Surgical stapling device

p00001Surgical stapling device.

BACKGROUND

p000031. Technical Field

p00004The present invention is related to a surgical stapling device, for treating hollow tissue organs. More particularly, the present invention is related to a surgical stapling device that has an approach mechanism.

p00005two. Background of the related technique

p00006Anastomosis 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 end sections are joined. Depending on the desired anastomosis process, the final sections can be joined by circular reconstruction methods, from end to end, or from side to side of the organs.

p00007In 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 inner tissue from the circular series of staples driven to release a tubular duct. Examples of devices for performing circular anastomosis of hollow organs are described in US Pat. Nos. 6,053,390, 5,588,579, 5,119,983, 5,005,749, 4,646,745, 4,576,167 and 4,473,077.

p00008Typically, these devices include an elongated rod having a handle part at a proximal end thereof, for effecting the device operation and a clamp holding component disposed at the distal end thereof. An anvil assembly, which includes an anvil stem with an anvil head attached, is mounted on the distal end of the device, adjacent to the staple holding component. The opposite end portions of the hollow organ tissue (or organs) to be stapled are held between the anvil head and the staple fastener component of the device. The fastened tissue is stapled by driving one or more staples from the staple fastener component, so that the ends of the staples pass through the tissue and are deformed by the anvil head. Concurrently, an annular blade is advanced to extract tissue within the hollow organ and release a tubular conduit within the organ.

p00009Surgical stapling devices to perform 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 anvil head and the staple holding component of the surgical stapling device are inserted, through the anus and into the rectum, with the head of the anvil and staple clamp component in an open or not very close position. Thereafter, a pursed string suture is used to pull the internal hemorrhoidal tissue and / or mucous tissue, toward the anvil rod. Next, the anvil head and the staple clamp component are approximate to hold the hemorrhoidal tissue and / or the mucous tissue, between the anvil head and the staple clamp component. The stapling device is fired to remove the hemorrhoidal tissue and / or the mucous tissue and to staple the cut tissue.

p00010Despite its success and the 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 anvil head to the staple holding component, the visibility of access to the surgical site is limited, especially during the processes for the treatment of hemorrhoids. Moreover, during the approach of the anvil head with the component that holds the staples 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 crowded into a gap of the defined tissue between the anvil head and the staple clamp component of the instrument. This can result in deformed staples and / or inefficient removal of all desired tissue.

p00011Consequently, there is a continuing need in the art for a circular stapling device for tissue treatment, which can provide improved visibility and access to a surgical site. Moreover, there is a need that continues in the art, of a circular stapling device for the treatment of tissue, which can quickly and easily position the tissue to be removed, within the staple clamp component of the surgical stapling device.

p00012WO 2005/009216 falls within the terms of Article 54 (3) of the EPC and describes a circular stapling device that includes a tensioning device that includes a tissue hook member positioned so that it can be moved between an anvil and a sheath or helmet assembly to place the tissue into a hole in the sheath or helmet assembly.

p00013More specifically, a hollow stem of the tissue engaging member defines a longitudinal hole to slidably receive the anvil stem. The shape of the hole and the rod that prevent the rotation of the hollow rod around the anvil rod are not described.

SUMMARY

p00015The present invention is directed to a surgical stapling device as defined in claim 1.

BRIEF DESCRIPTION OF THE DRAWINGS

p00017The above features of the surgical stapling device described now will be readily apparent and will be better understood by referring to the detailed description of embodiments or embodiments, which are described below with reference to the drawings, in which:

p00018Figure 1 is a perspective view of an embodiment of the surgical stapling device constructed in accordance with the principles of the present invention; Figure 2 is a perspective view of the distal part of the surgical stapling device illustrated in Figure 1; Figure 3 is an enlarged view of the indicated area of ​​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, with the separate parts, of the approach mechanism of the surgical stapling device illustrated in Figure 1; Figure 5 is a perspective view, with the separate parts, of the anvil assembly and the tissue tensioning 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-approximation 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 ​​detail illustrated in Figure 8; Figure 9a is a perspective view of the distal end of the surgical stapling device illustrated in Figure 1, located adjacent to a lumen of a vessel, with a pursed string suture applied to the portion of the vessel, the anvil assembly in its non-approximation position and the tissue tensioning assembly in its advanced position; Figure 10a is a perspective view of the distal end of the surgical stapling device illustrated in Figure 1, located adjacent to a lumen of a vessel, with a pursed cord suture girded around the tissue tensioning rod, the anvil assembly in its position of non-approximation and the tensor assembly of the tissue in its advanced 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 lumen of a vessel, the anvil assembly in its non-approximation position and the tissue tensor 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-approximate position and the tissue tensor assembly in a partially retracted position; Figure 10d is an enlarged view of the indicated area of ​​the detail illustrated in Figure 10; Figure 11 is still a 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 Figure 11, 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 the rotation of the approach rotary knob to approximate the anvil assembly; Figure 13 is an enlarged view of the indicated area of ​​detail illustrated in Figure 13a; Figure 14a is a cross-sectional side view of the surgical stapling device illustrated in Figure 1, showing the rotation of the approach rotary knob to approximate the anvil assembly; Figure 14 is an enlarged view of the indicated area of ​​detail illustrated in Figure 14a; Figure 15 is a cross-sectional side view of the surgical stapling device illustrated in the

