Source: https://patents.google.com/patent/US9510833B2/en
Timestamp: 2019-06-26 12:36:49
Document Index: 37435368

Matched Legal Cases: ['art 5', 'art 93', 'art 96', 'art 92', 'art 96', 'art 92', 'art 96', 'art 93', 'art 93', 'art 93', 'art 92', 'art 93', 'art 93', 'art 92', 'art 93', 'art 5', 'art 110', 'art 113', 'art 113']

US9510833B2 - Applicator and tissue fastening method through natural orifice - Google Patents
US9510833B2
US9510833B2 US13/036,959 US201113036959A US9510833B2 US 9510833 B2 US9510833 B2 US 9510833B2 US 201113036959 A US201113036959 A US 201113036959A US 9510833 B2 US9510833 B2 US 9510833B2
US13/036,959
US20110152886A1 (en
2011-02-28 Application filed by Olympus Corp filed Critical Olympus Corp
2011-02-28 Priority to US13/036,959 priority patent/US9510833B2/en
2011-06-23 Publication of US20110152886A1 publication Critical patent/US20110152886A1/en
2016-10-25 Assigned to OLYMPUS CORPORATION reassignment OLYMPUS CORPORATION CHANGE OF ADDRESS Assignors: OLYMPUS CORPORATION
2016-12-06 Publication of US9510833B2 publication Critical patent/US9510833B2/en
This application is a continuation application of U.S. application Ser. No. 11/710,732 filed on Feb. 26, 2007, now abandoned, the entire contents of which is incorporated herein by reference.
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 layers of tissue, and the position of the anastomosis clamp is fixed by the stopper. Thereafter, the needle is pulled out of the tissue. The anastomosis clamp does not move because of the stopper; therefore, its front end part remains inside of the inside layer. When the instrument is removed from the tissue, the rest of the anastomosis clamp remains outside of the outside layer. When the coil shape of the anastomosis clamp is restored, the layers of the tissue are anastomosed.
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 FIG. 3, the tissue fastening tool 21 has a coil shape when it is in the no-load condition. If it is taken out of the deployed section 11A, it returns to its original coil shape by its self-restoring force. In this tissue fastening tool 21, 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 deployed section 11A in this state, assembly can be easily performed. The method of insertion in the deployed section 11A is not limited only to the method mentioned above. Moreover, the tight winding is not limited to the coil spring only.
As shown in FIG. 2, a stylet 22 is inserted in the deployed section 11A in addition to the tissue fastening tool 21. The stylet 22 is inserted to the base end side relative to the tissue fastening tool 21 such that it can be freely advanced/retracted. It is a pusher that pushes the tissue fastening tool 21 from the deployed section 11A by operating the operation part 5 through the needle tube 11.
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.
Next, the procedure to make bypass between common bile duct and duodenum after joining them is described here. As shown in FIG. 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, the endoscope 2 is inserted from the patient's mouth. The endoscope 2 is inserted in the duodenum Dd, which is the upper alimentary tract. The condition outside the duodenum Dd is examined by the ultrasonic probe 28, 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.
Thereafter, the applicator 1 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 FIG. 9, the tissue fastening tool 21 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.
At this stage, the closed area is formed between the duodenum wall Wd and the common bile duct wall Wc by the tissue fastening tool 21; 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 FIG. 12. At this stage, the stylet 22 is slightly pulled back beforehand, and the incisive front end of the deployed section 11A is used to pierce the area Rc. When the deployed section 11A is pulled out, as shown in FIG. 13, the anastomosis hole Hc is formed in the closed area Rc fastened by the tissue fastening tool 21. As shown in FIG. 14, the bile Lb drains from the common bile duct Cb to the duodenum Dd through the anastomosis hole Hc, and jaundice is treated.
FIG. 27 shows the tissue fastening tool 21 detained in the tissue, and the drainage route for bile is ensured. The fastening force of the tissue fastening tool 21 of the present embodiment is strong; the duodenum wall Wd and the common bile duct wall We are compressed by the element wire 21A, the tissue inside the area Rc fastened by the tissue fastening tool 21 becomes ischemic condition due to poor blood circulation into the area Rc.
As shown in FIG. 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 We coalesce and join with each other all around at the outer periphery of the tissue fastening tool 21. When this occurs, the necrotized tissue and the tissue fastening tool 21 fall off, as shown in FIG. 29. The tissue fastening tool 21 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 the tissue fastening tool 21 falls off and the bypass hole becomes larger, a longer period of patency than that according to the first embodiment may be anticipated.
When forming the second part 93, a spacer 95 is used as shown in FIG. 35 and FIG. 36. The spacer 95 has a cylindrical shape, and a stepped bore 96 is formed in it. A slit 97 is formed parallel to the axial direction in the part 96A with large diameter of stepped bore 96. During manufacture, as shown in FIG. 37, the element wire 91A, which forms the tissue fastening tool 91, is wound over a core 98 to make the first part 92. Subsequently, it is covered by the spacer 95. In the spacer 95, a small diameter part 96B of bore 96 is passed through the core 98 and the first part 92 is inserted into a large diameter part 96A. The second part 93 is made by pulling out the element wire 91A from the slit 97 and winding it along the outside diameter of the spacer 95. The winding diameter of the second part 93 is decided by the outside diameter of the spacer 95. The two ends of the element wire 91A are fixed so that they do not become loose, and are then shaped by heat treatment.
