PARTIALLY REUSABLE SURGICAL STAPLER
A partially reusable surgical stapler for deploying staples into tissue. The stapler has a body with a distal end, a proximal end and a longitudinal axis therebetween. The proximal end includes a handle while the distal end includes a staple cartridge holder and an opposing anvil. The stapler also has an actuator module for deploying staples. The actuator module includes at least one longitudinally movable member for sequentially ejecting staples towards the anvil. The actuator module is readily removable and replaceable to and from the body. The components of the stapler body can be disassembled, reconditioned and reassembled for reuse in a different surgical procedure.
The present invention relates generally to surgical stapling instruments and, more particularly, to a surgical stapler which can be disassembled and portions reconditioned and sterilized for reuse in subsequent surgical procedures, and which includes a removable actuating module that can be reused with multiple staple cartridges during a single patient procedure.
BACKGROUND OF THE INVENTIONBefore surgical staplers were introduced, surgeons had to spend a great deal of time sewing the tissue of patients back together. This was the most time intensive aspect of a surgical procedure. Surgical staplers have decreased the amount of time that a user spends sewing tissue back together. Such surgical staplers are described in the following issued U.S. patents which are hereby incorporated herein by reference: U.S. Pat. No. 4,633,861 Chow et al.; U.S. Pat. No. 4,633,874 Chow et al.; and U.S. Pat. No. 5,129,570 Schulze et al.
One concern with surgical staplers has been assuring that the staplers used during a procedure are sterile. Reusable staplers have typically been relatively complicated mechanical instruments which are difficult to sterilize after use. Hence, it was once desired that surgical staplers be completely disposable. As more than one surgical stapler may be required in a surgical procedure, for economical reasons disposable surgical staplers having reloadable staple cartridges have been developed. These reloadable staple cartridges have comprised a combination of staples and a firing module for discharging the staples. Typically the cutting instrument is included in the firing module. Therefore, each time a stapler is reloaded with a new staple cartridge, a new knife and firing assembly is also inserted into the stapler. Numerous staple cartridges are normally used during a single patient procedure, resulting in the repeated replacement of the knife and firing elements for the same patient. Since a knife is usually not worn out after a staple cartridge has been emptied, the knife and firing assembly could be reused with additional staple cartridges within the same patient. Reusing the firing assembly within a single patient procedure would not require additional sterilizing and can decrease the costs incurred during the procedure. Recently, there has also been a desire to make portions of a surgical stapler reusable, so that a portion is disposable and a portion is reusable in subsequent procedures. Reusing portions of the stapler reduces the costs associated with surgical procedures, and also decreases the surgical waste.
Thus, to reduce the costs associated with surgical procedures, there is a need for a surgical stapler that can be disassembled and portions of the stapler reconditioned for subsequent use. In particular, there is a need for a surgical stapler in which the firing and cutting components may be reused with multiple staple cartridges within a single patient procedure in order to decrease the amount of materials utilized with the stapler. There is also a need for a surgical stapler that can be easily assembled and disassembled to allow reconditioning and reuse of some of the stapler parts. In addition, there is a need for a partially reusable stapler that incorporates a disposable firing module to allow the more complex cutting and stapling components to be easily replaced between surgical procedures. Further, there is a need for a partially reusable stapler in which the reusable parts have a simple, one-piece design to facilitate effective reconditioning of the parts between procedures. The present invention provides a partially reusable surgical stapler which achieves these objectives.
SUMMARY OF THE INVENTIONIn accordance with the present invention, a partially reusable surgical stapler is provided for deploying staples into tissue. The stapler has a body with a distal end, a proximal end and a longitudinal axis therebetween. The proximal end includes a handle while the distal end includes a staple cartridge holder and an opposing anvil. The stapler also has an actuator module for deploying staples. The actuator module includes at least one longitudinally movable member for sequentially ejecting staples towards the anvil. The actuator module is readily removable and replaceable to and from the body.
