Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
2001-01-03
2003-02-25
Calvert, John J. (Department: 3765)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
C606S145000, C606S148000, C112S169000, C112S080030
Reexamination Certificate
active
06524321
ABSTRACT:
BACKGROUND OF THE INVENTION AND RELATED ART STATEMENT
The present invention relates to a closure device used for a medical purpose, and more particularly, it relates to a closure device for suturing a puncture site in a blood vessel after an angioplasty procedure.
In angioplasty called percutaneous transluminal coronary angioplasty (PTCA), for example, a catheter having a balloon at the distal end (balloon catheter) is introduced into a body of a patient to enlarge a constriction in a vessel, such as a coronary artery. In order to introduce the catheter into the vessel, a small puncture is incised in a femoral artery, and a guide wire and the balloon catheter are introduced therefrom and guided to an aorta. Then, the guide wire and the balloon catheter are further pushed to a constriction in the coronary artery to enlarge the constriction.
After the PTCA procedure is completed, the guide wire and the catheter are withdrawn from the femoral artery, and the puncture in the femoral artery is treated to stop bleeding for several hours, such as four to seven hours. During this period, the patient has to lie on the bed in a hospital, resulting in wasting time for the patient and adding an additional cost for the procedure.
One of the most basic methods for closing the puncture is to apply pressure to the puncture site for 3 to 4 hours until bleeding stops, called “compression”. In this method, the patient is immobilized on the bed for 6 to 10 hours.
The puncture may be manually sutured by a needle and a thread or suture, which can securely close the puncture. However, it is very difficult to master the technique for suturing the small puncture in the blood vessel manually, resulting in requiring a long learning. Also, it take time for the manual suturing.
Accordingly, in recent years, collagen plug devices and suturing devices have been developed to reduce the time for the patient to lie on the bed after the PTCA procedure. The collagen plug device is used for closing the puncture by the collagen plug. Although the collagen plug device is easy to use, it does not work well with a larger puncture, and a success ratio for closing the puncture is not desirable.
The suturing devices have been developed in order to make the suturing easier. For example, as shown in
FIG. 13
, a conventional suturing device is formed of a shaft
101
with a bend area
102
, and a needle
103
with a suture
104
. The shaft
101
has a needle passage
105
for receiving the needle
103
, a needle well
106
, a guide wire passageway
107
, and a space S between the needle well
106
and the needle passageway
105
.
In the suturing device, after the PTCA procedure, the guide wire
108
used for guiding the balloon catheter is left in the vessel, and the shaft
101
is introduced into the vessel through the puncture by sliding the shaft
101
over the guide wire
108
. The space S of the catcher
102
is located at the puncture to encompass a wall of the blood vessel, and the needle
103
with the suture
104
located in the needle passage
105
is pushed by a needle pusher
109
to enter the needle well
106
through the wall of the blood vessel in the space S. When the needle
103
is placed in the needle well
106
, the needle pusher
109
is withdrawn from the needle passage
105
(in FIG.
14
), and the suture is pulled away through the slit S. Then, the shaft
101
with the needle is withdrawn from the vessel through the puncture over the guide wire as shown in
FIG. 15
, so that the suture
104
attached to the needle
103
passes through the wall of the vessel to form one stitch.
Then, the needle
103
is removed from the needle well
106
and is placed in the needle passage
105
manually, and the above procedures is repeated at an opposite side of the puncture, so that the two portions with the puncture therebetween are sutured. Thereafter, the guide wire
108
is removed from the vessel, and a knot is made between the two ends of the suture to close the puncture.
In this conventional suturing device, however, there are the following problems. Firstly, in order to close the puncture by suturing, the suture must pass through the two portions beside the puncture, but the conventional suturing device can suture only one point at a time. Thus, after the needle with the suture passes through the one point, the needle with the suture has to be removed from the needle well by hand, and the needle with the suture has to be reintroduced into the needle passageway in the shaft. Then, the shaft has to be reintroduced into the vessel for suturing at the second portion, and the procedure for suturing has to be repeated. Thus, the operation of the conventional suturing device is cumbersome.
Secondly, it is effective for the suturing procedure to hold the vessel wall at the puncture while the suturing is made. In the conventional suturing device, however, although the space in the catcher helps positioning the shaft at the puncture site, the catcher can not sufficiently hold the vessel wall while suturing the vessel wall around the puncture.
In view of the problems in the conventional procedures, the present invention has been made, and an object of the invention is to provide a closure device for a puncture in a vessel, which can suture two portions beside the puncture at a time and is operated easily.
Another object of the invention is to provide a closure device as stated above, which can hold the vessel wall at the puncture securely while the needles pass through the vessel wall.
A further object of the invention is to provide a closure device as stated above, wherein the suturing can be done at once without handling the needle manually.
Further objects and advantages of the invention will be apparent from the following description of the invention.
SUMMARY OF THE INVENTION
A closure device for a puncture in a vessel, i.e. blood vessel, of the invention is basically formed of a needle holder having a pair of first needle passages at a front side, and a needle catcher located at the front side of the needle holder to be movable thereto. The needle catcher has a pair of second needle passages aligned with the first needle passages. Also, the closure device includes a pair of needle pushers or pushing shafts slidably located in the first needle passages, and a needle handle attached to the needle pushers for actuating the needle pushers.
In the invention, a pair of needles joined with a suture is disposed in the first needle passages at a side close to the needle catcher. When the needle handle is actuated, the needles in the first needle passages are pushed by the needle pushers and transferred to the second needle passages.
In operation, the closure device is located in the blood vessel such that the first needle passages are located above two wall portions of the vessel with a puncture hole therebetween. The needle handle is operated to push the needles to the second passages while passing through the wall portions of the vessel. Then, the closure device is removed from the blood vessel, and the suture passing through the two wall portions of the vessel are joined or tightened together. In this simple one procedure, the two wall portions are joined together by the suture. Thus, the closure device of the invention can be operated easily without skill.
The closure device of the invention further includes a guide shaft slidably disposed inside the needle holder and connected to the needle catcher. When the guide shaft is actuated, the needle catcher is moved relative to the needle holder. Thus, the wall portions of the blood vessel at the puncture can be securely held between the needle holder and the needle catcher when the needles pass therethrough.
The closure device further includes a needle catcher handle fixed to the guide shaft, and a spring disposed between the needle catcher handle and the needle holder for urging the needle catcher to be located close to the needle holder. Accordingly, the needle catcher can be handled easily.
In order to hold the needles with the suture, the needle holder includes sli
Calvert John J.
Kanesaka & Takeuchi
Smith James G
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