Two-stage electric burning EUS-HGS needle knife support releasing device

Abstract

The invention provides a two-section electric burning EUS-HGS needle knife support releasing device. The two-section electric burning EUS-HGS needle knife support releasing device comprises an electric burning puncture instrument, an electric burning expansion instrument and a support releasing instrument which are connected in an extending mode. The electric burning puncture instrument is provided with a first guide tube, an electric burning needle and a first operating part, wherein the electric burning needle is fixed on the first operating part, extends into the first guide tube from the first end and extends out of the second end of the first guide tube; the electric burning dilator is provided with a second guide tube, an annular cutter and a second operating piece, the annular cutter is fixed to the second operating piece and extends into the second guide tube from the third end of the second guide tube, and an annular cutter head extends out of the fourth end of the second guide tube. The support releasing instrument is provided with a support, an outer sleeve and a third operation piece, the annular cutter is sleeved with the support, and the support is sleeved with the outer sleeve and fixed to the third operation piece. The first operating piece can operate the electric burning needle to displace and extend out of the girdling cutter head, and the second operating piece can operate the girdling cutter to displace; the third operating piece can displace to drive the outer sleeve to be separated and release the support.

Description

Technical Field

[0001] The present invention relates to a two-stage electrocautery EUS-HGS (endoscopic ultrasound guided hepatogastrostomy) needle knife stent release device, and more particularly to an invention that adopts a two-stage electrocautery method to perform an EUS-HGS (endoscopic ultrasound guided hepatogastrostomy) operation, wherein an electrocautery puncture instrument, an electrocautery expansion instrument, and a stent release instrument are extended, connected, and integrated into one, and the integrated device can sequentially perform electrocautery puncture, electrocautery expansion, and stent release to complete the EUS-HGS (endoscopic ultrasound guided hepatogastrostomy) operation. Background Art

[0002] Endoscopic Retrograde Cholangio-Pancreatography (ERCP) is still the preferred method for bile duct drainage. However, some patients cannot undergo ERCP treatment, of which about 5% to 10% are due to inaccessible duodenal papilla or inability to insert the endoscope into the duodenal papilla, including anatomical changes, periampullary diverticulum, gastric outflow tract obstruction or in situ implantation of duodenal stents. In the past clinical treatment, when ERCP failed, percutaneous transhepatic biliary drainage (PTBD) could be further used. However, the incidence of adverse events such as bleeding, bile leakage, drainage tube dislocation, recurrent infection and acute cholangitis after PTBD is as high as 33%.

[0003] Nowadays, the technology of endoscopic ultrasound-guided bile duct drainage (EUS-BD) has gradually matured and been gradually accepted. It is considered to be an alternative surgery superior to PTBD. For patients with distal malignant bile duct obstruction, EUS-BD can even replace ERCP as a first-line treatment method. One of the EUS-BD procedures is endoscopic ultrasound-guided hepatogastrostomy (EUS-HGS). The operation mainly consists of four steps: puncture, guidewire placement, dilation, and stent placement. PCT patent No. WO2023199568A1 "Puncture device" provides an improved puncture needle for EUS-HGS (endoscopic ultrasound-guided hepatogastrostomy) surgery.

[0004] The detailed procedure of EUS-HGS (endoscopic ultrasonography-guided hepato-gastrostomy) is as follows:

[0005] 1. When the endoscopic ultrasound is inserted below the cardia, the dilated left intrahepatic bile duct can be clearly observed.

[0006] 2. Under the guidance of endoscopic ultrasound, avoid blood vessels, puncture the intrahepatic bile duct with a 19G FNA puncture needle, and aspirate with a needle knife or fistula knife (CST-10) to see dark brown viscous bile.

[0007] 3. Insert the guide wire under X-ray, adjust the direction to enter the lower bile duct, and repeatedly adjust it to pass through the narrow section to the duodenal cavity for retention.

[0008] 4. Use a bougie to dilate the puncture tract to 8.5Fr, and insert a 10mm to 60mm covered metal stent along the guide wire. After the stent is released, it spans the narrow segment.

