Disposable linear surgical stapler

A disposable linear surgical stapler includes a handle, anvil, staple cartridge and flexible shaft attaching the handle to the cartridge and transmitting a firing force exerted at the handle to the distant cartridge for sequentially implanting, forming and clinching staples in two staggered staple lines. A flexible cable in the flexible shaft pulls a firing wedge across a plurality of staple drivers in the cartridge. The anvil is adjustable to vary the gap between the anvil and staple cartridge.

This invention relates to a disposable linear surgical stapler, and more 
particularly to an improved linear surgical stapler for implanting staples 
into tissue. 
In recent years, an important medical trend has been the substitution of 
staples for conventional sutures in surgical procedures. Such staplers 
have simplified many procedures which were difficult to accomplish 
manually. Also, the use of surgical staplers has significantly reduced the 
time required for many procedures and thus reduced the time required for 
maintaining a patient under anesthetic. 
Linear surgical staplers for implanting a row of staples have been in use 
for some time. One early linear stapler, such as that shown in U.S. Pat. 
No. 3,080,564, included a permanent, rigid shaft, multi-use device wherein 
staples were manually loaded one-by-one. While such staplers performed 
well in a multiplicity of uses, they were complex in construction, 
expensive to manufacture, heavy, bulky, and difficult to load with 
staples. They also required continuous maintenance, cleaning and 
sterilizing after each use. 
Improvements to such staplers included improved reloading features such as 
those shown in U.S. Pat. Nos. 3,275,211 and 3,589,589. These improvements 
included the use of presterilized, disposable loading units or staple 
cartridges. While these improvements significantly reduced the time 
previously required for hand-loading of the staples, the basic instrument 
still had to be disassembled, cleaned, reassembled, and sterilized for 
each procedure. These staplers also required frequent maintenance and 
adjustment. 
Recently, rising hospital costs have generated an increasing interest in 
disposable surgical staplers. Disposable staplers are designed to 
eliminate as much work as possible (i.e., disassembly, cleaning, 
reassembly, sterilization, maintenance and adjustments), while not 
compromising surgical procedures, and improving overall efficiency. 
One such disposable stapler is shown in U.S. Pat. No. 4,383,634, for 
example. These staplers generally perform well. However, since the 
forward-most anvil-carrying jaw is pivoted, the anvil and cartridge may 
not approach each other in parallel relationship, making only a single gap 
setting achievable. Stated in another way, since the anvil and cartridge 
are pivoted at one end, there is only one position in which they are 
parallel to each other as they are pivoted. This permits only one gap 
setting for tissue as any other would produce a varying gap along the 
staple line due to a diverging orientation of the anvil and cartridge. 
This in turn would result in staples having formed legs of varying length 
along the suture line. 
To provide disposable staplers having differing gaps, manufacturers have 
simply supplied different staplers. Such staplers are frequently provided 
in a "tight" suturing version with short legged staples, and a "loose" 
suturing version, with staples having longer legs. The surgeon selects the 
appropriate stapler for the particular procedure in process. 
These aforementioned staplers have another difficulty inherently residing 
in their own rigid structures. While useful in many applications, it is 
often difficult to orient the stapler so as to implant a line of staples 
in exactly the right direction. Also, in some instances, it may be 
difficult to even apply the stapler to the tissue to be stapled in view of 
the tissue lying in limited access areas where it is difficult to place or 
maneuver the entire stapler. 
Accordingly, it has been one objective of this invention to provide an 
improved disposable linear surgical stapler, overcoming these difficulties 
previously associated with disposable staplers. 
A further objective of the invention has been to provide an improved 
disposable linear surgical stapler providing a plurality of tissue gap 
settings over which a plurality of single size staples can be properly 
implanted and formed. 
A further objective of the invention has been to provide an improved 
disposable linear surgical stapler useful in limited access areas and 
wherein an anvil and staple cartridge apparatus can be oriented in such 
area independently of, and spaced from, the position of the operating 
handle for the stapler. 
