Surgical stapling device

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DESCRIPTION

Surgical stapling device.

Background

1. Technical field

The present disclosure relates to a surgical stapling device for treating hollow tissue organs. More particularly, the present disclosure relates to a surgical stapling device having an approach mechanism.

2. Background of Related Art

Anastomosis is the surgical union of separate sections of hollow organs. Typically, an anastomosis process follows surgery in which a diseased or defective section of hollow tissue is removed and the remaining final sections are joined. Depending on the desired anastomosis process, the final sections can be joined by circular, end-to-end, or organ side-to-side reconstruction methods.

In a known process of circular anastomosis, two ends of the organ are joined by means of a stapling device that drives a circular series of staples through the end of each section of the organ, and simultaneously removes any interior tissue from the circular series of driven staples. to release a tubular conduit. Examples of devices for performing circular hollow organ anastomosis are described in US Patent Nos. 6,053,390, 5,588,579, 5,119,983, 5,005,749, 4,646,745, 4,576,167 and 4,473,077. Typically, these devices include an elongated shaft having a handle portion at a proximal end thereof for actuation of the device and a staple holding component disposed at the distal end thereof. An anvil assembly, including an anvil stem with an attached anvil head, is mounted on the distal end of the device, adjacent to the staple holding component. Opposing end portions of the tissue of the hollow organ (s) to be stapled are clamped between the head of the anvil and the staple holding component of the device. The clamped tissue is stapled by driving one or more staples from the staple holding component such that the ends of the staples pass through the tissue and are deformed by the head of the anvil. Concurrently an annular blade is advanced to remove tissue within the hollow organ and release a tubular conduit within the organ.

Surgical stapling devices for performing a circular anastomosis have also been used to treat internal hemorrhoids in the rectum. During the use of a circular stapling device for the treatment of hemorrhoids, the head of the incus and the staple holding component of the surgical stapling device are inserted, through the anus and into the rectum, with the head of the incus and the staple holding component in an open or not very rough position. Thereafter, a gathered string suture is used to pull internal hemorrhoidal tissue and / or mucosal tissue toward the anvil rod. Next, the anvil head and staple holding component are approximated to hold hemorrhoidal tissue and / or mucosal tissue, between the anvil head and the staple holding component. The stapling device is fired to remove hemorrhoidal tissue and / or mucosal tissue and to staple cut tissue.

US 5,915,616 discloses a surgical stapling apparatus having a locking mechanism for approaching an anvil member to a clamp assembly. The latch mechanism consists of a feed mechanism that operates with a two-stage feed, such that the initial movement of the feed mechanism moves the anvil a greater distance than a subsequent movement of the feed mechanism.

Despite its success and global acceptance of its many benefits, the use of circular anastomosis staplers presents a number of challenges. In particular, due to the close proximity of the incus head to the staple holding component, visibility of access to the surgical site is limited, especially during hemorrhoid treatment procedures. Furthermore, during the approach of the anvil head with the staple holding component of the surgical stapling device, it is sometimes difficult to properly position the tissue to be removed within the staple holding component of the surgical stapling device. Thus, the tissue can be packed into a tissue gap defined between the head of the anvil and the staple holding component of the instrument. This can result in warped staples and / or ineffective removal of all desired tissue.

Consequently, there is a continuing need in the art for a circular stapling device for tissue treatment that can provide improved visibility and access to a surgical site. Furthermore, there is a continuing need in the art for a circular tissue treatment stapling device that can quickly and easily position the tissue to be removed within the staple holding component of the surgical stapling device.

Summary

The invention provides a surgical stapling device as defined in claim 1.

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In accordance with the present disclosure, a surgical stapling device for treating hollow tissue organs is disclosed. The surgical stapling device includes a handle assembly, an elongated body portion, a distal head portion, and an approach mechanism. The elongated portion of the body extends distally from the handle assembly. The distal portion of the head is supported on a distal end of the elongated portion of the body and includes an anvil assembly and a sheath assembly. The sheath assembly supports a plurality of staples. The anvil assembly includes an anvil head assembly and an anvil stem. The anvil assembly is movable relative to the sheath assembly, between spaced positions and approximate positions.

The approach mechanism includes an approach rotary knob, an actuating member, and an extension mechanism. The approach control can be actuated connected to the actuation member and can be actuated to effect axial movement of the actuation member over a first distance. The extension mechanism can operate connected to the drive member and the anvil stem, such that axial movement of the anvil stem over the first distance effects axial movement of the anvil stem relative to the drive member over a second distance, such that the length of movement of the anvil assembly relative to the sheath assembly is greater than the first distance.

In one embodiment, the extension mechanism includes an elongated actuating stem having a proximal end securely connected to the approach knob, and a distal end rotatably attached to a tubular stent , such that rotation of the approach knob effects the rotation of the drive stem and tubular extender. The distal end of the tubular stent can be operated connected to the anvil stem and the actuating member includes a longitudinal bore. The actuating stem extends from the approach handle to the tubular extender, through the longitudinal bore. The actuating member includes a distal extension having a helical groove formed around it. The tubular stent includes a cam member located within the helical groove. Actuation of the approach knob causes rotation of the tubular stent about the distal extension of the drive member such that the cam member of the tubular stent moves relative to the helical groove. Movement of the cam member with respect to the helical groove effects an axial movement of the tubular member with respect to the drive member, over a second distance.

In one embodiment, the tubular stent is rotatably connected to the proximal end of the anvil stem. The elongated actuating stem may include at least one flat surface and the tubular stent may include a set screw for rotatably securing the tubular stent to the actuating stem.

In another embodiment, the extension mechanism includes an extension sleeve having a cam member supported thereon. To the proximal end of the anvil stem, a stent is fixedly attached. To the distal end of the actuating member, an extension of the actuating member is rotatably coupled, and includes a distal end securely attached to the extension sleeve. The drive member extension includes a first helical groove that is dimensioned to receive a leg that is securely attached to the stapling device, such that axial movement of the drive member extension relative to the leg effects rotation of the leg. extension of the actuating member and the extension sleeve relative to the actuating member. The extender includes a second helical groove that is dimensioned to receive a cam member supported on the extension sleeve. As the extension sleeve rotates relative to the stent, the stent and the anvil stem move axially relative to the actuating member over the second distance.