p00019Figure 1, showing the trigger trigger drive 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 invention; Figure 19 is a perspective view of the distal part of the surgical stapling device illustrated in the 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 stapling device surgical illustrated in figure 18; Figure 23 is a perspective view with the separate parts 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 the 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 ​​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 the actuation of the tissue tensioner assembly to a retracted position; Figure 29 is a cross-sectional side view of the surgical stapling device illustrated in the Figure 18, showing the rotation of the rotating approach to approximate the anvil assembly; Figure 30 is a cross-sectional top view of the distal portion of the stapling device. Surgical illustrated in Figure 18, the anvil assembly in its approach position and the tensioner assembly of the tissue 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 stapling device. surgical 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 invention; Figure 36 is a perspective view with the separate parts 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. invention, illustrating the anvil assembly in its non-approximation position; Figure 38 is a cross-sectional top view of the distal portion of the stapling device. surgical illustrated in figure 37; Figure 39 is an enlarged view of the indicated area of ​​detail illustrated in Figure 37; Figure 40 is a cross-sectional side view of the distal end of the stapling device. surgical, illustrating the actuation of the tissue tensioning device; Figure 41 is a cross-sectional side view of the surgical stapling device illustrated in the Figure 34, showing the anvil assembly in its approach position and the tensioner assembly in a fully retracted position; Figure 42 is a cross-sectional top view of the distal portion of the stapling device. surgical illustrated in figure 41; Figure 43 is an enlarged view of the indicated area of ​​detail illustrated in Figure 41; and 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 EMBODIMENTS

p00021Embodiments of the surgical stapling device described herein will now be described in detail, with reference to the drawings, in which similar numerical references designate identical or corresponding elements in each of the various views.

p00022Throughout 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 description focuses primarily on surgical staplers, it is conceived that the benefits of what is described herein can also be achieved in other fastener application devices, including two-piece fastener application devices and tissue sealing devices with energy aid, for example, radiofrequency (RF) tissue sealing devices.

p00023Figures 1-3 illustrate an embodiment of a surgical stapling device that is now described and which is generally illustrated by reference 10. In short, the surgical stapling device 10 includes a handle assembly 12, an elongated portion 14 of the body, a distal part 16 of the head and a tension assembly 34 of tissue. Although the elongated part 14 of the body is illustrated as being substantially straight, it is contemplated, as is known in the art, to provide a curved body part.

p00024The handle assembly 12 includes a stationary housing 12a, which defines a handle 18, a trigger trigger 20, an approach rotary control 22, a trigger indicator 24 and a trigger trigger blocker 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" of surgical stapling with tissue tensioner), and will not be treated in detail in this report.

p00025The head part 16 includes a sheath or helmet assembly 28 and an anvil assembly 30. The pod set 28

p00026or helmet is fixed to a distal end of the elongated part 14 of the body. The elongated portion 14 of the body includes an elongate groove 32, to slidably receive a tensioning member 104 of the tensioner assembly 34 of the tissue, which will be described in more detail below.

p00027The handle assembly 12 includes the proximal components of the approach and trip mechanisms of the device 10, a trip lock mechanism and an indicator mechanism. The firing mechanism, the trigger locking mechanism and the indicating mechanism are substantially the same as those described in WO 2004/112538 and 'WO 2005/009216 and will not be described in detail herein. The approach mechanism of the device 10 has been modified with respect to 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.

p00028Referring to Figures 2a, 2b, 4 and 8-10, the approach mechanism includes a rotary approach 22 (figures 2a and 2b), a rotating sleeve 36, a drive screw 38, a screw extension 40, an extension sleeve 42, a pin support member 44 and an extension rod 46. As illustrated in Figure 4, the distal end 46a of the extension rod 46 is rotatably coupled to a proximal end 48a of the stem 48 of the anvil of the anvil assembly 30. When the approach knob 22 is rotated or operated, the anvil assembly 30 moves relative to the sheath or hull assembly 28 (Figure 1) between separate and approximate positions in a manner described in detail below.

p00029The approach control 22 is fixed to the proximal end of the rotating sleeve 36, using any known fastening technique, for example pin (s), adhesives, key / groove configuration, welding, etc. The distal end 36a of the rotating sleeve 36 is rotatably fixed within the housing 12a of the handle assembly (Figure 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 rotating sleeve 36, and is received within the helical groove 38a of the drive screw 38. When the sleeve 36 is rotated by rotation of the approach control 22, the pin 50 moves inside the helical groove 38a, to axially move the drive screw 38 into the housing 12a of the handle assembly 12. The helical groove 38a has a step from about 0.09 thousandths / revolution to about 0.90 thousandths / revolution.

