Anastomosis deviceThis application is a partial continuation of application serial No. 10/175159 filed on date 2002, 6/20, which claims priority to provisional application serial No. 60/299618 filed on date 2001, 6/20.
Background
1. Field of the invention
The present invention relates to gastrointestinal and intestinal (including biliary) anastomosis and the like. The woven tube of wire of the present invention is a three-dimensional structure in which the outer loops or ends of the woven tube are folded or looped back in such a way that: it fixes the cavity interface of the anastomotic site to be involuted at the unfolding site. Depending on the material used, the woven tube may hold the lumen walls in apposition, either as a permanent fixation device, eventually encased by scar tissue, or temporarily held in place until sufficient healing occurs between the intestinal walls, e.g., until the anastomotic device falls off the intestine and passes safely, leaving an anastomosis that functions properly.
2. Description of the Prior Art
Surgical procedures often require joining (anastomosing) two lumens or hollow viscera. For example, in gastric bypass surgery for the treatment of morbid obesity, and during surgery for pancreatic cancer, the obstruction of the common bile duct is relieved by draining bile from the duct into the small intestine, requiring a permanent anastomosis between the stomach and the intestine. Surgical anastomosis generally involves manual suturing of two structures. This process can be technically demanding and time consuming. Such complex surgical procedures are more challenging during Minimally Invasive Surgery (MIS), where the surgeon is required to use instruments that are not specifically designed for such a purpose.
Disclosure of Invention
The present invention relates to woven tubes of wire for use in automated anastomotic delivery devices for use in MIS procedures where particular emphasis is placed. The main component is a woven tube of wire that is deformable to form an anastomosis device when inserted into the walls of two adjacent lumens or cavities. The use of such a device for joining (anastomosing) two gastrointestinal or intestinal (including biliary) tubes or lumens or the like is new.
The anastomotic delivery device is designed with a protective sleeve to encapsulate the woven tube and a removable nose assembly so that the woven tube can be inserted into the protective sleeve by a loading device. The woven tube is pulled longitudinally, making the tube longer and very small in diameter, and mounted onto a loading device. The loading device includes a sheath and an attached alignment cylinder and plunger. The loading device is designed to be incorporated into the end of the protective sleeve of the delivery device to facilitate reloading for multiple deployments. To load the woven tube into the delivery device, the nose assembly is removed from the delivery device and the loading device is incorporated onto the protective sleeve. The plunger of the loading device moves the woven tube into the protective sleeve of the delivery device. After the woven tube is mounted on the delivery device, the nose assembly is placed over the protective sleeve to encapsulate the woven tube between the nose assembly and the plunger.
The loaded delivery device is inserted into the appropriate tube or lumen by hand or by means of a previously placed guide wire. A small sharp blade, initially retracted into the center of the nose assembly, is exposed at its tip (e.g., by pressing a button on the handle) to assist the surgeon as the delivery device is passed through the wall of the tube or lumen. The nose assembly and protective sleeve penetrate both walls and are properly positioned to hold the tissue against the alignment sleeve on the delivery device, at which point it acts as a tissue stop. The woven tube is then partially deployed from the protective sleeve by movement of the piston while the alignment sleeve positions the tissue on the woven tube. Once the tissue is in the correct position, the woven tube is fully deployed from the protective sleeve, while the correct positioning of the tissue during closure of the woven tube is ensured by alignment struts or alignment buttress mechanisms. The closure of the woven tube is achieved by a force from the shape memory or elastic metal properties of the woven tube and/or by compression of the woven tube by the delivery device, which may provide a force against the petals of the woven tube in order to ensure a correct functional anastomosis.
