US20080208214A1 - Applicator and tissue fastening method through natural orifice - Google Patents

Abstract

The applicator related to the present invention is provided with a flexible sheath longer than the overall length of an instrument channel of a flexible endoscope; an operation part used outside the instrument channel; a deployed section that can be made to protrude from the front end of the sheath by operating the operation part and to pierce a tissue; a tissue fastening tool made of a superelastic wire formed in coil shape and housed inside the deployed section in a substantially extended condition; and a pusher that pushes out the tissue fastening tool from the deployed section when the operation part is operated.

Description

BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates to an applicator and tissue fastening method to perform the procedure for fastening tissues through a natural orifice.
• 2. Description of Related Art
• Transcutaneous insertion of medical instruments as a treatment of body organs is well known. This method is less invasive compared to incising the abdomen, and quick recovery is anticipated.
• A medical instrument used for transcutaneous procedures has a shaft made of hard material inserted in the body transcutaneously, with a forceps and so on provided at the front end of the shaft. For instance, a treatment instrument used in applications such as connecting hollow organs is disclosed in Japanese Unexamined Patent Application, First Publication No. 2005-193044. This intraluminal anastomosis device has a grasper fitted to the front end of the shaft that can freely open and close, and an anastomosis clamp inserted in the shaft. The anastomosis clamp can be pushed out from the front end of the shaft by the protruding device located at proximally to the operator. The anastomosis clamp is formed by annealing shape memory alloy into flat coil shape and inserting it in the shaft in the elongated condition. When the anastomosis clamp is used, the clamp is pushed out from the protruding device and inserted into the body. The surgical clamp is heated by body temperature and restored to its original coil shape. The hollow organs are joined by the restored anastomosis clamp.
• Other examples of dispensing the anastomosis clamp are disclosed in the international publication number WO2002/019923. Here, the anastomosis clamp is pushed out from the needle and dispensed to the tissue. For this reason, a stopper is provided to control the depth to which the needle pierces the tissue and the amount of the anastomosis clamp is dispensed into the tissue. When performing the procedure, the instrument containing the anastomosis clamp and the needle is deployed to the tissue. The needle is advanced to pierce the blood vessel, and the position of the anastomosis clamp is fixed by the stopper. Thereafter, the needle is pulled out of the blood vessel and the tissue. The anastomosis clamp does not move because of the stopper; therefore, its front end part remains inside the blood vessel. When the instrument is removed from the tissue, the rest of the anastomosis clamp remains outside the tissue. When the coil shape of the anastomosis clamp is restored, the blood vessel and layers of the tissue are anastomosed.
SUMMARY OF THE INVENTION
• The main object of the present invention is to fasten tissues through a natural orifice in comparison to the conventional procedures of fixing tissues transcutaneously so that invasiveness is reduced further and quick recovery can be anticipated.
• The applicator related to the first aspect of the present invention is provided with: a flexible sheath longer than the overall length of an instrument channel of a flexible endoscope; an operation part used outside the instrument channel; a deployed section that can be made to protrude from the front end of the sheath by operating the operation part and to pierce tissues; a tissue fastening tool made of a superelastic wire formed in coil shape and housed inside the deployed section in a substantially extended condition; and a pusher that pushes out the tissue fastening tool from the deployed section when the operation part is operated.
• The tissue fastening method through a natural orifice related to the second aspect of the present invention includes: inserting a deployed section housed in a substantially extended condition in a tissue fastening tool made of a superelastic wire formed in coil shape into the body through a flexible endoscope; piercing the deployed section into a tissue to be fastened; penetrating a tissue with a part of the tissue fastening tool housed in the deployed section and thereafter pushing it out of the deployed section to restore its original coil shape; and pulling out the deployed section from the tissue and thereafter pushing out the remaining part of the tissue fastening tool to restore its original coil shape.
• The method of manufacture of double coil spring related to the third aspect of the present invention includes: winding an element wire on the core; covering the element wire wound on the core by a spacer with a slit; pulling out the element wire from the slit to the outer periphery of the spacer and winding the element wire around the periphery of the spacer; and heat treating the element wire wound over the core and the spacer.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 shows the usage status of applicator inserted in an endoscope.
• FIG. 2 is a cross sectional view showing the applicator configuration.
• FIG. 3 is an external view of the tissue fastening tool.
• FIG. 4 shows an endoscope inserted in the duodenum.
• FIG. 5 is a cross sectional view showing the deployed section protruding from the front end of the applicator.
• FIG. 6 shows the penetrated deployed section extending from the duodenum toward the common bile duct.
• FIG. 7 shows the view when the stylet has been advanced to push out the tissue fastening tool halfway.
• FIG. 8 shows the disposition of the tissue fastening tool when it has been pushed out halfway.
• FIG. 9 shows the common bile duct pulled up in the duodenum with the deployed section pulled back from the condition inFIG. 8.
• FIG. 10 shows the fully pushed out tissue fastening tool.
• FIG. 11 is the external view of the tissue fastening tool detained in the tissue.
• FIG. 12 shows the closed area formed by the tissue fastening tool pierced by the deployed section.
• FIG. 13 shows the anastomosis hole formed by the deployed section.
• FIG. 14 shows a schematic drawing of the status of bile draining into the duodenum from the anastomosis hole.
• FIG. 15 is an explanatory drawing showing the formation of the anastomosis hole using a high-frequency knife.