[0009] The above-mentioned conventional EUS-HGS (endoscopic ultrasound-guided hepato-gastrostomy) operation has at least the following problems to be overcome:

[0010] 1. Use a puncture needle to puncture the stomach and liver into the intrahepatic bile duct to form a channel, and then use a bougie to expand the channel. During the operation, after the puncture forms the channel, the guide wire must be inserted into the affected area along the inside of the puncture needle. After the guide wire reaches the designated position, the puncture needle is pulled out. The EUS-HGS (endoscopic ultrasound-guided hepatogastrostomy) operation cannot be completed by a single instrument, and the length of the puncture needle, guide wire, bougie and other instruments is very long, which is inconvenient to operate.

[0011] 2. The puncture needle and the bougie are physically punctured, which will provide great resistance in the muscle layer of the stomach and liver. The puncture and expansion process is very painful, causing discomfort to the patient. Therefore, the puncture needle and the bougie need to be advanced step by step. After each advancement, it takes time for the patient to adapt, and the operation time is relatively long. Summary of the invention

[0012] Therefore, the object of the present invention is to provide a two-stage electrocautery EUS-HGS (endoscopic ultrasonography-guided hepato-gastrostomy) needle knife support release device.

[0013] The invention provides a two-stage electrocautery EUS-HGS (endoscopic ultrasound-guided hepato-gastrostomy) needle knife stent release device, comprising an electrocautery puncture instrument, an electrocautery expansion instrument, and a stent release instrument that interact and extend with each other.

[0014] The electrocautery puncture instrument comprises a first guide tube, an electrocautery needle and a first operating member. The first guide tube extends in an extension direction and comprises a first end and a second end. The electrocautery needle is fixed on the first operating member and extends from the first end of the first guide tube and extends from the second end. The first operating member is guided by the first guide tube and can operate the electrocautery needle to move in the extension direction.

[0015] The electrocautery expansion device includes a second guide tube, a circumcision knife and a second operating member. The second guide tube extends in the extension direction and includes a third end and a fourth end. The circumcision knife is fixed on the second operating member, and the circumcision knife extends from the third end of the second guide tube and has a circumcision knife head extending from the fourth end. The second operating member is connected to the second end of the first guide tube, and the second operating member is guided by the second guide tube to operate the displacement of the circumcision knife in the extension direction; the electrocautery needle passes through the circumcision knife and can be operated by the first operating member to extend from the circumcision knife head.

[0016] The stent release device comprises a stent, an outer sleeve and a third operating member. The stent is sleeved outside the circumcision knife and adjacent to the circumcision knife head, the outer sleeve is sleeved outside the stent and fixed on the third operating member, the third operating member is sleeved on the first guide tube and can be guided by the first guide tube to move from the second end to the first end in the extension direction, and at the same time drive the outer sleeve to disengage and release the stent, so that the stent expands in the radial direction.

[0017] Furthermore, the first guide tube has a plurality of indicating scales arranged along the extending direction, and the first operating member has an indicating member corresponding thereto. When the first operating member operates the electrocautery needle to move, the indicating scale corresponding to the indicating member can display the displacement length of the electrocautery needle. Furthermore, the first end of the first guide tube has a guiding portion, the guiding portion has two opposite slots, and the indicating member on the first operating member is two long handles extending therefrom, and the two long handles pass through the two opposite slots of the guiding portion and correspond to the indicating scales.

[0018] Furthermore, the electrocautery expansion device also includes an insulating kit covering the electrocautery needle to separate the electrocautery needle from the circumcision knife.

[0019] Furthermore, the third operating member of the stent release device abuts against the second operating member of the electrocautery expansion device, and the third operating member can be operated to link the second operating member, and the second operating member operates the circumcision knife to move from the third end of the second guide tube to the fourth end.

[0020] Furthermore, when the outer sleeve of the stent releasing device is sleeved outside the stent, it is equivalent to the radial width of the cutting blade head of the cutting blade, and the radial width is between 7Fr and 8.5Fr.

[0021] Furthermore, the stent of the stent release device is a coated stent.

[0022] Furthermore, there is a guide wire, which can be used to pull the electrocautery needle out of the first guide tube through the first operating member, and then insert the guide wire into the first guide tube.