The mechanical force of the woven tube against the lumen wall forming the anastomosis is dependent on the material used to produce the woven tube. By forming the woven tube from a thermal shape memory alloy, such as nitinol, heat from the body causes the woven tube to longitudinally contract to create the anastomosis. With a woven tube made of an elastic material, the force provided to hold the lumen walls in apposition occurs when the material elastically returns to the original shape. For woven tubes made of compressible material, the final shape of the woven tube is mechanically formed by the compression action of the delivery device. With either method, sufficient force is applied to the wall tissue to enlarge the hole between the two cavities (for drainage) and no leakage outside the two cavities occurs. For example, when used in the intestine, the mechanical force from the wire mesh of the anastomotic device holds the lumen walls in apposition, which may vary depending on the diameter and/or material properties of the wire, resulting in a permanently fixed anastomotic device or temporarily held in place until sufficient healing occurs between the intestines, at which time the anastomotic device falls off the intestine and safely passes, leaving a normally functioning anastomosis.
Additional objects, advantages and other novel features of the invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the foregoing or may be learned by practice of the invention.
Brief description of the drawings
FIG. 1 is a front elevation view of the woven tube of wire in a deployed form, wherein the outer ring or end of the woven tube has been deformed and everted to form petals which hold the walls of the lumen in apposition, the front and back petals of the deployed anastomosis device being shown in black and light grey lines, respectively;
FIG. 2 is a side view of a longitudinally stretched woven tube prior to placement into a protective sleeve of the delivery device;
FIG. 3A is a front view of a woven tube similar to FIG. 1, with the lumen wall removed;
FIG. 3B is a side view of the woven tube of FIG. 3A;
FIG. 4A is a cross-sectional view of the delivery device inserted into a body cavity by hand or as shown with a previously placed guide wire to a predetermined anastomosis site, with the woven tube loaded within the protective sleeve between the plunger and nose assembly, with the knife deployed, ready to pierce the cavity wall;
FIG. 4B shows the tip of the delivery device piercing the cavity wall with the retractable knife;
figure 4C shows the end of the delivery device passing through the perforation formed by the knife (now retracted) with the cavity wall overlying the protective sleeve and abutting against the alignment sleeve;
FIG. 4D shows the woven tube partially deployed from the end of the protective sleeve by movement of the plunger, nose assembly and alignment sleeve;
figure 4E shows the woven tube continuing to deploy by further movement of the piston, which can facilitate expansion of the woven tube. Simultaneously, the alignment sleeve pushes the tissue from the protective sleeve toward the center of the woven tube before the woven tube is fully deployed;
figure 4F shows the final pushing of the woven tube from the protective sleeve by movement of the plunger and nose assembly. Simultaneously, the alignment struts are deployed from the alignment sleeve at a predetermined angle, facilitating proper positioning of the tissue during closure of the woven tube;
FIG. 4G shows the delivery device within the woven tube deployed about the lumen;
FIG. 4H depicts the retraction of the alignment struts, the alignment sleeve positioned on one side of the deployed woven tube, and the nose assembly retracted to form a compressed support on the opposite side of the deployed woven tube to ensure complete closure;
FIG. 4I shows the delivery device with the nose assembly extended to retract the compressed support and withdrawn from the center of the deployed woven tube;
FIG. 4J shows the same effect of FIG. 4F, with the exception that the alignment struts are replaced by alignment struts that are eventually pushed from the protective sleeve by movement of the plunger and nose assembly, while the alignment struts are deployed over the alignment sleeve by movement of the plunger and nose assembly to ensure proper positioning of the tissue during closure of the woven tube;
FIG. 5A is a cross-sectional view of the loading device with the woven tube at the end of the loading device and the nose assembly removed from the delivery device;
fig. 5B shows the loading device at the end of the protective sleeve. Movement of the plunger in the loading device positions the woven tube within the protective sleeve; and
figure 5C shows the woven tube loaded inside the protective sleeve of the delivery device with the nose assembly in place.
PREFERRED EMBODIMENTS FOR CARRYING OUT THE INVENTION
The tube 10 has an overlapping weave design. The woven tube is designed to form a circular hole 12 between two layers of tissue 14, 16 so that the layers of tissue are held together to form a water tight seal. The deployed anastomosis device is essentially a woven tube 10 of wire 18, which is axially compressed as shown in figure 1.
