GB1592093A

GB1592093A - Repeating hemostatic clip applying instruments

Info

Publication number: GB1592093A
Application number: GB40738/77A
Authority: GB
Original assignee: United States Surgical Corp
Current assignee: United States Surgical Corp
Priority date: 1976-10-08
Filing date: 1977-09-30
Publication date: 1981-07-01
Also published as: JPS5367286A; JPS53105081A; AU2914477A; FR2383651B1; FR2383651A1; JPS6028499B2; AU518664B2; CA1125615A; JPS5717533B2; DE2744816A1; FR2366825B1; IT1091754B; GB1592094A; DE2744816C2; BR7706726A; FR2366825A1

Description

(54) REPEATING HEMOSTATIC CLIP APPLYING INSTRUMENTS (71) We, UNITED STATES SURGICAL CORPORATION, a Corporation of the State of New York, United States of America, of 150 Glover Avenue, Norwalk, Connecticut 06850, United States of America, do hereby dedare the invention, for which we pray that a patent may be granted to us, and the method by which it is to be performed, to be particularly described in and by the following statement: This invention relates to repeating hemostatic clip applying instruments. More particularly, it relates to a clip applying instrument for use in the rapid and repeated ligation of so called bleeders in surgical procedures.

After a surgeon has made his incision, it is necessary to clamp the tissue wherever blood is being lost due to the cutting of blood vessels. The usual technique is to clamp each so-called bleeder with a hemostat (locking dog-nosed pliers) as soon after the vessel is severed as possible. This controls the loss of blood until a ligature can be tied around the vessel. As many as 20 or more bleeders may be clamped by as many hemostats in common surgical procedures before they are tied. Thus, a single operation often requires the use of a large number of hemostats. These are handed to the surgeon and his assistants, one at a time, by the scrub nurse.

The surgical field often becomes cluttered with hemostats, which interfere with the surgeon's view and hinder the convenient application of additional hemostats. However, a good surgical practice requires the application of hemostats to all bleeders before any are tied.

The tying process requires one hand to hold the hemostat and two hands to pass the suture material around the hemostat and to form the ligature by tying a knot. This procedure thus requires two people. In addition, the ligatures must Ibe cut and the excess suture material removed from the incision.

used used hemostats must be handed to the scrub nurse and be readied for reuse. Thus, this entire technique for the achievement of hemostasis requires the coordination and teamwork of at least three people. The speed with which the bleeders may be tied off is often the determining factor in the time required for the opening stages of many surgical operations.

Many instruments have been disclosed in the prior art for ligating bleeders. However, none of these have come into general use, due to inherent deficiencies. Instruments such as disclosed in the specifications of United States Patents Nos. 3,033,204, 3,040,747, 3,169,526, 2,268,755 and 1,635,602, have been designed for aiding the surgeon in applying a single pretied length of suture material to a bleeder. Other instruments, such as that disclosed in United States Patent specification No. 2,371,082 are designed to apply a single collar of resilient material to a deep bleeder. However, these instruments, since they apply only one ligature at a time after which another preformed ligature must be fixed to the instrument before it can then be applied to the next bleeder, do not materially reduce the amount of time or effort required in a surgical procedure. Other more complex instruments, such as disclosed in the specifications of United States Patents Nos. 2,898,915 and 2,898,916 have Ibeen devised for automatically tying a successive plurality of ligatures from a spool of suture material. A repeating ligature gun for applying a plurality of pretied or preformed ligatures is disclosed in the specification of United States Patent No.

3,687,138. However, these prior art instru-- ments are complex, are difficult to load with the suture material, and, being complicated, are hard to disassemble and sterilize. None of the above mentioned prior art instruments have come into general use.

In order to obviate some of the above problems in the prior art, hemostatic clips have come into widespread use in surgery in recent years. In current surgical practice, these clips are used not only for occluding blood vessels but also for application to other structures such as nerves; for example, in vagotomy. A number of efforts have been made to facilitate loading of the clips into the instrument. This generally is done one at a time by a scrub nurse who then hands the instrument to the surgeon for application and receives the empty instrument back for reloading with another single clip. As the clips are small and difficult to handle, cartridges which hold the clips and then aid in loading the clips one at a time into the instrument have been developed. Since the clips are not firmly held in the instruments, they sometimes fall out during handling of the instrument by the scrub nurse and the surgeon prior to application.

What is needed is an instrument which will rapidly and repeatedly clamp and ligate bleeders; an instrument that can be operated with one hand; an instrument which does not leave any excess material, such as cut ends in the incision; an instrument which may Ibe reloaded Iby means of a cartridge with a plurality of preformed ligatures repeatedly during an operation; and an instrument which is easy to disassemble and sterilize.

It is also desirable that the instrument handle as much as possible in the same manner as prior art surgical instruments such as towel clamps, hemostats, and clip appliers. Furthermore, it would be a highly desirable feature of such an instrument if it were adapted to apply a hemostatic clip which has already been accepted in surgical practice and in particular approved by the United States Food and Drug Administration (FDA) for retention in the human body as the provision of any other material or even shape of clip or preformed ligature may be occasioned with years of tests and delay before FDA approval may be secured.

