AU2007347645A1

AU2007347645A1 - An indicator device for indicating features of surgical staples corresponding to an adjustable staple height

Info

Publication number: AU2007347645A1
Application number: AU2007347645A
Authority: AU
Inventors: Federico Bilotti; Michele D'arcangelo; Matteo Francazi; Alessandro Pastorelli
Original assignee: Ethicon Endo Surgery Inc
Current assignee: Ethicon Endo Surgery Inc
Priority date: 2007-02-28
Filing date: 2007-02-28
Publication date: 2008-08-28
Also published as: WO2008102392A9; CN101616631B; BRPI0721383A2; CA2680419A1; WO2008102392A8; CN101616631A; EP2124761A1; JP2010518943A; WO2008102392A1

Description

WO 2008/102392 PCT/IT2007/000143 1 DESCRIPTION "AN INDICATOR DEVICE FOR INDICATING FEATURES OF SURGICAL STAPLES CORRESPONDING TO AN ADJUSTABLE STAPLE HEIGHT" The invention relates in general to the field of 5 surgical stapling of body tissue by means of surgical staplers and in particular to an indicator device for .indicating features of surgical staples corresponding to an adjustable staple height Known surgical staplers comprise an insertion shaft, a 10 handle portion fitted to a distal end of the insertion shaft and a tissue manipulation portion fitted to a proximal end of the insertion shaft. The tissue manipulation portion holds a cartridge device which houses a group of surgical staplers and an anvil having 15 a staple forming surface suitable to co-operate with a proximal end surface of the cartridge device in order to clamp layers of tissue therebetween and to bend the ends of the staples when they are expelled from the cartridge device against the anvil. 20 The known surgical staplers further comprise an anvil approximation device and a staple driving device. The anvil approximation device includes a mechanism which is configured to move the anvil towards the cartridge device in order to clamp the tissue prior to 25 and during the application of the staples as well as to WO 2008/102392 PCT/IT2007/000143 2 widen the distance between the anvil and the cartridge device after the stapler has been "fired" in order to release the stapled, e.g. anastomosed, tissue. Particularly in so called circular staplers, the anvil 5 approximation device is often operated by a rotating knob arranged at the distal end of the handle portion and provided with a movement transmission and transformation mechanism which is functionally connected to both the rotating knob and the tissue manipulating 10 device in order to allow to adjust the effective distance (so called "staple height") between the proximal end surface of the cartridge device and the staple forming surface of the anvil. The staple driving device comprises an operating member 15 arranged at the handle portion of the stapler and a mechanism which transforms the movement of the operating member (e.g. a trigger lever) in a movement of a staple driving platform inside the cartridge device which drives ("fires") the surgical staples out of the 20 cartridge device, across the clamped tissue layers and against the staple forming surface of the anvil so that the staple ends are bent in a way to give the staple a more or less C or B shaped configuration. In modern circular staplers by Ethicon Endo-Surgery 25 Inc., the tissue clamping distance between anvil and WO 2008/102392 PCT/IT2007/000143 3 cartridge device or, in other words, the resulting staple height after "firing" the instrument is continuously adjustable in an operating range between a lower limit value (shortest possible distance and 5 highest possible tissue compression) and an upper limit value (widest possible distance and lowest possible tissue compression) which depend upon the size of the typically initially U-shaped surgical staple loaded in the stapler. Starting from a .given U shaped initial 10 staple shape and size (having substantially straight free ends), the staple height upper limit value corresponds to an approximately C shaped deformed staple (having substantially inwardly bent free ends) and the staple height lower limit corresponds to an 15 approximately B shaped deformed staple (having substantially inwardly and backwardly bent free ends). Because the shape of the staple and the staple height are crucial for the tissue holding features and for the tissue compression of the anastomosed tissue after 20 stapling, some modern surgical staplers are provided with an indicator device having a window with a scale divided in three distinguishable ranges - a lower range, an intermediate operating range and a higher range - as well as a pointer which is connected to the anvil 25 approximation device such that its position on the scale WO 2008/102392 PCT/IT2007/000143 4 depends from the staple height between the cartridge device and the anvil. With these modern staplers during or after clamping the tissue, surgeons can see from the window of the indicator device, whether the reached 5 staple height is outside the admissible operating range for the loaded staple size (pointer is in the upper or lower range of the scale) or whether it is within the admissible operating range (pointer is in the intermediate operating range which is distinguished by 10 color, e.g. green). Notwithstanding the fact that the known indicator device provides very precious information to the surgeons, it proved to be very difficult for many of them imagining the relationship between the indicator and the resulting 15 staple features. In view of this drawback of the prior art, the object of the invention is to provide an indicator device which permits to better envision the staple features resulting from a set gap between the anvil and the cartridge 20 device. This and other objects are achieved by an indicator device for indicating features of surgical staples corresponding to an adjustable staple height according to claim 1. 