[0023] The following effects can be achieved according to the above technical features:

[0024] 1. In the EUS-HGS (endoscopic ultrasound guided hepatogastrostomy) surgery, the present invention uses an electrocautery needle to puncture the stomach and liver to enter the intrahepatic bile duct to form a channel, and then uses a circumcision knife to expand the channel by electrocautery. This two-stage electrocautery method forms less resistance in the muscle layer of the stomach and liver, and can stop bleeding at the same time during the process of puncturing to form the channel and expanding the channel, so the pain perception is low and the operation time is short.

[0025] 2. The present invention extends and connects the electrocautery puncture instrument, electrocautery dilation instrument, and stent release instrument to form an integrated whole, so that the integrated device can sequentially perform electrocautery puncture, electrocautery dilation, and stent release to complete the EUS-HGS (endoscopic ultrasound-guided hepatogastrostomy) surgery.

[0026] 3. The electrocautery needle can be used directly as a guide wire to insert other medical devices. When the medical device needs to be placed deeper into the intrahepatic bile duct, the electrocautery needle can be withdrawn and the guide wire can be inserted.

[0027] 4. When the first operating member operates the electrocautery needle to move, the indicator on the first operating member corresponds to the indicator scale on the first catheter to display the displacement length of the electrocautery needle. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 It is a three-dimensional appearance diagram of the two-stage electrocautery EUS-HGS (endoscopic ultrasound-guided hepato-gastrostomy) needle knife support release device of the present invention.

[0029] Figure 2 It is a cross-sectional view of the two-stage electrocautery EUS-HGS (endoscopic ultrasound-guided hepato-gastrostomy) needle knife support release device of the present invention.

[0030] Figure 3 For the present invention Figure 2 A partial enlarged view of III.

[0031] Figure 4 For the present invention Figure 2 A partial enlarged view of IV.

[0032] Figure 5 For the present invention Figure 2 A partial enlarged view of V.

[0033] Figure 6 For the present invention Figure 2 A partial enlarged view of VI.

[0034] Figure 7 This is one of the schematic diagrams of the first operating member of the electrocautery puncture instrument operating the electrocautery needle to puncture the stomach and liver and enter the intrahepatic bile duct to form a channel during the implementation of the present invention.

[0035] Figure 8The second schematic diagram is a diagram showing that the first operating member of the electrocautery puncture instrument operates the electrocautery needle to puncture the stomach and liver and enter the intrahepatic bile duct to form a channel during the implementation of the present invention.

[0036] Fig. 9 The third schematic diagram is a diagram showing that the first operating member of the electrocautery puncture instrument operates the electrocautery needle to puncture the stomach and liver and enter the intrahepatic bile duct to form a channel during the implementation of the present invention.

[0037] Fig.10 One of the schematic diagrams of the second operating member of the electrocautery dilation instrument operating the circumcision knife to dilate the channel through the circumcision knife head during the implementation of the present invention.

[0038] Fig.11 The second schematic diagram of the second operating member of the electrocautery dilation instrument operating the circumcision knife to dilate the channel through the circumcision knife head during the implementation of the present invention.

[0039] Fig.12 When the present invention is implemented, the third operating member of the stent release device operates the outer sleeve to detach and release the stent, so that the stent expands in the radial direction and can support the inner wall of the channel.

[0040] Fig.13 The second schematic diagram shows that when the present invention is implemented, the third operating member of the stent release device operates the outer sleeve to detach and release the stent, so that the stent expands in the radial direction and can support the inner wall of the channel.

[0041] Fig.14 It is a schematic diagram of the present invention being implemented, when the support is completely released and abuts against the inner wall of the channel, and then exits the release device.

[0042] Fig.15 This is a schematic diagram of the implementation of the present invention, in which the electrocautery puncture instrument punctures the stomach and liver to enter the intrahepatic bile duct to form a channel, and then the electrocautery needle is withdrawn through the first operating member.

[0043] Fig.16 When the present invention is implemented, after the electrocautery needle is withdrawn, a guide wire is inserted into the intrahepatic bile duct to facilitate pushing an instrument such as a balloon into the intrahepatic bile duct.

