Gastrostomy tube system and operation method

Abstract

The invention discloses a gastrostomy tube system and an operation method. The gastrostomy tube system comprises a stomach tube assembly and a puncture assembly, the stomach tube assembly comprises a stomach tube body, an anchoring structure and an outer fixing part, the anchoring structure is arranged at the first end of the stomach tube body and used for stretching into a gastral cavity along with the first end of the stomach tube body and being fixed in the gastral cavity, the anchoring structure is made of memory alloy, and the outer fixing part is arranged at the second end of the stomach tube body. The outer fixing piece can deform under the body temperature environment to increase the section size, is arranged on the stomach tube body in a position adjustable mode and is used for being tightly attached to the outer side of the abdominal wall; the puncture assembly comprises a puncture needle and a guide wire, the guide wire can penetrate into the puncture needle, and the guide wire is used for penetrating into the puncture needle and guiding the anchoring structure and the first end of the stomach tube body to penetrate into. According to the stomach tube, the anchoring structure is arranged at the first end of the stomach tube body and is made of the memory alloy, so that the stomach tube body can be automatically deformed and unfolded to anchor the stomach tube body when the stomach tube is placed in a gastral cavity, the fixation is more reliable, and effective fixation can be kept for a long time.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and more particularly, to a gastrostomy tube system and surgical method. BACKGROUND

[0002] Patients with advanced esophageal cancer often have severe stenosis or obstruction of the esophageal lumen, resulting in inability to eat orally. In order to solve the problem of nutritional intake, a gastrostomy channel is usually established for such patients in clinical practice. A pseudo-gastrostomy channel is commonly established by percutaneous endoscopic gastrostomy (PEG), which is a standard and minimally invasive gastrostomy tube placement method: a gastroscope is inserted through the mouth, and the gastrostomy tube is placed into the stomach through the abdominal wall under the direct vision of the endoscope and fixed. However, PEG technology relies on a gastroscope to reach the stomach through the esophagus to complete the procedure, and therefore this method is not feasible for patients with esophageal cancer obstruction who cannot perform PEG orally.

[0003] For cases where PEG cannot be performed, surgical gastrostomy and laparoscopic-assisted gastrostomy are commonly used in clinical practice. Traditional open surgery directly cuts the stomach wall on the abdominal wall to place the stomach tube, which is traumatic; laparoscopic-assisted methods place the stomach tube into the stomach under the direct vision of the laparoscope through a small incision in the abdominal wall, which is less traumatic than open surgery, but still requires specialized equipment and is complex to operate. In addition, there are methods such as interventional radiology-guided gastrostomy, which place a catheter through the skin into the stomach under X-ray fluoroscopy, but such methods lack direct vision and have the risk of misplacement or bleeding.

[0004] Existing alternatives often use conventional gastrostomy tubes (such as simple balloon tubes), which are fixed internally relying on inflatable balloons or fixed mushroom head structures. These fixation methods have limitations in terms of reliability and long-term use: the balloon may lose support due to air leakage, the hard fixation head cannot adapt to different stomach wall thicknesses, and long-term compression may cause local tissue ulceration. SUMMARY

[0005] In view of the deficiencies of the prior art, the present application innovatively provides a gastrostomy tube system and surgical method, which can solve the technical problems of the prior art that gastrostomy tube surgery causes large trauma or complex operation to patients.

[0006] To achieve the above technical purposes, the present application discloses a gastrostomy tube system in a first aspect, comprising a stomach tube assembly and a puncture assembly, wherein, The stomach tube assembly comprises a stomach tube body, an anchoring structure and an external fixation member, the anchoring structure is arranged at the first end of the stomach tube body and is used to extend into the stomach cavity with the first end of the stomach tube body and be fixed in the stomach cavity, the anchoring structure is composed of a memory alloy and can change in size under a body temperature environment, The outer fixing part is adjustably arranged on the stomach tube body and is used for being tightly attached to the outside of the abdominal wall. The puncture assembly comprises a puncture needle and a guide wire, the guide wire can be inserted into the puncture needle, and the guide wire is used for inserting into the puncture needle and guiding the anchor structure and the first end of the stomach tube body to be inserted.

