is divided we claim a two-part cartridge
assembly for stapling a closed geometric pattern in hollow organs comprising a first part composed of a bowl-shaped body and an anvil providing a pair of concentric closed geometric arrays of grooves mounted on said bowl-shaped body and a second, staplecarrying, part composed of a guide body defining a pair of concentric closed geometric arrays of stapleholding grooves, a staple ejector means mounted in said guide body for movement relative thereto, and a knife carried by said ejector means Variations in staple dimensions and array patterns are easily provided by a variety of cartridge designs.
According to the present invention there is provided a two-part assembly for stapling a closed geometric pattern in the end portions of disconnected sections of hollow organs made of tissuue, the assembly comprising an anvilcarrying part having a first tissue-receiving space defined therein; a staple-carrying part having a second tissue-receiving space defined therein, said staple-carrying part being associated with said anvil-carrying part for clamping said disconnected sections of said organs therebetween with said end portions being received in said first and second spaces, said first and second spaces, during said clamping, defining a closed cavity; and relief means in at least one of said anvil-carrying and staple-carrying parts for communicating said closed cavity with the exterior of said assembly.
In our copending patent application No.
8035762, Serial No 1,602,563 also divided from patent application No 20869/78, Serial No 1,602,561 we claim a two-part assembly CD lto C 4 O 1,602,562 for stapling a closed pattern in hollow organs, said assembly comprising an anvil-carrying part composed of a bowl-shaped body and an anvil providing a closed circular array of stapleclinching grooves mounted on said bowl-shaped body, and a staple-carrying part composed of a guide body defining a closed circular array of staple-holding grooves, wherein the perimeter of the profile, in section through the axis of the anvil-carrying part is equal to or less than the circumference of the inner diameter of the closed circular array.
The invention will become more evident from a consideration of the following descriptive text given by way of example with reference to the accompanying drawings, in which:
Figure 1 is a view in side elevation showing the instrument assembled with a disposable cartridge; Figure 2 is an end view of the disposable cartridge illustrated in Figure 1; Figure 3 is a sectional view taken along line 3-3 of Figure 1; Figure 4 is a sectional view taken along line 4-4 of Figure 1; Figure 5 is an end view of the instrument looking at the adjustable wing nut; Figure 6 is a view partly in section through the main body of the instrument showing the manner in which the instrument is assembled and the handle is manipulated to cause the reciprocating motion of the driver; Figure 7 is a sectional view of Figure 6 taken along line 7-7; Figure 8 is a view in section through the body of the instrument showing the stop arrangement in detail; Figure 9 is a view in top plan partly in section of the staple carrying part of the disposable cartridge showing the keying arrangement; Figure 10 is a view in section through the staple carrying part of the disposable cartridge; Figure 11 is a view in section taken along line 11-11 of Figure 10; Figure lla is a view in section through the keying arrangement illustrating positions following staple ejection; Figure 12 is a front end view of the staple carrying part of the disposable cartridge showing the pusher and knife; Figure 13 is a detail section showing safety detent arrangement; Figure 14 is a front end view showing the pusher and staple guide; Figure 15 is a side elevational view showing coaction between staple and pusher; Figure 16 is a side view, partly in section, showing the anvil part of the disposable cartridge; Figure 16 a is a top view in section along line 16 a-16 a of Figure 16; Figure 17 is a view of Figure 16, with anvil removed; Figure 18 is a side elevational view of the anvil; Figure 19 is an elevational view of the anvil; Figure 20 is a view in section through the anvil; Figure 21 is a view in section through the anvil illustrating the manner in which a staple is clinched; and Figure 22 is a view in section through the anvil part of the disposable cartridge showing the staple line and knife cutting of tissue.
