JP2604833B2 - Plastic ligating clip - Google Patents

Description

The present invention relates to a plastic ligating clip, and more particularly to a plastic ligating clip.
The invention relates to a hemostatic clip, for example for surgery, made of a polymeric material and to a device for applying the clip.

BACKGROUND OF THE INVENTION Surgical clips, such as hemostatic clips and aneurysm clips, are often used to ligate blood vessels during surgery to stop blood flow. Surgical clips are used to block or occlude the fallopian tubes or vas deferens by aseptic operation. Such a clip is permanently installed in a predetermined place so that the ligated end of the blood vessel is closed within a predetermined time, that is, hemostasis or occlusion is performed.

Generally, U-shaped or V-shaped metal clips have been used for many years. The most common metals are alloys of tantalum, titanium or stainless steel, all of which deform in a closed position around the blood vessel and, due to the nature of the metal, remain deformed and the blood vessel is deformed. Resists spreading or opening forces.

Metal clips are available from Computer Tomography (Co)
Some interference with advanced technology diagnostic physiotherapy, including mputer Tomography, computed radiography (CATSCAN) and Magnetic Resonance Imaging (MRI) Cause In particular, the emergence of new MRI technology requires a clip that does not interfere. For example, existing MRI fast imaging techniques have increased the magnitude by at least an order of magnitude, increasing the sensitivity to the inhomogeneity of the magnetic field provided by the metal clip. While a magnetic field homogeneity of 1 × 10 ⁻⁵ is required, metal clips, especially stainless steel clips, can reduce the homogeneity of the clip area to the order of 10 ⁴ or less.

This situation is even more pressing with the development of analytical methods. That is, in vivo magnetic resonance spectroscopy (Magnetic Resonance Spectrosc
According to the latest developments in opy, electromagnetic resonance spectroscopy (MRS), the requirement for minimizing magnetic field disturbances is increasing (requires a magnetic field homogeneity of about 1 × 10 ^-7 ). . Existing metal clips preclude the use of MRS data taken with the metal clips in close proximity. The size of this area is 6 times the clip diameter for titanium and tantalum,
In the case of stainless steel, it is more than 50 times the clip diameter.

In order to solve this problem, plastic clips have recently been proposed. These clips should be as small as possible, for example, as small as their metal counterparts. The plastic clip requires a latching means to hold the closure of the clip once it is clamped around the vessel. This is because, unlike metal clips, there is insufficient resistance to the force of opening a blood vessel.

Currently, most of the new plastic clips on the market are made from biodegradable and absorbable polymeric materials. In general, absorbent clips do not reach the level of mechanical strength as in modern engineering plastics due to their relatively high water absorption, and therefore, to provide relative strength, a compromise of increased size is required. is required. The use of high performance polymer materials allows for increased design choices for improved functionality.

Accordingly, there is a need for the manufacture of small, safe, biocompatible, and robust polymer surgical clips.

The surgical clip of the present invention is made from a polymeric material,
Minimize interference with advanced technology diagnostic physiotherapy (eg CATSCAN, MRI and MRS). At the same time, such clips are about as small as the comparative metal clips, yet maintain sufficient strength in the clip latching mechanism in the closed position and possess high security.
Also, the shape of the clip is such that safety measures for handling and application are provided in order to avoid premature release of the application tool.

That is, the surgical clip provided by the present invention comprises first and second curved leg members which are joined at their proximal ends by hinge means and latch together at their distal closed positions. It is being fastened. Each of the leg members is substantially in the closed position, has opposed curved inner surfaces, and the inner surface of the first leg member is concave. The first leg member further has a hook joined to its distal end and curved toward the second leg member. The hook is adapted to engage the outer surface of the end of the second leg member when the clip is in the closed position. The shape of the outer surface of the second leg member facing the inner convex surface is concave. This shape provides a more secure latching mechanism.
Because the force to open the clip of the clamped blood vessel is applied, the second leg member becomes longer, the first leg member becomes shorter, and the distal end of the second leg member moves to the hook portion, This is because the engagement with the hook portion is strengthened. Since the thickness of the second leg member is less than without the outer concave surface, the second leg member deflects the clamping (clamping) in response to the force exerted by the clamped blood vessel, and also has the advantage that each leg member has Since the thickness connecting the inner and outer surfaces between the hinge means and the distal end is substantially equal to the thickness of the other leg members, all of the deflection required to accommodate vessel closure and clamping is achieved by two legs. It is distributed between the members so that breakage or destruction of the leg members can be avoided. In a preferred embodiment, the radius of curvature of the concave surface inside the first leg member is:
It is the same as the radius of curvature of the convex surface inside the second leg member. This provides a constant compressive force over the entire width of the vessel being clamped.

