WO2006081174A2

WO2006081174A2 - Methods and devices for soft tissue stapling

Info

Publication number: WO2006081174A2
Application number: PCT/US2006/002270
Authority: WO
Inventors: Brian Kelleher; Bryan Knodel
Original assignee: Brian Kelleher; Bryan Knodel
Priority date: 2005-01-24
Filing date: 2006-01-23
Publication date: 2006-08-03
Also published as: WO2006081174A3

Abstract

The methods and devices described herein provide for improved methods and devices for tissue stapling, and, in particular, for stapling a circular array of staples. The methods and devices may be particularly useful for placing columns of staples through a sleeve that is covering the stapling mechanism and into surrounding tissue. This may be useful for stapling tubular sleeves to tubular organs.

Description

PATENT

METHODS AND DEVICES FOR STAPLING TO SOFT TISSUE

BACKGROUND OF THE INVENTION

Field of the Invention

[01] The present invention relates to devices and methods for placing staples into soft tissues and in particular, to stapling columns of staples.

Description of the Related Art

[02] The securement of soft tissue segments has traditionally been done using suturing or stapling devices. However, attaching segments of tissue together is not always possible, especially when stapling to the wall of an organ that has a surface that is not easily accessible. As an example, when performing an endoluminal gastroplasty procedure staples may be attached to the wall of the stomach as an anchoring point for sutures or to accommodate two folds of the stomach wall. Since this procedure often requires direct visualization, an endoscope is placed down the esophagus. However this instrument occupies most of the available area of the esophagus. Therefore traditional stapling devices that are bulky, require large mechanical movements or prevent visualization are not suitable for this indication. Devices that can be introduced into the body attached to or with the aid of an endoscope and then apply a single column of staples or a circular array of staples into soft tissue would be beneficial. Furthermore a device that could staple a tubular sleeve to a tubular organ such as an esophagus, stomach, or intestine might be beneficial for treatments for gastro esophageal reflux disease (GERD) or obesity. Therefore a device that can be operated in conjunction with an endoscope, utilize a simple mechanical movement to actuate a stapling mechanism would be beneficial. BRIEF SUMMARY OF THE INVENTION

[03] The preferred methods and devices described herein provide for improved methods and devices for tissue stapling, and, in particular, for stapling single or multiple columns of staples into soft tissue. The device is sized to be positioned in the body with the aid of an endoscope and in one embodiment the device is coupled directly to the end of an endoscope for placement into the body. The device has a housing containing multiple staple cartridges positioned within the housing and arranged radially around the housing with each cartridge capable of delivering a column of staples. [04] A further aspect of the invention is a stapler that has a first configuration in which the radially arranged cartridges form essentially the same outside diameter as the housing. The device uses an activation member capable of moving the cartridges radially outward from the housing to a second configuration where the cartridges are adjacent to soft tissue. The activation member is also capable of deploying a column of staples from the cartridges into the soft tissue.

[05] A further aspect of the invention is a stapler that is capable of delivering a single column of staples to soft tissue or a circular array of staples to surrounding soft tissue. One possible benefit of the circular array is to staple to a tubular body organ such as an esophagus, intestine, duct or vessel. [06] A further aspect of the invention is a stapler that may also be used to drive staples through a tubular sleeve covering the stapling mechanism and into surrounding tissue. The device may be useful in attaching a sleeve to a tubular organ such as an esophagus, intestine, duct or vessel. Specifically the device may be effective in attaching a sleeve to a tubular body organ such as a duodenum, jejunum, ileum or colon. A sleeve so attached to the small intestine could be useful to limit the amount of nutrients that could be absorbed by the body in a procedure to control obesity. The sleeve could also be used as a shield to protect the lining of the intestines from normal digestive flow so that a portion of the intestines could heal after infection, trauma, wounds, anastomosis or disease such as inflammatory bowel disease. BRIEF DESCRIPTION OF THE DRAWINGS

[07] The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:

