The present disclosure relates to a thermopuncture implantation device in the field of medical apparatuses, and in particular, to a thermopuncture stent implantation device, which integrates cutting and injection functions.
Digestive tract-gallbladder anastomosis is that under an endoscope, a thermal implantation device punctures into the gallbladder at a target location through a gastric wall or a duodenal wall, a distal end of a fully covered double mushroom head stent is placed in the gallbladder, and a proximal end of mushroom heads is placed in the stomach or duodenum, so as to open up a passage between the digestive tract and the gallbladder, in other words, to recreate a new path between the digestive tract and the gallbladder. Afterwards, through a gastroscope and the newly built passage, stones in the gallbladder are removed by a stone removal basket, so as to achieve endoscopic gallbladder preservation and stone removal surgery, which provides a new treatment problem for patients with a gallbladder disease who are not suitable for surgery, and can also provide patients having good gallbladder function with a treatment method that can preserve the gallbladder function, improving the long-term quality of life of the patients. The stomach-pancreatic pseudocyst stent anastomosis is that under an endoscope, a large-diameter fully covered double mushroom head stent punctures into a pancreatic pseudocyst of a patient through the stomach, and is placed therein, so as to achieve the anastomosis between the stomach and the pancreatic pseudocyst, thereby fully draining the hydrops and sphacelus in the pancreatic pseudocyst.
In the duodenum-bile duct anastomosis, a traditional ERCP surgery is inserting a guide wire or other instrument into the duodenal papilla retrogradely from the duodenum through an ERCP endoscopy, to reach the common bile duct, and performing stones removal and biopsy treatment on the common bile duct, etc. For a patient into whose body the guide wire is difficult to insert, percutaneous puncture or surgical operation is usually required, which may lower the patient's quality of life or bring a greater trauma.
Regarding gastrointestinal anastomosis, a patient who has been vomiting because a passage of food in the stomach into the intestine is blocked due to tumor invasion, is either subjected to laparotomy to establish a new gastrointestinal passage, or can only rely on intravenous nutrition for support, in the past. For those patients who are old or whose physical conditions are no longer suitable for laparotomy, their quality of life is extremely low, which also bring a heavy burden to their families Gastrointestinal anastomosis is that under an endoscopic ultrasonography scope (EUS), a large diameter fully covered double mushroom head stent punctures into a nearness small bowel through the stomach, and is placed therein, to open up a passage between the stomach and the small intestine, in other words, to recreate a new path between the stomach and the small intestine, thereby solving influence of duodenal obstruction on the life of patients.
In the past, such “bypass” construction requires laparotomy under general anesthesia, which is more traumatic. A minimally invasive surgery under an endoscopy has less trauma, short operation time, small pain and quick recovery, which fully shows the advantages of endoscopic minimally invasive surgery. In recent years, with the continuous development and upgrading of endoscopic technology and various instrument accessories, the endoscopy plays an increasingly important role in the diagnosis and treatment of various diseases of the digestive system, especially the continuous innovation of the minimally invasive surgery under endoscopy provides a new minimally invasive treatment method for many patients with gastrointestinal and biliary and pancreatic diseases who are unable or unwilling to undergo a surgery. Currently, in the above four traditional surgeries, the stent is usually a metal double mushroom head stent with a diameter of φ10 mm-φ16 mm, and an outer diameter of a matching thermal implantation device is φ3.5 mm-φ3.6 mm (10.5 Fr-10.8 Fr), and a traditional ultrasound endoscopic channel is φ3.7 mm, because the gap is too small, a traditional charged implantation device cannot move freely back and forth in the endoscopic channel, which is a main reason why the above surgeries are difficult to perform. At the same time, the outer diameter of an ultrasound endoscope is φ14 mm, which is 4 mm larger than the outer diameter of a traditional gastroscope (φ10 mm), thus it is more inconvenient to operate and has relatively fewer places to reach.
Therefore, in order to carry out a stomach gallbladder anastomosis, a gastrointestinal anastomosis, and a human body natural orifice transluminalendoscopic surgery (NOTES), etc., through gastroscope, it is necessary to design a smaller charged implantation device, and simplify release step of the stent through a gastroscopic channel, so as to release the stent more safely and quickly.