[0044] Explanation of the reference numerals: 1-electrocautery puncture instrument; 11-first guide tube; 111-first end; 112-second end; 113-indicator scale; 114-guide portion; 115-notch; 12-electrocautery needle; 13-first operating member; 131-long handle; 132-protrusion; 2-electrocautery dilation instrument; 21-second guide tube; 211-third end; 212-fourth end; 22-circumcision knife; 221-circumcision knife head; 23-second operating member; 24-insulating kit; 3-stent release instrument; 31-stent; 32-outer sleeve; 33-third operating member; 4-guide wire; A-stomach; B-liver; B1-intrahepatic bile duct; C-channel; D-extension direction; S-power cord. DETAILED DESCRIPTION

[0045] In view of the above technical features, the main effects of the two-stage electrocautery EUS-HGS (endoscopic ultrasound-guided hepato-gastrostomy) needle knife support release device of the present invention can be clearly presented in the following embodiments.

[0046] See also Figure 1 and Figure 2 As shown, the two-stage electrocautery EUS-HGS (endoscopic ultrasound-guided hepato-gastrostomy) needle knife stent release device of this embodiment includes an electrocautery puncture instrument 1, an electrocautery expansion instrument 2, and a stent release instrument 3 that interact with and extend to each other.

[0047] See also Figure 1 , Figure 2 and Figure 3As shown, the electrocautery puncture instrument 1 includes a first guide tube 11, an electrocautery needle 12 and a first operating member 13. The first guide tube 11 extends in an extension direction D and includes a first end 111 and a second end 112. The first guide tube 11 has a plurality of indicator scales 113 arranged along the extension direction D. The distance between adjacent indicator scales 113 is 1 cm. The indicator scales 113 are adjacent to the first end 111. The first end 111 of the first guide tube 11 also has a guide portion 114. The guide portion 114 has two opposite notches 115. The electrocautery needle 12 is fixed on the first operating member 13, and the electrocautery needle 12 extends from the first end 111 of the first guide tube 11 and can extend from the second end 112. The first operating member 13 is guided by the first guide tube 11 and can operate the electrocautery needle 12 to move in the extension direction D. The first operating member 13 has an indicator member corresponding to the indicator scale 113. When the first operating member 13 operates the electrocautery needle 12 to move, the indicator scale 113 corresponding to the indicator member can display the displacement length of the electrocautery needle 12. In this embodiment, the indicator scale 113 is an inwardly concave groove. The indicator member on the first operating member 13 is two extended long handles 131. The two long handles 131 have protrusions 132. The two long handles 131 pass through the two opposite notches 115 of the guide portion 114 and correspond to the indicator scale 113 so that the protrusions 132 extend into the grooves of the indicator scale 113.

[0048] See also Figure 1 , Figure 2 , Figure 4 , Figure 5 and Figure 6 As shown, the electrocautery expansion instrument 2 includes a second guide tube 21, a circumcision knife 22 and a second operating member 23. The second guide tube 21 extends in the extension direction D and includes a third end 211 and a fourth end 212. The circumcision knife 22 is fixed on the second operating member 23, and the circumcision knife 22 extends from the third end 211 of the second guide tube 21 and has a circumcision knife head 221 extending from the fourth end 212. The second operating member 23 is connected to the second end 112 of the first guide tube 11. For example, the second operating member 23 is fixedly connected to the second end 112 of the first guide tube 11, and the second operating member 23 is guided by the second guide tube 21 to operate the displacement of the circumcision knife 22 in the extension direction D. The electrocautery needle 12 passes through the circumcision blade 22 and can be operated by the first operating member 13 to extend from the circumcision blade head 221 . The electrocautery expansion device 2 further includes an insulating sleeve 24 covering the electrocautery needle 12 to separate the electrocautery needle 12 from the circumcision blade 22 .