25 The above object is also achieved by a surgical stapling WO 2008/102392 PCT/IT2007/000143 5 device according to claim 18 and by a demonstration device for training, explanation and sales activity according to claim 19. The dependent claims cover advantageous embodiments of the invention. 5 According to the invention, the indicator device for indicating features of surgical staples corresponding to an adjustable staple height comprises a housing and support structure, an actuating device received in the housing and having an adjustable staple height setting 10 member and a display device received in the housing and support structure and co-operating with the actuating device such that the display device visualizes a staple feature corresponding to a staple height set by the staple height setting member, 15 wherein the display device is configured to visualize a deformed shape feature of the staple corresponding to the set staple height. This makes it possible to directly envisioning the relationship between the deformed shape of the staple to 20 be applied and the set staple height or, in other words, the set gap between the anvil and the cartridge device. As a matter of fact, the lack of information about the deformed shape resulting from the set gap between anvil and cartridge device was a major reason for the 25 difficulties surgeons encountered by imagining the WO 2008/102392 PCT/IT2007/000143 6 result of their intervention by means of adjustable surgical stapling. These and other details and advantages of the present invention shall be made apparent from the accompanying 5 drawings and the description thereof, which illustrate embodiments of the invention and, together with the general description of the invention given above, and the detailed description of the invention given below, serve to explain the principles of the present 10 invention. Fig. 1 illustrates an isometric view of a sales demo device incorporating an indicator device according to an embodiment of the invention; Fig. 2 illustrates an exploded view of the device in 15 figure 1; Fig. 3 illustrates a partial isometric view of the device in figure 1, wherein the housing is partially removed; Fig. 4 illustrates a longitudinal cross-section of a 20 detail of the device in figure 1; Fig. 5A and 5B illustrate the display of staple features corresponding to a set open staple configuration according to an embodiment of the invention; Fig. 6A and 6B illustrate the display of staple features 25 corresponding to a maximum possible staple height WO 2008/102392 PCT/IT2007/000143 7 according to an embodiment of the invention; Fig. 7A and 7B illustrate the display of staple features corresponding to a minimum possible staple height according to an embodiment of the invention; 5 Fig. 8 illustrates a lateral view of a surgical stapling instrument comprising an indicator device according to an embodiment of the invention; Fig. 9 is a close-up view of a screen or window of an indicator device according to an embodiment of the 10 invention. Turning to the figures, the reference numeral 1 denotes an indicator device for indicating features of surgical staples corresponding to an adjustable staple height. The indicator device 1 comprises an elongate housing 2 15 which forms a handle portion 3 and supports a display device 4 with at least one display screen or window 5 arranged in an outer surface 6 of the housing 2 and visibly facing outward from the latter. The housing 2 further supports an actuating device 7 with an 20 adjustable staple height setting member 8, for instance a manually operable rotary knob arranged at a distal end 9 of the housing 2 and a transmission device 10 which cooperates with both the setting member 8 and the display device 4. 25 The setting member 8 allows the user to adjustably set a WO 2008/102392 PCT/IT2007/000143 8 staple height and the display device 4 and the actuating device 7 are configured such that the display device 4 visualizes a deformed shape feature of the staple corresponding to the staple height set by means of the 5 setting member 8. In accordance with an embodiment, the display device 4 is configured to visualize the shape of the deformed staple ends 11 corresponding to the set staple height. In accordance with a further embodiment, the display 10 device 4 is configured to visualize the shape of the entire deformed staple corresponding to the set staple height. In accordance with yet a further embodiment, the display device 4 is configured to visualize, together with the 15 deformed shape features of the staple, at least part of a profile 12 of an anvil staple forming surface corresponding to the set staple height. In accordance with yet a further embodiment, the display device 4 is configured to visualize, together with the 20 deformed shape features of the staple and possibly but not necessarily together with the profile 12 of the anvil staple forming surface, at least part of a profile 13 of a cartridge device end surface corresponding to the set staple height. 