The woven tube 10 is determined by the wire diameter, the number of circumferential and longitudinal openings or diamonds 20, the length of the tube and the central diameter. The openings or diamonds 20' at the longitudinal ends of the elongated woven tube are referred to as petals when the device is in the deployed shape (see fig. 1).
In use, the woven tube 10 is forced into an elongated form (smaller diameter than shown in FIG. 2), placed through the opening between the wall tissues of the two lumens, and allowed or forced to return to the flattened shape shown in FIG. 1. During the process, the tissue of the two lumen walls is compressed between the petals of the flattened tube (see fig. 1) with the central diameter 12 of the flattened tube constituting the opening between the lumens.
For example, the woven tube 10 may be used through a common bile duct and pushed through the duct so that it connects the duct to the jejunum. After the connection is made, the tube is deformed and everted so that its ends are spread out like petals and a connection is made between the two ducts. Depending on the wire diameter and/or material properties used, the woven tube 10 may be used as a permanent fixture to hold the lumen walls in apposition and eventually enclosed by scar tissue or temporarily held in place until sufficient healing occurs between the tissue layers at which time the anastomotic device falls off the intestine and safely passes, leaving a properly functioning anastomosis. As a general rule, larger wire diameters can produce greater mechanical forces, as well as a tendency for the anastomotic device to slough off the intestine. For example, by selecting the annealing temperature of the wire metal, the properties of the material can be altered to facilitate permanent or temporary fixation.
The woven tube 10 may be made of a shape memory metal. Shape memory metals are alloys that change their plasticity when heated, allowing them to change shape. If the shape memory metal is annealed in the desired form (in longitudinally compressed form), after it has recovered its shape (in the form of a cylindrical tube), it will recover its annealed shape (flat form) if reheated at a significantly lower temperature. The very specific property of thermal memory is particularly conducive to the design of low profile and flexible delivery systems. The preferred shape memory metal is a titanium-nickel alloy, most preferably a near equiatomic alloy of titanium and nickel, known as nitinol. Special nitinol alloys that also have super elastic properties can change shape at body temperature.
The woven tube 10 may also be made of an elastic material. In this case, the applied force holds the lumen walls in apposition while elastically restoring the wire material to its original form.
As another alternative, the woven tube 10 may be made of a compressible wire material. In this case, the final shape of the woven tube is mechanically formed by the compression action of the delivery device.
The anastomotic delivery device 22 is designed with a protective sleeve 26 to encapsulate the woven tube 10 and the removable nose assembly 30 such that the woven tube 10 can be inserted into the protective sleeve 26 by a loading mechanism 42. The woven tube 10 is pulled longitudinally, making the tube longer and very small in diameter, and installing it into the loading mechanism 42. The loading mechanism 42 includes a housing 48 and a plunger 50 and includes an alignment cylinder 52 designed to be coupled to the end of the protective sleeve 26 of the delivery device 22 to facilitate reloading for multiple deployments. To load the woven tube 10 into the delivery device 22, the nose assembly 30 is removed from the delivery device 22 and the loading device 42 is incorporated onto the protective sleeve 26. The woven tube 10 is moved into the protective sleeve 26 of the delivery device 22 by the plunger 50 of the loading mechanism 42. After the woven tube 10 is installed in the delivery device 22, the nose assembly 30 is reinstalled so as to enclose the woven tube 10 between the nose assembly and the barrel piston 36.
Nose assembly 30 includes a first hollow shaft 54 that is coupled within the bore of barrel piston 36. The nose assembly also includes a second hollow shaft 56 which is telescopically received in the hollow bore of the first hollow shaft 54. The nose assembly has a streamlined nose 58 and a rounded base 60. The proximal end of the first hollow shaft 54 is attached to the circular base 60. The proximal end of the second hollow shaft 56 is attached to the streamlined nose 58. The nose assembly also has a central rubber or plastic cylinder 62 located between the streamlined nose 58 and the rounded base 60. A first stop 64 is attached to the distal end of the streamlined nose 58 and a second stop 66 is attached to the proximal end of the rounded base 60.