In another embodiment, the stapling device includes a tissue tensioning assembly that includes a tissue engaging member slidably positioned on the anvil stem, an elongated link, and an actuating member. The elongated hinge connects the actuating member with the tissue engaging member. In one embodiment, the tissue engaging member includes a locking member for releasably engaging a series of axially spaced teeth located on the anvil stem to releasably secure the tissue engaging member in a plurality of fixed axial locations, along the anvil stem.

In one embodiment, the locking member includes a spring brake and the tissue engaging member includes a hollow body that is slidably positioned around the anvil stem. The anvil stem and the hollow body may be shaped such that they prevent rotation of the hollow body around the anvil stem, that is, the hollow body may define a hexagonal bore and the anvil stem may have a hexagonal cross section.

Other features and advantages of the present disclosure will be apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention.

Brief description of the drawings

The above features of the surgical stapling device now disclosed will be readily apparent and better understood with reference to the detailed description of embodiments, which are described below with reference to the drawings, in which:

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Figure 1 is a perspective view of one embodiment of the surgical stapling device constructed in accordance with the principles of the present disclosure;

Figure 2 is a perspective view of the distal portion of the surgical stapling device illustrated in Figure 1;

Figure 3 is an enlarged view of the indicated area of ​​the detail illustrated in Figure 2;

Figures 2a-2b are perspective views of the approach mechanism of the surgical stapling device illustrated in Figure 1;

Figure 4 is a perspective view, parts separated, of the approach mechanism of the surgical stapling device illustrated in Figure 1;

Figure 5 is a perspective view, parts separated, of the anvil assembly and tissue tensioner assembly of the surgical stapling device illustrated in Figure 1;

Figure 6 is a side view of the tissue tensioning assembly of the surgical stapling device illustrated in Figure 1;

Figure 7 is a cross-sectional view of the tissue tensioning device, taken along section line 7-7 illustrated in Figure 6;

Figure 8 is a cross-sectional side view of the surgical stapling device illustrated in Figure 1, showing the anvil assembly in its non-approach position;

Figure 9 is a cross-sectional view of the surgical stapling device illustrated in Figure 1, taken along section line 9-9 illustrated in Figure 8;

Figure 10 is an enlarged view of the indicated area of ​​the detail illustrated in Figure 8;

Figure 9a is a perspective view of the distal end of the surgical stapling device illustrated in the figure.

I, located adjacent to a lumen of a vessel, with a gathered string suture applied to the vessel portion, the anvil assembly in its non-approximation position, and the tissue tension assembly in its forward position;

Figure 10a is a perspective view of the distal end of the surgical stapling device illustrated in Figure 1, positioned adjacent a vessel lumen, with a gathered string suture wrapped around the tissue tension stem, the anvil assembly at its non-approach position and the tissue tensioning assembly in its forward position;

Figure 10b is a cross-sectional top view of the distal end of the surgical stapling device illustrated in Figure 10a, located adjacent to a vessel lumen, the anvil assembly in its non-approaching position, and the tissue tensioning assembly in a partially retracted position;

Figure 10c is a cross-sectional side view of the distal end of the surgical stapling device illustrated in Figure 10a, located adjacent to the lumen of a vessel, the anvil assembly in its non-approaching position, and the tissue tensioning assembly in a non-approaching position. partially retracted;

Figure 10d is an enlarged view of the indicated area of ​​the detail illustrated in Figure 10;

Figure 11 is a still perspective view of the surgical stapling device illustrated in Figure 1, showing the anvil assembly in its approach position and the tissue tensioning assembly in a fully retracted position;

Figure 12 is a perspective view of the distal end of the surgical stapling device illustrated in the figure.

II, the anvil assembly in its approach position and the tissue tensioning assembly in a fully retracted position;

Figures 12a-12b are perspective views of the approach mechanism of the surgical stapling device illustrated in Figure 1, showing the anvil assembly in its approach position and the tissue tensioning assembly in a fully retracted position;

Figure 13a is a cross-sectional top view of the surgical stapling device illustrated in Figure 1, showing rotation of the rotary approach knob to approximate the anvil assembly;

Figure 13 is an enlarged view of the indicated area of ​​the detail illustrated in Figure 13a;

Figure 14a is a cross-sectional side view of the surgical stapling device illustrated in Figure 1, showing rotation of the rotary approach knob to approximate the anvil assembly;

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Figure 14 is an enlarged view of the indicated area of ​​the detail illustrated in Figure 14a;

Figure 15 is a cross-sectional side view of the surgical stapling device illustrated in Figure 1, showing actuation of the trigger trigger of the handle mechanism;

Figure 16 is a cross-sectional view taken along line 16-16 illustrated in Figure 15;

Figure 17 is an enlarged view of the indicated area of ​​the detail illustrated in Figure 15;

Figure 18 is a perspective view of another embodiment of the surgical stapling device constructed in accordance with the principles of the present disclosure;

Figure 19 is a perspective view of the distal portion of the surgical stapling device illustrated in Figure 18;

Figure 20 is an enlarged view of the indicated area of ​​the detail illustrated in Figure 19;

Figures 21-22 are perspective views of the approach mechanism of the surgical stapling device illustrated in Figure 18;

Figure 23 is a perspective view, parts separated, of the approach mechanism of the surgical stapling device illustrated in Figure 18;

Figure 24 is a cross-sectional side view of the surgical stapling device illustrated in Figure 18;

Figure 25 is a cross-sectional view taken along line 25-25, illustrated in Figure 24;

Figure 26 is an enlarged view of the indicated area of ​​the detail illustrated in Figure 24;

Figure 27 is a cross-sectional side view taken along the line of section 27-27 illustrated in Figure 26;

Figure 28 is a cross-sectional view of the distal end of the surgical stapling device illustrated in Figure 18, showing actuation of the tissue tension assembly to a retracted position;

Figure 29 is a cross-sectional side view of the surgical stapling device illustrated in Figure 18, showing the rotation of the rotary approach to approach the anvil assembly;

Figure 30 is a top cross-sectional view of the distal portion of the surgical stapling device illustrated in Figure 18, the anvil assembly in its approach position and the tissue tensioning assembly in a fully retracted position;