The hinge means comprises a thin portion of the clip. The hinge means is formed by a continuous curve of large radius,
It has the appropriate thickness to help reduce stress concentrations at the hinge. Each of the first and second leg members further has a peninsula formed by extension of the inner surface of the leg member.
The peninsula is such that when the clip is in the closed position, it extends substantially to the inner surface of the hinge means, so that the clamped vessel can reach the hinge area where complete occlusion can be avoided. Ingress is prevented.

In another embodiment of the hinge means, the hinge means has a curved slot extending side by side therein, the slot being arranged between the inner curved concave surface of the hinge means and the side curved convex surface, preferably a convex surface. Closer to the concave surface. A hinge with a slot increases the flexibility of the hinge as compared to a hinge of the same thickness (but without the slot). The slot is separated from the blood vessel clamped between the inner surfaces of the two leg members, but the internal concave surface of the hinge prevents a portion of the blood vessel from entering the hinge area where there is no possibility of blockage of the blood vessel. Is done.

The inner and outer surfaces of the hook are substantially continuously curved to prevent excessive stress concentration at each corner or small radius of the hook.

In addition, the clip of the present invention includes a means for engaging the clip with a suitable pinset-type application device, wherein the engaging means sandwiches at least a first leg member intermediate the hinge means and the hook. It consists of a pair of bosses located on both sides and a pair of bosses located on both sides sandwiching the second leg member at the end of the second leg member. The boss of the second leg member extends beyond the end and is spaced at regular intervals. It forms two parallel planes which are separated and which prevent a relative lateral movement of the two legs when the clip is closed.
These bosses are used by the application tool when applying with the clip.

The sides of the end of the hook are tapered to reduce the thickness of the outer surface of the end of the hook so that alignment can be achieved during the initial stage of clip closure.

In addition, the clip of the present invention is provided on the inner surfaces of both leg members.
It may have a plurality of protrusions to help hold the clamped vessel. The protrusions may be in the form of a ratchet (claw) or a wedge (wedge).
Provides one-way movement of the blood vessel to the clip (the blood vessel does not exit the clip).

The present invention also provides a ligating clip application device having means for engaging a boss provided on a side surface of a leg portion with two legs. The jaws of the applicator include a groove for receiving the clip and a notch near each jaw end of the wall on either side of the groove. Each wall also includes an arched wall adjacent to the outside of the notch.

Furthermore, the device according to the invention has a projection on the floor of each groove, which is directed towards the opposite jaw and close to the concave notch. Each of the projections engages the leg of the clip and serves to force the leg and leg together following the closure of the jaw.

The clip of the present invention comprises first and second curved leg members having their proximal ends joined by thin hinge means and movable from an open position to a closed position. Closing the clip allows the vessel to be clamped between the substantially parallel opposing curved inner surfaces. The first leg member has an inner concave surface and a hook at a distal end, and the hook portion is curved toward the second leg member.

The device of the present invention also comprises a pair of handles pivoting about a hinge point, the handles extending beyond the hinge point to form a pair of clip closing jaws, wherein the jaws have first and second jaws. Means are provided for engaging bosses located on both sides of the biped member.

Hereinafter, the present invention will be described more specifically with reference to the accompanying drawings.

FIG. 1 is an enlarged perspective view of a surgical clip of the present invention, FIGS. 2A to 2D are front views of the clip of FIG. 1 and partial views thereof, and FIG. 3 is a view of the clip of FIG. FIG. 4 is an enlarged plan view of a pin-set type application device used with the clip of the present invention, FIG. 5 is an enlarged cutaway perspective view of a first jaw of the application device of FIG. 4, and FIG. Fig. 5 is a bottom view of the first jaw, Fig. 6 is an enlarged cutaway perspective view of the second jaw of the application tool of Fig. 4, Fig. 6A is a bottom view of the second jaw of Fig. 6, and 7A to 7E. The figures show the fourth to fourth figures when applying the clip of the present invention.
FIG. 6A is a view for explaining how to use the application device shown in FIG. 6; FIG. 8 is an enlarged side view showing another specific end of the clip leg member of FIG. 1; FIG. 10 is a front view as seen from line 9-9, FIG. 10 is a top view as seen from the line 10-10 at the end of FIG. 8, and FIG. 11 shows another specific hook portion of the clip of FIG. FIG. 12 is an enlarged side view, FIG. 12 is a top view of the hook portion of FIG. 11 as viewed from line 12-12, FIG. 13 is an enlarged perspective view showing a second specific example of the clip of FIG. 1, and FIG. FIG. 15 is an enlarged perspective view showing a third embodiment in the closed position of the clip of FIG. 1, FIG. 15 is a perspective view of a first leg member of the clip of FIG. 14, and FIG. 16 is a second view of the clip of FIG. 17 is a perspective view of the leg member, FIG. 17 is a partially cut-away plan view of the first leg member of FIG. 15,
FIG. 18 is an enlarged perspective view showing a fourth specific example of the clip shown in FIG.

