US 3463156 A
Description (OCR text may contain errors)
g- 26, 1969 E. B. MCDERMOTT 3,463,156
HEMOSTATIC CLIP AND APPLICATOR Filed May 27, 196 5 2 Sheets-Sheet 1 EDWARD B, McDERMOTT ATTORNEY g- 1969 E. B. M DERMOTT HEMOSTATIC CLIP AND APPLICATOR 2 Sheets-Sheet 2 Filed May 27, 1965 FIG IO INVENTOR EDWARD B. McDERMOTT BY Low'M-Q J ATTORNEYS United States Patent 3,463,156 HEMOSTATIC CLIP AND APPLICATOR Edward B. McDermott, 23 Flower Lane, Manhasset, N.Y. 11030; Bernard Rackear, executor of said Edward B. McDermott, deceased Filed May 27, 1965, Ser. No. 459,151 Int. Cl. A611) 17/12; B65d 63/10 US. Cl. 128-325 13 Claims This invention relates generally to hemostatic devices and more particularly to a metallic clip and applicator therefor.
Surgical operations normally require the tying off of considerable numbers of blood vessels during the making of an incision. Because no suitable clip of acceptable characteristics has been available, hand tying with standard suture materials has been a necessity. In deep surgery, hand tying is difficult for the surgeon to perform, especially where space is anatomically limited. The positiveness of such ligations is also a source of serious concern to the surgeon. At lesser depth, the hundreds of bleeders which the surgeon must tie off take up as much as three-quarters of the total operating time.
It is accordingly an object of this invention to provide a positive, quick-closing hemostatic clip.
Another object of the invention is to provide a metallic clip which closes and locks merely by the application of pressure at the jaws of an applicator device.
Another object of the invention is to provide a hemostatic clip which is compatible with growth processes such that the clip is accepted by the body over a considerable period of time.
A further object of the invention is to provide an improved surgical applicator for a hemostatic clip of improved speed and certainty of result in tying ofi blood vessels.
A still further object of the invention is to provide an improved method of hemostasis.
These and other objects of the invention will be evident as the description proceeds in connection with the drawings in which:
FIG. 1 is a perspective view of the jaws of an applicator clamp, a blood vessel, and a clip being closed thereon, according to this invention;
FIG. 2 illustrates the jaws of the clamping device of FIG. 1 and a hemostatic clip to be applied thereby, not yet inserted;
FIG. 3 is a sectional view of the clamping jaws, blood vessel, and clip of FIG. 1 inserted therein;
FIG. 4 is a sectional view of the apparatus as in FIG. 3 with the jaws partially closed;
FIG. 5 is a sectional view of the apparatus of FIG. 3 in the closed position;
FIG. 6 is a cross-sectional view of a preferred form of stock for manufacture of a hemostatic clip;
FIG. 7 shows an alternative form of the hemostatic clip;
FIG. 8 shows an alternative form of hemostatic clip stock;
FIG. 9 shows an alternative form of the applicator including an open-jaw position lock; and
FIG. 10 shows details of the positioning lock.
The objects of the invention are achieved by the use of an applicator and a formed clip of somewhat flattened wire-like material arranged to be folded together to pinch off blood flow through veins or arteries. A self-locking feature is provided in the construction of the clip so that it is held closed in the manner of a safety pin, but of simpler structure, and of material suitable for temporary or permanent use within living tissue. A special applicator provides ease and speed of performing the clamping operation at the time time locking the clasp in the closed position. A clip of round-edged flat material is preferred to avoid damage to surrounding tissue and is preformed with an open side arranged to be closed firmly and locked at one end while leaving throughout the body of the clip an open space sufiicient for the wall of the blood vessel being closing olf. Application is by a simple squeezing operation at the handles of the applicator; while premaiurlec closing of the clip is prevented by a jaw-positioning Proceeding to a more detailed description of the applicator, attention is directed first to FIG. 1 wherein there is shown at 10 an applicator of suitable type, here illustrated as a set of forceps somewhat like a conventional temporary blood vessel hemostasis clamp, suited for manual operation to close a blood vessel. Such a clamp, when modified to serve as an applicator tool, is provided with contoured jaws 11 and 12 attached together through a suitable pivot point 13, or otherwise through multiple pivot points to provide a parallel-jaw operation. In either case, it is convenient to employ narrow jaws of stainless steel, or the like, extended from handles as at 14 and 15 by which the jaws are operated. Conventionally, in such clamps, jaws 11 and 12 are disposed at an offset angle to handles 14 and 15 in order to facilitate operation of the jaws adjacent to the side of an incision. Jaws 11 and 12 are shown illustratively of a shortened form of applicator.