[0007] Further, the anchor structure is composed of a plurality of wire-shaped or sheet-shaped structure segments, the plurality of structure segments have a contraction state of approaching each other and a deployment state of moving away from each other, In a body temperature environment, the plurality of structure segments are in the deployment state.

[0008] Further, the structure segments are coated with a protective layer, and the protective layer is a biocompatible substance.

[0009] Further, the outer fixing part is a disc-shaped structure, a sliding hole is formed on the disc-shaped structure, the second end of the stomach tube body passes through the sliding hole, the hole diameter of the sliding hole is smaller than the outer diameter of the stomach tube body, and the sliding hole and the outer wall of the stomach tube body can be clamped and fixed in position.

[0010] Further, the outer fixing part is further provided with a fixing clamp, and the fixing clamp is used for clamping and fixing the outer wall of the stomach tube body.

[0011] Further, the stomach tube assembly further comprises a guide sleeve, the inner diameter of the guide sleeve is greater than the outer diameter of the stomach tube body, The anchor structure is located in the guide sleeve during placement into the stomach cavity, and the guide sleeve keeps the anchor structure in the contraction state.

[0012] Further, the guide sleeve is a rigid or semi-rigid tube.

[0013] Further, the anchor structure is made of a nickel-titanium alloy material.

[0014] The second aspect of the present application discloses a surgical method of the above-mentioned stomach fistula tube system, and the placement surgery of the stomach fistula tube is performed under laparoscopy.

[0015] Further, the method comprises the following steps: The pneumoperitoneum is established by general anesthesia, and a laparoscope head and a laparoscope stomach clamp are placed into an abdominal incision, A puncture point is selected to place a puncture device, the puncture needle is placed through the puncture device and is made to pierce into the stomach cavity, The guide wire is inserted into the stomach cavity through the puncture needle, The anchor structure and the first end of the stomach tube body are guided into the stomach cavity along the guide wire, and the anchor structure is deployed in a body temperature environment, withdraw the guide wire and the puncture device, pull the stomach tube body to make the anchor structure fit on the stomach wall, adjust the position of the external fixing member to make the external fixing member fit on the abdominal wall, Suture the incision.

[0016] The present application has the following advantages: The stomach fistula tube system provided by the present application is provided with an anchor structure at the first end of the stomach tube body, and the anchor structure is made of a memory alloy, so that the anchor structure can be deformed and expanded to anchor the stomach tube body when being placed in the stomach cavity, and the fixation is more reliable and can be maintained effectively for a long time. The operation can be completed through a laparoscope, without a gastroscope, and the operation is convenient, the trauma to the patient is small, and the safety is higher. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 Fig. 1 shows a structure schematic diagram of the stomach fistula tube system of the embodiment of the present application (anchor structure expansion); Figure 2 Fig. 2 shows an anchor state schematic diagram of the stomach tube assembly of the embodiment of the present application; Figure 3 Fig. 3 shows a structure schematic diagram of the stomach tube assembly of the embodiment of the present application (including a guide sleeve); Figure 4 Fig. 4 shows a structure schematic diagram of the stomach tube assembly of another embodiment of the present application (including a guide sleeve).

[0018] In the drawings, 1, stomach tube assembly; 11, stomach tube body; 111, anchor section; 112, channel section; 113, connecting structure; 12, anchor structure; 13, external fixing member; 14, guide sleeve; 2, puncture assembly; 21, puncture needle; 211, bevel; 22, guide wire; 3, stomach cavity; 4, abdominal wall. DETAILED DESCRIPTION

[0019] The stomach fistula tube system and the operation method provided by the present application will be explained and described in detail below in combination with the drawings of the specification.

[0020] In order to improve the fixation reliability and use convenience of the stomach fistula tube, some improved designs have appeared, for example, some researches propose to use a spoke expansion type internal fixation mechanism to replace the balloon structure which is prone to failure. This kind of design expands the internal fixation end through a mechanical structure, avoids the risk of balloon rupture, and improves the fixation stability. However, most of the above-mentioned improved schemes still need to rely on an endoscope or special instruments to be placed through the mouth, and are not suitable for patients with blocked esophageal passage. Therefore, there is an urgent need for a stomach fistula tube system which does not need to rely on a gastroscope for oral operation and is designed for laparoscopic placement under direct vision, so as to safely and efficiently establish a long-term nutrition channel for patients with severe esophageal stenosis.