Referring now to the drawings in detail, a preferred embodiment of the instrument with disposable cartridge mounted thereon according to the teachings of the present invention is depicted in Figures 1 and 6 As shown, the instrument comprises a main body portion or housing defining a throughbore 11 and having an integrally formed rear handle part 12 Projecting from the housing 10 is a pivotally mounted handle part 14, pivotably mounted to the housing 10 by means of pivot pin 16 The handle part 12 is received in the palm of the hand of the operator and the handle part 14 is grasped by the fingers of the same hand When the fingers are squeezed toward the palm, handle part 14 is pivoted about pin 16 and brought toward handle part 12 A conventional safety bar 18, terminating in a knob 20 bearing against the pivotable handle part 14 and which, in turn, is pivotally mounted on a pin 22 set into the housing 10, serves as a safety to prevent the accidental actuation of handle part 14.
Safety 18 is conventional in both function and structure.
Projecting from the forward end of the body portion or housing 10 is an outer tube body portion 30 which extends forwardly and terminates at a substantial distance from housing 10 Received on the remote end of tube 30 is a disposable cartridge referred to generally by the reference numeral 40 Attachment of disposable cartridge 40 to the tube 30 is effected by means of a threaded coupling sleeve 42 in a manner which will be described hereinafter The disposable cartridge 40 comprises a staple carrying member 44 and an anvil carrying member 46 Concentrically mounted within the tube 30, is a driver tube and a rod 52 Driver tube 50 reciprocates within tube 30 and serves as a pusher for ejecting staples; the rod 52 reciprocates independent of driver tube 50 and serves to position the anvil carrying member 46 relative to the staple carrying member 44 The rod 52 extends entirely through the instrument with one end projecting out of the front of the instrument to receive and carry the anvil carrying member 46 and the other end Trojecting out of the back of the instrument through 3 1,0,6 3 a wing nut 60 The rear end of the rod 52 is threaded as indicated to the right of Figure 1 and is in threaded engagement with an internally threaded sleeve extension 110 of wing nut 60.
As illustrated in Figure 3, the inside diameter of tube 50 is slightly enlarged at its remote end, for the purpose of relieving the contact between the rod 52 and driver tube 50 over a substantial area without any loss of function.
As shown in Figure 5, an end cap 62 is applied to the rear of the instrument and effects a closure of throughbore 11 Cap 62 secures stepped bushing 304 against shoulder 306 in throughbore 11 The smallest bore through bushing 304 supports reduced part 106 of the rod 52 and teminates in bevelled shoulder 130.
Holes 64 are provided in the cap 62 in order to accommodate a suitable spanner wrench to enable the attachment of the cap 62 into a suitably threaded terminal part of throughbore 11 at the rear of the instrument The cap 62 contains an external thread on its flange part that coacts or threadedly engages with the thread formed in the terminal part of throughbore 11.
Referring now to Figures 6, 7, and 8, the internal arrangement for the housing 10 will now be described in detail As already noted, the cap 62 contains an external thread which threadedly engages with an internal thread suitably formed in the terminal part of the throughbore 11 This threaded engagement is identified generally by the reference numeral 66 Throughbore 11, at its end proximal to the disposable cartridge mounting, receives the outer tube 30 which extends into the throughbore 11 terminating at the entry to an enlarged region 70 of the bore 11 The housing 10 and the tube 30 are rigidly interconnected in the bore 11 so that there is no relative motion between them The driver tube 50 extends coaxially within the sleeve 30 and projects therefrom into the enlarged region 70 whereupon it is threadedly connected at its end by means of threads 74 with a short thicker sleeve 72 This sleeve 72 in turn is connected by means of threads 76 with a terminating cap 78 This terminating cap 78 defines on its inner surface an inclined stop shoulder 81 The driver tube 50 together with the short sleeve 72 and the cap 78 being threaded together all move as a unit The short sleeve 72 being somewhat thicker than the driver tube 50 accommodates on either side a roller 80 which is mounted on a short stub shaft 88 pressed into a recess defined in the short sleeve 72.
Rollers 80 are provided on diametrically opposed sides of the short sleeve 72 and serve as the means by which the driver tube 50 is reciprocated in the instrument Also, the underneath side of the short sleeve 72 is provided with a suitable tapped hole 84 into which is threaded a projection 82 The stub or projection 82 extends downwardly, as portrayed in Figure 6 of the drawings, and terminates in the plane of a slot 84 defined in the housing 10 The purpose of the stub or projection 82 is to maintain a proper orientation for the driver tube 50 as it 70 reciprocates back and forth; hence, stub or projection 82 in cooperation with slot 84 prevents driver tube 50 from rotating during reciprocation.