Figure 31 is an enlarged view of the indicated area of ​​the detail illustrated in Figure 29;

Figures 32-33 are perspective views of the approach mechanism of the surgical stapling device illustrated in Figure 18, showing the anvil assembly in its approach position and the tissue tensioning assembly in a retracted position;

Figures 34-35 are perspective views of another embodiment of the approach mechanism, constructed in accordance with the principles of the present disclosure;

Figure 36 is a perspective view, parts apart, of the approach mechanism of the surgical stapling device illustrated in Figure 34;

Figure 37 is a cross-sectional side view of the surgical stapling device of the present disclosure, illustrating the anvil assembly in its non-approaching position;

Figure 38 is a cross-sectional top view of the distal portion of the surgical stapling device illustrated in Figure 37;

Figure 39 is an enlarged view of the indicated area of ​​the detail illustrated in Figure 37;

Figure 40 is a cross-sectional side view of the distal end of the surgical stapling device, illustrating actuation of the tissue tensioning device;

Figure 41 is a cross-sectional side view of the surgical stapling device illustrated in Figure 34, showing the anvil assembly in its approach position and the tensioner assembly in a fully retracted position;

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Figure 42 is a cross-sectional top view of the distal portion of the surgical stapling device illustrated in Figure 41;

Figure 43 is an enlarged view of the indicated area of ​​the detail illustrated in Figure 41; Y

Figures 44-45 are perspective views of the approach mechanism illustrated in Figure 34, showing the anvil assembly in its approach position and the tissue tensioning device in a retracted position.

Detailed description of the realizations

Embodiments of the surgical stapling device disclosed in this specification will now be described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the various views.

Throughout this description, the term "proximal" will refer to the part of the device closest to the operator, and the term "distal" will refer to the part of the device furthest from the operator. Although this disclosure is primarily focused on surgical staplers, it is envisioned that the benefits of what is disclosed herein may be achieved in other fastener application devices as well, including two-piece fastener application devices and tissue sealing devices with energy aid, for example radio frequency (RF) tissue sealing devices.

Figures 1-3 illustrate a now disclosed surgical stapling device embodiment which is generally illustrated at 10. Briefly, the surgical stapling device 10 includes a handle assembly 12, an elongated portion 14 of the body, a distal head portion 16, and a tissue tensioner assembly 34. Although elongated body portion 14 is illustrated as being substantially straight, it is contemplated, as is known in the art, to provide a curved body portion.

Handle assembly 12 includes a stationary housing 12a, which defines a handle 18, a trigger trigger 20, an approach rotary knob 22, a trigger indicator 24, and a trigger lock 26. Each of these components functions substantially as described in WO 2004/112538, entitled "Surgical Stapling Device" and in WO 2005/009216, entitled "Surgical Stapling Device With Tissue Tensioner". Tissue Tensioner Surgery), and will not be studied in detail in this report.

The head portion 16 includes a sheath assembly 28 and an anvil assembly 30. Sheath assembly 28 is attached to a distal end of elongated body portion 14. The elongated body portion 14 includes an elongated slot 32, for slidably receiving a tensioning drive member 104 of the tissue tensioning assembly 34, which will be described in more detail below.

Handle assembly 12 includes the proximal components of the approach and firing mechanisms of device 10, a firing lock mechanism, and an indicating mechanism. The trigger mechanism, the trigger lock mechanism and the indicator mechanism are substantially the same as those described in WO 2004/112538 and 'WO 2005/009216 and will not be described in detail here. The approach mechanism of device 10 has been modified from that described in documents WO 2004/112538 and 'WO 2005/009216, to provide better visibility and improved access to the surgical site. These modifications will be studied now.

Referring to Figures 2a, 2b, 4 and 8-10, the approach mechanism includes a rotary approach knob 22 (Figures 2a and 2b), a rotary sleeve 36, a drive screw 38, a screw extension 40, an extension sleeve 42, a pin support member 44, and an extension stem 46. As illustrated in FIG. 4, the distal end 46a of the extension stem 46 is rotatably coupled to a proximal end 48a of the anvil stem 48 of the anvil assembly 30. When approach knob 22 is rotated or actuated, anvil assembly 30 moves relative to sheath assembly 28 (FIG. 1) between spaced and coarse positions in a manner that is described in detail below.

Approach knob 22 is attached to the proximal end of rotary sleeve 36, using any known fastening technique, eg pin (s), adhesives, key / groove configuration, welding, etc. The distal end 36a of the rotatable sleeve 36 is rotatably fixed within the housing 12a of the handle assembly (FIG. 1) in the manner described in WO 2004/112538. There is a pin 50 (FIG. 8) that extends through the distal end 36a of the rotary sleeve 36, and is received within the helical groove 38a of the drive screw 38. As sleeve 36 is rotated by rotation of approach knob 22, pin 50 moves within helical groove 38a to axially move drive screw 38 within housing 12a of handle assembly 12. Helical groove 38a has a pitch of between about 0.09 thousandths / revolution to about 0.90 thousandths / revolution.

The distal end 38b (FIG. 4) of the drive screw 38 includes an axial bore 52 (FIG. 8) and a transverse through hole 54 (FIG. 4). The proximal end of the extension screw 40 includes a reduced diameter portion 40a, having a transverse hole or aperture 40b. There is a coupling pin or member 56 which is

ES 2 335 591 T3 extends through through holes 54 and 40b of drive screw 38 and screw extension 40, respectively, to securely attach screw extension 40 to distal end 38b of drive screw 38. When the drive screw 38 is moved axially by rotation of the approach knob 22, this movement results in an axial movement of the screw extension 40. It is envisioned that the drive screw 38 and screw extension 40 may be formed integrally or monolithically.

The outer surface of screw extension 40 includes helical channel 58. In one embodiment, helical channel 58 has a pitch of between about 0.06 thousandths / revolution to about 0.40 thousandths / revolution and, in In a particularly useful embodiment, channel 58 has a pitch between about 0.120 thousandths / revolution to about 0.330 thousandths / revolution.