• FIG. 16 is an example of modification showing a hole for delivering the tissue fastening tool to the side of the deployed section.
• FIG. 17 is an external view showing an example of modification of the tissue fastening tool.
• FIG. 18 is an external view showing an example of modification of the tissue fastening tool.
• FIG. 19 is an external view showing an example of modification of the tissue fastening tool.
• FIG. 20 is an external view showing an example of modification of the tissue fastening tool.
• FIG. 21 is an external view showing an example of modification of the tissue fastening tool.
• FIG. 22 is an external view showing an example of modification of the tissue fastening tool.
• FIG. 23 shows the rounded ends of the tissue fastening tool.
• FIG. 24 shows the spherical ends of the tissue fastening tool.
• FIG. 25 shows an example of modification of the end of the tissue fastening tool.
• FIG. 26 shows a schematic explanatory drawing of the process of restoring the tissue fastening tool.
• FIG. 27 shows the detention of the tissue fastening tool when its clamping force is large.
• FIG. 28 shows the necrotized tissue fastened by the tissue fastening tool.
• FIG. 29 shows the status of the fistulous opening formed when the tissue fastening tool and the necrotized tissue have fallen into the duodenum side.
• FIG. 30 is a tissue fastening tool with coil shapes of varying winding diameters.
• FIG. 31 shows the tissue fastening tool shown inFIG. 30 detained in the tissue.
• FIG. 32 shows the tissue fastening tool and the necrotized tissue fallen into the duodenum side.
• FIG. 33 shows the coil shaped tissue fastening tool partially overlapping in the radial direction.
• FIG. 34 shows the coil shaped tissue fastening tool partially overlapping in the radial direction as seen from A inFIG. 33.
• FIG. 35 is an external view of the spacer used when manufacturing the coil ofFIG. 33.
• FIG. 36 is a cross sectional view as seen from the line B-B inFIG. 35.
• FIG. 37 is an explanatory drawing of the procedure for forming the coil shape of the tissue fastening tool.
• FIG. 38 shows the tissue fastening tool detained in the tissue and fastening forces acting in the radial direction.
• FIG. 39 is a cross sectional view of the applicator when a tissue fastening tool and a stent are used together.
• FIG. 40 shows the deployed section protruded by pushing the slider.
• FIG. 41 shows the tissue fastening tool pushed out halfway by pushing the stylet.
• FIG. 42 shows the status of detention of the tissue fastening tool.
• FIG. 43 shows the deployed section piercing the location where the tissue fastening tool is detained, and the stent pressing against a tissue.
• FIG. 44 shows the applicator retracted after a stent has been twisted into the tissue.
• FIG. 45 shows the bile drainage opening formed after detaining the tissue fastening tool.
• FIG. 46 is an explanatory drawing showing the rotation of duodenum wall and common bile duct wall, and the misalignment of the drainage opening.
• FIG. 47 shows the state when the tissue fastening tool, stent, and necrotized tissue have fallen into the duodenum side.
• FIG. 48 shows the aligned condition of the stent screw pitch and coil pitch of the tissue fastening tool.
• FIG. 49 shows the stent with flap.
• FIG. 50 shows the deployed section processed for ultrasonic wave reflection.
• FIG. 51 is an explanatory drawing of the mode of using the dilator.
• FIG. 52 is an external view of the dilator.
• FIG. 53 shows an example of modification of the dilator.
• FIG. 54 is an external view of the tissue fastening tool with a grasping part.
• FIG. 55 is an external view of the tissue fastening tool with a grasping part.
• FIG. 56 shows the recovery operation of the tissue fastening tool using a grasping forceps.
• FIG. 57 shows a plurality of tissue fastening tools detained adjacent to each other.
• FIG. 58 shows the procedure for joining fistulous openings using a high-frequency knife after the tissue fastening tools has fallen off.
• FIG. 59 shows an elongated hole formed by joining the fistulous openings.
• FIG. 60 shows tissue fastening tool detained in one tissue and distended.
DETAILED DESCRIPTION OF THE INVENTION
• Embodiments are described here. The same reference numbers are affixed to the same elements in each mode of the embodiments. Duplication of explanations is omitted.
FIRST EMBODIMENT
• As shown inFIG. 1, the applicator, which is a flexible treatment instrument, is provided with aninsertion portion3 that passes through an instrument channel of anendoscope2. Theinsertion portion3 has a flexiblehollow sheath4 longer than the instrument channel. The base end of thesheath4 placed outside the body has anoperation part5 fitted thereto. Asurgical portion6 is disposed at the front end of thesheath4 drawn out from the front end of theendoscope2 and led into the body.
• As shown inFIG. 2, thesurgical portion6 is formed from a deployedsection11A at the front end of aneedle tube11 that can be freely advanced/retraced through thesheath4. Theneedle tube11 is hollow, passes throughsheath4 and connects with theoperation part5. Theneedle tube11 cannot be expanded/contracted, but it has the flexibility to bend to a certain extent when it is inserted into the body. Theneedle tube11 has only a deployedsection11A at the front end; only the deployedsection11A may be free to protrude in thesheath4. If theoperation tube5 is connected to the deployedsection11A made of material with higher flexibility than theneedle tube11, the insertability can be enhanced further.
• The front end of the deployedsection11A is cut incisively, and an opening is formed at the front end. Atissue fastening tool21 is housed within the deployedsection11A. Thetissue fastening tool21 is inserted after substantially stretching theelement wire21A. As shown inFIG. 3, thetissue fastening tool21 has a coil shape when it is in the no-load condition. If it is taken out of the deployedsection11A, it returns to its original coil shape by its self-restoring force. In thistissue fastening tool21, a tightly wound coil spring made of a superelastic alloy such as NiTi may be used. The superelastic alloy exhibits superelasticity when a specific temperature is exceeded; it maintains its properties of shape memory in environments below a specific temperature. Accordingly, if the coil spring is extended in temperature environments at which shape memory characteristics are active, the extended state can be retained. If inserted in the deployedsection11A in this state, assembly can be easily performed. The method of insertion in the deployedsection1 IA is not limited only to the method mentioned above. Moreover, the tight winding is not limited to the coil spring only.