25 In accordance with yet a further embodiment, the display WO 2008/102392 PCT/IT2007/000143 9 device 4 is configured to visualize the deformed staple shape features in a magnified scale compared to the real size of a corresponding surgical staple. Advantageously, the visualized deformed staple shape features are 5 generated with reference to a surgical staple dimension which is about 4 to 5 times larger than the corresponding real staple size. This magnification of the visualized deformed staple shape features with respect to the real staple size allows the user to 10 immediately see and understand the deformed staple shape without any need to get the eye particularly close to the display screen or window 5. It will be appreciated by those skilled in the art, that the display device 4 can comprise any suitable known 15 visualization and screen display and control technology, as for instance a digital electronic display connected to an electronic control circuit which cooperates with the actuating device 7. An example for such a digital electronic display is a Liquid Crystal Display (LCD). 20 In accordance with an embodiment of the present invention, the display device 4 comprises an at least partially visible reversibly deformable staple dummy 14 which is configured to cooperate with the actuation device 7 such that it deforms to the visualized and 25 preferably but not necessarily magnified deformed staple WO 2008/102392 PCT/IT2007/000143 10 shape in dependence from the set staple height. With reference to the embodiment illustrated in figures 2, 3 and 4, the display device 4 comprises a base plate 15 connected to the housing 2 and defining a system of 5 channels or guide grooves 16 reproducing the shape of the progressively deforming staple ends and suitable to slidably receive and guide ends 17 of the staple dummy 14 in order to reversibly deform them in progressively deformed shapes. The guide grooves 16 define edges 18 10 having approximately the shape of at least a portion of an anvil staple forming surface and, in accordance with an embodiment, the guide grooves 16 are arranged or emphasized (e.g. by color) such as to visualize at least part of the anvil staple forming surface together with 15 the progressively deformed staple dummy ends 17 corresponding to the set staple height. The base plate 15 further comprises a driver guide 19 formed on a side opposite the system of guide grooves 16 and configured to slidably receive a driver portion 20 20 which has a shape adapted to firmly hold a basis 21 of the staple dummy 14. The driver portion 20 is slidably received by the driver guide 19 of the base plate 15 and the free ends 17 of the staple dummy 14 are at least partially inserted in the guide grooves 16 while its 25 basis 21 is fixed to the driver portion. The guide WO 2008/102392 PCT/IT2007/000143 11 grooves 16 act as an anvil portion and the driver guide 19 is configured such that the driver portion 20 and the anvil portion (grooves 16) are facing each other and are movable relative to one another in response to a 5 movement of the. actuating device 7. In response to such a relative motion between the driver portion 20 and the anvil portion (grooves 16), the free ends 17 of the staple dummy 14 enter more or less deeply into the grooves 16, thereby adopting and visualizing the more or 10 less deformed shape of the staple ends corresponding to a set staple height. In accordance with one embodiment, the staple dummy 14 comprises a generally filiform, tightly wound helical spring. 15 As already mentioned above, adjustable staple height setting member 8 may comprises a rotary knob. This is particularly advantageous as the anvil movement mechanism in a surgical stapling device also comprises a rotary knob for manually approximating the anvil to the 20 cartridge device. Those skilled in the art will immediately appreciate that the use in the indicator device 1 of a setting member and actuating device which are similar or identical to the anvil movement mechanism of a surgical stapling instrument allows not only a very 25 realistic simulation of different staple heights during WO 2008/102392 PCT/IT2007/000143 12 training, explanation and sales activities, but also a simple implementation of the indicator device in existing stapling instrument concepts. In accordance with an embodiment (Fig. 2, 3 and 4), the 5 rotary knob 8 is fixed to the housing 2 such that it is translationally locked but free to rotate about a longitudinal axis L and the actuation device 7 comprises a transmission rod 22 with a threaded portion 23 mating a corresponding threaded hole formed in the rotary knob 10 8 so that a rotational movement of the rotary knob 8 generates a translational movement of the transmission rod 22 which is axially movable but rotationally locked. The driver portion 20 of the display device 4 is connected to the transmission rod 22 through a 15 connecting pin 24 so that the translational movement of the transmission rod displaces the driver portion 20 relative to the guide grooves 16 (anvil portion), thereby deforming the staple dummy in dependence from the set rotational position of the rotary knob 8. 20 In accordance with a further embodiment, the display device 4 comprises a scale 25 which indicates an admissible operating range 26 of staple height for a determined staple type and a pointer 27 whose position along the scale 25 is variable in dependence from the set staple 25 height and indicates the latter on scale 25.

