BRPI0702376B1 - surgical instrument in connection with a pneumatically energized tool and method for processing the same - Google Patents

Abstract

pneumatically energized surgical cutting and fixation instrument with audible and visual feedback aspects. The present invention relates to a surgical instrument for use in connection with a pneumatically energized tool having an operably supported launching mechanism therein which is movable between an unengaged position and a driven position. a pneumatically energized drive system operably communicates with the pneumatically energized tool and is configured to selectively apply at least one launch force to the pneumatically energized tool launch mechanism of sufficient magnitude to cause the launch mechanism to move from the non-triggered position to the triggered position in response to a gas flow from a gas source that is fluidly coupled to the pneumatically energized drive system. at least one return device communicates with the pneumatically energized drive system to provide feedback with respect to at least one of: (a) the magnitude of the launch force when the pneumatically energized drive system moves the release mechanism from position fired to fired and (b) a relative position of the launching mechanism when the launching mechanism is moved between the ungrounded and fired positions.

Description

Invention Patent Descriptive Report for SURGICAL INSTRUMENT IN CONNECTION WITH A PNEUMATICALLY ENERGIZED TOOL AND METHOD FOR PROCESSING THE SAME.

INVENTORS [001] Frederick E. Shelton, IV, a U.S. citizen having the address of P.O. Box 373, New Vienna, New Vienna, Ohio 45159,

Jerome R. Morgan, a U.S. citizen residing at 3275 S. Whitetree Circle, Cincinnati, Ohio 45236,

Eugene L. Timperman, a U.S. citizen residing at 10639 Silverbrook Drive, Cincinnati, Ohio 45240 and

Leslie M. Fugikawa, a U.S. citizen residing at 1000 Ligorio Avenue, Cincinnati, Ohio 45218.

CROSS REFERENCE WITH RELATED APPLICATIONS [002] This application relates to the following U.S. patent applications filed simultaneously, which are hereby incorporated by reference:

(1) PNEUMATICALLY POWERED SURGICAL CUTTING AND FASTENING INSTRUMENT WITH ACTUATOR AT DISTAL END; Inventors: Frederick E. Shelton, IV, Jerome R. Morgan, Eugene L. Timperman, and Leslie M. Fugikawa (K & LNG 060344 / END5911USNP);

(2) PNEUMATICALLY POWERED SURGICAL CUTTING AND FASTENING INSTRUMENT WITH A VARIABLE CONTROL OF THE ACTUATING RATE OF FIRING WITH MECHANICAL POWER ASSIST; Inventors: Frederick E. Shelton, IV, Jerome R. Morgan, Eugene L. Timperman, and Leslie M. Fugikawa (K & LNG 060323 / END5913USNP);

(3) PNEUMATICALLY POWERED SURGICAL CUTTING AND FASTENING INSTRUMENT WITH MECHANICAL LINKAGE

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2/110

COUPLING END EFFECTOR AND TRIGGER MOTION; Inventors: Frederick E. Shelton, IV, Jerome R. Morgan, Eugene L. Timperman, and Leslie M. Fugikawa (K & LNG 060346 / END5912USNP);

(4) PNEUMATICALLY POWERED SURGICAL CUTTING AND FASTENING INSTRUMENT WITH REPLACEABLE POWER SOURCES; Inventors: Frederick E. Shelton, IV, Jerome R. Morgan, Eugene L. Timperman, and Leslie M. Fugikawa (K & LNG 060326 / END5955USNP);

(5) PNEUMATICALLY POWERED SURGICAL CUTTING AND FASTENING INSTRUMENT WITH IMPROVED VOLUME STORAGE; Inventors: Frederick E. Shelton, IV and Jerome R. Morgan; (K & LNG 060327);

(6) PNEUMATICALLY POWERED SURGICAL CUTTING AND FASTENING INSTRUMENT WITH MANUALLY OPERATED RETRACTION APPARATUS; Inventors: Frederick E. Shelton, IV, Jerome R. Morgan, Eugene L. Timperman, and Leslie M. Fugikawa (K & LNG 060328 / END5957USNP); and (7) SURGICAL CUTTING AND FASTENING INSTRUMENT WITH DISTALLY MOUNTED PNUEMATICALLY POWERED ROTARY DRIVE MEMBER; Inventors: Frederick E. Shelton, IV, Jerome R. Morgan, Eugene L. Timperman, and Leslie M. Fugikawa (K & LNG 060329 / END5958USNP).

BACKGROUND [003] The present invention relates, in general, to surgical instruments and, more particularly, pneumatically powered surgical cutting and clamping instruments. The present invention can have application in conventional open and endoscopic surgical instrumentation, as well as application in robotic assisted surgery.

[004] Surgical cutting and fixing instruments (staplers) have been used in the prior art to simultaneously make a

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3/110 longitudinal incision in the tissue and apply staple lines on opposite sides of the incision. Such instruments generally include a pair of collaborative jaw elements that, whether the instrument is intended for endoscopic or laparoscopic applications, are capable of passing through a cannula passage. One of the jaw elements receives a staple cartridge having at least two laterally spaced rows of staples. The other jaw element defines an anvil having staple-forming cavities aligned with the rows of staples in the cartridge. The instrument includes a plurality of reciprocal wedges which, when conducted in the distal direction, pass through the openings in the staple cartridge and engage drivers that support the staples to effect the release of the staples to the anvil.

[005] Over the years, a variety of different methods for driving the cutting and clamping components have been developed. For example, U.S. Patent No. 6,978,921 to Shelton, IV and others describes a surgical stapling instrument that uses staple and tissue cutting components that are conducted through the manual actuation of various trigger mechanisms on the handle. Other surgical stapling devices have been developed that use battery powered motors. Such a device is described in U.S. Patent No. 5,954,259 to Viola et al.

[006] Still other surgical staplers are powered by a source of pressurized gas. For example, U.S. Patent No. 6,619,529 to Green et al. Describes a surgical stapler that uses a source of pressurized gas in the handle that is used to energize a cylinder that is also located inside the handle. The cylinder houses a piston assembly that is driven by the admission of pressurized gas into the cylinder. The piston is configured to act together with the components located in the elongated tube portion

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4/110 do and handle element to cause the disposition of the clamps and the surgical knife in the end executor mounted in the distal direction. Such a design, however, uses a complex collection of components to transmit the movement of the piston mounted on the handle to the components located in the end portion of the device. In addition, when using such a device, there is a risk that the energy source will be depleted during the surgical procedure because there is no way to monitor the amount of gas remaining in the gas cartridge. If this occurs during release or retraction cycles, such devices lack the means to easily replace the spent container with a new container or auxiliary power source.

[007] Another pneumatically powered surgical stapling device is described in US Patent Publication No. US 2006/0151567 to Roy. This device uses a pneumatically powered motor or piston system supported on the handle of the device to create a movement that is used to drive the end executor. This device can be powered by removable cartridges or an external power source, such as the hospital's supply of pneumatic air or gas.

[008] Such pneumatically powered devices that use cartridges or containers on the handle portion of the device are also hampered by the size of the gas cylinder required to store the pressurized gas in sufficient volumes to facilitate the actuation of the device a desired number of times in one minimum usable pressure. In the past, devices designed for large numbers of applications / procedures would require that a large cylinder be used or, if smaller cylinders were used, such cylinders would have undesirably high pressures. In addition, devices that use removable cartridges that can be used a

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5/110 unlimited number of times must be processed and sterilized again. Such provisions can dramatically change performance capabilities and may therefore be less desirable.

[009] Other problems exist with the previous pneumatically driven cutters. For example, after the surgeon activates the instrument using a single key or activation trigger, the instrument progresses through or at least attempts to complete the launch cycle. The launch components can then be retracted by the drive system. Although the surgeon using the device described in US Patent Publication US 2006/0151567 can interrupt the release cycle and / or adjust the flow of gas to the device via a trigger assembly, there is no way to monitor the progress of the device . In addition, such prior devices lack a means to manually retract the knife and release bar mechanism, in case the operating pressure is lost or interrupted during the procedure. In addition, this device lacks a means to enable the clinician to manually apply additional force to the drive system to assist with the advancement of the launch mechanism or to delay its advance.

[0010] Consequently there is a need for a pneumatically powered surgical stapling device that does not require the use of an extensive collection of components to transfer the pneumatically generated stapling and release movements to the components of the end executor.

[0011] There is another need for a pneumatically energized surgical stapling device that provides a means for the surgeon to control and monitor the progress of the device as it moves through the release and retraction cycles.

[0012] There is another need for a gram device

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6/110 pneumatically energized surgical plating that provides tactile feedback and others to the surgeon regarding the forces encountered during launch and also notification of when the device has reached its triggered position and is ready to be retracted.

[0013] There is a need for a pneumatically powered surgical stapling device that is economical and has the ability to easily switch between energy sources, while limiting the number of times that such sources can be switched.

[0014] There is another need for methods and apparatus for more efficient storage of gas in cylinders used to energize surgical stapling devices such that more uses can be energized from a single cylinder.

[0015] There is yet another need for a pneumatically powered stapling device that has the means to manually retract the knife and launch bar assembly in the event that pneumatic energy is lost or interrupted.

[0016] There is still another need for devices with one or more of the aspects mentioned above and that also have an end executor that can be selectively articulated in relation to the handle assembly and / or portion of the elongated shaft assembly in which it is attached .

[0017] There is yet another need for devices with one or more of the aspects identified above that are also capable of accommodating removably affixed end executors to facilitate the use of the device in connection with disposable end executor arrangements.

SUMMARY [0018] In a general aspect, the present invention is directed to a surgical instrument for use in connection with a tool

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7/110 pneumatically powered having a release mechanism operably supported on it that is movable between an un-actuated position and an actuated position. In various modalities, the surgical instrument comprises a pneumatically powered drive system that communicates operably with the pneumatically powered tool and is configured to selectively apply at least one launch force to the pneumatically powered tool's release mechanism of sufficient magnitude to make causing the launch mechanism to move from the non-triggered position to the triggered position in response to a gas flow from a fluidly coupled gas source in the pneumatically powered drive system. At least one feedback device communicates with the pneumatically powered drive system to provide feedback with respect to at least one of:

(a) the magnitude of the release force when the pneumatically powered actuation system moves the launch mechanism from the non-actuated to the actuated position; and (b) a relative position of the launch mechanism when the launch mechanism is moved between the non-triggered and the triggered positions.

[0019] In another general aspect, the present invention is directed to a surgical instrument comprising a handle assembly and a closing drive that is supported by the handle assembly. The closing drive can be configured to generate a closing movement and an opening movement. An elongated shaft assembly can be coupled to the handle assembly such that it communicates with the closing drive to transfer the opening and closing movements. A pneumatically powered drive system is supported by at least one of the

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8/110 handle assembly and the elongated shaft assembly and is configured to selectively generate at least one of a release force and a retraction force. The instrument may also include an end runner that is coupled to the elongated shaft assembly. In various embodiments, the end runner may comprise an elongated channel that is sized to receive a staple cartridge therein. The end executor may also comprise an anvil that is pivotally coupled to the elongated channel and is pivotally responsive to the opening and closing movements of the elongated shaft assembly. In addition, the end executor may comprise a launching mechanism that is operably supported within one of the elongated channel and the staple cartridge and is movable from an un-actuated position to an actuated position in response to an application of the launch of the drive system. The release mechanism can also be movable from the driven position to the non-driven position in response to another application of the retraction force of the drive system. The surgical instrument may also comprise at least one feedback device that communicates with the drive system to provide feedback with respect to at least one of:

(a) a magnitude of the launch force when the drive system moves the launch mechanism from the non-driven to the driven position; and (b) a relative position of the launch mechanism when the launch mechanism is moved between the non-triggered and the triggered positions.

DRAWINGS [0020] Various embodiments of the present invention are described here by way of example in conjunction with the following figures, where similar numerals can be used to describe similar parts

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9/110 and in which:

figure 1 is a perspective view of an embodiment of a surgical cutting and fixing instrument of the present invention;

figure 2 is an exploded view of an end executor arrangement that can be used in connection with various embodiments of the present invention;

figure 3 is a top view of the end executor of figures 1 and 2 with the anvil portion removed from it and the closing tube assembly illustrated in broken lines;

figure 4 is a cross-sectional side view of the end executor arrangement of figure 3 with the anvil portion attached to it and shown in an open position;

figure 5 is a top cross-sectional view of a portion of a joint control that can be used with various embodiments of the present invention;

figure 6 is an upper cross-sectional view showing the articulation of the end executor shown in figure 1;

Figure 7 is a view of the exploded assembly illustrating an embodiment of an arrangement of the closing tube and shuttle assembly supported within the handle assembly with other components housed within the housing assembly being omitted for clarity;

figure 8 is a cross-sectional view of an arrangement of the housing arrangement of various embodiments of the present invention;

Figure 8A is a partial cross-sectional view of a portion of a lock trigger locking system that can be used in connection with various embodiments of the present invention;

figure 8B is a cross-sectional view of another

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10/110 modality of the handle assembly of the present invention where the source of pressurized gas is external to the handle assembly;

figure 8C is a cross-sectional view of another embodiment of the handle assembly of the present invention;

figure 9 is another cross-sectional view of the handle assembly of figure 8;

figure 10 is a side view of a knife bar arrangement and a launch drive element comprising a two-stage cylinder assembly of various embodiments of the present invention with the cylinder assembly shown in cross section;

figure 11 is another side view of the knife bar and two-stage cylinder arrangements shown in figure 10 with the knife bar in the extended position;

figure 12 is a side view of another knife bar and launch drive element of the present invention with the knife bar being retracted into a cylinder assembly shown in cross section;

figure 13 is another side view of the knife and cylinder bar arrangements shown in figure 12 with the knife bar in the extended position;

figure 14 is a top view of an end executor and support assembly arrangement housing the knife bar and cylinder arrangements shown in figures 12 and 13;

figure 15 is a cross-sectional side view of the end executor and support assembly arrangement shown in figure 14 with the anvil portion attached to it and in the open position;

figure 16 is a cross-sectional view of a handle set that can be used in connection with the reprePetition mode 870180138022, from 10/05/2018, pg. 12/144

11/110 seated in figures 12-15;

Figure 16A is a cross-sectional view of another handle assembly that can be used in connection with the embodiment shown in Figures 12-15 where the pressurized gas source is external to the handle assembly;

figure 16B is a cross-sectional view of another embodiment of the handle assembly of the present invention;

Figure 17 is a top view of another knife bar and support assembly arrangement that supports another launch drive element in the form of a bellows assembly of another embodiment of the present invention;

figure 18 is a cross-sectional side view of the arrangements of the end executor and support set of the embodiment shown in figure 17, figure 19 is a partial cross-section view of a bellows assembly of the modalities represented in figures 17 and 18;

figure 20 is an enlarged view of a portion of the bellows assembly of figure 19;

figure 21 is a cross-sectional view of an embodiment of the handle assembly that can be used in connection with the embodiments shown in figures 17-20;

figure 21A is a cross-sectional view of another embodiment of the handle assembly that can be used in connection with the embodiments of figures 17-20 where the pressurized gas source is external to the handle assembly;

figure 21B is a cross-sectional view of another embodiment of the handle assembly of the present invention;

figure 22 is a perspective view of another surgical cutting and fixation instrument according to other modalities

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12/110 of the present invention;

figure 23 is a cross-sectional side view of the end executor and support set of the embodiment shown in figure 22;

figure 24 is a cross-sectional view of the arrangement of the quick-disconnect joint of the embodiment of figures 22 and 23 before coupling the distal axis assembly to the proximal axis assembly;

figure 25 is a cross-sectional view of the proximal axis assembly taken along line 25-25 in figure 24;

figure 26 is a partial perspective view of the distal axis assembly attached to the proximal axis assembly with a portion of the distal axis assembly clearly omitted, figure 27 is a cross-sectional side view of the modal joint assembly figures 24-26 with the distal axis assembly coupled to the proximal axis assembly;

figure 28 is a perspective view of a portion of the distal axis assembly prior to attachment to a portion of the proximal axis assembly;

figure 29 is a partial cross-sectional view of another quick disconnect joint arrangement that can be used with the embodiment shown in figures 12-16A;

figure 30 is a cross-sectional view of the proximal axis assembly taken along line 30-30 in figure 29;

figure 31 is a perspective view of a portion of a proximal axis assembly that can be used in connection with the modalities shown in figures 22-30;

figure 32 is a perspective view of another surgical cutting and fixation instrument of the present invention that uses a pneumatically operated articulation joint in various modes. Petition 870180138022, of 10/05/2018, pg. 12/164

13/110 activities of the present invention;

figure 33 is a partial perspective view of a portion of the articulation joint securing a distal support segment to a proximal support segment of the embodiment shown in figure 32;

figure 34 is another perspective view of the joint arrangement of figure 33 with the cover removed from it and illustrating the distal support segment articulated in relation to the proximal support segment;

figure 35 is an exploded view of the articulation joint arrangement of figures 33 and 34;

figure 36 is a cross-sectional side view of the joint assembly of figures 33-35;

figure 37 is a perspective view of an embodiment of the key set of the present invention;

figure 38 is a side projection view of the key assembly of figure 37;

figure 39 is a cross-sectional view of the key assembly of figures 37 and 38 taken along line 39-39 in figure 37;

figure 40 is a cross-sectional view of the key assembly in the off position taken along line 40-40 in figure 38;

figure 41 is another cross-sectional view of the key assembly of figures 37-40 in an actuated position;

figure 42 is a cross-sectional view of the key assembly of figure 41 taken along line 42-42 in figure 41;

figure 43 is a bottom view of the key assembly of figures 37-42;

Figure 44 is a cross-sectional view of an assembly

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14/110 handle that has the key set of figures 37-43 in it and houses a source of pressurized gas;

figure 45 is a cross-sectional view of a handle assembly having the key assembly of figures 37-43 therein and where the pressurized gas source is external to the handle assembly;

figure 46 is a perspective view of another stapling and surgical cutting instrument of the present invention using the articulation joint modalities shown in figures 33-36 and the quick disconnect joint modalities shown in figures 23-31;

Fig. 47 is a cross-sectional view of the quick-disconnect joint arrangement of the embodiment of Fig. 46 before coupling the distal axis assembly to the proximal axis assembly;

figure 48 is a cross-sectional view of the gasket assembly of the modalities of figure 47 taken along line 48-48 in figure 47;

figure 49 is a perspective view of another embodiment of the surgical cutting and fixing instrument of the present invention;

figure 50 is an exploded view of an end executor arrangement that can be used in connection with the embodiment shown in figure 49;

figure 51 is an exploded view of an end executor arrangement, support assembly and closing tube assembly that can be used in connection with the embodiment shown in figure 49;

figure 52 is a cross-sectional side view of the end executor, support assembly and closing tube assembly of figure 51 with the anvil portion omitted for clarity;

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15/110 figure 52A is a cross-sectional side view of an end executor, support assembly and closing tube assembly of another non-limiting embodiment of the present invention where the pneumatically powered motor is supported in the direction distal to the handle set;

figure 52B is a cross-sectional side view of an end executor, support assembly and closing tube assembly of another non-limiting embodiment of the present invention in which the pneumatically powered motor is supported distally to the assembly of fist;

figure 53 is a cross-sectional view of a handle assembly that can be used in connection with the embodiment of figure 49;

figure 53A is a cross-sectional view of another handle assembly that can be used in the manner of figure 49 where the source of the pressurized gas is external to the handle assembly;

figure 54 is another cross-sectional view of the handle assembly of figure 53;

figure 55 is a side view of a relative positioning trigger arrangement of various embodiments of the present invention;

Fig. 56 is a schematic of an embodiment of the control system of the present invention that can be used in connection with various embodiments of the present invention;

figure 57 is a cross-sectional view of a detachable stock portion separated from a primary fixing portion of various embodiments of the wrist assembly of the present invention;

figure 58 is a partial cross-sectional view showing the detachable stock portion coupled to the fixing portion

