Apparatus for ligating blood vessels, nerves and other anatomical structures

Apparatus for ligating blood vessels, nerves or other anatomical structures, such as Fallopian tubes, utilizing a modified form of a standard hemostat, including a removable pair of hemostat jaw inserts of non-toxic, substantially rigid material, each releasably secured to a jaw of the hemostat, each insert having removably formed therein at least one clip member, locking structure contained by at least one of the clip members adapted lockingly to engage the other of the clip members, whereby the jaws of the hemostat can be opened to any desired width and then closed, locking the clip members to form a ligating clip over or in a blood vessel or other anatomical structure and opening the jaws causes the joined clip members to break away from the inserts. A method of using said apparatus and process comprising the steps of removably locking the inserts on the jaws of a hemostat, opening the jaws to any desired width and placing the jaws on opposed sides of a blood vessel, nerve or other anatomical structure to be closed, closing the jaws, engaging the locking structure of the clip members on either side of the anatomical structure, opening the jaws to break away the clip members from said inserts and leaving the clip members in locking engagement on or in the blood vessel or other anatomical structure.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
The invention relates to surgical clips and hemostat constructions 
therefor, for the purposes of ligating (closing off) blood vessels, nerves 
or other anatomical structures during a surgical or other medical 
procedure on a human being or other animal. 
2. State of the Art 
The conventional method for ligating blood vessels or other anatomical 
structures utilizes the tying off, with a thread, of the blood vessels or 
other structures. Since a surgical procedure can be characterized as a 
struggle against bleeding, quickness and certainty are important for 
sealing off the cut end of a blood vessel. It is also always desirable to 
make any surgical procedure as brief as possible for the convenience of 
the patient and the economical use of the time of medical personnel and 
facilities. The string ligation technique is undesirable, because of the 
time which it takes, the requirement that two persons be involved in the 
ligation procedure and the sometime difficulty of access to remote 
anatomical locations for string ligating. 
Some surgeons have adopted the use of metal clips in lieu of such string 
ligation procedures. Metal clips of th type most commonly used currently 
are disclosed and illustrated in U.S. Pat. No. 3,363,628, and an 
applicator construction illustrating a method of application of such a 
metal clip is illustrated in U.S. Pat. No. 3,326,216. 
Other types of metal clip constructions are illustrated in U.S. Pat. Nos. 
3,270,745, 3,347,239, 3,867,944 and 3,439,522. Still other types of clips 
and applications therefor are illustrated in U.S. Pat. Nos. 3,954,108, 
3,882,854, 3,924,629 and 3,856,016. 
Although the commonly used metal clips comprise, in some respects, an 
advance over the prior art of ligation they do possess several substantial 
disadvantages. The metal clips are quite small, on the order of 3 mm. or 
more in length, and are difficult to handle. A primary disadvantage is the 
inconvenience of and time consumed in placing the clip in the applicator 
and placing the clip over the blodd vessel before closure. Also, metal 
clips occasionally drop into the surgical opening and may be difficult to 
locate and remove. 
One shortcoming of the prior art use of small metal clips may be understood 
by the analogy of attempting to thread a needle having a small eye. It is 
difficult to get the thread through the needle because of the size of the 
eye. Similarly, the U-shape of the surgial clips of the prior art and 
their extremely small size and opening makes it difficult to get the clip 
accurately placed in proper position over the blood vessel before closure. 
This difficulty means that the use of the clips of the prior art is 
relatively time-consuming and therefore undesirable because of the 
timportance of shortening the duration of surgery as much as possible. 
The instant invention, when compared to the prior art, may be analogized to 
the use of a needle with a large eye being threaded with the same piece of 
thread. The large eye facilitates the insertion of the thread 
therethrough. Similarly, the fastening of the inserts (sometimes also 
referred to as clip assembly members) to hemostat jaws provides a greater 
opening for movement with respect to the structure being ligated. 
An important advantage of this invention is that it reduces the ligation 
procedure from two steps to one step, since the placing of the hemostat 
over the blood vessel to close off flow in the blood vessel automatically 
closes and locks the clip members in place, so that when the hemostat is 
opened up and removed the clip is automatically left in place, avoiding 
the necessity of a second step to place a metal clip in place or to 
otherwise ligate the vessel. 
BRIEF SUMMARY OF THE INVENTION 
The invention is directed to a surgical clip construction comprised of two 
discreet clip members and inserts carrying each of said clip members, an 
applicator therefor, and a method of ligating blood vessels and other 
anatomical structures in human beings and other animals using the hemostat 
and clip construction of this invention. 
The applicator is desirably a modified form of the conventional types of 
hemostats, part of the jaws of which have been removed to accommodate the 
insert, so that the modified hemostat of this invention is used by the 
surgeon or surgical nurse in the smae manner as conventional hemostats are 
used for the purpose of closing a blood vessel or other anatomical 
structure. 
In one embodiment of the invention, the insert carrying a clip member is 
seated in a cut-out portion of the modified hemostat jaw, and in another 
embodiment of the invention the insert forms the distal end of the 
hemostat jaw. The insert is of such size and design as to be easily 
handled and readily and lockingly attached to the modified hemostat. 
Each insert has a break-away surgical clip member formed therein, and each 
of the two cooperating inserts of a single unit has, in face-to-face 
relation to the other, a surgical clip member formed therein or attached 
thereto. The surgical clip members are weakly connected to the inserts at 
one or more locations, where they are firmly held in place but can easily 
break away from the inserts. The clip members are provided with suitable 
locking means, such as male and female members, which may be located on 
one or both of the clip members to engage the opposite clip member to lock 
the clip members in place on either side of the blood vessel or other 
anatomical structure. 
Each insert and corresponding clip member is desirably injection molded as 
a single unit of a suitable substantially rigid, non-toxic, 
pharmaceutically acceptable polymeric material, chosen for proper 
characteristics of rigidity, resilence or snapability or other appropriate 
characteristic for locking of the male and female members, ease of 
separation at the breakaway points and ease and economy of fabrication. In 
an embodiment of the invention, the surgical clip members may be formed of 
a suitable material which will ultimately dissolve in the body after the 
structure has, for example, sealed itself closed. Several alternative 
embodiments of the invention are illustrated utilizing different types of 
locking means for locking the two clip members together. It is desirable 
that the plastic material of which the inserts and clip members are made 
be substantially rigid, in order to prevent any significant deformation of 
th clip when located in place, which could cause leakage, but is somewhat 
bendable to conform to the shape of the structure being closed. Depending 
on the locking construction used in any given clip embodiment, the clip 
plastic material must have sufficient resilience or "snapability", more 
fully described below, to provide an effective lock. 