The present disclosure provides a brand-new method to solve bile duct obstruction, and meanwhile the method saves surgery time, saves surgical instruments, reduces the difficulty of surgery, providing possibility for more doctors to carry out this surgery. A thermopuncture stent implantation device according to the present disclosure eliminates an inner tube and a conductive wire of a traditional implantation device, and replaces them with a conductive part, which achieves the purpose of supporting the stent and meanwhile has the function of transmitting high-frequency electricity. An outer diameter of the existing thermopuncture implantation device can be reduced from 3.5 mm-3.6 mm (10.5 Fr-10.8 Fr) to 3.15 mm (9.5 Fr), so that the thermopuncture implantation device can pass through a traditional gastroscopic channel of φ3.2 mm, providing possibility for doctors to perform more advanced digestive tract-gallbladder anastomosis, duodenum-bile duct anastomosis, stomach-pancreatic pseudocyst stent anastomosis, gastrointestinal anastomosis, NOTES surgery and so on.
In the following, one end of a conductive head is defined as a distal end, and an end of the implantation device connected to an external power source is defined as a proximal end.
The thermopuncture stent implantation device has a proximal end and a distal end, a distal end of a front handle is provided with an outer tube, the outer tube extends from the proximal end to the distal end, an outer diameter of the distal end of an outer tube is less than or equal to 3.15 mm, an insulating middle tube is provided in the outer tube, and extends from the proximal end to the distal end, a conductive part is provided in the insulating middle tube, the insulating middle tube and the conductive part extend from the proximal end to the distal end, a terminal of the proximal end of the conductive part can be connected to an external power source; a boosting tube is provided between the proximal end of the outer tube and the insulating middle tube, the distal end of the boosting tube and the proximal end of the insulating middle tube are connected with each other; the distal end of the conductive part is provided with an insulating part, a conductive head is distributed on the insulating part, and the conductive head is connected with the conductive part to achieve a conductive function, and the stent, after being compressed, is located in a space between the distal end of the conductive part and the outer tube, and the front handle is connected to the proximal end of the outer tube, and moved backwards along the boosting tube, to drive the outer tube to move backwards to release the stent. The conductive part not only conducts electricity, but also supports the stent. Compared with a traditional stent implantation device, the conductive part reduces an inner tube and a guide wire, and at the same time, it can conduct electricity, cut tissues, and release the stent after reaching a lesion site.
There is a certain gap between the insulating part and the conductive part, the conductive head is provided at a terminal of the distal end of the implantation device, one end of the conductive head can extend from the distal end to the proximal end to enter the gap between the insulating part and the conductive part, and thus be connected with the conductive part to achieve a conductive function, the other end of the conductive head is covered on an outer surface of the insulating part.
Preferably, the conductive part is a hollow conductive part.
More preferably, the terminal of the proximal end of the conductive part is connected with a Luer connector to achieve liquid injection.
Preferably, the conductive part is a conductive wire.
Preferably, the conductive part is a nickel-titanium wire.
Preferably, the conductive part is a metal material. More preferably, the conductive part is a stainless steel material.
Preferably, the material of the insulating part is ceramic.
The outer tube includes a proximal outer tube and a distal outer tube, the proximal outer tube and the distal outer tube are connected in a taper. The boosting tube extends towards the proximal end and is connected with a rear handle, and a positioning part is provided between the front handle and the rear handle. An outer surface of the conductive part at a certain distance from the conductive head is covered with a resistance part. The conductive head comprises two or four conductive wires, and the two or four conductive wires are evenly distributed within a groove on an outer surface of the insulating part. The other end of the conductive head close to an outer side is completely covered on the outer surface of the insulating part, and when cutting with the conductive head, a cut surface of a wound is a circular surface. An outer surface of the conductive part can be covered with a riveting tube, an end of the conductive head can extend from the distal end to the proximal end to enter the gap between the insulating part and the conductive part, and achieve the conductive function by connection of the riveting tube and the conductive part.
The outer diameter of the thermopuncture stent according to the present disclosure is smaller than the outer diameter of the stent implantation device in the prior art, and provides a new minimally invasive treatment method for many patients with gastrointestinal and biliary and pancreatic diseases who are unable or unwilling to undergo a surgery.