To these ends, a preferred embodiment of a disposable linear surgical 
stapler according to the invention includes a staple cartridge and anvil 
pivoted together, an operating handle substantially independent of the 
cartridge and anvil, and a flexible stapler operating shaft operably 
interconnecting the handle and the stapler cartridge. The flexible shaft 
includes a cable within a flexible conduit and is operable to transmit an 
operating force, applied at the handle, to the staple cartridge for 
driving staples through tissue and against the aligned anvil. 
An anvil is provided with a gap control apparatus for adjusting the 
distance between the staple cartridge and anvil, after the two components 
are aligned and latched, so that a plurality of single size staples can be 
uniformly implanted and formed along a staple line and over a plurality of 
gap settings. 
A one-way rotatable firing knob is provided on the handle and is connected 
through the cable to a firing wedge in the staple cartridge. The firing 
wedge is pulled along a line of staple drivers to sequentially fire 
staples toward the anvil, through the tissue to be sutured, and against 
the anvil. 
The anvil includes a plurality of staple clinching pockets configured to 
form and clinch staples over at least two discrete gaps between the anvil 
and staple cartridge. 
A one-way start apparatus is utilized to prevent firing knob rotation in 
the wrong direction. 
In order to insure proper anvil and staple cartridge alignment, the staple 
cartridge is provided with an alignment pin and a latch lug, both of which 
are received and held in alignment receiving pockets within ends of the 
anvil apparatus. The latch lug is releasable to permit selective opening 
of the anvil and cartridge jaws. 
Accordingly, it will be appreciated that the improved disposable linear 
surgical stapler can be utilized in limited access areas, the relatively 
small anvil and cartridge end being easily oriented in small areas, while 
the handle remains outside such areas, and connected to the cartridge only 
by the cable and flexible conduit. 
Moreover, the stapler provides different tissue gap settings for single 
size staples, and operation of the stapler is facilitated by sequential 
staple firing.

Turning now to the drawings, there is shown in FIG. 1 a disposable linear 
surgical stapler 10 according to the invention. The stapler 10 includes a 
handle 11, an elongated flexible shaft 12 and a cartridge/anvil structure 
13, including a cartridge means 14 and an anvil means 15 pivoted to each 
other at pivot point 16. 
The stapler 10, according to a preferred embodiment of the invention, is 
useful for implanting two staggered rows of staples in tissue or organs 
such as those disposed in the alimentary canal or digestive tract. In 
general, and as will be further appreciated, the tissue is clamped in a 
gap G between the cartridge means 14 and the anvil means 15. A safety 17 
in handle 11 is then retracted to the position shown in FIG. 1, and firing 
knob 18 is rotated in the clockwise direction of arrows 19 in order to 
implant the staggered rows of staples in the tissue. 
The utilization of the flexible shaft 12 permits the cartridge/anvil 
structure 13 to be oriented independent of the handle 11, with the 
flexible shaft operatively connecting the staple cartridge means 14 and 
the handle 11 for the implantation of staples, while removing the 
necessary apparatus of the handle 11 from immediately adjacent the tissue 
site in a surgical procedure. 
FLEXIBLE SHAFT 
Referring now to FIGS. 2 and 3, the flexible shaft 12 includes a flexible 
corrugated outer covering 25, a flexible conduit 26 and a flexible cable 
27 slidably disposed within the conduit 26. Conduit 26 is preferably 
formed of spirally wrapped wire defining an open interior passageway. 
Also included in the flexible shaft 12 is a flexible tension wire 28 
preferably attached to the flexible conduit 26 along the length thereof. 
Tension wire 28, by virtue of its connection to the flexible conduit 26, 
prevents undesirable firing of the stapler due to inadvertent extensions 
of the flexible conduit 26. 
Flexible tension wire 28 has a foward end 29 which is connected to the 
anvil/staple structure 13 and a rearward end 30 which is connected to the 
handle 11. The forward and rearward ends 29 and 30 of the flexible tension 
wire 28 are secured to the cartridge means 14 and the handle 11 
respectively by any suitable means. Outer covering 25 serves as a 
flexible, sterilizable covering for the conduit 26 and provides a barrier 
between the metal conduit and surrounding tissues which otherwise might 
get pinched in the spring-wound conduit. 
STAPLE CARTRIDGE 
Details of the various components and features of the stapler 10 are 
perhaps seen best in FIGS. 2 and 3, with occasional reference to FIGS. 