Extension sleeve 42 is tubular and slidably positioned around screw extension 40. There is a pin or cam member 60 that extends through a hole or opening 62, formed in a proximal end 42a of extension sleeve 42. Pin 60 is slidably located within helical channel 58 of screw extension 40 so that when screw extension 40 is displaced axially, in response to rotation of approach knob 22, extension sleeve 42 is rotated around onto screw extension 40 and moves axially over it as pin 60 moves through helical channel 58.

The distal end 42b of the extension sleeve 42 includes a transverse hole or opening 62a for receiving a pin or coupling member 64. Pin 64 is received within a through hole 66 formed in the proximal end of extension stem 46 to rotatably and axially fix extension sleeve 42 to extension stem 46. When the approach knob 22 is rotated to axially move the drive screw 38 and screw extension 40, and to rotate and axially move the extension sleeve 42, about the screw extension 40, the extension stem 46 is rotated. also about its longitudinal axis and axially displaced with the extension sleeve 42.

The extension stem 46 includes a helical groove 70, formed around its outer surface. In one embodiment, helical groove 70 has a pitch of between about 0.50 thousandths / revolution to about 0.85 thousandths / revolution. In a particularly useful embodiment, the pitch of the helical groove 70 is 0.836 thousandths / revolution. There is a pin support member 44 that is securely attached to a driver 72 (Figures 9 and 10) of device 10. Pin support member 44 is supported around extension stem 46 by means of a pair of pins. or screws 74. Driver 72 and pin support member 44 remain in a fixed location within body portion 14, during approach of device 10. There is a pin or cam member 76 that extends through the pin support member 44 into the helical groove 70 of the extension stem 46. When the extension stem 46 is rotated by means of the extension sleeve 42, the movement of the helical groove 70 with respect to the fixed pin 76 produces an axial movement of the extension sleeve 42 and the extension stem 46, relative to the screw 38. drive and screw extension 40.

As illustrated in FIG. 4, the distal end of helical groove 70 includes a linear section 70a. When the extension stem 46 is in its most proximal or retracted position (FIG. 14), the pin 76 is located in the linear section 70a of the helical groove 70. Thus, when pusher 72 is actuated to eject staples from sheath assembly 28, in the manner described in detail in WO 2004/112538 and 'WO 2005/009216, pin 76 moves freely through the section. linear 70a of the helical groove 70, without causing additional movement of the extension rod 46.

The distal end of the extension stem 46 includes a hub portion 46a defining an axial bore 80 (FIG. 9) for receiving a proximal end of the anvil stem 48 of the anvil assembly 30. The proximal end 48a of the anvil stem 48 includes an annular channel 82. There is a pair of pins 84 which extend through openings 86 formed in the hub portion 46 of the extension stem 46, through an annular channel 82 to securely axially and rotatably fix the extension stem 46 to the stem 48. of the anvil.

Referring to Figure 5, the anvil assembly 30 includes an anvil stem 48 and an anvil head assembly 49, including an anvil body 90, an anvil cap 91, a support plate 92, an anvil ring 94 cutting ring, a cutting ring cap 96 and an anvil plate 98. In one embodiment, the anvil cap 91 includes openings 122 and the anvil body 90 includes openings 123 that together define a fluid conduit to relieve pressure that may be generated within the anvil assembly 30. See figure 5. Anvil cap 91 is attached to the distal end of anvil body 90, and includes a tapered and blunt distal face 91a that provides smooth introduction of anvil head assembly 49 into the lumen. The anvil cap 91 is attached to the anvil body 90 using any known fastening technique, including a press fit, adhesives, screws, pins, friction, etc.

Anvil body 90 defines an outer annular channel 106 and an inner annular channel 108, and includes a central post 110. The central post 110 is dimensioned to be received within an axial bore 112 (FIG. 9) formed at the end. distal of the anvil stem 48. There is a pin 114 that extends through openings or holes 116 and 118 formed in anvil stem 48 and center stem 110, respectively, to securely attach anvil stem 48 to center post 110.

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Backing plate 92, cutting ring 94, and cutting ring cover 96 may form an integrated assembly. Alternatively, the components can be independent and stacked. In one embodiment, backing plate 92 is formed from a hard material, such as steel or other surgically admitted metal, and includes a central through hole 120 that is positioned around central post 110 of anvil body 90. . The support plate 92 includes a raised circular platform 92a and an outer annular washer 92b. The cutting ring 94 is dimensioned so that it is positioned over the outer annular washer 92b of the support plate 92, and may be attached thereto using similar adhesives. In one embodiment, cutting ring 94 is formed from a relatively soft material, such as polyethylene, and is molded onto backing plate 92.

The cutting ring cap 96 may be formed from a plurality of layers of material, as disclosed in provisional application serial number 60 / 554,564 ("Application '564"), which is the priority of the document. WO 2005/091986, entitled "Anvil Assembly With Improved Cut Ring" and filed March 19, 2004. As disclosed in the '564 application, the cap 96 may include a plurality of layers including a first layer separate from the cutting ring 94, formed from a relatively soft material, for example polypropylene, a second layer formed from a material relatively hard, for example a polyester such as Mylar^®, available from DuPont, and a third layer made of a relatively hard material, for example polyester such as Mylar^®. Alternatively, only one or more layers of relatively hard material may be provided. The plurality of layers can be held together, for example, with an adhesive. Alternatively, other fastening techniques can be used to secure the layers together, for example welding, casting, molding, compression, etc. The first layer is soft relative to the second and third layers, to allow penetration of a knife blade of a surgical instrument to improve tissue cutting. Although the stapling device 10 is not typically intended to cut through the staples, certain layers of the cover 96 are harder and provide a more rigid support for cutting through the staples, which may be inadvertently positioned between the sheet of the blade of a surgical stapling device (not shown) and the cutting ring cap 96. In one embodiment, the first layer has a thickness in the range of about 0.0005 "(0.013mm) to about 0.0015" (0.038mm). In a particularly useful embodiment, the first layer has a thickness of about 0.001 "(0.025mm) and the second and third layers have a thickness in the range of about 0.0015" (0.038mm) to about 0. .0025 "(0.064mm). In a particularly useful embodiment, the thickness of the second and third layers is about 0.002 "(0.051mm). Alternatively, other materials with different thicknesses can be used to construct the different layers of the cap 96. Furthermore, other material configurations can be used to form the relatively hard material layer (s), for example interlocking, braided, woven materials. and nonwovens.