WO 2008/102392 PCT/IT2007/000143 13 In accordance with a yet further embodiment of the invention, a numeric staple height indication 28 (e.g. a millimeter or fractions-of-millimeter scale) is arranged in visual relationship with the pointer 27. 5 The display device may comprise a single display screen or window 29 (as illustrated e.g. in figure 9) which visualizes all staple features, such as shape and height or, alternatively, the display device comprises a first display screen or window 5 visualizing the deformed 10 shape feature of the staple and a second display screen or window 30 visualizing the scale 25, 28 and pointer 27. In accordance with an embodiment (fig. 3, 4) , the first and second display screens or windows 5, 30 are arranged 15 opposite to one another on the housing 2. In order to move the pointer 27 in dependence of the set staple height, the pointer 27 can be directly or indirectly connected to the same transmission rod 22 which acts on the driver portion 20 for the staple dummy 20 14. Figure 5A and 5B shows an exemplary illustration of the relationship of the visualized staple shape and staple height for an open staple. Figure 6A and 6B shows an exemplary illustration of the 25 relationship of the visualized staple shape (B-shape) WO 2008/102392 PCT/IT2007/000143 14 and staple height at a staple height of e.g. 2,5mm at the beginning (upper limit) of the admissible range of staple heights. Figure 7A and 7B shows an exemplary illustration of the 5 relationship of the visualized staple shape (C-shape) and staple height at a staple height of e.g. 1mm at the end (lower limit) of the admissible range of staple heights. As has been already explained above, the staple immage, 10 e.g. the staple dummy, and also the scale 25 are preferably magnified with respect to the corresponding realistic staple size and staple height. Figure 8 illustrates an example of a surgical stapling instrument 31 comprising a frame 32 having a body 15 portion 33 and a handle 34 as well as a staple fastening assembly 35 in the distal region of the instrument. The staple fastening assembly 35 includes a cartridge device 36 which comprises at least one row of staples and defines a distal end surface, and an anvil 37 which 20 defines a proximal staple forming surface which is movable relative to the cartridge device 36 and adapted to cooperate with the cartridge device 36 for forming the ends of the staples exiting from the cartridge device 36. The stapling instrument 31 comprises further 25 a moving device adapted to move the anvil relative to WO 2008/102392 PCT/IT2007/000143 15 the cartridge device and a staple driving device adapted to drive the staples out of the cartridge device towards the anvil. According to an aspect of the present invention, the stapling instrument 31 comprises an 5 indicator device 1 as described above. The indicator device may be directly implemented in the handle 34 of the stapling instrument and the actuation device of the indicator device cooperates with the moving device of the stapling instrument. 10 While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention to restrict or in any way limit the scope of the appended claims to 15 such detail. Additional advantages and modifications may readily appear to those skilled in the art.