1, 2A-2D and 3, there is shown a surgical clip 10 which is a preferred embodiment of the present invention. The clip 10 comprises a first curved leg member 12 and a second curved leg member 14, both of which are joined at their proximal ends by a hinge 16. The first leg member 12 has an inner concave surface 20 and a curved hook 22 joined to a distal end. The inner surface 24 of the second curved leg member 14 is convex such that it is substantially parallel to the inner concave surface 20 when the clip 10 is closed. That is, the radius of curvature of the inner concave surface 20 is substantially the same as that of the inner convex surface 24. The hook portion 22 is curved toward the distal end of the second leg member 14.

The inner side surface 26 and the outer side surface 28 of the hook portion 22 are continuously curved, and the outer side surface 28 has a first curvature while reducing the radius of curvature.
Continuing from the outer convex surface 30 of the leg member, the inner surface 26 has a first radius while reducing the radius of curvature to a constant final radius of curvature.
It continues from the inner concave surface 20 of the leg member 12. In a preferred embodiment, the thickness between the inner surface 20 and the outer surface 30 of the first leg member (including between the inner surface 26 and the outer surface 28 of the hook) is each constant over its length.

The second leg member 14 has a banana-shaped contour along the length between the inner convex surface 24 and the outer concave surface 38. The thickness of the distal end decreases sharply due to the change in the radius of curvature at point 42 on the inner surface 24, forming an inner curved bevel surface 44 (ending at the tip 46) and a relatively flat bevel surface 48 forming an outer concave surface.
38 is connected to the tip 46.

The thickness connecting the inner side surface 24 and the outer side surface 38 between the hinge portion 16 and the distal end of the second leg member 14 may be changed at a rate of 10 to 20%, and the thickness of the leg member 14 is the most in the central region. large. Generally, the thickness of the second leg member 14 is substantially the same as the thickness of the first leg member 12, except for the central variation.
The leg members may be slightly thicker. However, the first leg member
It is also possible to adjust the thickness of the first leg member 12 by increasing the central region of the thickness of 12 and modifying the outer convex surface 30 of the first leg member 12, but the radius of curvature of the inner concave surface 20 is The radius of curvature of the inner convex surface 24 of the second leg member 14 is equal to the radius of curvature. Since the thickness of the center of the second leg member 14 is slightly large, when the clip 10 is clamped around the blood vessel 300, the second
The first leg member 12 bends slightly more than the leg member 14.
However, because the outer concave surface 38 of the second leg member 14 is substantially deflected during closure, the placement of the second leg member 14 requires the two leg members necessary to clamp the blood vessel 300 and latch the clip 10. The total flexure of the legs 12, 14 is distributed approximately equally by the legs 12, 14.

The hinge 16 has a thickness between the inner surface 50 and the outer surface 52 substantially smaller than the thickness of the two leg members 12 and 14. The outer surface 52 of the hinge 16 connects the outer surfaces 30 and 38 of the two leg members 12 and 14 in a continuous curve. The legs 12 and 14 have peninsulas 56 and 58, respectively, which extend toward the inner side 50 of the hinge 16.
The peninsula portions 56, 58 are at a fixed distance from the proximal ends of the leg members 12, 14 connected to the hinge portion 16, and are formed by extensions of the inner surfaces 20, 24 of the leg members 12, 14. . Peninsula 56
And 58 extend substantially to the inner surface 50 of the hinge 16 and when the clip 10 is closed around the blood vessel 300, the letter "C"
Openings 60 and 62 are formed (see FIG. 3).

The first leg member 12 has a pair of cylindrical bosses 68 and 70 joined on both sides sandwiching the first leg member 12, and the bosses 68 and 70 are located between the hook portion 22 and the hinge portion 16, preferably the hook portion 22. It is located nearby. The bosses 68, 70 extend laterally from the first leg member 12.

The second leg member 14 has a pair of cylindrical bosses 72 and 74,
The bosses 72 and 74 have tips 46 on both sides sandwiching the second leg member 14.
And extend in the lateral direction. In a preferred embodiment, the coaxial centerlines of the bosses 72 and 74 pass through the distal end of the second leg member 14. FIG. 2C shows the relationship between the tip 46 and the center of the boss 72 when the boss 74 is removed. Bosses 72 and 74 have opposite faces 76 and 78
Extend beyond the tip 46 while leaving at regular intervals.

FIG. 4 shows a pin set-type clip applier 80, which comprises two handles 82 and 84 crossed together at a hinge 86 and connected together. Handles 82 and 84 are biased by springs 88 and are in the open position. Handles 82 and 84 extend beyond hinge 86 to form first and second jaws 90 and 92, respectively.

