SKIN CLIP APPLIER

Abstract: Skin clips are placed by skin clip appliers to close an incision too slowly and inaccurately and there is trauma to the patient when the skin clip is removed. To increase the speed and the accuracy of placing a skin clip, a skin clip applier (20) for placing skin clips (10) to close a wound comprises a handle assembly (30) including an actuating element and a cartridge assembly (40) adapted to be affixed to said handle assembly and including skin clip-deforming jaw elements (41, 42) which are actuated by operation of the handle assembly to place and deform preformed skin clips (10) delivered individually to said deforming jaws, to close a wound. To decrease the trauma when the skin clip is removed, the skin clip comprises a concave crown (114), a pair of legs (115, 116, 117, 118) divided into two segments and a point (119, 120) at the free end of each leg.

Description: SKIN CLIP ΛPPLIΞR » Field of the Invention This invention relates to a skin clip applier use¬ ful for placing skin clips or staples into the skin across a wound to close the wound and to retain it in a closed and healing position. Background of the Invention Whenever it is necessary to close an incision or a wound, v/hether ' at the convpletion of a surgical procedure or to repair accidental damage, it is becoming more and more common fςr the attending surgeon to choose to use metal skin clips or staples instead of thread sutures. ' This has become true with the development of stapling devices, or skin clip appliers , particularly suited for surgical use and the consequent speed with which incision or wound closure can be accomplished by the surgeon with such devices as compared to the use of thread suture ma- terials with needles and the required time-consuming tying of the suture material. See, for example, U.S. Patents 3,643,851 and 3,717,294 which describe skin staplers and U.S. Patent 4,014,492 which describes a particular type of staple. • . ■ . " hen staples or skin clips are used for incision cr wound closure, they are removed with a special removal tool or extractor such as dis- O PI BAD RI * v ' riPO — O _ closed in U.S. Patent 4,025,520, or an adoption of the staple remover, originally designed for removal of staples from paper or like material, shown in U.S. Patent 2,202,984. 5 Brief S mmary The skin cl p applier of the present invention overcomes disadvantages of prior skin clip appliεrs or stapling devices which results in an improvement in the speed and accuracy with v/hich skin clips may be placed _0 to close an incision or a wound and an improved shape of the skin clip when deformed into place as an incision or a wound closing element by the present skin clip applier. Such improved shape of the placed skin clip results in considerably less trauma to the patient when the skin ^ 5 clip is removed. The specific advantages of the present skin clip applier as compared to prior devices will be explained more fully in the following detailed description of an illustrative specific embodiment of the invention. The skin clip applier of this invention ' is formed 2ø of a combination of a handle assembly and a ' cartridge assembly v/hich may be adapted to fit together so that an empty cartridge may be removed and replaced with a cartridge full of preformed skin clips. The closing action of the handle assembly functions to actuate a pair __ of jaws in the cartridge assembly and deform into place as a wound closing element a preformed skin clip which is fed betv/een the- jaws as the leading one of a plural¬ ity of skin clips pre-loaded into the cartridge assembly on a clip carrier and moved coward and between the pair of jaws by the action of a clip pusher which is biased Cϊ rl -3- toward the jaws. Th pair of jaws are pivoted on a ' single stud/ preferably v/ith elongated- pivot holes in each jaw to provide limited movement toward and away from the surface of the skin into which a skin clip is to. be placed. Such movement, permits the points of the skin clip, to, be placed into the skin before actual deformation of the skin clip begins and assists in the approximation and closure of the incision or wound. Brief Description of the Drawings The skin clip applier of this invention will be described in more detail v/ith reference to the accompany¬ ing drawings which show illustrative specific embodiment of the invention which includes an improved skin clip as well, as the skin clip applier. Xn the drawings: Fig. 1 is- a perspective view