The arrangement for reciprocating the driver 75 tube 50 is illustrated best in Figures 6 and 7.
As already noted, the short sleeve 72 carries rollers 80 on diametrically opposed sides, the rollers 80 being mounted for free rotation by means of short stubs 88 which are pressed 80 into the short sleeve 72 in the manner best illustrated in Figure 7.
The handle part 14 is provided at its lower end with a bifurcated member 90, the legs of which are identified by the reference numeral 85 92 These legs 92 are fashioned as forks 94 which engage the rollers 80 The bifurcated member 90 is designed with an upstanding central projection 96 which fits into a slot 97 defined in the lower part of the handle part 14 90 Pins 98 projecting through holes formed in projection 96 hold the bifurcated member 90 to the handle part 14 Handle part 14 pivots about pin 16 as shown in Figure 6, and forks 94 cooperating with rollers 80 cause driver 95 tube 50 to reciprocate in tube 30 A spring 56 received around tube 50 in region 70 biases sleeve 72 against the reciprocation produced by handle part 14 The left end of spring 56 is held against the end of tube 30 100 The rod 52 extends completely through the tube 30 and housing 10 of the instrument As will be evident from Figure 8, the rod is provided with a bevelled shoulder 100 connecting the main portion of the rod 52 with a reduced 105 portion 102 which in turn defines a bevelled shoulder 104 with a further reduced part 106 of the rod 52 The extreme right end of the rod is a further reduction in diameter, this portion being identified by the reference 108, and this 110 reduced section 108 is threaded throughout its length.
The wing nut 60, which appears at the rear of the instrument, is provided with a sleeve extension 110 A reduced portion 112 inter 115 connects sleeve 110 with the hub of nut 60, which reduction defines a groove into which a retaining ring 124 is received for the purpose of securing the wing nut 60 and its sleeve extension 110 onto the end cap 62 The 120 sleeve extension 110 as well as nut 60 define a throughbore through which rod 52 passes.
The bore within the sleeve extension 110 is threaded to threadedly engage with the threads defined on the reduced portion 108 of the rod 125 52 By the arrangement described, when the cap 62 is threaded into the housing 10 with the wing nut 60 held thereon by means of the retaining ring 124, the wing nut 60 will not translate when rotated because of being secured 130 1,602,562 _r sto the end cap 62 in the manner described.
Accordingly, sleeve extension 110, acting as a nut on the threaded part of rod 108, will cause the rod 52 to reciprocate.
The bevelled shoulder 104 acts as a stop working against a bevelled shoulder 130 defined in the bushing 304 The furthest position of the rod 52, that it may assume when driven to the right by means of sleeve extension 110, is illustrated in Figure 8 with the bevelled shoulder 104 and the bevelled shoulder 130 in contact This also represents the closest approach of the anvil-carrying part 46 to the staple-carrying part 44 of the disposable is cartridge This position of closest approach is illustrated in Figure 1 and is selected to define a space between the two parts of the disposable cartridge that is equal to the minimum spacing required to accommodate tissue from whatever hollow body organs are to be stapled by the instrument of the present invention.
Referring now to Figures 9, 10 and 11, the staple-carrying part 44 of the disposable cartridge will now be described in detail The part 44 is an assembly comprised of a main body portion 140 having a semi-ovate shape terminating at its right end in a small diameter neck 141 having external threads 142 These threads 142 cooperate with an internally threaded coupling sleeve 42 which is retained on the end of the tube 30 by means of shoulder 146 A guide member 148 provided with a slot coacting with a projection 152 defined on the main body part 140 for orientation is secured to the main body part 140 by an adhesive or the like, the area of securement being identified by the reference numeral 154 The guide member 148 forms a guide face 156 which defines two concentric circular series of spaced staple-receiving slots 158 Received within the guide member 148 and the main body part 140 is a staple ejection member 160, which fits concentrically within the main body part 140, terminates in a long neck 161 nad is adapted to be contacted by the end of driver tube 50 The forward end of the staple ejector is defined with two concentric rings of peripherally spaced fingers 162, each one of which is received within a staple-receiving slot 158 Hence, upon advancing the staple ejector by driver tube 50, the fingers 162 will pass further into the staple-receiving slots 158, ejecting staples contained therein axially outwardly The staple ejector 160 is reinforced with a plurality of ribs 164 at least two of which are provided with suitable plastic projections or bosses 166 A knife 168 in the form of an open cup with the rim defining the knife edge 170 is mounted within the staple ejector 160 by means of holes 173 through which the bosses 166 project In mounting, the bosses 166 are "hot staked" to fasten the knife 168 onto the staple ejector 160 so that advancement of the staple ejector 160 also advances knife 168.