[08] FIG. Ia is a schematic view of one embodiment of a stapling device shown coupled to the end of a flexible endoscope; [09] FIG. Ib is a schematic view of another embodiment of a stapling device shown coupled to the end of a flexible endoscope;

[10] FIG. 2 is a close-up perspective view of the stapling device showing an array of staple rows in a retracted configuration;

[11] FIG. 3 is a schematic view of the stapling device of FIG. 1 showing the actuating wires extending from the working lumen of a flexible endoscope;

[12] FIG. 4 is a perspective view of the stapling device of FIG. 2 in an expanded condition;

[13] FIG. 5 is a schematic view of the stapling device of FIG. 4 with the staples fully formed; [14] FIG. 6 is a partial schematic view of a single staple cartridge assembly with the staples fully formed;

[15] FIG. 7 is a section view of the staple cartridge;

[16] FIG. 8 is a detailed section view of the stapling mechanism;

[17] FIG. 9 is an alternate detailed section view of the stapling mechanism; [18] FIG. 10a is a schematic view of the staple cartridge in a collapsed configuration with the cartridge body and casing removed;

[19] FIG. 10b is a schematic view of the staple cartridge of FIG. 10a with the staple in the fully formed position;

[20] FIG. 11 is a schematic view of the staple cartridge with the staple in the fully formed position;

[21] FIG. 12 is a section view of the staple in the fully formed position; [22] FIG. 13 is a perspective view of the stapler of FIG. 4 showing an array of staple rows in an expanded configuration and the staples deployed;

[23] FIG. 14a is a perspective view of an alternative embodiment of the stapling device with a sleeve encasing a retracted staple cartridge; [24] FIG. 14b is a perspective view of an alternative embodiment of the stapling device with a sleeve encasing an expanded staple cartridge;

[25] FIG. 15a is a perspective view of FIG. 14b with staples deployed through the sleeve;

[26] FIG. 15b is a section view of FIG. 15a with staples deployed through the sleeve and soft tissue;

[27] FIG. 16 is a perspective view of an alternate embodiment of FIG. 15a with a sleeve encasing an expanded array and with staples deployed through the sleeve.

DETAILED DESCRIPTION OF THE INVENTION

[28] Figures 1-13 depict one embodiment of a stapling device 100 for placing staples into soft tissue. The stapling device 100 is sized to be able to be introduced to the patient through the esophagus or rectum. The stapling device 100 may also be sized to accommodate other anatomical vessels, passageways, ducts or tubular organs of the body. In other words, although a particular size is illustrated, it is expected that the size can be increased or further reduced to be compatible with the anatomical conditions necessary. In the embodiment illustrated, the stapling device has an approximate outer diameter similar to an endoscope 200. The stapling device 100 has a generally cylindrical shape and is designed to be passed easily into a body organ or particularly a tubular organ. The stapling device 100 is particularly suited for the use in the esophagus, stomach or intestines.