According to the present invention there is provided a hemostatic clip applying instrument comprising a pair of movable mating jaw members connected for relative opening and closing movement of co-operating jaws at their forward ends, one of the jaw members being provided with an operating lever movable therewith and the other of the jaw 'members being provided with a hemostatic clip receiving channel extending lengthwise thereof for guiding clips therein to a loca tion between the co-operating jaws, a pusher for pushing clips one at a time along the channel to said location, and a second operating lever so connected to said other jaw member that movement of said second lever relative to said other jaw member is operative to reciprocate said pusher in said 'channel, sequencing means being provided such that upon movement of said operating levers towards each other, first said pusher is operative to move to its advance position for pushing a clip to said location and then said jaws are brought together for deforming such advanced clip.

Preferably means for reciprocating the pusher in the channel comprises a bell crank pivoted to said other jaw member and having two lever arms, one of which is connected to said second operating lever and the other of which is connected pivotally to the remote end of the pusher. Preferably also, the sequencing means comprises a cam surface of constant radius with a drop-off and a cam follower co-operable with said surface, one of the cam surface and the cam follower being movable with the pivoted movement of the bell crank and the other of the cam surface and cam follower being mounted to the first operating lever whereby upon bringing together of the operating levers the cam follower will ride on the constant radius of the cam surface during the first part of the closing motion between the operating levers and will then drop off into said drop-off during the said second part of the closing motion between the operating levers to permit the jaws to be brought together.

The instrument may include a hemostatic clip cartridge comprising a plurality of Ushaped planar hemostatic clips in vertical alignment forming a U-shaped stack, stackguide means confining and guiding said Ushaper stack for motion along the vertical axis of said stack, spring means biasing said stack downward; stop means at the bottom of said stack-guide rneans for preventing said stack from further downward motion, said stop means cooperating with said stack-guide means to form a rearward aperture for receiving a clip pusher and a forward rectangular slot for passing a single clip; and clip-guide means comprising a channel member extending horizontally from said forward slot, the width of said forward slot corresponding to the width of the channel in said clip-guide means whereby in use of the cartridge the lowermost clip of the stack may be pushed by a clip pusher through said forward slot and into said clipguide means. Such a hemostatic clip cartridge is claimed specifically, in our copending divisional patent application No. 8010852 (Serial No. 1,592,094) which has substantially the same disclosure as the present application.

For a fuller understanding of the nature of the invention, reference should be had to the following detailed description given by way d example with reference to 'the accompanying drawings in which: FIGURE 1 is -a top perspective view of a repeating hemostatic clip applying instrument and multi-clip cartridge in accordance with the invention therefor assembled and ready for operation.

FIGURE 2 is a top view of the instrument shown in FIGURE 1 in partial cross section along the plane 2-2 of FIGURE 1.

FIGURE 3 is an enlarged top view, partially cut away, of the instrument shown in FIGURE 1 with the cross section of FIGURE 2 extended and the instrument partially actuated to move a clip from the cartridge to the clip applying jaws.

FIGURE 4 is an enlarged top view, partially in cross section section, similar to FIGURE 3 showing the instrument fully actuated to close the clip between the jaws.

FIGURE 5 is an enlarged cut away view showing a detail of the jaws.

FIGURE 6 is a cross-sectional view, partially cut away, taken along the line 6-6 of FIGURE 2.

FIGURE 7 is an enlarged exploded perspective cut away view of the clip applying jaws and a portion of the cartridge mount.

FIGURE 8 is an exploded diagrammatic view showing the small number of basic parts of the instrument of FIGURE 1.

FIGURE 9 is an enlarged cross-sectional cut away view taken along the plane 9-9 of FIGURE 2.

FIGURE 10 is a top cross-sectional cut away view taken along the line 1W10 of FIGURE 9.

FIGURE 11 is a cross-sectional view taken along the line 11-11 of FIGURE 9.

FIGURE 12 is an enlarged top perspective view of the cartridge of the invention shown in FIGURE 1.

FIGURE 12A is an end plan view of the -cartridge shown in FIGURE 12.

FIGURE 13 is an enlarged perspective bottom view similar to FIGURE 12.

FIGURE 14 is an enlarged perspective diagrammatic top view of the clips and clip follower of the cartridge of FIGURE 1.

FIGURE 15 is a partial cross-sectional top view, partially cut away, similar to FIGURE 2, of an alternative embodiment of the invention having a different clip advancing mechanism.

FIGURE 16 is a top view partially in crosszsection and partially cut away similar to FIGURE 15 showing the alternative embodiment with the clip advance mechanism fully 'advanced.

FIGURE 17 is a partial cross-sectional view partially cut away taken along the line 17-17 of FIGURE 15.

FIGURE 18 is a top perspective view similar to FIGURE 1, partially cut away, of an alternative embodiment having curved jaws for improved handling and visibility.

FIGURE 19 is a top plan view of another alternative embodiment of the invention having a single pivot and a floating bell crank pusher actuating mechanism.

FIGURE 20 is a top plan diagrammatic view of an alternative form of clip cartridge.

FIGURE 21 is a top plan view of .a Ushaped clip having a V-shaped connecting section.

The same reference characters refer to the same elements throughout the several views of the drawings.

In general, the illustrated instruments are similar in function to existing single clip applying instruments such as disclosed in the specification of United States Patent No.

3,713,533 in that with one actuation of the instrument, one clip is applied to tissue by being crushed thereabout by a pair of jaws.

The clips are preferably also of substantially the same material size and shape when closed about the tissue as the formed clips disclosed in that patent. The present instrument, in its preferred embodiment, is substantially similar in shape to present single clip applying instruments which are, in fact, designed much like numerous types of hemostats and other surgical clamps, having two ring handles and a generally elongated form which permits controlled handling and good visibility at the tip.

The present instrument differs from previously proposed single clip applying instruments in that a disposable cartridge is provided which holds a plurality of clips and feeds them to the instrument one at a time.