FIG. 5 is an enlarged cutaway view of a portion of the first jaw 90.
FIG. 5A is a plan view of the first jaw 90 shown in FIG. 5, and both show the detailed structure of the first jaw 90. 1st Joyo 90
Has a groove 96 which extends from a position 97 behind the jaw tip to the tip. The thickness of the outer wall 98 of the groove 96 increases as approaching the jaw end, the arched outer wall 100 at the jaw end, and the inner adjacent wall 102 having a rearwardly inclined surface 103 and a concave notch 104. Are formed. Wall 102
Of the wall 98 forming the groove 96 is horizontally adjacent to the inner surface of the wall 98. If the thickness of the wall 98 is increased to form the outer arcuate wall 100 and the adjacent wall 102, the notch 104 extends beyond the upper surface of the wall 98 toward the opposing jaw 92 to form a round shoulder 105. The adjacent arched wall 100 also rises to the same extent from the upper surface of the wall 98. The floor 99 of the groove 96 extends at regular intervals from the upper surface of the wall 98 of the joyo 90 and extends from the rear end 97 of the groove 96 and continues until the floor 99 extends along the slope 101 toward the opposite giyo 92. A projection 108 is formed at a position where the notch 104 exceeds the upper surface of the wall 98. The projection 108 falls straight down onto the flat portion 128 of the first jaw 90, and the flat portion 128 extends to the tip. The first jaw 90 has a flat outer bottom surface 106
Having.

FIG. 6 is an enlarged cutaway view of a portion of the second jaw 92.
FIG. 6A is a plan view of the second jaw 92 in FIG. 6, and the detailed structure of the second jaw 92 is the same (same as the structure of the first jaw 90).
It is shown. The second jaw 92 has a groove 110,
Extends from a position 112 behind the jog tip to the tip.
The thickness of the outer wall 114 of the groove 110 is wider as approaching the jaw end, and an arched outer wall 116 at the jaw end,
A rearwardly facing inclined surface 119 and an inner adjacent wall 118 having a concave notch 120 are formed. The inner surface of the wall 118 has grooves 11
It is horizontally adjacent to the inner surface of the wall 114 forming the zero.
When the wall 114 increases in thickness to form the walls 116 and 118, the notch 120 extends beyond the front of the wall 114 toward the opposite jaw 90 to form a round shoulder 121. Arched wall 116
Also rise from the upper surface of the wall 114 to the same extent. Groove 110 floor
111 is parallel to the upper surface of the wall 114 of the second jaw 92 at regular intervals and extends from the rear end 112 of the groove 110 and continues until the floor 111 extends along the slope 125 toward the opposite jaw 90; A projection 124 is formed at a position where the notch 120 exceeds the upper surface of the wall 114. The projection 124 falls straight down onto the flat portion 126 of the second jaw 92, and the flat portion 126 extends to the tip. The second jaw 92 has a flat outer bottom surface 122.

FIGS. 7A to 7E show the application of clip 80
Are shown. The clip 10 is in the open position, in which case the two leg members 12 and 14 at the hinge are provided.
Although the axis angles are acute, the clip 10 may be open to approximately 90 degrees or more. At a rate comparable to the open state of the clip 10, the first and second jaws of the application device 80 are
90 and 92 are biased to open, and the flat surface 126 of the second jaw 92 and the flat surface 128 of the first jaw 90 are respectively moved to the bosses 72 and 74 of the second leg member 14 and the outer surface 30 of the first leg member 12. To the vicinity of the hook. Applicable device 80
Is moved in the direction of arrow 700 in FIG.
68, 70 are pushed in, proceeding on the inclined surfaces 103 and 119 facing the rear of the walls 102 and 118, and further pushing in the clips to close them slightly, as shown in FIG.
Fits in notches 120 and 104.

The notches 104, 120 of each Joyo are spaced apart from one another in the Joyo by grooves 96, 110 of each Joyo, the distance of which is at least equal to the width of the clip 10, and the cutouts 104, 120 are bosses 68, 120. 70, 72, 74 are provided at positions that can receive them. The concave notch keeps the clip aligned and locked in the jaw during closure. The concave notches 104 and 120 are pressed against the boss to begin closing the clip.

After the boss pairs 72, 74 and 68, 70 are fitted in the concave notches, the raised shoulders 108 and 124 of the jaws 90 and 92 are pressed against the outer surfaces of the leg members 12 and 14, and the closure of the clip 10 is continued. (See FIGS. 7B-7E). The outer surface 32 of the hook 22 may accidentally engage the inner surface 24 near the curved bevel surface 44 of the leg member 14 (see FIG. 7C). As the leg members continue to be pressed together, the rounded outer surface of the hook 22 slides along the curved bevel surface 44 and then around the tip 46 (see FIG.
7D), the flat surface 35 at the end of the hook 22 engages the flat bevel surface 48 on the outside of the leg member 14, and thus the clip 10 can be closed (FIG. 7E). Groove 96 and
110 accommodates the entire clip in the jaw during the closing operation. As can be seen in FIG. 7D, the legs are flexed by the force acting on the closing clip, coordinating the movement of the hook of leg 12 around the rounded tip of leg 14.