In the method of the invention, the jaws of a modified form of hemostat 
including inserts having breakaway locking clip members are placed about a 
blood vessel, nerve or other anatomical structure to close the same and 
prevent fluid flow, if any, therethrough. The jaws of the hemostat are 
completely closed, locked in position if desired and then opened, thereby 
leaving a surgical clip locked in place by virtue of the closing and 
opening of the modified hemostat. 
OBJECTS OF THE INVENTION 
It is therefore an object of this invention to provide a safe and effective 
surgical clip construction which may be used quickly and easily. 
Yet another object of this invention is to provide a surgical clip 
construction which may be used with a modified form of conventional 
hemostat, where each clip member is part of a jaw insert of the hemostat, 
so that the jaws may be opened as wide as possible to locate the blood 
vessel or other anatomical structure with respect to the clip members, 
before the jaws of the hemostat are closed to lock the clip members in 
place. 
A further object of this invention is to provide a surgical hemostat and 
clip construction, whereby the jaws of the hemostat are modified to 
incorporate two inserts, each including a breakaway clip member, so that 
the hemostat may be applied to a freshly cut blood vessel, for example, 
and, when removed, leave a locked surgical clip in place. 
A still further object of this invention is to provide a surgical clip 
construction which is inexpensive, easy to use, and reduces the time 
necessary to occlude the blood vessel or other anatomical structure. 
Another object of this invention is to provide a surgical clip construction 
of a soluble polymeric or other material, which will dissolve after it has 
outlived its usefulness. 
Yet another object of this invention is to provide a surgical clip 
construction and modified form of hemostat which, in use, is virtually 
identical to the conventional form of hemostat, so that it is most 
convenient for use by the medical profession. 
Still another object of this invention is to provide a surgical clip 
construction which can easily, quickly, safely and effectively be inserted 
in the jaws of an applicator which resembles a conventional hemostat. 
An additional object of this invention is to provide a quick, easy and safe 
method for applying surgical clips to blood vessels, nerves and other 
anatomical structures.

DETAILED DESCRIPTION OF THE INVENTION 
Viewing FIG. 1, there is illustrated a modified hemostat in accordance with 
this invention and generally designated by the numeral 10. The hemostat 10 
is of a type which is generally well known in the art, is made of surgical 
steel or similar materials, and is comprised of handles 12 and 14, 
releasable locking members 16 and 18 and finger grips 20 and 22. The two 
handles are rotatably connected by pin 24 and terminate in jaws 26 and 28. 
Hemostats come in numerous sizes and shapes and, as more fully described 
below, the components of this invention can be adapted for application to 
any size or shape of hemostat. 
Hemostats modified in accordance with the principles of this invention may 
have a cut-out portion in each jaw adapted to seat a suitable insert, 
sometimes referred to as a clip assembly member, of which the clip member 
is a part. For example, viewing FIG. 2, hemostat jaw 26 has a cut-out 27 
defined by its upper surface at the distal end thereof, and also differs 
from a conventional hemostat by having apertures 34 and 38 extending 
through the jaw. The jaw 26 has a serrated upper surface 30. The purpose 
of the serrations is to permit the peaks of the serrations of one jaw to 
project into the valleys of the serrations of the opposing jaw and thereby 
provide a better locking grip on whatever is being grasped by the hemostat 
in the closed position. 
Seated in hemostat jaw 26 is jaw insert member 50. The insert 50, as best 
seen in FIGS. 2 and 3, is an elongated, generally rectangular member, 
terminating at its end in a rounded tip 62 and a sleeve member 64. Insert 
50 has a serrated upper surface 56, abutted on its two long edges by the 
somewhat recessed edge members 58 and 60. The serrations 56 on upper 
surface 54 of the insert may be of the same size, spacing and depth as the 
serrations 30 of the lower jaw 26, and are intended to function in the 
same manner as the serrations of a conventional hemostat. Insert 50 has a 
lower surface 52 which is seated in the cut-out 27 of the hemostat jaw 26. 
Protruding from and forming an integral part of insert 50 is a dart or 
locking member 80 which extends downwardly through aperture 34 in the 
hemostat jaw. Locking member 80 helps secure insert 50 to the jaw 26. The 
dart 80 comprises a shaft portion 82 and an enlarged head 84. In the 
illustrated embodiment the enlarged head 84 has a pyramidal shape, of 
square cross-section, although the shape of the head may vary as more 
fully described below. The maximum dimension of head 84 is greater than 
the maximum dimension of aperture 34. The "snapability" characteristic of 
the head 84 and aperture 34 is necessary in order to allow the head to 
enter and pass through aperture 34, after which head 84 expands and 
aperture 34 contracts to lock an end of insert 50 to the jaw 26. 
The end of insert 50 at the distal end of jaw 26 is locked to the jaw 26 by 
the sleeve 64, which overlies the distal end 42 of jaw 26, so that the 
distal end of the jaw 26 slides into the sleeve 64 and the distal end of 
the jaw 26 is securely held within the sleeve by a close fit, although a 
positive locking means may also be used, as illustrated in other 
embodiments of the invention. 
Forming part of the insert 50, and connected thereto only at the four 
corners 71a, 71b, 71c and 71d, by breakaway point contacts, is the clip 
member 70. In the embodiment illustrated, the clip member 70 is elongated 
and rectangular. Except for the four connections noted above, where the 
clip member 70 is attached to the insert 50, it is separated from the 
insert 50 by spaces 66 at its opposite sides and 68 at its opposite ends. 
The connecting portions 71a, 71b, 71c and 71d are very thin and rigid and 
may be point connections or thin, perforated or non-perforated webs, so 
that the clip member 70 will easily break away from insert 50 as more 
fully described below. 