of the skin clip applier approximately in the position of use after having placed skin, clips to close an incision. Fig. 2 shows three steps in. the deformation by the skin clip applier of a, single skin clip which is being * placed to close an incision or a wound. Fig. 3 is a side view of the handle of the skin clip applier partly in section. Fig. 4 is a section of the cartridge taken along line 4-4- of Fig. 3. • Fig. 5 is an enlarged partial view of the applier showing- the skin clip in position between the jaws of the skin clip applier just prior to actual deformation. Fig. 6 is a side view partly in section of the cartridge assembly. Fig. 7 is a view partly in section of the cart¬ ridge taken along line 7-7 of Fig. 6. ' Fig. 8 is a section of the cartridge taken along line 8-8 of Fig. 6. Fig. 9 is a perspective and exploded view showing the relation of parts of the cartridge assembly to the actuating element of the handle assembly. Fig- 10 is a side view partly in section of the cartridge assembly including jaws modified to include hawk bill projections at their distal ends. Fig. 11 is a view of the hawk bill jaws taken along line 11—11 of Fig. 10 and showing a reverse cut skin clip in position between the jaws just, prior to actual deformation. Fig. 12 is a partial view of the hawk bill jaws . of Fig. 11 showing a reverse cut skin clip in position between the jaws after completion of deformation but before release of the skin clip. Fig. 13 is a partial view of one of the hawk bill jaws of Fig. 11 partly in section sliowing the skin clip ■ retaining groove or coining slot in the deforming surface of the jaw. Fig. 14 is a section of the hawk bill jaw taken along line 14-14 of Fig. 13. Fig. 15 is a perspective view of a closed incision after the placement of skin clips. Fig. 16 is a view of a preformed skin clip with reverse cut points. Figs. 17, 18 and 19 are views showing the reverse cut. skin clip in three stages of deformation. K E \ Detailed Description With reference to the accompanying drawings, the same parts are identified by the same reference numerals in Figs. 1 through 9. 5 In Figure 1, a specific embodiment of the skin clip applier of the present invention, indicated generally by reference numeral * 20, is shown in an atti¬ tude of use after having placed five skin clips 10 to close a wound or an incision 11. The skin clip applier 10 20 includes a handle assembly 30 and a cartridge assembly 40 which are detachable one from the other. It is to be understood, however, that the skin clip applier of this invention may have a handle assembly and cartridge- assembly incorporated into a ■ * • * •■ - ■ ' unitary device rather than as detachable elements. Figure 2 (three views) shows a skin clip 10 in progressive stages of deformation during the placing of the ' skin clip 10. In the first,view f the points 12 of . the skin clip 10 have ' just punctured the skin as the ^ bottom edge of the cartridge assembly 40 of the skin clip applier 20 is brought into contact with the incision or wound 11. At this stage the deformation of the skin clip 10 has not acutally begun, but the skin clip 10 ' is held in a position, as will be explained 25 n more detail hereina er, such 'that the points 12 -6- extend below the bottom edge of the cartridge assembly 40 to permit contact v/ith and penetration of the skin to maintain the approximation of the wound or incision site- In the second view, the skin clip 10 5 has been partially deformed and the points 12 of the skin clip 10 have substantially completed their penetration to hold the wound or incision 11 in a closed position. In the third view, the skin clip 10 is fully deformed and placed to hold the wound or ' incision together. 0 It should be noted here that the fully deformed skin clip 10 is holding the wound or incision 11 closed in a butted relationship. If desired, the wound may be approximated in a slightly everted attitude and the ' skin clips 10 applied. In either procedure, the top 5 of the skin clip 10 is not touching but is slightly separated from the wound or incision 11, and the top' of the skin clip 10 is bowed downwardly to a slight extent, i.e.. It has not been deformed to a point that the top of the skin clip 10 is absolutely straight. 