4-8. Turning now to FIG. 2, various components of the stapler 10 are shown 
in exploded perspective form for the purposes of clarity of description. 
The cartridge/anvil structure 13 includes a cartridge means 14 and an 
anvil means 15. 
The cartridge means 14 includes a cartridge body 35, a cartridge lid 36, 
and a catridge support channel or housing 37. Cartridge support channel 37 
is provided with lugs 38 and 39, defining a pivot line 16 about which the 
cartridge means 14 and anvil means 15 are pivoted together. 
Within cartridge body 35 are disposed a plurality of staple drivers 40, the 
structure of which is best seen in FIG. 6. These drivers are substantially 
identical and for clarity will be referred to by the numeral 40 or by the 
numeral 40 followed by a letter where differentiation is necessary. Staple 
drivers 40 have lower bifurcated portions forming respective staple 
driving legs 41 and 42, which are offset with respect to each other. A top 
view of the drivers 40 as in FIG. 7 illustrates the offset nature of the 
respective legs of the drivers 40. 
Each leg 41, 42 has a respective staple-engaging end 43, 44, and the legs 
41 and 42 are joined at their upper ends, forming cam surfaces 45 and 46 
which taper upwardly to form an apex 47 centrally of the driver 40. Driver 
leg 41 also includes an elongated guide rib 48, while leg 42 includes an 
elongated guide rib 49, which ribs extend downwardly from the respective 
cam surfaces 45 and 46. As will be appreciated, the respective driver legs 
41 and 42 are operative to engage and fire staples in two offset or 
staggered rows. To this end, it will be further noted that leg 41 slightly 
overlaps leg 42. It will also be noted that actuation of a single driver 
40 will be operable to drive two staples at the same time by means of legs 
41 and 42 operating on a staple in each of the staggered rows. 
Returning now to the cartridge means 14, it will be appreciated that the 
body 35 and the housing 37 are provided with respective projections and 
detents, such as those projections 51, 52 and 53, and respective detents 
54, 55 and 56, for positioning and holding the housing 37 on the cartridge 
body 35 when the stapler is assembled. Moreover, it will be appreciated 
that the cartridge body 35 has a foward end 57 and a rearward end 58. 
Also, it will be appreciated that cartridge body 35 is provided with a 
plurality of staple-ejecting apertures 59 making up one staple row, and 
staple ejecting apertures 60 making up a second, staggered staple row. 
Staple-ejecting apertures 59 lie in one row 61, while staple-ejecting 
apertures 60 lie in an adjacent, parallel but staggered row 62, the 
apertures 60 being staggered by approximately one-half staple width from 
the apertures 59 in the row 61. The rows 61, 62 in the preferred 
embodiment are about 60 millimeters in length, but it shall be appreciated 
that other size staplers according to the invention can be made, such as 
in staple row lengths of 90 millimeters and 120 millimeters, for example. 
Turning now to further details of the cartridge means 14, attention is 
directed to FIGS. 3, 5, 7 and 8. FIG. 7 is a partial cross-sectional view 
looking down into the cartridge body 35 from a position above the drivers 
40 depicted in FIG. 7 as drivers 40, 40a and 40b, each of which is similar 
in construction. 
The lefthand side of FIG. 7 corresponds generally to the forwardmost end 57 
of the cartridge means 14 and includes a wedge pocket area 65. Tapered 
surfaces 66 and 67 define a rearward end of the wedge pocket 65 and serve 
as guiding surfaces as will be described. 
The cartridge body 35 comprises elongated side walls 68 and 69. A plurality 
of elongated vertical projections, or guide rails, 70 through 73 extend 
from the side wall 68 toward the opposite side wall, while an offset 
plurality of elongated rectangular projections 74 through 77 extend from 
the opposite side wall 69 toward the side wall 68. The guide rails are 
essentially identical, except the forwardmost guide rail 70a differs from 
the other guide rails in the provision of the tapered surface 66 adjacent 
wedge pocket 65. Guide rail 74 differs from the other guide rails by 
virtue of the tapering surface 67 at the rearward end of the wedge pocket 
65. 