[0049] See also Figure 1 , Figure 2 , Figure 4 and Figure 6As shown, the stent release device 3 includes a stent 31, an outer sleeve 32 and a third operating member 33. The stent 31 is a coated stent, and the length can be made into 8 cm, 10 cm, or 12 cm according to the demand, and the stent 31 is sleeved outside the circumcision knife 22 and adjacent to the circumcision knife head 221. The outer sleeve 32 is sleeved outside the stent 31 and fixed on the third operating member 33, and the outer sleeve 32 is sleeved outside the stent 31. The radial width of the circumcision knife head 221 of the circumcision knife 22 is equivalent when the outer sleeve 32 is sleeved outside the stent 31, and the radial width is between 7Fr (2.33mm) and 8.5Fr (2.83mm). The third operating member 33 is sleeved on the first guide tube 11 and can be guided by the first guide tube 11 to move from the second end 112 to the first end 111 in the extension direction D, and at the same time drive the outer sleeve 32 to disengage and release the stent 31, so that the stent 31 expands in the radial direction. In this embodiment, the third operating member 33 of the stent release device 3 is against the second operating member 23 of the electrocautery expansion device 2, so that the third operating member 33 can be operated to link the second operating member 23, and the second operating member 23 operates the circumcision knife 22 to move from the third end 211 of the second guide tube 21 toward the fourth end 212.

[0050] See also Figures 7 to 9 As shown, when performing EUS-HGS (endoscopic ultrasound guided hepatogastrostomy) surgery, the power cord S is connected to the connector of the first operating member 13 of the electrocautery puncture instrument 1 to energize the electrocautery needle 12. After that, the electrocautery needle 12 can be aligned with the intrahepatic bile duct B1 with the assistance of X-ray / ultrasound and the endoscopic probe and pushed against the first operating member 13, so that the first operating member 13 operates the electrocautery needle 12 to move and extend from the circumcision blade 221. The electrocautery needle 12 is continuously pushed out and enters the intrahepatic bile duct B1 through electrocautery puncture of the stomach A and liver B to form a channel C. The physician can control the displacement length of the electrocautery needle 12 entering the intrahepatic bile duct B1 through the long handle 131 of the first operating member 13 corresponding to the indicator scale 113 of the first guide tube 11. After the electrocautery needle 12 forms the channel C through the intrahepatic bile duct B1, the power cord S is removed from the connector of the first operating member 13.

[0051] See also Fig.10 and Fig.11As shown, after the electrocautery needle 12 forms a channel C that penetrates the intrahepatic bile duct B1, the power cord S is connected to the connector of the second operating member 23 of the electrocautery expansion device 2, and then the second operating member 23 can be pushed against with the assistance of X-ray / ultrasound and an endoscopic probe to operate the circumcision knife 22 to move, so that the circumcision knife head 221 is pushed along the channel C formed by the electrocautery needle 12, thereby expanding the channel C that penetrates the intrahepatic bile duct B1 by electrocautery again. In this embodiment, the method of pushing against the second operating member 23 is that the doctor pushes against the third operating member 33 of the support release device 3, and the third operating member 33 pushes against the second operating member 23 to link the second operating member 23 to move, and the support 31 and the outer sleeve 32 also move synchronously. After the circumcision knife head 221 expands the channel C that penetrates the intrahepatic bile duct B1, the power cord S is removed from the connector of the second operating member 23.

[0052] The present invention forms a channel C that penetrates the intrahepatic bile duct B1 through the two-stage electrocautery method of the electrocautery needle 12 and the circumcision knife 22. The resistance formed in the muscle layer of the stomach A and the liver B is relatively small, and bleeding can be stopped simultaneously during the process of puncturing to form the channel C and expanding the channel C. The pain perception is relatively low and the operation time is short.

[0053] See also Fig.12 and Fig.13 As shown, after the channel C that passes through the intrahepatic bile duct B1 is formed and expanded, the third operating member 33 of the stent releasing device 3 is pulled back along the second end 112 of the first guide tube 11 toward the first end 111. The third operating member 33 will simultaneously drive the outer sleeve 32 to detach and gradually release the stent 31. The stent 31 is no longer covered by the outer sleeve 32, but expands radially and supports against the inner wall of the channel C of the intrahepatic bile duct B1.

[0054] See also Fig.14 As shown, when the stent 31 is completely released and abuts against the inner wall of the channel C of the intrahepatic bile duct B1, the whole release device is withdrawn. The blocked bile can be discharged through the channel C through the stomach A. The stent 31 adopts a covered stent to prevent bile from being discharged into the abdominal cavity and causing inflammation and infection. Other medical treatment needs for the intrahepatic bile duct B1 can also be performed through the channel C.