• As shown inFIG. 2, astylet22 is inserted in the deployed section1 A in addition to thetissue fastening tool21. Thestylet22 is inserted to the base end side relative to thetissue fastening tool21 such that it can be freely advanced/retracted. It is a pusher that pushes thetissue fastening tool21 from the deployedsection11A by operating theoperation part5 through theneedle tube11.
• Theoperation part5 has a hollowoperation part body31 to which thesheath4 is fixed. Aconnector32 is inserted on the side of the front end in theoperation part body31, and is fixed by the securingscrew33. Aslider34 is fitted on the base end side of theoperation part body31 such that it can be advanced/retracted freely.
• Internal thread41 is formed in theconnector32, and it can be connected to the connector42 (refer toFIG. 1) of the instrument channel of theendoscope2. Oneannular groove32A is formed in the part of theconnector32 inserted in theoperation part body31. If the tip of the securingscrew33 is tightened when fitted in thegroove32A, theoperation part body31 and theconnector32 become fixed, and they can no longer rotate or advance/retract in the axial direction. If the securingscrew33 is loosened slightly, theconnector32 can be rotated along thegroove32A. If the securingscrew33 is loosened further and taken off from thegroove32A, theconnector32 can be rotated and advanced/retracted.
• Theslider34 is a member for advancing/retracting theneedle tube11; it is fitted such that it can move only in the advancing/retracting direction in theoperation part body31. Aprotective tube43 and theneedle tube11 are fixed on the inside of the slider. Theprotective tube43 is fixed more to the outside than theneedle tube11; it prevents deflection of theneedle tube11. Furthermore, theprotective tube43 is attached to the O-ring45 supported on the side of theoperation part body31 by a friction fit. It offers the feel of the operation by generating resistance when theslider34 is advanced/ retracted, and also prevents the backflow of air or mucus from the body. The O-ring45 is made of a flexible material such as silicone rubber.
• Thestylet22 that passes through theneedle tube11 is pulled out penetrating through theslider34. Astylet knob46 is fitted at its end. Afirst groove22A and asecond groove22B are carved onto thestylet22 at specific spacing in the advancing/retracting direction. Thesegrooves22A,22B give a ‘click’ feeling when they form a friction fit with the O-ring47 supported on the side of theslider34. Thesecond groove22B is installed to correspond to the position at which thetissue fastening tool21 starts to get pushed out; it has the role of preventing thetissue fastening tool21 from being needlessly pushed out and of enhancing operability. Thefirst groove22A is placed between the start of the push-out and the completion of push-out of thetissue fastening tool21. For example, it may be at a position corresponding to the position at which thetissue fastening tool21 is pushed out halfway. Thefirst groove22A gives a “click” feeling to the advance/retraction of thestylet22, and also has the role of controlling the push-out amount of thetissue fastening tool21. Although only onefirst groove22A is illustrated, the position of thefirst groove22A may be shifted and two grooves may be provided. The O-ring47 prevents the backflow of air or mucus from the body, and is made of a soft material such as silicone rubber.
• Thestylet22 is provided with flexibility that enables it to be inserted in the instrument channel of theflexible endoscope2, but if the flexibility of the exposed part outside theslider34 at the front side is reduced, operability can be improved.
• FIG. 1 shows the linear scanning type ultrasonic endoscope as theendoscope2 used together with theapplicator1. Theendoscope2 is provided with aflexible insertion portion26 that extends from theoperation part25 used outside the body. Aknob25A for bending the front end part of theinsertion portion26 into a curve andvarious buttons25B are provided in theoperation part25. Acover27 is fitted at the front end of theinsertion portion26. Anultrasonic probe28 is fitted to thecover27. Theultrasonic probe28 is placed on the flat plane passed through the axial line of theinsertion portion26. A plurality of ultrasonic transducers are disposed along the periphery of the circular arc shape. Furthermore, theendoscope2 is provided with aforceps elevator29 for delivery of the front end of theapplicator1 in the lateral direction, and the direction of delivery of theapplicator1 can be adjusted at a portion located proximally to the operator. Theendoscope2 may be provided with ultrasonic probe of other types. Moreover, an endoscope not provided with theultrasonic probe28 may also be used. In this case, an ultrasonic probe used outside the body, an X-ray device, a magnetic resonance imaging (MRI) device, or a computerizing tomography (CT) device may be used jointly.
• Next, the procedure to make bypass between common bile duct and duodenum after joining them is described here. As shown inFIG. 4, this kind of procedure is performed when the duodenal papilla Dp is obstructed by a tumor Tr preventing bile drainage, consequently the bile assimilates in the blood and causes jaundice. This procedure enables the direct drainage of bile from the common bile duct Cb to the duodenum Dd. First, theendoscope2 is inserted from the patient's mouth. Theendoscope2 is inserted in the duodenum Dd, which is the upper alimentary tract. The condition outside the duodenum Dd is examined by theultrasonic probe28, and an appropriate location proximally to the common bile duct Cb for the procedure is searched around the stomach St side in relation to the duodenal papilla Dp.
• Theapplicator1 is advanced through the instrument channel, and the protruding direction is adjusted with theforceps elevator29. As shown inFIG. 5, theslider34 of theoperation part5 is pushed into theoperation part body31. Theneedle tube11 fixed in theslider34 advances, and the deployedsection11A protrudes from the front end of thesheath4. Since thesecond groove22B is joined to theslider34 through the O-ring47, thestylet22 advances together with theneedle tube11.
• As a result, the deployedsection11A passes completely through from the inside to the outside of the duodenum wall Wd, as shown inFIG. 6, and furthermore, passes through the outside to the inside of the common bile duct wall Wc.
• As shown inFIG. 7, afirst groove22A is joined by friction with the O-ring47 by pushing thestylet knob46. Thestylet22 pushes out thetissue fastening tool21 into the common bile duct Cb from the front end opening of the deployedsection11A only for a length substantially equal to the distance thestylet knob46 has moved. The push-out distance at this stage should preferably be a length equivalent to substantially half the total length of thetissue fastening tool21. As shown inFIG. 7 andFIG. 8, a part of thetissue fastening tool21 pushed into the common bile duct Cb restores itself into coil shape because of superelasticity.