p00030The distal end 38b (Figure 4) of the drive screw 38 includes an axial bore 52 (Figure 8) and a through transverse hole 54 (Figure 4). The proximal end of the extension screw 40 includes a portion 40a of reduced diameter, which has a hole or transverse opening 40b. There is a pin or coupling member 56 extending through through holes 54 and 40b of the drive screw 38 and the screw extension 40, respectively, to fixedly attach the extension 40 of the screw to the distal end 38b of the screw 38 of drive When the drive screw 38 moves axially by turning the approach knob 22, this movement results in an axial movement of the screw extension 40. It is conceived that the drive screw 38 and the screw extension 40 can be integrated or monolithically formed.

p00031The outer surface of the screw extension 40 includes a helical channel 58. In one embodiment, the helical channel 58 has a passage from about 0.06 thousandths / revolution to about 0.40 thousandths / revolution and, in A particularly useful embodiment, channel 58 has a step between about 0.120 thousandths / revolution to about 0.330 thousandths / revolution. The extension sleeve 42 is tubular and is slidably located around the extension 40 of the screw. There is a pin or cam member 60 extending through a hole or opening 62, formed at a proximal end 42a of the extension sleeve 42. The pin 60 is slidably located within the helical channel 58 of the screw extension 40, so that when the screw extension 40 moves axially, in response to the rotation of the approach control 22, the extension sleeve 42 is rotated about over the extension 40 of the screw and moves axially thereon, as the pin 60 travels through the helical channel 58.

p00032The distal end 42b of the extension sleeve 42, includes a transverse hole or opening 62a, to receive a coupling pin or member 64. The pin 64 is received within a through hole 66 formed at the proximal end of the extension rod 46, to rotatably and axially fix the extension sleeve 42 to the extension rod 46. When the approach knob 22 is rotated to axially move the drive screw 38 and the screw extension 40, and to rotate and axially move the extension sleeve 42, around the extension 40 of the screw, the extension rod 46 is rotated also around its longitudinal axis and axially displaced with the extension sleeve 42.

p00033The extension rod 46 includes a helical groove 70, formed around its outer surface. In one embodiment, the helical groove 70 has a passage 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 fixed to an impeller 72 (Figures 9 and 10) of the device 10. The pin support member 44 is supported around the extension rod 46, by means of a pair of pins or screws 74. The impeller 72 and the pin support member 44 remain in a fixed place within the body part 14, during the approach of the device 10. There is a pin or cam member 76 extending through the pin support member 44 into the helical groove 70 of the extension rod 46. When the extension rod 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 rod 46, with respect to the screw 38 drive and screw extension 40.

p00034As illustrated in Figure 4, the distal end of the helical groove 70 includes a linear section 70a. When the extension rod 46 is in its most proximal or retracted position (Figure 14), the pin 76 is located in the linear section 70a of the helical groove 70. Thus, when the impeller 72 is actuated to eject the clips from the sheath or hull assembly 28, in the manner described in detail in WO 2004/112538 and WO 2005/009216, the pin 76 travels freely through the linear section 70a of the helical groove 70, without producing additional movement of the extension rod 46.

p00035The distal end of the extension rod 46 includes a hub portion 46a that defines an axial bore 80 (Figure 9) to receive a proximal end of the stem 48 of the anvil of the anvil assembly 30. The proximal end 48a of the stem 48 of the anvil includes an annular channel 82. There is a pair of pins 84 extending through openings 86 formed in the hub portion 46 of the extension rod 46, through an annular channel 82 for axially and rotatably securing the extension rod 46 to the Anvil stem 48.

p00036Referring to Figure 5, the anvil assembly 30 includes an anvil stem 48 and anvil head assembly 49, including an anvil body 90, anvil lid 91, a support plate 92, a ring 94 of cut, a cover 96 of the cutting ring and a plate 98 of the anvil. In one embodiment, the anvil cover 91 includes openings 122 and the anvil body 90 includes openings 123 that jointly define a fluid conduit to relieve the pressure that may be generated within the anvil assembly 30. See figure

p000375. The anvil lid 91 is attached to the distal end of the anvil body 90, and includes a tapered and blunt distal face 91a that provides a smooth introduction of the anvil head assembly 49 into the lumen. The anvil cover 91 is fixed to the anvil body 90 using any known fastening technique, including a snap fit, adhesives, screws, pins, friction, etc.

p00038The anvil body 90 defines an outer annular channel 106 and an inner annular channel 108, and includes a central post

p00039110. The central post 110 is sized so that it is received within an axial bore 112 (Figure 9) formed at the distal end of the anvil stem 48. There is a pin 114 extending through the openings or holes 116 and 118 formed in the stem 48 of the anvil and in the central stem 110, respectively, to fixedly attach the stem 48 of the anvil to the central post 110.

p00040The support plate 92, the cutting ring 94 and the cover 96 of the cutting ring can form an integrated assembly. Alternatively, the components can be independent and stacked. In one embodiment, the support 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 located around the central post 110 of the anvil body 90 . The support plate 92 includes an elevated circular platform 92a and an outer ring washer 92b. The cutting ring 94 is sized so that it is positioned on the outer annular washer 92b of the support plate 92, and can be fixed thereto using adhesives to the like. In one embodiment, the cutting ring 94 is formed from a relatively soft material, such as polyethylene, and is molded on the support plate 92.