Applicator 10 may be a hemostasis clamp of conventional type somewhat modified to exhibit channeled jaw surfaces 16 and 17, and may be slender and elongated to reach deep within an incision without occupying excessive space therein. As will be seen in FIG. 2, surface 16 has a. straight, flat-bottomed channel 21, nearly rectangular in section, running longitudinally from the tip of the jaw. Surface 17 on the opposing face is of the same construction. The opposing channels 21 and 22 are laterally parallel and have nearly coincident center lines when closed. The depth of each channel is the same as the thickness of the stock of hemostatic clip 20. Each channel is sufficiently wider than the hemostatic clip to permit longitudinal motion therein.
In FIG. 3 may be seen pin 19 rising perpendicularly from the bottom of groove 21 towards clearance hole 18 in opposing jaw 11. Hole 18 and pin 19' are preferably located on the lateral midlines of grooves 22, 21. Pin 19 acts as a locator stop for hemostatic clip 20' when it is inserted into the applicator jaws. It is positioned according to the dimensions of the hemostatic clip to be applied thereby so that the hooked end of portion 23 is safely back from the tip of jaw 11. The pin also acts as a firm stop behind hemostatic clip 20 when a vessel is brought into the hemostatic clip and pressed against the inner wall near clip bend 28, as seen in FIG. 5'.
In addition to the flat-bottomed grooves and the stop pin described above, the applicator, as adapted from a standard hemostasis clamp, differs in another important feature, more particularly shown in FIGS. 9 and 10. The jaws 11 and 12' correspond to jaws 11 and 12 of FIGS. 1 and 2, while handles '14 and 15 correspond to handles 14 and 15. While the form of the clamp differs considerably from that of FIG. 1, it illustrates an alternative type of clamp adaptable as a clip applicator in generally the same manner, but includes an additional feature serving to expedite the completion of blood vessel tie-oif, and avoiding certain difliculties which would otherwise arise.
One of the problems with U-shaped or V-shaped clips presently in use is that they frequently fall from the applying forceps before they can be applied to a vessel. The hemostatic clip described hereafter fits so tightly into opposing channels 21 and 22 that it cannot be dislodged during ordinary surgical procedure. However, if a nurse during loading, or a surgeon before clip application, should accidentally close the forceps jaws partially, the clip would then be partially closed and upon release of the accidental pressure, the clip would fall from the jaws. To prevent this, a position lock is added to a standard clamp. In this form of clamp a strong and rigid conventional arrangement includes a tongue portion 41 which is a broadened and somewhat thinned section of the handle 15' which is positioned within a slotted portion 42 of the handle 14. One of the handles may be provided with a return spring 43 tensioned to cause reopening of the jaws when they have been closed during use.
The open-jaw stop or position lock may be fitted to one of the handles, and consists of positioning member 44 mounted on the inside of the handle being fitted with hole 45 to receive screw 46 passing through member 44 to retain the same in rotatable position about the axis of the screw 46 mounted perpendicular to the handle. Handles 14 and 15' are appropriately cut away to receive the body of the positioning member between the handles when closed. However, a spacing land 47 is provided at one side of the member 44 having a suflicient height so that the handles can be closed only suficiently to grasp the open clip between jaws 11' and 12. Adjacent spacing land 47 there is a flush portion 48 which, when placed between the handles, permits their complete closing to clench the clip in the jaws '11 and 12. Preferably, screw 46 is provided with a spring washer 49' shaped to provide tension on the member 44 thereby to retain it either in the open or the closed position and thereby to make the spacing land 47 effective to prevent the premature closing of the jaws beyond a predetermined open-jaw spacing, or to permit the full closing of the jaws when the flush land 48 lies between the handles. Member 44, when in the closed position as at 51, provides a position lock against which considerable pressure can be applied as the surgeon grasps the clamp and prepares to apply the clip to a vessel, while the released position as shown at 52 is the position of member 44 when the hemostatic clip is to be closed on a vessel.
Clip 20 is preferably formed of a stainless steel such as the alloy known in the trade as 316 L, which is particularly suitable for the purpose since it is compatible with body processes. When made of such a material and suitably shaped without sharp or cutting edges, a foreign body of this type and configuration may be permanently retained within the flesh, or may be removed at the close of an operation. Such a clip constitutes a highly eflicient hemostasis device when used in conjunction with the above described applicators and is found to be effective in saving time and sometimes the life of a patient. Other materials may be substituted for alloy 316 L but these materials should be selected for compatibility with the body and must possess suitable characteristics of rigidity and bendability.