The guide rails 70 through 77 are provided with curved driver guiding 
surfaces such as that shown at 78 in guide rail 74. These curved or 
concave surfaces extend longitudinally of the guide rails for reception of 
the guide ribs 48, 49 of the drivers 40. For example, as shown in FIG. 7, 
guide rib 48 extends into the concave guide surface 78, while the guide 
rib 49 of the same driver extends into the concave guide surface 78a of 
the guide rail 71. 
The guide rails 70 through 77 are provided with elongated staple channels 
80 for receiving staples "S" or "S-1" beneath the drivers. These staples 
preferably have legs about 4.0 to 5.0 millimeters in length and are 
formed of wire about 0.009" to 0.011" in diameter, although other sizes 
and shapes may also be useful. The staples S and S-1 are slightly wider 
than the respective driver legs, and thus ends of the staples S and S-1 
are shown in the view of FIG. 7 extending outwardly from beneath the 
driver legs. 
Each of the guide rails 70 through 77 include an upper tapered surface, 
such as at 81, which tapers from the respective side walls 68, 69 
downwardly toward the bottom of the cartridge. At the righthand edge of 
FIG. 7, the driver has not been shown in order to clearly illustrate the 
staples S and S-1 and their disposition within the cartridge body 35. It 
will be appreciated that the respective guide rails 70 through 77 define 
driver receiving channels for reception of the respective drivers. For 
example, rails 71 and 72 define therebetween a portion of a driver 
receiving channel 82 for the leg 41 of the driver 40a, while the rails 75 
and 76 define another offset portion of the same driver receiving channel 
for receiving the leg 42 of the driver 40a. 
In FIG. 7 a single row 62 of staples S is shown at an upper portion of the 
figure, while another row 61 of staples, S-1, is shown at a lower portion 
of the figure. It will be appreciated then that the legs 41 of the 
respective drivers are disposed over a row 62 of staples S, while the 
respective legs 42 of the same drivers are disposed over a row 61 of 
staples S-1. 
At the bottom of the driver channels 82, an elongated rib 83 is provided 
for closing off the bottom of the cartridge body 35 to prevent the drivers 
from falling out of the cartridge body 35. 
Finally, it should further be noted that each rail includes a forward face 
84 facing the opposite wall 68 and 69 of the cartridge body 35. These 
generally flat faces 84 surround the respective concave surfaces 78 and 
define a path "P" as will be further described. 
In summary, then, the respective drivers 40 are slidably received within 
driver receiving channels 82, while the respective staples S and S-1, in 
their respective staggered rows, are received in the staple channels 80 
beneath the drivers and in position for driving outwardly of the cartridge 
body 35 when the drivers are actuated against the staples. 
A wedge 90 is disposed within the cartridge body 35, as will now be 
described. Wedge 90 includes a wedge blade 91 and a wedge base 92. Wedge 
blade 91 has a lower wedging surface 93 for engaging the cam surfaces 45 
or 46 of the respective drivers 40 to drive them against the staples and 
fire the staples from the cartridge body 35. 
Preferably, the wedge 90 is metallic and base 92 is crimped about the cable 
27, as shown in FIG. 5. Alternately, of course, the wedge itself could be 
molded from any suitable material and attached to the cable 27 in any 
suitable manner. 
Wedge 90 is originally disposed in the wedge pocket 65 at forward end 57 of 
the cartridge body 35. Guide surfaces 66 and 67 function to guide wedge 
blade 91 into path P, between rails 70-77 and are elongated in a direction 
normal to wedge movement. 
The operation of the wedge surface 93 against the respective drivers is 
perhaps best seen in FIG. 3, where it can be appreciated that the wedge 
surface 93 has already engaged and pushed drivers 40c and 40d downwardly. 
Moreover, it will be appreciated that the surface 93 has further engaged 
drivers 40e, 40f and 40g and pushed them against the staples to varying 
extents. Driver 40h has not yet been contacted by the wedge surface 93. 
In this regard, it will be further appreciated that the operation of the 
respective drivers, such as driver 40c for example, is operative to fire 
staples S-1 (not shown in FIG. 3) and S outwardly of the cartridge body 35 
and against the anvil means 15 in two staggered rows. Only the row 62 of 
staples S is shown in FIG. 3. Thus, when wedge 40c has been activated by 
the wedge 90, for example, a staple S is formed and clinched as shown FIG. 