A two-headed key 180 is press fitted into an opening or slot defined in the outer tube 30.
The outer head 182 of the key is somewhat enlarged and coacts with a slot defined in the small neck of the main body part 140 to maintain this body part 140 and the associated guide member 148 in a predetermined indexed orientation with respect to the double-headed key 180 The driver tube 50 is provided with an elongated slot through which the key 180 passes in a loose fashion and the rod 52 is provided with a close fitting slot 184 into which the other end of the key 180 is received.
When initially assembled, the guide member 148 and the staple ejector 160 which define mutually opposed detents 190 and 192, respectively, are orientated such that detent 192 formed on the outer periphery of the staple ejector 160 is to the right of the detent 190 as shown in Figure 13 The purpose of these mutually opposed detents is to prevent any outward motion of the staple ejector 160 and its associated knife 168, that is outward from the face 156, and thereby prevent any accidental discharge of staples or accidental projection of the knife, before assembly onto tube 30.
When the staple carrying part of the disposable cartridge is assembled onto the end of the outer tube 30 by means of the sleeve 42 and the mutually engaging threads of the sleeve and the small neck of the main body part 140, the main body part 140 will be drawn to a position such that the staple ejector 160 will engage the free end of the driver tube 50 and then be moved slightly outwardly relative to the main body part 140.
This will cause the detents 190 and 192 to reverse themselves from the position shown in Figure 13 to the position shown in Figure The staple-carrying part 44 will then be ready for use.
The rod 52 is provided at its free end with a key 200 for the purpose of indexing the anvil-carrying part 46 to the rod 52 The rod 52 is also provided at its free end with a tapped hole 202 for the purpose of detachably mounting the anvil-carrying part 46.
The anvil-carrying part 46 is illustrated in Figures 16-22 inclusive and comprises a plastic body portion 210 of cup shape with a central hub 212 defining a bore 214 A stud 216 is received through the bore 214 and is characterized by knob 48 at one end and a screw thread 220 at its other end with a reduced section 222 defined between its ends.
The threading 220 matches the internal threading of the bore at the end of rod 52 Clips 224 defined by the portion 210 project into the bore 214 and engage the shoulder defined by the reduced section 222 to hold stud 216 captive in bore 214 but allowing it to rotate freely The body portion 210 in the vicinity of bore 214 is cut out at 226 to accommodate the key 200 at the end of the rod 52 Holes 1.602562 A 1,602,562 49 provide venting for the anvil carrying part 46 Metal anvil 230 having two concentric circular arrays of spaced staple clinching grooves 232 and a central hole 233, is mounted onto body portion 210 by "hot staking" Body portion 210 defines a plurality of ribs 234 at least two of which are provided with projections or bosses 236 Anvil 230 defines matching holes 238 and after mounting, bosses 236 are melted to form rivets 240 to lock anvil 230 on, see particularly Figure 22 Anvil 230 is also provided with punched out lips 242 to secure a cutting block 244 of annular configuration, that cooperates with knife 168.
Cutting block 244 is rubber, soft plastic or the like Anvil 230 defines a cutout or keyway 231 as an extension of hole 233 that coacts with key 200 to insure the proper orientation and indexing for grooves 232 of the anvil 230 relative to slots 158 of the staple carrying part 44 Anvil 230 has vent holes 47 which communicate with the vent holes 49 in body 210.