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Primary 16/110 of a cuff assembly of various embodiments of the present invention;

figure 59 is a partial cross-sectional view of the detachable stock portion and primary fixation portion of figure 58 with the head and cylinder related components omitted for clarity;

figure 60 is a cross-sectional view of the detachable stock portion and primary fixing portion of figures 58 and 59 taken along line 60-60 in figure 59;

figure 61 is a cross-sectional view of the detachable stock portion and primary fixation portion of figures 58,59 and 60 taken along line 61-61 in figure 59;

figure 62 is a cross-sectional view of the detachable stock portion and primary fixing portion of figures 58-61 taken along line 62-62 in figure 59;

figure 63 is another partial cross-sectional view of the detachable stock portion and primary fixing portion of figures 58-62 taken along line 63-63 in figure 59;

figure 64 is a diagrammatic view of an embodiment of the locking system of the present invention in an initial position;

Fig. 65 is another diagrammatic view of the locking system of Fig. 64 illustrating its action when the stock portion is initially attached to the primary fixing portion of the handle assembly;

figure 66 is another diagrammatic view of the locking system of figures 64 and 65 before the second separation of the stock portion from the primary fixing portion of the handle assembly;

Fig. 67 is another diagrammatic view of the locking system of Figures 64-66 that illustrates the positions of the system components when the stock portion has been attached to the portion

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17/110 of primary fixation;

figure 68 is another diagrammatic view of the locking system of figures 64-67 which illustrates the position of the system components during the second fixing of the stock portion to the primary fixing portion;

Fig. 69 is another diagrammatic view illustrating the locking system after the stock portion has been attached to the primary fixing portion for the second and final time;

figure 70 is a perspective view of another embodiment of the surgical cutting and fixing instrument of the present invention;

figure 71 is a cross-sectional view of an embodiment of the handle assembly that can be used in connection with the instrument shown in figure 70;

Fig. 72 is a exploded view of a shuttle and retract rod assembly of various embodiments of the present invention;

Fig. 72A is an exploded view of a shuttle and retract rod assembly of other embodiments of the present invention;

Fig. 73 is an assembled view of the components shown in Fig. 72 with its cylinder assembly in a fully extended position;

figure 74 is a rear projection view of an embodiment of the shuttle assembly of the present invention;

Fig. 75 is another rear projection view of the hook assembly of Fig. 74 with the retracting rod and thrust bar extending into the opening of the thrust bar and with the thrust bar attached to the connector element;

figure 76 is a perspective view in rear projection

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18/110 of the left side portion of the shuttle assembly;

Figure 77 is another perspective view in rear projection of the left side portion of the shuttle assembly;

figure 78 is a schematic representation of an arrangement of the control system that can be used with the modalities shown in figures 70-77;

Fig. 79 is an upper cross-sectional view of an arrangement of the handle assembly of the embodiments shown in Figures 70-78 with the cylinder assembly in an extended position;

Fig. 80 is another top cross-sectional view of an arrangement of the handle assembly of the embodiments shown in Figs. 70-79 with the cylinder assembly in a retracted position;

Figure 81 is a cross-sectional view of a handle assembly of the modalities shown in Figures 70-80;

figure 81A is a cross-sectional view of a handle assembly modality that can be used with the embodiment shown in figures 70-80 where the pressurized gas source is external to the handle assembly;

Fig. 82 is another cross-sectional view of the handle assembly of Fig. 81 where the cylinder assembly is extended;

Fig. 83 is another cross-sectional view of the handle assembly of Fig. 81 where the cylinder assembly is retracted; and

Fig. 83A is a cross-sectional view of a handle assembly of the embodiment shown in Fig. 72B where the cylinder assembly is retracted and the launch rod is in its most proximal position.

Detailed Description [0021] With reference to the drawings where similar numerals represent similar components for all the various views, figure 1

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19/110 represents a surgical stapling and cutting instrument 10 that is capable of practicing several unique benefits of the present invention. The embodiment illustrated in figure 1 includes a handle assembly 300, an elongated shaft assembly 100 and an end holder 12 that is connected to the elongated shaft assembly 100. Various embodiments of the present invention may include an end holder that is hingedly attached in the set of elongated shaft 100 and articulated driven by bending cables or strips such as those described in US Patent Application Serial No. 11 / 329,020, filed on January 10, 2006, entitled SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR, the description of which is incorporated herein by reference. However, as the present detailed description proceeds, those skilled in the art will find that various embodiments of the present invention can be successfully practiced in connection with the end executor arrangements that use different articulation mechanisms and controls and, as will be explained in more details below, can even be used successfully with non-articulated end executor arrangements.

[0022] As can be seen in figure 1, the handle assembly 300 of the instrument 10 may include a closing trigger 302 and a release trigger 310. It will be seen that instruments having end performers directed to different surgical tasks may have numbers or different types of triggers or other controls suitable for the operation of an end executor. The end executor 12 is shown separate from the handle assembly 300 by the preferably elongated shaft assembly 100. A clinician can articulate the end executor 12 with respect to the axis assembly 100 using a hinge control 200.

[0023] It should be verified that spatial terms such as vertical,

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20/110 horizontal, right, left etc. are provided here with reference to the figures assuming that the longitudinal axis of the surgical instrument 10 is coaxial with the central axis of the elongated axis assembly 100, with the triggers 302,310 extending downward at an acute angle from the base of the handle assembly 300. real practice, however, the surgical instrument 10 can be oriented at various angles and, as such, these spatial terms are used in relation to the surgical instrument itself 10. In addition, proximal is used to represent a perspective of a clinician who is behind of the handle assembly 300 which places the end executor 12 distal or distant from itself.

[0024] As used here, the term pressurized gas refers to any gas available for use in pneumatically powered systems used in a sterile environment. Non-limiting examples of such media include compressed air, carbon dioxide (CO2), nitrogen, oxygen, argon, helium, sodium hydride, propane, isobutane, butane chlorofluorocarbons, dimethyl ether. Ethyl methyl ether, nitrous oxide, hydrofluoroalkanes (HFA) - for example, HFA 134a (1,1,1,2, -tetrafluoroethane) or HFA 227 (1,1,1,2,3,3,3heptafluoropropane).

[0025] As used here, the term fluidly coupled means that the elements are coupled together with an appropriate line or other means to allow the passage of pressurized gas between them. As used here, the term line as used in the supply line or return line refers to an appropriate passage formed of rigid or flexible duct, pipe, piping, etc. to transport pressurized gas from one component to another.

[0026] As used here the terms pneumatic signal or pneumatically actuated signal refer to the flow of gas from a pressurized gas source to one or more components that are coupled

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21/110 with fluidity in the pressurized gas source or the gas flow between the components that are coupled with fluidity.

[0027] As used here, the phrase substantially transversal to the longitudinal axis where the longitudinal axis is the axis of the axis, refers to a direction that is almost perpendicular to the longitudinal axis. It will be verified, however, that the directions that deviate a little from the perpendicular to the longitudinal axis are also substantially transversal to the longitudinal axis.

[0028] Figure 2 illustrates an exploded view of a type of pneumatically operated tool set or end runner that can be used in various embodiments of the present invention. The pneumatically operated tool set 12 shown in figures 1-4 is configured to act as an end cutter. As the present detailed description proceeds, however, it will be seen that a number of unique and new drive arrangements of the modalities of the present invention could also conceivably be used to drive other end executors configured to perform other surgical tasks and thus requiring removal , modification or addition of components than shown in the figures. Also, it will be seen that the end performers 12 shown in figures 1-4 can be customized for specific surgical applications.

[0029] A type of end executor that can be used with various modalities of the present invention is represented in figure 2. As can be seen in that figure, end executor 12 uses an E-beam launching mechanism (knife set) 30 which, in addition to cutting the fabric and launching staples located in a staple cylinder accommodated therein, advantageously controls the spacing of an anvil portion of the end executor 12 in relation to the staple cylinder. Various aspects of mechanisms

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22/110 E-beam launch methods are described in U.S. Patent No. 6,978,921, entitled Surgical Stapling Instrument Incorporating an EBeam Firing Mechanism to Shelton, IV and others, the relevant portions of which are hereby incorporated by reference. As the detailed description proceeds, however, those skilled in the art will find that other knife configurations and launching mechanisms can be used advantageously without departing from the spirit and scope of the present invention.

[0030] As used here, the term launching mechanism refers to the portion or portions of the pneumatically powered tool and / or end executor that moves from an un-engaged position where the launching mechanism may be essentially at rest to an engaged position or final where that portion or portions were moved or repositioned to a final position where such movement of the same resulted in the tool completing one or more actions in response to the application of at least one launch movement on it. The launching mechanism may comprise, for example: (i) components that are fully supported by the pneumatically powered tool and interface with components in the surgical device; (ii) a combination of components that are located on the pneumatically powered tool and the surgical device or (ii) components that are supported by the surgical device and are movable in and out of the pneumatically powered tool. As used here, the term launch stroke refers to the actual movement of the launch mechanism from the non-triggered position to the triggered position. The term retraction stroke refers to the return movement of the release mechanism from the triggered position to the non-triggered position.

[0031] As can be seen in figure 2, the ex executor

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23/110 trembling 12 includes a distal element which, in various non-limiting embodiments, comprises an elongated channel 20 having an articulably translatable anvil 40 attached to it. The elongated channel 20 is configured to receive and support a staple cartridge 50 which is responsive to the knife assembly 30 for guiding the staples 70 for forming contact with the anvil 40. It will be found that, although a readily replaceable staple cartridge is described advantageously here, a staple cartridge consistent with aspects of the present invention can be permanently attached or integral with the elongated channel 20.

[0032] In various embodiments, the launching mechanism or knife set 30 includes vertically spaced pins that control the spacing of the end executor 12 during launch. In particular, upper pins 32 are arranged to enter an anvil cavity 42 near the pivot between the anvil 40 and the elongated channel 20. See Figure 4. When launched with the anvil 40 closed, the upper pins 32 advance in the distal direction. a slit in the longitudinal anvil 44 extending distally through the anvil 40. Any minor upward deflection in the anvil 40 is overcome by a downward force provided by the upper pins 32.

[0033] Knife assembly 30 also includes a knife bar cover 34 which engages upward a groove in channel 23 (figure 2) formed in elongated channel 20, thereby cooperating with upper pins 32 to pull anvil 40 and the elongated channel 20 firmly closer in the event of excessive tissue stuck between them. In various embodiments, the knife assembly 30 may advantageously include intermediate pins 36 that pass through a launch drive slot (not shown) formed on a lower surface of the cartridge 50 and an ascending surface of the alon channel.

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24/110 cattle 20, thereby driving the clamps 70 therein as described below. The intermediate pins 36, sliding against the elongated channel 20, advantageously resist any tendency of the end executor 12 to become trapped closed at its distal end. However, the unique and new aspects of the various embodiments of the present invention can be achieved through the use of other knife set arrangements.

[0034] Back to figure 2, a cutting edge shown in the distal direction 38 between the upper and intermediate pins 32,36 in the knife set 30 goes through a vertical slot shown in the proximal direction 54 in the cartridge 50 to cut the stuck tissue. The affirmative positioning of the knife set 30 with respect to the elongated channel 20 and anvil 40 ensures that an effective cut is performed. In various embodiments, the lower surface of the anvil 40 can be provided with a plurality of staple forming cavities therein (not shown) which are arranged to correspond with a plurality of staple openings 58 on an upper surface 56 of the staple cartridge 50 when the staple cartridge 50 is received within the elongated channel. In various embodiments, the staple cartridge 50 can be snapped into the elongated channel 20. Specifically, extension aspects 60.62 of the staple cartridge 50 engage with friction and so that they can be released into the recesses 24,26, respectively of the elongated channel 20.

[0035] As can also be seen in figure 2, the clamp cartridge 50 comprises a cartridge body 51, a wedge sleigh 64, clamp drivers 66, clamps 70 and a cartridge tray 68. When assembled, the tray cartridge 68 holds wedge sled 64, clamp drivers 66 and clamps 70 within cartridge body 51. Elongated channel 20 is coupled to handle assembly 300 by elongated shaft assembly 100 which includes a section

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25/110 support or distal frame 110 and a support section or proximal frame 130. The elongated channel 20 has fixation holes placed in the proximal direction 22 which each receive a corresponding channel support element 114 formed at the distal end of the distal support section 110. The elongated channel 20 also has anvil cam slots 28 that pivotally receive a corresponding anvil pivot 43 on the anvil 40. A closing sleeve assembly 170 is received over the support assembly 102 and includes the segment distal closing tube 180 and a proximal closing tube segment 190. As will be discussed below, the axial movement of the closing sleeve assembly 170 in relation to the support assembly 102 causes the anvil 40 to articulate in relation to the elongated channel 20.

[0036] As can be seen in figure 2, a retaining spring 112 is mounted on the distal support segment 110 as a lock for the knife assembly 30. Square distal and proximal openings 111,113 are formed at the top of the distal support segment 110 to define a clip bar 115 between them which receives an upper arm 116 of the closing spring 112 whose lower arm extended distally 118 exerts a downward force on a distal end of a cylinder assembly 501 supporting the piston bar portion 35 protruding from knife set 30 as will be discussed in more detail below. It will be verified that several modalities can include other types of locks or without locks at all.

[0037] In the embodiment shown in figures 1-6, the end executor 12 can be articulated in relation to the segment of the proximal closing tube 190 (and handle set 300) by a collection of cables or bands that are curved to pull the end executor 12 around a pivot 104. Those skilled in the art

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26/110 will understand that such an arrangement represents only one of the many articulation arrangements that can be used in connection with these types of devices. In this embodiment, the proximal end of the distal support segment 110 has a shoulder 122 therein. The distal end of the proximal support segment 130 is provided with a spike 134 having an opening 136 therethrough. The proximal support segment 130 is positioned in relation to the distal support segment 110, such that the opening 136 is aligned coaxially with an opening 124 in the shoulder 122 to enable the pivot pin 138 to extend through it. See figure 4. Such an arrangement, when assembled, allows the end executor 12 to articulate in relation to the proximal support segment 130 around the pivot axes A-A.

[0038] As indicated above, this modality uses strips to articulate the end executor 12. In particular, the strips 150,160 can extend in the distal direction to the articulation pivot 104 as shown in figures 2 and 3. The stripe 150 can be extend through the proximal closing tube segment 190 along its left side where it is routed around the strip member 160 and transversely to the right side of the proximal closing tube segment 190. There, the strip 150 can be mechanically coupled to the shoulder 122, for example, at the connection point 123. Likewise, the strip 160 can extend through the proximal closing tube segment 190 along its right side where it is routed around the strip element 150 and transversely to the left side of the proximal closing tube segment 190. There, the strip 160 can be mechanically coupled to the shoulder 122 at the connection point 125.

[0039] Figure 3 is a top view of the end executor and support assembly 102 with the closing tube assembly

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27/110

100 represented in dashed lines. Figure 4 is a partial cross-sectional side view of the same portion of the instrument 10. As can be seen in Figure 4, tracks 150 and 160 are shown offset from one another to prevent interference with movement in a non-limiting manner. . For example, range 150 is shown in a lower position than range 160. In another non-limiting mode, the vertical positioning of ranges 150 and 160 can be inverted. As can also be seen in Figures 2 and 3, the strip element 150 extends around a pin 140 in the spike portion 134 of the proximal frame segment 130. Likewise, strip 160 extends around pin 142 in the spike portion 134 of the proximal frame segment 130. See also, figure 2.

[0040] Portions of strip 150 and 160 can extend from the shoulder 122 and along the segment of the proximal closing tube 190 to the articulation control 200, shown in figure 5. The articulation control 200 can include an articulation cursor 202 , a frame 204 and a housing 206. Portions of strip 150,160 can pass through the hinge slider 202 through slot 208 or another opening, although it is found that portions of strip 150,160 can be coupled to slider 202 by any suitable means. The articulation cursor 202 can be one-piece, as shown in figure 5, or it can in a non-limiting mode, include two pieces with an interface between the two parts defining the slot 208. In a non-limiting mode, the articulation cursor 202 may include multiple slits, for example, with each slot corresponding to one of the portion of strip 150,160. Housing 206 may cover the various components of control 200 to prevent debris from entering.

[0041] In various modalities, portions of strip 150,160 can be supported on frame 204 at connection points 210,212 located

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28/110 located proximal to the slot 208. The non-limiting mode of figure 5 shows that the strip portions 150, 160 are pre-curved from the connection points 210,212 to the slot 208 located near the longitudinal axis of the pipe segment. proximal closure 190. It will be seen that the portions of strip 150,160 can be supported anywhere on the instrument 10 located proximal to the slot 208, including the handle assembly 300.

[0042] In use, the modality of figure 2 can have an un-articulated position as shown in figure 3. The articulation control 200 and bands 150,160 are shown in a position centered approximately on the longitudinal axis of the axis assembly 100. In this way , end runner 12 is in a neutral or non-hinged position. In figure 6, the articulation control 200 is shown with the articulation cursor 202 pushed through the articulation frame to the right side of the axis assembly 100. In this way, the bands 150,160 are curved to the right side of the axis assembly 100 It can be seen that the curvature of the strip 150 to the right exerts a laterally directed force on the shoulder 122 which is displaced from the pivot point of the shoulder 122. This displacement force causes the shoulder 122 to rotate around the pivot pivot 104, in this way causing the end executor 12 to pivot to the right as shown. It will be seen that pushing the articulation cursor 202 to the left side of the shaft assembly 100 can exert a laterally directed force on the tracks 150,160, bending both bands 150,160 to the left side of the shaft assembly 100. The curvature of the track 160 then exerts a laterally directed force on the shoulder 122, which as above, is displaced from the pivot point of the shoulder 122. This, in turn, causes the shoulder 122 to rotate around the pivot pivot causing the end executor 12 to pivot to the left.

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29/110 [0043] In various embodiments, the shaft assembly 100 is comprised of a closure tube assembly 170 that is received in the support assembly 102. See figure 2. The closure pipe assembly 170 comprises a pipe segment distal closure tube 180 and a proximal closure tube segment 190. The distal closure tube segment 180 and the proximal closure tube segment 190 can be manufactured from a polymer or other suitable material. The proximal closing tube segment 190 is hollow and has an axial passage 191 extending through it that is sized to receive a portion of the support assembly 102 therein.

[0044] In the embodiment shown in figures 2 and 4, a double pivot closure joint 172 is used. It will be appreciated that the invention is not limited to the double pivot closure joint design and can include any suitable closing tube or sleeve, or no closing tube or sleeve at all. With particular reference to figure 4, the segment of the distal closing tube 180 has ears of upper and lower proximal projection 182,184. The segment of the distal closing tube 180 also includes a horseshoe opening 185 and projection 186 to engage the opening / closing projection of the anvil 46 on the anvil 40 to cause the anvil 40 to articulate between the open and closed positions as will be discussed in more details below. See figure 2.

[0045] The proximal closing tube segment 190 is similarly provided with an upper spindle extending distally 192 and a lower spindle extending distally 194. An upper double pivot link 174 includes distal and proximal pivot pins that projecting upwards 175,176 which respectively engage an upper distal pin hole 183 in the upper proximal projection spike 182 and an upper proximal pin hole 193 in the projection spike

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Upper distal 30/110 192. The joint arrangement also includes a lower double pivot link 177 that has distal and proximal pivot pins projected downward 178,179 (not shown in figure 2, but see figure 4) that respectively engage a pin hole distal lower 187 in the lower proximal projection spike 184 and a lower proximal pin hole 195 in the lower distal projection spike 194.