p00041The cover 96 of the cutting ring may be formed from a plurality of layers of material, as described in the provisional application with 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 on March 19, 2004. As described in the application '564, the cover 96 may include a plurality of layers including a first layer separated from the cutting ring 94, formed from a relatively soft material, for example polypropylene, a second layer formed by a material relatively hard, for example a polyester such as Mylar®, available in DuPont, and a third layer formed of a relatively hard material, for example polyester such as Mylar®. Alternatively, only one or more layers of relatively hard material can be arranged. The plurality of layers can be held together, for example, with an adhesive. Alternatively, other fastening techniques can be used to fix the layers together, for example welding, casting, molding, compression, etc. The first layer is soft with respect to the second and third layers, to allow the penetration of a blade of a surgical instrument to improve tissue cutting. Although the stapling device 10 is not typically intended for cutting 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 located between the sheet of the blade of a surgical stapling device (not shown) and the cover 96 of the cutting ring. In one embodiment, the first layer has a thickness in the range of about 0.0005 '' (0.013 mm) to about 0.0015 '' (0.038 mm). In a particularly useful embodiment, the first layer has a thickness of about 0.001 '' (0.025 mm) and the second and third layers have a thickness in the range of about 0.0015 '' (0.038 mm) to about 0.0025 '' (0.064 mm). In a particularly useful embodiment, the thickness of the second and third layers is about 0.002 '' (0.051 mm). Alternatively, other materials with different thicknesses can be used to construct the different layers of the cover 96. Moreover, other material configurations can be used to form the layer or layers of relatively hard material, for example interwoven, braided, woven materials and nonwovens.

p00042The anvil plate 98 is fixed in the outer annular channel 106 of the anvil body 90, using any known fastening technique, for example, welding, copper welding, corrugated, pins, screws, etc., and includes a plurality of bags of deformation of staples, as described in WO 2004/112538 and 'WO 2005/009216.

p00043Referring to FIGS. 4-7, the fabric tensioner assembly 34 is slidably supported on the anvil stem 48 of the anvil assembly 30, and includes a fabric tensioner 100, a tension joint 102 and a drive member 104 of the tensor. The fabric tensioner 100 (Figures 5-7 and 13) includes a hollow body 130 and a distal part 132 of the head, which defines an opening or through bore 134 (Figure 5). The distal head portion 132 may include a plurality of proximally angled projections 132a, formed around its periphery (Figure 3). The protrusions 132a are configured so that they engage the tissue. In the alternative mode, the head part 132 may include a smooth surface without protrusions. 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 rod 148, prevents the rotation of the tensioner 100 with respect to the anvil stem 48. The use of other cross sections and configurations is contemplated. The tensioner 100 is slidably located around the shaft 48 of the anvil, and includes a spring brake 136 (Figure 10d) that is positioned so that it releasably fits with a rack or a series of axially displaced teeth 138, to retain so releasable the tensioner 100 in axially fixed positions along the stem 48 of the anvil. As illustrated in Figure 10d, each tooth 138 has a distal face 138a and a proximal face 138b. In one embodiment, the distal face 138a defines an angle greater than with respect to a vertical axis, that the

p00044angle defined by the proximal face. In a particularly useful embodiment, the angle a is between about 45 ° and about 75 °, and the angle is between about 15 ° and about 45 °. In another embodiment, the angle a is about 60 ° and the angle is about 30 °. The angles a and allow the tensioner 100 to move more easily along the stem 48 of the anvil, in a proximal direction.

p00045Referring to FIGS. 2, 6 and 7, the tensioning member 104 is connected to the tensioner 100 of the fabric by means of the joint 102. The joint 102 includes a proximal enlargement 102a and a distal enlargement 102b. In the base 104a of the drive member 104 there is a cut or recess 140a (Figure 7), sized to receive the enlargement 102a. Within the through bore 134 of the fabric tensioner 100, a cut or recess 140b is formed, sized to receive the enlargement 102b. Enlargements 102a and 102b are located within recesses 140a and 140b to secure the drive member 104 to the fabric tensioner 100, so that the movement of the drive member 104, along the elongate body 14, causes the tensioner to move 100 tissue along the stem 48 of the anvil. A stop member 150 is located on the anvil rod 48, in a position such that it limits the extent of the proximal displacement of the tensioner 100 around the anvil stem 48. The stopper member 150 can be attached to the anvil stem 48 using, for example, threaded screws. Alternatively, the stop member 150 may be monolithic formed

p00046or integrally with the stem 48 of the anvil.

p00047Returning to Fig. 14, the tensioner actuating member 104 includes a hook member 160 by means of a finger, which extends radially outwardly from its base 104a and is positioned so that it can be operated by a finger or an operator's hand . The base 104a is slidably located within a channel 162 formed in an elongated part 14 of the body of the stapling device 10. An intermediate member 164 of the drive member 104 extends through the groove 32 formed in the elongated part 14 of the body, to interconnect the base 104a with the finger engagement member 160. When the hooking member 160 has slid along the elongated part 14 of the body of the stapling device 10, the fabric tensioner 100 travels along the stem 48 of the anvil.