[0055] The present invention extends and connects the electrocautery puncture instrument 1, the electrocautery dilation instrument 2, and the stent release instrument 3 to form a whole, so that the electrocautery puncture, electrocautery dilation, and stent release described above can be performed in sequence by the integrated device to complete the EUS-HGS (endoscopic ultrasound-guided hepatogastrostomy) surgery.

[0056] See also Fig.15 and Fig.16As shown, when a medical device (such as a balloon) needs to be inserted deeper into the intrahepatic bile duct B1, the electrocautery needle 12 can be withdrawn from the first guide tube 11 through the first operating member 13, and then a guide wire 4 is inserted into the first guide tube 11 and gradually extended into the intrahepatic bile duct B1.

[0057] Based on the description of the above embodiments, one should be able to fully understand the operation, use and effects of the present invention. The above embodiments are only preferred embodiments of the present invention and should not be used to limit the scope of implementation of the present invention. That is, any simple equivalent changes and modifications made based on the contents of the present invention specification are within the scope of the present invention.

Claims

1. A two-stage electrocautery EUS-HGS needle knife bracket release device, characterized in that: include: An electrocautery puncture instrument comprises a first guide tube, an electrocautery needle and a first operating member, wherein the first guide tube extends in an extension direction and comprises a first end and a second end, the electrocautery needle is fixed on the first operating member, and the electrocautery needle extends from the first end of the first guide tube and extends from the second end, and the first operating member is guided by the first guide tube and can operate the electrocautery needle to move in the extension direction; An electrocautery expansion instrument comprises a second guide tube, a circumcision knife and a second operating member, wherein the second guide tube extends in the extension direction and comprises a third end and a fourth end, the circumcision knife is fixed on the second operating member, and the circumcision knife extends from the third end of the second guide tube and has a circumcision knife head extending from the fourth end, the second operating member is connected to the second end of the first guide tube, and the second operating member is guided by the second guide tube to operate the circumcision knife to move in the extension direction; the electrocautery needle passes through the circumcision knife and can be operated by the first operating member to extend from the circumcision knife head; A stent release device includes a stent, an outer sleeve and a third operating member. The stent is sleeved outside the circumcision knife and adjacent to the circumcision knife head. The outer sleeve is sleeved outside the stent and fixed on the third operating member. The third operating member is sleeved on the first guide tube and can be guided by the first guide tube to move from the second end to the first end in the extension direction, while driving the outer sleeve to disengage and release the stent, so that the stent expands in the radial direction.

2. The two-stage electrocautery EUS-HGS needle knife support release device according to claim 1, characterized in that: The first guide tube has a plurality of indicating scales arranged along the extending direction, and the first operating member has a corresponding indicating member. When the first operating member operates the electrocautery needle to move, the indicating scale corresponding to the indicating member can display the displacement length of the electrocautery needle.

3. The two-stage electrocautery EUS-HGS needle knife support release device according to claim 2, characterized in that: The first end of the first guide tube has a guide portion with two opposite slots. The indicator on the first operating member is two extended long handles that pass through the two opposite slots of the guide portion and correspond to the indicator scale.

4. The two-stage electrocautery EUS-HGS needle knife support release device according to claim 1, characterized in that: The electrocautery expansion device also includes an insulating kit covering the electrocautery needle to separate the electrocautery needle from the circumcision knife.

5. The two-stage electrocautery EUS-HGS needle knife support release device according to claim 1, characterized in that: The third operating member of the stent release device abuts against the second operating member of the electrocautery expansion device, and the third operating member can be operated to link the second operating member, and the second operating member operates the circumcision knife to move from the third end to the fourth end of the second guide tube.

6. The two-stage electrocautery EUS-HGS needle knife support release device according to claim 1, characterized in that: When the outer sleeve of the stent release device is sleeved outside the stent, it is equivalent to the radial width of the cutting blade head of the cutting blade, and the radial width is between 7Fr and 8.5Fr.

7. The two-stage electrocautery EUS-HGS needle knife support release device according to claim 1, characterized in that: The stent of the stent release device is a covered stent.

8. The two-stage electrocautery EUS-HGS needle knife support release device according to claim 1, characterized in that: A guide wire is provided, which can be used to draw the electrocautery needle out of the first guide tube through the first operating member, and then insert the guide wire into the first guide tube.

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