[29] The stapling device 100 is shown in Figure 1 coupled to the end of an endoscope 200. The stapling device 100 has a center axis that may be coincident with the center axis of the endoscope 200 or may be offset from the axis of the endoscope as will be further explained later. Additionally, the locational terms proximal and distal used herein refer to the location of the device relative to the entrance point in the body. That entrance point i may be the mouth, nose, anus, urethra or a surgical puncture or cut. A proximal location would refer to a position closer to the body entrance site and distal would refer to a position inside the body and further away from the body entrance site. The stapling device 100 is coupled to the endoscope 200 with an attachment element 102. The attachment element 102 is designed to couple the stapling device 100 to the end of the endoscope 200. In this configuration, the stapling device 100 would have an opening down the center of the device that would permit the use of the endoscope optical system. In this way the operator would be able to visualize the target location for the application of the staples and then direct the stapling device 100 to that site. The stapling device 100 may also be attached to the side of the endoscope 200 using other attachment means. In this configuration the stapling device 100 could be coupled to the endoscope in a side-by-side orientation whereby the device is positioned alongside one of the outside edges of the endoscope. In another possible configuration, the stapling device 100 is coupled to the endoscope such that the device partially overlaps the diameter of the endoscope in a manner that the working lumens of the endoscope are covered but the optics and light source lumens are unrestricted. The attachment element 102 may be a flexible collar that attaches to the end of the stapling device 100 and endoscope 200 with friction. Other mechanical attachments are possible including but not limited to bayonet, press fit, threaded, or screwed attachments. The attachment should be secure so that the stapling device 100 does not separate under normal endoscopic manipulations of the endoscope 200. The stapling device 100 may be coupled to the endoscope prior to introduction to the patient's body or may be introduced separately and then coupled to the endoscope inside the body. However it is also anticipated that the stapling device may be operated without direct attachment to the endoscope but still use endoscopic guidance for positioning inside the body. [30] The stapling device 100 is constructed with a generally cylindrical housing 121 that is shown coupled to the attachment element 102. The housing 121 has openings 122 formed or cut into its sides. These openings 122 are rectangular shaped and are sized to accommodate at least one elongated staple cartridge 120 that is arranged parallel to the long axis of the housing 121. Preferably multiple staple cartridges 120 are positioned in the housing in multiple openings 122 located in the housing 121 and arranged around the long axis of the housing 121 as shown in Figure 2. These cartridges 120 are coupled to the housing but the position of these cartridges 120 relative to the housing 121 can change. For example, in Figure 2, the cartridges 120 are shown having a first configuration or a retracted position in which the outside diameter of the cartridges 120 is essentially the same as the outside diameter of the housing 121 and close to the diameter of the endoscope. In this first configuration, the cartridges 120 lie along the longitudinal axis of the stapling device 100. In this retracted position, the outer or working diameter of the stapling device 100 is minimized for introduction into the esophagus or other body structure using an endoscope. [31] The stapling cartridges 120 have a deployment and stapling mechanism that is actuated by actuation members 105 as shown in Figures 2 and 3. These members 105 are coupled to the stapling cartridges 120 at one end and may pass through the housing 121 the collar 102 and into the working lumen 106 of the flexible endoscope 200 so that they can be manipulated by the operator outside the patient's body. Alternatively these members 105 could pass alongside the outside of the stapling device and/or endoscope. Each stapling cartridge 120 may be coupled to an individual actuation member 105. This permits the activation of a single actuation member 105 at one time for activation of a single cartridge 120 and deployment of a single column of staples. Alternatively more than one member 105 can be activated at a time for activation of multiple cartridges 120 for simultaneous deployment of more than one column of staples. Conversely, all the stapling cartridges 120 may be coupled to a single actuation member 105 so that all the stapling cartridges 120 may be activated together as one unit.

[32] The position of the cartridges 120 relative to the housing 121 may be modified so that the stapling cartridges 120 are positioned in a second or expanded configuration as shown in Figure 4. In this second or expanded configuration, the stapling cartridges 120 form an outer diameter that is larger than the outer diameter of the housing 121. Thus the stapling device 100 can be small enough for introduction through an esophagus in the first or retracted configuration and can expand to a second configuration with a larger diameter that is beneficial to position the stapling cartridges 120 next to soft tissue. In one embodiment the stapling device 100 can be expanded 0.5-3 times its original diameter to bring the stapling cartridges 120 adjacent to the inner walls of the soft tissue such as an esophagus, stomach or intestine. [33] The cartridges 120 are coupled to the housing 121 of the stapling device with a linkage system 126 as shown in Figure 5. The linkage system 126 is comprised of an upper linkage pair 130 and a lower linkage pair 132. These linkage pairs have holes at both the inside 131 and outside 133 ends and are hingedly attached to the upper cartridge end 134 and the lower cartridge end 136 with outside pivot elements 137. The upper linkage pairs 130 and the lower linkage pairs 132 are also hingedly attached to the side walls 139 of the openings 122 in the housing 121 with inside pivot elements 138. These pivot elements 137 and 138, act as pivot pins that can be driven through the holes in the linkage pairs 130 and 132 and through holes in the stapling cartridges 120 and the side walls 139 of the openings 122. The actuation member 105 enters the cartridge at point A and its distal end is attached to the inside mechanism of the cartridge. The actuation members 105 are initially positioned on the outside of the housing 121 but then re-enter the housing 121 through window 141 and travel through the stapling device 100 and into the working lumen 106 of the endoscope 200. hi this layout, as the actuation member 105 is moved in a proximal direction parallel to the axis of the housing 121, the cartridges move between a first or collapsed configuration and a second or expanded configuration. Likewise the cartridges and their linkages pairs can be coupled to the housing in such a way that as the actuation member 105 is moved in a distal direction parallel to the axis of the housing 121, the cartridges move between a first or collapsed configuration and a second or expanded configuration.