3, and an offside staple S-1 (not shown) is also formed and clinched by 
operation of the driver 40c, and so on for each of the drivers in the 
cartridge body 35. Thus, a staple S-1 is fired simultaneously to a staple 
S in another row, however, the drivers are engaged sequentially so staples 
in the same row are fired, formed and clinched sequentially. 
In order to capture the drivers 40 within the cartridge body 35, and in 
order to provide a guide for the wedge 90, cartridge lid 36 is disposed 
along the top of the cartridge as shown in FIGS. 5 and 8. Cartridge lid 36 
is provided with a slot 96 for receiving the blade 91 of the wedge 90. 
Furthermore, the lid 36 is provided with projections 97 and 98, for 
example, for securing the cartridge lid 36 on the cartridge body 35 while 
also maintaining proper spacing between cartridge walls 68 and 69. 
The housing 37 is disposed over the cartridge body 35 and serves to 
slidingly capture the wedge 90 between the cartridge lid 36 and the 
housing 37 so that the wedge is free to slide through the slot 96 and 
within the path P (FIGS. 5 and 7) in order to engage the respective 
drivers 40 to fire staples S and S-1. 
It should be appreciated that the cartridge body 35, including walls 68, 
69, rails 70-77 and rib 83 are preferably formed from an integral molding 
of any suitable material such as plastic. 
ANVIL 
Returning now to FIGS. 2 and 3, anvil means 15 will now be described in 
detail. The anvil means 15 comprises an anvil block 101 including an anvil 
insert 102 and an anvil 103 containing a series of staple pockets 104 for 
forming and clinching staples, such as shown in FIG. 3. Pockets 104 are 
shown in FIG. 1. 
As mentioned above, the anvil 103 is adjustable in order to provide 
different sized gaps G. In particular, a sliding retention plate 105 is 
disposed between the insert 102 and a cam plate 106. A screw 107 captively 
secures the retention plate 105 and the cam plate 106 within an anvil 
support channel 110 by a threaded connection to a manually operable slide 
switch 111, while two screws 108 and therefor 109 secure the slide plate 
105 to the insert 102. 
As best seen in FIG. 3, the cam plate 106 is provided with cam surfaces 112 
and 113. Accordingly, and as shown in FIG. 3 for example, the anvil 103 
can be extended outwardly of the anvil means 15 toward cartridge means 14 
by sliding the retention plate 105 and the cam plate 106, as a unit. For 
example, and as shown in FIG. 3, the anvil 103 is in a retracted position. 
The heads of screws 108 and 109 reside on lower portions (as viewed in 
FIG. 3) of the respective cam surfaces 112 and 113. However, when slide 
switch 111 is engaged and moved to the right, as viewed in FIG. 3, it will 
be appreciated that the retention plate 105 and cam plate 106 also slide 
to the right and the heads of screws 108 and 109 ride up the respective 
cam surfaces 112 and 113 to a higher portion thereof, thereby extending 
the anvil 103 outwardly and toward the cartridge means 14. 
Of course, it will be appreciated that the screws 108 and 109 extend 
through slots 114 and 115 respectively in the plate 105, while screw 107 
secures together the plate 105, the cam plate 106 and the sliding switch 
111. If desired, respective projections and detents can be provided in the 
mating faces of the plate 105 and cam plate 106 to prevent their movement 
with respect to each other. 
it will also be appreciated that the position of the anvil 103 can be 
adjusted by means of adjusting the screws 108 and 109. For example, it is 
desirable to produce an anvil surface which is parallel to the cartridge 
means 14 when the anvil means 15 is latched to the cartridge means 14. 
Accordingly, and during manufacture of the invention, the screws 108 and 
109 can be adjusted to a predetermined extension so that they produce, in 
combination with the cam plate 106, a parallel positioning of the anvil 
103 with respect to both the entire anvil means 15 and the cartridge means 
14. 