[0046] In use, the closing tube assembly 170 is moved in the distal direction to close the anvil 40, for example, in response to the actuation of the closing trigger 310. The anvil 40 is closed by distal translation of the tube assembly. closing 170 in support assembly 102, causing the rear part of the horseshoe opening 185 to hit the opening / closing projection 46 on the anvil 40 and make it articulate to the closed position. To open the anvil 40, the closing tube assembly 170 is moved axially in the proximal direction on the support assembly 102 causing the projection 186 to contact and push against the opening / closing projection 46 to articulate the anvil 40 to the open position.

[0047] Figure 7 illustrates an exploded view of a non-limiting wrist assembly 300 of the various embodiments of the present invention. In the embodiment shown in figure 7, the handle assembly has a pistol stock configuration and is formed of a housing element on the right 320 and a housing element on the left 330 which are molded or otherwise made of a polymer or other suitable material and are designed to come together. Such housing elements 320 and 330 can be secured together by pressure aspects, handles and molded sockets or otherwise formed therein and / or by adhesive, screwdrivers, screws, clips etc. The upper portion 322 of the housing element on the right 320 joins with a corresponding upper portion 323 of the left housing element 330 to form an indicated primary housing portion

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31/110 as 340. Similarly, the lower stock portion 324 of the right housing element 320 joins with the lower stock portion 334 of the left housing element to form a stock portion generally indicated as 342. In the embodiment shown in figure 7, the entire stock portion 342 is integral with the primary housing portion 340. Such an arrangement may be particularly well suited for applications where a pressurized gas source is permanently installed within the stock portion 342. Such an arrangement is also suitable for use with pressurized gas sources that are external to the handle assembly 300 and connected to the control components housed therein through a hole or holes in the housing assembly. In other embodiments, as will be described in more detail below, the stock portion 342 is detachable from the primary housing portion 340. As will be seen as the present detailed description proceeds, such a provision provides a multiplicity of benefits and advantages. Those skilled in the art will easily find, however, that the handle assembly 300 can be provided in a variety of different shapes and sizes.

[0048] For the sake of clarity, figure 7 only illustrates the components used to control the axial movement of the closing tube assembly 170 that finally controls the opening and closing of the anvil 40. As can be seen in this figure, a shuttle closure 400 which is coupled to the closing trigger 302 by a hinge assembly 430 is supported within the primary housing portion 340. The closing shuttle 400 can also be made of two pieces 402,404 which are molded or otherwise made of a polymer or other suitable material and are designed to come together. For example, in the embodiment illustrated in figure 7, the right portion 402 can be provided with fastener columns 403 which are designed to be received within

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32/110 corresponding sockets (not shown) in the left portion 404. The right and left portions 402,404 can otherwise be held together by pressure elements and / or adhesives and / or screws, screwdrivers, clips etc. .. How can To be seen in this figure, a retaining groove 196 is provided at the proximal end of the segment of the proximal closing tube 190. The right portion 402 of the closing hook 400 has a right retaining flange segment 405 that is adapted to cooperate with a left retaining flange segment (not shown) on the left portion 404 of the closing hook 400 to form a retaining flange assembly that extends into the retaining groove 196 in the proximal closing tube segment 190.

[0049] As can also be seen in figure 7, a retaining handle on the right support assembly 326 protrudes into the housing element on the right 320. Such handle 326 projects into an elongated slot or window 406 in the portion to the right 402 of the closing hook 400. A similar closing hook holding handle (not shown) projects into the housing element on the left 330 to be received in another window or slot 408 provided on the left side 404 of the closing hook 400. The retaining handles serve to non-movably attach the proximal end 133 of the proximal support segment 130 (not shown in figure 7) to the handle assembly 300 while allowing the closing hook 400 to move in the axial direction in relation to it. The retaining handles can be mechanically attached to the proximal end of the proximal support segment 130 by, for example, screws, dies, adhesive, pressure aspects, etc. In addition, the closing shuttle 400 is provided with guide rails that extend laterally 410,411. Rail 410 is configured to be received with a slide inside the

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33/110 rail guide 328 on the right housing element 320 and rail 411 is configured to be received by sliding within a rail guide (not shown) on the left housing element 330.

[0050] The axial movement of the closing shuttle 400 and the closing tube assembly 170 in the distal direction (arrow C) is created by moving the closing trigger 302 to the stock portion 342 of the handle assembly 300 and the axial movement of the shuttle closing mechanism 400 in the proximal direction (arrow D) is created by moving the closing trigger 302 away from the stock portion 342. In various embodiments, the closing hook 400 is provided with a connector projection 412 that facilitates fixing the assembly of the closing joint 430 on it. See figures 8 and 9. The closing hinge assembly 430 includes a yoke portion 432 that is hinged pinned to the projection of connector 412 by a pin 414. The closing hinge assembly 430 also has a closing arm 434 that it is hingedly pinned to a yoke set 304 formed on the closing trigger 302 by a closing pin 436 as shown in figure 7. The closing trigger 302 is hingedly mounted within the handle assembly 300 by a pivot pin 306 that extends between the right housing element 320 and the left housing element 330.

[0051] When the clinician wishes to close the anvil 40 to secure the tissue inside the end executor 12, the clinician pulls the closing trigger 302 to the stock portion 342. When the clinician pulls the closing trigger 302 to the stock portion stock 342, the closing hinge assembly 430 moves the closing hook 400 in the distal C direction until the closing hinge assembly 430 moves to the locked position shown in the figure

8. When in this position, the articulation assembly 430 will tend to retain the closing hook 400 in that locked position. When the

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34/110 closing shuttle 400 is moved to the locked position, the closing tube assembly 170 is moved distally in the support assembly 102 causing the closing / opening projection 46 on the anvil 40 to be contacted by the proximal end of the horseshoe opening 185 in the distal closing tube segment 180 to thereby articulate the anvil 40 to the closed (clamped) position.

[0052] In various embodiments, to further retain the closing hook 400 in the closed position, the closing trigger 302 can be provided with a removable locking mechanism 301 which is adapted to engage the stock portion 342 and maintain remotely the closing trigger 302 in the locked position. Other locking devices can also be used to remotely retain the closing hook 400 in the locked position. In the embodiment shown in figures 8,8A, 8B and 9, the closing trigger 302 includes a flexible longitudinal arm 303 that includes a side pin 305 extending from it. The arm 303 and the pin 305 can be made of molded plastic, for example. The gun butt portion 342 of the handle assembly 300 includes an opening 350 with a side extension wedge 352 disposed therein. When the closing trigger 302 is retracted, pin 305 engages wedge 352 and pin 305 is forced downward (i.e. arm 303 is rotated CW) by the bottom surface 354 of wedge 352. When pin 305 passes fully bottom surface 354, the CW force on the arm 303 is removed and the pin 305 is rotated CCW, such that pin 305 comes to rest in a notch 356 behind wedge 352, thereby locking the closing trigger 302. Pin 305 is also held in place in the locked position by a flexible stop 358 extending from wedge 352.

[0053] To unlock the closing trigger 302, the operator can further compress the closing trigger 302, causing the

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35/110 pin 305 engages an inclined rear wall 359 of opening 350, forcing pin 305 upward beyond flexible stop 358. Pin 305 is then free to travel out of an upper channel in opening 360, such that the trigger of closure 302 is no longer locked in the butt portion of pistol 342. Additional details of such an arrangement can be found in US Patent Application Serial No. 11 / 344,020, filed January 31, 2006 and titled Surgical Instrument Having A Removable Battery for Shelton, IV and others, the relevant portions of which are hereby incorporated by reference. Other removable locking arrangements could also be used.

[0054] In various embodiments of the present invention, knife assembly 30 may have a portion of substantially rigid piston bar 35 projecting from it or otherwise attached to it which is part of a drive element 500 that is operably supported by the distal support segment 110 and configured to apply at least two actuation movements (for example, launch movement and retraction movement) in the knife set 30. In the modalities represented in figures 3,4,10 and 11, the The drive 500 comprises a two-stage pneumatically driven cylinder assembly 501. The knife assembly 30 may comprise a single component or it may be provided in multiple parts to facilitate easier assembly of the instrument 10. For example, as shown in figures 10 and 11, the knife bar assembly 30 comprises a distal portion 31 containing the upper pins 32, the lid 34, the intermediate pins 36 and the fa 38. The distal portion 31 can be provided with an opening 33 dimensioned therein to receive a protrusion 37 provided at the distal end of the piston bar portion 35. The protuberance 37 can be received with friction within the opening 33 and / or retained therein by adhesive, solderPetition 870180138022, of 10/05/2018, p. 12/39

36/110 gem etc.

[0055] The cylinder assembly 501 comprises a first cylinder housing 510 that has a first closed proximal end 512 and a first open distal end 514 that opens within a first axial passage 516 within the first cylinder housing 510. The assembly of cylinder 501 also comprises a second cylinder housing 520 having a second proximal end 522 and a second open distal end 524 which opens within a second axial passage 526. The second closed proximal end 522 has a first piston head 528 formed therein is dimensioned relative to the first axial passage 516 to create a substantially hermetic slide seal with the first wall 511 of the first cylinder housing 510 to define a first cylinder area 515 between the distal side of the first proximal end 512 and the proximal side of the first piston head 528. The first distal end 514 of the prime The first cylinder housing 510 also has a first inwardly extending flange 517 formed therein to establish a substantially airtight slide seal with the outer wall surface of the second cylinder housing 520 to define a second cylinder area 518 between the proximal side. the first flange 517 and the distal side of the first piston head 528.

[0056] A first passage 527 is provided through the first piston head 528. As can also be seen in figures 10 and 11, the proximal end of the piston bar 35 extends through the second open distal end 524 of the second cylinder housing 520 and into the second axial pass 526. A second piston head 530 is formed in or otherwise attached to the proximal end of the piston bar 35. The second piston head 530 is dimensioned in relation to the second pass

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Axial 37/110 526 to create a substantially airtight slide seal with a second wall 521 of the second cylinder housing 520 to define a third cylinder area 532. The second distal end 524 of the second cylinder housing 520 also has a second flange which extends inwardly 525 formed therein to establish a substantially hermetic slide seal with the piston rod 35 to define a fourth cylinder area 534 between the proximal side of the second flange 525 and the distal side of the second piston head 530.

[0057] As can be seen in figures 3 and 4, the cylinder assembly 501 is mounted within the distal support segment 110. In various embodiments, a pair of master pins 519 is provided at the proximal end of the first cylinder housing 510. Master pins 519 are received within master pin holes 119 in the distal support segment 110 to enable cylinder assembly 501 to pivot within the distal support segment 110 around a pivot axis BB. See figure 3. A first supply line or supply line 540 extends from a directional control valve 610 in the handle assembly 300 (figures 8 and 9) through the proximal closing tube segment 190 to be coupled to the first proximal end. 512 of the first cylinder housing 510 to supply pressurized gas through a first supply orifice 513 or opening at the first proximal end 512 of the first cylinder housing 510. See figures 10 and 11. In addition, a second supply line 542 extends of the directional control valve 610 through the proximal closing tube segment 190 and is connected in the first cylinder housing 510 adjacent to the distal end 514 thereof to supply pressurized gas into the second area of the cylinder 518 through a second orifice 529.

[0058] With reference to figures 8-11, the extension and retraction of the

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38/110 launching mechanism or knife set 30 will now be explained. As can be seen in Figures 8 and 9, supply lines 540 and 542 are coupled to a conventional directional valve 610 that is part of an actuator system 600 housed inside the handle housing 350. In various embodiments, the directional valve 610 can be manually moved between the forward (extended) and reverse (retracted) positions with a selector switch 612 or push buttons that are accessible through the handle housing 350. See figure 1. In the mode shown in figures 8 and 9, a source removable 620 pressurized gas is used. As will also be discussed in detail below, such a source of pressurized gas comprises a cylinder 622 that can be refillable with a preferred pressurized gas. Those skilled in the art will find, however, that non-replaceable / refillable sources (cylinders) of pressurized gas could also be effectively used. In still other embodiments, the handle assembly 300 may be provided with an orifice 616 for supplying pressurized gas from an external source 618 of pressurized gas. For example, instrument 10 could be coupled to the compressed air supply of installation 618 through a flexible supply line 617. See figure 8B.

[0059] The unique and new aspects of the removable / refillable cylinder 622 will be discussed in more detail below. However, in order to explain the extension and retraction of piston bar 35 and knife assembly 30, it can be seen that the pressurized gas flows from cylinder 622 (or external pressure source 618) through a supply line 650 to inside a variable force actuator which may comprise a conventional 660 ratio valve. As can be seen more particularly in Figures 9 and 55, the ratio valve 660 is coupled to a supply hinge 662 which is attached to an activation trigger 670. As used here, the

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39/110 variable power actuation joint term comprises at least the ratio valve 660 and the activation trigger 670 and their respective equivalent structures. In various embodiments, the trigger trigger 670 is supported adjacent to the release trigger 310 which is pivotally coupled to the handle assembly 300 by a pivot pin 370 that extends between the housing element on the right 320 and the housing element on the left 330 Compression of the activation trigger 670 inwards towards the release trigger 310 causes the ratio valve 660 to increase the flow of pressurized gas flowing from the cylinder 622 into a supply line 680 coupled to the directional valve 610. Depending on from the position of directional valve 610, pressurized gas will flow into supply line 540 or 542. For example, when directional valve 610 is triggered by the clinician to launch knife set 30, pressurized gas can flow through the line supply 540 into the first cylinder area 515 through the first opening 527 in the first piston head 528 and into the third cylinder area 532 with activation of the trigger 670. As the pressurized gas enters the third cylinder area 532, the second piston head 530 forces the piston rod 35 in the distal direction. The gas located in the fourth cylinder area vent from there through the discharge opening 523 in the second cylinder housing 520. Similarly, the gas contained in the second cylinder area 518 can vent from there through the second opening 529 into the second supply line 542. The second supply line 542 carries the vented gas to directional valve 610 where it is finally vented from there. Continued application of pressurized gas to the first area of cylinder 515 and to the third area of cylinder 532 causes knife assembly 30 to be fully extended through end executor 12. When knife assembly 30 passes through ex

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40/110 trembling 12, it cuts the tissue stuck in it and launches the staples 70 in the staple cartridge 50 (leads the staples into the forming contact with the lower surface of the anvil 40). After knife set 30 has advanced to its most distal position on end runner 12, the clinician stops applying pressurized gas by releasing the trigger 670.

[0060] To retract the release mechanism or knife set 30, the clinician manually moves the selector switch 612 or the appropriate button to adjust the directional valve 610 to the retract position and begins to compress the activation trigger 670 which causes the pressurized gas flows into the second supply line 542. The gas flowing through the second supply line 542 enters the second cylinder area 518 which causes the second cylinder housing 520 to retract proximally into the first housing cylinder 510. The gas in the first area of cylinder 515 can vent through the first supply opening 513 into the first supply line 540. The gas that passes through the first supply line 540 enters directional valve 610 where it is vented so. After the pressurized gas entering the second cylinder area 518 has caused the second cylinder housing 520 to retract into the first cylinder housing 510 as shown in figure 10, the gas passing through the second opening 529 is now able to pass through the discharge opening 523 in the first cylinder housing 510 and into the fourth cylinder area 534. When the pressurized gas enters the fourth cylinder area 534, the second piston head 530 pulls the piston bar 35 proximally to inside the second cylinder housing 520. The gas in the third cylinder area 532 passes through the first opening 527 into the first cylinder area 515 from which it is vented in the manner described above.

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41/110 [0061] The variable force actuator in the form of the 660 ratio valve of various embodiments of the present invention can use springs or other guiding means (not shown) to orient the ratio valve 660 to an un-actuated position. When in the non-actuated position, the ratio valve 660 can be configured to prevent any gas flow from the gas sources 620 or 618 through an orifice (not shown) inside the valve 660. Thus, when the trigger 670 is in the position not triggered, the device is essentially turned off.

[0062] In the modalities described above, the ratio valve 660 can be mechanically coupled to the activation trigger 670 by the supply articulation arm 662 such that, when the clinician squeezes the activation trigger 670 inwards towards the release trigger 310 , the articulation arm 662 causes the ratio valve 660 to allow the gas flow to increase through valve 660. Thus, the quick squeezing of the activation trigger 670 can cause the release rate of the device to increase and decrease the rate at which the 670 activation trigger is pulled decreases the launch rate. Thus, the amount of gas flow allowed through the ratio valve 660 can be substantially proportional to the amount of manual force applied to the trigger trigger 670.

[0063] In other modalities, the 660 ratio valve can be electronically controlled such that with the activation of the activation trigger, the 660 ratio valve digitally releases its gas. The ratio valve 660 discharges a small amount of gas in a pulse manner and the firmer the trigger trigger 670 is pulled, the closer the pulses will be. Such an arrangement serves to selectively regulate the volume of gas used to drive the device.

[0064] Also, in still other modalities, the mechanism of

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42/110 actuation can comprise a different type of mechanism that is not articulated supported in relation to the handle assembly such as the 670 activation trigger. For example, the activation trigger could comprise a spring-loaded slide switch, etc. Thus, the protection provided for these modalities of the present invention should not be limited only to the modalities that use an articulated trigger trigger.

[0065] Also in several modalities, a manometer 541 can be coupled with fluidity in the supply line 540 as shown in figures 8 and 8A. A window 543 can be provided through a corresponding portion of the cuff assembly 300 to enable the clinician to see the manometer 541 or other arrangements can be used to enable the clinician to see the manometer 541 during use. See figure 7. In various modalities, the 541 pressure gauge can comprise an electronically energized pressure gauge or a dial gauge. In these non-limiting modalities, the 541 manometer provides a resource to provide feedback on the forces encountered during the launch course. Those skilled in the art will understand that, in certain non-limiting modalities, the force required to drive the launching mechanism is directly proportional to the pressure in the cylinder assembly 501. If these forces are small, then the cylinder assembly 501 does not require large pressures triggered. On the other hand, if the forces required to drive the cylinder assembly 501 are high, more gas will have to be released into the cylinder assembly 501 by increasing the pressure therein to fully activate the launch mechanism. The 541 manometer serves to provide the clinician with a reading proportional to the forces being experienced by the end executor.

[0066] In other various embodiments, an audible output 545 can be provided on supply line 540 as shown in figure 8C.

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43/110

Such an audible outlet allows a small amount of gas to be released from the 540 supply line. The height of the resulting whistle caused by the discharge of that gas would increase as the pressure forces increased. The clinician can then relate the height of the whistle to the forces experienced by the launch mechanism. Thus, such a provision provides the clinician with an audible feedback mechanism to monitor the launch forces being experienced by the 500 drive system and finally the launch mechanism.

[0067] Several non-limiting modalities can also be provided with the ability to automatically notify the clinician when the launch mechanism has reached the end of the launch course. For example, as shown in figure 4, a load limit switch 546 can be provided within the distal support segment 110 to detect an embedded or otherwise activated activation element 547 on the launch rod 35 as shown in figure 11. The activation element 547 is so located that when the launching bar 35 and the launching mechanism reach the end of the launching stroke, the activation element 547 is detected by the load limit switch 546 which can be electrically coupled to the directional control valve 610 to transmit an appropriate signal to it. Upon receipt of such a signal, the 610 directional control valve can be configured to automatically switch to the retract position and allow the launch mechanism to retract. In addition, the load limit switch 546 can be coupled to an indicating element generally indicated as 549 in the figure

8. In various modalities, the indicating element can provide the clinician with an audible signal, a visual signal or a combination of audible and visual signals indicating that the launch mechanism has reached the end of the launch course. For example, the element of in

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44/110 can include a sound generating device, a vibration generating device, etc. or a combination of such devices. The load limit switch and related control components can be powered by a battery (not shown) supported in housing assembly 300 or it can be supplied with electrical power from an external source of electrical power. Thus, various non-limiting modalities of the present invention can be provided with a feature to provide the clinician with a visual and / or audible signal indicating that the launching mechanism has reached the end of the launching stroke and / or a means to automatically retract the pneumatically. release mechanism for the non-triggered position.