As seen in FIGS. 4 and 6, clip member 70 is formed with an integral male 
member 74 at one end. Male member 74 has an upstanding shaft 76 of square 
cross-section terminating in an enlarged pyramidal head 78. At the other 
end of the clip member 70 is an aperture 72, positioned and adapted 
lockingly to be engaged by a corresponding shaft 96 and head 98 of male 
member 94 on the opposing clip member 71. 
Jaw 28 of hemostat 10 is similar to jaw 26, except that the cut-outs and 
apertures are opposed to the corresponding cut-outs and apertures on jaw 
26. Jaw 28 has serrated surfaces 32 and the serrations 56 of jaw insert 
90, which is seated on jaw 28, may correspond in size, shape and spacing 
to the serrations 32, in similar manner to the serrations on the jaw 26 
and insert 50. 
Jaw 28 has apertures 36 and 40 extending through it. The purpose of these 
apertures is the same as that of apertures 34 and 38 in jaw 26. Insert 90 
has a rounded tip 62 and a sleeve 64 which engage the distal end of jaw 28 
in the same manner as rounded tip 62 and sleeve 64 engage jaw 26, as seen 
in FIG. 2. 
Forming a part of insert 90 is a clip member 71 which is almost identical 
with clip 70, except for the placement of the respective male and female 
members 94 and 92. The male members 74 and 94 may, if desired be located 
at or near the ends of the clip members on which they are formed, but the 
apertures 72 and 92 must be spaced from the ends of the clip members. 
Insert 90 has a protruding male member 94 proximate the distal end of jaw 
28, in juxtaposition with the aperture 72 in clip member 70. Male member 
94 has a shaft 96 and enlarged head 98, which are of the same size and 
dimensions as the corresponding parts of male member 74. Clip member 71 
similarly has an aperture 92, of the same size and shape as aperture 72, 
and adapted lockingly to admit male member 74 to join one end of clip 
member 70 to the juxtaposed end of clip member 71. 
In operation, the foregoing embodiment of the invention functions as 
follows. The specially designed hemostat 10 is initially in the unloaded 
condition, so that its jaws 26 and 28 do not contain a set of inserts 50 
and 90, and the inserts would be first loaded onto the corresponding jaws. 
This step could be done manually or automatically, the inserts being taken 
from a suitable sterile container or package, where they may be packaged 
individually or in bulk, and loaded onto the sterile hemostat 10. 
The insert 50 and 90 may each desirably be at least about 10 mm. in length, 
and one reason for this length is to make the inserts of a size that can 
easily be handled manually, the end sleeves able to be placed quickly and 
easily over the respective jaws so that the distal ends of the hemostat 
jaws, respectively 42 and 44, engage in the corresponding sleeves 64 of 
the two inserts. 
After the distal ends of the jaws have been slid into their corresponding 
sleeves, the male members or darts 80 are pressed into the respective 
apertures 34 and 36, heads 84 of the male members thereby engaging and 
locking inserts 50 and 90, respectively, into jaws 26 and 28. The inserts 
50 and 90 are then securely fastened in place. 
In preparation for surgery, a nurse or nurse's aid can pre-load a large 
number of modified hemostats of this invention with inserts in accordance 
with this invention, so that no time is taken during the surgical 
procedure for loading the surgical clips into or on the hemostat. 
Although the inserts of this invention may be loaded manually onto or into 
the jaws of the modified hemostats of this invention, it is preferred that 
the loading be done by the use of a suitable magazine (not shown). The 
magazine would be loaded with one or more pairs of inserts in spaced 
opposition to each other and separated by a suitable rigid member which 
keeps the clip members from locking during the loading operation. The 
magazine could be formed with two opposed outer surfaces, each defining 
grooves to guide the hemostat jaws to the inserts. The hemostat jaws (in 
the embodiment of FIGS. 1 to 6, for example) would be inserted in the 
magazine grooves at an angle which corresponds to the angle of the 
magazine's loading faces, the distal ends of the jaws would be inserted in 
the corresponding jaw-engaging sleeves of the inserts and the male members 
of the inserts would be snapped into place in the corresponding apertures 
of the hemostat jaws. The hemostat would then be removed from the magazine 
with the inserts in place, ready for use. 
The magazines may be pre-packaged in sterile condition to ensure the 
sterility of the inserts and clip members in use. 
The hemostat is then placed in a suitable tray, readily accessible for use 
when needed. Whenever surgery is in progress, and, for example, blood 
vessels are being cut and must immediately be closed off to prevent 
bleeding, the surgical clips and hemostats of the invention are 
immediately ready. The surgeon, an assistant, or other medical 
professional who is closing off the blood vessels will take a suitable 
size and shape of hemostat, for example hemostat 10, and pinch the blood 
vessel between the portion of the jaws of the hemostat where clip members 
70 and 71 are located. The jaws of the hemostat can be opened to any 
desired width, thereby to facilitate the placement of the blood vessel 
between the opposing clip members 70 and 71. The handles 12 and 14 of the 
hemostat would then be closed, and locking members 16 and 18 would lock 
the hemostat in the closed position. In this situation, the unit is in the 
position illustrated in Figure 5, where the jaws 26 and 28 are closed, and 
the corresponding peaks and valleys of the teeth 30 and 32 of the jaws and 
teeth 56 of the inserts are seated adjacent to each other. Between the 
clip assembly members now joined the blood vessel or other anatomical 
structure being closed off is sealingly seated. 
When the respective male members 74 and 94 lock in their corresponding 
apertures 92 and 72, the heads 78 and 98 occupy, in part, the space 
created by the apertures 40 and 38 in the respective jaws of the hemostat. 
In this locked position, the hemostat may be allowed to remain in place 
for as long as desired. When it is desired to remove the hemostat, the 
locking members 16 and 18 are unlocked, in the normal and usual manner, 
and the handles 12 and 14 are separated. The force which keeps the two 
clip members locked together, by virtue of the engagement of male members 
74 and 94, and the force which keeps the inserts 50 and 90 fastened to the 
jaws, is greater than the force needed to separate the four corners 71a, 
71b, 71c and 71d which connect clip member 70 to insert 50 and the four 
similar corners connecting clip member 71 to insert 90, so that when the 
jaws 26 and 28 of the hemostat are closed and then opened, the clip 
members 70 and 71 break away from the inserts, allowing the hemostats to 
be removed, while leaving the surgical clip locked in place about the 
blood vessel or other anatomical structure. 