0 -Both of these conditions are important from the standpoint of patient comfort both in case of any swelling of the wound or incision site 11 and the subsequent removal of the skin clips 10, and both conditions are brought about by the action of 25 . the skin clip applier 20. The handle assembly 30, as shown in Figure 3, includes, a frame 31, a handle 32, a compression spring 33, a pivot axel 34, and a cam 35. The frame 31 and handle 32 are connected through the pivot a:-;ei 34 30 so that the gripping end of the handle 32 is permitted CV-PI - to move about the pivot axel 34 into contact with (dotted outline) and away from (solid outline) the frame 31. On the opposite end of the handle 32, i.e., on the other side of pivot axel 34 and at the 5 extreme end, the cam 35 is attached and is the actuating element of the handle assembly 30 which cooperates with those elements of the cartridge assembly 40 which actually deform a skin clip 10 during placement of the skin clip 10. The compression spring 10 33 is present to bias the handle 32 in the open posi¬ tion, i.e., with the gripping portion at. its most remote position from the frame 31- The open end or pivot axel 34 end of the frame 31 * is shaped to receive the cartridge assembly 40 therein in such a manner that •^5 the cam 35 is positioned v/ithin the ' cartridge assembly 40 in order to be in engagement" " ith certain, elements therein as will be explained in detail hereinaf er. The cartridge assembly 40 is shown in detail in Figures 4 through 9 which illustrate the various 0 elements of the cartridge assembly 40 and how such elements function to present and deform a skin clip 10 when actuated by the downward movement of cam 35 as the result of closing the handle 32 into virtual contact with the frame 31 when the surgeon closes his 25 hand while gripping the frame 31 and handle 32 of the handle assembly 30 of the skin clip applier 20. The cartridge assembly 40 includes jaws 41 and 42 pivoting on stud 43 v/hich is fastened into front plate 45. The hub 44 shown on the front plate 45 is not a .-•required element but is present simply to provide a ore substantial bulk of material into which the stud 43 can be fastened. Jaws 41 and 42 are formed with elongated holes 41a and 42a which fit over stud 43 and provide for limited vertical motion of the jaws 41 and 42 as will become apparent from the subsequent description. Torsion spring 46 is mounted on and around stud 43 after the jaws 41 and 42 are placed thereon. One free end of torsion spring 46 is attached to jaw 41 at 41e and the other free end is attached ' to jaw 42 at 42e in a manner such that the jaws 41 and 42 are biased both in the uppermost posi¬ tion " permitted by the elongated holes 41a and 42a and in an open position, i.e. , the deforming surfaces 41b - and 42b are at their most separated position and the cam bearing surfaces- 41c and 42c are at their closest position. The deforming surfaces 41b and 42b must move in the same plane, and the cam bearing surfaces 41c and 42c most conveniently move in the same plane. Consequently, one of the jaws is offset sufficiently to move the deforming surface and the cam bearing surface into line v/ith those of the other jaw. with the cartridge assembly 40 connected to the handle assembly 30., when cam 35 is moved from its extreme biased position to its opposite limited position by the closing of the handle 32 to or into the frame 31, the specifically shaped undersurface of cam 35 contacts the cam bearing surfaces 41c and 42c of jaws 41 and 42 and smoothly moves these surfaces 41c and 42c down and apart, as best illustrated in Figure 4. As a consequence of this movement of cam bearing surfaces 41c and 42c, the whole bodies of the jaws 41 and 42 are moved down to the limit provided by the elongated holes 41a and 42a and the deforming surfaces 41b and 42b move into skin clip deforming relation.. Stops 47 and 48 are provided in the form of bosses on the inside surf ce of front plate 45 to- limit the movement of jaws 41 and 42 to prevent excess deformation of skin clip 10. - As the. deforming surfaces- 41b and 42b are moved toward each other by the action of cam 35 when the handle is being closed, the skin clip 10 positioned therebetween (as best illustrated in Figure 5) v/ill be deformed through the stages illustrated in Figure 2. During such deformation of skim- clip-10, it is held in proper position with the aid of grooves or coining . slots 41d and 42d in the deforming surfaces 41b and 42b and the upward movement of skin clip 10 as it is deformed is limited by the stop 49 which is shown as a boss on the inside surface of front plate 45 but may be provided elsewhere, as- for example, on the forward end of carrier cover 52. The