Anvil plate 98 is attached to outer annular channel 106 of anvil body 90, using any known fastening technique, eg, welding, brazing, corrugated, pins, screws, etc., and includes a plurality of pockets. of staple deformation, as disclosed in documents WO 2004/112538 and 'WO 2005/009216.

Referring to Figures 4-7, the tissue tensioner assembly 34 is slidably supported on the anvil stem 48 of the anvil assembly 30, and includes a tissue tensioner 100, a tension link 102, and an actuator actuating member 104. tensor. Tissue tensioner 100 (Figures 5-7 and 13) includes a hollow body 130 and a distal head portion 132, which defines an aperture or through bore 134 (Figure 5). The distal head portion 132 may include a plurality of proximally angled shoulders 132a formed around its periphery (FIG. 3). The ribs 132a are configured to engage tissue. In the alternative mode, the head portion 132 may include a smooth surface without ridges. The through bore 134 may include a non-circular configuration, for example a hexagonal configuration that closely corresponds to the cross section of the anvil stem 48. The hexagonal configuration of the through bore 134 and the cross section of the anvil stem 148 prevent rotation of the tensioner 100 with respect to the anvil stem 48. The use of other cross sections and configurations is contemplated. Tensioner 100 is slidably positioned around anvil stem 48, and includes a spring brake 136 (Figure 10d) that is positioned to releasably engage with a rack or series of axially offset teeth 138, to releasably retain the tensioner 100 at axially fixed positions along the anvil stem 48. As illustrated in FIG. 10d, each tooth 138 has a distal face 138a and a proximal face 138b. In one embodiment, the distal face 138a defines a greater angle α with respect to a vertical axis than the angle β defined by the proximal face. In a particularly useful embodiment, the angle α is between about 45 ° and about 75 °, and the angle β is between about 15 ° and about 45 °. In another embodiment, the angle α is around 60 ° and the angle β is around 30 °. Angles α and β allow tensioner 100 to move more easily along anvil stem 48, in a proximal direction.

Referring to Figures 2, 6, and 7, tensioner drive member 104 is connected to tissue tensioner 100 via link 102. Link 102 includes a proximal enlargement 102a and a distal enlargement 102b. A cutout or recess 140a (FIG. 7) is formed in the base 104a of the drive member 104, dimensioned to receive the enlargement 102a. Within the through bore 134 of the fabric tensioner 100, a cutout or recess 140b is formed, sized to receive the enlargement 102b. Enlargements 102a and 102b are located within recesses 140a and 140b to secure drive member 104 to tissue tensioner 100 so that movement of drive member 104, along elongated body 14, effects tensioner movement. 100 of tissue along the anvil stem 48. An abutment member 150 is located on the anvil stem 48, in a position such that it limits the extent of proximal displacement of the

ES 2 335 591 T3 tensioner 100 around anvil stem 48. Stop member 150 may be attached to anvil stem 48 using, for example, threaded screws. Alternatively, stop member 150 may be formed monolithically or integrally with anvil stem 48.

Returning to Figure 14, the tensioner actuation member 104 includes a finger engagement member 160, which extends radially outward from its base 104a and is positioned so that it can be actuated by a finger or an operator hand. . The base 104a is slidably located within a channel 162 formed in an elongated portion 14 of the body of the stapling device 10. An intermediate member 164 of drive member 104 extends through slot 32 formed in elongated body portion 14, to interconnect base 104a with finger engagement member 160. When the latch member 160 has slid along the elongated portion 14 of the body of the stapling device 10, the tissue tensioner 100 moves along the anvil stem 48.

Figures 9-14a illustrate the operation of the approach mechanism and tissue tensioning assembly 34 of surgical stapling device 10.

Figures 9-10a illustrate surgical stapling device 10 in the non-approximate pre-firing condition. In this condition, the anvil assembly 30 is in its most distal position, with the anvil head assembly 49 located in a separate position from the sheath assembly 28. The tissue tensioner 100 of the tissue tensioner assembly 34 is located in a more distal position around the anvil stem 48, and the actuating member 104 is located adjacent the proximal end of the sheath assembly 28 (FIG. 9a). Drive screw 38 and screw extension 40 are located in an advanced position within handle assembly 12, and cam member 60 is located at the distal end of helical channel 58 of screw extension 40 so that A vacuum 42d is defined within the extension sleeve 42. Cam member 76 is located within the proximal end of helical groove 70, such that pin support member 44 is located around the proximal end of extension stem 46.

The surgical stapling device 10 can be used to join the ends of two lumens or to treat and / or remove a part of a single lumen, for example during a surgical procedure for the treatment of hemorrhoids, for example, mucosectomy, hemorrhoidectomy, etc. ., as will be studied in more detail below. In such procedures, the distal portion 16 of the head is inserted into the lumen of a vessel 190, for example the anus, with the device 10 in its non-approximate pre-firing condition. A shirred suture 192 is sewn or formed into a portion of vessel 190 to be treated and / or removed (FIG. 9a). The shirred suture 192 is then tightened to collapse the interior walls of vessel 190 around tissue tensioner 100 (FIG. 10a). In one embodiment, the proximal end of the hollow body 130 of the tissue tensioner 100 includes annular projections 130a that prevent the shirred suture from sliding past the proximal end of the body 130.