[0068] As can be seen in figures 4, 10 and 11, a locking protuberance 39 can be formed at the base of the piston bar 35. When the knife assembly 30 is in the fully retracted position as shown in figure 4, the arm 118 of the retaining spring 112 applies a guiding force to the distal end of the cylinder assembly 501. Because the cylinder assembly 501 is pivotally mounted within the distal support segment 110 by master pins 519, the distal end of the cylinder assembly 501 pivots down into the distal support segment 110 and also causes locking protrusion 39 on piston bar 35 to fall into a locking opening 21 in the elongated channel 20. This arrangement serves to lock knife assembly 30 in the retracted position in by virtue of the friction engagement of the locking protuberance 39 with the elongated channel portions 20 defining the locking opening therein. As can be seen in Figures 10 and 11, the locking protrusion 39 has a proximal ramp surface 39 'and a distal ramp surface 39 to enable the locking protrusion to easily enter and exit the locking opening in the elongated channel

20. Those skilled in the art will easily find that other disabilities

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45/110 knife bar locking positions can be used successfully without departing from the spirit and scope of the present invention. [0069] Figures 12-16A illustrate another embodiment of the present invention where the driving element 500 comprises a cylinder assembly 800 which is similar in construction to the cylinder assembly 501 described above, except for the differences mentioned below. For example, in this embodiment, springs 850,852 are used to retract piston bar 35. As can be seen in Figures 12 and 13, cylinder assembly 800 includes a first housing 810 that has a first closed end 812 and a first bore supply 813 through it. A first supply line 840 is attached to the first closed end 812 to supply pressurized gas through the first supply orifice 813. In this embodiment, the first cylinder housing 810 lacks the second opening 529 which has been described in connection with the various embodiments described above. A second cylinder housing 820 is received by sliding into the first cylinder housing 810 and has a second closed proximal end 822 that has a first piston head 828 formed therein. A first cylinder area 815 is defined between the first closed end 812 and the first piston head 828. A first retraction spring 850 is provided between the first piston head 828 and a first flange 817 formed at the distal end of the first piston housing. cylinder 810. The first retraction spring 850 serves to orient the second cylinder housing 820 to the retracted position of the first cylinder 810 as shown in figure 12. The piston rod 35 has a stepped end 35 'that is sized to enter the second distal end 824 of the second cylinder housing 820. A second flange 825 is formed at the second distal end 824 to obtain a substantially bypass seal with the stepped portion 35 'of the step bar

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46/110 as 35. A second piston head 830 is provided at the proximal end of the staggered piston bar section 35 'to define a third cylinder area 832 between the second piston head 830 and the first piston head 828. One first opening 827 is provided through the first piston head 828 to enable air to pass between the first cylinder area 815 and the third cylinder area 832. A second retraction spring 852 is provided between the second flange 825 and the second head of piston 830 as shown in figure 12 to orient the second piston head 830 and staggered piston bar 35 'to the fully retracted position within the second cylinder housing 820 as shown in figure 12.

[0070] This embodiment of the present invention can be operated as follows. As can be seen in figure 16, the handle assembly 300 is provided with a replaceable source 620 of pressurized gas as discussed above. However, those skilled in the art will find that non-replaceable sources (cylinders) of pressurized gas could also be effectively used. In still other embodiments, the handle assembly 300 can be provided with an orifice 616 to facilitate the attachment of the directional control valve 610 and related components to an external source of pressurized gas 618. See figure 16A. For example, instrument 10 could be coupled to the installation's compressed air line via a flexible supply line 617.

[0071] To operate the instrument, the clinician moves the 612 direction control valve selector switch (figure 1) or push buttons to the forward (extension) position and begins to press the 670 activation trigger that allows the pressurized gas flows from cylinder 622 (or external source 618) through supply line 680 through directional control valve 610 and into supply line 840. Pressurized gas flows from the first supply line 840 through

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47/110 through the first supply port 813 into the first area of cylinder 815, through the first opening 827 and into the third area of cylinder 832. The gas entering the third area of cylinder 832 causes the second head piston 830 and the stepped portion 35 'of piston bar 35 move in the distal direction. After the second piston head 830 has moved to a fully extended position (figure 13), the gas continuing to enter the first cylinder area 815 orients the second housing 820 to its fully extended position. After knife set 30 has been advanced to its most distal position on end executor 12, the clinician discontinues the application of pressurized gas by releasing the 670 activation trigger.

[0072] To retract the release mechanism or knife set 30, the clinician 30 moves the selector switch on the directional valve 612 to the reverse (retraction) position where the first supply line 840 is connected to a vent on the directional valve 610. The gas in the third cylinder area 832 and the first cylinder area 815 can escape through the first supply port 813 into the supply line 840 and are finally vented through the directional valve 610. As the gas exits the third area cylinder 832, the second retraction spring 852 retracts the staggered portion 35 'of the piston rod 35 into the second cylinder housing 820. Likewise, as the gas exits the first cylinder area 815, the first spring retraction device 850 guides the second cylinder housing 520 into the first cylinder housing 810.

[0073] Also in this modality, a manometer 541 can be coupled with fluidity in the supply line 840 as shown in figures 16 and 16A which can work in the manner described above and serves to provide the clinician with a reading proportional to the forces being experienced by the executor end point. In several other moPetition 870180138022, of 10/05/2018, p. 51/124

48/110 dalities, an audible output 545 can be provided on supply line 840 as shown in figure 16B which can work in the manner described above to provide the clinician with an audible feedback mechanism to monitor the release forces being experienced by the delivery system drive 500 and finally the release mechanism. In other alternative embodiments, a load limit switch 546 (figure 15) can be provided within the distal support segment 110 to detect an activation element 547 (figures 12 and 13) embedded in the launch rod 35 to automatically control the key directional 610 and / or provide visual and / or audible signals indicating that the launch mechanism has reached the end of the launch course.

[0074] Figures 17-21A illustrate yet another embodiment of the present invention where the driving element 500 comprises a bellows assembly 900. The bellows assembly 900 can have a distal end 902 which is secured to the distal portion 31 of the assembly of the knife bar 30. The distal end 902 has a protrusion 904 formed therein that is sized to be received in an opening 33 in portion 31. Protrusion 904 can be received with friction within the opening 33 and / or retained there by adhesive, welding , etc. The distal portion 31 can be constructed and configured as described in detail above.

[0075] The bellows assembly 900 also includes an expandable / retractable bellows portion 910 that is sized to extend and retract within a bellows passage 117 in the distal support segment as shown in figure 18. The bellows portion 910 can be formed with wire retaining rings 912 as shown in figure 20 and be secured to a base portion 914 that is non-movably secured to the distal support segment 110 or comprises an integral portion of the distal support segment 110. The base 914 can be arrested

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49/110 in the distal support segment 110 by adhesive, screwdrivers, etc. A supply port 916 is provided through the bellows base 914 and a supply line 940 is attached to supply port 916. Supply line 940 is also coupled to directional control valve 610 in handle assembly 300. See figures 21 , 21A. The directional control valve 610 also communicates with a vacuum port 620 mounted on handle assembly 300 through a vacuum line 922. Vacuum port 620 is affixable to a vacuum source 630, for example, via a flexible line 632. The vacuum source can be a permanent vacuum supply line in the facility. A flexible vacuum line 632 can be attached to orifice 620 in vacuum source 630 to enable the clinician to freely manipulate the instrument.

[0076] This instrument can be provided with the closing tube assembly 170 and closing trigger 310 described above. Thus, the fabric can be attached to the end executor 12 in the manner described above. After the tissue has been attached to the end executor 12, the clinician can launch the instrument as follows. The clinician moves the 612 selector switch (figure 1) or buttons to the directional control valve 610 to the forward (extension) position and begins to tighten the 670 activation trigger. As the 670 activation trigger is pulled, the ratio valve 660 allows pressurized gas to flow from pressure source 620 (figure 21) or 618 (figure 21A) to directional control valve 610. directional control valve 610 allows pressurized gas to flow through the supply line 940 into the bellows 910 causing it to expand distally. When the bellows 910 extends distally, it guides the knife assembly 30 through the end executor 12 cutting the tissue stuck in it and driving the clips 70 on the staple cartridge 50 to the forming contact with the bottom surface of the

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50/110 anvil 40. After knife set 30 has been driven to its most distal position on end executor 12, the clinician releases trigger 670. To retract knife set 30, the clinician moves the selector switch 612 for directional control valve 610 to the retract position to thereby allow vacuum source 630 to be coupled to supply line 940. Applying vacuum to supply line 940 causes bellows 910 to retract to its retracted position shown in figure 18. After the 910 bellows has been fully retracted, the clinician can move the 612 selector switch or buttons to a position where the directional control valve stops applying vacuum to the 940 supply line. , the remaining vacuum within supply line 940 can serve to retain bellows 910 in the stowed position.

[0077] In the embodiment shown in figure 21, a removable source 620 of pressurized gas is used. As will also be discussed in detail below, such a pressurized gas source comprises a cylinder 622 that can be refillable. Those skilled in the art will find, however, that non-replaceable / refillable sources (cylinders) of pressurized gas or pressurized fluid could also be used effectively. In still other embodiments, the handle assembly 300 may be provided with an orifice 616 for supplying pressurized gas to an external source of pressurized gas. For example, instrument 10 could be coupled to the installation's compressed air line through a flexible supply line 617. See figure 21A.

[0078] Also in this modality, a manometer 541 can be coupled with fluidity in the supply line 940 as shown in figures 21 and 21A which can work in the manner described above and serves to provide the clinician with a reading proportional to the forces being experienced by the executor end point. In several other ways

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51/110 dalities, an audible output 545 can be provided on supply line 940 as shown in figure 21B which can function in the manner described above to provide the clinician with an audible feedback mechanism to monitor the release forces being experienced by the delivery system drive 500 and finally the release mechanism. In other alternative embodiments, a load limit switch 546 (figure 18) can be provided within the distal support segment 110 to detect an activation element 912 '(figure 20) in the bellows assembly 900 to automatically control directional key 610 and / or providing visual and / or audible signals indicating that the launching mechanism or knife assembly 30 has reached the end of the launching stroke.

[0079] Figures 22-27 illustrate a non-articulated disposable end executor 12 that uses many of the unique and new attributes of the modalities described above. As can be seen in figure 23, this embodiment can use the end executor 12 and any of the drive elements 500 which have been described in detail above. In this embodiment, however, the end executor 12 can be disposable and attached to a distal axis assembly 1010 that can be releasably detachable on a proximal axis assembly 1020 by a single, new quick disconnect joint usually indicated as 1000. After end runner 12 has been used, end runner 12 and the distal shaft assembly 1010 on which it is attached can be detached from the proximal shaft assembly 1020 and, if desired, discarded. A new sterile end executor 12, complete with its own distal shaft assembly 1010 and cylinder arrangement, can then be attached to the proximal shaft assembly 1020 to complete another surgical procedure. As will be explained in more detail below, the 1010 distal axis assembly includes a 1110 distal support segment

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52/110 and a distal closure tube segment 1180. The proximal shaft assembly 1020 includes a proximal support segment 1150, a proximal closure tube segment 1190 and a release sleeve 1200.

[0080] The distal support segment 1110 and the proximal support segment 1150 cooperate to form a support set 1030. In this embodiment, the distal support segment 1110 can be substantially identical to the distal support segment 110 as described in detail above , except that their respective proximal ends differ. Likewise, the proximal support segment 1150 can be substantially identical to the proximal support segment 130 as described above, except that its distal end differs to enable the distal support segment 1110 and proximal support segment 1150 to be coupled together in a manner not articulated. Also in this embodiment, the segment of the distal closure tube 1180 can be substantially identical to the segment of the distal closure tube 180 described above except that its proximal ends differ. Likewise, the segment of the proximal closing tube 1190 can be substantially identical to the segment of the proximal closing tube 190, except that its distal ends differ to enable the segment of the distal closing tube 1180 and segment of the proximal closing tube 1190 are attached to each other in a non-articulated manner.

[0081] As can be seen in figure 23, a retaining spring 112 is mounted on the distal support segment 1110 as a lock for the piston bar 35. The distal and proximal square openings 1111,1113 are formed at the top of the distal support 1110 for defining a clip bar 1115 between them which receives an upper arm 116 of the retaining spring 112 whose lower arm of distal extension 118 exerts a downward force at one end

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53/110 distal to the cylinder assembly as discussed above. It will be seen that various modalities may include other types of crashes or none at all.

[0082] The proximal end 1114 of the distal support segment 1110 has a distal connector portion 1116 formed therein. See figures 24 and 27. As can be seen in figure 24, the distal connector portion 1116 has a first distal supply hole 1117 which is coupled to the first segment of the supply line 540 '. A second distal supply orifice 1120 is provided in the distal connector portion 1116 and is coupled to a second supply line segment 542 '. As can be seen in figure 23, the first segment of the supply line 540 'is coupled to the first supply port 513 in the first cylinder housing 510 and the second segment of the supply line 542' is coupled to the second supply port 529 in the distal end of the first housing 510. A first portion of the supply nozzle 1118 protrudes in the proximal direction of the first distal supply orifice 1117 as shown. A second supply nozzle portion 1122 protrudes outwardly in the proximal direction of the second supply orifice 1120.

[0083] Similarly, the distal end 1152 of the proximal support segment 1150 has a second connector portion 1154 that has a first proximal supply hole 1156 that is coupled to another first supply line segment 540. The second connector portion 1154 also has a second proximal supply orifice 1160 in it which is coupled to another second supply line segment 542. The first proximal supply orifice 1156 is configured to removably receive the first supply nozzle 1118 in it (figure 27) and the second proximal supply orifice 1160 is sized to removably receive the second supply nozzle 1122 therein. How can

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54/110 be seen in figures 24 and 27, a first O-ring seal 1158 is associated with the first proximal supply orifice 1156 to form a substantially airtight (or fluid-tight) seal between the first segment of the supply line 540 'and another first segment of the supply line 540 when the first nozzle 1118 is inserted into the first proximal supply hole 1156. When coupled together in this way, the first segments of the supply line 540' and 540 are joined to form a first line supply 540. Likewise, a second O-ring seal 1162 is associated with the second proximal supply orifice 1160 to form another substantially airtight (or fluid-tight) seal between the second supply line segment 542 'and another second segment of supply line 542 when the second supply nozzle 1122 is inserted into the second supply orifice nearby to 1160. When coupled together in this manner, the second supply line segments 542 'and 542 form a second supply line 542. Those skilled in the art will understand that other detachable coupling arrangements, quick disconnect arrangements can be used to connect the first segment of the supply line 540 'with another first segment of the supply line 540 and the second segment of the supply line 542' with another second segment of the supply line 542 without departing from the spirit and scope of the present invention.

[0084] The distal connector portion 1116 and the proximal connector portion 1154 can be configured so that they can be joined in only one orientation. For example, as shown in figure 24, the distal connector portion 1116 can be provided with a notched portion 1119 which is adapted to join with another notched portion 1155 on the proximal connector portion 1154 for ga

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55/110 ensure that the first nozzle 1118 engages the first proximal supply orifice 1156 and the second nozzle 1122 engages the second proximal supply orifice 1160 during installation. Such a unique new fixing arrangement prevents inadvertent attachment of the first nozzle 1118 to the second proximal supply orifice 1160 and the second nozzle 112 to the first proximal supply orifice 1156. Other key-like configurations can be used to ensure that the connector portion distal 1116 and the proximal connector portion 1154 are coupled in the appropriate orientation.

[0085] As can also be seen in figures 24 and 27, the distal end 1152 of the proximal support segment 1150 has a hollow sleeve portion 1170 that protrudes in the distal direction. Such hollow sleeve portion 1170 is sized to receive the proximal end 1114 of the distal support segment 1110 therein. To remotely lock the distal support segment 1110 on the proximal support segment 1150, a pair of opposing holding elements 1124 is formed at the proximal end 1114 of the distal support segment 1110. The holders 1124 are located in flexible projections 1126 cut or otherwise formed in the distal support segment 1110, such that when the proximal end 1114 of the distal support segment 1110 is inserted into the hollow sleeve portion 1170 of the proximal support segment 1150 and the first nozzle 1118 is coupled with a seal in the first proximal supply 1156 and the second nozzle 1122 is coupled with a seal in the second proximal supply orifice 1160, the holding elements 1124 are received in the corresponding openings 1172 in the hollow sleeve portion 1170. See figures 24 and 27.

[0086] The removable fixation of the distal closing tube segment 1180 in the proximal closing tube segment 1190 will be described with reference to figures 24-27. As can be seen in these

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56/110 In these figures, the proximal end 1182 of the distal closing tube segment 1180 has at least two bayonet locking projections 1184 projecting in a proximal direction from there. Each locking projection 1184 has a conical locking wedge 1186 formed therein that are dimensioned to be received in corresponding locking openings 1194 in the proximal closing tube segment 1190. When in the position shown in figures 26 and 27, the distal support segment 1110 is locked in the proximal support segment 1150 to form the support assembly 1030 and the distal closing tube segment 1180 is locked in the proximal closing tube segment 1190 to form the closure tube assembly 1178. Such an arrangement allows the closure tube assembly 1178 moves proximally and distally in support assembly 1030 to open and close anvil 40 on end executor 12 in the various ways described above.

[0087] To attach the distal axis assembly 1010 to the proximal axis assembly 1020, the user aligns the proximal end 1012 of the distal axis assembly 1010 with the distal end 1022 of the proximal axis assembly 1020 as shown in figure 24 and below inserts the distal end 1012 into the proximal end 1022. When holders 1124 are received at locking openings 1172 and locking wedges 1186 are received at openings 1194, distal shaft assembly 1010 is locked into proximal shaft assembly 1020. The anvil 40 can be closed by moving the closing tube assembly 1178 distally by holding the closing trigger 310 and pivoting it to the butt portion 342 of the handle assembly 300 in the ways described above. The knife bar 30 can be driven by the activation of the activation trigger 670 in the ways described above. [0088] To enable the distal axis assembly 1010 to be easily detached from the proximal axis assembly 1020, several modali

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57/110 dies use a release sleeve arrangement. In these embodiments, a release sleeve segment 1200 is slidably hinged over the proximal support segment 1150 between the proximal support segment 1150 and the proximal closing tube segment 1190. In various embodiments, the proximal end of the release sleeve 1200 can be provided with a release button 1204 that protrudes through a corresponding slot 1196 at the proximal end 1195 of the proximal closing tube segment 1190. See figures 22 and 31. Such an arrangement allows the release sleeve 1200 to be moved axially in the distal and proximal direction in the proximal support segment 1150 without impairing the axial path of the proximal closing tube segment 1190 in the support set 1030.

[0089] As can be seen more particularly in figure 27, the distal end 1202 of the release sleeve 1200 is chamfered inward and is oriented such that it is adjacent to the two locking openings of the closing tube 1194 in the segment of the closing tube proximal 1190. To release the distal axis assembly 1010 from the proximal axis assembly 1020, the user moves the release button distally in slot 1196 to move the release sleeve 1200 in the distal direction. When the chamfered distal end 1204 of release sleeve 1200 contacts locking wedges 1186, locking wedges 1186 are moved inwardly out of engagement with locking openings 1194 in the proximal locking tube segment 1190. The additional movement of the release sleeve 1200 in the distal direction causes a second chamfered inner edge 1206 in release sleeve 1200 to contact locking holders 1124 and orient them inwardly out of engagement with openings 1172 in the proximal support segment 1150, thereby enabling that the distal shaft assembly 1010 is separate from the support assembly

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58/110 proximal 1020.