[0021] The stomach fistula system provided by the application is provided with an anchoring structure at the first end of the stomach tube body, and the anchoring structure is composed of a memory alloy, so that the anchoring structure can be deformed and expanded automatically to anchor the stomach tube body when being placed in the stomach cavity, and the anchoring is more reliable and can be effectively fixed for a long time. The operation can be completed through a laparoscope, without a gastroscope, and the operation is convenient, the trauma to the patient is small, and the safety is higher. The application will be described in detail in combination with specific embodiments. In some embodiments, the application provides a stomach fistula system, as shown in Figure 1 、 Figure 2 The stomach fistula system includes a stomach tube assembly 1 and a puncture assembly 2, and the stomach tube assembly 1 can be inserted into the stomach cavity 3 through the puncture assembly 2 and fixed. The stomach tube assembly 1 includes a stomach tube body 11, an anchoring structure 12 and an external fixing member 13. The stomach tube body 11 is a flexible tube, which is optionally made of medical silica gel or polyurethane material, has an outer diameter of about 4 mm-8 mm, an inner diameter of about 3 mm-6 mm (consistent with a conventional stomach fistula tube, commonly 14-24 Fr), and an effective length of 30 cm-70 cm. The length can be selected according to the body type of the patient to ensure that the length of the external retention part is appropriate for fixation, and the stomach tube body 11 can be inserted into the stomach cavity 3 through the abdominal wall 4. The anchoring structure 12 is arranged at the first end of the stomach tube body 11 and is used to be inserted into the stomach cavity 3 with the first end of the stomach tube body 11 and fixed in the stomach cavity 3. The anchoring structure 12 is composed of a memory alloy and can be deformed to increase the cross-sectional size in a body temperature environment (such as 36-37 degrees Celsius), so that the cross section is larger than the abdominal wall stoma, thereby abutting against the stomach wall to prevent the first end of the stomach tube body 11 from coming out. The external fixing member 13 is adjustably arranged on the stomach tube body 11 and is used to be tightly attached to the outside of the abdominal wall 4. The anchoring structure 12 and the external fixing member 13 jointly clamp the stomach wall and the abdominal wall 4, and can fix the stomach tube body 11.

[0022] The puncture assembly 2 includes a puncture needle 21 and a guide wire 22, and the guide wire 22 can be inserted into the puncture needle 21. The guide wire 22 is used to guide the first end of the anchoring structure 12 and the stomach tube body 11 to be inserted. Optionally, the puncture needle 21 can adopt an existing needle tube with an inclined port 211, so that the guide wire 22 can be easily inserted. The guide wire 22 is used to guide the stomach tube body 11 to be inserted and withdrawn after being inserted.

[0023] In some embodiments, the anchoring structure 12 is composed of multiple segments of wire or sheet structure, which have a contracted state of approaching each other and an expanded state of moving away from each other, for example, forming the shape of an umbrella rib, a petal, or a basket, etc. At room temperature (20-30 degrees Celsius), the multiple segments are plastically compressed into the contracted state, so that the cross section is similar in size to the cross section of the gastric tube body 11, facilitating insertion into the stomach cavity 3. At body temperature, the multiple segments are in the expanded state, and the expanded diameter can be 20-30 mm. After expansion, the anchoring structure 12 can be attached to the stomach wall (the expanded diameter is larger than the stoma diameter, ensuring reliable anchoring), and can fix the gastric tube body 11 to prevent the first end from coming out. Optionally, the anchoring structure 12 is composed of a nickel-titanium memory alloy, and the transition temperature can be adjusted to be close to body temperature, ensuring easy deformation at room temperature and rapid recovery of the rigid shape at 37°C in the body. In addition, the nickel-titanium alloy has excellent fatigue performance and can withstand tens of thousands of deformations without damage, making it suitable for long-term implantation. The anchoring structure 12 can be set in different forms as needed, such as three segments forming a three-prong structure, or four segments forming a four-prong structure, or a multi-petal petal structure, as long as it can form a support surface in contact with the stomach wall after expansion. For patients of different body types, the anchoring structure 12 can have different specifications to match the thickness of the stomach wall and the stoma diameter.