surface 49a of stop 49 is curved to fit the arcuate shape of the top of skin -clip 10 and this assists in maintaining a slight downward bow in the top of the skin clip 10 when it is fully deformed as shown in the third and last view, of Figure.2. As explained' previously, this slight downward bow in the top of the fully deformed skin clip 10 is an important feature from the standpoint of patient comfort, particularly curing the removal of skin clip 10. The skin clip delivery system forming a part of the cartridge assembly 40 includes a skin clip carrier (or slide) 50, a skin.clip pusher 51, a skin clip carrier cover 52, and a biasing spring 53 to bias the skin clip pusher 51 and thereby the skin clips 10 on 5 carrier 50 toward the front plate 45 and the deforming jaws 41 and 42. Skin clip carrier 50 forms the bottom of the cartridge assembly 40 and carrier cover 52 fits over ^ carrier 50 * to provide a passageway for the skin clips 10 and skin clip pusher 51 and prevent any binding of skin 0 clip pusher 51 on carrier 50. Carrier cover 52 includes a slot 52c to permit passage of- the skin clip pusher boss 51a. The forward ends 50a and 52a of the carrier 5-0 and carrier cover 52- abut and are fastened to front plate 45 to form the major portion of-the cartridge assembly 5 40. Skin clips 10 are loaded onto carrier 50 and skin clip pusher 51 is then placed on the carrier 50. Biasing spring 53, preferably a. constant force spring such as a saddle spring, is then affixed to the forward end52a of carrier cover 52 and toskin clip pusher 51. As shown in Q Figure 9, the free ends in coil form of spring 53 are placed in the spring wells 52b- of carrier cover 52 and the loop or middle of the spring 53 is placed around the boss 51a of the skin clip pusher 51 to bias the skin clips 10 toward the deforming jaws 41 and 42. A -_ specially shaped boss 54 on the inside wall of front plate 45 provides, a partial- cover for the spring wells 52b and thereby retains the ends of spring 53 therein. In Figure 9, a clip 10 is shown resting on the carrier 50 which s shaped to conform to the preformed CMPΓ clip 10. When contacted by the angled (about 30 as • shown) forward face or contact surface of the ' pusher 51, the clip 10 will assume an angled position on carrier 50 (as. most clearly shown in Figure 6) such that the clip 10 is. at all times parallel to ' the inside surface of the front plate.45 and the plane of deforming movement of the jaws . 41 and 42. The forward end of skin clip carrier 50 is provided with a lift 50b which serves to prevent the clips 10 from sliding off the forward end of carrier 50 and also locates or positions each clip 10 so that it is properly presented to the deforming jaws.41 and 42. The bottom of front plate 45 and the bottom of skin clip carrier 50 are cut out to provide a channel 55 slightly wider than a deformed skin clip 10 to permit the skin clip applier 20 to pass over the everted wound and any skin clips implanted in the wound. As shown in Figures 1 and 6, the front plate 45 πiay be provided v/ith. a positioning guide 44a. tb assist in the accurate placing of the skin clips 10. Figs.. 10 through 19 illustrate a preferred form of jaws 141,142 for the applier and a preferred skin clip 110 for use with the applier. These hawk bill jaws 141, 142 are interchangable with the jaws 41,42 described in connection with Figsv 1-9,. nd either the preferred reverse cut skin clip 110 or skin clip 10 previously described can be used in the applier with either pair of jaws. Hov/ever, the use of hawk bill jaws 141,142 and the reverse cut skin clip 110 provide advantages • which will beexplained in detail hereinafter. As noted above, the functioning of the skin clip applier 20 remains the same when employing the preferred hawk, bill jaws 141,142 or when implanting the preferred 5 reverse cut skin clips 110. Consequently, in Figs.10- 14 the parts of the cartridge have been identified with reference numerals identical to those of Figs. 1-9 except that the reference, numerals of Figs. 10—14 have- been increased by 100. In Fig. 11, a stop (such as the stop 49,49a of Figs- 5,8, and 9) has been represented by an arrow directed downwards against the top of the crown of the reverse cut skin clip 110 positioned in the hawk bill jaws 141,142. Figs. 11, 12 and 13 show the hawk bill jaws 141, 142 in which the distal ends terminate in hawk bill projections 141h and 142h, each formed at an obtuse angle to its contiguous deforming surface 141b(not