[34] The cartridges 120 house a staple mechanism that deploys box type staples 140 into soft tissue adjacent to the expanded cartridge. This mechanism is actuated by the operator by pulling on at least one of the actuation members 105. The cartridges 120 are shown in the expanded condition with the staples 140 deployed in Figure 5. In one embodiment a single cartridge is enabled at a time so that one column of staples is deployed at once. In another embodiment more than one cartridge is enabled at a time thus deploying several columns of staples at a time. The soft tissue is not shown in Figure 5 but the staples would be embedded in surrounding adjacent tissue when deployed as shown. Figure 6 shows a close-up view of an isolated cartridge assembly with an upper linkage pair 130, pivot element 137 and formed staples 140. [35] The cartridge 120 is designed to form a box staple 140 from a piece of wire. The stapling cartridge 120 is an assembly constructed using a casing 150 that is attached to the linkage system 126 using pivot elements 138. The casing 150 encloses the body 152, driver 154, former 156, the wedge 158 and the distal end of the actuation member 105 as shown in Figure 7. The wedge 158 is attached to the distal end of the actuating member 105 and the wedge 158 can be configured so that it can move along a small track 160 formed along the inside edge of the casing 150. The initial movement of the stapling cartridges 120 from the refracted position to the expanded position and also the actual staple forming process is initiated when the operator pulls on member 105. However separate actuation members could be provided with one actuation member to move the stapling cartridges 120 from the retracted position to the expanded position and another to actuate the staple forming process independently from each other. As a pulling force is applied to the actuation member 105, a force is transferred to the wedge 158 that moves it forward in the direction of arrow A until it contacts the first driver 154. Because the force required to rotate the linkage system 126 about the pivot element 138 in the direction of arrow B is less than the force required to move the driver 154, the linkage system 126 first rotates about the pivot element 138 and the casing 150 moves from the retracted position to the expanded position. The linkage system 126 continues to rotate as shown until the rotational movement is prevented. This occurs by at least two methods. First, the housing has a stopper 151, shown in Figure 5 that is formed on the side of the opening 122 that prevents the linkage system 126 from rotating more than 90°. This stopper may be a welded bump or a formed or bent piece of the housing openingl22 that is positioned on the opening edge. When the linkage system rotates to 90°, at least one of the linkage pairs strikes the stopper and further rotation of the linkage system 126 and further translation of the casing 150 in the direction of arrow A is prevented. Secondly, as the stapler cartridge 120 moves from the retracted to the expanded configuration, it is possible that the cartridge will contact the inner walls of a tubular body organ such as an esophagus or intestine before one of the linkage pairs contacts the stopper. In this case the body organ will stop the movement of the cartridge 120. This is an advantageous condition because it insures that the stapler cartridge 120 will be firmly seated against the target tissue site before the stapler is activated. [36] If the actuation member 105 is pulled further with increasing force against either two of the described conditions, eventually the force required to move the wedge 158 and driver 154 will be less than that to move the cartridge 120, and the wedge 158 will continue to exert a force in the direction of arrow A against the driver 154, [37] As shown in the Figures 8 and 9, as the wedge moves along the track 160 in the direction of arrow A, the slanted edge 162 of the wedge 158 strikes the rounded edge 163 of the driver 154 and a force vector will move the driver in the direction of the arrow C shown. The movement of the driver 154 is confined by channels 164 and 165 formed in the body 152. These channels permit the driver to move only in the direction shown. The driver moves upward in the direction of arrow C until it hits the bottom of the staple 140 and it begins to move the pre-formed staple 140 upward. The upward movement of the staple is next prevented by the end 159 of the former 156. The staple 140 is now confined between the driver 154 and the end of the former 159. However, as the driver 154 continues upward as it is being driven by the wedge 158, the middle of the staple 140 is bent flat which forces the outside edges to move outward eventually forming a box shape. As the upper slanted surface of the driver 170 strikes the lower slanted surface of the former 172, the former 156 is moved in the direction of the arrow D as shown in Figure 9. This moves the former 156 out of way of the now fully formed staple 140. [38] With only one wedge 158 per stapling cartridge, the wedge is designed to pass under the driver 154 and be pulled until the next driver 154a is contacted. The wedge 158 moves driver 154a in a similar manner as driver 154. This occurs in sequence until the last driver in the column is moved and the last staple in the cartridge is driven into the adjacent soft tissue. Although only one wedge 158 is described, it is anticipated that a stapling cartridge 120 may have as many wedges as there are drivers in the stapling mechanism so that every staple can be driven into adjacent soft tissue in the cartridge column at the same time.