In operation, wing nut 60 is rotated to advance rod 52 out from the end of tube 30.
A staple carrying part 44 of a disposable cartridge 40 is fitted over rod 52 and tube 30 and attached to tube 30 by sleeve 42.
The geometry of these parts is such that key 180 engages the neck of staple carrying part 44 before the threading engages to draw part 44 onto tube 30 to its seated position During the last turns of sleeve 42, the end of driver tube 50 engages the staple ejector 160 to reverse the detents 190 and 192 from the position shown in Figure 13 to the position shown in Figure 10.
Next, the anvil carrying part 46 is assembled into the end of projecting rod 52 To this end, the knob 48 is grasped and the pointed threaded end of stub 216 is introduced into the tapped hole in the end of rod 52 Key 200 is received at this time in keyway 231 of anvil 230 before the threading engages, whereafter knob 48 is rotated to seat threaded end 220 of stud 216 into the tapped hole at the end of rod 52 and draw the key 200 into the keyway 231 Keys 180 and 200 assure that slots 158 and grooves 232 are properly aligned Wing nut 60 is then rotated to retract rod 52 and thus bring anvil part 46 close to staple carrying part 44.
In this condition, the instrument is inserted into the patient through the hollow organ that is to be stapled At this time, the patient has been prepared such that the hollow organ to be stapled has been cut and there are two cut ends to be joined together by means of the instrument of the present invention The instrument is inserted through the hollow organ until it projects from one of the cut ends The wing nut 60 is rotated to extend the rod 52, thereby creating a substantial gap between the anvil-carrying part 46 and the staple-carrying part 44.
Now, with reference to Figure 22, the cut end of the hollow organ through which the instrument is protruding is fashioned with a drawstring suture and drawn over the staplecarrying part 44 about the rod 52 The 70 other cut end of the hollow organ is pulled over the anvil-carrying part 46 and by means of a drawstring suture is tied closely about the rod 52 Thus, the two cut ends of the hollow organ will be interposed between the anvil 75 part 46 and the staple-carrying part 44 At this time, the wing nut 60 is rotated to cause retraction of the rod 52 whereupon the anvilcarrying part 46 will be brought into close proximity with the staple-carrying part 44 80 Wing nut 60 is turned until a sufficient back pressure is felt caused by squeezing the tissue interposed between the staple carrying part 44 and the anvil-carrying part 46.
At this time, the rod 52 will occupy a 85 position within the body 10 of the instrument either as shown in solid lines in Figure 8 with the stop 104 bearing against the stop 130, or due to a greater than minimum thickness of entrapped tissue, the stop 104 will be axially 90 displaced off the stop 130 to the left as shown in phantom.
With the apparatus in the condition described, that is, with the cut ends of the hollow organ to be stapled drawn around the 95 two disposable parts of the cartridge and the instrument properly closed, the safety 18 is released by pivoting away from the handle part 14 toward the handle part 12 in the manner shown in phantom in Figure 6 and 100 the handle is grasped with the handle part 12 resting in the palm of the hand and the fingers curled about the handle part 14 When the fingers are drawn toward the palm of the hand in the manner of making a first, the handle 105 part 14 will be rotated about its pivot pin 16 clockwise as shown in Figure 6 toward the handle part 12 This causes the forks 94 to advance the rollers 80 and the sleeves 72 axially to the left as shown in Figure 6 and as 110 indicated by the arrow This action will force the driver tube 50 which is threaded into the sleeve 72 to the left as viewed in Figure 6 against the bias of spring 56 Advancement of driver tube 50 will in turn produce an advance 115 ment of the staple ejector 160 since the neck 161 of this part is in contact with the end of the driver tube 50 Advancement of the staple ejector 160 will cause the fingers 162 to move through the respective slots 158 ejecting the 120 staples 159 contained therein The action of the fingers 162 against the staples 159 is depicted in Figure 15; the forward faces of the fingers 162 are all provided with a V-groove 163 in which the crossbar of the U-shaped 125 staple 159 is received This assures a better contact between the finger 162 and the staple 159 during ejection.