[0090] The modality shown in figures 22-28 can be effectively used with a cylinder set 501 of the type described above. The embodiment shown in figures 29 and 30 can be effectively used with the cylinder assembly 800 or the bellows assembly 900 described above. As can be seen in figures 29 and 30, the distal connector portion 1116 only has an orifice 1300 formed therein that is coupled to the supply line segment 940 '. A first supply nozzle 1302 protrudes in the proximal direction of the first distal supply orifice 1300 as shown. Likewise, the connector portion 1154 has only one proximal supply orifice 1306 which is coupled to another first segment of the supply line 940. Proximal supply orifice 1306 is configured to removably receive the first supply nozzle 1302 in him. As can be seen in figures 29 and 30, an O-ring seal 1308 is associated with proximal supply orifice 1306 to form a substantially airtight (or fluid-tight) seal between the first segment of the supply line 940 'and a another first segment of the supply line 940 when the supply nozzle 1302 is inserted into the proximal supply orifice 1306. When coupled together in this manner, the first segments of the supply line 940 'and 940 are joined to form a first supply line 940 Supply line 940 can then supply pressurized gas to cylinder assembly 800 or bellows assembly 900 in the ways described above.

[0091] Figure 32 illustrates an alternative articulable surgical cutting and stapling instrument 2000 with a pneumatically energized joint joint assembly 2002 that can be used in connection with the end executor 12 and the closing tube assembly 170 described above. This modality can also use

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59/110 use the cylinder assembly 501 described above. As can be seen in figures 33-35, joint assembly 2002 includes a support set 2004 that comprises a distal support segment 2010 that has a pivot element 2014 protruding from its proximal end 2012. The pivot element 2014 has a fin actuator 2016 projecting from it. As shown in figure 35, cylinder assembly 501 is pivotally mounted within the distal support segment 2010 on master pins 519.

[0092] The pivot element 2014 is articulated received within a pivot socket 2034 formed at the distal end 2032 of the proximal support segment 2030. The pivot element 2014 is free to articulate in relation to the proximal support element 2030 around the pivot geometric axis AND IS. See figure 36. As can be seen in figure 35, the distal end 2032 of the proximal support segment 2032 has a groove 2036 formed therein to accommodate a portion of the first supply line 540. Similarly, a second groove 2038 is provided at the distal end 2032 of the proximal support segment 2030 to accommodate the second supply line 542 therein. Supply lines 540,542 pass around pivot socket 2034 and into the proximal end 2012 of the distal support segment 2010 where they are attached to cylinder assembly 501 in the various ways described above. Those skilled in the art will find that a sufficient amount of clearance can be provided on supply lines 540 and 542 within the hollow proximal support segment 2030 to allow the distal support segment 2010 to freely articulate around the pivot geometric axis EE in relation to the proximal support segment 2030. By supporting the supply lines 540,542 in the slots 2036,2038, respectively, these supply lines will not interfere with the axial path of the closing tube assembly 170 in relation to the supposition set 870180138022, from 10/05 / 2018, p. 63/124

60/110 t and 2004.

[0093] As can also be seen in figure 35, a first vertical supply passage 2040 is provided in communication with the pivot socket 2034. Similarly, a second vertical supply passage 2050 is also provided in communication with the pivot socket 2034 as shown in figure 35. A third supply line 2042 extending from a key set 2100 mounted on handle assembly 300 communicates with the first vertical supply pass 2040 and a fourth supply line 2052 extending from key set 2100 communicates with the second vertical passage 2050. To assemble the joint assembly 2002, the pivot element 2014 is inserted into the pivot socket 2034 and a cover 2060 is attached to the proximal support segment 2030 as shown with screwdrivers 2062 or other suitable fasteners. Thus, the pressurized gas entering the first vertical supply passage 2040 of the third supply line 2042 will cause the distal support segment 2010 to articulate around the pivot geometric axis EE in the F direction and the pressurized gas entering the second supply orifice. vertical supply 2050 from the fourth supply line 2052 will cause the distal support segment 2010 to articulate in relation to the proximal support segment 2030 around the pivot axis EE in the G direction. See figure 34.

[0094] With reference to figures 37-45, the construction and operation of key set 2100 of the various modalities will be explained. In various non-limiting embodiments, the key set 2100 comprises a key block 2110 that has a supply hole 2112 therein. Supply port 2112 is coupled to a supply line 651 to receive pressurized gas from the pressurized gas source 620 (figure 44) or 618 (figure 45). In particular, supply line 651 can extend from supply line 650

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61/110 for orifice 2112. A key cavity 2114 is provided in key block 2110 and is sized to pivotally receive a body portion 2150 from a selector element assembly 2130 therein. A pivot rod 2151 protrudes out of the base of the body portion 2150 to be pivotally accommodated in the pivot hole 2111 in the key block 2110. See figure 39. This arrangement allows the selector element assembly 2130 to be selectively rotated around the axis of the HH key. See figure 38. A pair of O-rings 2152,2154 or other suitable sealing elements can be provided as shown in figures 38 and 39 to establish a substantially hermetic seal between the body portion 2150 of the selector element assembly 2130 and the block key 2110. A stem 2156 protrudes from the body portion 2150 to receive a selector handle 2158. Rotation of the selector handle 2158 causes the body portion 2150 to rotate within the key cavity 2114. As can be seen in Fig. 39, supply port 2112 communicates with a supply pass 2116 on key block 2110 which communicates with a head area 2118 also formed on key block 2110.

[0095] The body portion 2150 of the selector element assembly 2130 has a central supply hole 2160 through it that communicates with the head area 2118. A third supply passage 2045 is provided in key block 2110. See figure 40 The third supply passage 2045 extends between key cavity 2114 and a third supply hole 2044 in which the third supply line 2042 is secured. Likewise, a fourth supply pass 2055 is provided in key block 2110 and extends between key cavity 2114 and a fourth supply hole 2054 in which the fourth supply line 2052 is attached. When the selector element assembly 2130 is positioned as

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62/110 shown in figure 40, the pressurized gas entering the key block 2110 through supply port 2112 into supply passage 2116 passes into head area 2118 and can flow into central supply passage 2160 However, the pressurized gas will be blocked at the end of the central supply passage 2160. Thus, the switch is in the off position in figure 40.

[0096] To articulate the distal support segment 2010 to the right (opposite of the position shown in figure 34), the selector element assembly 2130 is articulated to the position illustrated in figure 41. As can be seen in this figure, the pressurized gas entering key block 2110 through supply port 2112 through supply port 2116 and into head area 2118 is transferred through central supply port 2160 into third supply port 2045 and into third row supply 2042. The pressurized gas then flows into the first vertical 2040 supply pass and contacts the 2016 actuator fin on the 2014 pivot element to force the 2014 pivot element in the F direction. The pressurized gas on the opposite side of the 2016 actuator fin enters the second vertical passage 2050 and flows into the fourth 2052 supply line. As the pressurized gas enters the fourth orifice heat 2054 in key block 2110, it flows into the fourth supply passage 2055 and into a fourth ventilation passage 2170 in the body portion 2150. The fourth ventilation passage 2170 communicates with a ventilation area with a lower cut 2155 in the body portion 2150 in the selector element assembly 2130. See figure 43. Thus, the pressurized gas in the fourth supply line 2052 is vented through the fourth ventilation passage 2170 and out of the key through the ventilation area with lower cut 2155.

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63/110 [0097] To articulate the distal support segment 2010 to the position shown in figure 34, the clinician rotates the selector element assembly 2130, such that the central supply passage 2160 now extends between the head area 2118 and the fourth supply passage 2055. Thus, the pressurized gas flowing from the supply line 651 into the supply passage 2116 and into the head area 2118 flows through the central supply passage 2160 into the fourth supply passage 2055. Pressurized gas flows out through the fourth supply hole 2054 and into the fourth supply line 2052. The fourth supply line 2052 transfers the pressurized gas into the second vertical supply passage 2050. When the pressurized gas enters the second vertical supply passage 2050, the actuator fin 2016 articulates the pivot element 2014 in the G direction. See figure 34. The gas on the opposite side of the fin d actuator 2016 flows through the first vertical supply passage 2040 and into the third supply line 2042. Gas leaves the third supply line 2042 into the third supply passage 2045 and flows into a third ventilation passage 2180 provided in the body portion 2150. The third ventilation passage 2180 is oriented to vent the gas out through the lower cut ventilation area 2155.

[0098] Another unique and new aspect of this modality is an arrangement with an automatic neutral aspect that allows the clinician to lock the 2010 distal segment portion (and end executor 12) in a desired articulated position simply by releasing the handle of the selector key 2158. More specifically, a return spring 2190 configured as shown is mounted on key block 2110 as shown in figures 40, 41 and 43. To retain spring 2190 on key block 2110, a pair of opposite lugs 2192,2194

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64/110 protrudes from the lower surface 2113 of the key block 2110. The spring 2190 is retained within the slots 2193,2195 in the lugs 2192,2194, respectively. See figure 43. As can be seen in figure 43, a return rod 2153 protrudes from the body portion 2150 of the selector element assembly 2130. The return rod 2153 is received between the free ends 2196,2198 of the return spring 2190. Figure 43 illustrates the body portion 2150 in the neutral or closed position.

[0099] Thus, when the clinician wishes to articulate the end executor 12, he or she rotates the selector handle 2158 to move the body portion 2150 of the selector element assembly 2130 in the rotational direction corresponding to the desired articulation path. When the clinician rotates the body portion 2150, it is rotated against the force generated by one of the free ends 2196.2198 of the return spring 2190. After the clinician has articulated the end executor 12 to the desired position, he or she releases the selector handle 2158 and the return spring 2190 moves the body portion 2150 to the closed position, which holds the end executor 12 in that position. If the clinician wishes to adjust the hinged position of the end executor 12, he or she merely rotates the handle of selector 2158 in the desired direction to achieve the desired position and then releases the handle 2158 to retain the end executor 12 in that position.

[00100] Figure 44 illustrates the arrangement of the control system components used in connection with key 2100 for various non-limiting modalities of the present invention. As can be seen in this figure, a removable source 620 of pressurized gas is used. Gas flowing from source 620 flows through supply line 650 to ratio valve 660 and through supply line 651 to orifice 2112 in key set 2100. In the embodiments shown in figure 44, source 620 comprises a replaceable tube

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65/110 speed / refillable 622 which is supported within the stock portion 342 of the housing assembly 300. The cylinder 622 can be refillable. Those skilled in the art will find, however, that non-replaceable / refillable sources (cylinders) of pressurized gas could also be effectively used. In still other embodiments, the handle assembly 300 may be provided with an orifice 616 for supplying pressurized gas from an external source 618 of the pressurized gas. For example, the instrument could be coupled to the installation's compressed air line (not shown) via a flexible 617 supply line. See figure 45.

[00101] Figures 46-48 illustrate the use of the 2002 joint joint arrangement in connection with a 1000 'quick disconnect joint of the type and construction described above. In this arrangement, however, a total of four holes are used. As can be seen in Figure 47, the distal connector portion 1116 has a first distal supply hole 1117 that is coupled to the first segment of the supply line 540 '. A second distal supply orifice 1120 is provided in the portion of the distal connector 1116 and is coupled to a second segment of the supply line 542 '. A first portion of the supply nozzle 1118 protrudes in the proximal direction of the first distal supply orifice 1117 as shown. A second supply nozzle portion 1122 protrudes outwardly in the proximal direction of the second supply orifice 1120.

[00102] The distal connector portion 1116 also has a third distal supply hole 1117 'which is coupled to a third segment of the supply line 2042'. A fourth distal supply hole 1120 'is provided in the portion of the distal connector 1116 and is coupled to a fourth segment of the supply line 2052'. A third portion of the supply nozzle 1118 'projects proximally to the third distal supply orifice 1117' as shown.

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66/110

A fourth supply nozzle portion 1122 'protrudes outwardly in the proximal direction of the fourth supply orifice 1120'.

[00103] Similarly, the distal end 1152 of the proximal support segment 1150 has a second connector portion 1154 that has a first proximal supply hole 1156 that is coupled to another first supply line segment 540. The second connector portion 1154 also has a second proximal supply orifice 1160 in it which is coupled to another second supply line segment 542. The first proximal supply orifice 1156 is configured to removably receive the first supply nozzle 1118 in it and the second orifice proximal supply 1160 is dimensioned to removably receive the second supply nozzle 1122 therein. As can be seen in Figure 47, a first O-ring seal 1158 is associated with the first proximal supply orifice 1156 to form a substantially airtight (or fluid-tight) seal between the first segment of the supply line 540 'and a another first segment of the supply line 540 when the first nozzle 1118 is inserted into the first proximal supply orifice 1156. When coupled together in this manner, the first segments of the supply line 540 'and 540 are joined together to form a first supply line 540 Similarly, a second O-ring seal 1162 is associated with the second proximal supply hole 1160 to form another substantially airtight (or fluid-tight) seal between the second supply line segment 542 'and another second supply line segment 542 when the second supply nozzle 1122 is inserted into the second proximal supply orifice 1 160. When coupled together in this manner, the second supply line segments 542 'and 542 form a second supply line 542.

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67/110 [00104] In addition, the distal end 1152 of the proximal support segment 1150 has a second connector portion 1154 that has a third proximal supply orifice 1156 'that is coupled to another third segment of the 2042 supply line. The second connector portion 1154 also has a fourth proximal supply orifice 1160 'in it which is coupled to another fourth segment of the 2052 supply line. The third proximal supply orifice 1156' is configured to removably receive the third nozzle. supply 1118 'in it and the fourth proximal supply hole 1160' is dimensioned to removably receive the fourth supply nozzle 1122 'in it. As can be seen in Figure 47, a third O-ring seal 1158 'is associated with the third proximal supply orifice 1156' to form a substantially airtight (or fluid-tight) seal between the third segment of the 2042 'supply line. and another third segment of the supply line 2042 when the third nozzle 1118 'is inserted into the third proximal supply orifice 1156'. When coupled together in this manner, the third segments of the supply line 2042 'and 2042 are joined to form a third line 2042. Likewise, a fourth O-ring seal 1162' is associated with the fourth proximal supply orifice 1160 ' to form another substantially airtight (or fluid tight) seal between the fourth segment of the supply line 2052 'and another fourth segment of the supply line 2052 when the fourth supply nozzle 1122' is inserted into the fourth proximal supply orifice 1160 '. When coupled together in this manner, the fourth segments of supply line 2052 'and 2052 form a fourth supply line 2052. Those skilled in the art will understand that other detachable coupling arrangements, quick disconnect arrangements can be used without departing from the spirit and

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68/110 of the scope of the present invention.

[00105] As indicated above in the background section here, as the cutter systems become smaller and smaller, the challenges to develop a pneumatically powered system that can generate the necessary actuation forces become greater. Such problems were a little easier to deal with by using electric motors to drive the rotary driveshafts. The rotary movement can be easily transmitted via long, flexible or articulating drive axes. Although great progress has been made in the size and torque capacities of the electric motor, the effectiveness of such systems will be limited because the size of the distal elongated shaft diameter and the size of the motor that can be fitted in this area for the motor must be so close of the stapling mechanism as possible. In many current applications, the desired size of the shaft diameter prevents the electric motor from being located at the distal end of the system while being able to provide enough energy to drive the system.

[00106] The following modalities deal with such problems and inconveniences associated with the use of electric drive motors. As will be discussed below, these modalities use a pneumatically powered motor to transmit the rotary energy to a rotary driven cutter. Pneumatically powered engines generally produce torques and revolutions per minute that are proportional to the pressure and volume of the gas transmitted to the engine. In the non-limiting modalities shown in figures 49-56, an articulated transmission shaft assembly is used to transmit the rotary movement of the pneumatically powered motor to the end executor. Those skilled in the art will understand, however, that the unique and new aspects of these modalities of

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69/110 the present invention can also be effectively used in connection with other known rotary driven end performers and other surgical instruments that use a flexible drive shaft arrangement to transmit the rotary drive motion to the cutter. In addition, the unique and new aspects of these embodiments of the present invention can be effectively used in connection with non-articulated end executor arrangements.

[00107] Figures 49-56 illustrate a surgical cutting and stapling instrument 1500 of the present invention that uses a rotary driven cutter 1512. There are a variety of rotary driven cutters and other surgical instruments. For example, such a rotary cutter arrangement is described in US Patent Application No. Serial 11 / 343,447, filed January 31, 2006 and entitled Motor Driven Surgical Cutting and Fastening Instrument With Adaptive User Feedback for Shelton, IV and others, the relevant portions of which are incorporated herein by reference. Other examples are described in the US Patent Application entitled Manually Driven Surgical Cutting and Fastening Instrument for Shelton, IV and others, filed June 27, 2006 (KLNG No. 050704 / END5779USNP), the relevant portions of which are hereby incorporated by reference .

[00108] Figure 50 is an exploded view of the end executor 1512 according to several non-limiting modalities. As shown in the illustrated embodiment, end runner 1512 may include an elongated channel 1520 that is sized to receive a pneumatically operated tool. The pneumatically operated tool of various non-limiting modalities comprises a clamp cartridge 50 that operably supports a release mechanism thereon. This modality includes a set of

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70/110 wedge sled 1530 that carries a portion of knife 1538 on it. The wedge sled assembly 1530 is threaded on a helical drive thread 1560. A bearing 1522, positioned at a distal end 1521 of the elongated channel 1520 receives the helical drive thread 1560, allowing the helical drive thread 1560 to rotate freely with in relation to the elongated channel 1520. The helical drive thread 1560 can interface with a threaded opening (not shown) of the wedge sled assembly 1530, such that the rotation of the drive thread 1560 causes the wedge sled assembly 1530 translate in the distal or close direction (depending on the direction of rotation) through the elongated channel 1520 between a fully extended or triggered position where the clamps supported on the cartridge have all been released and a fully retracted or non-triggered position. In this way, when the helical drive thread 1560 is rotated in one direction, the wedge sled assembly 1530 is driven distally through the cartridge 50 by cutting the tissue stuck inside the end executor 1512 and launching the staples into the cartridge 50 for forming contact with the lower surface of an anvil 40 which is hingedly coupled to the elongated channel 1520. The sled portion 1532 of the wedge sled assembly 1530 may be made, for example, of plastic and may have an inclined distal surface 1534 As the wedge sled assembly 1530 traverses the elongated channel 1520, the angled front surfaces 1534 can push up or guide the staples in the staple cartridge 50 through the attached fabric and against the anvil 40. Anvil 40 turns the staples, thereby stapling the cut fabric. When the wedge sled assembly 1530 is retracted, knife portion 1538 and sled portion 1532 may be disengaged, thereby leaving sled portion 1532 at the distal end of elongated channel 1520. Those versed

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71/110 in the art will verify that other tools pneumatically operated with other launching mechanisms can be used. [00109] Figures 51 and 52 illustrate an arrangement of the transmission shaft to transmit the rotational movement to the helical drive thread 1560 of a pneumatically driven motor in the handle assembly 300. As can be seen from the reference to figure 51, this modality you can use a closure tube assembly 170 which has been described in detail above. The closing tube assembly 170 is received with a slide on a support assembly 1540 comprising a proximal support segment 1542 which rotationally supports a main (or near) rotational drive shaft 1544 which communicates with a secondary drive shaft ( or distal) 1546 via a bevel gear assembly 1550 that includes gears 1552,1554,1556. The secondary drive shaft 1546 is connected to a drive gear 1548 that engages a proximal drive gear 1562 of the helical drive thread 1560. The vertical bevel gear 1552 is pivotally supported in an opening 1543 at the distal end of the proximal support segment 1542 A distal support segment 1570 can be used to wrap the secondary drive shaft 1546 and drive gears 1548,1554. Collectively, the main drive shaft 1544, the secondary drive shaft 1546 and the pivot assembly (for example, the bevel gear assembly 1550) are sometimes referred to here as the main drive shaft assembly.