[39] The stapling cartridge 120 can be returned back to the retracted position by pushing on the actuation member 105 opposite to arrow A. Because the wedge 158 is prevented from moving opposite to arrow A by the driver 154, as the actuation member 105 is pushed, the linkage system 126 now rotates in the opposite direction as arrow B and causes the casing to move until the cartridge 120 is once again retracted inside the housing 121. In this configuration, the cartridge and the housing once again have a similar outside diameter. Alternatively, the cartridge 120 could employ a spring system to return the cartridge 120 back to the retracted position once the force on the actuation member 105 is released. [40] Figure 10a shows a cartridge assembly with the casing 150 and the body 152 removed for clarity. The pre-formed shape of the staple 140 is shown prior to bending. As the wedge 158 moves in the direction of the arrow, the driver 154 is moved in a direction perpendicular to the arrow and strikes the staple 140 at points 180 and 181. Since the staple apex 183 is restrained by the end of the former 159, the staple bends about its apex 183 until formed into a box shape as shown in Figure 10b. As the movement of the driver continues as described, the driver 154 next contacts the former 156. At this point the end of the former 159 is shown retracted away from the apex 183 of staple 140. The stapling cartridge 120 is shown in Figure 11 with the former 156 retracted and the fully formed box staple 140 protruding out of the casing 150. As the stapling cartridge is retracted, the staple which is attached to soft tissue remains behind attached to the soft tissue. A stapling cartridge 120 may have only one staple mechanism but preferably more than one staple mechanism is configured inside each casing 150.

[41] The assembly of all the working parts of the stapling mechanism except the wedge is shown in Figure 12. The driver 154 is shown displaced upward by the wedge 158 the maximum distance until it contacts the body 152 at plane 185. The former 156, is displaced by the driver 154 until it contacts the body 152 at plane 186 and the staple 140 is fully formed. As shown the staple 140 is formed perpendicular to the stapling device 100 axis. However in another embodiment the staple 140 could be formed parallel to the cable axis. This is accomplished by rotating the staple mechanism 90° as compared to the cable axis.