• Thereafter, the applicator I is retracted, the deployedsection11A is pulled out of the common bile duct Cb, and is pulled back into the duodenum Dd. As shown inFIG. 9, thetissue fastening tool21 restored to its original coil shape, forms a closed space and comes into annular contact with the inner wall of the common bile duct Cb. This part becomes the anchor, and the common bile duct Cb is pulled toward the duodenum Dd so as to form an anastomosis.
• Thestylet knob46 is advanced further, and the remaining part of thetissue fastening tool21 is pushed out from the deployedsection11A by thestylet22. As shown inFIG. 10, thetissue fastening tool21 is completely released from theapplicator1, and the part on the side of the duodenum Dd is also restored to its original coil shape because of the superelasticity. As a result, the duodenum wall Wd and the common bile duct wall Wc are fastened by thetissue fastening tool21 in a close contact condition. As shown inFIG. 10 andFIG. 11, thetissue fastening tool21 is detained in coil shape on both the duodenum Dd side and the common bile duct Cb side, that is, when viewed from the axial direction of the coil, thetissue fastening tool21 is detained in an annular contact condition with the tissue.
• At this stage, the area of tissue other than the area where thetissue fastening tool21 penetrates through the duodenum wall Wd and the common bile duct wall Wc are joined; therefore, the deployedsection11A is again advanced, and passed completely through the tissue of the closed area Rc formed by the tissue fastening tool from the duodenum wall Wd to the inside of the common bile duct wall Wc, as shown inFIG. 12. At this stage, thestylet22 is slightly pulled back beforehand, and the incisive front end of the deployed section I1 A is used to pierce the area Rc. When the deployedsection11A is pulled out, as shown inFIG. 13, the anastomosis hole Hc is formed in the closed area Rc fastened by thetissue fastening tool21. As shown inFIG. 14, the bile Lb drains from the common bile duct Cb to the duodenum Dd through the anastomosis hole Hc, and jaundice is treated.
• The area of the anastomosis hole Hc can be adjusted by puncturing the deployedsection11A several times, or by moving the deployedsection11A in the punctured state. Also, as shown inFIG. 15, a large fistulous opening Hc2 may be formed by incising with the high-frequency knife51. The high-frequency knife51 may be inserted instead of theapplicator1 or approached through a separate instrument channel.
• According to the present embodiment, the duodenum Dd and the common bile duct Cd can be joined by procedure through a natural orifice. Moreover, a bypass procedure for linking both organs can be performed. By selecting the duodenum Dd as the first hollow organ and the common bile duct Cb as the second hollow organ, the drainage path of the bile can be ensured when the duodenal papilla Dp is obstructed. In the conventional procedure through a natural orifice, a stent was inserted in the duodenal papilla Dp, but in cases of advanced obstruction, stent could not be inserted. According to this embodiment, treatment of jaundice can be correctly performed. Compared to transcutaneous procedures, the invasiveness can be reduced. Even locations that are difficult to perform transcutaneously, can be easily treated. In the conventional procedure, open abdominal surgery has been performed to anastomose the common bile duct and the duodenum. However, the physical burden on the patient was heavy; sometimes the bile is leaked out from a slight gap in the sutured section between the common bile duct and the duodenum into the abdominal cavity, causing a serious side effect called bile peritonitis. When an anastomosis is formed between the common bile duct and the duodenum according to the present invention, bile does not leak out into the abdominal cavity from between the common bile duct and the duodenum. Accordingly, there is no concern of bile peritonitis to occur.
• Furthermore, long term patency of the bypass is anticipated by this embodiment. In the conventional procedure for inserting stent, a foreign object was detained in the body; therefore, as early as one month, and latest by three months to about six months, the internal hole for the stent becomes obstructed and bile can no longer be drained. Thus, periodic stent replacement was necessary, placing a heavy burden on patients. According to the present embodiment, the bypass hole through which the bile drains does not obstruct easily because it is a luminal tissue.
• The first hollow organ in the treatment of jaundice may be in the upper alimentary tract. The upper alimentary tract includes the stomach St in addition to the duodenum Dd. The second hollow organ may be the gall bladder Gb, cystic duct or extrahepatic bile duct.
• As shown inFIG. 16, anopening52 may be provided at the side of the deployedsection11A, and thetissue fastening tool21 may be pushed in from this opening. The coil spring of thetissue fastening tool21 can be formed laterally with the tissue in the penetrated condition. At this stage, if theguide wire53 is delivered from the front end opening of the deployedsection11A, two procedures can be performed with one penetration: detention of thetissue fastening tool21 and the pass-through of theguide wire53. The second additional procedure is not limited to the pass-through of theguide wire53 only. Procedures such as injection of a drug solution, a contrast agent, and so on may be performed.
• FIG. 17 toFIG. 22 show the other embodiments of the tissue fastening tool.
• Thetissue fastening tool61 shown inFIG. 17 has both ends of the element wire in convolute form. The part that mainly penetrates the tissue is straight.
• Thetissue fastening tool62 shown inFIG. 18 has a coils of varying winding diameter. The winding diameter is the smallest at the central part in the axial direction and the diameter gradually increases as it approaches either end.
• Thetissue fastening tool63 shown inFIG. 19 has a part that extends in a straight line in the axial direction. From both ends of this part, a spiral shape loops back toward the central part. The loop-back part has a winding diameter that gradually increases as it approaches the central part.
• Thetissue fastening tool64 shown inFIG. 20 has an elliptical shape when viewed in the axial direction. If the longer axis of the elliptical shape is aligned in the longitudinal direction of the hollow organ, large puncture area can be ensured even for narrow hollow organs as shown by the broken lines. The shape is not limited to elliptical shape; a shape long on one side such as oblong shape or rectangular shape may also be used. The same effects can be obtained for these shapes also.