[0024] Optionally, the segments of the anchoring structure 12 are coated with a protective layer made of biocompatible material. For example, a medical silicone rubber coating, a PTFE coating, or a titanium oxide coating can be used, which can act as a barrier to prevent direct contact between the anchoring structure 12 and the tissue, and improve biocompatibility. The protective layer also prevents biological adverse reactions caused by nickel ions and provides a smooth surface to reduce frictional damage to the tissue during insertion. The protective layer can also increase the friction when the anchoring structure 12 is expanded, preventing the anchoring structure from slipping in the stomach.

[0025] In some embodiments, the external fixing member 13 is a disc-shaped structure with a sliding hole formed therein, and the second end of the gastric tube body 11 passes through the sliding hole. Optionally, the sliding hole has a diameter smaller than the outer diameter of the gastric tube body 11, and the sliding hole and the outer wall of the gastric tube body 11 can be fixed in position by clamping. Under the action of external force, the gastric tube body 11 can be pulled to move the external fixing member 13, and after the external force is removed, the interference fit between the gastric tube body 11 and the sliding hole can fix the position of the external fixing member 13.

[0026] Optionally, the external fixator 13 is also equipped with a fixing clip, which is used to clamp and fix it to the outer wall of the gastric tube body 11. The fixing clip is located on one side of the external fixator 13. After the position of the external fixator 13 is adjusted, the fixing clip can clamp onto the gastric tube body 11, and can play a double fixing role in conjunction with the sliding hole. The fixing clip can cause minor deformation of the gastric tube body 11, so as not to affect the normal use of the gastric tube body 11. The external fixator 13 can conform to the skin around the stoma, partially cover the periphery of the stoma, and leave a drainage and observation port. When the anchoring structure 12 opens in the gastric cavity 3, the external fixator 13 can be moved to conform to the skin and lock, so that the gastric wall can be firmly "clamped" between the anchoring structure 12 and the external fixator, forming a sealed gastric wall-abdominal wall channel to prevent leakage of gastric contents.

[0027] In some embodiments, such as Figure 3 As shown, the gastric tube assembly 1 also includes a guide sleeve 14, the inner diameter of which is larger than the outer diameter of the gastric tube body 11. The anchoring structure 12 is located within the guide sleeve 14 during insertion into the gastric cavity 3, and the guide sleeve 14 keeps the anchoring structure 12 in a contracted state. The guide sleeve 14 makes it easier for the anchoring structure 12 to penetrate into the gastric cavity 3 and prevents premature deployment of the anchoring structure 12 during insertion, which could lead to insertion failure. After the anchoring structure 12 has penetrated into the gastric cavity 3, removing the guide sleeve 14 allows the anchoring structure 12 to deploy automatically. Optionally, the guide sleeve 14 is a rigid or semi-rigid tube, which can better constrain the anchoring structure 12 and also make it easier for the gastric tube body 11 to penetrate into the gastric cavity 3. After the guide cannula 14 delivers the anchoring structure 12 to the appropriate position in the stomach cavity 3 through the abdominal wall channel, the guide cannula 14 is slowly retracted to release the constraint on the anchoring structure 12. The anchoring structure 12 immediately returns to its unfolded state under the influence of body temperature, unfolding into the preset anchoring shape. Then, the gastric tube body 11 is gently pulled to make the anchoring structure 12 fit tightly against the inner wall of the stomach. Then, the position of the external fixator 13 is adjusted so that it fits tightly against the skin and is then fixed in position, completing the anchoring of the gastric tube body 11.

[0028] Optionally, the external fastener 13 can be removed and cleaned separately, and can be replaced and cleaned without disturbing the internal anchor, thus maintaining hygiene at the skin inlet.