In another embodiment, the present invention provides a partially reusable surgical stapler having an upper jaw member with a proximal handle end and a distal anvil end. A lower jaw member having a proximal channel-shaped frame and a distal staple cartridge channel is aligned with the upper jaw. An actuator module, having at least one longitudinally moveable member for sequentially ejecting staples towards the anvil, is readily removable and replaceable to and from the lower jaw frame. A staple cartridge containing a plurality of staples is removably disposed within the staple cartridge channel. A latching member for connecting the upper and lower jaws together is provided at an intermediate position along a longitudinal axis of the stapler. The latching member is moveable relative to the upper and lower jaw members to place the stapler in a series of different locking states. The different locking states include an assembly state for connecting and disconnecting the latching member to the jaw members, and a closed, latched state in which the latching member is locked to the jaw members.
Referring now to the drawing figures, in which like numerals indicate like elements throughout the views,
As shown in
Cylindrical pins 54 extend from opposite sides of upper jaw 22 proximal of tissue stops 52. Pins 54 fit inside vertical slots on lower jaw 24 to connect the upper and lower jaws together. Upper jaw 22 also includes a pair of curved notches 60 near the proximal end of channel sidewalls 32a, 32b. Notches 60 interact with projections 62 on lower jaw 24, as shown in
As shown in
An opening 76 is formed through bottom wall 66 at an intermediate position along lower jaw 24. Sidewalls 64a, 64b extend downward on opposite sides of opening 76 to form distally angled projections 80. Along the distal edge of projections 80, sidewalls 64a, 64b are shaped to form a straight-sided slot 82 having a circular end 88. The diameter of circular end 88 is slightly larger than the width of the slot 82. Proximal of projections 80 the outer surfaces of sidewalls 64a, 64b include a latching member positioning feature. As shown in
The distal end of staple cartridge 90 includes a tapered tip to facilitate the insertion of lower jaw member 24 into a hollow tubular body organ. Proximal of the tapered tip, staple cartridge 90 is provided with a pair of outwardly extending protrusions 102. A pair of spaced, parallel flanges 104 extends rearward from opposite sides of staple cartridge 90. Legs 110 extend downward from flanges 104 at the proximal end of the staple cartridge. Each leg 110 is provided with a rounded, downwardly facing notch 112. When cartridge 90 is assembled on lower jaw 24, protrusions 102 are loosely received in notches 72 in the lower jaw side walls, and legs 110 extend through opening 76 in the lower jaw bottom wall 66. Leg notches 112 engage a pin on latching member 30, as will be described below, to hold the cartridge within lower jaw channel 70. A pair of wings 114 extends upward and outward from sidewalls 92a, 92b at the proximal end of cartridge 90. Wings 114 function as finger grips which allow staple cartridge 90 to be manually inserted into and removed from lower jaw 24. Using wings 114, cartridge 90 can be lifted out of jaw opening 76 and notches 72, to remove the cartridge from lower jaw 24 following use. Additionally, wings 114 engage lower jaw sidewalls 64a, 64b at the proximal end of cartridge channel 70, as shown in
As mentioned above, stapler 20 includes a latching member 30 for connecting the upper and lower jaws members together at an intermediate position along the longitudinal length of the stapler. Preferably, jaw members 22, 24 are connected together at a location adjacent to the proximal ends of anvil 44 and staple cartridge 90. In the preferred embodiment, shown in
Each side wall 124a, 124b of latching member 30 includes a distally-extending C-shaped hook member 140 provided with a forwardly facing notch 142 for engaging upper jaw pins 54. As shown in
Stapler 20 also includes means for retaining the latching member in a series of different latching states. Referring to
As latching member 30 rotates, hook members 140 are drawn along the sides of lower jaw member 24. As hook members 140 swing alongside lower jaw sidewalls 64a, 64b, the bulbous ends of spring arms 150 contact detent bumps 84 on the sidewalls. To move spring arms 150 between the detent bumps 84, additional force is applied to latching member 30 to cause the spring arms to flex towards the hook members 140, so that the ends of the spring arms can ride over the bumps. With spring arms 150 positioned between detent bumps 84, as shown in
As latch pin 122 continues to rotate within slot end 88, drawing latching member 30 closer to lower jaw member 24, hook member inner cam surfaces 144 rotate over the opening of alignment slots 56, blocking the slots and locking upper jaw pins 54 within the slots. Spring arms 150 also ride along detent bumps 84 to engage the concave outer edge of the top bump. In this pre-closed state, shown in