The heads 78 and 98 may be made sufficiently sharp and rigid to be able to 
pierce tissue. Therefore, the surgical clips of the invention can be used 
to pierce the structures to which they are applied, providing an even 
better ligation than otherwise could be the case. The clip could also be 
used to tie off areas of human tissue other than discrete tubular members 
or nerves such as a bleeding surface. 
It is notable that the process set forth above can be varied without 
departing from the spirit and scope of the invention. For example, inserts 
50 and 90 need not be inserted in the jaws of the hemostat prior to the 
surgical procedure; they can be inserted when needed. Furthermore, the 
hemostat can be removed immediately after the blood vessel is closed off 
and need not be left in place for any period of time after the clip 
members are locked in place. 
The inserts 50 and 90 and clip members 70 and 71 may be formed as a single, 
integral unit of one material for ease and economy of fabrication. The 
material must be substantially rigid to allow the male members to form a 
secure locking engagement of the two clip members and securely to hold 
closed any structure to which the clip members are applied. The clip 
members should be sufficiently bendable to be able to bend around and 
substantially conform to the blood vessel or other anatomical structure 
being ligated with the clip of this invention. 
The material fo the clip members must also possess the ability for heads of 
the male members 78 and 98 and their corresponding apertures 72 and 92 to 
deform when the heads enter the apertures, so that the enlarged portion of 
the head may pass through the smaller aperture to form a locking 
engagement. This characteristic is known in the art as "snapability" and 
is necessary when the type of locking construction shown in FIGS. 1 to 6, 
for example, is used. If, on the other hand, the locking arrangement of 
FIGS. 11 and 12 is used, snapability is not essential for the clip 
members; rather some resilience is required, so that the fingers 406 will 
initially bend out of the way during closure of the clip members and then 
lock in place as seen in Figure 12. 
The material of the clip members must also be nontoxic and capable of 
residing inside a human or other animal body, as the case may be, for 
prolonged periods of time without any deleterious effects. The material 
must also be susceptible to sterilization, such as by the use of ethylene 
oxide or steam. 
Although any number of polymeric materials, have the desirable 
characteristics, particularly desirable such materials are known by the 
trademarks "Delrin" and "Celcon," which are products of E.I. du Pont de 
Nemours & Company and Celanese Corporation, respectively, Both are acetal 
resin base polymeric resins of polyformaldehyde, "Delrin" being a 
homopolymer and "Celcon" being a copolymer. Among the properties which 
make "Delrin" desirable are: high mechanical strength and rigidity, 
excellent fatigue endurance, resistence to moisture and other solvents, 
excellent dimensional stability, ease of fabrication, resiliency, natural 
lubricity and a reasonably high melting point. Some specific values for 
the physical properties possessed by "Delrin" include: a tensile strength 
of 10,000 pounds per square inch (at 0.2 in./min. and at 73.degree. F.), a 
tensile secant modulus of 520,000 pounds per square inch (at 1% strain, 
0.2 in./min. and 73.degree. F.), a flexurol yield strength of 14,100 
pounds per square inch at 0.05 in./min. and 73.degree. F.), a compressive 
modulus of 670,000 pounds per square inch (at 0.05 in./min. and 73.degree. 
F.), a compressive stress of 5,200 pounds per square inch at 1% def. and 
18,000 pounds per square inch at 10% def. (both at 0.05 in./min. and 
73.degree. F.), a shear strength of 9,500 pounds per square inch (at 
73.degree. F.), a coefficient of linear thermal expansion of 0.000055 
inches per inch per degree Fahrenheit, a specific grauity of 1.4 and a 
melting point of 347 degrees Fahrenheit. Furthermore, these resins are 
particularly suited to injection molding with either plunger or screw type 
molding machines although the screw injection machine is preferred. The 
properties of these resins make possible snap and press-filting assembly 
techniques, thereby providing a simple, economical, and rapid means of 
assembling members of these resins to other plastic materials or metals. 
In addition, "Delrin" has been fed to rats for 91 days at a dietary level 
of 25 percent and no significant differences between control and test rats 
in body weight, food consumption, food efficiency or clinical history 
resulted therefrom. Moreover, hematological and pathological studies 
disclosed no changes attributable to the feeding of such resin. 
It may be desirable to form the insert of one material and the clip member 
of another material. For example, it may be desired to form the inserts of 
plastic and the clip members of metal and to fasten them together in 
breakaway fashion by the use of an adhesive. The metal may be formed with 
suitable locking means to provide a proper closure of the clip members. In 
addition, the various components of the clip members, such as the male 
members' heads, may be formed of different materials from the other 
components. However, for economy and ease of fabrication, one plastic 
material is preferred. 
If desired, a radioopaque material can be incorporated in or applied to the 
polymer from which the clip members are fabricated, so that the clips may 
be seen on an X-ray. 
FIG. 22 shows an embodiment of the clip members similar to those in FIGS. 1 
through 6. The clip member 1170 has in this instance an upstanding shaft 
that is comprised of two sections 1176 and 1175 as opposed to the single 
shaft 76 of clip member 70 as illustrated in FIGS. 4 and 6. Clip member 
1171 also has a dual section upstanding male shaft 1195 and 1196. The 
purpose of these dual shafts is to prevent the inner nonplanar surface of 
clip member 1170 from touching the inner nonplanar surface of clip member 
1171 thereby creating a space 1175 between the two interlocked clip 
members. In actual operation male head 1178 of clip member 1170 
deformingly enters and lockingly passes through female aperture 1192 of 
clip member 1171. The passage of male shaft 1176 through said aperture is 
stopped when the upper surface 1177 of the larger lower section of the 
upstanding male member 1175 reaches aperture 1192. Similarly, male member 
1194 has a male shaft comprised of two sections 1196 and 1195 of differing 
sizes. When male head 1198 deformingly enters and passes through aperture 
1172 of clip member 1170 its passage is stopped, after it has passed 
therethrough and lockingly engaged clip member 1170, by surface 1197 of 
the larger section of male shaft 1195. Thus surfaces 1197 and 1177 prevent 
the nonplanar surfaces of the two clip members 1170 and 1171 from coming 
together, thereby creating space 1175. This clip member embodiment is 
especially useful in that it will cause only minimal trauma to the 
anatomical structure being occuluded. 