[42] The fully deployed stapling device 100 is shown in Figure 13 with the stapling cartridges 120 extended, the staples deployed and the actuation member 105 outside the lower portion of the. housing 121 but inside the upper portion of the housing 121. The extension of the stapling cartridges 120 and the deployment of the staple 140 can be actuated independently with independent actuation members 105. This would allow the location of the extended stapling cartridges 120 to be confirmed prior to stapling. Similarly, a single stapling cartridge 120 can be actuated independently from other stapling cartridges 120. However the extension of the stapling cartridges 120 and the deployment of the staple 140 can also be actuated at the same time utilizing the same or different actuation members. Likewise, multiple stapling cartridges 120 can be actuated simultaneously so as to deploy staples in columns around a cylinder.

[43] In another embodiment of the current device, the stapling device 100 may be used to attach sleeves to the soft tissue walls found inside cavities or vessels of the body. Examples of these are the esophagus, smaller portions of the stomach, the small and large intestines or blood vessels. A sleeve 300 as shown in Figure 14a may be positioned over the stapling device 100 prior to insertion into the body or placed over the stapling device 100 once inside the body. The sleeve 300 has a collapsed configuration that has an effective diameter similar to that of the retracted stapling cartridges 120. The sleeve 300 can be expanded to a second configuration with a larger diameter by the cartridges 120 when they are expanded as previously described. The sleeve 300 may be folded in the collapsed state and then unfolded to its maximum diameter when the cartridges 120 expand. The sleeve 300 may also be constructed from an elastic material so that the sleeve expands from a first configuration with a diameter close to that of the retracted cartridge 120 to a second expanded condition when the cartridge subassembly is expanded. The cartridges 120 are shown in Figure 14a in the collapsed condition. The cartridges 120 can then be expanded until the cartridges 120 approximate the diameter of the inside diameter of the target organ. In this expanded condition, the sleeve 300 is positioned between the expanded cartridges 120 and the inside diameter of the target organ as shown without any staples in Figure 14b. [44] As the staples are deployed, the staple 140 pierces the sleeve 300 before penetrating the tissue as shown in Figure 15a. This action attaches the sleeve 300 to the soft the tissue with multiple staples placed in columns around the perimeter of the sleeve. The staple is sized to penetrate the sleeve 300 and multi layers of soft tissue 350 as shown in Figure 15b. By penetrating the tissue layers a firm anchor to the tissue is possible. The placement of multiple columns of staples may provide a secure and stable attachment to the target organ or vessel and may prevent the leakage of body fluids or food in between the organ or vessel and the sleeve. [45] In another embodiment described previously, the staples 140 can also be formed longitudinally so that they are formed parallel to the actuating cable axis. Figure 16 illustrates this condition when used in conjunction with a sleeve 300. The staples 140 are placed through the sleeve 300 in a similar fashion to the configuration shown in Figure 15 a. However the column of staples is perpendicular to the staples shown in Figure 15 a. As can be appreciated, the staples can be placed at any angle convenient and are not limited to any particular orientation.

[46] The sleeve 300 can be manufactured from various materials to modify the permeability of the sleeve 300 so that the sleeve 300 restricts the passage of substances across it or enhances the passage of others. In one embodiment the sleeve 300 is made of a non-permeable material that does not allow the passage of biochemical substances, nutrients, liquids or gases to diffuse across it. In another embodiment the sleeve is made of a semi-permeable membrane that selectively permits certain biochemical substances, nutrients, liquids and gases to diffuse across it. The permeability of the sleeve 300 may be engineered to restrict molecules of a certain molecular weight or size. The sleeve 300 may be designed to chemically bond with certain substances so that they are not able to pass through the sleeve 300. The sleeve 300 may be coated with various pharmacological agents or chemical coatings enhance or inhibit biological or chemical reactions. Varying the permeability of the sleeve 300 may have important uses. For example it may be beneficial to staple a tubular membrane to the inside of the intestine that selectively permits the passage of certain vitamins, amino acids, hormones, biochemicals or nutrients that are generally good for the body while blocking the passage of other substances across the membrane. Particularly this may be useful for the treatment of obesity. The sleeve 300 could be positioned along portions of the stomach or the small or large intestines as a way to modify the digestion of food by an obese patient.