[0029] In some embodiments, the gastric tube assembly 1 further includes a traction wire, one end of which is connected to the anchoring structure 12, and the other end extends along the inner lumen of the gastric tube body 11 to the outside. When it is necessary to remove the gastric tube, the traction wire can be pulled to retract the anchoring structure 12, and then the anchoring structure 12 can be retracted into the guide cannula 14 in conjunction with the guide cannula 14, and then pulled out of the body together with the guide cannula 14.

[0030] The present application utilizes the characteristics of memory alloy material to enable the anchoring structure 12 to "change shape with temperature and mechanical state". When placed, the anchoring structure 12 is compressed by the external guide sleeve 14 to maintain an elongated form, facilitating the delivery into the body through a small incision; after positioning, the constraint is removed, and the anchoring structure 12 is stimulated by the body temperature to restore the original expanded form, automatically expanding and adhering to the inner side of the gastric wall to achieve anchoring and fixation. The anchoring structure 12 provides continuous elastic support force after expansion, gently pressing the gastric wall against the abdominal wall to form a closed channel. This self-expanding anchoring does not require complex mechanisms to be operated manually, and the expansion can be completed by utilizing the properties of the material itself, simplifying the surgical procedure. It provides a percutaneous minimally invasive placement and long-term reliable fixation of the gastrostomy tube anchoring scheme for patients who cannot be placed orally.

[0031] In some embodiments, the present application also provides a surgical method of the above-mentioned gastrostomy tube system, which is performed under laparoscopy for the placement of the gastrostomy tube, and optionally includes the following steps: Establish a pneumoperitoneum under general anesthesia, and place a laparoscope head and a laparoscopic stomach clamp through an abdominal incision; Optionally, two 5mm trocars are placed through a 10mm umbilical incision under general anesthesia, and a 5mm laparoscope head and a laparoscopic stomach clamp are placed respectively.

[0032] Place a trocar at the puncture point, insert a puncture needle 21 through the trocar, and make the puncture needle 21 penetrate into the gastric cavity 3; Optionally, the gastric puncture point is selected under the visual environment through the laparoscope head, and optionally, the appropriate part of the anterior wall of the stomach is selected to avoid the rich blood vessels at the lesser curvature and greater curvature of the stomach, thereby reducing bleeding. Then, the external puncture point of the abdominal wall is selected, which optionally includes reducing the pneumoperitoneum pressure to less than 6mmHg, so as to select the projection of the gastric wall on the abdominal wall under the direct vision of the laparoscope head combined with external force pressing the abdominal wall, and determine the external puncture point of the abdominal wall, so that the later formed sinus is the shortest, rather than a diagonal sinus. Finally, a 5mm trocar is placed at the selected external puncture point of the abdominal wall.

[0033] Pass the guide wire 22 through the puncture needle 21 into the gastric cavity 3; Optionally, the left hand holds the laparoscopic stomach clamp to clamp above the gastric puncture point, locally lifts the gastric wall, and places the puncture needle 21 at the trocar placed at the external puncture point of the abdominal wall to enter the gastric cavity 3. The method of determining the entry into the gastric cavity 3 includes: 1, a breakthrough feeling; 2, no resistance when aspirating, and gastric juice can be aspirated; 3, no resistance when injecting a small amount of normal saline. After determining that the puncture needle 21 enters the gastric cavity 3, the guide wire 22 is inserted into the puncture needle 21 from the bevel 211 of the puncture needle 21 and into the gastric cavity 3, and then the puncture needle 21 is pulled out.

[0034] The anchoring structure 12 and the first end of the gastric tube body 11 are guided into the gastric cavity 3 along the guide wire 22, and the anchoring structure 12 expands in the body temperature environment; Optionally, a guide sleeve is placed along the guide wire 22, and the first end of the gastric tube body 11 and the anchor structure 12 are simultaneously introduced into the gastric cavity 3 along the guide sleeve 14. After being introduced into the gastric cavity 3, the guide sleeve is removed, and the anchor structure 12 is automatically unfolded into an anchor shape in the gastric cavity 3. The guide wire 22 and the puncture device are removed, the gastric tube body 11 is pulled to make the anchor structure 12 adhere to the stomach wall, the position of the external fixing member 13 is adjusted, the external fixing member 13 is adhered to the skin of the abdominal wall and fixed, and the anchoring of the gastric tube body 11 is completed.