[00110] As can be seen in figures 53 and 54, several modalities of the instrument 1500 are powered by a source of pneumatic energy in the form of pressurized gas 620. In the modalities represented in these figures, the source 620 comprises a replaceable / refillable tube 622 that is supported within the co portion

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72/110 fit 642 of the housing assembly 300. The cylinder 622 can be refillable. Those skilled in the art will find, however, that non-replaceable / refillable sources (cylinders) of pressurized gas could also be effectively used. In still other embodiments, the handle assembly 300 may be provided with an orifice 616 for supplying pressurized gas from an external source 618 of pressurized gas. For example, instrument 1500 could be coupled to the installation's compressed air line (not shown) through a flexible supply line 617. See figure 53A.

[00111] The unique and new aspects of the removable / refillable cylinder 622 will be discussed in more detail below. However, in order to explain the drive system to provide the rotary movement for the end executor 1512, it can be seen that the pressurized gas flows under pressure from cylinder 622 or external pressure source 618 through a supply line 650 to inside a conventional ratio valve 660. The ratio valve 660 is coupled to a supply hinge 662 that is attached to an activation trigger 670. See figures 53 and 58. In various embodiments, the activation trigger 670 is supported adjacent to a path monitoring element or relative position release trigger 310 'which is pivotally coupled to the handle assembly 300 by a pivot pin 370 extending between the housing element on the right 320 and the housing element on the left 330. The relative position trigger 310 'can be made of plastic or other suitable material and has a portion with a substantially cross section U-shaped to accommodate the 670 activation trigger as shown. The clinician can position his hand on the stock portion 352 of the housing assembly 300 such that his three lower fingers are on the relative position trigger 310 'and his index finger is on the trigger 670. The trigger squeeze

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73/110 of activation 670 inwards towards the relative position trigger 310 'causes the ratio valve 660 to allow the gas to pass under pressure through it from the source 620 (or 618 in figure 53A) into a line of supply 680 on the directional control valve 1610.

[00112] As can be seen in figure 56, directional control valve 1610 has an advanced position section 1620, a stop section 1630 and a reverse section 1640. The sections of the control valve 1620,1630,1640 can be manually displaced by pressure buttons 1612 and 1614 that project through the handle housing 300. See figures 49 and 56. Two supply / discharge lines 1700,1710 extend from the directional control valve 1610 to a 1730 pneumatically powered conventional motor. , when the clinician moves the control valve 1610 to the forward position, the forward passage 1622 allows the pressurized gas to flow from the supply line 680 and into the supply / discharge line 1700 to cause the pneumatically driven motor 1730 to start the drive shaft of the 1732 engine in a first direction which will result, as will be discussed in more detail below, in the transmission of rotary motion to the drive shaft 1544 that will drive the wedge sled assembly 1532 and knife portion 1538 distally through end runner 1512 on a launch stroke. The gas that leaves the 1730 pneumatically powered engine through the supply line 1710 is discharged through a vent hole 1632. When the control valve 1610 is switched to the reverse position, the gas that passes through the supply line 680 can flow through the 1710 supply line into the 1730 pneumatically powered engine. The gas leaving the 1730 pneumatically powered engine through the 1700 supply / discharge line is discharged through

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74/110 of the vent hole 1632. When the control valve is in the stopped position, the supply line 1680 and the supply / discharge line 1710 are closed and the supply line 1700 is connected to the ventilation hole 1632. See figure 56.

[00113] As can also be seen in figure 56, the output shaft 1732 of the pneumatically powered motor 1730 may have a first transmission gear 1734 on it which is in engagement with a second transmission gear 1736 which is mounted on an input shaft 1738 of a planetary gear assembly 1740. The planetary gear assembly 1740 has an output shaft 1742 that is coupled to the proximal end 1545 of the drive shaft 1544 by a conventional shaft coupling element 1743 to transmit the rotary motion to it. Thus, when the control valve 1610 is switched to the forward position, the output shaft 1732 of the pneumatically powered motor 1730 grants a rotary movement to the transmission shaft 1544 through gears 1734,1736 and the planetary gear set 1740 to make with the wedge sled assembly 1530 and the knife portion 1538 to drive through the cartridge 50 by cutting the tissue attached to the end runner 1512 and leading the clamps in the cartridge 50 into forming contact with the anvil 40. When the control valve 1610 is switched to the reverse position, the output shaft 1732 of the pneumatically powered motor 1730 grants an opposite rotary movement to the drive shaft 1544 to retract the wedge sled assembly 1530 and knife portion 1538 in a proximal direction back through cartridge 50.

[00114] The modalities represented in figures 49-56 also have unique and new additional aspects that improve the operability of the instrument and provide several ways of returning to the clinician, so that the clinician can monitor the position of the sled set.

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75/110 wedge 1530 and knife portion 1538 inside the cartridge 50 when it is advanced distally in it and also retracted. Back to figure 56 again, it can be seen that a return gear 1750 is provided on the drive shaft 1544 or on the output shaft 1742 of the planetary gear assembly 1740. The return gear 1750 is in contact with a gear gear knife position 1752 which is mounted on a 1754 threaded knife position axis. The knife position axis 1754 can be supported by appropriate bearing arrangements (not shown) that facilitate its free rotation on them. A proximal load limit switch 1760 is associated with the proximal end 1756 of the axis 1754 and a distal load limit switch 1770 is associated with the distal end 1758 of the axis 1754. A knife indicator 1780 is threaded onto the position axis with a 1754 knife for the distal and proximal path over it. When the drive shaft 1544 is rotated in the direction that causes the wedge sled assembly 1530 and knife portion 1538 to move distally through cartridge 50, knife indicator 1780 also moves proximally toward distal load limit switch 1770. The distal load limit switch 1770 is oriented such that when wedge sledge 1530 and knife portion 1538 are in the most distal position, knife indicator 1789 triggers the load limit switch distal 1770. A window is provided on the left housing element 330 (or right housing element 320) depending on the location of the knife position axis 1754 in the housing assembly 300), such that the clinician can see the position of the indicator 1780 knife to determine the position of the throwing mechanism (wedge set 1530 and knife portion 1538) within its launch stroke and also to provide the clinician with means to monitor the position of the set wedge joint 1530 during the retraction course.

[00115] Also in several modalities, a distal pilot line

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76/110

1772 can be provided from supply line 650 for distal load limit switch 1770. A line of distal load limit switch 1774 can be provided between distal load limit switch 1770 and directional control valve 1610. Thus , when the wedge sled assembly 1530 and knife portion 1538 have completed the release stroke and the knife indicator 1780 activates the distal charge limit switch 1770, the charge limit switch 1770 allows gas to flow under pressure from the supply line 650 to the distal load limit switch line 1774 and into the directional control valve 1610 which, in various modalities, causes the directional control valve 1610 to automatically switch to the reverse position and thereby make with the 1730 pneumatically powered motor reversing and finally granting a reverse rotary motion to the 1544 drive shaft. As the 1730 pneumatically powered motor reverses the axis transmission axis 1544, the reverse rotary movement is transmitted to the knife position axis 1754 to thereby drive the knife position indicator 1780 back to the proximal load limit switch 1760. A proximal pilot line 1662 can also extends between the proximal load limit switch 1660 and the supply line 650, such that when the knife position indicator 1780 triggers the proximal load limit switch 1660 (meaning the wedge sledge 1530 and the knife portion 1538 moved to their fully retracted position), the proximal load limit switch 1660 then allows gas to flow into a line of proximal load limit switch 1664 and into directional control valve 1610 to cause the 1610 directional control valve automatically switches to the stopped position.

[00116] In several modalities, a first whistle powered by air 1790 or another suitable sound generation device can be

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77/110 communicate with the distal charge limit switch line 1774 (or distal charge limit switch 1770) such that when the distal charge limit switch 1770 is activated at the end of the launch stroke, the air passing through from the distal load limit switch line 1774 activates the first whistle 1790 to provide the clinician with an audible signal indicating that the wedge / knife sled has reached the end of the launch stroke. In the same way, a second air powered whistle 1792 or other suitable sound generating device can communicate with the proximal load limit switch 1760 such that when the proximal load limit switch 1760 is activated at the end of the retraction stroke , the air that passes through the line of the proximal load limit switch 1764 activates the second whistle 1792 to provide the clinician with another audible signal indicating that the wedge / knife sledge has reached the end of the retraction stroke. In other modalities, for example, battery-powered light-emitting diodes or other signal devices can communicate with the 1770.1760 distal and proximal load limit switches to provide the user with another indication when the wedge / knife sled reached the end of the launch course and / or the retraction course. In alternative modalities, the 1790,1792 whistles can be replaced by pressure sensors or manometers to indicate when the device has reached the end of the launch stroke and / or the retraction stroke.

[00117] In the various modalities represented in figures 49-56, the pneumatically driven motor is supported within the handle set 300. In the modalities represented in figures 52A and 52B, the pneumatically powered motor 1730 'is located within the distal support section 110 The drive shaft of the 1546 motor has a transmission gear 1548 'on it that is in engagement with the proximal transmission gear 1562 of the helical drive thread 1560. Figure 52A represents such an air motor

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78/110 mounted in the distal direction pneumatically energized in connection with an articulation joint 104 as described above. The modality shown in figure 52B uses a pneumatically energized articulation joint assembly 2002 as described above. Such distal-mounted air motor arrangements could also be used in connection with surgical instruments that use other articulated joint arrangements or used in connection with instruments where the end executor does not articulate in relation to the handle assembly or portion of the assembly. elongated shaft on which it is attached. Those skilled in the art will understand that such pneumatically energized engine arrangements mounted in the distal direction minimize the energy losses that can be encountered through elongated transmission shaft arrangements for modalities where the engine is supported in the handle assembly and the launching movements and retraction must be transmitted through the articulation joint to the end executor. The modalities such as those shown in figures 52A and 52B only require that two lines 1710 and 1760 pass through the articulation joint to energize the 1730 'engine. Lines 1710 and 1760 can comprise flexible or similar piping and are less likely to limit articulation joints when compared to other arrangements that require one or more drive elements to pass through the joint.

[00118] Also, several modalities of the present invention can be constructed to provide the user with a tactile feedback form with respect to the relative position of the instrument's launch components. In some embodiments, this is accomplished by associating the path monitoring element or relative position trigger 310 'to the forward and retracted movements applied to the transmission shaft or release mechanism of the device. More I left

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79/110 cularly and with reference to figures 53-55, this embodiment may include a return hinge assembly 1800 which, in various non-limiting embodiments, may comprise a 1801 threaded manual return shaft which is threaded onto a locking element. nut 334 which is mounted with rotation on a portion of upper fixing plate 332 of the relative position trigger 310 '. The distal end of the 1801 manual return shaft has a universal joint portion 1802 that supports a 1804 manual return gear that is in engagement with the 1752 knife position gear. When the directional control valve 1610 is in the forward position, the pneumatically powered motor 1730 drives the drive shaft 1544 such that the launching mechanism in the form of a wedge sleigh 1530 and knife portion 1538 is driven distally through the cylinder (launch stroke). The return gear 1750 drives the knife position gear 1752, which in turn drives the manual return gear 1804. The manual return gear 1804 then rotates the manual return shaft which, due to its threaded engagement with the nut 334, pull the trigger of relative position 310 'to the stock portion 342 of the handle assembly 300, thereby providing the clinician with a tactile indication of the advance of the wedge sled 1530 and knife portion 1538. Those skilled in the art will understand that if the clinician tries to articulate the relative position trigger 310 'to the stock portion 342 of the handle assembly 300, the manual return axis 1801 and the nut 334 will prevent any path from them. However, the relative position trigger 310 'will automatically articulate in relation to the advance and retraction of the wedge sled 1530 and knife portion 1538. This arrangement provides the clinician with an automatic tactile indication of the advance and retraction of the wedge sled assembly 1530 and knife portion 1538 (release mechanism) simply by holding the relative position trigger 310 'by

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80/110 the entire surgical procedure. Thus, the clinician does not have to look for anything to obtain such a return. Such a provision provides the clinician with a non-visual one-hand feedback of the progress of the launching mechanism between the non-triggered and the triggered position and also when the launching mechanism is traveling back from the triggered position to the non-triggered position.

[00119] Various modalities can also be provided with another tactile feedback arrangement, generally indicated as 333. For example, as can be seen in figures 53-56, the upper plate portion 332 of the relative position trigger 310 'can be provided with a series of 335 slots, holders, grooves, etc. which are designed to interface with a spring arm 337 mounted within the handle assembly 300 when the relative position trigger 310 'pivots around pin 370 during the release and retraction strokes. When the upper fixing plate portion 332 pivots with the relative position trigger 310 ', the end of the spring arm 337 falls into each successive slot 335 and serves to grant (in series) a force to the fixing plate portion upper 332 that can be felt by the clinician when holding the trigger of relative position 310 '. Thus, when the 310 'relative position trigger advances, the clinician will be provided with a series of additional tactile return movements corresponding to the movement of the release mechanism to confirm that the 310' relative position trigger (and finally the release mechanism) ) is advancing during the launch course or retracting during the retraction course, whatever the case may be. In addition, when the end of the 337 spring arm falls into each successive slit, it can create an audible sound, click, etc., to provide the clinician with audible feedback regarding the movement of the launch mechanism through the launch stroke. and the retraction course. So, this

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81/110 modality provides a series of (at least two) audible sounds that refer to the movement of the launching mechanism between the non-activated and the activated positions.

[00120] Those skilled in the art will find that the 1500 instrument represents a major improvement over the previous pneumatically powered cutter arrangements. For example, several modalities provide a means for the clinician to monitor the position of the launch mechanism (wedge sled / knife) when it is being driven through its launch course. In some embodiments, when the wedge / knife sledge reaches the end of its launch stroke, it is automatically retracted. Once in the fully retracted position, the control valve can be automatically switched to a stopped position, thereby discontinuing the air supply from the 618 or 620 source to the 1730 pneumatically powered engine. If, however, during the activation process, the clinician wants to stop the wedge / knife sled from advancing distally in the cylinder, he or she can simply manually switch the 1610 control valve to the reverse position and continue to activate the 670 activation trigger to supply pressurized gas to the engine pneumatically powered 1730 until the wedge / knife sled is moved to the desired retracted position. What's more, the unique new 310 'relative position trigger provides the clinician with manual or tactile feedback that he or she can feel while holding the 310' relative position trigger. Also, the clinician may be provided with audible signals when the wedge / knife sledge has reached the end of the launch stroke and / or has been fully retracted.

[00121] The converse will also verify that the unique and new advantages provided by the path monitoring device can also be achieved when using the drive elements 500,800 or bellows set 900 by connecting each of these

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82/110 actuating elements on the upper fixing plate portion 332 or other portion of the relative position trigger 310 'by a flexible impulse / traction cable (not shown) or rigid element (for non-articulated modes) such that the feed and the retraction of these actuating elements is directly or indirectly associated with the relative position trigger 310 '. This unique and new arrangement can also be used with the modality represented in figures 70-83 described below.

[00122] As indicated above, the 1800 return hinge assembly not only automatically moves the relative position trigger 310 'in a ratio that corresponds with the rate of movement of the release mechanism in order to provide the clinician with a means to monitor In the progress of the launch mechanism, the return hinge assembly 1800 may use threads or other means that would effectively hinder or greatly limit the clinician's ability to manually hinge the 310 'relative position trigger. In such non-limiting embodiments, the only moment when the relative position trigger 310 'moves is when the return hinge assembly moves it. In still other embodiments, the manual movement of the relative position trigger 310 'can be prevented by an engine (not shown) or another gas cylinder (not shown) configured to prevent any articulated path of the relative position trigger 310' when activated . For example, the presence of force on the trigger 670 activates the gas release, but until the launch mechanism starts to move, the relative position trigger 310 'could not substantially move, and if the launch mechanism stopped from moving, then the 310 'relative position trigger movement would cease.

[00123] In several other modalities, however, the 1800 return hinge assembly can be so constructed that

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83/110 to provide the clinician with the ability to assist the drive element in the form of a 1740 pneumatically powered motor during the launch stroke in order to add strength to it or delay the advancement of the launch mechanism if the clinician so wishes. In these various embodiments, for example, the 1801 return axis can be formed with an acme-type thread or other thread arrangement or configuration that would actually allow the clinician to apply pressure to the 310 'relative position trigger and thereby grant a rotational force on shaft 1801 by virtue of its engagement with nut 334. By granting a rotational movement on shaft 1801, the clinician also applies a rotational force on gear 1804 that is engaged with gear 1750 which is articulated on the shaft of transmission 1544. Thus, if the launching mechanism encounters resistance, the clinician can apply the mechanically generated energy to the transmission shaft 1544 by squeezing the trigger of the relative position 310 '. If the clinician want to slow down or delay the movement of the mechanism, the clinician can apply force in a position to trigger on 310 'which in turn resist / decrease the rotation shaft 180 ¹ and gear 1804 and finally rotation transmission shaft 1544.

[00124] Various modalities described above have been described in conjunction with the use of a material storage element in the form of a removable cylinder 622 to supply gas under pressure to operate the device. In various embodiments, the removable cylinder 622 can initially be filled with gas under pressure and be refillable. In other embodiments, the cylinder may not be the type that can be refilled. For example, cylinder 622 may comprise a conventional disposable cylinder filled with carbon dioxide. After the cylinder is empty, the user removes it from the handle assembly and replaces it with a new filled cylinder. Other types of gases that can

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84/110 can be used, for example, are compressed air, carbon dioxide (CO2), nitrogen, oxygen, argon, helium, sodium hydride, propane, isobutane, butane, chlorofluorocarbons, dimethylether, methyl ethyl ether, nitrous oxide, hydrofluoroalkanes (HFA): HFA 134a (1,1,1,2, tetrafluoroethane) or HFA 227 (1,1,1,2,3,3,3, -heptafluoropropane). Such an arrangement provides a great improvement over the previous provisions of a pneumatically powered surgical instrument. However, the number of times the instrument can be used is dependent on the volume of gas that can be stored in such cylinders and the need to effectively maintain the sterility of the device.

[00125] Other embodiments of the present invention use a cylinder 622 that stores the material in a non-gaseous liquid state when at a storage pressure and then at least some of the liquid vaporizes when placed under a lower pressure with activation of the device. Examples of such liquids that can be used in these embodiments include nitrous oxide, dimethylethyl ether, methyl ethyl ether, sodium hydride, propane, isobutane, butane, hydrofluoroalkanes (HFA): HFA 134a (1,1,1,2, -tetrafluoroethane ) or HFA 227 (1,1,1,2,3,3,3, -heptafluoropropane) and carbon dioxide (CO2) under higher pressures.

[00126] Figure 57 represents a non-limiting example of a cylinder 622 that has one of the liquid materials 624 mentioned above in it. The cylinder 622 can be made of steel, aluminum or other material that is compatible with the liquid / vapors stored in it and capable of withstanding the internal pressures generated therein. When using such surgical instruments of the types described here, the clinician frequently turns the handle set 300 in a variety of positions including upside down to obtain the desired position of the end executor 12. In these modalities, therefore, to prevent the liquid undesirably move out of cylinder 622 to

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85/110 within the control system during such manipulation, a membrane 626 is provided inside the cylinder 622. The membrane 626 can be made of material that prevents the passage of liquid material through it, but allows the vapor 628 formed from the liquid to pass through the membrane 626. Thus, the clinician can freely manipulate the handle assembly 300 without the danger of liquid material 624 passing into the directional control valve 1610 and / or pneumatically powered motor 1730. Although the cylinder 622 is illustrated with construction of one piece, cylinder 622 can be manufactured in two or more pieces to facilitate the installation of liquid material 624 and membrane 626 in it. Suitable sealing element (s) can be used to establish fluid-tight seals between the various portions of the cylinder in such an embodiment. In addition, a filling hole (not shown) can be provided to fill the cylinder

622.