The thermopuncture implantation device (diameter of 3.15 mm) according to the present disclosure can accommodate a double mushroom head metal stent that is braided by a nickel-titanium wire and has a diameter of φ10 mm-φ16 mm, and can enter into stomach, duodenum and other organs through a traditional gastroscopic channel of 3.2 mm; the implantation device is electrified to puncture a stomach wall or an intestinal wall, and enter into the small intestine, gallbladder, pancreatic cyst, common bile duct and other structures, to release the stent precisely, and it can anastomose the above tissues with the stomach wall or the intestinal wall respectively, to achieve drainage, gallbladder protection, stone removal, bypass opening and other functions.
It can be inferred from the above that in the case where the traditional ultrasound endoscopic channel is φ3.7 mm, when the outer diameter of the implantation device of the present disclosure is increased from 3.15 mm (9.5 Fr) to 3.5 mm-3.6 mm (10.5 Fr-10.8 Fr), then a cross-sectional area of the implantation device will be increased by 23-31%, as calculated by the formula (π*R1*R1)/(π*R2*R2), where R1=3.5/2 or 3.6/2, and R2=3.15/2, so that a double mushroom head metal stent that is braided by a nickel-titanium wire and has a larger diameter (e.g., φ18 mm) than diameter φ16 mm can be fitted into the thermopuncture implantation device of the present disclosure. For example, When the diameter of the stent is 18 mm, (π*R3*R3)/(π*R4*R4)=126% where R3=18/2 mm, R4=16/2 mm, that is, a cross-sectional area of the stent with a diameter of 18 mm is increased by 26% compared with the stent with a diameter of 16 mm Since the increase of the cross-sectional area of the implantation device is 23-31%, the stent with a cross-sectional area increase of 26% can be placed into the implantation device.
In order to make the purpose, technical solutions and advantages of the present disclosure more explicit, the present disclosure will be further illustrated in detail in combination with accompanying drawings and embodiments hereinafter. It should be understood that specific embodiments described herein are only used for explaining the present disclosure, instead of limiting the present disclosure.
In the following, an end of a conductive head is defined as a distal end, and an end of a stent implantation device connected to an external power source is defined as a proximal end.
As shown in
The outer tube 21 includes a proximal outer tube 211 and a distal outer tube 212. The proximal outer tube 211 is provided at the distal end of the front handle 30, and can be fixed with the front handle 30 through the outer tube locking cap 25, the safety lock 26 is provided at the proximal end of the front handle 30, and the safety lock 26 has threads, which can be matched with threads on the proximal end of the front handle 30, and installed thereon. The insulating middle tube 23 and a stent are arranged within the outer tube 21, the proximal end of the stent abuts against the distal end of the insulating middle tube 23, and the distal end of the stent is close to the insulating part 12, leaving a certain gap; the proximal outer tube 211 and the distal outer tube 212 are connected in a taper. The boosting tube 22 is provided between the proximal outer tube 211 and the insulating middle tube 23, the boosting tube 22 can be made of a stainless steel material, the distal end of the boosting tube 22 and the proximal end of the insulating middle tube 23 are connected with each other; such taper design of the proximal outer tube 211 and the distal outer tube 212 makes the size of the distal outer tube 212 entering a lesion site less than or equal to 3.15 mm, and the boosting tube 22 is provided between the proximal outer tube 211 and the insulating middle tube 23, to provide a force required to release the stent. The insulating middle tube 23 can be made from a special polymer material polyether ether ketone, has high-performance electrical insulating property and thus can isolate the high-frequency electricity of the conductive part 13 from the boosting tube 22, so that the operator can completely avoid the risk of electric shock. The boosting tube 22 extends towards the proximal end and is connected with the rear handle 31, the conductive base 32 is provided at the proximal end of the rear handle 31, there is the conductive plug 33 within the conductive base 32, and the conductive plug 33 can be connected to the conductive head 11 through the conductive part 13, so as to achieve electrifying.
The positioning part 27 may be further provided between the front handle 30 and the rear handle 31, the positioning part 27 can be designed as a structure of a safety buckle 24. As shown in
An outer surface of the conductive part 13 at a certain distance from the conductive head 11 can be covered with the resistance part 28. The resistance part 28 can provide a certain resistance for the stent when the stent is released, so that the stent is not easy to slip to the outside of the lesion.