Accordingly, it will be appreciated that the anvil means 15 provides an 
extensible anvil which is capable of defining at least two different gaps 
between the cartridge means 14 and the anvil means 15. A larger gap G is 
provided when the screws 108 and 109 reside in lower portions of the cam 
plate 106, and a smaller gap is produced when the cam plate 106 is moved 
so that the cam surfaces 112 and 113 engage the screws 109 and 108, 
respectively, to project the anvil outwardly of the anvil means 15, all 
while maintaining the anvil 103 in parallel relationship to the anvil 
means 15 and to the cartridge means 14, to provide a uniform gap G for 
whatever gap is selected. 
Anvil means 15 is also provided with a cartridge means latch 120 mounted 
within the anvil support channel 110. The cartridge means latch 120 is 
perhaps best shown in FIG. 3 and includes a spring-loaded extensible latch 
member 121 urged by spring 122 in a forward direction, or to the left as 
viewed in FIG. 3, and against the stop which comprises a rivet 123. An 
actuating button 124 extends outwardly of the latch 120 and is manually 
operable to push the latch member 121 in a rearward direction, or to the 
right as viewed in FIG. 3, to unlatch the cartridge means 14, as will be 
described. 
Of course, it is desirable to operably align the cartridge means 14 with 
the anvil means 15 and as well to latch the cartridge means 14 to the 
anvil means 15. In this regard, the preferred embodiment of the invention 
includes means for appropriately aligning, both longitudinally and 
laterally, the cartridge means 14 with the anvil means 15. As shown in 
FIG. 2, the cartridge body 35 is provided with a positioning lug 130 and a 
combination positioning and latching lug 131. Moreover, the anvil 103 is 
provided with positioning recesses 132 and 133 therein for receiving the 
respective lugs 130 and 131. Accordingly, when the cartridge means 14 and 
the anvil means 15 are pivoted together about pivot point 16, the lug 130 
is received within the recess 132 and the combination positioning and 
latching lug 131 is received within the recess 133, the recess surfaces 
guiding and positioning the respective lugs, and thus maintaining the 
cartridge means 14 and anvil means 15 in aligned condition. 
Also, it will be appreciated that the lug 131 includes a detent for 
engaging with an upper detent portion of the latch member 121 of the latch 
120. As the lug 131 is received within the recess 133, it engages the 
latch member 121, pushes it rearwardly, and thereafter permits the latch 
member to move forwardly, holding the lug 131 within the anvil means 15 
and thus latching the cartridge means 14 and the anvil means 15 together. 
HANDLE 
Turning now to FIGS. 2, 3 and 4, the handle will now be described in 
detail. The handle 11 comprises right and left handle portions 140 and 141 
secured together by appropriate peripheral lap joints, as shown at 142 in 
FIG. 4, and suitable hollow post and pin connection (not shown) 
respectively integral with the portions 140, 141. 
The firing knob 18 is mounted externally of the handle portion 140 and has 
legs 146 extending therethrough for engagement with a cable pulley or 
spool 147. As shown in FIG. 4, spool 147 includes a depending shank 148 
which is externally threaded. An internally threaded nut 149 is mounted on 
the shank 148. Nut 149 has a plurality of peripheral teeth 150 on the 
outer circumference thereof. 
Handle portion 141 is provided with a circumferential array 151 of tooth 
receiving receptacles surrounding an upstanding post 152. When the right 
and left handle portions 140 and 141 are joined together, the shank 148 
fits over the upstanding post 152 with the nut 149 residing on the shank 
148 and the teeth 150 residing in the various receptacles of the array 
151. Accordingly, when the firing knob 18 is turned, spool 147 and shank 
148 also turn. Since the nut 149 is held against turning by virtue of the 
array 151, the nut translates or moves along the shank 148. 
When the handle 11 is assembled, the nut 149 is originally placed on the 
shank 148 tightly against the bottom of the spool 147, as shown in FIG. 4. 
Accordingly, rotation of the firing knob 18 in a counterclockwise 
direction (as viewed in FIG. 1) is not possible since that direction of 
rotation would cause the nut 149 to move upwardly even more tightly 
against the spool 147. Since the nut 149 is restrained from rotating and 
engages the spool 147, the spool 147 comprises a stop means which impedes 
further movement of the nut 149 along the shank 148 toward the spool 147. 