FIGS. 7 and 8 show another embodiment of the insert and clip member 
construction of the invention. The clip members of FIGS. 7 and 9 are 
similar to those of FIGS. 1 to 6. The heads 78' and 98' of the clip 
members 70' and 71' are conical, rather than pyramidal as shown in FIGS. 1 
to 6, and their mating female apertures 72' and 92' are therefore circular 
in cross-section. Each of the hemostat jaws, respectively designated 26' 
and 28', has a dart-like aperture, respectively designed 102 and 104, 
formed in its outer surface near its distal end. 
The tip engaging members 64' are pointed at their ends 62', as seen in FIG. 
8, and each terminates in an inwardly extending elongated dart-like member 
106, which engages into aperture 102 or 104, as the case may be, to 
facilitate the locking in place of the respective inserts. In the 
embodiment of FIGS. 7 and 8, the locking members 80' and the corresponding 
apertures 34' and 36' in jaws 26' and 28' are shown as located close to 
the distal end of the jaws, in order to provide greater restraint 
proximate to clip members 70' and 71', although their precise location is 
a matter of choice. 
As best seen in FIG. 8, each clip member is fastened to its insert at only 
three points, namely, points 71a', 71b' and 71e', in a manner similar to 
that illustrated in FIG. 3, but with a triangular space 68' at one end 
rather than the rectangular space 68 of FIG. 3. At the distal end of the 
jaw, the clip member 70' is fastened to the tip engaging member 64' at the 
point 71e, so that the clip member is fastened to the insert at only three 
points, thereby facilitating its breaking away from the insert. Also, 
because the darts 80' are closer to the clip members 70' and 71' and the 
tip engaging collar 64' is anchored with dart-like members 106, there is a 
greater support of the clip members, facilitating the breakaway of the 
clip members 70' and 71' after the clip members have been locked together 
by the closing of the hemostat jaws and their subsequent opening. In all 
other respects clip members 70' and 71' and inserts 50' and 90' function 
in the manner described with respect to the embodiment of FIGS. 1 to 6. 
In the embodiment of FIGS. 7 and 8, it may be desired to form tip engaging 
member 64' as a sleeve, in the manner illustrated in FIGS. 2 and 5, to 
avoid the possibility of losing the tip engaging member when the clip 
members 70' and 71' break away from inserts 50' and 90'. 
It may also be desirable to form insert 50' with upper surface 54' and 
serrations 56' in a manner similar to surface 54 and serrations 56 of FIG. 
2 through 6 wherein clip members 70' and 71' would be surrounded by 
surface 56' but separated from said surface by spaces 66' similar to 
spaces 66 of FIG. 3. 
Illustrated in FIG. 9 is another modification of the insert of the 
invention, substantially the same as that of FIGS. 1 to 6, but adapted for 
use on a hemostat having curved jaws. In this instance, the only 
difference is that the hemostat jaws 26" and 28" (not shown) are curved, 
the corresponding cut-outs 52" (not shown) in the jaws to accommodate the 
inserts 50" would be curved, and the inserts 50" themselves could also be 
curved. The clip members 70" and 71" (not shown) could remain linear, as 
in FIGS. 7 and 8, or curved as in FIG. 9. The insert 50" of FIG. 9 could, 
if desired, be substantially identical to the insert of FIG. 3, as 
illustrated, or of any of the other embodiments. 
FIG. 10 shows schematically another embodiment of the hemostat of the 
invention, of a type further illustrated in FIGS. 20 and 21. The hemostat 
of FIG. 10 has shortened, flat-ended jaws 26"' and 28"', and the inserts 
210 and 212 form the distal end of the jaws. In this embodiment, the metal 
jaw portions 26"' and 28"' are formed with suitable non-circular 
cross-section male members, respectively designated 206 and 208, and the 
inserts 210 and 212 are formed with corresponding mating apertures 214 and 
216, so that the male members tightly and securely fit in the apertures. 
Male members 206 and 208 respectivley, which are of non-circular 
cross-section, lockingly seat in the corresponding apertures 214 and 216 
in the inserts 210 and 212. Male members 206 and 208 and apertures 214 and 
216 may, if desired, be formed with "snap-in" locking means to provide a 
more secure engagement of the jaws and inserts. The inserts 210 and 212 
are shown schematically in FIG. 10 and the clip members and other details 
are not illustrated therein. However, the clip members incorporated in 
inserts 210 or 212 of FIG. 10 could be any of the embodiments illustrated 
herein or any other clip construction within the purview of this 
invention. 
In FIGS. 20 and 21 there is illustrated an embodiment of the invention, 
similar to that of FIG. 10, wherein the hemostat jaws 26"" and 28"" are 
cut short and the inserts 310 and 312 form the distal ends of the jaws 
26"" and 28"". The hemostat jaws of this embodiment are formed with 
respective noncircular cross-section apertures 314 and 316 and male 
members 306 and 308 of the inserts 310 and 312 to seat in those apertures 
to secure removably the inserts to the hemostat jaws. In this embodiment 
of the invention, insertion and removal of the inserts 310 and 312 into 
the modified hemostat are particularly simple. A tight fit of male members 
306 and 308 in apertures 314 and 316 may be facilitated by tapering the 
male members and apertures slightly. This tapering would also make the 
inserts easier to apply to the jaws. The male members 306 and 308 may also 
be formed with "snap-in" enlargements (not shown) to engage suitable 
enlargement (not shown) at the inner ends of apertures 314 and 316 to 
provide a positive locking connection. 
In the embodiment illustrated in FIGS. 20 and 21, the clip members 370 and 
371 are similar to the ones illustrated in FIGS. 3, 5 and 6. However, 
because there are no jaws of the hemostat extending in the area of the 
clip member, there is no need for male members and sleeves to lock the 
inserts to the hemostat jaws, since this function is done by the members 
306 and 308. Therefore, in the embodiment of FIG. 21, the inserts are 
simpler than in the embodiment of FIGS. 1 to 6. The respective clip 
members 370 and 371 are formed in inserts 310 and 312 and are attached 
thereto, in breakaway fashion in four corners, similar to the manner 
illustrated in FIG. 3, for example. The clip member construction per se is 
otherwise identical to that illustrated in FIGS. 3, 5 and 6 with cut-out 
portions 338 and 340 formed in the inserts 310 and 312, respectively, to 
permit the heads 378 and 398 of male members 374 and 394 to pass through 
corresponding apertures 392 and 372 to seat in the locked position. 