FIG. 3 shows a state in which the clip 10 is applied to the blood vessel 300 in a closed state. In a preferred embodiment, the second
The radius of curvature of the inner convex surface of the leg member 14 is substantially the same as the radius of curvature of the inner concave surface of the first leg member 12. By this,
The compressive forces exerted by the leg members 12 and 14 of the clip 10 can be relatively evenly distributed over the width of the clamped blood vessel 300. The blood vessel 300, particularly if it is large or dilated, exerts a reaction force on the leg member of the clip after application and tends to open the clip. The outer concave surface 38 reduces the thickness of the second leg member 14 so that the second leg member 14 flexes and lengthens in response to the force from the clamped blood vessel 300 to open the clip 10. When the member 14 becomes longer, the end of the second leg member 14 tries to enter the hook portion 22 further. At the same time, the forces from the clamped blood vessels acting on the first leg member 12 tend to shorten the first leg member 12 and bring the hook 22 closer to the hinge 16 and the distal end of the second leg member 14. . With this arrangement, a safer latching is achieved. Further, the thickness of the second leg member 14 is smaller than the case where the outer concave surface 38 is omitted,
And since the thickness between the inner and outer surfaces of the first leg member is substantially the same, the total deflection required to accommodate vessel closure and clamping is distributed between the two leg members, A considerable amount of deflection is absorbed by the second leg member,
This helps to increase the safety of the latching effect and to avoid premature breakage of the leg members. The thickness of the central region of the second leg member is slightly greater than the thickness of the first leg member or the thickness of the corresponding central region, but this avoids a flattened passage which facilitates the removal of the latch. This is because the bending of the second leg member is slightly less than that of the first leg member. However, both leg members may be of the same thickness.

Since the purpose of such a clip is to occlude or close a blood vessel, the blood vessel must be completely occluded. In some clips, a portion of the blood vessel may fit into the gap adjacent the inner surface of the hinge and not block at the clip leg. Such a situation allows blood or fluid to pass through the distal occlusion of the blood vessel. To avoid this in the clip of the present invention, each leg member 12, 14 has peninsulas 56 and 58, which are formed by the extension of the inner surface of each leg member, and when the clip is closed, It extends substantially rearward and contacts the inner wall 50 of the hinge. The gaps remaining in the hinge area are "C" shaped gaps 60 and 62, which are located on the opposite sides of the peninsula from the inner surface of both leg members that clamp the blood vessels. The peninsula is formed at a fixed distance from the leg member connected to the hinge to avoid closing resistance caused by compressing the leg member when closed in the hinge region. The narrow hinge is also strong because of the continuous curve formed by its inner and outer surfaces, and the clamped blood vessel is not confined by the gap.

Regarding the hinge, FIG. 18 shows another embodiment of the clip 310.
The clip 310 is identical to the clip 10 of FIGS. 1-3 except for the hinge 316. Clip 310 comprises first and second curved leg members 312 and 314, which are joined at their proximal ends by hinges 316. The first leg member 312 has an inner concave surface 320 and a curved hook 322 joined to the distal end. Inner surface 32 of second curved leg member 314
4 is convex and, when closing the clip, is substantially parallel to the inner concave surface 320, i.e. the convex surface 32
The radius of curvature of 4 is substantially the same as the radius of curvature of the concave surface 320. The outer surface 338 of the second leg member 314 is concave between the hinge portion 316 and the distal end. Hinge part 316 is continuous curved concave surface 3 on the inside
50 and an outer continuous curved surface 352, the concave surface 350 joins the inner concave surface 320 and the inner convex surface 324, and the outer surface 352 is the outer convex surface 3
The outer concave surface 338 is joined to the inner concave surface 338, and is spaced apart from the inner concave surface 350 by a certain distance. Hinge portion 316 further includes a curved slot 353 located between hinge curved surfaces 350 and 352 and closer to hinge concave surface 350 than hinge convex surface 352. The slot 353 extends all the way through the hinge 316, with opposite ends 355 and 357 reaching the proximal ends of the legs 312 and 314, respectively. The slot 353 provides additional flexibility to the hinge 316, but the inner concave surface 350 does not allow the clamped vessel portion to be trapped within the slot 353.

Bosses 72 on both sides extending beyond the tip 46 of the leg member 14 and
When closing the clip by the inner surface of 74,
The hook portion and the leg member 14 are prevented from moving laterally relative to each other.

By providing continuous, relatively large radii of curvature on both the inner and outer sides of the hinge and hook, sharp internal corners are created which result in undesirable stress concentrations leading to clip breakage.