When latching member 30 is rotated to a closed, operative state (shown in
To disassemble stapler 20, latching member 30 is rotated away from lower jaw member 24 to draw upper jaw pins 54 out of hook notches 142. Latching member 30 may be rotated away from upper and lower jaw members 22, 24 by pulling on the curved latching arm tip 162. As a counter rotating force continues on latching arm 120, spring arms 150 move through detent bumps 84, enabling hook members 140 to swing through and way from the lower jaw sidewalls 64a, 64b. Latching member 30 is rotated around in the direction of staple cartridge 90 until latching member 30 returns to the initial, open position shown in
Turning now to
As shown in
Returning now to
Returning to
As shown in
As shown in
A leaf spring 250, shown in
In an initial firing position, shown in
After pusher block 180 advances through knife offset section 226, the distal edge of the block contacts the distal end point 230 of knife support bar 214. This contact between pusher block 180 and knife support bar 214 causes the knife support bar to begin advancing distally, along with the pusher block and pusher bars 190, as knob 182 is advanced. As knife support bar 214 moves distally, knife blade 222 is guided by central slot 220 and rear cartridge extension 116 into central longitudinal slot 94 of staple cartridge 90 and central longitudinal slot 46 of anvil 44. As knife blade 222 advances through cartridge extension 116, the blade deflects lock out pin 106 out of the path of the advancing support bar. Knife blade 222 and pusher bar tips 206 advance simultaneously through staple cartridge 90 driving staples through openings 96 and cutting tissue. Knife blade 222 is advanced into staple cartridge 90 slightly behind pusher bars 190 so that staples are formed into the tissue gripped between the anvil and cartridge prior to the knife blade advancing and cutting the tissue between the staple rows.
After the knife and pusher bars have been fully advanced by knob 182 (or advanced to the desired forward position), pusher block 180 is retracted within module pan 172 by drawing the actuating knob back proximally through jaw guide slot 186. Initially, as pusher block 180 is drawn proximally, pusher bars 190 are drawn proximally while knife support bar 214 remains in a distal, stationary position due to the offset section 226 in the support bar. As the distal pusher block edge retracts into contact with proximal knife bar offset point 232, the knife support bar 214 begins to retract proximally with the pusher block and bars. As knife support bar 214 retracts within guide block 200, the support bar is lifted up by leaf spring 250 into contact with the guide block, until the knife locking cut out 224 catches a center post 256 (
After actuator knob 182 is fully retracted, as shown in
A new staple cartridge 90 can be loaded into lower jaw 24 by pushing the flanged, distal end of the cartridge against the distal end of the lower jaw cartridge channel 70, and pushing down on wings 114 to lower legs 110 through jaw opening 76. Cartridge legs 110 are pushed through lower jaw opening 76 until leg notches 112 snap onto latch pin 122. As the proximal end of staple cartridge 90 is pushed down, lockout pin 106 on the cartridge depresses knife support bar 214 at locking notch 228 against the counter force of leaf spring 250. The force of lockout pin 106 pushes knife support bar cutout 224 down and out of contact with guide block center post 256. As knife support bar 214 is pushed down, the support bar is realigned with guide block center slot 220 to enable the support bar to pass distally through the slot and into the new cartridge. The safety lockout feature is thus reset during loading of a new staple cartridge. With a new cartridge loaded, the stapler can be reassembled by placing upper jaw 22 over lower jaw 24 and reinserting upper jaw pins 54 into lower jaw alignment slots 56. Latching hook members 140 are pivoted back over the opening of slots 56 until pins 54 are lodged within notches 142. With pins 54 locked within hook member notches 142, and latching member 30 pivoted into position about lower jaw 24, the stapler is closed and ready to fire staples from the new cartridge.
The reusable upper and lower jaw and latching member components described above are provided to a user in a non-sterile package. Prior to assembly of stapler 20, the components are cleaned with pH neutral enzymatic cleaners, and then steam autoclaved to sterilize the components. This conditioning procedure is also followed prior to each subsequent reuse of the components. Actuator module 170, due to it multiple movable components, is designed for single patient use to eliminate the complexity of cleaning the module. The actuator module is provided to the user in a sterile disposable package which is opened in the sterile field. Staple cartridge 90 is also delivered as a sterile disposable package that is opened in the sterile field.