For example, in use for side-to-side intestinal anastomosis, the delivery device 22 is manually inserted into the body cavity, or as shown, positioned at a predetermined puncture site of the first intestinal segment 28, adjacent or distal to the intended anastomosis site, by means of a previously placed guide wire 38 (which passes through the second hollow shaft 56 and the aperture in the blade 34) through a rotator or tube (not shown) and the streamlined nose 58 of the delivery device 22, and the delivery device 22 is advanced intraluminally to the anastomosis site.
The second bowel segment 32 is brought into close apposition to the first bowel segment at the anastomosis site and the tissue is positioned on the alignment sleeve 40 by piercing the walls of the first segment 28 and the second segment 32 with the blade 34 initially retracted in the center of the streamlined nose 58 and into the lumen of the second segment, as shown in fig. 4C. The woven tube 10 is deployed in the sequence of figures 4D, 4E, 4F, 4G, and 4H at the juncture of the apposition holes formed by the blades 34 and assumes a petal shape at that location to maintain apposition of the two bowel segments. In fig. 4G, 4H and 4I, the deployment of the woven tube 10 through two layers of intestine is shown. The opposed petals 20 on opposite sides of the two layers of intestine 28, 32 preferably intersect each other as shown in figures 1, 3A and 3B.
Referring to the sequence of fig. 4D, 4E, 4F, 4G, and 4H, the nose assembly 30 is moved away from the proximal end of the protection sleeve 26 as shown in fig. 4D. Simultaneously, the cylindrical plunger 36 and the alignment sleeve 40 are advanced toward the proximal end of the protection sleeve 26, as also shown in FIG. 4D. The cylindrical plunger 36 partially forces the woven tube 10 away from the end of the protective sleeve 26 while the alignment sleeve 40 pressurizes the two layers of bowel 28, 32.
The woven tube 10 continues to be deployed by pushing the cylindrical piston 36 further towards the proximal end of the protective sleeve 26, as shown in fig. 4E. At the same time, the alignment sleeve 40 is advanced to the proximal end of the protection sleeve 26 and pushes the tissue from the protection sleeve 26 toward the center of the woven tube 10 before the woven tube is fully deployed.
The woven tube 10 is forced out of the protective sleeve 26 by moving the cylindrical piston 36 to the proximal end of the protective sleeve 26, as shown in fig. 4F. At the same time, the alignment struts 44 received in the slots on the alignment sleeve 40 are moved to a predetermined angular position to support the intestinal walls 28, 30. For example, the alignment struts 44 may be elastic wires or superelastic state nitinol wires.
Fig. 4G shows the woven tube 10 fully deployed, at this stage, with the alignment struts 44 still in a state supporting the intestinal walls 28, 30.
As shown in fig. 4H, the alignment post 44 has been retracted into its housing on the alignment sleeve 40. The streamlined nose 58 has been moved toward the distal end of the delivery device 22 by the second hollow shaft 56. This movement results in compression of the hollow rubber or plastic barrel 62 which forms a compressed support 62' in snug contact with the deployed woven tube 10 to ensure complete closure.
To remove the device from the unrolled woven tube 10, a hollow rubber or plastic barrel 62 is retracted into the tip assembly 30 by movement of the second hollow shaft 56. The delivery device 22 is then removed from the center of the unrolled woven tube 10 as shown in figure 4I.
Fig. 4J shows another embodiment, for example, where the alignment struts 44 have been replaced with alignment struts 46. Fig. 4J shows the same conveying sequence as fig. 4F. As shown in FIG. 4J, the proximal end of the alignment buttress mechanism 46 is attached to the proximal end of the alignment sleeve 40, and thus, the deployment of the alignment buttress mechanism 46 causes it to assume a looped shape that properly positions the tissue during the closure of the woven tube 10. For example, the alignment support mechanism 46 may be a plastic mesh sleeve or a plastic tube with a longitudinal slit.