Preferably, the clip stock is of flattened metallic wire such as would be produced by taking a standard round wire of the selected alloy and passing it through pinch rollers to produce flattened surfaces on opposite sides, leaving rounded edges as at 38 and 39 of FIG. 6. Wire of flattened form is utilized to prevent any cutting through of the blood vessel when the jaws are firmly clamped together, and has desirably rounded edges as at 39, serving both to prevent any tendency to cut the vessel 30 or the surrounding tissue if left in place bearing against the flesh. The material from which the clip is made is preferably annealed so that the clip may be bent for closing and locking without appreciable elastic return. It may be formed of alloy wire drawn to a shape, as illustrated in FIG. 6 or FIG. 8, or may be round wire rolled flat in one dimension as in FIG. 6, or in perpendicular dimensions as in FIG. 8. In either case, it has a broad inner face and rounded edges.
Clip 20 is preformed to have a generally straight portion 23 extending throughout substantially half the length of a suitably precut strip. Portion 23 becomes the back of a clip resembling a safety pin of which the front closure member 24 is illustrated as bent about an arc comparable to the length of the straight portion 23. Thus closure portion 24 has one end which may be linearly extended into hook 26 as portion 24 becomes flattened to the form shown at 25 when the jaws are closed. While portion 24 is illustrated as arcuate, it may, of course, be of other shape such that its overall length, while bowed, is insufficient to reach from its junction with portion 23 to hook portion 26 at the opposite end of portion 23. Hook 26 is preferably formed by bending the strip about a suitable radius 27, for example, approximating the lateral dimension of the flattened wire. Closure member 24 is bent at the opposite end of back portion 23 about a radius 28, preferably approximating four times radius 27.
It will be noted that the clip has a reverse bend 29 near the hook such that the bend 26 of the hook portion is offset from the linear portion by an amount approximately double the thickness of the wire. This construction facilitates entry of the vessel 30 and, by turning the opening in hook 26 from a sidewise direction to more of an upward position, permits point 33 to descend into the hook more easily. Points 32 and 33 are brought into locked engagement wherein the clip portion 35 is clenched between hook portions 34 and 32. A clamping action resulting from closing jaws 11 and 12 causes closure of the clip and flattening of the bend in closure element 24 while leaving a portion 35 bent with respect to flat portion 25, portion 35 then being approximately parallel to the back leg 34 of the book. This construction assures a correct bending about points 27 and 28 and a straightening of element 24 as illustrated in FIG. 5.
In addition to faciliating closure, reverse bend 29 confers other distinct advantages. First, it increases the opening between hook end 32 and closure arm end 33 so that the surgeon may more easily introduce vessels into the inside of the hemostatic clip. Second, it is bend 29 which makes it possible for hook end 32 to close into a position in line with portion 25 (FIG. 5). This coplanar condition produces a closed hemostatic clip with no free ends to pierce surrounding tissue. Third, bend 29, in conjunction with the three layers of wire in the clench area (portion 35, and hook sides 34 and 32) preserves the size of the open space occupied by vessel 30. This assures that the opening between the parallel arms of the closed hemostatic clip (portion 23 and portion 25) is always the same, regardless of the amount of pressure used to close jaws 11 and 12. Because of this built-in safeguard, a surgeon cannot cut a vessel by closing the hemostatic clip too tightly, while permitting a complete clenching, and a more rapid hemostasis operation is facilitated.
Recapitulating, the clip may be described as having a straight back portion 23 which is connected at a first bend 24' to the front closure member 24, and which is connected at the reverse bend 29 to the hook 26. The length of the wire forming the front closure member 24 is greater than the straight line distance from the bend 24 to the outer end of the hook 26; yet, the outer end of the bowed closure member 24 is farther from the bend 24' than is the outer end of the hook 26. The presence of the reverse bend 29 causes one leg 34 of the hook 26 to lie on an opposite side of the longitudinal axis of the back portion 23 from the front closure member. The reverse bend is closer to the hook-forming bend 27 than to the bend 24; and, the outer leg 32 of the hook 26 is shorter than the leg 34 which extends immediately from the reverse bend.
While a preferred form of the hemostatic clip has a shape generally as at 20, including the reverse bend at 29, the latter may be omitted and the back portion left straight as at 31 in FIG. 7, but lacks the advantages of bend 29 noted above, but it can be made to function if it is properly proportioned. Closure arm 24 should be about ten percent longer than the length of back portion, exclusive of portion to be covered by the hook. The length of the hook may approximate one-quarter of the length of the upper arm. The hook and the upper arm must be bent on suitable radii so that, on closing, end 33 clears end 32, while appropriate clenching can still be accomplished.