Other instruments have been patented for repeatedly applying surgical clips or ligatures such as disclosed in United States Patent Specifications Nos. 2,227,139, 2,968,041, 3,082,426, 3,844,289, 3,638,847 and 3,841,521.

However, although the need for a repeating hemostatic clip applying instrument has been recognized for decades, none is presently in the market or in clinical use.

Deficiencies in prior art repeating instruments which have led to their nonuse in clinical practice may be categorized as: instruments that are too complex with a very large number of parts; instruments 'which obscure the physicians' field of view; gun type instruments which meet great resistance on the part of surgeons used to ring-handled plier type instruments; instruments with a great many small moving interfaces between parts which make them subject to frictional failure, extremely difficult to sterilize without disassembly, and -extremely difficult to disassemble and re-assemble for good sterilization practice; lack of simple replaceable cartridges; operation which requires pulling of tissue into the instrument; and complex cartridge mechanisms which lead to prohibitive cartridge costs.

With the present instrument there is obtained optimal visibility to the tip, incorporation of an inexpensive multiple clip containing cartridge which can be rapidly changed, and completely automatic one hand operation, preferably with a ring handle configuration, these factors being crucial if the instrument is to be clinically useful.

A disposable cartridge, removably mounted on the instrument holds a plurality of clips in alignment with a channel on the instrument. The instrument then removes the clips, one at a time, from the cartridge and feeds them through the channel to the jaws for application to the tissue.

This principle of having the cartridge feed the clips to a position on the instrument remote from the jaws and then having the instrument feed each clip to the jaws permits the cartridge to be placed remote from the jaws out of the line of visibility. It also permits the simplest possible construction of the jaws, that is, of only two pieces, which further aids visibility.

The instrument thus has a pair of clip applying jaws with a channel leading thereto from a remote position where a cartridge containing a plurality of clips may be removably affixed. It, in addition, has a clip feed mechanism and appropriate sequencing and spring return means so that, in operation, when a pair of ring handles are squeezed together, the forwardmost clip is removed from the cartridge, fed to the jaws and clamped about isssue positioned therebetween, and, upon release, the instrument returns to a position ready to repeat The instrument is basically comprised of four main portions: (1) a first pivoted member comprising a ring handle with a wide distal portion terminating in one jaw member; (2) a second pivotal member having a wide distal portion terminating in the other jaw member; (3) a clip pushing mechanism; and (4) an elongated ring handle. One of the distal portions is provided with a chan nel for a pusher to push the hemostatic clips to the-jaws. This distal portion also has a cartridge receiving portion. The other distal -portion acts as a cover for the channel. A linkage is provided beween the ring handles and the clip pushing mechanism for pushing the clip out of the cartridge, forward to the jaws and then allowing the jaws to close.

This is accomplished in two embodiments of the invention by providing a rotating bell crank on a proximal- extension of the pusher channel member.

The bell cranks each have a cam which is engaged by an extension on one of the ring handles and is operated by an extension on the other ring handle to rotate when the handles are first closed to operate the push member. The cam has a cut away portion into which the extension on the opposite ring handle then falls to allow the handle to close the jaws.

In another embodiment of the invention, the bell crank is free floating and is connected by its center pivot to one ring handle and at one of its outer pivots to the other ring handle, and at the other outer pivot t6 a link connected to the pusher. This free fldating- bell crank linkage, by its geometry, causes the'pusher to ;be operated against the force of a weak spring. Thereafter the ring handle to which no jaw is connected, biassed by another spring, is able to come down against a surface of the jaw mechanism to which no ring handle is connected to close the jaws.

The clip cartridge itself is claimed in our cop enduing divisional patent application No.

80 in which we claim a hemostatic clip cartridge comprising a plurality of U-shaped planar hemostatic clips in vertical alignment forming a U-shaped stack, stack-guide means confining and guiding said U-shaped stack for motion along the vertical axis of said stack, spring means biasing said stack downward; stop means at the bottom of said stack-guide means for preventing said stack from further downward motion, said stop means cooperating with said stack-guide means to form a rearward aperture for receiving a clip pusher and a forward rectangular slot for passing a single clip, and clip-guide means comprising a channel member extending horizontally from said forward slot, the width of said forward slot corresponding to the width of the channel in said clip-guide means, whereby in use of the cartridge the lowermost clip of the stack may be pushed by a clip pusher through said forward slot and into said clip-guide means.

As used herein, U-shaped indicates a clip having two substantially parallel arms con nected by a bight of constant radius, by a V-shaped section, or by any variation of these.

The clips are preferably rectangular in cross section and provided with a knurled pattern on the inside surface to help retain tissue. A rectangular cross section having a height/width ratia of 2/1 is particularly preferred to prevent the clips from twisting as they are closed and to provide the closed clip with a square cross section. The clip may be of any convenient size and con struted of any biomedically acceptable material. A particularly preferred clip is one formed of tantalum and having a uniform rectangular cross section' of 0.015 in. wide by 0.030 in. high. The inside surface of the clip is preferably coined in a diamond knurl pattern to increase the gripping power of the clip on the tissue.

More particularly, referring to FIGURE 1, a repeating hemostatic clip applying instrument according to the invention is generally indicated at 42. It comprises a left and a right jaws 44 and 46 at the end of left and right distal end portions 48 and 50.