FIGS. 8 to 12 show modifications to the clip, which are provided with means for guiding the clip in a locking manner. Outer tapers 802 and 804 are formed on the inside opposing surfaces of both side bosses 72 and 74 at the distal end of the leg member 14, each of which extends from the side surface of the second leg member 14 and becomes larger, The circumference of the bosses 72 and 74 can be grasped. These tapers 802 and 804 are present on the curved bevel surface 44 and become smaller as approaching the tip 46.

Tapers 806 and 808 are provided at the end of the hook portion 22,
The width of the outer surface becomes narrower as approaching the flat surface 35 of the hook portion (see FIGS. 11 and 12). Slide the narrow outer surface of the hook end to the curved bevel surface 44 to
Between the opposing surfaces of 72 and 74, a large opening created by tapers 802 and 804 is received. As the hook continues to slide between the lateral bosses, the tapered openings of the bosses 72 and 74 become narrower, aligning the first leg member 12 and the second leg member 14.

FIG. 13 shows another specific example of the clip shown in FIGS.
The clip 10 'of FIG. 13 further has a plurality of projections 1302 on the inner surface 20' of the first leg member 12 ', while the second leg member 14'.
Are provided with a plurality of projections 1304 on the inner side surface 24 'thereof. These projections 1302, 1304 are in the form of a wedge, with the wedge opening facing the hinge 16 '. Such protrusions engage the tissue of the blood vessel being clamped, causing the blood vessel to clip.
It assists in suppressing horizontal or vertical sliding during or after 0 'closure. By the way, it is preferable that the clip clamps the blood vessel with substantially 90 ° sensitivity to the axis of the blood vessel. Dynamic blood vessels may move or beat, and such movements may cause the clip to become misaligned, degrading clip performance and function. The projection also helps prevent such a drop.

The clips shown in FIGS. 1 to 13 are preferably made of an integrally molded plastic. The plastic material to be selected is commonly used in surgical implantation procedures and has biocompatibility.
A number of relatively robust engineering plastics available today are preferred. Two examples of suitable plastics are polyethylene terephthalate (PET) and polyoxymethylene. These are both thermoplastic materials,
It can be injection molded, extruded or otherwise subjected to thermal processing to form shaped articles and filaments. Other molding grade polyesters and polybutylene terephthalate (PBT) can also be used.

As mentioned above, plastic surgery clips, such as hemostatic clips, are preferably as small as their metal equivalents. The preferred slip can be made as small as about 7 mm in the closed state from the back of the hinge to the outside of the hook. This is comparable to a metal haemostatic clip of average size with a closed length of about 6 mm.
The maximum thickness of each leg member of the polymer clip of the present invention is 1.
Approximately 0mm or less, weight is about 0.015g, volume is
It is 0.01 cm ³ and the opening is 4 mm or more.

In a preferred embodiment, the radius of curvature of the inner surface 20 of the first leg member 12 starts at 0.166 inches near the peninsula 56,
It changes to 0.222 inches in the center area and to 0.052 inches and then to 0.007 inches for the hook portion 22. The outer surface starting from end 32 of hook 22 is 0.045 inches, and 0.036 inches. The radius of curvature changes from 0.108 to 0.246 inches, and around hinge 16 to 0.171 inches, since the hook is at the end and the outer surface of the leg member 12 continues to the hinge. The outer surface 52 of the hinge has a radius of 0.042 inches, the outer concave surface 38 of the second leg member 14 begins with a radius of 0.161 inches, and the tip 46
It is 0.231 inch near (radius 0.003 inch). The radius of the curved bevel surface 44 is up to the start of the inner convex surface 24 of the leg member 14.
0.044 inches, the convex surface 24 is 0.222 inches, and 0.166
Inches. These radii are indicative of a portion of the degree of curvature of the clip 10, from which it can be seen that the curved surfaces are generally continuous. The centers of such radii are generally not the same, even for concave and convex surfaces, such as the inner and outer surfaces of the leg members. Although these radii represent preferred clip radii, it should be understood that alterations or modifications of these radii are within the scope of the curved clip of the present invention.

14-17, another polymer clip 200 is shown, which is made from two parts. The clip 200 includes a first leg member 212 having an inner curved concave surface 220 and an outer curved convex surface 230. The first leg member 212 has a hook portion 222 integrally formed at the end thereof and having the same function and shape as the hook portion 22 of the clip 10. Further, the first leg member 212 has a cylindrical socket portion 216 integrally formed at a proximal end thereof. The cylindrical socket portion 216 is approximately half the thickness of the first leg member 212 measured from one surface to the opposite surface of the first leg member 212 along the axis of the socket portion.
The first surface of the cylindrical socket portion 216 is a side surface of the first leg member 212.
It is the same plane as 250. Opening 251 of socket part 216
First grows at a distance from this surface along the axis of the socket portion 216 and suddenly narrows to form an inner annular ledge 252. The opening maintains a constant diameter at a distance 254, increases at short distances, and opens at the opposite surface 256 of the socket.