Accordingly, it is impossible to initially rotate the firing knob 145 in 
an undesirable or inoperative direction. On the other hand, if the firing 
knob 18 is rotated in a clockwise direction, as shown in FIG. 1 in the 
direction of the arrow 19, the pulley 147 and the shank 148 are rotated, 
with the nut 149 moving downwardly toward the bottom of handle portion 
141. The threads on the shank 148 are constructed so that the nut 149 
reaches the bottom of the handle portion 141 just after the wedge has 
engaged all the drivers and all of the staples have been fired, formed and 
clinched, thus preventing further rotation of the firing knob 18 and 
signalling the stapling operation has been completed. 
Of course, it will be appreciated that the spool 147 includes a receptacle 
means 155 for receiving the end 156 of the cable 27 such that when the 
spool 147 is rotated, the cable is wrapped around the spool, pulling the 
cable within the handle 11. It will also be appreciated that the flexible 
conduit 26 is secured within the receptacle 157 of handle 11 so that the 
conduit 26 cannot move within the handle 11. Thus the cable 27 is pulled 
through the conduit 26 upon rotation of knob 18 and spool 147, thereby 
pulling the wedge 90 through path P in the cartridge body 35. Moreover, it 
will be appreciated that the forward end 29 of the flexible conduit 26 is 
provided with an adapter 158 for securing the conduit 26 to the cartridge 
means 14, and preventing the cartridge means 14 from being drawn toward 
handle 11. 
Also it will be appreciated that when the firing knob 18 is rotated in a 
clockwise direction, the cable 27 wraps around pulley 147 and is pulled 
through the conduit 26, thus pulling the wedge 90 through the cartridge 
body 35. This causes the wedge surface 93 to sequentially engage the 
drivers 40 and fire the staples from the cartridge body 35 against the 
anvil 103 and through any tissue which is captured in the gap G between 
the cartridge means 14 and the anvil means 15. 
Also provided within handle 11 is a safety for preventing any rotation of 
the firing knob 18 and the spool 147 until such is desired. This safety is 
perhaps best shown in FIG. 3 and comprises a safety lug 165 and a safety 
slide switch 166. Switch 166 is connected to the lug 165 for moving the 
lug forwardly and backwardly, in the direction of the arrow A as shown in 
FIG. 3. The spool 147 is provided with a depending circumferential flange 
167 having a lug receiving recess or cut-out 168 slightly larger than 
safety lug 165. Accordingly, forward motion of switch 166 urges the lug 
165 into the recess or cut out 168 in the flange 167, and prevents 
rotation of spool 147 in any direction. Accordingly, the stapler cannot be 
operated until the switch 166 is moved rearwardly, withdrawing the lug 165 
from the spool 147. This prevents inadvertent firing of the stapler. 
OPERATION 
It will be appreciated that the stapler 10, according to a preferred 
embodiment of the invention, is manufactured and provided with a single 
load of staples S and S-1 disposed in the cartridge means 14 and in the 
two staggered rows 61, 62 as described, with the drivers 40 poised on top 
of the respective staples S-1 and S. 
Turning now to FIGS. 9-12, it will be appreciated that the cartridge means 
14 and the anvil means 15 may originally be secured together. When it is 
desired to utilize the stapler, the button 124 is manually depressed, as 
shown in FIG. 9, whereupon the cartridge means 14 and anvil means 15 can 
be pivoted to an open position. In this regard, a detent (not shown) may 
be provided in the anvil support channel for cooperating with a projection 
on the lugs 38 and 39 in order to maintain the anvil at about a 40.degree. 
open relationship with respect to the cartridge means 14. 
Thereafter, tissue such as intestinal tissue T, as shown in FIG. 10, is 
inserted between the cartridge means 14 and the anvil means 15. The 
cartridge means 14 and anvil means 15 are then pivoted about pivot point 
16 until the latching lug 131 is received within the recess 133, and is 
latched by the latch 120. 
The safety switch 166 is then moved rearwardly to unlock the spool 147 and 
the firing knob 18 is rotated in a clockwise direction, as shown in FIG. 
11, to pull the flexible cable 27 into the handle. 