Referring to 10b-12b, once the lumen has collapsed around tissue tensioner 100, tissue tensioner assembly 34 can be actuated to pull tissue from vessel 190 to be removed, toward sheath assembly 28 of stapling device 10 This allows the tissue to be removed more easily to retract into a second void 28a defined within the sheath assembly 28, to allow subsequent removal of the desired tissue. It is contemplated that the tissue tensioner assembly 34 may be actuated to reposition the tissue tensioner 100 on the anvil stem 48, a multiplicity of times and / or in any degree of approximation of the device 10. The tissue tensioner assembly 34 is actuated pulling a drive member 104 proximally, as indicated by arrow "A" in FIG. 10c. Proximal movement of actuation member 104 is translated via hinge 102 toward tissue tensioner 100, such that tissue tensioner 100 is displaced proximally as indicated by arrow "B" of FIG. 10c, along length of anvil stem 48. As illustrated in Figures 10 and 10d discussed above, as tissue tensioner 100 travels proximally on anvil stem 48, elastic brake 136, which is located on elastic arm 136a, sequentially engages teeth. 138 axially spaced, formed on anvil stem 48, to selectively retain tissue tensioner 100 at any of a multiplicity of positions along anvil stem 48. Engagement between teeth 138 and brake 136 causes elastic arm 136a to flex upward to move brake 136 over teeth 138, during longitudinal movement of fabric tensioner 100. Stop member 150 defines the most proximal position of tissue tensioner 100 on anvil stem 100. In its most proximal position, the tissue tensioner 100 should be positioned in the proximal portion of the recess 28a of the sheath assembly 28, when the stapling device 10 is fully approximated. Thus, the fabric tensioner 100 will typically be retractable about ½ inch (12.7 mm) to about one inch (25.4 mm), and in one embodiment, about% inch (19.05 mm). . However, the distance that the tissue tensioner will retract will vary in proportion to the total length of the sheath assembly and the length of the sheath assembly can be selected based on its selected use. Thus, it is envisioned that the retraction length of the tissue tensioner 100 may exceed one inch (25.4 mm) or be less than U inch (12.7 mm).

Referring to Figures 13a-14, when approach knob 22 rotates in the direction indicated by arrow "C" in Figure 13a, sleeve 36 rotates around drive screw 38 to drive pin 50 along helical groove 38a of drive screw 38 and drive drive screw 38 proximally into sleeve 36. Since extension screw 40 is secured to drive screw 38 by coupling member 56, proximal movement of drive screw 38 effects proximal movement of extension screw 40.

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Cam member 60 (FIG. 14) extends inwardly from extension sleeve 42 into helical channel 58 of screw extension 40. As the screw extension 40 moves linearly with respect to the extension sleeve 42, the cam member 60 is forced to travel through the helical channel 58, to effect rotation of the extension sleeve 42 about its longitudinal axis. Since the extension sleeve 42 is attached to the extension stem 46 by means of the pin 64, as the extension sleeve 42 rotates about its longitudinal axis, the extension stem 46 also rotates about its longitudinal axis.

As best seen in FIG. 13, pin support member 44 is securely attached to driver 72 of stapling device 10. Driver 72 is stationary within elongated body 14, during approach of stapling device 10. Thus, the cam member 76, which extends through the pin support member 44 into the helical groove 70 of the extension stem 46, remains stationary within the elongated body portion 14, during approach of the device. stapler 10. As extension stem 46 rotates, within elongated body 14, cam member 76 moves along helical groove 70 to displace extension stem 46 and extension sleeve 42, proximally with respect to to the drive screw 38 and to the screw extension 40. Since the extension stem 46 is rotatably coupled to the anvil stem 48, this anvil stem 48 is displaced proximally with the extension stem 46. Relative movement between drive screw 38 and extension stem 46 allows the input travel of drive screw 38 to be amplified for greater output travel of anvil stem 48. Thus, the length of movement of the anvil head assembly 49, relative to the sheath assembly 28, can be extended considerably without having to change the length of the drive screw 32 and / or the handle assembly 12. The ability to provide greater clearance between the anvil head assembly 49 and the sheath assembly 28 in a compact instrument allows improved visibility at the surgical site and simplifies access to the surgical site.

As illustrated in Figure 14, when the stapling device 10 is fully approximated, the screw extension 40 is positioned within the recess 42d of the extension sleeve 42. It should be noted that the anvil stem 48 has a hexagonal cross section and is slidably received through a correspondingly shaped bore (not shown) in the sheath assembly 28. Thus, the anvil stem 48 only moves linearly and does not rotate with the extension stem 46.

Referring to Figures 15-17, after the surgical stapling device 10 has been approximated, the firing trigger lock 26 can be rotated toward the housing 12a of the handle assembly 12 and the firing trigger can be rotated in the indicated direction. by arrow "D" in FIG. 15, to eject staples from sheath assembly 28 and remove tissue. The operation of the firing mechanism is described in detail in WO 2004/112538 and 'WO 2005/009216 and will not be studied in detail here. As illustrated in Figure 17, when firing trigger 20 is rotated, driver 72 moves distally within elongated body 14. As pin support member 44 is attached to driver 72, pin support member 44 it also travels distally with the pusher 72. In the approaching condition of the stapling device 10, the pin 76 of the pin support member 44 is located in the linear section 70a of the helical groove 70. Thus, during actuation of the firing mechanism of the stapling device 10, the distal movement The pin support member 44 advances the pin 76 through the linear section 70a of the helical groove 70 and does not cause any further movement of the extension stem 46.

Figures 18-33 illustrate another embodiment of the now disclosed surgical stapling device, generally illustrated at 200. Referring to Figures 18 and 19, the surgical stapling device 200 includes a handle assembly 212, an elongated portion 214 of the body, a distal portion 216 of the head, and a tissue tension assembly 234. Although elongated body portion 214 is illustrated as being substantially straight, it is contemplated, as is known in the art, that a curved body portion be provided.

As disclosed with reference to surgical stapling device 10, handle assembly 212 includes a housing 212a that defines a handle 218, a firing trigger 220, an approach rotary knob 222, a firing indicator 224, and a trigger interlock 226. shooting. Each of these components functions substantially as described in applications WO 2004/112538 and 'WO 2005/009216, and will not be studied in detail here.

Head portion 216 includes a sheath assembly 228 and an anvil assembly 230. Sheath assembly 228 is attached to a distal end of elongated body portion 214. The elongated body portion 214 includes an elongated slot 232 for slidably receiving the tensioner drive member 304 of the tissue tensioner assembly 234, which will be described in more detail below.

The handle assembly 212 includes the proximal components of the approach and firing mechanisms of the surgical stapling device 200, a firing lock mechanism, and an indicator mechanism. The trigger mechanism, the trigger lock mechanism and the indicator mechanism are substantially as described in WO 2004/112538 and 'WO 2005/009216 and will not be described in more detail here. The approach mechanism of device 200 has been modified with respect to that described in documents WO 2004/112538 and 'WO 2005/009216, to provide better visibility and improved access to the surgical site. These modifications will be studied now.