The clip members 370 and 371 are attached to the inserts 310 and 312 only 
at three or four corners, by thin perforated or non-perforated webs (not 
shown), so that they will break away from the inserts when the clip 
members are locked and the jaws opened. A small space, respectively 302 
and 304, is present in each insert, to illustrate that the insert is not 
attached to, but is spaced from, the back of its clip member. 
Once the inserts 310 and 312 have been secured to the hemostat jaws 26"" 
and 28"", the invention is used in the manner described with respect to 
the embodiment of FIGS. 1 to 6. 
Viewing FIGS. 11 and 12, there is illustrated another embodiment of the 
surgical clip of the invention which uses two upstanding fingers 406 to 
lock the two clip members 402 and 404 in place. The surgical clip 400 
comprises the two clip members 402 and 404. Clip member 402 is formed with 
a pair of integral, upstanding fingers 406, one at each end. Each finger 
406 comprises an upstanding portion 408 and an end portion 410, each end 
portion 410 having lip portion 412, which is adapted to overlie and engage 
the underlying upper clip member 404. 
The lip 412 is triangular and tapers inwardly and downwardly, so that as 
the upper clip segment 404 is lowered, its sides 422 force the fingers 406 
outwardly until the upep clip member is in place, in the locking position 
illustrated in FIG. 12, at which time the resilience of fingers 406 causes 
them to spring inwardly so that lips 412 overlie top 420 of segment 404, 
and lips 412 lock the two clip members 402 and 404 in fastened position. 
The clip members 402 and 404 have respective serrated inner surfaces 416 
and 418 and the serrations may be staggered so that the peaks of the 
serrations 416 are opposite to the valleys of the serrations 418 to ensure 
a tight closure of a blood vessel or other anatomical structure by the 
clip. 
The clip 400 is desirably utilized as part of an insert (not shown), such 
as, for example, the insert illustrated in FIGS. 1 to 6. In that instance, 
the clip members 402 and 404 would each be an integral part of an insert, 
for example units 50 and 90 of FIG. 2, and would be fastened thereto, in 
break-away manner, by connections at, for example, four corners. The 
closure of clip members 402 and 404 by fingers 406 would be sufficiently 
strong that, when the jaws of the hemostat to which the inserts are 
fastened are being pulled apart, the clip members 402 and 404 would break 
away from the respective inserts. The hemostat, in the case of the 
embodiment of FIG. 2, or the insert, if the clip construction 400 is used 
in the embodiment illustrated in FIGS. 20 and 21, for example, would 
contain a suitable recess in the upper jaw or insert, as the case may be, 
to allow for the seating of the ends 410 of the fingers 406. 
It is not necessary that both fingers 406 be located on the lower clip 
member 402. Rather, they could both be located on the upper clip member 
404. Depending upon what type of closure construction is desired, suitable 
space will have to be provided in the opposing hemostat or insert to allow 
the ends of the fingers 406 to be seated. It may also be desired to 
incorporate one or more additional fingers 406 on one or both of the clip 
members intermediate thei ends to prevent lateral motion of the clip. 
FIG. 23 illustrates another embodiment of the surgical clip substantially 
similar to the surgical clip generally designated 400 as shown in FIGS. 11 
and 12. In this embodiment, however, the serrated surfaces 416' and 418' 
cannot touch. The serrations of these surfaces are such that peaks on one 
surface are juxtaposed to valleys on the other. Thus space labeled 417' is 
created and appears as a zig-zag opening. In operation clip members 402' 
and 404' perform in a manner similar to the operation of clip members 402 
and 404 of FIG. 12 except that the two upstanding fingers 406' at each end 
of clip member 402' have a wide portion at each end designated 405' and 
407' and a narrow portion 408'. This difference in size creates a 
shelf-like surface designated 419' and 421'. When clip member 404' is 
lowered it forces fingers 406' outward due to the triangular shape of lips 
410'. Clip member 404' passes under said lips and the resilient fingers 
406' move inwardly such that lips 412' lock the two clip members together. 
The height of portions 405' and 407' prevent clip 404' from continuing 
downward. Clip member 404' comes to rest on surfaces 419' and 421'. In 
practice the surgical clip illustrated in FIG. 23 will not apply as much 
pressure to the lumen of the occluded vessel. It is therefore useful in 
procedures where a minimum amount of trauma is desirable. 
FIG. 13 illustrates yet another embodiment of surgical clip, generally 
designated by numeral 500, and including lower clip member 502 and upper 
clip member 504. As described more fully with respect to the embodiment of 
FIGS. 11 and 12, this clip would be part of a suitable insert, in the 
manner illustrated in FIGS. 1 to 6 or FIGS. 20 and 21, for example, and 
would be attached to the insert in a breakaway manner. In the embodiment 
of FIG. 13, each of the clip members 502 and 504 is seen to include a male 
member, respectively 506 and 508, each of which includes a vertical shaft 
510 and head 512. The diameter of the heads 512 is somewhat larger than 
the diameter of the circular apertures, respectively designated 514 and 
516, in the opposing clip members. In the illustrated embodiment, the 
heads 512 are conical. 
In the embodiment illustrated in FIG. 13, the clip member 502 has a 
relatively narrow portion 520 and a somewhat circular, enlarged portion 
522. Upper clip member 504 similarly has a relatively narrow portion 524 
and an enlarged portion 526. The reason for having relatively narrow 
sections 520 and 524 is to provide as small and compact a clip as 
possible, whereas the enlarged portions 522 and 526 are necessary to 
provide requisite strength surrounding the aperture to be engaged by the 
opposing locking heat to ensure a firm lock. 