p00048Figures 9-14a illustrate the operation of the approach mechanism and the tension assembly 34 of the tissue of the surgical stapling device 10.

p00049Figures 9-10a illustrate the 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 or hull assembly 28. The fabric tensioner 100 of the fabric tensioner assembly 34 is located in a more distal position around the anvil stem 48, and the actuating member 104 is located adjacent to the proximal end of the sheath or hull assembly 28 (Figure 9a). The drive screw 38 and the screw extension 40 are located in an advanced position within the assembly 12 of the handle, and the cam member 60 is located at the distal end of the helical channel 58 of the screw extension 40, so that a vacuum 42d is defined within the extension sleeve 42. The cam member 76 is located within the proximal end of the helical groove 70, so that the pin support member 44 is located around the proximal end of the extension rod 46.

p00050The 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 process for the treatment of hemorrhoids, for example, mucosectomy, hemorrhoidectomy, etc., as will be studied in more detail below. In such processes, the distal part 16 of the head is inserted into the lumen of a vessel 190, for example in the anus, with the device 10 in its approximate predisparo condition. A suture 192 of thread gathered in a part of the vessel 190 to be treated and / or removed is sewn or formed (Figure 9a). Next, suture 192 of gathered yarn is squeezed to collapse the inner walls of vessel 190, around tissue tensioner 100 (Figure 10a). In one embodiment, the proximal end of the hollow body 130 of the fabric tensioner 100 includes annular projections 130a that prevent the suture of the gathered yarn from sliding along the proximal end of the body 130.

p00051Referring to 10b-12b, once the lumen has collapsed around the tissue tensioner 100, the tissue tensioner assembly 34 can be actuated to pull the tissue from the vessel 190 to be removed, toward the sheath or helmet assembly 28 of the device stapling 10. This allows the tissue to be removed to more easily retract into a second vacuum 28a defined within the sheath or hull assembly 28, to allow subsequent removal of the desired tissue. It is contemplated that the tissue tensioner assembly 34 can be actuated to reposition the tissue tensioner 100 on the anvil stem 48, a multiplicity of times and / or at any degree of approximation of the device

p0005210. The tensioning assembly 34 of the fabric is actuated by pulling a driving member 104 proximally, as indicated by the arrow "A" of Figure 10c. The proximal movement of the actuating member 104 is moved by means of the joint 102 towards the fabric tensioner 100, so that the fabric tensioner 100 moves proximally as indicated by the arrow "B" of Figure 10c, at length of the anvil stem 48. As illustrated in Figures 10 and 10d studied above, as the fabric tensioner 100 travels proximally on the anvil stem 48, the elastic brake 136, which is located on the elastic arm 136a, sequentially engages the teeth 138 axially spaced, formed on the stem 48 of the anvil, to selectively retain the tissue tensioner 100 in any of the multiplicity of positions along the stem 48 of the anvil. The engagement between the teeth 138 and the brake 136 causes the elastic arm 136a to flex upwards to move the brake 136 over the teeth 138, during the longitudinal movement of the fabric tensioner 100. The stopper member 150 defines the most proximal position of the fabric tensioner 100 on the anvil stem 100. In its most proximal position, the fabric tensioner 100 must be positioned in the proximal part of the recess 28a of the sheath or helmet 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 ¾ inch (19.05 mm) . However, the distance that the tissue tensioner will retract will vary in proportion to the total length of the sheath or helmet assembly and the length of the sheath or helmet assembly may be selected based on its selected use. Thus, it is envisioned that the retraction length of the fabric tensioner 100 may exceed one inch (25.4 mm) or be less than ½ inch (12.7 mm).

p00053Referring to Figures 13a-14, when the approach knob 22 rotates in the direction indicated by the arrow "C" of Figure 13a, the sleeve 36 rotates around the drive screw 38 to drive the pin 50 along the helical groove 38a of the drive screw 38 and bring the drive screw 38 proximally into the sleeve 36. Since the extension screw 40 is fixed to the drive screw 38 by means of the coupling member 56, the proximal movement of the drive screw 38 effects the proximal movement of the extension screw 40.

p00054The cam member 60 (Figure 14) extends inwardly from the extension sleeve 42 into the helical channel 58 of the screw extension 40. When the extension 40 of the screw travels linearly with respect to the extension sleeve 42, the cam member 60 is forced to move along the helical channel 58, to rotate the extension sleeve 42 about its longitudinal axis. Since the extension sleeve 42 is fixed to the extension rod 46 by means of the pin 64, as the extension sleeve 42 rotates about its longitudinal axis, the extension rod 46 also rotates about its longitudinal axis.