To assemble stapler 20, actuator module 170 is removed from its packaging and inserted proximal end first into the proximal channel of lower jaw member 24. Actuator module 170 snaps into place when proximal detent bumps 178 engage lower jaw retention features 86. The distal end of the actuator module is then rotated down into the channel shaped frame of lower jaw 24. With actuator module 170 within the lower jaw channel, protector cap 234 is pushed down to snap cap lips 240 into indentations 74 on the lower jaw sidewalls 64a, 64b. Pushing down on protector cap 234 pushes guide block center section 212 through lower jaw opening 76, aligning guide block slot 212 with lower jaw slot 82, and locking the actuator module in place within the lower jaw member 24. With actuator module 170 loaded into lower jaw member 24, latching member 30 is attached to the lower jaw by inserting latch pin 122 into slots 82 and 212, as described above. Latching member 30 is rotated relative to lower jaw member 24 to the partial locked-in position shown in
A new staple cartridge 90 is next inserted into lower jaw cartridge channel 70 in the manner described above. After a staple cartridge is loaded, upper jaw member 22 is placed over lower jaw member 24, with pins 54 inserted into alignment slots 56. Latching member 30 is pivoted relative to the upper and lower jaw members 22, 24 to place the stapler into the pre-close position (shown in
If additional stapling and cutting is desired to complete the procedure, latching member 30 is pivoted back to the partially locked-in state so that upper jaw 22 can be removed, and the used staple cartridge discarded and replaced with a new staple cartridge. After the new cartridge is in place, latching member 30 can be pivoted back through the pre-close and closed states to enable tissue to again be positioned, clamped and stapled using the new cartridge. Once all the required tissue is transected, latching member 30 is removed by rotating the member back to the open state (shown in
In the present invention, actuator module 170 is a separate component from staple cartridge 90, enabling spent staple cartridges to be replaced during a single patient procedure without replacing the actuator module. Accordingly, the actuator module may be used multiple times in the same patient with different staple cartridges. Using the single piece module pan 172 as a supporting structure for the actuator module components enables the actuator module to be easily assembled into and disassembled from the lower jaw channel. The reusable stapler components have a simple, single piece design to facilitate repeated reconditioning and reuse of the parts. The detachable design of the latching member facilitates easy disassembly and reassembly of the reusable components of the stapler. Further, once the stapler is assembled, the retaining and locking features of the latching and lower jaw members prevent accidental disassembly during a procedure.
The foregoing description of a preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiment was chosen and described in order to best illustrate the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to best utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto.
Claims
1. A surgical stapler for deploying staples into tissue, said stapler comprising:
- a. a body having a distal end, a proximal end and a longitudinal axis therebetween, said proximal end comprising a handle and a distal end comprising a staple cartridge channel and an opposing anvil; and
- b. an actuator module for deploying staples, said actuator module including at least one longitudinally moveable member for sequentially ejecting staples towards said anvil, said actuating module being readily removable and replaceable to and from said body.
2. The surgical stapler of claim 1, further including a staple cartridge containing a plurality of staples, said staple cartridge being disposed within said staple cartridge channel.
3. The surgical stapler of claim 2, wherein said stapler body comprises an upper jaw member and a lower jaw member each being formed as a single piece, said upper jaw member having a pair of stationary pins and said lower jaw member comprising a pair of alignment slots, said upper jaw pins being inserted into said lower jaw slots to align said jaw members.
4. The surgical stapler of claim 3, wherein said stapler further comprises a latching member for connecting said upper and lower jaw members together at an intermediate position along said longitudinal axis of said stapler, said latching member being moveable relative to said upper and lower jaw members.
5. The surgical stapler of claim 4, wherein said latching member is moveable relative to said upper and lower jaw members to place said stapler in a series of different locking states.
6. The surgical stapler of claim 5, wherein said latching member is formed as a single piece component that can be connected to said stapler in a closed locking state and disconnected from said stapler in an open locking state.