• Thetissue fastening tool65 shown inFIG. 21 has non-slipconvex parts65A provided intermittently on the element wire. Theconvex part65A is provided in a protruding condition facing the tissue when detained in the body. As shown in thetissue fastening tool66 inFIG. 22, theconvex part66A may be formed by shaping a part of the element wire in wavy form.
SECOND EMBODIMENT
• As shown inFIG. 23, the two ends71 of theelement wire21A in thetissue fastening tool21 are of rounded shape obtained by chamfering the corners. As shown inFIG. 25, theend73 may be folded back in a U-shape also. Spherical shapes larger than the element wire diameter may be used, as in the two ends72 shown inFIG. 24. In this case, the spherical parts may be formed integrally during manufacture, or may be made by caulking and fixing the separate members into this structure. The fixation method used may be brazing, soldering, bonding, or tight fit. When housed in the deployedsection11A or when pushing with thestylet22, jamming thetissue fastening tool21 inside the deployedsection11A or the friction between thetissue fastening tool21 and the deployedsection11A is reduced.
• According to the embodiment shown inFIG. 24, by making the angle between the inside wall of the deployedsection11A and theelement wire21A as small as possible, the sliding motion can be improved. Furthermore, for example, as shown by the detention state when theend72 exists as inFIG. 26, when the tissue fastening tool restores its original coil shape in the body, theend72 of theelement wire21A moves on the surface of the tissue as mentioned above. However, it becomes difficult for theend72 of theelement wire21A to engage with the tissue, and is thus easy for the original coil shape to be restored. Similar effects can be obtained at the other ends71,73.
THIRD EMBODIMENT
• FIG. 27 shows thetissue fastening tool21 detained in the tissue, and the drainage route for bile is ensured. The fastening force of thetissue fastening tool21 of the present embodiment is strong; the duodenum wall Wd and the common bile duct wall Wd are compressed by theelement wire21A, the tissue inside the area Rc fastened by thetissue fastening tool21 becomes ischemic condition due to poor blood circulation into the area Rc.
• As shown inFIG. 28, when the ischemic condition continues, the tissue within the area Rc becomes necrotized. On the other hand, the duodenum wall Wd and the common bile duct wall Wc coalesce and join with each other all around at the outer periphery of thetissue fastening tool21. When this occurs, the necrotized tissue and thetissue fastening tool21 fall off, as shown inFIG. 29. Thetissue fastening tool21 is later discharged. After the tissue falls off, a large diameter anastomosis hole (fistulous opening) Hd is formed. At this stage, the portion all around the anastomosis hole Hd connecting the common bile duct Cb and the duodenum Dd has coalesced; therefore, the bile cannot leak out between the common bile duct Cb and the duodenum Dd to the abdominal cavity. Accordingly, there is no concern of bile peritonitis to occur. According to this embodiment also, similar to the first embodiment, long term patency of the anastomosis hole Hd as the bypass is anticipated. According to this embodiment, since thetissue fastening tool21 falls off and the bypass hole becomes larger, a longer period of patency than that according to the first embodiment may be anticipated.
• Thetissue fastening tool21 is not detained for a long period in the body according to the present embodiment. A fistulous opening Hc of size substantially equal to the size of thetissue fastening tool21 can be formed.
FOURTH EMBODIMENT
• As shown inFIG. 30, thetissue fastening tool81 is provided with afirst part82 of winding diameter d1 in coil shape, and asecond part83 of winding diameter d2 larger than thefirst part82. The material and the method of manufacture of thetissue fastening tool81 are the same as in the first embodiment.
• When housing thetissue fastening tool81 in the deployedsection11A, the portion corresponding to thesecond part83 is inserted first. When fastening the tissue, substantially half thefirst part82 is delivered from the deployedsection11A within the common bile duct Cb, and the original coil shape is restored. Subsequently, the deployedsection11A is pulled back into the duodenum Dd, and the remaining substantial half of thefirst part82 and the part equivalent to thesecond part83 are delivered, and the original coil shape is restored. As shown inFIG. 31, thepart82 with small winding diameter holds and detains the duodenum wall Wd and the common bile duct wall Wc, while thepart83 with the large winding diameter is detained in the duodenum Dd.
• The coil spring is tightly coiled, and the tissue is compressed by thetissue fastening tool81; therefore, with the passage of time, the tissue is necrotized, and the tissue falls off in the closed area Rc formed by the coil. At this stage, as shown inFIG. 32, thesecond part83 with large winding diameter is larger than thefirst part82, so thetissue fastening tool81 and the tissue fall off into thesecond part83 side, that is, into the duodenum Dd side. A fistulous opening Hc2 of size substantially equivalent to the winding diameter of thefirst part82 is formed between the duodenum Dd and the common bile duct Cb, and from this opening, the bile is drained. Until the tissue is necrotized, the surrounding tissue coalesces; therefore, the common bile duct Cb does not separate from the duodenum Dd. The fallen-offtissue fastening tool81 is discharged outside the body together with foodstuff.
• According to this embodiment, the direction in which thetissue fastening tool81 falls off is prescribed by varying the winding diameter. If the fall-off direction is set to the duodenum Dd side, then thetissue fastening tool81 can be correctly discharged out of the body without any additional manipulations.
FIFTH EMBODIMENT
• As shown inFIG. 33 andFIG. 34, thetissue fastening tool91 is provided with afirst part92 wound in coil shape, and asecond part93 extended to a specific diameter and wound on the outside of thefirst part92. The material and the method of manufacturing thetissue fastening tool91 are the same as in the first embodiment.