Referring to FIGURES 1 and 8, left jaw 44 is mounted to the distal end 48 of a left jaw actuating member generally indicated at 52 comprising the aforesaid distal end 48, pivot hole 54, handle shaft 56, handle ring 58, and sequencing stop extension 60. Distal end 48 is provided with a cartridge clearance cut out 62 (see also FIGURES 7 and 9). A jaws return spring 64 is attached to the handle shaft 56 by means of appropriate rivets, screws, or the like 66.

Still referring to FIGURES 1 and 8, particularly FIGURE 8, the right jaw 46 and right distal extension 50 are part of a single main body generally indicated at 68. Main body 68 has a pivot hole 70, commonly pivoted to pivot hole 54 on left jaws actuating member 52 around a pivot 72 shown in FIGURE 1. The main body 68 has a channel formed therein by alternating slots 74 in the bottom thereof and 76 in the top thereof which overlap to form a continuous channel which terminates at an elongated cut out 78 for receiving the cartridge generally indicated at 80.

The pusher channel is extended as clip channel 82 on the bottom side of the distal end 50 of the main body 68 to the right jaw 46.

The main body 68 is also provided with stabilizing flanges 84, bell crank pivot hole 86, a pusher actuating member stop 88, a pusher actuating member pivot 90 to which a pusher actuating member, generally indicated at 92, is pivoted by means of a pivot hole 94 therein, and a pivot 97 (FIGURE 1).

Still referring to FIGURES 1 and 8, particularly FIGURE 8, the pusher actuating member 92 comprises a handle shaft 96, a ring handle 98, and a bell crank actuator extension 100 having a bell crank pivot slot 102 therein. The pusher actuating member 92 is provided with a pusher return spring 104 which is preferably less strong than the jaws return spring 64.

Still referring to FIGURES 1 and 8, particularly FIGURE 8, a clip pusher, generally indicated at 106, is preferaably provided with a thin forward portion 108 and a thick rearward portion 110. It is connected by means of pivot 112 to a pusher link 114, which in turn is connected by means of a pivot 116 (Figure 1) to a bell crank, generally indicated at 118. As best seen in FIGURE 1, bell crank 118 is provided at one end with a bifurcated arm 122 straddling a narrow portion of pusher link 114 and at its opposite end with a bifurcated arm 124 straddling bell crank actuator extension 100.

A pivot pin 126 is fixed in arm 124 and rides in bell crank pivot slot 102 (FIGURE 8).

Still referring to FIGURES 1 and 8, the bell crank 118 is provided with a sequencing stop surface 128 on which sequencing stop extension 60 rides, see Figures 2 and 3, a sequencing drop-off cut out 130, Figure 2, and a main pivot 132 pivoted to the bell crank pivot hole 86 by means of pivot 134 (FIGURE 1)-sequencing stop surface 128 and cut out 130 forming a cam.

The main body 68 is relieved at 95 for rotation of bell crank 118 and at 951 for rotation of the link 114 and rotation of bell crank 118 (FIGURES 1 and 2).

Now referring to FIGURES 9 through 13, a plurality of U-shaped hemostatic clips, generally indicated at 136, are stacked vertically in clip chamber 170 of cartridge 80 formed by guide means 158, 160 and 166.

Clip stack 136 is perpendicular to the plane of pusher 106 with the lowermost clip 142 resting in the plane of pusher 106 on clip stop platform 162. Platform 162 cooperates with clip chamber guide means to form a rearward aperture for receiving pusher 106 and a forward rectangular slot 169 for passing clip 142 from the cartridge. Clip guide means 152 which also functions as an interlocking mechanism for interlocking the cartridge with the instrument, has a channel corresponding in width to the width of clips 136 and slot 169 for guiding and aligning clip 142 as it is pushed from the clip stack into clip channel 82 by pusher 106. Lowermost clip 142 resting on platform stop 162, forward slot 169 and the channel in clip guide 152, are all aligned with clip channel 82 extending to jaws 44 and 46 when cartridge 80 is mounted on instrument 42 as best seen in FIGURE 9.

In operation, with the cartridge 80 mounted to the instrument 42 as illustrated in FIGURES 1 through 4, the pusher 106 extends to just behind the clips 136. The surgeon places the jaws 4446 about tissues to be clipped. He then doses the two ring handles 58-98. First the pusher actuating member 92 moves about pivot 97 against pusher return spring 104, this rotates the bell crank counter-clockwise pushing the pusher 106 by means of pusher link 114 to cause the lowermost clip 142 (FIGURE 9) in the clip stack 136 to be advanced through slot 169 and the channel of clip guide means 152 into channel 82 to between the jaws 44 and 46 as shown in FIGURE 3. Since the jaws 4446 surround tissue, the clip 142 is pushed around the tissue and remains in the jaws. As shown in FIGURES 5 and 7, the jaws 4446 are preferably provided with clip slots 138 extending from the clip channel 82 and opening at a two degree angle therefrom. This angle assures that the jaws will be parallel when closed. Small detents (not shown) may be disposed at the forwardmost end of the clip slots 138 (FIGURE 7) to stop distal motion of the clip.

During the above action, and referring to FIGURE 3, the sequencing stop extension 60 has been riding on the sequencing stop surface 128 of the bell crank 1.18. However, once the pusher 106 has advanced to its farthest position (at this position actuating member handle shaft 96 contorts stop 88), the sequencing stop extension 60 drops into the sequencing drop cutoff 130 on the bell crank 118. This allows the left jaw actuating member 52 to rotate about pivot pin 72 thereby bringing the left jaw 44 against the right jaw 46, to close the clip 142 all as shown in FIGURE 4. The sequencing drop cutoff 130 positively prevents return of the pusher 106 so that the clip is positively locked between tissue, jaws 4446, and the distal end of the pusher 106 until the jaws are closed.