7. The surgical stapler of claim 6, wherein said latching member further comprises a latch pin, said latch pin being insertable into and removable from a slot on said stapler body for connecting and disconnecting said latching member to said stapler.
8. The surgical stapler of claim 7, wherein said stapler further comprises retaining means on said stapler body for retaining said latching member in said different locking states relative to said upper and lower jaw members.
9. The surgical stapler of claim 6, wherein said latching member is a single piece component, and wherein said upper jaw member, said lower jaw member and said latching member can be disassembled from said stapler and individually reconditioned for reuse in a different patient procedure.
10. The surgical stapler of claim 8, wherein said retaining means can hold said latching member in a pre-close locking state in which said upper jaw pins are prevented from disengaging from said lower jaw slots yet said staple cartridge can move relative to said anvil.
11. The surgical stapler of claim 8, wherein said retaining means can hold said latching member in a partially locked in state in which said latching member is connected to said lower jaw member, yet said upper jaw pins can disengage from said lower jaw slots to enable said upper and lower jaw members to be separated.
12. The surgical stapler of claim 8, wherein said latching member further comprises hook latch members moveable relative to opposing sidewalls of said lower jaw member, said hook latch members engaging said upper jaw pins in a closed locking state to fix said upper and lower jaw members together in an operative position.
13. The surgical stapler of claim 7, wherein said actuator module further comprises structure for facilitating mounting and removal of said module from said stapler body.
14. The surgical stapler of claim 13, wherein said actuator module structure comprises a channel-shaped pan holding said at least one longitudinally moveable member, said pan being insertable into and removable from a channel-shaped frame of said lower jaw member to permit said longitudinally moveable members to move between said pan and said staple cartridge.
15. The surgical stapler of claim 14, wherein said actuator module further comprises an opening aligned with said stapler body opening along said longitudinal stapler axis, said latch pin being insertable into and removable from said actuator module opening when said pin is connected to said stapler body to hold said actuator module within said stapler body.
16. The surgical stapler of claim 15, further comprising structure for connecting and disconnecting staple cartridges to said stapler body relative to said actuator module, wherein multiple staple cartridges may be used with a single actuator module within said stapler body.
17. The surgical stapler of claim 16, wherein said longitudinally moveable members comprise a cutting member and a pair of staple actuating bars, and said actuator module further includes a guide means for aligning said cutting member and staple actuating bars with a staple cartridge for reciprocal movement between said actuator module and said staple cartridge.
18. A surgical stapler for deploying staples into tissue, said stapler comprising:
- a. an upper jaw member having a proximal end comprising a handle and a distal end comprising an anvil;
- b. a lower jaw member having a proximal channel-shaped frame and a distal end comprising a staple cartridge channel;
- c. an actuator module for deploying staples, said actuator module including at least one longitudinally moveable member for sequentially ejecting staples towards said anvil, said actuator module being readily removable and replaceable to and from said lower jaw channel;
- d. a staple cartridge containing a plurality of staples disposed within said staple cartridge channel; and
- e. a latching member for connecting said upper and lower jaw members together at an intermediate position along a longitudinal axis of said stapler, said latching member being moveable relative to said upper and lower jaw members to place said stapler in a series of different locking states.
19. The surgical stapler of claim 18, wherein said upper jaw member, said lower jaw member and said latching member are single piece components that can be disassembled from said stapler, separately reconditioned, and subsequently reassembled for reuse in a different tissue stapling procedure.
20. The surgical stapler of claim 18, further comprising retaining means on said latching member for holding said latching member to said lower jaw member in one or more of said different locking states.
21. The surgical stapler of claim 18, wherein said latching member is in an initial, open state for assembly to said upper and lower jaw members, and moves relative to said jaw members to a closed, locked state prior to operation of said stapler to prevent said latching member from disengaging from said upper and lower jaw members during use.
Type: Application
Filed: Jun 12, 2008
Publication Date: Dec 17, 2009
Inventors: ANIL K. NALAGATLA (Mason, OH), Sudhir B. Patel (Mason, OH), Debasish Pradhan (Sambalpur)
Application Number: 12/137,571
International Classification: A61B 17/068 (20060101);