p00055As best seen in Figure 13, the pin support member 44 is fixedly attached to the impeller 72 of the stapling device 10. The impeller 72 is stationary within the elongated body 14, during the approach of the stapling device 10. Thus, the cam member 76, which extends through the pin support member 44 into the helical groove 70 of the extension rod 46, remains stationary within the elongated part 14 of the body, during the approach of the device stapling 10. As the extension rod 46 rotates, within the elongated body 14, the cam member 76 travels along the helical groove 70 to move the extension rod 46 and the extension sleeve 42, proximally with respect to to drive screw 38 and screw extension 40. Since the extension rod 46 is rotatably coupled to the stem 48 of the anvil, this stem 48 of the anvil travels proximally with the extension rod 46. The relative movement between the drive screw 38 and the extension rod 46 makes it possible to amplify the input path of the drive screw 38 for a longer output path of the anvil rod 48. Thus, the length of the movement of the anvil head assembly 49, with respect to the sheath or hull assembly 28, can be considerably enlarged without having to change the length of the drive screw 32 and / or the handle assembly 12. The ability to provide greater separation between the assembly 49 of the anvil head and the assembly 28 of the sheath or helmet in a compact instrument, allows improved visibility at the surgical site and simplifies access to the surgical site.

p00056As illustrated in Figure 14, when the stapling device 10 is completely approximate, the extension 40 of the screw is located within the recess 42d of the extension sleeve 42. It should be noted that the stem 48 of the anvil has a hexagonal cross section and is slidably received through a bore (not illustrated) with a corresponding shape, in the assembly 28 of the sheath or hull. Thus, the anvil rod 48 only moves linearly and does not rotate with the extension rod 46.

p00057Referring to Figs. 15-17, after the surgical stapling device 10 has been approximated, the trigger 26 of the trigger trigger can be turned toward the housing 12a of the handle assembly 12a and the trigger trigger can be turned in the direction indicated by arrow "D" of Figure 15, to eject clips from the sheath or hull 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 herein. As illustrated in Figure 17, when the trigger 20 is rotated, the impeller 72 travels distally within the elongated body 14. As the pin support member 44 is fixed to the impeller 72, the pin support member 44 it also travels distally with the impeller 72. In the approach 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 of 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 rod 46.

p00058Figures 18-33 illustrate another embodiment of the now described surgical stapling device, generally illustrated with reference 200. Referring to Figures 18 and 19, surgical stapling device 200 includes a handle assembly 212, a part elongate 214 of the body, a distal part 216 of the head and a tension assembly 234 of the tissue. Although the elongated part 214 of the body is illustrated as being substantially straight, it is contemplated, as is known in the art, that a curved body part be provided.

p00059As described with reference to the surgical stapling device 10, the handle assembly 212 includes a housing 212a defining a handle 218, a trigger trigger 220, a rotary control 222 approach, a trigger indicator 224 and an interlock 226 of the trigger trigger. Each of these components functions substantially as described in the applications WO 2004/112538 and 'WO 2005/009216, and will not be discussed in detail herein.

p00060The head part 216 includes a sheath or helmet assembly 228 and an anvil assembly 230. The sheath or helmet assembly 228 is fixed to a distal end of the elongated part 214 of the body. The elongated portion 214 of the body includes an elongate groove 232 for slidably receiving the tensioner drive member 304 of the fabric tensioner assembly 234, which will be described in more detail below.

p00061The handle assembly 212 includes the proximal components of the approach and trigger mechanisms of the surgical stapling device 200, a trigger locking mechanism and an indicating 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 herein. The approach mechanism of the device 200 has been modified with respect to 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.

p00062Referring to Figures 21-28, the approach mechanism includes a rotary approach 222, a rotary sleeve 236, a drive screw 238, a screw extension 240, a drive rod 242 (Figure 23) and an extender 246. The distal end of the tubular extender 246 is rotatably coupled to a proximal end 248a of the anvil stem 248 of the anvil assembly 230. When the approach knob 222 is rotated or operated, the anvil assembly 230 moves relative to the sheath or hull assembly 228 (figure 24) between separate and approximate positions in a manner described below.

p00063The approach control 222 is fixed to the proximal end of the rotating sleeve 236, using any known fastening technique, for example, pins, adhesives, a key / groove configuration, welding, etc. The distal end of the rotating sleeve 236 is rotatably fixed with the housing 212a of the handle assembly (Figure 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 rotating sleeve 236 and is received within a helical groove 238a of the drive screw 238. When the sleeve 236 is rotated by turning the approach knob 222, the pin 250 moves within the helical groove 238a of the drive screw 238, to axially move the drive screw 238 into the housing 212a of the handle assembly 212a.

p00064A distal end 238b (Figure 23) of the drive screw 238 includes an extension 240 of the screw. Screw extension 240 includes a helical channel 258 formed around an outer surface thereof. In one embodiment, the 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 around 0,120 thousandths / revolution to around 0,330 thousandths / revolution. When the drive screw 238 moves axially by turning the approach control 222, the extension 240 of the screw also moves axially within the housing 212a of the handle assembly 212. It is envisioned that the drive screw 238 and the screw extension 240 may be formed as independent components that are fixedly connected using, for example, a pin or pins.

p00065The drive screw 238 and the screw extension 240 are tubular and define an axial conduit 239 therethrough. The drive rod 242 has a proximal end 242a that is fixedly attached to the approach knob 222, so that the rotation of the approach knob 222 effects the rotation of the drive rod 242. In one embodiment, the proximal end 242a includes a series of ridges 243 and the approach control 222 is molded around the proximal end 242a. Other techniques for securing the driving rod 242 to the approach control 222 are also contemplated. The drive rod 242 has an elongate body 242b having at least one longitudinally flat surface 242c. In one embodiment, body 242a has a hexagonal cross section (Figure 27). The drive rod 242 extends through the through bore 239 of the drive screw 238 and the extension 240 of the screw in a longitudinal through bore 247 defined by the extender 246.

