Applicator and tissue fastening method through natural orifice
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.
Latest Olympus Patents:
- BENDING TUBE OF ENDOSCOPE, ENDOSCOPE, AND MANUFACTURING METHOD FOR BENDING TUBE OF ENDOSCOPE
- IMAGE PICKUP UNIT FOR ENDOSCOPE AND ENDOSCOPE
- ELECTRONIC COMPONENT HOLDING MEMBER AND ENDOSCOPE
- SEMICONDUCTOR APPARATUS, IMAGE PICKUP UNIT, ENDOSCOPE, AND METHOD FOR MANUFACTURING SEMICONDUCTOR APPARATUS
- FULL-THICKNESS RESECTION METHOD
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 INVENTIONThe 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.
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 EMBODIMENTAs shown in
As shown in
The front end of the deployed section 11A is cut incisively, and an opening is formed at the front end. A tissue fastening tool 21 is housed within the deployed section 11A. The tissue fastening tool 21 is inserted after substantially stretching the element wire 21A. As shown in
As shown in
The operation part 5 has a hollow operation part body 31 to which the sheath 4 is fixed. A connector 32 is inserted on the side of the front end in the operation part body 31, and is fixed by the securing screw 33. A slider 34 is fitted on the base end side of the operation part body 31 such that it can be advanced/retracted freely.
Internal thread 41 is formed in the connector 32, and it can be connected to the connector 42 (refer to
The slider 34 is a member for advancing/retracting the needle tube 11; it is fitted such that it can move only in the advancing/retracting direction in the operation part body 31. A protective tube 43 and the needle tube 11 are fixed on the inside of the slider. The protective tube 43 is fixed more to the outside than the needle tube 11; it prevents deflection of the needle tube 11. Furthermore, the protective tube 43 is attached to the O-ring 45 supported on the side of the operation part body 31 by a friction fit. It offers the feel of the operation by generating resistance when the slider 34 is advanced/ retracted, and also prevents the backflow of air or mucus from the body. The O-ring 45 is made of a flexible material such as silicone rubber.
The stylet 22 that passes through the needle tube 11 is pulled out penetrating through the slider 34. A stylet knob 46 is fitted at its end. A first groove 22A and a second groove 22B are carved onto the stylet 22 at specific spacing in the advancing/retracting direction. These grooves 22A, 22B give a ‘click’ feeling when they form a friction fit with the O-ring 47 supported on the side of the slider 34. The second groove 22B is installed to correspond to the position at which the tissue fastening tool 21 starts to get pushed out; it has the role of preventing the tissue fastening tool 21 from being needlessly pushed out and of enhancing operability. The first groove 22A is placed between the start of the push-out and the completion of push-out of the tissue fastening tool 21. For example, it may be at a position corresponding to the position at which the tissue fastening tool 21 is pushed out halfway. The first groove 22A gives a “click” feeling to the advance/retraction of the stylet 22, and also has the role of controlling the push-out amount of the tissue fastening tool 21. Although only one first groove 22A is illustrated, the position of the first groove 22A may be shifted and two grooves may be provided. The O-ring 47 prevents the backflow of air or mucus from the body, and is made of a soft material such as silicone rubber.
The stylet 22 is provided with flexibility that enables it to be inserted in the instrument channel of the flexible endoscope 2, but if the flexibility of the exposed part outside the slider 34 at the front side is reduced, operability can be improved.
Next, the procedure to make bypass between common bile duct and duodenum after joining them is described here. As shown in
The applicator 1 is advanced through the instrument channel, and the protruding direction is adjusted with the forceps elevator 29. As shown in
As a result, the deployed section 11A passes completely through from the inside to the outside of the duodenum wall Wd, as shown in
As shown in
Thereafter, the applicator I is retracted, the deployed section 11A is pulled out of the common bile duct Cb, and is pulled back into the duodenum Dd. As shown in
The stylet knob 46 is advanced further, and the remaining part of the tissue fastening tool 21 is pushed out from the deployed section 11A by the stylet 22. As shown in
At this stage, the area of tissue other than the area where the tissue fastening tool 21 penetrates through the duodenum wall Wd and the common bile duct wall Wc are joined; therefore, the deployed section 11A 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 in
The area of the anastomosis hole Hc can be adjusted by puncturing the deployed section 11A several times, or by moving the deployed section 11A in the punctured state. Also, as shown in
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 in
The tissue fastening tool 61 shown in
The tissue fastening tool 62 shown in
The tissue fastening tool 63 shown in
The tissue fastening tool 64 shown in
The tissue fastening tool 65 shown in
As shown in
According to the embodiment shown in
As shown in
The tissue fastening tool 21 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 the tissue fastening tool 21 can be formed.
FOURTH EMBODIMENTAs shown in
When housing the tissue fastening tool 81 in the deployed section 11A, the portion corresponding to the second part 83 is inserted first. When fastening the tissue, substantially half the first part 82 is delivered from the deployed section 11A within the common bile duct Cb, and the original coil shape is restored. Subsequently, the deployed section 11A is pulled back into the duodenum Dd, and the remaining substantial half of the first part 82 and the part equivalent to the second part 83 are delivered, and the original coil shape is restored. As shown in
The coil spring is tightly coiled, and the tissue is compressed by the tissue fastening tool 81; 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 in
According to this embodiment, the direction in which the tissue fastening tool 81 falls off is prescribed by varying the winding diameter. If the fall-off direction is set to the duodenum Dd side, then the tissue fastening tool 81 can be correctly discharged out of the body without any additional manipulations.
