Surgical ligation clip with increased ligating force

Abrading – Abrading process

Reexamination Certificate

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C451S056000

Reexamination Certificate

active

06290575

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to the field of ligation clips for surgical procedures, and more particularly, but not by way of limitation, to relatively small clips which are adapted for use in laparoscopic surgery.
2. Description of the Prior Art
There are many designs for surgical clips included in the prior art, some of which are particularly adapted for use in laparoscopic surgery. For example, U.S. Pat. No. 5,593,414 to Shipp, et al., which is assigned to the assignee of the present invention, discloses one form of surgical ligation clip to which the present invention can be applied. It has also been recognized that there are sometimes problems with surgical ligation clips slipping off of the blood vessel or other member to which they are clipped, and it is suggested in U.S. Pat. 5,593,414 that the gripping force of the clip can be enhanced by use of ridges, notches, or various other treatments to the clamping surfaces thereof
U.S. Pat. No. 5,620,452 discloses a surgical clip with penetrating members to prevent the clip from slipping off of the vessel.
U.S. Pat. No. 5,487,746 discloses a surgical clip having openings through which a portion of the clamped tissue will protrude.
U.S. Pat. No. 4,799,481 discloses a clip with tissue gripping grooves. These grooves offer some increase in removal force. Additionally the grooves substantially complicate the manufacturing process of such clips.
U.S. Pat. No. 5,601,573 discloses a clip having a surface characterized by a series of cross-hatches or dimples 97 as seen in FIG. 12.
U.S. Pat. Nos. 4,624,254 and 4,509,518 shows at FIGS. 35-40 a clip surface characterized by a series of longitudinal slots.
U.S. Pat. No. 4,799,481 shows a clip surface characterized by a series of cross hatches.
Tests on such clips as those of U.S. Pat. NoS. 4,624,254 and 4,799,481 are reported in
Journal of Laparoendoscopic Surgery,
Vol. 6, No. 2, 1996, p.99, and in
Arch. Surgery,
Vol. 127, June 1992, p.718.
U.S. Pat. No. 5,695,502 shown in FIGS. 7A-7C a clip having grooves or teeth 106.
U.S. Pat. No. 5,509,920 discloses a clip having complementary bumps and recesses to grip a vessel.
U.S. Pat. No. 5,501,693 discloses a clip having a complementary rib and groove for gripping.
U.S. Pat. No. 4,450,840 discloses at col. 4, 1.50-55 the use of ridges or grooves on a clip. Similar disclosure is found in U.S. Pat. No. 4,450,839 at col. 4, 1.47-50.
U.S. Pat. No. 4,449,530 discloses a clip having a diamond pattern 16 to improve gripping.
U.S. Pat. No. 4,976,722 discloses a clip having complementary protrusions and recesses for gripping.
U.S. Pat. No. 4,979,950 discloses a clip having a pattern of grooves for gripping tissue.
The following two articles discuss problems of clip slippage:
Arnaud, et al., “Migration and Slipping of Metal Clips After Celioscopic Cholecystectomy,
Surg. Laparoscope & Endoscopy:
Vol. 3, No. 6, pp. 487-88 (1993); and
Klein, et al., “Comparison of titanium and absorbable polymeric surgical clips for use in laparoscopic cholecystetomy”,
Surg. Endoscopy,
Vol. 6, pp. 753-758 (1994).
The following patent references show other clip constructions, most of which have grooves or the like on the clips:
U.S. Pat. No. 3,439,523;
U.S. Pat. No. 3,270,745;
U.S. Pat. No. 3,439,522;
U.S. Pat. No. 4,146,130;
U.S. Pat. No. 5,171,250; and
U.S. Pat. No. 5,192,288.
Thus it is seen that there is a need for improved techniques for treatment of the surface of ligation clips and other surgical instruments which are intended to grip blood vessels or the like, so as to reduce the incidence of clips slipping out of place.
The present invention provides such a surface treatment which can be applied to spring clips like those of U.S. Pat. No. 5,593,414 or to other surgical instruments. Also provided are preferred constructions for such spring clips and surgical instruments.
SUMMARY OF THE INVENTION
A method of treatment of the surface of the surgical instrument is provided which includes steps of blasting the surface with a stream of particles and thereby roughening the surface so that the surface will more effectively grip human tissue than would an untreated surface.
In a preferred method, the particles are white aluminum oxide having a grit size in the range from about 100 to about 180, and preferably with a grit size of about 150.
When such a treatment is provided to a titanium drawn wire clip for approximately two seconds, dramatic changes are created in the surface texture of the clip.
Prior to treatment the drawn wire clip has a surface topography defined by regular dimpled surface features and occasional smeared metal plateaus, all of which has a directional characteristic generally parallel to the length of the wire. After the preferred treatment, the surface topography of the treated metal wire clip is free of such smooth metal plateaus and regular dimpled surface features. Instead, the operative treated surface of the clip has a surface topography characterized by irregular multi-faceted jagged surface features having dimensions on the order of 1 to 10 microns.
Standard tests show that this treatment increases the coefficient of friction of a spring type ligation clip on material that is typically used to simulate body vessels in clip removal tests from a value of approximately 0.25 for the untreated clip up to a value in the range of 0.65 to 0.71 for a clip which has received the most preferred surface treatment.
Preferred processes are disclosed for treating the surface of various surgical instruments including ligation clips.
Also disclosed are improved surgical instruments and ligation clips having such treated surfaces.
It is therefore an object of the present invention to provide improved surgical instruments having surfaces which may more securely grip a ligated blood vessel or the like.
Another object of the present invention is the provision processes for manufacturing such surgical instruments.
Still another object of the present invention is the provision of an improved ligation clip which is less likely to slip off of a ligated vessel.


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Papainoannou, Thanassis, M.S., Daykhovsky, Leon, M.D., Grundfest, Warren S., M.D.: “Safety Evaluation of Laparoscopically Applied Clips”:Journal of Laparoendoscopic Surgery1996: 6(2):99-106.
Nelson, Tomothy M., M.D., Nakashima, Masanobu, M.D., Mulvihill, Sean J., M.D.: “How Secure Are Laparoscopically Placed Clips? An In Vitro and In Vivo Study”:Arch Surg.1992: 127:718-720: pub. Dec. 8, 1991.
Arnaud, Jean-Pierre, M.D., Bergamaschi, Roberto, M.D.,: “Migration and Slipping of Metal Clips After Celioscopic Cholecystectomy”:Surgical Laparoscopy&Endoscopy1993: 3(6): 487-488: pub. 1993 Raven Press, Ltd., New York.
Klein, R.D., Jessup, G., Ahari, F., Connolly, R.J., Schwaitzberg, S.D.: “Comparison of titanium and absorbable polymeric surgical clips for use in laparoscopic cholecystectomy”:Surgical Endoscopy1994: pub. 1994 Springer-Verlag New York Inc.

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