• When forming thesecond part93, aspacer95 is used as shown inFIG. 35 andFIG. 36. Thespacer95 has a cylindrical shape, and a steppedbore96 is formed in it. Aslit97 is formed parallel to the axial direction in thepart96A with large diameter of stepped bore96. During manufacture, as shown inFIG. 37, theelement wire91A, which forms thetissue fastening tool91, is wound over a core98 to make thefirst part92. Subsequently, it is covered by thespacer95. In thespacer95, asmall diameter part96B ofbore96 is passed through thecore98 and thefirst part92 is inserted into alarge diameter part96A. Thesecond part93 is made by pulling out theelement wire91A from theslit97 and winding it along the outside diameter of thespacer95. The winding diameter of thesecond part93 is decided by the outside diameter of thespacer95. The two ends of theelement wire91 A are fixed so that they do not become loose, and are then shaped by heat treatment.
• When housing thetissue fastening tool91 in the deployedsection11A, the portion corresponding to thesecond part93 is inserted first. When fastening the tissue, the portion corresponding to thefirst part92 is delivered from the deployedsection11A within the common bile duct Cb, and the original coil shape is restored. The deployedsection11A is pulled back into the duodenum Dd, the portion corresponding to thesecond part93 is delivered and the original coil shape is restored. As shown inFIG. 38, the fastening tool is placed such that the duodenum wall Wd and the common bile duct wall Wc are held between thesecond part93 and thefirst part91. In addition to the spring force generated when the coil spring is stretched, in thetissue fastening tool91, a force generated in the radial direction to reduce the diameter also acts on the tissue. The fastening force in the radial direction is generally greater than the spring force in the axial direction, so the tissue can be secured more firmly. If the tissue has been necrotized because of the fastening, thetissue fastening tool91 and the tissue fall off into thesecond part93 side with large diameter. A large diameter opening can be formed and also thetissue fastening tool91 can be made to fall off with certainty into the duodenum Dd side.
• According to the present embodiment, by overlapping a part of theelement wire91A wound in coil shape in the radial direction, the force for fastening the tissue is increased. Also, by forming a large diameter part, the direction in which thetissue fastening tool91 falls off is specified. If the fall-off direction is set to the duodenum Dd side, then thetissue fastening tool91 can be discharged out of the body without any additional manipulation.
• Thetissue fastening tool91 according to the present embodiment can be made easily by using the method of manufacturing the double coil spring using thespacer95.
SIXTH EMBODIMENT
• As shown inFIG. 39, theapplicator101 has a double-tube construction with apusher tube102 provided on the outside of thesheath4 that covers theinsertion portion3. Astent103 is friction fitted at the front end of thesheath4.
• Thepusher tube102 is flexible, and has substantially the same outside diameter as thestent103. The inside diameter of thepusher tube102 is slightly larger than the inside diameter of thestent103, and is not engaged with thestent103.
• Thestent103 has a cylindrical shape, and its front end has a tapered surface enabling it to be smoothly connected to the outside diameter part of the deployedsection11A. Moreover, athread104 formed by ridges in spiral shape is provided on the outer periphery.
• When adetention tool105 made of thetissue fastening tool21 andstent103 is detained in the body, as shown inFIG. 40, the deployedsection11A is protruded more to the front end side than thestent103, and thereafter, the common bile duct wall Wc is pierced from the duodenum wall Wd. In this case, thestent103 is detained in the duodenum Dd side. As shown inFIG. 41, thestylet22 is advanced until thefirst groove22A engages with the O-ring47 of theslider34, and it pushes substantially half of the front end side of thetissue fastening tool21 in the common bile duct Cb. Next, the deployedsection11A is pulled back to the duodenum Dd side, and the remaining part of thetissue fastening tool21 is pushed with thestylet22. As shown inFIG. 42, the tissue fastening tool holds the duodenum wall Wd and the common bile duct wall Wc, restoring its coil shape.
• As shown inFIG. 43, the area Rc fastened by thetissue fastening tool21 is pierced by the deployedsection11A, and the front end of thestent103 is deployed to the tissue. At this stage, thestylet22 is slightly pulled back beforehand, and the incisive front end of the deployedsection11A is used to pierce the area Rc.
• The securingscrew33 on the side of theoperation part5 is loosened slightly. Theoperation part body31 is rotated around the axial direction with respect to theconnector32 in the direction shown by the arrow AAI. Thesheath4 fixed to theoperation part body31 rotates, and thestent103 friction fitted to it also rotates.Thread104 is formed on the outer periphery of thestent103. If thestent103 is rotated while pressing it against the duodenum wall Wd, thestent103 is screwed into the duodenum wall Wd and the common bile duct wall Wc using the through hole formed by the deployedsection11A as a guide. At this stage, by keeping thestylet22 pushed in completely, the front end of thestylet22 protrudes slightly from the front end of the deployedsection11A; therefore, the body cavity tissues are not damaged by the incisive front end of the deployedsection11A.
• When thestent103 is adequately screwed into the duodenum wall Wd and the common bile duct wall Wc, and the common bile duct Cd and the duodenum Dd are linked, thestent103 is separated from theapplicator101. Initially, the deployedsection11A is pulled back and stored in thesheath4. The securingscrew33 is further loosened such that theoperation part body31 becomes movable in the axial direction after crossing thegroove32A of theconnector32. As shown by the arrow AA2 inFIG. 44, theoperation part body31 is pulled away from theconnector32, and thesheath4 is retracted. Thepusher tube102 is in contact with theconnector32 and it does not retract. Since thepusher tube102 does not move, thestent103 disposed at the front end of thepusher tube102 also does not move from its position. As a result, the friction fit of thestent103 and thesheath4 is released, and only thestent103 is detained. The bile will thus drain through the route ensured by thestent103 from the common bile duct Cb to the duodenum Dd.
• As shown inFIG. 45, the duodenum wall Wd and the common bile duct wall Wc are fastened by thetissue fastening tool21. When the bile drain opening is formed by the anastomosis hole Hc penetrating both walls Wd and Wc, the duodenum Dd and the common bile duct Cb may rotate, as shown inFIG. 46, around the center at point Pp through which theelement wire21A penetrates the tissue. In this case, the positions of the bile drain openings punctured in each of the two walls Wd and Wc may become misaligned, and bile drainage cannot take place. When thestent103 is made to penetrate the walls Wd and Wc, the positional relationship between the duodenum Dd and the common bile duct Cb becomes stable, thereby stable bile drainage opening can be ensured.