FIFTH EMBODIMENTAs shown in
When forming the second part 93, a spacer 95 is used as shown in
When housing the tissue fastening tool 91 in the deployed section 11A, the portion corresponding to the second part 93 is inserted first. When fastening the tissue, the portion corresponding to the first part 92 is delivered from the deployed section 11A within the common bile duct Cb, and the original coil shape is restored. The deployed section 11A is pulled back into the duodenum Dd, the portion corresponding to the second part 93 is delivered and the original coil shape is restored. As shown in
According to the present embodiment, by overlapping a part of the element wire 91A 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 the tissue fastening tool 91 falls off is specified. If the fall-off direction is set to the duodenum Dd side, then the tissue fastening tool 91 can be discharged out of the body without any additional manipulation.
The tissue fastening tool 91 according to the present embodiment can be made easily by using the method of manufacturing the double coil spring using the spacer 95.
SIXTH EMBODIMENTAs shown in
The pusher tube 102 is flexible, and has substantially the same outside diameter as the stent 103. The inside diameter of the pusher tube 102 is slightly larger than the inside diameter of the stent 103, and is not engaged with the stent 103.
The stent 103 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 deployed section 11A. Moreover, a thread 104 formed by ridges in spiral shape is provided on the outer periphery.
When a detention tool 105 made of the tissue fastening tool 21 and stent 103 is detained in the body, as shown in
As shown in
The securing screw 33 on the side of the operation part 5 is loosened slightly. The operation part body 31 is rotated around the axial direction with respect to the connector 32 in the direction shown by the arrow AAI. The sheath 4 fixed to the operation part body 31 rotates, and the stent 103 friction fitted to it also rotates. Thread 104 is formed on the outer periphery of the stent 103. If the stent 103 is rotated while pressing it against the duodenum wall Wd, the stent 103 is screwed into the duodenum wall Wd and the common bile duct wall Wc using the through hole formed by the deployed section 11A as a guide. At this stage, by keeping the stylet 22 pushed in completely, the front end of the stylet 22 protrudes slightly from the front end of the deployed section 11A; therefore, the body cavity tissues are not damaged by the incisive front end of the deployed section 11A.
When the stent 103 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, the stent 103 is separated from the applicator 101. Initially, the deployed section 11A is pulled back and stored in the sheath 4. The securing screw 33 is further loosened such that the operation part body 31 becomes movable in the axial direction after crossing the groove 32A of the connector 32. As shown by the arrow AA2 in
As shown in
Moreover, the stent 103 can be easily inserted in the tissue because its front end has a reduced diameter. The stent 103 can be screwed in easily but it does not come off easily because a ridged thread 104 is formed on the outer periphery of the stent 103. Either a fine, the reduced diameter of the front end or thread 104 may be provided, or both may not be provided.
When the fastening force of the tissue fastening tool 21 is large, as shown in
The coil pitch of the tissue fastening tool 21 and the pitch of the thread 104 may be made to substantially coincide, as in the stent 103A shown in
As shown in
As shown in
The processed part 110 can also be used in the applicator 1 in which stent 103 and pusher tube 102 are not provided.
EIGHTH EMBODIMENTAs shown in
When the detention tool 105 is inserted in the body, the convex part I 13A of the dilator 113 becomes a stopper and prevents the stent 112 from falling off. The deployed section 11A is disposed on the inside of the dilator 113 and it prevents deformation of the dilator 113. Therefore, the stent 112 does not move by crossing over the convex part 113A.
Similar to the embodiment mentioned above, when the common bile duct Cb is fixed to the duodenum Dd by the tissue fastening tool 21, a through hole is formed by the deployed section 11A in the area Rc fastened by the tissue fastening tool 21, and the dilator is advanced. The dilator 113 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 deployed section 11A is retracted and pulled out from the tissue. The deployed section 11A is retracted toward the base end side passing the convex part 113A of the dilator 113.
The pusher tube 102 is pushed to push out the stent 112 so that it crosses over the convex part 113A of the dilator 113. At this stage, the deployed section 11A is not on the inside of the dilator 113. The dilator 113 deforms in the direction of the reduced diameter with the slit 114 as the starting point, and allows the stent 112 to move. When the detention of the stent 112 is complete, the applicator 111 is pulled out together with the entire dilator 113.
As shown in
As shown in
As shown in
As shown in
Claims
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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 5, wherein:
- the front end of the stent has a reduced diameter.
7. The applicator according to claim 5, wherein:
- a thread protrudes from the outer periphery of the stent.
8. The applicator according to claim 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 to claim 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 to claim 5, wherein
- the stent push-out tool is disposed more to the outside than the deployed section.
11. The applicator according to claim 1, wherein
- the deployed section is processed for ultrasonic wave reflection.
12. The applicator according to claim 1, wherein
- the tissue fastening tool is made of tightly wound coil.
13. The applicator according to claim 1, wherein
- the end of the element wire of the tissue fastening part is chamfered.
14. The applicator according to claim 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 to claim 1, wherein
- the tissue fastening tool has ends that are folded back.
16. The applicator according to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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.
Type: Application
Filed: Feb 26, 2007
Publication Date: Aug 28, 2008
Applicant: Olympus Medical Systems Corp. (Tokyo)
Inventors: Masatoshi Sato (Yokohama-shi), Kunihide Kaji (Hachioji-shi)
Application Number: 11/710,732
International Classification: A61B 17/10 (20060101);