[47] Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Thus it is intended that the scope of the present invention herein should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.

Claims

What is claimed is:

1. An apparatus for stapling to soft tissue, said apparatus sized to be inserted into the body with the use of an endoscope comprising: a housing having an elongated staple cartridge; said cartridge having a stapling mechanism that is capable of simultaneously deploying a column of staples into soft tissue.

2. The housing of claim 1 further comprising: more than one elongated staple cartridge wherein said elongated cartridges are aligned side to side along their long axis and radially arranged so that the cartridges form a circle.

3. The radially arranged cartridges of claim 2 further comprising: said cartridges having a first configuration with a first outside diameter wherein the first outside diameter is sized for the introduction of the stapler into the body; and said cartridges having a second configuration with a second outside diameter wherein the second outside diameter is larger than the first outside diameter.

4. The cartridges of claim 3 further comprising: an actuation member capable of moving at least one cartridge from said first configuration to said second configuration and deploying a column of staples into soft tissue once at least one cartridge has been moved to said second configuration.

5. The apparatus of claim 4 further comprising: a tubular sleeve that is sized to fit over the outside of the cartridges while in a first configuration and either expand or unfold as the cartridges move to a second configuration; said actuation member capable of deploying a column of staples through said sleeve and into soft tissue; and said deployment securing the sleeve to the soft tissue.

6. The tubular sleeve of claim 5 wherein the permeability of the sleeve can be modified to restrict or enhance the diffusion of substances across the sleeve.

7. The stapling mechanism of claim 1 further comprising: a casing which houses a wedge which is attached to the actuation member; a driver that is driven into a piece of pre-formed wire by the wedge when moved by the actuation member; a former that restricts release of the wire until after it is formed into a staple by the driver.

8. An apparatus for stapling multiple columns of staples to soft tissue in the body comprising: a housing containing multiple staple cartridges arranged radially around the housing and each cartridge capable of delivering a column of staples; an actuation member capable of moving the cartridges radially outward from the housing to a position adjacent to soft tissue and deploying a column of staples from the cartridge into the soft tissue.

9. The apparatus of claim 8 further comprising: a tubular sleeve covering the outside of the housing and cartridges; and an actuation member capable of moving the cartridges radially outward from the housing to a position adjacent to soft tissue and deploying a column of staples from the cartridge through the tubular sleeve and into the soft tissue.

10. The sleeve of claim 9 wherein the permeability of the sleeve can be modified to restrict or enhance the diffusion of substances across the sleeve.

11. A system for attaching a tubular sleeve to the wall of a tubular organ comprising: a stapling device capable of delivering a circular array of staples into said wall; a tubular sleeve covering the outside surface area of the stapling device such that when the stapling device is activated; the sleeve is secured to the tubular walls of the organ by the staple array.

12. A method of stapling to soft tissue inside the body comprising: positioning a stapling apparatus having at least one elongated staple cartridge adjacent to soft tissue inside the body; the staple cartridge containing a column of staples; activating an actuation member to move the cartridge next to the soft tissue and deploy a column of staples into the soft tissue.

13. The method of activating an actuation member in claim 12 wherein said step further comprises: causing the actuation member to move a wedge along the length of the cartridge; said movement causing the wedge to move a driver; said driver shaping a pre-formed piece of wire into a staple; a former that restricts release of the wire until after it is formed into a staple by the driver; and driving the staple into soft tissue. 14, A method of stapling to soft tissue inside the body to provide a reinforced staple comprising: positioning a stapling apparatus having at least one elongated staple cartridge adjacent to soft tissue inside the body; the staple cartridge containing a column of staples and having a sleeve between the cartridge and the soft tissue; and activating an actuation member to move the cartridge next to the soft tissue and deploy a column of staples through the sleeve and into the soft tissue.