The distal end of the stent implantation device further includes the conductive head 11, the insulating part 12 and the conductive part 13. When the conductive plug 33 is connected to an external high-frequency power source, the high-frequency power source is transmitted to the conductive head 11 through the conductive part 13, so that the stent implantation device has electrical cutting function, to perform a high-frequency cutting on a human tissue. The conductive part 13 can be any kind of medical metal material, such as nickel titanium material or stainless steel material; the conductive part 13 is arranged within the insulating middle tube 23, extends from the distal end to the proximal end, and is connected to the conductive plug 33 through the rear handle 31, the size of the outer diameter of the conductive part 13 can be designed according to actual needs, the present disclosure can reduce an outer diameter of an implantation part of an existing thermopuncture stent implantation device from 3.5 mm-3.6 mm (10.5 Fr-10.8 Fr) to below 3.2 mm (9 Fr) through a design of the conductive part 13, and preferably, it can be reduced to 3.15 mm (9.5 Fr). In addition, the conductive part 13 can be a hollow conductive part, so as to achieve the function of liquid injection and development, and the conductive part 13 can also be designed as a conductive wire. When the conductive part 13 is designed as a hollow conductive part, a cross-sectional diagram taken along B-B position in
When the conductive part 13 is designed as a conductive wire, the conductive wire can adopt different sizes according to requirements. A cross-sectional diagram taken along B-B position in
The insulating part 12 is located at the distal end of the conductive part 13, there is a certain gap between the insulating part 12 and the conductive part 13, one end of the conductive head 11 can extend from the distal end to the proximal end, to enter the gap between the insulating part 12 and the conductive part 13, so as to be connected with the conductive part 13 to achieve a conductive function, and the other end of the conductive head 11 is covered on an outer surface of the insulating part 12. High-frequency electricity is transmitted to the conductive head 11 at the distal end of the stent implantation device through the conductive part 13, so that the stent implantation device has an electrical cutting function, and can perform a high-frequency cutting and puncture on a human tissue. The insulating part 12 can be made of, such as, a ceramic material, which can prevent tissues from sticking, and make cutting more convenient.
The conductive part 13 according to the present disclosure replaces an inner tube and a conductive wire of a traditional stent implantation device, having a conductive function, and replacing an outer diameter φ1.1 mm of an original inner tube and an outer diameter φ0.3 mm of the original conductive wire with a diameter less than φ0.4 mm of the conductive part 13, with the total diameter being reduced by a space of φ1 mm (a space of 3 Fr), so that a conventional covered gastrointestinal stent (10 mm-16 mm) can be installed; and since φ3.5 mm-φ3.6 mm (10.5 Fr-10.8 Fr) of the outer diameter of an original traditional thermal implantation device is reduced to 3.15 mm (9.5 Fr), an electric implantation device can smoothly pass through a gastroscopic channel of φ3.2 mm.
The structures of the conductive head 11, the insulating part 12 and the conductive part 13 at the distal end of the stent implantation device according to the present disclosure are as shown in
As shown in
As shown in
As shown in
When the stent implantation device according to the present disclosure is used, after the conductive plug 33 is connected to an external high-frequency power source, the high-frequency power source is transmitted to the conductive head 11 through the conductive part 13, so that the stent implantation device has an electrical cutting function, and can cut the diseased distal tissue 40; if the conductive part 13 is a hollow conductive part, it is connected with an external Luer connector, so as to make the stent implantation device have a liquid injection function.
As shown in
The above descriptions are only preferred embodiments of the present application, so that those skilled in the art can understand or implement the present application. Multiple amendments to these embodiments and combinations thereof will be obvious to those skilled in the art, and general principles defined herein can be achieved in the other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will be not limited to these embodiments shown herein, but shall comply with the widest scope in consistent with the principles and novel features disclosed herein.
Number | Date | Country | Kind |
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201810606565.2 | Jun 2018 | CN | national |
This application is a continuation of International Application No. PCT/CN2018/099489, filed on Aug. 9, 2018, which claims priority to Chinese Patent Application No. 201810606565.2, filed on Jun. 13, 2018, both of which are hereby incorporated by reference in their entireties.
Number | Date | Country | |
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Parent | PCT/CN2018/099489 | Aug 2018 | US |
Child | 17119147 | US |