When the surgeon now releases the pressure on the handle shafts 56 and 96 of the left jaw actuating member 52 and pusher actuating member 92, the jaw return spring 64 first rotates left jaw actuating member 52 about pivot pin 72 under action of the jaws return spring 64 until it comes against the head of adjustment screw 144 mounted to the main body 68. Cam surface 130, being released by stop extension 60, rotates about pivot 134 and pusher actuating member 92, under the action of pusher return spring 104, rotates about pivot 97 returning the instrument to its rest position shown in FIGURE 2.

The clips may also be mounted in the cartridge 80 with their open ends slightly resiliently pressed together so that they tend to widen when released. This allows them to widen when they reach the jaws 4446 and to be resiliently retained therein. Alternatively, the clearance between the jaws may be made smaller than the channel through which the clips are pushed, so that they are resiliently squeezed down when they reach the jaws to be retained therein.

The clip slots may also be provided with transversely oriented serrations for retaining the clips therein, in the manner disclosed in U. S. Patent No. 3,713,533.

Again, referring to ;FIGURES 9 to 13, the cartridge 80 comprises a main body portion 146, preferably of transparent plastics material for low cost manufacture and to allow the user to see the number of clips 136 remaining in the stack or magazine and a leaf spring 148 mounted thereto, by suitable attachment means, for example, a screw 150. Spring 148 may be attached by means of a heat sealed plastic rivet or might even ;be integrally molded with the body '146 if a suitable plastic were employed. The cartridge 80 fits snugly into cartridge cut out 78 in right jaw extension 50. The forward end of the cartridge body 146 is provided with a forward clip guide means and retention tongue 152. Since the cartridge closely fits into the cut out 78, no other retention means is required. However, a detent and recess may be provided at the rear extension 154 of the cartridge body 146 and the rear end 156 of the cut out 78, or on other suitable parts of the cartridge and adjacent parts of the instrument.

The cartridge body is provided with guide surfaces 158 and 160 for guiding the clip magazine or stack 136 and at the bottom thereof with a clip platform stop 162, which fits into the cartridge clearance cut out 62 in the distal left jaw extension 48. The end of the spring 164 preferably extends through a cut out 166 to provide a visual indication of the number of clips remaining in the stack 136.

Spring pressure and friction prevents bottom clip 142 from moving either forward or rearward when the cartridge is out of the instrument. A clip follower 172 is provided for applying the 90 and 94 when the instrument was assembled. Furthermore, the cartridge cut out 50 and main body 68 could be formed as part of the left jaws actuating member in which case the right jaws actuating member would comprise only the right jaw 46, the distal extension 50, the pivot hole 90, and the pusher actuating member stop 88, which also acts as the right jaws actuating member when contacted by the handle shaft 96 of the pusher actuating member 92.

Now referring to FIGURE 19, a single pivot instrument is generally indicated at 220. It comprises a main body 222 having a jaws extension 224 terminating in lower jaw 226. The upper finger loop extension 228 is integral with the main Ibody 222 and terminates in upper finger loop 230. Lower finger loop extension 232 is pivoted to the main body at pivot 234 and terminates in lower finger loop 236. Upper jaw 238 is mounted to an arm also pivoted at pivot 234 and terminating at an asymmetrical Tshaped extension generally indicated at 240.

The lowermost extension 242 is contacted with lower finger loop extension 232 when the two finger loops 230 and 236 are brought together and this causes the T-shape extension 240 and the upper jaw 238 to pivot about pivot 234 against the action of a spring 244 mounted at one end to finger loop extension 228 and engaging the uppermost portion 246 of the T-shaped extension 240.

The pusher mechanism is mounted in the main body 222 and a portion of the pusher channel 248 may be seen. The distal end of the pusher 250 is pivoted at pivot 252 to link 254. Link 254 is pivoted at pivot 256 to floating Ibell crank 258 which is pivoted at pivot point 260 and connected at its other end at pivot 262 to lowermost finger loop extension 232. Pivot 260 is connected to link 264 which in turn is connected at its other end at pivot 266 to spring 265 which may be integral with spring 244 both being mounted to uppermost finger loop extension 228. Travel of spring 265 is preferably limited by stop 268 integrally formed with uppermost finger loop extension 228.

When the two finger loops 230 and 236 are brought together pivot 260 moves to position 2601 and the linkages and other pivots move to the positions shown by the dotted lines and circles connected to point 2601. This causes the pusher to move fully forward pushing the clip from the cartridge 269 forward in between the jaws 226 and 238. As the front end of finger loops 230 and 236 are brought closer together, pivot 266 moves to point 2661 and lowermost finger loop extension 232 moves to position 2321 shown by dotted lines thus engaging the T-extension 240 and dosing the uppermost jaw 238 against the lower jaw 226.

Now referring to FIGURE 20, an alternative form of clip cartridge 270 having clipstack 272 therein may be provided with an internal clip leg or with supporting flanges 274 to prevent the clips 272 from bending inward within the cartridge 270. It will be understood that the walls of the cartridge 276 and 278 which engage the back bight 280 of the clipstack 272 need not continue all the way around the clips but merely need to engage the back of the clips to prevent them from moving backward in the stack.

In FIGURE 21 there is shown a preferred form of U-shaped clip 300 having straight legs 302 and a V-shaped bight 304. The apex 306 of the bight 304 provides a crease which insures that the clip will close at the apex. This provides smoother operation of the instrument and insures that the legs 302, when closed on a bleeder, are of the same length. Otherwise, clip 300 is the same as those previously described.