The preferred form of hemostatic clip is applied in closing a blood vessel by placing back element 23 either in channel 16 or 17 resting against pin 19 with point 33 of the front portion resting in the opposite channel, there held under slight pressure such that clip 20 will not slide from channels 16 and 17 during placement of the jaws around vessel 30. Upon inserting vessel 30 within a clip placed on applicator jaws and adjacent to pin 19, member 44 may be rotated to the unlocked position and the jaws may then be closed by a quick grasping action on the handles whereby the jaws are forced together to close and lock the clip. During the clamping operation, portion .24 first bends primarily around center 28 until point 33 comes into contact with the clip back 23, or portion 34 beyond bend 29. Further closure of the jaws causes point 33 to advance along the slope 34 until it passes a position beneath point 32 or hook 26. Further pressure on jaws 11 and 12 causes increased bending to occur at the end 37 of the clip and a sharpending of the bend 36 around center 27 until point 32 engages portion 35 adjacent point 33 then in contact with portion 34. The clip is thus closed and firmly clenched. FIG. 4 illustrates an intermediate closure position wherein a blood vessel 30 placed in the jaws of an applicator as in FIG. 3 is partially closed oif, being shown fully closed in FIG. 5 wherein the clip is locked by closure of hook point 32 over end 35 of the closure element.
A clip formed as in FIG. 7 is closed and clenched in substantially the same way by causing bowed portion 24 to be flattened against back portion 23 with point 33 underlying point 32 of hook 26 as the clip is closed into its flattened condition to clench therein point 33.
By means of apparatus as illustrated a positive and easy application is made of a homostatic clip of minimum size requiring only a few seconds for each application. It will be appreciated that an improved method of closing blood vessels is achieved by the use of the applicator and clip, and that this method of hemostasis permits much more rapid tying off of blood vesels, with better security from slippage or accidental opening by virtue of the clenching operation inherent in the closing of hook 26 to clench and retain therein end 35 of the front closure member when straightened as at 25.
While the invention has been described with respect to particular embodiments, it is intended that the invention be not so limited but that it include all equivalents within the scope of the following claims.
What is claimed is:
1. A hemostatic clip formed from an elongated member, comprising a substantially straight back portion,
a bowed front closure member extending from one end of the back portion at a first bend, said front closure member having an outer end disposed transversely from the back portion,
a hook extending from another end of the back portion and terminating in an outer end of the elongated member, said hook having two legs interconnected by a second bend and located to form an open slot facing generally toward the front closure member,
6 and a third bend at the juncture of the hook and the end of the back portion to locate one leg of the hook on an opposite side of the longitudinal axis of the back portion from the front closure member.
2. A hemostatic clip according to claim 1 in which the leg of the hook which extends from the back portion is longer than the other leg of the hook.
3. A hemostatic clip according to claim 2 in which the first bend is closer to the third bend than to the outermost end of the bowed front closure member.
4. A hemostatic clip according to claim 3 in which the Zhirg bend is closer to the second bend than to the first 5. A hemostatic clip according to claim 2 in which the single elongated member is a fiat-sided wire having a uniform thickness.
6. A hemostatic clip according to claim 1 in which the first bend is closer to the third bend than to the outermost end of the bowed front closure member.
7. A hemostatic clip according to claim 6 in which the single elongated member is a flat-sided wire having a uniform thickness.
8. A hemostatic clip according to claim 6 in which the third bend is closer to the second bend than to the first bend.
9. A hemostatic clip according to claim 1 in which the single elongated member has a uniform thickness.
10. A hemostatic clip according to claim 9 in which the single elongated member is a fiat sided wire.
11. A hemostatic clip according to claim 1 in which the third bend is closer to the second bend than to the first bend.
12. A hemostatic clip according to claim 1 having the following characteristics:
(a) the elongated member is a flat wire of uniform thickness;
(b) the distance from the first bend to the free end of the hook is greater than the straight line distance from the first bend to the outer end of the front closure member and less than the length of the wire in the front closure member;
(c) the second bend is closer to the free end of the hook than to the third bend; and
(d) the third bend is closer to the second bend than to the first bend.
13. The method of hemostasis including the steps of placing a blood vessel between the back portion and the front closure member of the hemostatic clip described in claim 1, bending the clip to bring the front closure member toward the back portion until the outer end of the front closure member contacts the elongated member adjacent the third bend, bending a major portion of the bowed front closure member into parallelism with said back portion, and bringing the legs of the hook together to engage the outer end of the front closure member.
References Cited UNITED STATES PATENTS 3,270,745 9/1966 Wood 128325 3,120,230 2/1964 Skold 128325 2,598,901 6/1952 Garland 24--30.5
F. BARRY SHAY, Primary Examiner GREGORY E. MCNEILL, Assistant Examiner US. Cl. X.R.