[0035] Suture the incision; Check the patency of the gastrostomy tube, check the abdominal cavity under laparoscopic direct vision, remove the two puncture devices in the umbilical region, the laparoscope head, and the laparoscopic stomach clamp, and suture the incision.

[0036] The present application can be completed by laparoscopy, completely avoiding the need for oral tube placement. Even if the esophagus is completely obstructed and cannot pass through the endoscope, the present application can still safely complete the placement of the gastrostomy tube under laparoscopic direct vision. This reduces the difficulty and risk of surgery, so that patients with advanced esophageal cancer can also receive minimally invasive nutrition tube implantation. Laparoscopic direct vision ensures that the entire process can be monitored, reducing the risk of misplacement in other organs or causing bleeding and infection, and is safer and more reliable than blind puncture or X-ray guidance. In addition, laparoscopic minimally invasive operation, only 1 cm small incision in the umbilical region, the patient has no pain and discomfort after surgery, and can recover diet early. It conforms to the concept of rapid recovery; laparoscopic minimally invasive + interventional thought makes the trauma smaller, the patient recovers faster, and embodies the humanistic concern.

[0037] In some embodiments, if the entire system needs to be removed, the anchor structure 12 can be retracted and pulled out together with the sleeve under laparoscopic direct vision. This scheme can avoid the risk of gastric wall damage or stoma tearing caused by traditional tube removal. The specific operation steps are as follows: 1) preoperative preparation: operate under laparoscopic direct vision, ensure full monitoring of the gastric wall and stoma, gently pull the gastric tube body 11, and confirm the position and fixation state of the anchor structure 12. 2) Start the traction line recovery: slowly pull the traction line outside the body; the anchor structure 12 shrinks due to stress, and the original unfolded “umbrella / petal” shape memory alloy pieces gradually close; at this time, the diameter of the anchor structure 12 is reduced to close to the diameter of the tube body, avoiding scratching the gastric wall. 3) Cooperate with the guide sleeve protection: simultaneously advance the guide sleeve to cover the outside of the gradually shrinking anchor structure 12; the presence of the sleeve can avoid the anchor piece rubbing the gastric wall or the stoma edge during the retraction process. 4) Remove the entire system: when the anchor structure 12 is completely housed in the guide sleeve, the doctor slowly pulls out the “gastric tube body + anchor structure + guide sleeve” as a whole under laparoscopic direct vision; since the anchor has been completely retracted and wrapped by the sleeve, the stoma will not be stretched or torn. 5) Stoma treatment: check the stoma and gastric wall, if necessary, it can be directly sutured; if necessary, a new system can be placed again.

[0038] In some embodiments, asFigure 4 As shown, the gastric tube body 11 can also be made in a segmented structure, including an anchoring segment 111, a channel segment 112 and a connecting structure 113, so that when the gastric tube body 11 is blocked or aged, it can be replaced individually without disturbing the anchoring structure 12. Exemplarily, the connecting structure 113 is arranged at the part of the gastric tube body 11 located outside the body, and is connected in a detachable manner, such as through an interface similar to a luer lock or a socket bayonet. The part located inside the abdominal wall constitutes the anchoring segment 111, and the anchoring structure 12 is arranged on the anchoring segment 111. The other part constitutes the channel segment 112, which is detachably connected with the anchoring segment 111. When the gastric tube body 11 needs to be replaced due to blockage or aging, the doctor only needs to twist or pull out the channel segment 112 outside the body, and then insert a new channel segment 112 and lock it through the connecting structure 113, without pulling or removing the anchoring structure 12 inside the body, so as to realize quick and safe maintenance and significantly reduce the need for reoperation.

[0039] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation of the present application.