Claims

1. An indicator device (1) for indicating features of surgical staples corresponding to an adjustable staple height comprises a housing and support structure (2), an 5 actuating device (7) received in the housing and support structure (2) and having an adjustable staple height setting member (8) and a display device (4) connected to the housing and support structure (2) and co-operating with the actuating device (7) such that the display 10 device (4) visualizes a staple feature corresponding to a staple height set by the staple height setting member (8), wherein the display device is configured to visualize a deformed shape feature of the staple corresponding to 15 the set staple height.

2. An indicator device (1) according to claim 1, wherein the display device (4) is configured to visualize the shape of the deformed staple ends (11) corresponding to the set staple height. 20

3. An indicator device (1) according to claim 1 or 2, wherein the display device (4) is configured to visualize the shape of the an entire deformed staple (14) corresponding to the set staple height.

4. An indicator device (1) according to any one of the 25 preceding claims, wherein the display device (4) is WO 2008/102392 PCT/IT2007/000143 17 configured to further visualize, together with the deformed shape features of the staple, at least part of a profile (18) of an anvil staple forming surface corresponding to the set staple height.

5 5. An indicator device (1) according to any one of the preceding claims, wherein the display device (4) is configured to further visualize, together with the deformed shape features of the staple, at least part of a profile (13) of a cartridge device end surface 10 corresponding to the set staple height.

6. An indicator device (1) according to any one of the preceding claims, wherein the display device (4) is configured to visualize the deformed staple shape features in a magnified scale compared to the real size 15 of the corresponding surgical staple.

7. An indicator device (1) according to any one of the preceding claims, wherein the display device (4) comprises a digital electronic display connected to an electronic control circuit which cooperates with said 20 actuating device (7).

8. An indicator device (1) according to any one of the preceding claims, wherein the display device (4) comprises an at least partially visible reversibly deformable staple dummy (14) configured to cooperate 25 with the actuation device (7) such that it deforms to WO 2008/102392 PCT/IT2007/000143 18 the visualized deformed staple shape in dependence from the set staple height.

9. An indicator device (1) according to the preceding claim, wherein the display device (4) comprises a guide 5 system (16) holding said staple dummy so that the staple dummy (14) moves within the guide system (16) to assume the deformed shape corresponding to the set staple height.

10. An indicator device (1) according to the preceding 10 claim, wherein the display device (4) comprises a driver portion (20) holding a basis (21) of the staple dummy (14) and an anvil portion (16) having guide grooves or channels reproducing the shape of the progressively deforming staple ends and suitable to receive ends (17) 15 of the staple dummy (14) in order to reversibly deform them in progressively deformed shapes, the driver portion (20) and the anvil portion (16) being arranged one facing the other and configured to move relative to one another in response to a movement of the actuating 20 device (7).

11. An indicator device (1) according to the preceding claim, wherein the anvil portion (16) provides a visual representation (18) of an anvil staple forming surface.

12. An indicator device (1) according to any one of 25 claims 8 to 11, wherein the staple dummy (14) comprises WO 2008/102392 PCT/IT2007/000143 19 a tightly wound helical spring.

13. An indicator device (1) according to any one of the preceding claims, wherein the display device (4) comprises a scale (25) indicating an operating range 5 (26) of staple height for a determined staple type and a pointer (27) whose position on the scale (25) depends from the set staple height.

14. An indicator device (1) according to the preceding claim, wherein said visualization device (4) comprises a 10 numeric staple height indication (28) arranged in relationship with the pointer (27).

15. An indicator device (1) according to the preceding claim, wherein the display device (4) comprises a first display screen or window (5) visualizing said deformed 15 shape feature of the staple and a second display screen or window (30) visualizing said scale (25) and pointer (27).

16. An indicator device (1) according to the preceding claim, wherein said first and second display windows (5, 20 30) or screens are arranged opposite to one another on said housing and support structure (2).

17. An indicator device (1) according to the preceding claim, wherein said adjustable staple height setting member (8) comprises a rotary knob and the actuation 25 device (7) comprises further a screw drive (22, 23) WO 2008/102392 PCT/IT2007/000143 20 which cooperates with the rotary knob (8) and applies a translational movement to said driver portion (20) and/or to said pointer (27) of the display device (4).

18. A surgical stapling instrument (31) comprising: 5 - a frame (32) having a body portion (33) and a handle (34) , - a staple fastening assembly (35) in the distal region of said instrument (31), the staple fastening assembly (35) including a cartridge device (36) which comprises 10 at least one row of staples and defines a distal end surface, and an anvil (37) which defines a proximal staple forming surface which is movable relative to the cartridge device (36) and adapted to cooperate with the cartridge device (36) for forming the ends of the 15 staples exiting from the cartridge device (36), - a moving device adapted to move the anvil (37) relative to the cartridge device (36), - a staple driving device adapted to drive the staples out of the cartridge device (36) towards the anvil (37), 20 wherein said stapling instrument (31) comprises an indicator device (1) according to any one of the preceding claims and said actuation device (7) of the indicator device (1) cooperates with the moving device of the stapling instrument (31) acting as adjustable 25 staple height setting member (8). WO 2008/102392 PCT/IT2007/000143 21

19. A demonstration device for training, explanation and sales activity, comprising an indicator device (1) according to any one of claims 1 to 17.