The foregoing description of the preferred embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications and variations are possible in light of the above teachings. The embodiments were chosen and described to provide the best illustration of the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.
Claims
(modification according to article 19 of the treaty)
1. An anastomosis device for joining lumens or hollow organs which deploy at two adjacent lumen interfaces, comprising a woven tube of wire having longitudinally separated ends with an overlapping wire mesh design, the tube being longitudinally extendable so as to cause the tube to become longer in length and smaller in diameter, the tube being formed of a thermal shape memory alloy, a resilient wire or a compressible wire, having circumferentially separated outer rings or ends, at each longitudinally separated end of the woven tube of wire which thermally or mechanically causes the tube to become larger in diameter as it deploys and to longitudinally contract and deform and evert as it is inserted into the apertures of the walls of two adjacent lumens at the lumen interface at the site of anastomosis, the ends of the tube being thermally or mechanically deformed, and everted to form petals that compress and hold the walls of the two adjacent lumens in apposition, the wire diameter and/or material properties of the tube being selected such that mechanical forces of the deployed tube cause the deployed tube to temporarily remain in place until sufficient healing occurs at which time the deployed tube falls off leaving an anastomosis that is functional.
2. The device of claim 1, wherein the thermal shape memory alloy is a titanium-nickel alloy.
3. The device of claim 1, wherein said opposed petals are interdigitated.
4. An anastomotic delivery device comprising a woven tube of wire having longitudinally spaced ends, with an overlapping wire mesh design, said tube having circumferentially spaced outer loops at each longitudinally spaced end of said woven tube of wire, a protective sleeve enclosing said tube, a plunger pushing said tube from one end of said protective sleeve, a nose assembly including a streamlined nose providing a smooth surface for insertion into a body lumen or cavity, a first alignment mechanism for placing tissue from said protective sleeve onto said tube during deployment, a second alignment mechanism for assisting in positioning tissue during closure of said tube, a compression device inserted into said nose assembly for ensuring closure of said deployed tube, said tube being made of a thermal shape memory alloy, a resilient wire compressible or a wire, so that the tube becomes larger in diameter, thermally or mechanically, and contracts, and compresses and flattens axially, and causes the outer ring of the tube to deform and evert, thereby compressing and holding the walls of two adjacent cavities in apposition.
5. The device of claim 4, wherein said device further comprises a blade which is initially retracted in the center of said streamlined nose adapted to expose the tip thereof to assist the surgeon in incising the walls of the lumen or cavity while passing through said delivery device.
6. The device of claim 4, wherein the first alignment mechanism is an alignment sleeve surrounding the protection sleeve.
7. The apparatus of claim 4, wherein the second alignment mechanism is an alignment post or an alignment support mechanism.
8. The device of claim 4, wherein the compression device is a hollow rubber or plastic barrel.
9. The apparatus of claim 4, wherein the thermal shape memory alloy is a titanium-nickel alloy.
10. The device of claim 4, wherein the tube longitudinally contracts to cause the ends of the tube to deform and evert into petals to create the anastomosis.
11. The device of claim 10, wherein said opposed petals are interdigitated.
12. An anastomotic delivery device comprising a woven tube of wire having longitudinally spaced ends with an overlapping wire mesh design, the tube having circumferentially spaced outer loops at each longitudinally spaced end of the woven tube of wire, a protective sleeve enclosing the tube, an alignment sleeve surrounding the protective sleeve for pushing tissue from the protective sleeve onto the tube during deployment, a hollow piston received within the protective sleeve for pushing the tube from the end of the protective sleeve, the nose assembly comprising a hollow shaft adapted to be received within the hollow piston and providing a streamlined nose for providing a smooth surface for insertion into a body lumen or body cavity, an alignment mechanism to assist in positioning tissue during deployment of the tube, and a constriction device inserted on the nose assembly for causing closure of the deployed tube, the tube is made of a thermal shape memory alloy, an elastic wire or a compressible wire so that the tube thermally or mechanically becomes larger in diameter and contracts and axially compresses and flattens out and causes the outer ring of the tube to deform and evert, thereby compressing and holding the walls of two adjacent cavities in apposition.