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 FIG. 38, the fastening tool is placed such that the duodenum wall Wd and the common bile duct wall We are held between the second part 93 and the first part 92. In addition to the spring force generated when the coil spring is stretched, in the tissue fastening tool 91, 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, the tissue fastening tool 91 and the tissue fall off into the second part 93 side with large diameter. A large diameter opening can be formed and also the tissue fastening tool 91 can be made to fall off with certainty into the duodenum Dd side.
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 AA1. 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.
As shown in FIG. 50, the front end of the deployed section HA may be processed for ultrasonic wave reflection. The surface of this processed part 110 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 deployed section 11A can be easily confirmed by ultrasonic wave observation.
When the detention tool 105 is inserted in the body, the convex part 113A 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.
As shown in FIG. 58, if the fistulous openings Hc2 formed by the tissue fastening tool 21 are not linked, the high-frequency knife 51 is used to dissect the coalesced portions. The area around the fistulous opening Hc2 becomes the coalesced range shown by dotted line in FIG. 58. Even if dissection is performed within the coalesced range, the bile does not leak from between tissue and tissue. As shown in FIG. 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 deployed section 11A 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 in FIG. 60, manipulation may be performed so as to distend the tissue with the center as the location that is partially penetrated.
an endoscope including a connector and an instrument channel,
an applicator configured to be connected to the connector of the instrument channel of the endoscope when inserted into the instrument channel, and
a tissue fastening tool formed of an elastic wire, the tissue fastening tool including:
a first part having a plurality of first loops, the first part being formed from a portion of the elastic wire including one end of the elastic wire, the first part being formed around a longitudinal axis of the plurality of first loops, the first part having a restoring force enabling an entire circumference of two adjoining first loops of the plurality of first loops to abut each other, each of the plurality of first loops having a same winding outer diameter from one end of the first part to an other end of the first part; and
a second part formed by winding an other part of the elastic wire including an other end of the elastic wire, the second part being formed around the longitudinal axis of the plurality of first loops, the second part having a second loop which has an inner diameter larger than the winding outer diameter of the plurality of first loops,
wherein the applicator includes:
a flexible sheath that is configured to be inserted into an alimentary tract through a natural orifice;
a needle tube that includes a sharp end provided on a distal end thereof and a lumen which is extended inside the needle tube along a longitudinal axis of the flexible sheath, the needle tube being configured to be freely advanced or retracted along the longitudinal axis of the flexible sheath;
a pusher that is configured to push the tissue fastening tool housed in the needle tube,
wherein the tissue fastening tool is housed in the needle tube such that the one end of the elastic wire is located on a distal opening side of the needle tube and the other end of the elastic wire is located at a pusher side in the needle tube, and the pusher is configured to push the other end of the elastic wire, and
wherein the first part is configured to be released from the needle tube by pushing the other end of the elastic wire with the pusher, and
wherein when the two adjoining first loops of the plurality of first loops are released from the needle tube the adjoining first loops are configured to clamp a tissue held therebetween so as to necrotize the tissue by the restoring force.
2. The tissue fastening system according to claim 1, wherein the one end of the elastic wire or the other end of the elastic wire is chamfered.
3. The tissue fastening system according to claim 1, wherein the one end and the other end of the elastic wire have a substantial spherical shape of diameter larger than a diameter of the elastic wire.
4. The tissue fastening system according to claim 1, wherein the one end and the other end of the elastic wire are folded back.
5. The tissue fastening system according to claim 1, wherein the one end and the other end of the elastic wire are folded back so as to enable grasping.
6. The tissue fastening system according to claim 1, wherein the tissue fastening tool is configured to detach from the tissue toward the other end of the elastic wire after the tissue held between the two adjoining first loops is necrotized.
7. The tissue fastening system according to claim 1, wherein the pusher is capable of advancing or retracting relative to the tissue fastening tool housed in the needle tube in a state that the pusher is disposed separated from a proximal end of tissue fastening tool.
8. The tissue fastening system according to claim 1, wherein the one end of the elastic wire constituting the first part is configured to be pushed out from the needle tube at first by pushing the other end of the elastic wire constituting the second loop by the pusher and the other end of the elastic wire constituting the second part is configured to be pushed out from the needle tube after all of the plurality of first loops are pushed out from the needle tube.
US13/036,959 2007-02-26 2011-02-28 Applicator and tissue fastening method through natural orifice Active US9510833B2 (en)
US11/710,732 Continuation US20080208214A1 (en) 2007-02-26 2007-02-26 Applicator and tissue fastening method through natural orifice
US20110152886A1 US20110152886A1 (en) 2011-06-23
US9510833B2 true US9510833B2 (en) 2016-12-06
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