The second leg member 214 has an inner convex surface 224 and an outer concave surface 238. The outer concave surface 238 is connected to the distal end 239 of the leg member 214 by a flat bevel surface 256. The leg member 214 has a large cylindrical body 260 integrally formed at the proximal end, and the thickness of the cylindrical body 260 along the axis is about half the thickness of the leg member 214. The outer end surface of the cylinder 260 is flush with the side surface of the leg member 214. A small-diameter cylinder 264 is integrally formed with a large cylinder 260, and the cylinder 264 is coaxial with the cylinder 260 and extends outward along a common axis. The end of the small-diameter cylinder 264 has a trapezoidal shape, and forms an annular ledge 268 spaced apart from the end of the small-diameter cylinder by a constant distance.

The cylindrical socket portion 216 of the first leg member 212 is
4 can be received by snap fitting. When the end of the small-diameter cylinder is pushed into the large opening of the socket on the surface 256 of the leg member 212, the small-diameter cylinder 264 enters the socket 216,
The ridge 268 at the end of the small-diameter cylinder is a constant-diameter portion 254 of the socket.
And the ends are passed through the inner ledge 252.
At this point, the end of the small-diameter tubular body is properly snap-fitted to the area formed on the ridge 252 of the socket, by which the trapezoidal portion of the small-diameter tubular body 264 can be received. The ridge 252 engages with the ridge 268 to prevent the two leg members from separating after snapping together the two leg members. By providing a large circular hinge portion having such a configuration, an extremely strong hinge is provided, and particularly when the clip is applied to a blood vessel in a closed state, the hinge portion between the hinge portion can be damaged.

Although the surgical clip of the present invention described here is particularly suitable for hemostatic use, it can also be applied to other applications such as fallopian tube clip or vas deferens clip.

[Brief description of the drawings]

1 and 2A are a perspective view and a front view showing an example of the clip of the present invention, FIGS. 2B to 2D are partially enlarged views of FIG. 2A,
FIG. 3 is a perspective view showing a state in which the clip of FIG. 1 is applied to a blood vessel, FIG. 4 is a plan view showing an example of the device of the present invention, and FIGS. 5 and 5A are diagrams of the device of FIG. FIGS. 6 and 6A are enlarged perspective views and bottom views showing the second jaw of the application tool shown in FIG. 4, and FIGS. 7A to 7E are first views showing the first jaw. FIG. 8 is an explanatory view showing the use relationship between the clip shown in FIG. 4 and the application tool shown in FIG. 4, FIG. 8 is an enlarged side view showing another example of the end of the first leg member of the clip shown in FIG. 1, FIG. FIG. 11 is a front view and a top view taken along lines 9-9 and 10-10 in FIG. 8, FIG. 11 is an enlarged side view showing another hook portion of the clip in FIG.
FIG. 13 is a top view as seen from the line 12-12 in FIG. 11, FIG. 13 is a perspective view showing a second example of the clip of the present invention, and FIGS. 14-17 show a third example of the clip of the present invention. 14 is a perspective view of the clip in a closed state, FIGS. 15 and 16 are perspective views of the first and second leg members of the clip, and FIG.
18 is a side view showing a fourth embodiment of the clip of the present invention, wherein 10, 10 ', 200, 310: clips, 12, 12', 212, 312: first leg members, 14 , 14 ', 214, 314: second leg member, 16, 16', 316: hinge, 56, 58: peninsula, 353: slot, 216: socket, 25
1: Opening, 260: cylindrical body, 264: small diameter cylindrical body, 268: ridge, 20, 20 ',
220,320: inside concave surface of the first leg member, 22,22 ', 222,322: hook portion, 24,24', 224,324: inside convex surface of the second leg member, 30,23
0,330: Outer convex surface of the first leg member, 38,238,338: Outer convex surface of the second leg member, 44,44 ', 48,256: Bevel surface, 46,46', 239:
Tip, 80: Applicable device, 82, 84: Handle, 86: Hinge, 90, 92:
Giyo, 96, 110: groove, 98, 114: outer wall, 99, 111: floor, 100, 1
16: Arched outer wall, 101, 125: Slope, 103, 119: Slope, 1
04, 120: concave notch, 105, 121: round shoulder, 108, 124: protrusion, 12
6,128: Flat part.