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Referring to Figures 21-28, the approach mechanism includes a rotary approach knob 222, a rotary sleeve 236, a drive screw 238, a screw extension 240, a drive stem 242 (Figure 23), and an extender. 246. The distal end of the tubular stent 246 is rotatably coupled to a proximal end 248a of the anvil stem 248 of the anvil assembly 230. When approach knob 222 is rotated or actuated, anvil assembly 230 moves relative to sheath assembly 228 (FIG. 24) between spaced and coarse positions in a manner described below.

Approach knob 222 is attached to the proximal end of swivel sleeve 236, using any known fastening technique, eg, pins, adhesives, a key / groove configuration, welding, etc. The distal end of rotary sleeve 236 is rotatably secured with handle assembly housing 212a (FIG. 24) in the manner described in WO 2004/112538. There is a pin 250 (FIG. 24) that extends through the distal end 236a of the rotary sleeve 236 and is received within a helical groove 238a of the drive screw 238. As sleeve 236 is rotated by rotation of approach knob 222, pin 250 moves within helical groove 238a of drive screw 238 to axially move drive screw 238 within housing 212a of handle assembly 212.

A distal end 238b (FIG. 23) of drive screw 238 includes a screw extension 240. Screw extension 240 includes a helical channel 258 formed around an outer surface thereof. In one embodiment, helical channel 258 has a pitch of between about 0.06 thousandths / revolution and about 0.40 thousandths / revolution, and in a particularly useful embodiment, channel 258 has a pitch of between about 0.120 thousandths / revolution to about 0.330 thousandths / revolution. When the drive screw 238 is axially displaced by rotation of the approach knob 222, the screw extension 240 is also displaced axially within the housing 212a of the handle assembly 212. It is envisioned that the drive screw 238 and screw extension 240 may be formed as separate components that are securely attached using, for example, a pin or pins.

Drive screw 238 and screw extension 240 are tubular and define an axial passage 239 therethrough. The drive stem 242 has a proximal end 242a that is securely attached to the approach knob 222, such that rotation of the approach knob 222 effects the rotation of the drive stem 242. In one embodiment, proximal end 242a includes a series of ridges 243 and approach knob 222 is molded around proximal end 242a. Other techniques for securing the actuator stem 242 to the approach knob 222 are also contemplated. The actuator stem 242 has an elongated body 242b having at least one longitudinally extending flat surface 242c. In one embodiment, body 242a has a hexagonal cross section (Figure 27). Drive stem 242 extends through through bore 239 of drive screw 238 and screw extension 240 into a longitudinal through bore 247 defined by extender 246.

A proximal end 246b of the stent 246 includes a transverse opening 274 dimensioned to receive a cam member 276. Screw extension 240 is located within proximal end 246b of tubular stent 246, such that cam member 276 slidably sits within helical channel 258 of screw extension 240. A set screw 277 (FIG. 27) extends through a central portion of the tubular stent 246 and is located contiguously or abuts one of the at least one longitudinally extending planar surface 242c of the drive stem 242. Set screw 277 operates to rotatably lock drive stem 242 to extender 246, while allowing axial movement of drive stem 242 relative to extender 246.

Referring to Figures 29-33, in use, when the approach knob 222 is actuated or turned as illustrated by arrow "G" in Figure 29, the actuation screw 238 retracts or is axially displaced toward the interior of handle assembly 212 and actuator stem 242 rotates about its longitudinal axis. Since the extender 246 is rotatably attached to the drive stem 242 by means of the set screw 277, the extender 246 also rotates about its longitudinal axis. As extender 246 rotates, cam member 276 is driven along helical channel 258 of screw extension 240 to effect axial movement of extender 246 relative to drive screw 238.

A distal end of the extender 246 includes a hub portion 246a dimensioned to receive a proximal end 248a of the anvil stem 248 of the anvil assembly 230. Proximal end 248a of anvil stem 248 includes an annular channel 282. A pair of pins 284 extend through openings 286 formed in the hub portion 246a of the tubular stent 246, through a portion of the annular channel 282, to axially and rotatably fix the tubular stent 246 to the anvil stem 248. Thus, when stent 246 moves axially in response to rotation of approach knob 222, anvil stem 248 moves axially to move anvil head assembly 249 relative to sheath assembly 228. The travel distance of the anvil head assembly 249 relative to the sheath assembly 228 will be equal to the distance the drive screw 238 moves axially, plus the distance the extender moves axially. 246 with respect to the extension 240 of the screw.

Anvil assembly 230 and tissue tensioner assembly 234 are substantially similar to anvil assembly 30 and tissue tensioner assembly 34, as previously described, and will not be discussed in more detail herein.

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Figures 34-35 illustrate another embodiment of the now disclosed surgical stapling device, generally illustrated at 400. Referring to Figure 37, the surgical stapling device 400 includes a handle assembly 412, an elongated body portion 414 , a distal head portion 416, and a tissue tensioner assembly 434. Although elongated body portion 414 is illustrated as being substantially straight, it is contemplated that, as is known in the art, a curved body portion is also provided.

As disclosed with reference to the surgical stapling device 10, the handle assembly 412 includes a housing 412a that defines a handle 418, a firing trigger 420, an approach rotary knob 422, a bulbous firing indicator 424, and a firing interlock 426. trigger trigger. Each of these components functions substantially as described in WO 2004/112538 and 'WO 2005/009216 and will not be discussed in more detail here.

The head portion 416 includes a sheath assembly 428 and an anvil assembly 430. Sheath assembly 428 is attached to a distal end of elongated body portion 414. The elongated body portion 414 includes an elongated slot 432 for slidably receiving a tensioner drive member 504 of the tissue tensioner assembly 434, which will be described in more detail below.

The handle assembly 412 includes the proximal components of the approach and firing mechanisms of the surgical stapling device 400, a firing interlock mechanism, and an indicator mechanism. The firing mechanism, the firing interlocking mechanism and the indicator mechanism are substantially as described in WO 2004/112538 and 'WO 2005/009216 and will not be described in more detail here. The approach mechanism of device 400 has been modified from that described in WO 2004/112538 and 'WO 2005/009216 to provide better visibility and improved access to the surgical site. These modifications will be studied now.