FIG. 14 illustrates yet another embodiment of the clip of this invention, 
again intended to be utilized as part of an insert to be attached to a 
hemostat in the manner illustrated in FIGS. 1 to 6 or FIGS. 20 and 21. In 
the embodiment of FIG. 14, clip 600 comprises clip members 602 and 604, 
each of which is provided with a male member, respectively designated 606 
and 608, and an opposing female aperture, respectively designed 616 and 
622. The apertures are seen to be square in cross-section, rather than 
circular, as illustrated, for example, in FIG. 13. The male members 606 
and 608 therefore have correspondingly shaped truncated-pyramidal head 
members 612, adapted to seat lockingly in the opposing apertures 616 and 
622 of the mating clip members. 
Rather than the pointed peaks and valleys of serrations, the serrations 
illustrated have flattened peaks and valleys 620 and 618. In the 
illustrated embodiment, a square head and flattened peaks and valleys may 
be desired because they reduce the prospect that a small piece of plastic 
would break off and become lodged in the patient's body and are easier to 
fabricate. Rounded peaks and valleys are also desirable because they would 
minimize tissue damage. 
Surgical clips similar to those illustrated in FIGS. 4, 5, 6 and 11 and 14 
were illustrated in FIGS. 22 and 23. The essential modification 
illustrated in FIGS. 22 and 23 was the incorporation of a feature whereby 
the two clip members could be lockingly joined together while retaining 
some physical space between their respective serrations thereby minimizing 
the trauma that the tighter fitting clips would produce. It is within the 
scope of this invention that all of the surgical clips presented herein 
could incorporate this feature. The purpose of FIGS. 22 and 23 was merely 
to illustrate its application to two of the surgical clips of this 
invention. 
The embodiment of the invention illustrated in FIGS. 15 and 16 is 
substantially identical to that of FIGS. 7 and 8, except for the means 
utilized to fasten the inserts to the respective distal ends of the 
hemostat jaws 726 and 728. This embodiment illustrates another 
construction of the clip members or inserts to provide a secure and easy 
fastening of the inserts to the hemostat jaws. In the illustrated 
embodiment, each of clip members 770 and 771 is fastened at one end at two 
points to the corresponding inserts and is fastened at one point at its 
other end to the overhanging locking member 702, which extends through a 
cutout 704 in the tip of the respective jaw 726 or 728, as the case may 
be, releasably and lockingly engaging the respective upper and lower 
surfaces, as the case may be, of the jaws 726 and 728. 
FIGS. 17, 18 and 19 illustrate yet another embodiment of the insert, 
similar to those illustrated in FIGS. 2, 3, 5, 7, 8, and 15 and 16, but 
providing a construction for fastening each insert to the tip of its 
corresponding hemostat jaw, respectively designated 826 and 828. In the 
embodiment of FIGS. 17, 18 and 19, each of the inserts has attached 
thereto, at one end, a pair of arrow-like pins 802 of circular 
cross-section with conical tips. The clip members 870 and 871 are fastened 
to the isnert in breakaway fashion by connecting portions 871a, 871b, 871c 
and 871d. The connecting portions 871a, 871b, 871c and 871d are similar to 
connecting portions 71a, 71b, 71c and 71d where clip member 70 is attached 
to insert 50 as in FIG. 3. The tip of the hemostat, as illustrated in FIG. 
19, is formed with a pair of grooves 808 and 810, in which the bodies 804 
of the pins 802 are seated, so that the pins snap in and lock the insert 
in place by virtue of the head 806 of the respective pins. In the 
drawings, two pins and grooves are illustrated for each insert, although 
more or fewer pins and grooves could desirably be utilized. 
FIG. 24 illustrates yet another embodiment of the insert or clip assembly 
member of this invention. It functions in a manner similar to that 
presented in FIGS. 2 through 8 except that a plurality of clip members 970 
are attached thereto rather than a single clip member 70. In practice clip 
members 970 will lockingly engage clip members 971 (not shown) when the 
hemostat jaws on which said inserts carrying said clip members are closed. 
In FIG. 24 the male members 978 have conical heads and shafts of 
cylindrical cross-section. Female apertures 972 are therefore accordingly 
circular also. The distance between adjacent clip members 973 is a matter 
of choice depending on the desired use. When the jaws of the hemostat 
containing said clip members are lockingly engaged and then removed, the 
clip members 970 will break away from clip assembly members illustrated in 
FIG. 24. If it is desired to have a line of clips with a large space 
between each clip, then space 973 would be large. If, on the other hand, 
it is desired that the line of clips be very close together, then space 
973 can be made as small as desired. Space 973 could be reduced to zero in 
which case breakaway points 971a and 971b of the front clip member would 
also serve as breakaway points 971c' and 971d' for the second clip member 
970 and so forth down the line. 
In practice a surgeon would close the jaws of the hemostat having attached 
thereto inserts of the kind illustrated in FIG. 24. This closing would 
then create a line of occluding clips. The surgeon could then repeat the 
procedure parallel to the first line and produce a second series of clips, 
allowing him to sever the anatomical structure therebetween with only a 
minimal amount of leakage therefrom. 
FIG. 25 illustrates another embodiment of the insert of this invention 
which is similar to that illustrated in FIG. 24; however, instead of a 
single row of clip members attached to the insert there are two parallel 
rows of clip members attached to the insert. When the two jaws of a 
hemostat each containing an insert similar to that illustrated in FIG. 25 
are closed about an anatomical structure, the two rows of clip members on 
each hemostat jaw will lockingly interengage and the opening of said 
hemostat jaws will cause two rows of surgical clips to be engaged about 
said anatomical structure. The proximity of the clip member 1070 to each 
other could be varied by varying spaces 1073 as described for the insert 
represented in FIG. 24. Furthermore, the distance between the adjacent 
rows could also be varied by varying space 1077. Clip members 1070 and 
1070' could be moved close enough together so that the vacant space 1066 
adjacent to space 1077 and vacant space 1066' also adjacent to space 1077 
would coincide. Then the breakaway points 1071a and 1071d of clip member 
1070 would then coincide with breakaway points 1071c' and 1071b' of clip 
1070'. 