• Moreover, thestent103 can be easily inserted in the tissue because its front end has a reduced diameter. Thestent103 can be screwed in easily but it does not come off easily because aridged thread104 is formed on the outer periphery of thestent103. Either a fine, the reduced diameter of the front end orthread104 may be provided, or both may not be provided.
• When the fastening force of thetissue fastening tool21 is large, as shown inFIG. 47, the necrotized tissue T2, and thetissue fastening tool21 andstent103 fall off, and the fistulous opening Hc2 is formed. In this embodiment also, long term patency of the fistulous opening Hc2 for bypass is possible because thetissue fastening tool21 and thestent103 fall off.
• The coil pitch of thetissue fastening tool21 and the pitch of thethread104 may be made to substantially coincide, as in thestent103A shown inFIG. 48. Thestent103 is fitted into thetissue fastening tool21, so fall-off can be prevented further. In this case, the diameter at one end of thedetention tool105 is generally large, while that at the other end is small. When the tissue is necrotized, it falls off into the large diameter side, so the large diameter side is detained such that it is disposed in the duodenum Dd.
• As shown inFIG. 49, it is preferable to provide at least oneflap108 on the side of one end of thestent103B. The width d3 with theflap108 in the open condition is larger than the inside diameter d4 of the coil of thetissue fastening tool21. Thedetention tool105 falls off in the direction in which theflap108 is provided. The present invention is not limited to thisflap108, and a convex part such as a flange may be provided instead.
SEVENTH EMBODIMENT
• As shown inFIG. 50, the front end of the deployedsection11A may be processed for ultrasonic wave reflection. The surface of this processedpart110 is roughened by dimples or by sand blasting, so as to diffuse the reflection of ultrasonic waves. During the procedure, the amount pierced by the deployedsection11A can be easily confirmed by ultrasonic wave observation.
• The processedpart110 can also be used in theapplicator1 in whichstent103 andpusher tube102 are not provided.
EIGHTH EMBODIMENT
• As shown inFIG. 51, theapplicator111 is provided with adilator113 to assist in inserting thestent112 in the tissue. Thedilator113 is of cylindrical shape such that the deployedsection11A can pass through. The front end has aconvex part113A that protrudes in the direction of the enlarged diameter. The front end side and the base end side of theconvex part113A are both inclined. As shown inFIG. 52, at least oneslit114 is formed in the axial direction.
• When thedetention tool105 is inserted in the body, the convex part I13A of thedilator113 becomes a stopper and prevents thestent112 from falling off. The deployedsection11A is disposed on the inside of thedilator113 and it prevents deformation of thedilator113. Therefore, thestent112 does not move by crossing over theconvex part113A.
• Similar to the embodiment mentioned above, when the common bile duct Cb is fixed to the duodenum Dd by thetissue fastening tool21, a through hole is formed by the deployedsection11A in the area Rc fastened by thetissue fastening tool21, and the dilator is advanced. Thedilator113 enters the common bile duct Cb while widening the through hole. When the front end of the stent enters the common bile duct Cb, the deployedsection11A is retracted and pulled out from the tissue. The deployedsection11A is retracted toward the base end side passing theconvex part113A of thedilator113.
• Thepusher tube102 is pushed to push out thestent112 so that it crosses over theconvex part113A of thedilator113. At this stage, the deployedsection11A is not on the inside of thedilator113. Thedilator113 deforms in the direction of the reduced diameter with theslit114 as the starting point, and allows thestent112 to move. When the detention of thestent112 is complete, theapplicator111 is pulled out together with theentire dilator113.
• As shown inFIG. 53, theslit114 of thedilator113 may be opened up to the front end. The front end part of thedilator113 becomes more deformable, and thestent112 becomes more easy to push out.
NINTH EMBODIMENT
• As shown inFIG. 54 andFIG. 55, thetissue fastening tool21 has graspingparts121 and122 formed at the ends of theelement wire21A. These graspingparts121 and122 become the starting points for removal of thetissue fastening tool21. For example, as shown inFIG. 56, if thegrasping part122 is held by the graspingforceps123 through theendoscope2 and rotated, thetissue fastening tool21 wound in coil shape can be easily pulled out from the tissue. When they are to be used in combination with thestent103, the graspingparts121 and122 are formed at positions and of sizes that do not interfere with thestent103.
TENTH EMBODIMENT
• As shown inFIG. 57, a plurality oftissue fastening tools21 are detained in the tissue in a straight line. Thetissue fastening tool21 used is one in which the fastening force can necrotize the tissue. Ifapplicator1 is used, thetissue fastening tool21 can be disposed at the desired position, and a plurality oftissue fastening tools21 can be brought in proximity to each other and disposed. Accordingly, when eachtissue fastening tool21 falls off together with the tissue that it necrotized, a continuously long hole is formed in the direction in which thetissue fastening tools21 are arrayed.
• As shown inFIG. 58, if the fistulous openings Hc2 formed by thetissue fastening tool21 are not linked, the high-frequency knife51 is used to dissect the coalesced portions. The area around the fistulous opening Hc2 becomes the coalesced range shown by dotted line inFIG. 56. Even if dissection is performed within the coalesced range, the bile does not leak from between tissue and tissue. As shown inFIG. 59, a continuous long hole Hc3 can be formed. The long hole Hc3 is not limited to a straight line shaped hole. The preferred embodiments have been described as above. However, the present invention is not limited to the descriptions above; they are limited only by the scope of claims appended here. The tissues fixed by the tissue fastening tool or detention tool in each of the embodiments are not limited to two separate tissues or organs. The deployedsection11A is passed through all layers of tissues sequentially when fixing two tissues, but when one tissue is to be fixed, a part of the layers are penetrated. As shown inFIG. 60, manipulation may be performed so as to distend the tissue with the center as the location that is partially penetrated.