Referring again to FIGURES 1 to 4, it will be understood that the pusher return spring 104 acting between the main body 68 and the pusher actuating member 92, could be located anywhere in the operating chain between the bell crank actuator extension, the bell crank 118, the pusher link 114 or the clip pusher 106, and the main body 68.

All that is required is that a force cause the pusher member 106 to return to its normal position. This will also cause the entire mechanism including the pusher actuating member 92 to return to its normal rest position. Thus a compression spring may be located within the main body operating directly on the pusher 106 tor the link pin 112 or a coil spring may operate between the main body 68 and the bell crank 118, or between the bell crank and the pusher link, or between the bell crank and the bell actuator extension. Similarly, the jaws return spring 64 may be replaced by any spring providing ultimately a rotational force between the left jaw actuating member 52 and the right jaw 46. Thus, compression springs may be mounted between the main body 68 and the handle shaft 56 or between the distal extension 48 and 50, for a coil spring may act at the pivot hole or at the pivot 72 (FIGURE 1). Similarly, a coil spring acting at the pivot 97, between the main body 68 and the pusher actuating member 92 could replace the pusher return spring 104.

Many different sequencing mechanisms could be employed, which, upon bringing the two ring handles 58 and 98 together, would cause the pusher 106 to advance the lowermost clip 142, and then the jaws 44 and 46 to close, closing the clip. One such instrument employing a free floating bell crank is illustrated in Figure 19. This instrument also emp]oys a single pivot. Now referring to Figure 19, many other sequenc ing mechanisms will come to mind, for example, a rack and gear mechanism for advancing the pusher. However, it will be noted simple mechanisms have been provided employing only rotary contacts for low friction and smooth operation, which also provide very long pusher travel for relatively small closure travel between the ring handles.

All of the clips in the cartridge need not be stacked as shown in FIGURE 9. All that is necessary is that the bottom most clip 142 be presented at the end of the pusher and the beginning of the clip channel leading to the jaws. Thus, the clips might be mounted horizontally in a plane above the pusher, all biased by a spring forward, and another spring would be provided for biasing the forwardmost clip downward against the dip platform stop so that it would be in position at the forward end of the pusher 'for being pushed into the clip channel.

WHAT WE CLAIM IS:- 1. A hemostatic clip applying instrument comprising a pair of movable mating jaw members connected for relative opening and closing movement of co-operating jaws at their forward ends, one of the jaw mem fibers being provided with an operating lever movable therewith and the other of the jaw members being provided with a hemostatic clip receiving channel extending lengthwise thereof for guiding clips therein to a location between the co-operating jaws, a pusher for pushing clips one at a time along the channel to said location, and a second operating lever so connected to said other jaw member that movement of said second lever relative to said other jaw member is operative to reciprocate said pusher in said channel, sequencing means being provided such that upon movement of said operating levers towards 'each other, first said pusher is operative to move to its advance position for pushing a clip to said location and then said jaws are brought together for deforming such advanced clip.

2. An instrument according to claim 1, wherein each of said jaws has a groove along the inner mating surface thereof, the grooves in said jaws being aligned with the channel, said grooves defining said location for the receipt of clips between said jaws.

3. An instrument according to claim 2, wherein stops are provided in said grooves to limit movement of a dip towards the free ends of the jaws.

4. An instrument according to claim 1, 2 or 3 wherein means are provided for mounting a multi-clip cartridge to the channel at a location such that the pusher is operative, in use of the instrument, to push clips, one at a time, from the cartridge along the channel to said location.

5. An instrument according to any preceding claim, wherein the first and second jaw members are directly pivoted together.

6. An instrument according to any preceding claim, wherein said second operating lever is pivotally connected to said other jaw member.

7. An instrument according to any preceding claim, wherein the sequencing means comprises spring means such that upon bringing of the first and second levers together said second operating lever is movable relative to said other jaw member against the bias of one spring before said one jaw is movable relative thereto against the bias of another, stronger, spring.

8. An instrument according to any preceding claim, wherein means for reciprocating the pusher in the channel comprises a bell crank pivoted to said other jaw member and having two lever arms, one of which is connected to said second operating lever and the other of which is connected pivotally to the remote end of the pusher.

9. An instrument according to claim 8, in which the sequencing means comprises a cam surface of constant radius with a drop off and a cam follower co-operable with said surface, one of the cam surface and the cam follower being movable with the pivoted movement of the bell crank and the other of the cam surface and cam follower being mounted to the first operating lever whereby upon bringing together of the operating levers the cam follower will ride on the constant radius of the cam surface during the first part of the closing motion between the operating levers and will then drop off into said drop-off during the said second part of the closing motion between the operating levers to permit the jaws to be brought together.

10. An instrument according to any preceding claim, wherein said jaw members and said second operating lever are pivoted about the same pivot.

11. An instrument according to any preceding claim, comprising a stack of at least two U-shaped clips stacked in a second channel on said other jaw member intersecting said first channel, and means forcing said clips down said second channel towards said first channel whereby operation of the pusher will push the lowermost one of the clips in the said stack along said first channel to said location.

12. An instrument according to claim '11, wherein said first channel is aligned with the centre line of said instrument and is offset from the axis of pivotal connection of the two jaw members.