It will be appreciated that the dimensions of the clip can be varied 
considerably to accommodate the particular application for which the clip 
is used. For example, blood vessels for which the clip could be used come 
in greatly varying sizes, and the clip would desirably be produced in a 
number of different sizes and shapes (for example, they could be curved or 
straight), for use with different sizes and shapes of hemostats, to 
accommodate to particular purposes for which the clip is being used. The 
particular sizes and shapes of clips can be varied within broad ranges and 
will be readily apparent to the skilled artisan. For example, if the clip 
is to be used for tubal ligation, its dimensions would be substantially 
greater than would be the case if it were used to tie off small blood 
vesesls in the brain or in pediatric surgery or to approximate fascia or 
to mark areas of neoplasia. In addition, the clip members could be formed 
with different types of inner faces than the serrations illustrated since 
many different face designs are known in the art. 
In a clip utilized to tie off small blood vessels, the length of the clip 
member would be about 3 mm. or more, the maximum length depending on its 
purpose. Its width would be about 0.5 mm. or more. 
In the embodiments of the invention, the surgical clip members of the 
invention have been illustrated as part of an insert which is part of a 
modified hemostat mechanism and this composition is, indeed, the preferred 
method of application of the clip formed by the joined clip members of the 
invention. It is, however, within the purview of the invention that the 
clip members be formed in individual unites, without the use of inserts or 
the modified hemostate mechanisms illustrated and applied by the use of 
hemostats alone with manual insertion in the hemostats. This method would 
be cumbersome and is not, however, the preferred form of the invention. 
In the practice of the process of the invention, a modified hemostat is 
most desirably utilized. The modified hemostat may be of the type 
illustrated in FIGS. 1 to 6, for example, where the metal hemostat jaws 
extend to the ends of the insert, or the type illustrated in FIGS. 20 and 
21, for example, where the inserts are firmly fastened to shortened 
hemostat jaws and in fact form an extension of the hemostat jaws. The 
inserts are fastened to the respective hemostat jaws, desirably in advance 
of any surgical procedure, and a series of loaded hemostats of various 
sizes and shapes of inserts, as needed, are located in a suitable 
accessible location in the operating room. 
When a surgical procedure has progressed to the point where the surgical 
clip is required to ligate a blood vessel or other anatomical structure, 
such as a Fallopian tube, the surgeon or other medical professional would 
grasp the applicable size and shape of hemostat, with the inserts already 
in place, and place the open jaws of the hemostat so that the clip members 
of the insert are on opposite sides of the anatomical structure to be 
ligated. The handles of the hemostat would then be closed to lock the jaws 
of the hemostat closed by the engagement of conventional locking members, 
and the blood vessel or other tubular structure is then closed. If it is 
desired initially to leave the hemostat in place until a later time, the 
hemostat can be left in place with the jaws of the hemostat locked over 
the closed anatomical structure, to be removed at a later time. 
When it is desired to remove the hemostat (which may be immediately after 
the jaws are closed) leaving a locked clip in place, the handles of the 
hemostat are moved to unlock the handle locking members and the handles 
are then separated to separate the jaws of the hemostat. When the hemostat 
jaws are initally closed, the respective male locking members entered or 
engaged the corresponding female locking members to lock the clip members 
to each other with the anatomical structure securely ligated therebetween. 
When the jaws of the hemostat are opened, the force necessary to separate 
the locked clip members or to separate the inserts from the jaws is 
stronger than the force necessary to break the breakaway portions which 
hold the clip members to the inserts. Accordingly, when the jaws are 
opened, the joined clip members breakaway from their corresponding 
inserts, and there remains in place a closed, locked properly positioned 
surgical clip securely ligating the anatomical structure. The inserts are 
then manually removed from the modified hemostat. 
As has been noted, it may be desired to apply the clip so that the male 
locking members thereof actually pierce the tissue of the structure being 
occluded to ensure a better fastening of the clip on the anatomical 
structure and to prevent sliding of the clip along the longitudinal axis 
of the anatomical structure. 
The embodiments of this invention have been presented with each clip 
assembly member or insert having only a single clip member attached 
thereto; however this presentation has been used for the simplicity that 
it achieves in the detailed explanations of the embodiments of this 
invention. It is contemplated and within the perview of this patent that 
each clip assembly member or insert could contain more than one clip 
member as illustrated in FIGS. 24 and 25. For example, the clip assembly 
member illustrated in FIGS. 20 and 21 could contain a plurality of clip 
members as shown in FIGS. 24 and 25. The advantages of multiple clip 
member inserts is obvious. It is therefore contemplated that such multiple 
clip assembly members are within the scope of this patent. 
Although the invention has been described with respect to use with humans, 
it will be appreciated that the invention can also be used for performing 
surgical procedures in other animals. 
The particular materials from which the clip and insert are formed are a 
matter of choice, so long as they are reasonably economical to fabricate, 
are safe and effective and possess the desired characteristics to allow 
the two clip members to lock in place satisfactorily and to ligate the 
anatomical structure closed. 
It may be desired to form the hemostat and insert as a single unit of 
plastic material, which may be discarded in its entirety after the 
surgical clip has been locked in place and it is within the purview of 
this invention to do so. In that event, the inserts would not have to be 
separately handled and placed in locked positions in the hemostat jaws. 
If the surgical clip is to dissolve in the body fluids, after a period of 
residence in vivo, it may be fabricated of a material which is slowly 
absorbable in the body fluids, such as collagen, gelatin, albumin, dried 
blood or synthetic soluble materials. In that event, it might be desired 
to fabricate the clip and insert of different materials and fasten the 
clip members in the inserts by the use of small amounts of properly placed 
adhesives, which will release upon the opening forces of the hemostat 
jaws. 
Although the jaws, clips and inserts are illustrated as having serrated 
inner surfaces, it is within the scope of this invention for those 
surfaces to be planar or to have other linear or non-linear configurations 
than the serrations illustrated, so long as the blood vessel or other 
anatomical structure is sufficiently firmly held between the clip members. 
In applying the surgical clips of this invention, it is preferable to use 
applicators which closely resemble conventional types of hemostats. 
However, other shapes and types of applicators may be used, if desired, 
without departing from the scope of this invention. 
The clip members of this invention could be used for purposes other than 
ligating anatomical structures. For example, radioopaque clip members 
could be used to approximate fascia, mark areas of neoplasia or otherwise 
tag or mark areas of tissue not readily accessible by other means. 
There are disclosed herein the preferred embodiments of the invention, 
although it will be appreciated that the particular shapes, dimensions, 
materials and similar characteristics of the invention may be varied 
without parting from the spirit and scope of this invention.