Referring to Figure 21, the action that takes place during ejection of the staple 159 is 130 1,602,562 generally depicted; as the staples 159 are advanced or ejected out from the slots 158, they are contacted by grooves 232 of the anvil 230 and bent into a conventional Bshape as depicted in Figure 21 Simultaneously with the advancement of the staple ejector 160, the knife 168, which is carried by the staple ejector 160, is axially advanced toward the anvil-carrying part and the knife edge 170 of the knife 168 will intersect with the interposed tissue ends of the trapped hollow organs (shown in phantom in Figure 22 at 300 and 302) The cutting edge 170 of the knife 168, which is circular in configuration, cuts through the tissues 300 and 302 and into the annular cutting block 244, which is held within the anvil 230 by means of the punched out parts 242, as previously described The advancing of driver tube 50 continues until stop 80 engages stop 100 on rod 52, the location of stop 100 being variable relative to the cartridge 44 and housing 10 in dependence upon tissue thickness However, regardless of the variable location of stop 100, driver tube 50 will travel whatever distance is necessary to bend the staples always into the same configuration There is, of course, a maximum limit to tissue thickness which a specific staple length can accommodate Figure 22 depicts in phantom the two concentric circular arrays of staples 159 which join together the ends of the hollow organ to be joined The excess portion of the ends of the hollow organ to be joined are severed by the action of knife edge 170 The vent holes 47 in anvil 230 and vent holes 49 formed in the body 210 allow for relief of gas, fluid or excess tissue trapped within the instrument on account of the procedure of stapling Thus during the closure of the cartridge 44 against the anvil part to clamp the tissue prior to stapling, the interior space between the cartridge and anvil becomes fluid-tight and were it not for the vent holes considerable pressure could be generated within the cavity after it has become fluid-tight but before the actual stapling action occurs The severed ends 300 and 302 of the hollow organ are retained around the centre rod 52 within the cavity defined between the anvil-carrying part and the staple-carrying part.
The next step in the procedure would be to rotate wing nut 60 to slightly increase the spacing between the anvil-carrying part and the staple-carrying part to allow the stapled part of the hollow organ to be withdrawn from oetween these instrument parts and passed over the anvil-carrying part 46 so that the instrument may be withdrawn To this end, the anvil.
carrying part 46 is provided with an external configuration of bowl-shape to facilitate the removal of the stapled organ from between the two parts 46 and 44 and passing of the stapled part of the organ over part 46.
This removal can be accomplished without stretching of the joined seam because the perimeter of the profile, in section through the axis as shown in Figure 16, of anvil-carrying part 46 is equal to or less than the circumference of the inner ring of staples represented by the inner circular array of spaced staple clinching grooves 232 in Figure 19 Thus with such a small perimeter for the sectional profile the inner periphery of the stapled seam can have one portion thereof brought against the side of the rod 52 while a diametrically opposite portion of the periphery is eased over the edge of the anvil-carrying part 46 before being brought to the periphery of the knob 48 to permit the remainder of the seam to pass over the anvil-carrying part 46.
Although the present invention has been shown and described in terms of a preferred embodiment, it will be appreciated that various changes may be made For example, the attachment of the anvil-carrying part 46 and the staple-carrying part 44 has been shown as a threaded engagement or attachment It is important that the attachment be one that may be easily performed in an operating theater and under difficult or extreme conditions Accordingly, any known technique for effecting connection between the parts 44 and 46 and the outer tube 30 and the rod 52, respectively, which would enable quick attachment and detachment would be suitable, for example, bayonet types of connections.
WHAT WE CLAIM IS:1 A two-part assembly for stapling a closed geometric pattern in the end portions of disconnected sections of hollow organs made of tissue, the assembly comprising an anvilcarrying part having a first tissue-receiving space defined therein; a staple-carrying part having a second tissue-receiving space defined therein, said staple-carrying part being associated with said anvil-carrying part for clamping said disconnected sections of said organs therebetween with said end portionsbeing received in said first and second spaces, said first and second spaces, during said clamping, defining a closed cavity; and relief means in at least one of said anvil-carrying and staplecarrying parts for communicating said closed cavity with the exterior of said assembly.