et a1. Blum Adair Stokes Auth et al. Sagae Cosman Staub

4,946,463 4,953,559 4,960,133 4,961,729 4,979,948 4,994,060 5,002,051 5,009,656 5,013,312 5,021,059 5,035,695 5,038,789 5,047,028 5,049,148 5,053,046 5,057,105 5,061,267 5,061,274 5,073,166 5,078,743 5,080,660

A A A A A A A A A A A A A A A A A A A A A

* * * * * * * * * * * * * * * * * * * * *

8/1990 9/1990 10/1990 10/1990 12/1990 2/1991 3/1991 4/1991 5/1991 6/1991 7/1991 8/1991 9/1991 9/1991 10/1991 10/1991 10/1991 10/1991 12/1991 1/1992 1/1992

4,370,980 A

*

2/1983

4,390,018 4,404,971 4,411,266 4,418,692 4,424,833 4,470,415 4,476,862 4,483,338 4,492,231 4,498,475 4,520,823 4,522,205 4,532,924 4,539,987 4,548,207 4,625,724

* * * * * * * * * * * * * * * *

6/1983 9/1983 10/1983 12/1983 1/1984 9/1984 10/1984 11/1984 1/1985 2/1985 6/1985 6/1985 8/1985 9/1985 10/1985 12/1986

4,637,392 A

*

4,645,491 4,671,274 4,672,969 4,682,596 4,708,136

A A A A A A A A A A A A A A A A

A A A A A

Sinofsky ...................... .. 606/8

Wright Salerno Hewson Vaillancourt Geddes et al. Rink et al. Dew et a1. Reimels Parins etal. Kensey et al. Weber, Jr. et al. Frazin Qian Mehl Janese Malone etal. Zeiher Kensey Parks et al. Mikalov et al. Buelna

Lottick ...................... .. 606/42

5,085,659 A

*

2/1992

Rydell

Zukowski LeVeen et al. Cosman Guay Spector et al. Wozniak Pao Bloom et al. Auth Schneiderman LeVeen et al. Taylor et al. Auth et al. Nath et al. Reimels Suzuki et al.

5,088,997 5,108,392 5,108,420 5,108,421 RE33,925 5,116,332 5,122,137 5,122,139 5,129,882 5,131,394 5,133,714 5,141,515 5,147,316 5,147,357 5,151,098 5,151,102

* * * * * * * * * * * * * * * *

2/1992 4/1992 4/1992 4/1992 5/1992 5/1992 6/1992 6/1992 7/1992 7/1992 7/1992 8/1992 9/1992 9/1992 9/1992 9/1992

Delahuerga et al. Spingler Marks Fowler Bales et al. Lottick Lennox Sutter Weldon etal. Gehlbach Beane Eberbach Castillenti Rose et al. Loertscher Kamiyama et a1.

1/1987

Sorochenko

5,156,613 A

* 10/1992

* 2/1987 * 6/1987 * 6/1987 * 7/1987 * 11/1987

Evans Sorochenko Dew Bales et al. Saito

5,158,561 5,159,925 5,183,464 5,188,634 5,190,541

* 10/1992 Rydelletal. * 11/1992 Neuwirth et al. * 2/1993 Dubrulet al. * 2/1993 Hussein et al. * 3/1993 Abele et al.

A A A A E A A A A A A A A A A A

A A A A A

Sawyer ..................... .. 606/213

US RE40,863 E Page 3

5,192,300 A 5,192,302 A

* *

5,207,675 A

*

3/1993 Fowler 3/1993 Kenseyetal.

5,383,899 A 5,411,520 A

* * *

1/1995 Hammerslag 5/1995 Nashetal.

5/1993 Canady ..................... .. 606/40

5,413,571 A

5,217,024 A *

6/1993 Dorseyetal.

5,415,657 A *

5/1995 Taymor-Luria

5,217,451 A 5,217,458 A 5,217,459 A

* * *

6/1993 Freitas 6/1993 Parins 6/1993 Kamerling

5,419,765 A 5,431,639 A 5,437,631 A

5/1995 Weldonetal. 7/1995 Shaw 8/1995 JanZen

5,217,460 A *

6/1993 Knoep?er

5,441,517 A *

8/1995 Kenseyetal.

5,220,924 A 5,221,259 A

* *

6/1993 FraZin 6/1993 Weldon et al.

5,507,744 A * 6,200,313 B1 *

4/1996 Tay et a1. .................... .. 606/50 3/2001 Abe et al. ................... .. 606/34

5,221,281 A

*

5,222,974 A * 5,226,908 A

*

*

5,269,780 A 5,275,616 A

5,277,696 A 5,281,216 5,282,799 5,282,827 5,290,310

A A A A

*

* * *

7/1993 Yoon

12/1993 Roos 1/1994 Fowler

1/1994 Hagen .

1/1994 2/1994 2/1994 3/ 1994

Kllcek Rydell Kensey et al. Makower et al.

5’292’332 A * 3/1994 Le.e 5,304,117 A * * 4/1994 Wllk 5,306,254 A 5,320,639 A

4/1994 Nash etal. *

6/1994

Rudnick

5,324,306 A * 6/1994 Makower et al, 5,364,389 A * ll/l994 Anderson 5,370,660 A

FOREIGN PATENT DOCUMENTS EP

0482350 A2 *

EP

0 517 243

EP W0 W0 W0

l/ 1995 Gershony et a1.

‘V1992 12/1992

0 521595 A2 * 7/1993 WO 90/14796 * 12/1990 WO 92/05740 * 4/1992 WO 92/22252 * 12/1992

W0

WO 93/21844

* 11/1993

W0

WO94/24948

* “H994

OTHER PUBLICATIONS

Article entitled “Repair of small blood Vessels With the . . . . NeodymiumiYAG laser: A prelimlnary report,, by KK. Ja1n dW G an

-

.

h S

on“ ’

1 85 N urgemvo-



6 0-

684 688 * ’PP-

*

-

Product literature for VasosealTM Vascular Sealant by Datas cope, 10 pages, undated.*

* 12/1994 Weinstein et al.

5,383,896 A *

Katsaros et al.

6/1993 Klicek

6/1993 Kensey etal.

5,230,349 A 7/1993 Langberg * 5,257,635 A 11/1993 Langberg * 5,258,006 A 11/1993 Rydellet al. * * *

* * *

5/1995

* cited by examiner

US. Patent

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Apparatus and method for sealing vascular punctures

Oct 22, 1993 - (US); Hans Mische, St. Cloud, MN (US) .... 4,168,708 A * 9/1979 Lepley, Jr. et al. 5,035,695 A * 7/1991 ... 4,404,971 A * 9/1983 LeVeen et al.

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