shown) and 142b and each projecting toward the other. The hawk bill projections 141h, 142h provide an improved grip on the skin clip 10 or ' 110 when it is positioned for deformation and they prevent premature release or loss of the skin slip 10 or 110 from the applier jaws 141,142. Consequently, improper or incomplete deformation " of the skin clip is prevented. In addition, until the deformed and implanted skin clip 10 or 110 is actually released by the user of the applier, the applier can be used to manipulate the tissue into which the skin clip is implanted. Fig. 16 shows the preformed shape of the reverse cut skin clip 110, and Figs. 17-19 show the three pro- gressive stages of deformation during the implanting of skin clip 110 as are shown in the three views of Fig.2 with respect to skin clip 10. As shown in Fig. 16, skin clip 110 is preformed, .g. , from stainless wire, with an arcuate, concave crov/n 114, and a pair of legs " • • 115,117 and 116,118, one leg extending from each end of the crown 114. Each leg has two segments 115, 117 or 116, 118. Each first segment 115 or 116 extends from the crown 114 at an obtuse angle ( about 150°) to the crown 114 and away from the center line of the clip 110. 10 Each second segment 117 or 118 extends av/ay from first segment-115 or 116 at approximately a 90° angle and toward the center line of the clip 110. • Each second segment 117 or 118 ends in a point 119 or 120 formed by terminating the second segment 117 or 118 on a line approximately ^ parallel to the center line of the clip 110. Preferably, each of the legs 115, 117 or 116, 118 is approximately the same length, as the crown 114, with each ' of the first seg¬ ments 115 or 116 longer than each of the second segments 117 or 118 while -maintaining the symetry of the clip 110. 20 The skin clip 110 has several advantages over the . skin clip .10 because of the angle of the points 119 , 120 of skin clip 110 as compared to the angle of points 12 of skin clip 10. Better implantation or penetration into the skin prior to deformation is achieved by the 2 5 sharper angled points 119, 120 of skin clip 110 which pierce skin like needles without any danger of skidding across .surface of the skin- .In addition, because the opening between points 119 and 120 is wider by two dia¬ meters of the wire from which equivalent clips 110 and 30 clips lOare formed, skin clip 110 will gather more tissue and accomplish a tighter wound closure with slight eversion. The skin clip applier of the present invention is simple and sturdy in construction and functions to place skin clips in a wound or incision closing site in a manner that results in a minimum of patient discom- fort because it provides room for any swelling of the site and results in a shape of placed skin clip which can be removed with the least trauma. This latter result is accomplished because of the slight downward bow of the top of the skin clip . (shown in last view of Fig-2 and Fig-;19) which minimizes rotation or warping of the skin clip by the customary removal tool or ex¬ tractor, and consequently, during removal it minimizes any distortion or scraping by the withdrawing pointed legs of the skin clip of th entry holes formed by the pointed legs during placement of the skin clip. The downward, bow of the skin clip placed by the skin clip applier of the present invention requires less force to deform during removal than the upward bow of those skin clips placed by other skin clip . appliers. Skin clip appliers or staplers which utilize an anvil about which a skin.clip or staple is formed must ' of necessity have an upward bow to the top of such a skin clip because the anvil limits the deformation to a theoretical flat or straight top of such a skin clip, but in practice an " upward bow will be present. Such upward bow has been found to occassionallv cause warping and rotation during removal by the customary removal tools. The skin clips used by the skin clip applier of the present invention are customarily of stainless steel, and 316L stainless steel is preferred. The skin clips are conventionally formed of stainless steel wire which may be of varying thickness, and the skin clips may be of various sizes- Because the skin clips used by the present applier are preformed into the particular shape described hereinbefore, a lesser force is required to deform the clip into its final wound— closing shape. This makes it possible to provide an applier the use of which is less tiring to the surgeon.