Claims (21)

(57) [Claims] 1. A polymeric surgical clip comprising first and second curved leg members, the two leg members being joined at their proximal ends by elastic hinge means, each of the leg members being a vascular clamp. A vascular clamp inner surface of one leg member facing the vascular clamp inner surface of the other leg member;
The leg member has a flexible hook at its distal end that curves toward the second leg member, and the second leg member has a complementary lock at its distal end with respect to the hook, As the first and second leg members move about the hinge means from the open position to the closed position, the hook flexes around the distal end of the second leg member to lock the clip in the closed position, The inner surface of the leg member has a concave radius of curvature between the hinge means and the hook portion, the inner surface of the second leg member has a convex radius of curvature between the hinge means and its distal end, and a second radius. A surgical clip made of polymer, characterized in that the outer surface of the leg member has a concave radius of curvature between the hinge means and its distal end. 2. The clip according to claim 1, wherein the outer surface of the first leg member has a convex radius of curvature. 3. The thickness connecting the inner surface and the outer surface between the hinge means of the first leg member and the hook portion, and the thickness connecting the inner surface and the outer surface between the hinge means of the second leg member and the end thereof. The clip of claim 1, wherein the clips are substantially the same. 4. The clip according to claim 1, wherein the radius of curvature of the concave surface inside the first leg member is substantially equal to the radius of curvature of the convex surface inside the second leg member. . 5. The hinge means forms part of the clip,
The thickness of the means is smaller than the thickness of the first and second leg members, and the outer surface thereof forms a curved surface connected with the outer surfaces of the first and second leg members. The clip according to claim 1. 6. The first and second leg members are each spaced apart from the hinge means by a predetermined distance, and each have a peninsula at a point where the leg member is connected to the hinge means. 6. The clip of claim 5, wherein the inner surface of the leg member extends substantially to the inner surface of the hinge means when the clip is in the closed position. 7. The hinge means forms a part of the clip,
And an outer curved surface that forms a continuous curved surface with the outer surfaces of the first and second leg members, and an inner curved surface that is spaced apart from the hinge outer surface by a predetermined distance. 2. The clip according to claim 1, wherein the hook has a continuous curved surface with the inner surfaces of the first and second leg members so as not to have any internal corners. 8. The hinge means having a curved slot between its inner and outer curved surfaces, the outer surface of the slot being concave with respect to the slot, and the inner surface of the slot being convex with respect to the slot. The clip according to claim 7. 9. The clip of claim 8 wherein the slot is closer to the inner concave surface of the hinge means than to the outer convex surface of the hinge means. 10. The clip according to claim 1, further comprising means for engaging the device to which the clip is applied, the engagement means being connected to the first and second leg members. 11. A hooking means sandwiching a pair of bosses joined on both sides sandwiching a first leg member intermediate the hinge means and the hook portion, and a second leg member at an end of the second leg member. 11. The clip according to claim 10, comprising a pair of bosses joined on both sides, with both sides sandwiching the first and second leg members extending between the inner and outer surfaces of the leg members. 12. A portion of the pair of bosses joined to the second leg member extends longitudinally beyond the distal end to form substantially parallel spaced apart parallel surfaces, and the parallel surfaces define the clip. 12. The clip of claim 11, wherein when the is in the closed position, relative lateral movement of the first and second leg members is prevented. 13. The end portions of the hook portion taper toward each other to reduce the thickness of the hook portion, and the inner surface of the boss of the second leg member in the extension portion tapers from the second leg member. 13. The clip of claim 12, wherein said clip is adapted to receive a tapered portion of said hook portion and to guide said clip to a closed position. 14. An inner surface of the clip,
The clip of claim 1, wherein a plurality of protrusions are provided to improve vessel retention during closure of the clip. 15. A clip according to claim 12, wherein each of said projections is a wedge open to said hinge means. 16. The clip according to claim 1, wherein the hinge means is formed integrally with the first and second leg members, and the hook portion is formed integrally with the first leg member. 17. A cylindrical socket formed integrally with a proximal end of the first leg member, and a protruding cylindrical body formed integrally with a proximal end of the second leg member, 2. The clip according to claim 1, wherein said socket is adapted to receive the projecting cylinder by snap fitting. 18. A device for applying a ligating clip having two legs on a lateral side surface of a leg portion thereof, wherein the ligating clip pivots around a hinge point and extends from the hinge point to face each other. A pair of handles forming a pair of clip closing jaws having a defined inner working surface, each of the jaws having a clip receiving groove fitted in its inner working surface, the groove being disposed aft from the jaw tip. A ligature extending to a point, and wherein the length of the groove is at least equal to the length of the clip applied in the device, and each of the jaws includes means for engaging the clip engaging means Clip application equipment. 19. The means for engaging the clip engaging means comprises a wall located on each side of each jaw groove, including a concave notch near the show end, and an outer arched wall adjacent the notch. 19. The application device according to claim 18, wherein: 20. The method according to claim 19, wherein the rear wall of each concave notch projects from the groove in the direction of the opposite jaw, and the height of the adjacent arcuate wall is substantially equal to the height of the protruding rear wall. Applicable appliances. 21. The method according to claim 20, wherein the bottoms of the grooves of the two jaws form a projection facing the opposite jaw between the notches projecting toward the opposite jaw. Applicable appliances.