Claims (30)

1. An applicator comprising:

a flexible sheath longer than the overall length of instrument channel of a flexible endoscope;

an operation part used outside the instrument channel;

a deployed section that can be made to protrude from the front end of the sheath by operating the operation part and to pierce tissues;

a tissue fastening tool made of a superelastic wire formed in coil shape and housed inside the deployed section in a substantially extended condition; and

a pusher that pushes out the tissue fastening tool from the deployed section when the operation part is operated.

2. The applicator according toclaim 1, wherein

the tissue fastening tool comprises a first part wound in coil shape, and a second part in coil shape with a winding diameter greater than that of the first part.

3. The applicator according toclaim 1, wherein

a part of the tissue fastening tool is wound over by a double winding with a slit in the radial direction.

4. The applicator according toclaim 1, wherein

the operation part is provided with a stopper that stops the pusher once it has pushed an amount equivalent to substantially half the overall length of the substantially extended tissue fastening tool.

5. The applicator according toclaim 1, further comprising:

a stent disposed on the outside of the deployed section; and

a stent push-out tool in contact with the stent used for pushing out the stent.

6. The applicator according toclaim 5, wherein:

the front end of the stent has a reduced diameter.

7. The applicator according toclaim 5, wherein:

a thread protrudes from the outer periphery of the stent.

8. The applicator according toclaim 5, wherein

the cross section in the radial direction of the stent is smaller than the inside diameter when the tissue fastening tool is restored to its original coil shape.

9. The applicator according toclaim 5, wherein

the stent is provided with part that protrudes wider than the inside diameter of the tissue fastening tool when its original coil shape is restored.

10. The applicator according toclaim 5, wherein

the stent push-out tool is disposed more to the outside than the deployed section.

11. The applicator according toclaim 1, wherein

the deployed section is processed for ultrasonic wave reflection.

12. The applicator according toclaim 1, wherein

the tissue fastening tool is made of tightly wound coil.

13. The applicator according toclaim 1, wherein

the end of the element wire of the tissue fastening part is chamfered.

14. The applicator according toclaim 1, wherein

the ends of the tissue fastening tool have a substantial spherical shape of diameter larger than the element wire diameter.

15. The applicator according toclaim 1, wherein

the tissue fastening tool has ends that are folded back.

16. The applicator according toclaim 1, wherein

the tissue fastening tool has ends that are folded back so as to enable grasping.

17. A tissue fastening method through a natural orifice comprising the steps of:

inserting a deployed section housed with a tissue fastening tool made of superelastic wire formed in coil shape in the substantially extended condition into the body through a flexible endoscope;

piercing the tissues to be fastened by the deployed section;

penetrating the tissues with a part of the tissue fastening tool housed in the deployed section and thereafter pushing it out from the deployed section and restoring to its original coil shape; and

pulling out the deployed section from the tissues, pushing out the remaining part of the tissue fastening tool, and restoring it to its original coil shape;

18. The tissue fastening method through the natural orifice according toclaim 17, further comprising the steps of:

piercing the tissues, which includes penetrating a second tissue after penetrating a first tissue; and

pushing out a part of the tissue fastening tool after penetrating the second tissue.

19. The tissue fastening method through the natural orifice according toclaim 18, wherein

the first tissue comprises a first organ, and the second tissue comprises a second organ.

20. The tissue fastening method through the natural orifice according toclaim 19, wherein

the first and the second organs are two different hollow organs; and

the first and the second tissues are walls of hollow organs.

21. The tissue fastening method through the natural orifice according toclaim 17, further comprising the steps of:

restoring the tissue fastening tool to its original coil shape; and

forming a through hole in the tissues at the center of the tissue fastening tool.

22. The tissue fastening method through the natural orifice according toclaim 18, further comprising the steps of:

passing a stent through the hole penetrating the tissues and formed at the center of the tissue fastening tool.

23. The tissue fastening method through the natural orifice according toclaim 22, further comprising the steps of:

restoring the tissue fastening tool to its original coil shape; and

compressing and necrotizing the tissues fastened by the tissue fastening tool.

24. The tissue fastening method through the natural orifice according toclaim 23, wherein

the tissue fastening tool and the stent are removed from the detention locations by falling off the necrotized tissue from the body.

25. The tissue fastening method through the natural orifice according toclaim 21, further comprising the steps of:

restoring the tissue fastening tool to its original coil shape; and

compressing and necrotizing the tissues fastened by the tissue fastening tool.

26. The tissue fastening method through the natural orifice according toclaim 25, wherein

the tissue fastening tool is removed from the detention location by falling off the necrotized tissues from the body.

27. The tissue fastening method through the natural orifice according toclaim 18, further comprising the steps of:

compressing the tissues with the tissue fastening tool;

coalescing and joining the tissues around the outside diameter of the tissue fastening tool; and

compressing and necrotizing the tissues on the inner periphery of the tissue fastening tool.

28. The tissue fastening method through the natural orifice according toclaim 27, wherein

the tissue fastening tool is removed from the detention location by falling off the necrotized tissues from the body and coalesced fistulous opening is formed between the first and the second tissues.

29. The tissue fastening method through the natural orifice according toclaim 28, wherein

the tissue fastening tool falls off to a specified side of either the first tissue or the second tissue when the tissue fastening tool is removed.

30. The method of manufacturing a double coil spring comprising the steps of:

winding the element wire on the core;

covering the element wire wound over the core by a spacer containing a slit;

taking the element wire from the slit to the outer periphery of the spacer, and winding the element wire around the outer periphery of the spacer; and

heat treating the element wire in the wound condition over the core and the spacer.

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