p00066A proximal end 246b of the extender 246 includes a transverse opening 274 sized to receive a cam member 276. The extension 240 of the screw is located within the proximal end 246b of the tubular extender 246, so that the cam member 276 is slidably located within the helical channel 258 of the extension 240 of the screw. A pressure screw 277 (Figure 27) extends through a central part of the tubular extender 246 and is contiguously located or rests on one of the at least one flat surface 242c extending longitudinally from the actuating rod 242. The pressure screw 277 functions so that it rotatably fixes the drive rod 242 to the extender 246, while allowing the axial movement of the driving rod 242 with respect to the extender 246.

p00067Referring to Figures 29-33, during use, when the approach knob 222 is operated or turned as illustrated by the arrow "G" of Figure 29, the drive screw 238 retracts or moves axially towards The interior of the handle assembly 212 and the drive rod 242 rotates about its longitudinal axis. Since the extender 246 is rotatably fixed to the drive rod 242 by means of the pressure screw 277, the extender 246 also rotates about its longitudinal axis. As the extender 246 rotates, the cam member 276 is driven along the helical channel 258 of the screw extension 240, to effect the axial movement of the extender 246 with respect to the drive screw 238.

p00068A distal end of the extender 246 includes a hub portion 246a sized to receive a proximal end 248a of the anvil stem 248 of the anvil assembly 230. The proximal end 248a of the anvil rod 248 includes an annular channel 282. A pair of pins 284 extends through the openings 286 formed in the hub portion 246a of the tubular extender 246, through a portion of the annular channel 282, to axially and rotatably fix the tubular extender 246 to the stem 248 of the anvil. Thus, when the extender 246 moves axially in response to the rotation of the approach control 222, the anvil rod 248 moves axially to move the anvil head assembly 249 with respect to the sheath assembly 228

p00069or helmet The distance of the travel of the assembly 249 of the anvil head assembly with respect to the assembly 228 of the sheath or helmet, will be equal to the distance in which the driving screw 238 moves axially, plus the distance in which it moves axially the extender 246 with respect to the extension 240 of the screw.

p00070The anvil assembly 230 and the fabric tension assembly 234 are substantially similar to the anvil assembly 30 and the fabric tension assembly 34, as described above, and will not be studied in more detail herein.

p00071Figures 34-35 illustrate another embodiment of the surgical stapling device that is now described, generally illustrated as 400. Referring to Figure 37, the surgical stapling device 400 includes a handle assembly 412, an elongated portion 414 of the body, a distal part 416 of the head and a tension assembly 434 of tissue. Although the elongated part 414 of the body is illustrated as being substantially straight, it is contemplated that, as is known in the art, a curved body part is also provided.

p00072As described with reference to the surgical stapling device 10, the handle assembly 412 includes a housing 412a that defines a handle 418, a trigger trigger 420, a rotating rotary knob 422, a bulbous trigger indicator 424 and an interlock 426 of the 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 herein.

p00073The head part 416 includes a sheath or helmet assembly 428 and an anvil assembly 430. The sheath or helmet assembly 428 is fixed to a distal end of the elongated part 414 of the body. The elongated portion 414 of the body includes a long slot 432 for slidably receiving a tensioner member 504 of the fabric tensioner assembly 434, which will be described in more detail below.

p00074The handle assembly 412 includes the proximal components of the approach and trigger mechanisms of the surgical stapling device 400, a trigger locking mechanism and an indicating mechanism. The firing mechanism, the trigger locking mechanism and the indicating mechanism are substantially as described in WO 2004/112538 and 'WO 2005/009216 and will not be described in more detail herein. The approach mechanism of the device 400 has been modified with respect to 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.

p00075Referring to FIGS. 34-39, the approach mechanism includes a rotary approach 422, a rotating sleeve 436, a driving screw 438 an extension 440 of the screw, a pin 442 supporting member, an extension sleeve 444 and an extender 446. A distal end 446a of the extender 446 is fixed to a proximal end 448a of the anvil stem 448 of the anvil assembly 430. When it turns

p00076or actuates the approach control 422, the anvil assembly 430 moves axially with respect to the sheath or hull assembly 428, between the separated and approximate positions in the manner described below.

p00077The approach control 422 is fixed to the proximal end of the rotating sleeve 436, using any known fastening technique, for example, pin (s), adhesives, key / groove configuration, welding, etc. The distal end 436a of the rotating sleeve 436 is rotatably fixed within the housing 421a of the handle assembly (Figure 37) in the manner described in WO 2004/112538. A pin 450 (Figure 37) extends through the distal end 436a of the swivel sleeve 436 and is received within a helical groove 438a of the drive screw 438. When the sleeve 436 is rotated by turning the approach control 422, the pin 450 travels inside the helical groove 438a to axially move the driving screw 438 into the housing 412a of the handle assembly 412.