Claims: What is claimed is: 1. A skin clip applier comprising in combination a handle assembly and a cartridge assembly, said handle assembly comprising a handle pivotally connected within its length to a frame, means to bias one end of handle away from frame, a cam element connected to opposite end of handle and means for affixing a skin clip cartridge assembly in operative relation to said cam element of said handle assembly, said cartridge assembly comprising a skin clip delivery system adapted to present individual -pre-formed skin clips serially to a pair of jaw elements pivotally mounted for de¬ forming said skin clips, means to bias said deforming jaws away from each other, and means for affixing an actuating handle assembly in operative relation to the jaw elements of said cartridge assembly to force said -jaws into deforming relation to a skin clip'. 2. A handle assembly for a skin clip applier comprising a handle pivotally connected within its length to a frame, means to bias one end of handle away from frame, a cam element connected to opposite, end " of handle and means for affixing a skin clip cartridge assembly in operative relation to said cam element of said handle assembly. 3. A cartridge assembly for a skin clip applier comprising a skin clip delivery system adapted to present individual pre-formed skin clips serially to a. pair of jaw elements pivotally mounted for deforming said skin clips, means to bias said deforming jaws away from each other, and means for affixing an actuat¬ ing handle assembly in operative relation to the jaw elements of said cartridge assembly to force said / jaws into deforming relation to a skin clip. 4. A skin clip applier comprising in combination a. handle assembly and a cartridge assembly, said handle assembly comprising a handle pivotally connected within its length to a frame-, means to bias one end of handle away from frame, and a cam element connected to opposite end of handle, said cartridge assembly being J joined to said handle assembly in operative relation . to said cam element of said handle assembly, said cartridge assembly comprising a skin clip delivery system adapted to present individual pre—formed skin clips serially to a pair of jaw elements pivotally * mounted for deforming said skin CUDS, means to bias said ' deforming jaws away from each other, and means for affixing an actuating handle assembly in operative 1 relation to the jaw elements of said cartridge assembly. to force said jaws into deforming relation to a skin clip. 5. * A skin clip applier according to claim 1 wherein each of said pair of jaw elements has a pivot 2 hole elongated to provide limited movement of said jaw elements to and away from a position of deformation of said skin clip by said jaw elements, means to bias said jaw elements away from said position of deformation, and means to move said jaw elements to said position 25 of deformation. 6. A cartridge assembly according to claim 3 wherein 'each of said pair- of jav/ elements has a pivot hole elongated to provide limited movement of said jaw elements to and away from a position of defor- 30 mation of said skin clip by said jav/ elements, means to bias said jaw' elements away from said position of deformation, and means .to move said jaw elements to said position of deformation. 7. A skin clip applier according to claim 4 wherein each of said pair of jaw elements has a pivot hole elongated to provide limited movement of said jaw elements to and away from a position of deformation of said skin clip by said jaw elements, means to bias said jaw elements away from said position of defor¬ mation, and means to move said jaw elements to said position of deformation. 8. A skin clip applier- cartridge assembly according- to any one of claims 1 and 3-7 wherein each of said jaw elements has a distal end terminating in a hawk bill projection, said hawk- bill projections being of equal size and shape, each hawk bill projection being formed at an obtuse angle to its continguous skin clip , deforming surface, and each said hawk, bill projecting toward the other * 9. A. preformed surgical skin clip for use in a skin clip applier cartridge assembly of the type- defined in any ' one of the preceding claims which comprises an arcuate, concave crown,, a pair of legs symetrically arranged with a leg•extending from each end of said crown, each, of said legs being divided into two segments, each first segment extending from, said crown at an obtuse angle to said crown and away from center line of said clip, each second setment extending from said first segment and toward center line of said clip and having a point ormed at free end by terminating said second segment along a line- approximately parallel to center line of sa£d clip. OMPI IPO

Inventors: GIERSCH ROBERT VAN CLEVE, HOEPPNER DOUGLAS KEITH, WALKLIN JOHN EDWARD, WEBB WILLIAM DAVID
Applicants: WECK & CO INC EDWARD, EDWARD WECK & CO INC
Application year: 1982
Main classification: A61B17
IPC codes: A61B17