[00127] In the modality shown in figure 57, when the clinician switches the directional control valve 1610 to the advanced position and activates the ratio valve 660, the pressure inside the cylinder 622 is decreased. Such a decrease in pressure causes liquid material 624 to start to vaporize and steam 628 to pass through membrane 626 and be used to energize the various control systems described above. Thus, by decreasing the pressure in cylinder 622, liquid material 624 begins to vaporize and pressurized steam 628 is used to energize the device.

[00128] Other modalities may use liquid materials that require combustion to convert the liquid material to its gaseous state. Examples of such liquid materials are propane, butane and other petroleum products. A conventional push-button igniter or other ignition system could be used to ignite the liquid material. In such applications, the other components of the

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86/110 device would be manufactured from materials and in such a way to safely disperse any heat / fumes generated by it. Still other embodiments can use phase change materials that are specifically designed to convert from solid to fluid, solid to gas or fluid to gas at a low pressure and temperature through the entry of heat. Examples of such materials are paraffin and numerous mixtures of sodium hybrids. These phase change materials can have large volumetric changes with the entry of heat into the system. Such devices would use a resource such as a burner to provide the heat required for the material. Again, the components of these devices that can be exposed to such heat would be designed and constructed of materials to safely dissipate heat and protect the clinician during use. [00129] The modality shown in figure 57 can be used with the variety of different types of cylinders described above and provides several advantages over other modalities where the cylinder is permanently mounted inside the handle assembly 300. More specifically and with reference to figure 57 , the cylinder 622 can be received inside a cavity 671 formed in the stock portion 342 of the handle assembly 300. To gain access to the cavity 671, the stock portion 342 can be manufactured in two easily separable parts or be provided with a panel removable cover (not shown) that fits or is otherwise removably attached to it. In various embodiments, the discharge end 630 of cylinder 622 is threaded into a threaded orifice 634 in a head block 632. Threaded orifice 634 communicates with a supply passage 636 which is opened and closed by a needle valve 638. In particular, in various embodiments, the needle valve 638 is threaded onto the head block 632, such that then the supply passage 636 can be opened and closed by turning the pressure valve.

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87/110 needle 638. However, other flow control or valve arrangements may be used.

[00130] To provide the clinician with an indication of the cylinder pressure during use, a conventional 640 gauge can be mounted in fluid communication with the supply passage 636. A 642 gauge window can be provided in the stock portion 342 for enable the user to see the 640 gauge during the course. See figure 49.

[00131] As can be seen in Figures 57 and 58, the cylinder 622 can be supported in a detachable stock portion 342 that is removably affixable to a primary fixation portion 344 that projects below the primary handle portion 340 The detachable stock portion 342 may be engaged with the primary attachment portion 344 by any suitable arrangement. For example, according to various embodiments, the engagement of the detachable stock portion 342 with the primary fixing portion 344 can be accomplished by a straight linear cursor arrangement as shown. As shown, for example, in Figures 57-59 and 61, the removable stock portion 342 also comprises first and second upper cursor tracks 367 and first and second lower cursor tracks 368. As can also be seen in these figures, the first upper cursor track 367 defines a ramp 369. Upper cursor tracks 367 are designed to be received within corresponding areas 384 defined in the primary handle portion 340 by panels 380 and 382.

[00132] The surgical instrument may also comprise a locking system 1900. The locking system 1900, shown in greater detail, for example, in figures 59 and 64-69, is structured and arranged to block the connection of the primary fixation portion 344 in the detachable stock portion 342 after the stock portion detaches

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Tactile 88/110 342 is disconnected from primary attachment portion 344 for a predetermined number of times. The predetermined number of times can be any number of times. Such an arrangement can be particularly advantageous in ensuring that the sterility of the device is effectively maintained by limiting the number of times that a device can be used. For example, according to various embodiments, the locking system 1900 can block the connection of the primary fixing portion 344 to the detachable stock portion 342 after the detachable stock portion 342 is disconnected from the primary fixing portion 344 twice. Although the locking system 1900 is shown predominantly within the primary housing portion 340, it is understood that according to other embodiments, the locking system 1900 may be predominantly within the detachable stock portion 342.

[00133] As shown in figure 59, the locking system 1900 comprises a counter 1902 and a locking assembly 1904 coupled to counter 1902. Counter 1902 is structured and arranged to advance when the detachable stock portion 342 is disconnected from the primary fixation 344 of handle assembly 300. As can be seen in figure 59, counter 1902 is connected to an axis 1906 which is supported by a shoulder 1908 connected to the right housing element 320. Counter 1902 comprises an index wheel 1910 coupled to the axis 1906 and a guide element 1912 coupled to the index wheel 1910. The guide element 1912 may comprise, for example, a torsion spring configured to orient the index wheel 1910 in a counterclockwise direction. See figure 59.

[00134] The 1910 index wheel defines protrusions 1914, 1914 ', 1941 that cooperate with the lock assembly 1904 to limit the advance of the 1910 index wheel. One of the protrusions

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89/110

1914 is structured and arranged to cooperate with the lock assembly 1904 to lock the connection of the detachable stock portion 342 to the primary attachment portion 344 after the stock portion 342 is disconnected from the primary attachment portion 344 for a predetermined number of times . Although the index wheel 1910 is shown as defining protrusions 1914, 1914 ', 1914, it is understood that according to other modalities, the index wheel 1910 can define notches that cooperate with the lock assembly 1904 to limit the advance of the wheel of the index 1910, and one of the notches can cooperate with the lock assembly 1904 to lock the connection of the detachable stock portion 342 to the primary attachment portion 344 after the stock portion 342 is disconnected from the primary attachment portion 344 by a predetermined number of times.

[00135] The 1906 axle is structured and arranged to allow the 1910 index wheel to be restored to a previous position. For example, axis 1906 can define an opening in hexagonal shape 1916 and a tool in hexagonal shape can be inserted through an opening 1918 in the housing element on the left 330 (shown in figure 60) and into the opening in hexagonal shape 1916 , then rotated clockwise to reset the 1910 index wheel to a previous position.

[00136] As shown in figure 59, the locking assembly 1904 comprises a locking element 1920, a guide of the locking element 1922, a door element 1924 and a guide element 1926. The door element 1924 is in contact with the locking element 1920, is pivotally connected to the guide of the locking element 1922 and cooperates with the protrusions 1914, 1914 ', 1914 to limit the advance of the index wheel 1910. The guide element 1926 is coupled to the door element 1924. The guiding element 1926 may comprise, for example, a torsion spring with

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90/110 figured to orient the door element 1924 in a clockwise direction. The operation of the 1900 locking system will be described in more detail here below with respect to figures 64-69.

[00137] As shown, for example, in figures 59-63, the handle assembly 300 also comprises a release system 1930 structured and arranged to initiate the disengagement of the segment of the detachable butt 342 from the primary attachment portion 344. The locking system release 1930 is within primary fixation portion 344 and comprises a release button 1932 and the first and second release elements 1934 connected to or integral with the release button 1932. The first and second release elements 1934 define each one, a 1936 release ramp. The 1930 release system also comprises first and second 1938 release pins in contact with the respective 1936 release ramps, first and second 1940 clamping springs in contact with the first and second release pins 1938 and first and second ejection springs 1942 in contact with the first and second lower cursor tracks 368. See figure 62. How it can be seen in figure 59, the free end 1941 of the springs 1940 extends through a corresponding hole 321 in the right housing element 320 and a corresponding hole 331 in the left housing element 330 into corresponding holes 372 in the upper cursor rails 367 to retain the detachable stock portion 342 in engagement with the primary attachment portion 344.

[00138] To initiate the disengagement of the detachable stock portion 342 from the stock fixing portion 344, the 1932 release button is advanced, causing the first and second release elements 1934 and the respective release ramps 1936 to also advance . As the 1936 release chutes advance, the 1936 release chutes cause the first and second

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91/110 beration 1938 change position. Changing the respective positions of the first and second release pins 1938 causes the first and second clamping springs 1940 to move upwards out of the holes 372 in the upper cursor rails 367 by a sufficient amount to allow the first and second the second upper cursor tracks 367 slide out of engagement with them. When the detachable stock portion 342 moves away from the primary stock holding portion 344, each of the first and second ejection springs 1942 releases stored energy, thereby respectively giving a force against each of the first and second cursor tracks lower 368. The force provided assists in disengaging the detachable stock portion 342 from the primary stock fixing portion 344. It is understood that, according to other modalities, the release system 1930 may comprise other components and / or configurations suitable for starting releasing the detachable stock portion 342 from the primary stock fixing portion 344.

[00139] With reference to figures 57 and 58, the distal end 637 of the supply passage 636 has a point 639 formed on it to enable the distal end 637 to pierce through the sterile sealing membrane 646 mounted inside an enclosed head chamber 644 provided in the primary fixing section 344. In particular, the distal end 637 of the supply passage 636 is inserted through a hole 645 in the 644 head chamber. The sterile membrane 646 can be manufactured from any suitable perforable material that can be sterilized and achieve a substantially fluid-tight or airtight seal between the distal end 637 of the supply passage 636 when inserted through it, but maintain the sterility of the area within the head chamber 644 when the end 637 of the supply passage 636 is repeated 870180138022 , of 05/10/2018, p. 95/124

92/110 moved from it.

[00140] As can also be seen in figures 57 and 58, the supply line 650 is fluidly coupled to the head chamber 644 such that the pressurized gas entering the head chamber 644 of the supply line 636 flows into the line supply 650. Figure 57 illustrates the detachable stock portion 342 prior to attachment to primary attachment portion 644. Figure 58 illustrates the stock portion 342 attached to primary attachment portion 344. As can be seen in figure 58, the distal end 637 of supply passage 636 drilled through sterile membrane 646. To assist with insertion of distal end 637 of supply passage 636 through sterile membrane, a compression spring 649 is provided between the wall of the detachable stock 342 and the head block 632. Such an arrangement provides some concession to the head block 632 when the distal end 637 of the supply passage 636 is ins through membrane 646.

[00141] Figures 64-69 illustrate the relative positions of the 1900 locking system components at various times during the fixation / separation process. Figure 64 illustrates the relative positions before the first complete engagement of the stock portion 342 in the primary fixing portion 344. The door element 1924 is in contact with the protrusion 1914, thereby preventing the index wheel 1910 from advancing.

[00142] The stock portion 342 is secured to the fastening portion 344 advancing the slide tracks 637 into the corresponding passages 384. The locking element 1920 projects into one of the passages 384 through a hole 381 in the panel 380 See figure 59. As the first and second upper cursor tracks 367 advance, ramp 369 on one of the first upper cursor tracks 367 contacts the locking element 1920 and causes

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93/110 that it moves upwards towards the index wheel 1910. When the locking element 1920 advances towards the indexing wheel 1910, the locking element 1920 causes the door element 1924 to advance away from the wheel index 1910. See figure 65. When the first upper travel track 367 and ramp 369 continue to advance, the locking element 1920 continues to advance to the index wheel 1910. When the stock portion 352 is fully engaged with the primary portion 351, the locking element 1920 is in contact with the protrusion 1914 which was initially in contact with the door element 1924, thereby preventing the index wheel 1910 from advancing as shown in figure 66.

[00143] After the disengagement of the stock portion 342 from the primary fixation portion 344 is initiated, the first and second upper cursor tracks 367 advance in the opposite direction, the ramp 369 defined by the first upper cursor track 367 allows the locking element 1920 advances away from index wheel 1910. When locking element 1920 advances away from index wheel 1910, locking element 1920 allows door element 1924 to advance towards index wheel 1910 and beyond protrusion 1914 as shown in figure 67. When the stock portion 342 is separated from the primary fixation portion 344, the locking element 1920 advances far enough from the index wheel 1910 to lose contact with the protrusion 1914 and allow the index wheel 1910 rotates until a second protrusion 1914 'contacts the door element 1924 as shown in figure 68.

[00144] At this point, counter 1902 has advanced one position, and the stock portion 342 is capable of being re-attached to the primary fixation portion 344. The fixation / separation cycle can be repeated. Figure 68 illustrates the second re-fixing process. When the stock portion 342 is fully engaged with the fixing portion

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Primary 94/110 344, the locking element 1920 is in contact with the protrusion 1914, thereby preventing the index wheel 1910 from advancing as shown in figure 69. At the end of the second cycle, when the stock portion 342 is separated from the primary fastening portion 344, the door element 1926 is in contact with a third protrusion 1914 as shown in figure 69. The third protrusion 1914 is structured and arranged to prevent the door element 1926 from advancing away from the index wheel 1910 by the locking element 1920, thereby preventing the primary fastening portion 344 from being fastened to the stock portion 342 (or attached to a replacement stock section). Therefore, according to these modalities, the surgical instrument is effectively an instrument with two uses. However, someone skilled in the art will find that the number of uses can be increased if the 1910 index wheel defines additional protrusions or notches. Other embodiments of the present invention lack the locking system 1900, but it is configured such that panels 382 or another portion or portions of the handle assembly 300 break or are otherwise deactivated to prevent re-attachment of the stock portion 342 or other butt stock on the handle assembly.

[00145] Figures 70-83 illustrate another unique and new pneumatically energized surgical cutting and fixing device 3010 of the present invention that provides the clinician with the ability to monitor the progress of the launch course while also providing the ability to manually retract the its launch components. This embodiment can be used in conjunction with the end executor 12 described above or with other end executor arrangements.

[00146] The elongated support set 3102 of this modality may comprise a proximal support segment 3104 which is fixed

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95/110 in a distal support segment 3106. In alternative embodiments, the elongated support set 3102 may comprise a single component. The elongated support assembly 3102 is substantially hollow and non-movably coupled to the housing assembly 300. As can be seen in Figures 79 and 80, the proximal end 3105 of the proximal support segment can be secured to the housing assembly by a handle right clamp 3110 protruding from the right housing element 320 and a left clamping handle 3112 protruding from the left housing element 330. The distal end of the elongated support element 3102 can be coupled to the elongated channel 20 in the manner described above .

[00147] Also in this embodiment, an elongated closing tube 3190 extends from the handle assembly 300 to the end executor 12. The distal end 3192 of the closing tube 3190 has a horseshoe opening 3194 through it and serves to interact with the opening / closing projection 46 on the anvil 40 in the manner described above when the closing tube 3190 is moved axially in the support element 3102. See figure 70.

[00148] As can be seen in figure 71, a shuttle set 3400 that is coupled to the closing trigger 302 by a hinge assembly 430 is supported within the primary housing portion 340. The shuttle set 3400 can also be manufactured in two pieces 3402,3404 that are molded or otherwise made of a polymer or other suitable material and are designed to come together. The 3402,3404 parts can be held together by pressure and / or adhesive elements and / or screws, screwdrivers, clips, etc. The right portion 3402 of the 3400 shuttle assembly has a 3405 right retaining flange segment that is adapted to cooperate with a left retaining flange segment (not shown) on the left portion 3404 of the 3400 shuttle assembly

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96/110 to form a retaining flange assembly that can extend into the retaining groove (not shown) at the proximal end 3196 of the elongated closure tube 3190 in the manner described above. The proximal end 3104 of the elongated support element 3102 extends into the opening 3403 formed at the distal end of the shuttle assembly 3400 and is non-movably attached to the right housing element 320 by the right holding handle 3110 extending through of opening 3406 and a left holding handle 3112 that extends through opening 3408 in the right portion 3402 and the left portion 3404, respectively. In addition, the 3400 shuttle assembly is provided with 3410.3411 side expansion guide rails. The rail 3410 is configured to be received with a slide within a corresponding rail guide on the right housing element 320 and the rail 3411 is configured to be received with a slide within a corresponding rail guide on the left housing element 330. Thus, the shuttle assembly 3400 and the closing tube 3190 can move axially with respect to the support assembly 3102 which is attached to the handle assembly 300.

[00149] The axial movement of the shuttle set 3400 and the elongated closing tube 3190 in the distal direction (arrow C) is created by moving the closing trigger 302 to the stock portion 342 of the handle assembly 300 and the axial movement of the assembly shuttle 3400 in the proximal direction (arrow D) is created by moving the closing trigger 302 away from the stock portion 342. In various embodiments, the shuttle 3400 is provided with a connector projection 3412 that facilitates attachment of the 3430 closing joint on it. See figures 71 and 72. The closing hinge assembly 3430 includes a yoke portion 3432 that is pivotally pinned to the projection of connector 3412 by a pin

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97/110

3414. The closing hinge assembly 3430 also has a closing arm 3434 that is pivotally pinned to a yoke assembly 304 formed on the closing trigger 302 by a closing pin 436 as illustrated in figure 71. The closing trigger 302 is pivotally mounted within the handle assembly 300 by a pivot pin 306 that extends between the housing element on the right 320 and the housing element on the left 330.

[00150] When the clinician wishes to close the anvil 40 and secure the tissue inside the end executor 12, the clinician pulls the closing trigger 302 towards the stock portion 342. When the clinician pulls the closing trigger 302 towards the butt portion stock 342, the closing pivot assembly 3430 moves the shuttle assembly 3400 in the distal C direction until the closing pivot assembly 3430 moves to the locked position shown in figure 71. When in that position, the pivot assembly 3430 will tend retain the 3400 hook assembly in that locked position. When the shuttle set 3400 is moved to the locked position, the closing tube 3190 is moved distally in the support set 3102 causing the closing / opening projection 46 on the anvil 40 to be contacted by the proximal end of the horseshoe opening 3194 at the distal end 3192 of the closing tube segment 3190 to thereby articulate the anvil 40 to the closed (clamped) position. To also retain the shuttle set 3400 in the closed position, a locking mechanism 301 can be used as described above.

[00151] As indicated above, these various modalities of the present invention use a unique new 4000 retraction rod set that allows the clinician to monitor the progress of the launch and retraction courses and also provides the ability to manually retract a launch bar 4030. As can be seen in

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98/110 Fig. 72, the retracting rod assembly 4000 includes a retracting rod 4010 which is secured by sliding pin to a 4020 thrust bar. In particular, retracting rod 4010 has an elongated slot 4012 through which slotted to receive two 4014 pins for sliding the retracting rod 4010 to the 4020 push bar. A retracting handle 4016 can be attached to the proximal end 4011 of the retracting rod 4010.

[00152] The impulse bar 4020 has a distal end 4022 which is designed to interface with the proximal end of an elongated launch bar 4030. As shown in figure 72, the proximal end 4032 of the launch bar 4030 has a portion of connector 4034 formed therein that is dimensioned to be received in a correspondingly formed connector opening 4024 at the distal end 4022 of the thrust bar 4020. Thus, the thrust bar 4020 can be used to axially push the launch bar 4030 in the distal direction to a launch stroke or pull the 4030 launch bar in the proximal direction for a retraction stroke. Those skilled in the art will find that the 4030 launch bar extends through the support set 3102. In alternative embodiments, the 4030 launch bar can have a rectangular, square, cross-sectional shape, etc. and be attached to the distal end 31 of the knife assembly 30 as described above or be connected to different types of knife bars and other end executor components that require axial movement to activate the end executor.

[00153] Figures 72-77 comprise several views of the 3400 shuttle assembly. As can be seen in these figures, the left shuttle portion 3404 includes two spaced vertical support walls 3416 and 3418 that define an opening of the shuttle bar.

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99/110 boost 3420 between them. The distal end 4022 on the impulse bar 4020 extends through the opening of the impulse bar 3420 to be coupled to the proximal end 4032 of the launch bar 4030. As can be seen in Figure 72, the proximal end 4026 of the impulse bar 4020 is coupled to a 4040 Z-shaped connector piece. In particular, the proximal end 4026 of the push bar can have a connecting handle 4028 protruding from there that can be received in an opening 4049 in a fixation projection 4042 at the proximal end 4041 of the 4040 Z-shaped connector part. See figure 72. However, the proximal end 4026 of the 4020 push bar can be secured to the 4042 mounting projection by a screwdriver or other suitable fasteners. The distal end 4045 of the Z4040 shaped connector part has a distal fixation projection 4046 on it that is adapted to be connected to a 5040 piston cylinder projecting from a 5000 pneumatically energized cylinder assembly.