When the cable 27 is pulled toward the handle 11, it pulls the wedge 90 
along the path P within the cartridge body 35, whereupon the wedge surface 
93 engages the cam surfaces, such as surfaces 45 on the respective drivers 
40. As each driver is engaged, it progressively fires a staple S and a 
staple S-1 across the gap G between the cartridge means 14 and the anvil 
means 15 through any tissue T therebetween and against the anvil 103 for 
forming and clinching the staples S and S-1. It will be appreciated that 
the staple driving is accomplished in a sequential fashion and while each 
driver drives two staples, all staples are not driven simultaneously but 
rather sequentially as the wedge 90 is moved through the path P to 
sequentially engage the respective drivers 40. Thus, all drivers are not 
simultaneously operated and firing force is reduced as compared to the 
force which may be necessary to simultaneously fire, implant, form and 
clinch all staples S and S-1. 
Once the safety switch 166 has been moved rearwardly, the spool 147 would 
ordinarily be free for rotation in either direction. Thus it would be 
possible to rotate the firing knob in an undesirable counterclockwise 
direction. The proper initial rotation direction, however, is assured by 
the travelling nut 149, since a resistance is encountered in turning the 
firing knob 18 in a counterclockwise direction due to the engagement of 
the nut 149 against the bottom of the spool 147. Accordingly, only proper 
clockwise direction is permitted in order that the spool 147 is properly 
rotated to pull the cable 27 and thus the wedge in order to fire the 
staples S and S-1. 
After the stapler 10 has been fired, and all staples S and S-1 implanted, 
formed and clinched in tissue T, the tissue can be excised by use of a 
scalpel as shown in FIG. 12. The cartridge means 14, anvil means 15, or 
both, can be used as a scalpel guide insuring that no excision is made too 
close to the implanted staples. 
Thereafter, button 124 is pinched to release the forward end 57 of 
cartridge means 14 from anvil means 15. The cartridge means 14 and anvil 
means 15 are then pivoted apart to release the closed tissue. 
It will be thus appreciated that the invention provides many advantages. 
For example, the handle 11 can be provided independently of the cartridge 
means 14 and anvil means 15, thus permitting the utilization of the 
stapler 10 in very limited access areas where the handle 11 can remain 
spaced from the area. It is only necessary to maneuver the cartridge and 
anvil structure into the area for utilization with particular tissue. Also 
it will be appreciated that since the cartridge means 14 and anvil means 
15 can be essentially operated with one hand, further access and utility 
in limited access areas is facilitated. 
Also, it will be appreciated that the cam adjustment means as described 
herein with respect to the anvil means 15 provides for a disposable, 
linear, flexible surgical stapler 10 having at least two different gap 
settings, so that different types and sizes of tissue can be accommodated, 
all while the anvil means 14 and cartridge means 15 are maintained in a 
parallel relationship. Accordingly, single size staples can be utilized 
for variable gap settings and it is not necessary, within the operating 
range of the apparatus 10, to provide different size staples, or staplers 
pre-loaded with different size staples. 
It will also be appreciated that the structure of the flexible stapler 10, 
as disclosed herein, provides for the utilization of optimum materials. 
For example, the cartridge housing 37 can be manufactured of metallic 
material, while remaining portions of the cartridge means 14 can be 
manufactured from plastic materials, at reduced expense, with greater 
manufacturing ease, and no sacrifice in strength or efficiency. 
Also it will be appreciated that the position lug 130 and the position and 
latch lug 131 can also be manufactured from any suitable materials and as 
well serve to maintain the cartridge means 14 and the anvil means 15 in 
proper longitudinal and lateral position with respect to each other during 
a stapling procedure. 
It should be appreciated that the structure of the drivers 40 provides the 
advantage of a single driver serving to fire staples in two staggered 
staple rows. The driver 40 is also reversible so that it fits into the 
driver channel 82 regardless of which leg 41 or 42 is oriented forwardly 
and which rearwardly. This universality is provided in part by the double 
cam surfaces 45, 46. 
Moreover, it will be appreciated that the construction of the cartridge 
body means 14, drivers 40, wedge 90, handle 11, shaft 12, and the anvil 
means 15, all as described, might be modified, yet still produce the 
results as described herein. 
These and other advantages and modifications will become readily apparent 
to those of ordinary skill in the art without departing from the scope of 
this invention and the applicants intend to be bound only the by the 
claims appended hereto.