Referring to Figures 34-39, the approach mechanism includes an approach rotary knob 422, a rotary sleeve 436, a drive screw 438, a screw extension 440, a pin support member 442, an extension sleeve 444. and a stent 446. A distal end 446a of stent 446 is attached to a proximal end 448a of anvil stem 448 of anvil assembly 430. When approach knob 422 is rotated or actuated, anvil assembly 430 moves axially relative to sheath assembly 428, between the spaced and coarse positions in the manner described below.

Approach knob 422 is attached to the proximal end of rotary sleeve 436, using any known fastening technique, eg, pin (s), adhesives, key / slot configuration, welding, etc. The distal end 436a of the rotatable sleeve 436 is rotatably fixed within the housing 421a of the handle assembly (FIG. 37) in the manner described in WO 2004/112538. A pin 450 (FIG. 37) extends through distal end 436a of rotary sleeve 436 and is received within a helical slot 438a of drive screw 438. As sleeve 436 is rotated by turning approach knob 422, pin 450 moves within helical groove 438a to axially move drive screw 438 within housing 412a of handle assembly 412.

A distal end 438b of drive screw 438 includes an axial bore 452 (FIG. 38) and a pair of transverse through holes 454. The proximal end of extension screw 440 is dimensioned to be received within axial bore 452 and includes an annular channel 455. There is a pair of pins 456 positioned through through holes 454 into annular channel 455, to rotatably attach screw extension 440 to drive screw 438. When the drive screw 438 is moved axially by turning the approach knob 422, this movement results in an axial movement of the screw extension 440.

The outer surface of screw extension 440 includes helical channel 458. In one embodiment, helical channel 458 has a pitch of between about 0.06 thousandths / revolution and about 0.40 thousandths / revolution and, in one embodiment, In a particularly useful embodiment, channel 458 has a pitch of between about 0.120 thousandths / revolution and about 0.330 thousandths / revolution. There is a pin support member 442 that is fixedly attached to housing 412a of handle assembly 412 via pin 476. In one embodiment, pin support member 442 is configured as an annular collar that is positioned around of screw extension 440. Pin 476 extends through an opening 477 in pin support member 442 into a helical channel 458 in extension screw 440. Thus, when screw extension 440 is displaced axially in response to rotation of approach knob 422, pin 476, which is axially attached to one end of handle assembly 412, is displaced through helical channel 458 of extension 440. of the screw, to cause rotation of the screw extension 440 with respect to the drive screw 438.

A distal end 440a of screw extension 440 is dimensioned to be received within extension sleeve 444, and includes a through bore 479. A proximal end 444a of extension sleeve 444 also includes a through bore 481. A pin 464 extends through through holes 479 and 481 of screw extension 440 and extension sleeve 444, respectively, to securely join screw extension 440 to extension sleeve 444. Consequently, when screw extension 440 is driven to rotate by pin 476, extension sleeve 444 will also rotate about its longitudinal axis.

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Extender 446 is located within extension sleeve 444. A helical channel 483 is formed around the stent 446. The helical channel 483 is dimensioned so that it can receive a cam member 460 that extends through an opening 485 formed in the extension sleeve 444. As extension sleeve 444 is rotated about its longitudinal axis, cam member 460 moves through helical channel 483 to effect axial movement of extender 446 relative to extension sleeve 444.

The distal end 446a of the stent 446 includes an axial bore 490 dimensioned to receive the proximal end 448a of the anvil stem 448. An opening 446b is formed in the distal end of the stent 446 and an opening 448 is formed in the proximal end 448a of the anvil stem 448. There is a pin 492 that extends through openings 446b and 448b to securely attach anvil stem 448 to extender 446.

Referring to Figures 40-45, in use, when the approach knob 422 is rotated to axially move the drive screw 438 within the housing 412a of the handle assembly 412, the screw extension 440 is axially displaced with the screw. 438 drive. When screw extension 440 is displaced axially, pin 476 that is supported on pin support member 442 is displaced within the helical channel of screw extension 440 to effect a rotation of screw extension 440 with respect to the screw. drive screw 438. Since extension sleeve 444 is attached to screw extension 440 by pin 464, extension sleeve 444 rotates with screw extension 440. As extension sleeve 424 rotates, cam member 460 moves within helical channel 483 of extender 446 to effect axial movement of extender 446, relative to extension sleeve 424. Since the anvil stem 448 is attached to the distal end 440a of the screw extension 440, the axial movement of the stent 446 effects an axial movement of the anvil stem 448. The overall axial distance that anvil head assembly 449 will travel relative to sheath assembly 30 will be the axial distance that drive screw 438 travels plus the axial distance that extender 446 travels relative to sleeve 444. of extension.

As illustrated in Figures 34-39, the tissue tensioner assembly 434 is formed as a substantially flat circular disk. It is contemplated that the tissue tensioner assembly 434 may function without the provision of a serrated edge as illustrated in previous embodiments. The operation and function of the anvil assembly 430 and tissue tensioner assembly 434 are substantially similar to the anvil assembly 30 and tissue tensioner assembly 34 and will not be discussed in further detail herein.

The surgical stapling devices disclosed herein are particularly suitable for use in surgical procedures for the treatment of hemorrhoids. Such processes include hemorrhoidectomies and processes to reduce the detachment of the mucous membrane. During a hemorrhoidectomy process, some or all of the hemorrhoids are removed using the surgical stapler. One such hemorrhoidectomy process is described in an article entitled “Removal of internal hemorrhoidal modules by means of devices designed for the application of circular anastomoses”. , by Mikail Yur'evich Kozubenko, located at the USSR Ministry of Health, Ukrainian Institute for Medical Practices on August 13, 1991. During a process to reduce mucous membrane detachment, a cross section of the mucosa between the rectus ampulla and the anal canal is removed to restore the normal anatomical relationship between the anal mucosa and hemorrhoids with the anal sphincters. Such a process to reduce the detachment of the mucous membrane is described in the article “Treatment of Hemorrhoids disease by reduction or mucosa and hemorrhoidal prolapse with a circular suturing device: a new procedure”. mucosal and hemorrhoidal detachment with a circular suture device: a new procedure ”) by A. Longo, published in the Congress of Endoscopic Surgery, June 3-6, 1998.