[00154] As can be seen in Fig. 79, cylinder assembly 5000 may comprise a first cylinder housing 5010 having a first closed proximal end 5012 and an open first distal end 5014 that opens in a first axial passage 5016 within the first cylinder housing 5010. Cylinder assembly 5000 also comprises a second cylinder housing 5020 that has a second proximal end 5022 and a second open distal end 5024 that opens in a second axial passage 5026. The second proximal end 5022 has a first head piston rod 5028 formed therein which is dimensioned with respect to the first axial passage 5016 to create a substantially hermetic sliding seal with the first wall 5011 of the first cylinder housing 5010 to define a first cylinder area 5015 between the distal side of the first pro end

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100/110 ximal 5012 and the proximal side of the first piston head 5028. The first distal end 5014 of the first cylinder housing 5010 also has a first inwardly extending flange 5017 formed thereon to establish a substantially airtight sliding seal with the surface of the outer wall of the second cylinder housing 5020 to define a second cylinder area 5018 between the proximal side of the first flange 5017 and the distal side of the first piston head 5028.

[00155] A first passage 5027 is provided through the first piston head 5028. As can also be seen in figure 79, a piston cylinder 5040 extends through the second open distal end 5024 of the second cylinder housing 5020 and into the second axial pass 5026. Piston cylinder 5040 has a proximal end 5042 and a closed distal end 5044. A second piston head 5046 is formed at the proximal end 5042 of piston cylinder 5040. The second piston head 5046 is dimensioned in relation to to the second axial passage 5026 to create a substantially airtight sliding seal with a second wall 5021 of the second cylinder housing 5020 to define a third cylinder area 5032. The second distal end 5024 of the second cylinder housing 5020 also has a second flange which extends inwards 5025 formed on it to establish a substantially sliding seal hermetically sealed with piston cylinder 5040 to define a fourth cylinder area 5034 between the proximal side of the second flange 5025 and the distal side of the second piston head 5030. An opening 5047 is provided through the second piston head 5046 into a 5048 passage in the 5040 piston cylinder.

[00156] As can be seen in figures 79 and 80, the cylinder set 5000 is mounted inside the housing set 300.

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101/110

A first supply line or supply line 5050 extends from a directional control valve 610 in the handle assembly 300 to be coupled to the first proximal end 5012 of the first cylinder housing 5010 to supply pressurized gas through a first supply port 5013 or opening at the first proximal end 5012 of the first cylinder housing 5010. In addition, a second supply line or supply line 5052 extends from the directional control valve 610 to the first cylinder housing 5010 adjacent to the distal end 5014 thereof for supply pressurized gas into the second cylinder area 5018 through a second orifice 5029. See figure 78.

[00157] With reference to figures 78 and 79, the extension and retraction of the launch bar 4030 will now be explained. As can be seen in figure 78, supply lines 5050 and 5052 are coupled to a conventional directional valve 1610 that is part of an actuator system 1600 housed within handle assembly 300. Directional control valve 1610 has a section of advanced position 1620, a stop section 1630 and a reverse section 1640. The control valve sections 1620,1630,1640 can be manually moved by the push buttons 1612 and 1614 that project through the handle housing 300. In various ways , a removable source 620 of pressurized gas is used. See figures 71 and 81-83. Those skilled in the art will find, however, that non-replaceable / refillable sources (cylinders) of pressurized gas could also be effectively used. In still other embodiments, the handle assembly 300 may be provided with an orifice 616 for supplying pressurized gas from an external source 618 of pressurized gas. For example, the instrument 3010 could be coupled to the compressed air supply of installation 618 through a line of

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102/110 flexible supply 617. See figure 81A.

[00158] Pressurized gas flows from cylinder 622 (or external pressure source 618) through a supply line 650 into a conventional ratio valve 660. As can be seen more particularly in Figure 78, ratio valve 660 it is coupled to a supply hinge 662 which is attached to an activation trigger 670. In several embodiments, the activation trigger 670 is supported adjacent to the release trigger 310 which is hingedly coupled to the handle assembly 300 by a pivot pin 370 that extends between the housing element on the right 320 and the housing element on the left 330. Tightening the activation trigger 670 inwardly towards the release trigger 310 causes the ratio valve 660 to allow more pressurized gas to pass through from it into a supply line 680 into directional valve 1610. Depending on the position of directional valve 1610, the pressurized gas will flow into the 5050 or 5052 supply line. For example, when directional valve 610 is actuated by the clinician to extend the launch bar 30, control valve 1610 is switched to the forward position such that forward passage 1622 allows the pressurized gas flows from supply line 680 into supply line 5050. Gas flowing through supply line 5050 enters the first area of cylinder 5015 through the first supply orifice 5013 at the closed end 5012 and through opening 5027 at the first piston head 5028 and into the third cylinder area 5032. Pressurized gas entering the third cylinder area 532 also passes through opening 5047 in the second piston head 5046 into the hollow piston cylinder 5040 and forces the piston cylinder 5040 in the distal direction. The gas located in the fourth cylinder area 5034 vent from there through the discharge opening 5023 in the second cylinder housing 5020.

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103/110

Similarly, the gas located in the second cylinder area 5018 can vent from there through the second opening 5029 into the second supply line 5052. The second supply line 5052 carries the vented gas to passage 1624 on directional valve 1610 where it is finally vented from the vent passage 1632. The continued application of pressurized gas to the first cylinder area 5015, the third cylinder area 5032 and passage 5048 to the piston cylinder 5040 causes the piston cylinder 5040 to extend distally as shown in the figures 73 and 79. When the piston cylinder 5040 extends in the distal direction, the Z-shaped connector 4040 also extends in the distal direction because of its attachment to the distal end 5044 of the 5040 piston cylinder. The Z-shaped connector 4040 forces the push bar 4020 in the distal direction which also forces the launch bar 4030 in the distal direction. As the launching bar 4030 moves in the distal direction, the distal end portion 31 of the knife assembly 30 attached to it is advanced through the cartridge 50 to cut the tissue trapped in the end executor 12 and release the staples. After knife set 30 has been advanced to its most distal position on end executor 12, the clinician discontinues the application of pressurized gas by releasing the 670 activation trigger.

[00159] This modality can also be provided with a feature to indicate when knife set 30 has reached its most distal position in cartridge 50. In particular, a distal pilot line 1772 can be provided from supply line 650 for the spanner. distal load limit 1770. A line of the distal load limit switch 1774 is provided between the distal load limit switch 1770 and the directional control valve 1610. Thus, when knife assembly 30 has completed the launch stroke, the 1770 distal load limit switch is so oriented with respect to a portion of the cylinder assembly

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104/110 dro 5000 such that it is activated by a portion of it. The distal load limit switch 1770 allows air to flow under pressure from the supply line 650 to the line of the distal load limit switch 1774 and into the directional control valve 1610 which, in various modes, causes the directional control valve 1610 automatically switches to the reverse position which, as will be discussed below, causes the 4030 launch bar to retract. In various modalities, a first air powered whistle 1790 or other suitable sound generating device can communicate with the line of the distal charge limit switch 1774 (or distal charge limit switch 1770) such that when the limit switch distal charge 1770 is triggered at the end of the launch stroke, air passing through the line of the distal charge limit switch 1774 activates the first whistle 1790 to provide the clinician with an audible signal indicating that knife set 30 has reached the end of the launch course. In alternative modes, pressure gauges, etc. can be used in place of the 1790 whistle to provide the clinician with an indication of when knife set 30 has reached the end of the launch stroke.

[00160] To pneumatically retract the launch bar 4030, the clinician can push the button 1612 to change the control valve 1610 to the reverse position and begin to press the activation trigger 670, which causes the pressurized gas to flow to within the second supply line 5052. Gas flowing through the second supply line 5052 enters the second cylinder area 5018 which causes the second cylinder housing 5020 to retract proximally into the first cylinder housing 5010. The gas in the first cylinder area 5015 can vent through the first supply opening 5013 into the first supply line 5040. The gas that passes through the first supply line 5040

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105/110 enters directional valve 1610 where it is vented from ventilation 1632. After the pressurized gas entering the second area of cylinder 5018 has caused the second cylinder housing 5020 to retract into the first cylinder housing 5010, the gas that passing through the second opening 5029 is now able to pass through the discharge opening 5023 in the first cylinder housing 5010 and into the fourth cylinder area 5034. When the pressurized gas enters the fourth cylinder area 5034, the second piston head 5046 pulls piston cylinder 5040 proximally into the second cylinder housing 5020. The gas in the third cylinder area 5032 passes through the first opening 5027 into the first cylinder area 5015 from where it is vented in the manner described above . When the piston cylinder 5040 is retracted, the 4040 Z-shaped connector moves proximally and pulls with it the 4020 push bar and the 4030 release bar that is attached to it.

[00161] In several embodiments, a proximal pilot line 1662 also extends between a proximal load limit switch 1760 and the supply line 650. The proximal load limit switch 1660 is so oriented in relation to the cylinder assembly 5000 or the 4040 connector such that when the 4030 launch bar has been fully retracted, the 1760 proximal load limit switch is activated and then allows air to flow into a 1764 proximal load limit switch line and into the 1610 directional control valve to cause the 1610 directional control valve to automatically switch to the stopped position. In alternative modes, a second air powered whistle 1792 or other suitable sound generating device can communicate with the 1760 proximal load limit switch such that when the 1760 proximal load limit switch is activated at the end of the retract stroke.

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106/110 tion, the gas passing through the line of the proximal load limit switch 1764 activates the second whistle 1792 to provide the clinician with another audible signal indicating that the launch bar 4030 and knife portion 30 have reached the end retraction course. In other modalities, for example, battery-powered light-emitting diodes or other signal devices can communicate with the 1770.1760 distal and proximal load limit switches to provide the user with another indication when the wedge / knife sled has reached the end of the launch course and / or the retraction course. Those skilled in the art will easily find that if, during the launch course, the clinician wishes to stop the launch course and retract the launch bar and knife, all he or she needs to do is manually switch the 1610 control valve to the reverse position.

[00162] In the examples described above, the clinician did not use the unique new 4000 retraction rod assembly of this embodiment of the present invention. The reaction rod assembly has multiple advantages. First, if during the course of the launch or retraction courses, pneumatic energy is inadvertently lost due perhaps to an empty supply cylinder 620 or otherwise due to an inadvertent interruption in the pressurized gas supply, the clinician can manually retract the bar (and knife set 30) simply by manually switching control valve 1610 to the reverse position and holding the stock of handle 4016 attached to the proximal end of the retraction rod and pulling the rod in the proximal direction until the release bar has completely retracted. See figure 83. Switching the control valve 1610 to the reverse position allows the gas in the cylinder assembly to be vented when the knife bar is retracted.

[00163] Another advantage provided by this modality of price

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107/110 This invention is the ability to visually monitor the progress of the launch of the launch bar and knife portion when they move in the distal direction during the launch course. This advantage can be achieved by simply pulling the retraction rod to its most proximal position shown in figure 83 before starting the launch stroke. When in that position, as the cylinder assembly 5000 advances the connector 4040, the thrust bar 4020 and the launch bar 4030 in the distal direction, the impulse bar 4020 pulls the retract bar 4010 in the distal direction with it due of the pin connection to it. In various embodiments, the length of the retracting rod 4010 is provided such that when the launching rod 4030 is fully extended, no portion of the retracting rod 4010 protrudes from the handle assembly 300. Thus, the clinician can determine the progress of the rod launcher 4030 and knife set 30 observing the portion of the retracting rod 4010 protruding from the handle set 300.

[00164] In alternative embodiments shown in figures 72A and 83A, the retracting rod 4010 can be provided with at least one and preferably at least two notches 4015 to receive pins 4014 in them. Those skilled in the art will find that such an arrangement will provide the clinician with the ability to visually monitor the progress of the 4030 launch bar and knife set 30 during the retraction course. In particular, when the launching bar 4030 is retracted, the thrust bar 4020 causes the retracting rod 4010 to move proximally out of the housing assembly 300 due to the engagement of the pins 4014 in the notches 4015. Thus, the The clinician can judge the distance that the launching bar 4030 has progressed during the retraction course by looking at the distance that the retracting rod 4010 projects out of the handle assembly 300. However, when the instrument is not in use, the retracting rod

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108/110

4010 can be pushed into the handle assembly to the position shown in figure 81.

[00165] Although several modalities of the invention have been described, it should be evident, however, that various modifications, alterations and adaptations to these modalities can occur for persons skilled in the art with the attainment of some or all of the advantages of the invention. For example, according to several modalities, a single component can be replaced by multiple components and multiple components can be replaced by a single component, to perform a given function or functions. This application, therefore, is intended to cover all such modifications, changes and adaptations without departing from the scope and spirit of the invention described as defined by the appended claims.

[00166] The devices described here can be designed to be discarded after a single use or they can be designed to be used multiple times. In any case, however, the device can be refurbished for reuse after at least one use. Reconditioning may include a combination of steps to disassemble the device, followed by cleaning or replacing particular parts and subsequent reassembly. In particular, the device can be disassembled and any number of particular parts or parts of the device can be selectively replaced or removed in any combination. With the cleaning and / or replacement of particular parts, the device can be reassembled for subsequent use in a reconditioning facility or by a surgical group immediately before a surgical procedure. Those skilled in the art will find that reconditioning a device can use a variety of different techniques for disassembly, cleaning / replacement and reassembly. The use of such techniques and the resulting refurbished device are all

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109/110 within the scope of this application.

[00167] Preferably, the invention described here will be processed before surgery. First, a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In a sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and the instrument are then placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays or higher energy electrons. The radiation kills bacteria on the instrument and the container. The sterile instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened at the medical facility.

[00168] Any patent, publication or other description material, in whole or in part, that is said to be incorporated by reference here is incorporated here only to the extent that the incorporated materials do not conflict with existing definitions, statements or other description material presented in that description. As such, and to the extent necessary, the description as explicitly presented here supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference here, but which conflicts with existing definitions, statements or other description material presented here will only be incorporated to the extent that no conflict arises between that incorporated material and the existing description material.

[00169] The invention that is planned to be protected should not be interpreted as limited to the particular modalities described. The modalities are, therefore, to be considered as illustrative rather than restrictive. Variations and changes can be made by others without departing from the spirit of the present invention. Of that

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Accordingly, it is expressly planned that all such equivalents, variations and changes that fall within the spirit and scope of the present invention as defined in the claims are to be covered by it.

Claims (12)

1. Surgical instrument (10) in connection with a pneumatically powered tool (12) having a launching mechanism (30) operably supported on it which is movable between an un-actuated position and an actuated position, the surgical instrument comprising: an acting set (660,670); a pneumatically powered drive system (500) that communicates operably with the pneumatically powered tool (12) and is configured to selectively apply at least one launch force to the launch mechanism (30) of the pneumatically powered tool (12) sufficient magnitude to cause the launch mechanism (30) to move from the non-triggered position to the triggered position in response to a gas flow from a gas source (622,618) located upstream from the actuation set (660,670) and fluidly coupled to the pneumatically energized drive system (500); characterized by the fact that it still comprises: at least one return device communicating with the gas flow downstream from the actuation set (660,670) of the pneumatically energized drive system (500) and being configured to provide feedback with respect to the magnitude of the release force as the pneumatically powered drive system (500) moves the launch mechanism (30) from the non-driven to the driven position. 2. Surgical instrument, according to claim 1, characterized by the fact that the magnitude of the release force is proportional to a pressure of the gas flow from the gas source (622,618) to the pneumatically energized drive systemPetition 870180138022, of 10/05/2018, p. 115/124 2/5 of (500) when the pneumatically powered drive system (500) moves the launch mechanism (30) from the non-triggered to the triggered position. 3. Surgical instrument, according to claim 1, characterized by the fact that at least one return device provides a visual indication of the magnitude of the launching force as the pneumatically energized drive system (500) moves the launching mechanism (30) from the non-triggered position to the triggered position. 4. Surgical instrument, according to claim 1, characterized by the fact that the return device provides a visual indication of a relative position of the launching mechanism (30) between the non-activated and activated positions when the launching mechanism (30) ) is moved between them by the pneumatically powered drive system (500). 5. Surgical instrument, according to claim 1, characterized by the fact that at least one return device comprises: a first visual feedback device to indicate the magnitude of the launching force as the pneumatically powered actuation system (500) moves the launching mechanism (30) from the non-actuated to the actuated position; and a second visual feedback device for indicating a relative position of the launching mechanism (30) as the launching mechanism (30) is moved between the non-actuated and actuated positions. 6. Surgical instrument according to claim 3, characterized by the fact that at least one return device comprises a pressure gauge (541) in fluid communication with a supply line (540) fluidly coupling the gas source Petition 870180138022, of 10/05/2018, p. 116/124 3/5 (622,618) to the pneumatically powered drive system (500). 7. Surgical instrument, according to claim 3, characterized by the fact that the return device at least provides an audible sound that has a tone that varies in proportion to the magnitude of the launching force being generated when the launching mechanism (30 ) is moved from the non-triggered to the triggered position. 8. Surgical instrument according to claim 7, characterized by the fact that at least one return device comprises at least one orifice in a supply line fluidly coupling the gas source (622,618) to the pneumatically energized drive system (500 ). 9. Surgical instrument according to claim 1, characterized by the fact that at least one return device comprises a release stroke indicator communicating with the pneumatically energized drive system (500) to provide an indication when the launch (30) has reached the triggered position. 10. Surgical instrument, according to claim 9, characterized by the fact that the pneumatically energized drive system (500) is further configured to selectively apply a retraction force to the launch mechanism (30) of the pneumatically energized tool (12) to cause the launch mechanism (30) to move from the triggered position to the non-triggered position in response to another flow of gas from the gas source (622,618) and where when the launch mechanism (30) reaches the triggered position, the release stroke indicator communicates with a flow control device in fluid communication with the gas source (622,618) and the drive system Petition 870180138022, of 10/05/2018, p. 117/124 4/5 pneumatically powered (500) to cause the gas flow to the pneumatically powered drive system (500) to be discontinued and allow another gas flow to flow into the pneumatically powered drive system (500) to cause the pneumatically powered drive system (500) applies the retraction force to the launch mechanism (30). 11. Surgical instrument, according to claim 1, characterized by the fact that it still comprises: a handle assembly (300); a closing drive operably supported by the handle assembly (300) and configured to generate a closing movement and an opening movement; an elongated shaft assembly (100) operably coupled to the handle assembly (300) and communicating with the closing drive to transfer the opening and closing movements; a pneumatically powered drive system (500) supported by at least one of the handle assembly (300) and the elongated shaft assembly (100) and being configured to selectively generate at least one of the release force and retraction force ; and an end executor coupled to the elongated shaft assembly (100), the end executor comprising: an elongated channel (20) sized to receive a staple cartridge (50) in it; an anvil (40) hingedly coupled to the elongated channel (20) and being hingedly responsive to the opening and closing movements of the elongated shaft assembly (100); and a launch mechanism (301) supported by Petition 870180138022, of 10/05/2018, p. 118/124 5/5 operable way within one of the elongated channel (20) and the staple cartridge (50) and being movable from an un-actuated position to an actuated position in response to an application of the retraction force from the control system pneumatically energized drive (500). 12. Method for processing the surgical instrument (10) as defined in claim 1, characterized by the fact that it comprises: obtain the surgical instrument, sterilize the surgical instrument; and store the instrument in a sterile container.