13. An instrument according to any preceding claim, wherein the sequencing means is adapted to cause said pusher to dwell at its furthermost advance against the rear of

**WARNING** end of DESC field may overlap start of CLMS **.

Claims

**WARNING** start of CLMS field may overlap end of DESC **. ing mechanisms will come to mind, for example, a rack and gear mechanism for advancing the pusher. However, it will be noted simple mechanisms have been provided employing only rotary contacts for low friction and smooth operation, which also provide very long pusher travel for relatively small closure travel between the ring handles. All of the clips in the cartridge need not be stacked as shown in FIGURE 9. All that is necessary is that the bottom most clip 142 be presented at the end of the pusher and the beginning of the clip channel leading to the jaws. Thus, the clips might be mounted horizontally in a plane above the pusher, all biased by a spring forward, and another spring would be provided for biasing the forwardmost clip downward against the dip platform stop so that it would be in position at the forward end of the pusher 'for being pushed into the clip channel. WHAT WE CLAIM IS:-

1. A hemostatic clip applying instrument comprising a pair of movable mating jaw members connected for relative opening and closing movement of co-operating jaws at their forward ends, one of the jaw mem fibers being provided with an operating lever movable therewith and the other of the jaw members being provided with a hemostatic clip receiving channel extending lengthwise thereof for guiding clips therein to a location between the co-operating jaws, a pusher for pushing clips one at a time along the channel to said location, and a second operating lever so connected to said other jaw member that movement of said second lever relative to said other jaw member is operative to reciprocate said pusher in said channel, sequencing means being provided such that upon movement of said operating levers towards 'each other, first said pusher is operative to move to its advance position for pushing a clip to said location and then said jaws are brought together for deforming such advanced clip.

a clip at said location between said jaws as said jaws are closed during use of the instrument.

14. An instrument according to any one of claims 1 to 10, including a hemostatic clip cartridge comprising a plurality of Ushaped planar hemostatic clips in vertical alignment forming a U-shaped stack, stackguide means confining and guiding said Ushaped stack for motion along the vertical axis of said stack, spring means biasing said stack downward; stop means at the bottom of said stack-guide means for preventing said stack from further downward motion, said stop means cooperating with said stackguide means to form a rearward aperture for receiving a clip pusher and a forward rectangular slot for passing a single clip; and dip-guide means comprising a channel member extending horizontally from said forward slot, the width of said forward slot corresponding to the width of the channel in said clip-guide means whereby in use of the 'cartridge the lowermost clip of the stack may be pushed by a clip pusher through said forward slot and into said clip-guide means.

15. 'An 'instrument according to claim 14, wherein the channel member of said clipguide means has an open bottom.

16. An instrument according to claim 14 or 15 wherein there is provided a clip follower bearing on the uppermost clip in said stack and having an outside dimension corresponding to the dimensions of said Ushaped stack, the spring means biasing the clip follower, and thus the stack downwards.

817. An instrument according to claim l6, wherein said clip follower has a planar surface bearing on the uppermost clip of said stack and a fulcrum contacting said spring means.

18. An instrument according to claim 17, wherein said fulcrum comprises a ridge extending across the center of said clip follower.

19. An instrument according to claim 14, 15, 16, 17 or 18 which includes an elongated cartridge body in which said stop means, said stack-guide means, said rearward aperture and said forward rectangular slot are formed; and wherein said spring means comprises an elongated leaf spring attached to the rear of said cartridge body.

20. An instrument according to any one of claims 14 to 19 wherein the stop means comprises a plate across the bottom of said guide means.

21. An instrument according to any one of claims 14 to 20, wherein said clips are of substantially uniform rectangular cross section.

22. An instrument according to claim 21, wherein the ratio of height to width of the rectangular cross section of each clip is approximately 2:1.

23. An instrument according to any preceding claim, wherein said U-shaped clips comprise two substantially parallel arms connected roy a bight of constant radius.

24. An instrument according to any one of claims 1 to 22, wherein said U-shaped clips comprise two substantially parallel arms connected by a V-shaped section.

25. An instrument according to any preceding claim, wherein the inner surface of said U-shaped clips is roughened relative to the other surface.

26. An instrument according to claim 25 wherein the said inner surface of said clips is coined in a diamond shaped, knurled pattern.

27. A repeating surgical dip applying instrument having a pair of delicate clip applying jaws, means to removably mount a clip dispensing cartridge remote from the jaws, a pair of ring handles, a clip pusher, and sequencing, actuating, and spring return means such that with the jaws placed about tissue to which a clip is to be applied, with a single uninterrupted motion of the surgeon's hand consisting of squeezing the ring handles together, the instrument sequentially removes one clip from the cartridge, feeds the clip to a position between the jaws about the tissue, flattens the clip about the tissue, and upon release of the ring handles, spring means return the instrument to its original position ready to repeat wherein the said instrument comprises: a pair of clip apply ing jaws, each having a clip slot, adapted to receive a clip positioned between the jaws in said clip slots and crush the clip fllat about tissue contained therebetween when the jaws are brought together, a pair of jaws actuating members having one of said jaws mounted at the end of each, and having pivot and stop means permitting motion only between a fully open position where said jaws are separated just enough to permit a nondeformed clip to fit therebetween, and a dosed position such that the jaws contact one another, the first of said jaws actuating members having an elongated slot with two equal short sides and one long side and means for mounting thereupon a clip dispensing cartridge such that one clip within said cartridge is aligned with said slot and the second of said jaws actuating members having a fiat surface which covers the slot in said first member such that an elongated channel of substantially rectangular crosssection is formed which does not substantially change in volume or dimension when the jaws are moved between the fully open and closed positions, a channel formed between said first and second jaws actuating members having two portions aligned with one another and a gap therebetween in which a clip held within a cartridge may be positioned, one forward portion of said channel extending from the gap towards the jaws and terminating such that a clip ejected from the end of the channel closest to the jaws when the jaws are in the fully open position will be located between the jaws, and a second portion extending from the gap generally towards the ring handles, an elongated clip pusher of substantially the same cross section as the channel adapted for axial motion within the channel such that the tip of the pusher may move from said second portion of the channel across said gap and through said first portion of the channel to a position where said tip is aligned with the open end of the channel adjacent to the jaws; a pair of handle shafts a first of which is formed integral with one of the jaws actuating members, a second of which is mounted moveably about a pivot such that the two ring handles may move towards and away from one another; a linkage operably interconnecting said second shaft with said pusher to move the pusher axially within the channel when the ring handles are moved with respect to one another; sequending means which maintain the jaws in the fully open position whenever the tip of the pusher is not aligned with the end of the channel adjacent to the jaws jaws actuating means operably interconnecting the two jaws such that, when said sequencing means permit, the jaws may be forced together thereby; and spring means urging the shafts apart.