[0040] In the present application, unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connection", "fixing" and the like should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise explicitly limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0041] In the description of the specification, the description of the terms "the embodiment", "one embodiment", "some embodiments", "example", "specific example", or "some examples" and the like means that the specific features, structures, materials or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present application. In the specification, the illustrative description of the above terms does not necessarily refer to the same embodiment or example. Also, the specific features, structures, materials or characteristics described can be combined in any suitable manner in at least one embodiment or example. In addition, the person skilled in the art can combine and combine the different embodiments or examples described in the specification and the features of the different embodiments or examples without contradiction.

[0042] In addition, the terms "first", "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined with "first", "second" can explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "a plurality of" is at least two, for example, two, three, etc., unless otherwise specifically limited.

[0043] The above is only the preferred embodiment of the present application, and is not intended to limit the present application. Any modification, equivalent replacement and simple improvement made on the essential content of the present application shall be included in the protection scope of the present application.

Claims

1. A gastrostomy tube system, characterized in that, The application relates to a gastric tube assembly and a puncture assembly, wherein, the gastric tube assembly comprises a gastric tube body, an anchoring structure and an external fixing member, the anchoring structure is arranged at a first end of the gastric tube body and is used for extending into a stomach cavity and being fixed in the stomach cavity along with the first end of the gastric tube body, the anchoring structure is composed of a memory alloy and can be deformed to increase the sectional size in a body temperature environment, the external fixing member is arranged on the gastric tube body in a position-adjustable mode and is used for being attached to the outside of an abdominal wall, the puncture assembly comprises a puncture needle and a guide wire, the guide wire can be inserted into the puncture needle, and the guide wire is used for being inserted into the puncture needle and guiding the anchoring structure and the first end of the gastric tube body to be inserted.

2. The gastrostomy tube system according to claim 1, wherein, The anchoring structure is composed of a plurality of wire-shaped or sheet-shaped structure segments, the plurality of structure segments have a contraction state of approaching each other and an expansion state of moving away from each other, the plurality of structure segments are in the expansion state in a body temperature environment.

3. The gastrostomy tube system according to claim 2, wherein, A protective layer is coated on the structure segments, and the protective layer is a biocompatible substance.

4. The gastrostomy tube system according to claim 1, wherein, The external fixing member is a disc-shaped structure, a sliding hole is formed in the disc-shaped structure, a second end of the gastric tube body passes through the sliding hole, the hole diameter of the sliding hole is smaller than the outer diameter of the gastric tube body, and the sliding hole and the outer wall of the gastric tube body can be clamped and fixed in position.

5. The gastrostomy tube system according to claim 2, wherein, A fixing clamp is further arranged on the external fixing member, and the fixing clamp is used for clamping and fixing the outer wall of the gastric tube body.

6. The gastrostomy tube system according to claim 2, wherein, The gastric tube assembly further comprises a guide sleeve, the inner diameter of the guide sleeve is greater than the outer diameter of the gastric tube body, the anchoring structure is located in the guide sleeve during placement into the stomach cavity, and the guide sleeve keeps the anchoring structure in the contraction state.

7. The gastrostomy tube system according to claim 6, wherein, The guide sleeve is a rigid or semi-rigid tube.

8. The gastrostomy feeding tube system according to any of claims 1-7, wherein, The anchoring structure is made of a nickel-titanium alloy material.

9. A surgical method of a gastrostomy tube system according to any one of claims 1-8, characterized in that, The gastric fistula tube placement operation is performed under laparoscopy.

10. The surgical method of claim 9, wherein, The operation comprises the following steps: an abdominal incision is made to place a laparoscope head and a laparoscopic stomach clamp, a puncture point is selected to place a puncture device, the puncture needle is placed through the puncture device and is stabbed into the stomach cavity, the guide wire is inserted into the stomach cavity through the puncture needle, the anchoring structure and the first end of the gastric tube body are guided into the stomach cavity along the guide wire, and the anchoring structure is expanded in a body temperature environment, the guide wire and the puncture device are withdrawn, the gastric tube body is pulled to make the anchoring structure attached to the stomach wall, the position of the external fixing member is adjusted, and the external fixing member is attached to the abdominal wall, the incision is sutured.

Images