p00078A distal end 438b of the drive screw 438 includes an axial bore 452 (Figure 38) and a pair of transverse through holes 454. The proximal end of the extension screw 440 is sized such that it is received within the axial bore 452 and includes an annular channel 455. There is a pair of pins 456 located through the through holes 454 into the annular channel 455, to rotatably fix the extension 440 of the screw to the drive screw 438. When the driving screw 438 moves axially by turning the approach control 422, this movement results in an axial movement of the extension 440 of the screw.

p00079The outer surface of the screw extension 440 includes a helical channel 458. In one embodiment, the helical channel 458 has a pitch of between about 0.06 thousandths / revolution and about 0.40 thousandths / revolution and, in A particularly useful embodiment, the channel 458 has a pitch between about 0.120 thousandths / revolution and about 0.330 thousandths / revolution. There is a pin support member 442 that is fixedly attached to the housing 412a of the handle assembly 412 by means of a pin 476. In one embodiment, the pin support member 442 is configured as an annular collar that is located around of the 440 screw extension. The pin 476 extends through an opening 477 of the pin support member 442 into a helical channel 458 of the extension screw 440. Thus, when the screw extension 440 moves axially in response to the rotation of the approach control 422, the pin 476 which is axially fixed to one end of the handle assembly 412, travels through the helical channel 458 of the extension 440 of the screw, to cause rotation of the extension 440 of the screw with respect to the driving screw 438.

p00080A distal end 440a of the extension 440 of the screw is sized to be received within the extension sleeve 444, and includes a through bore 479. A proximal end 444a of the extension sleeve 444 also includes a through bore 481. A pin 464 extends through the through holes 479 and 481 of the extension 440 of the screw and the extension sleeve 444, respectively, to fixedly connect the extension 440 of the screw to the extension sleeve 444. Consequently, when the extension 440 of the screw is actuated to rotate by means of the pin 476, the extension sleeve 444 will also rotate about its longitudinal axis.

p00081The extender 446 is located inside the extension sleeve 444. A helical channel 483 is formed around the extender 446. The helical channel 483 is sized so that it can receive a cam member 460 that extends through an opening 485 formed in the extension sleeve 444. When the extension sleeve 444 is rotated about its longitudinal axis, the cam member 460 travels through the helical channel 483 to effect an axial movement of the extender 446 with respect to the extension sleeve 444.

p00082The distal end 446a of the extender 446 includes an axial bore 490 sized to receive the proximal end 448a of the anvil stem 448. An opening 446b is formed at the distal end of the extender 446 and an opening 448 is formed at the proximal end 448a of the anvil stem 448. There is a pin 492 that extends through the openings 446b and 448b to fixedly attach the rod 448 of the anvil to the extender 446.

p00083Referring to Figures 40-45, during use, when the approach knob 422 is rotated to axially move the drive screw 438 into the housing 412a of the handle assembly 412, the screw extension 440 moves axially with the screw 438 drive. When the screw extension 440 moves axially, the pin 476 that is supported on the pin support member 442 moves within the helical channel of the screw extension 440, to rotate the screw extension 440 with respect to the drive screw 438. Since the extension sleeve 444 is fixed to the extension 440 of the screw by means of the pin 464, the extension sleeve 444 rotates with the extension 440 of the screw. When the extension sleeve 424 rotates, the cam member 460 travels inside the helical channel 483 of the extender 446 to effect an axial movement of the extender 446, relative to the extension sleeve 424. Since the anvil shank 448 is attached to the distal end 440a of the screw extension 440, the axial movement of the extender 446 effects an axial movement of the anvil shank 448. The overall axial distance that the assembly 449 of the anvil head will move with respect to the sheath or helmet assembly 30, will be the axial distance that the driving screw 438 travels plus the axial distance that the extender 446 travels relative to the 444 extension sleeve.

p00084As illustrated in Figures 34-39, the fabric tension assembly 434 is formed as a substantially flat circular disk. It is contemplated that the fabric tensioning assembly 434 can operate without the provision of a serrated edge as illustrated in previous embodiments. The operation and function of the anvil assembly 430 and the fabric tension assembly 434 are substantially similar to the anvil assembly 30 and the fabric tension assembly 34 and will not be discussed in more detail herein.

p00085The surgical stapling devices described herein are particularly suitable for use in surgical processes for the treatment of hemorrhoids. Such processes include hemorrhoidectomies and processes to reduce the shedding of the mucous membrane. During a hemorrhoidectomy process, some or all hemorrhoids are removed by the surgical stapler. One such process of hemorrhoidectomy is described in an article entitled "Removal of internal hemorrhoidal modules by means of devices designed for the application of circular anastomoses" ("Extraction of internal hemorrhoidal modules by means of devices designed for the application of circular anastomosis") by Mikail Yur'evich Kozubenko, located in the Ministry of Health of the USSR, Ukrainian Institute for Medical Practices on August 13, 1991. During a process to reduce the shedding of the mucous membrane, a cross section of the mucosa between the ampulla of the rectum 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 shedding 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" ("Treatment of hemorrhoids disease by reduction of the 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.