28. An instrument according to claim 27 wherein a portion of each of the jaws actuating members in the vicinity of the cartridge .and jaws are curved, a portion of the chan .nel is curved, and the pusher is adapted flex as it follows the curvature of the channel.

29. An instrument according to claim 27 .or 28 ,wherein said means for mounting thereupon a clip dispensing cartridge comprise: an elongated shallow slot in which part of the cartridge fits, axially aligned with the channel of the instrument but laterally displaced from said channel with an opening communicating between said elongated slot and the gap in said channel; and -an undercut at the end of said elongated slot closes to the jaws, of appropriate dimensions to permit a projecting alignment tongue of the cartridge to slide snugly therein, and thus align a clip within the cartridge with the channel of the instrument.

30. A hemostatic clip applying instrument according to claim 1, wherein a reciprocating mechanism operated by closing the operating levers for reciprocating the pusher along the channel comprises pivotal means for effecting a pivotal connection to the end of the pusher remote from the jaws; and a bell crank rotatable about an axis fixed with respect to said channel for at least a portion of the rotatable movement of said bell crank, and having one leg pivotally connected to said pivotal means, and another leg.being associated with one of said handle shafts so that said bell crank can be rotatably actuated thereby.

31. A hemostatic clip applying instrument according to claim 1, wherein the sequencing means is included as a reciprocating mechanism operated by dosing the pair of operating levers together and comprising a bell crank pivoted about an axis which is fixed in relation to the channel for at least a portion of the pivotal movement of the bell crank and having two lever arms, one lever arm being connected to one of the said second operating lever and the other lever arm being pivotally connected to the end of the pusher remote from the jaws, a cam provided with a surface of constant radius with a drop-off, and a cam follower, one of cam and the cam follower being carried by the bell crank and the other of the cam and the cam follower means being mounted to the first operating lever, the cam and cam follower being adapted to cooperate one with the other with the cam follower riding on the constant radius surface of the cam during the first part of closing motion between the operating levers before dropping into said drop-off for the 'second part of the closing motion between the operating levers.

32. A repeating instrument for applying surgical clips to blood vessels or other body tissue, said instrument comprising: an elongated 'main body portion; first and second opposed jaws, said first jaw being formed at one end of said main body portion, said second jaw being mounted to said main body portion for arcuate movement, wherein said jaws are capable of movement relative to each other between an opened position sized to receive a surgical clip, and a closed position sized to clinch said surgical clip; an elongated channel defined by said main body portion, said channel being of substantially constant cross-section for the passage of surgical clips to between said jaws; pusher means, movable within said channel and operable between first and second positions, for advancing a surgical cliP in said elongated channel, to Ibetween said jaws; first and second lever arms pivotally mounted to said mdin body portion, the distal end of each arm terminating in a handle for receiving a manually applied force; biasing means for normally biasing said lever arms away from said -main body por tion so that said lever arms assume an initial relative position with said handles being a first predetermined distance apart; said lever arms being capable of moving relative to each other in response to a manual force applied to said handles to a final relative position wherein said handles are a second predetermined distance apart, said second distance being less than said first distance, and, upon moving said lever arms from said initial relative position to said final relative position, said lever arms pass through an intermediate relative position wherein said handles are a third predetermined distance apart, said third distance being less than said first distance and greater than said second distance; pusher-sequencing means connecting one of said lever arms to said pusher means so that, during relative movement of said lever arms from said initial to said intermediate position, said pusher means advances from said first to said second position, wherein a surgical clip is advanced from said elongated channel to between said jaws, and during relative movement of said lever arms from said intermediate to said final position, said pusher means remains inactive, and during relative movement of said lever arms from said final position to said initial position, said pusher means moves from said second to said first position; and jaw sequencing means connecting the other of said lever arms to said second jaw so that, during relative movement of said lever arms from said initial to said inter mediate position, said jaws remain in said opened position, and during relative movement of said lever arms from said intermediate to said final position, said jaws move to said closed position, and during relative movement of said lever arms from said final to said initial position, said jaws move from said closed to said opened pos-ition.

33. A hemostatic clip applying instrument constructed and arranged to operate substantially as hereinbefore described with reference to and as illustrated in the accompanying drawings.

34. An instrument according to claim 30, including a hemostatic clip cartridge substantially as hereinbefore described with reference to and as illustrated in the accompanying drawings.