13. The device of claim 12, wherein said device further comprises a blade initially constricted in the center of said streamlined tip adapted to expose the tip thereof to assist the surgeon in incising the walls of the lumen or cavity while passing through said delivery device.
14. The apparatus of claim 12, wherein the alignment mechanism is an alignment brace or an alignment support mechanism.
15. The apparatus of claim 12, wherein the compression device is a hollow rubber or plastic barrel.
16. A method of deploying an anastomosis device, comprising mounting a woven tube of wire having longitudinally spaced ends with an overlapping wire mesh design inside a protective sleeve, the tube having circumferentially spaced outer loops at each longitudinally spaced end of the woven tube, inserting the device through a trocar or tube into a body cavity to a predetermined puncture site of a first segment proximal or distal to a desired anastomosis site, advancing the device intraluminally to the anastomosis site by hand or with the aid of a guide wire so that a second segment of tissue forms a close apposition to the first segment of tissue at the anastomosis site, puncturing the walls of the first segment and the walls of the second segment and entering the lumen of the second segment, deploying the tube from the protective sleeve at the juncture of apposition holes formed by the device, the ends of the tube becoming larger in diameter, thermally or mechanically, and contracts and axially compresses and flattens out and causes the outer ring of the tube to deform and evert, thereby compressing and holding the walls of two adjacent cavities in apposition.
17. The method of claim 16, wherein the first and second segments are intestinal segments.
18. The method of claim 16, wherein one of the first and second segments is a bile duct and the other of the first and second segments is a jejunum.
19. The method of claim 16, wherein the anastomosis is a face-to-face anastomosis.
20. The method of claim 16, wherein the mechanical force of the woven tube to hold the two segments in apposition is selected so that the deployed tube remains temporarily in place until the segments are sufficiently healed, at which point the tube falls off the segments, leaving an anastomosis that functions normally.
21. The method of claim 16, wherein the device is advanced to the anastomosis site with the aid of a previously placed guide wire.
22. The method of claim 16, wherein the tube is deployed from the protective sleeve by a plunger housed within the protective sleeve.
23. The method of claim 16, wherein during deployment, the tissue is pushed out of the protective sleeve and placed onto the woven tube by an alignment sleeve connected to the protective sleeve.
24. The method of claim 16, wherein the tissue is properly positioned by an alignment mechanism during deployment of the tube.
25. The method of claim 16, wherein closing of the deployed tube is ensured by compressing the tube distal to the protective sleeve.
26. The device of claim 1, wherein the woven tube of wire has an unobstructed exterior and interior, and wherein the tube is capable of being thermally or mechanically deformed and everted in such a manner as to leave the unobstructed exterior and interior of the woven tube of wire.
27. The device of claim 26, wherein the ends of the tube are thermally or mechanically deformed and everted, exerting sufficient force on the walls of two adjacent lumens to enlarge the hole between the two adjacent lumens to prevent drainage and leakage out of the two adjacent lumens only through the expanded woven wire tube.
28. The device of claim 4, wherein the woven tube of wire has an unobstructed exterior and interior, and the ends of the tube are thermally or mechanically deformed and everted in such a manner that the exterior and interior of the woven tube of wire remain unobstructed.
29. The device of claim 12, wherein the woven tube of wire has an unobstructed exterior and interior, and wherein the ends of the tube are thermally or mechanically deformed and everted in such a manner that the exterior and interior of the woven tube of wire remain unobstructed.
30. The device of claim 16, wherein the woven tube of wire has an unobstructed exterior and interior, and wherein the ends of the tube are thermally or mechanically deformed and everted in such a manner that the exterior and interior of the woven tube of wire remain unobstructed.