Insertion catheter for mucosal jejunostomy

Abstract

The insertion catheter comprises a catheter body, a positioning and blocking mechanism used for being inserted into the pancreas from the jejunum is arranged on the outer surface of the catheter body, the positioning and blocking mechanism comprises a top-shaped catheter sleeve and a plurality of supporting blocks, the top-shaped catheter sleeve is arranged on the outer surface of the catheter body, and the supporting blocks are arranged on the top-shaped catheter sleeve. The outer surface of the top-shaped pipe sleeve is in a concave arc shape, the diameter change range of the top-shaped pipe sleeve is 1-5 cm, the supporting block is arranged on the large-diameter side of the top-shaped pipe sleeve, one side of the supporting block is arranged on the outer surface of the pipe body, and the top-shaped pipe sleeve is provided with a contraction mechanism used for conveniently taking out the pipe body. By designing the blocking structure with the diameter change range of 1-5 cm, the device can be suitable for different patients, catheters with different diameters do not need to be selected for blocking, meanwhile, the catheters in the human body in the later period can automatically contract through the absorbable structure on the absorption surface of the human body, and the catheter can be conveniently taken out in the later period.

Description

Technical Field

[0001] The invention relates to the technical field of medical catheters, in particular to an insertion catheter used for mucosal jejunostomy. Background Art

[0002] Pancreatic fistula (PF) remains an important problem, resulting in the highest mortality and morbidity after pancreaticoduodenectomy (PD). PD is the main surgical method for the treatment of benign and malignant diseases of the pancreas and periampullary area. After complex surgery, a series of serious complications may occur, such as bleeding, PF, bile leak, peritonitis, pancreatitis, sepsis, seroperitoneum, and multiple organ dysfunction syndrome (MODS). During anastomosis, PJ remains a key step in digestive tract reconstruction after PD, which can lead to massive bleeding and fatal infection. Due to the rapid development of surgical techniques, the PJ value of PD patients has dropped to 5%, but the postoperative complications are as high as 30%-50%. Among them, the prevalence of PF is 10% on average. In order to reduce the incidence of PF, many attempts have been made to improve the surgical process, including ductal PJ with mucosal removal, invaginated PJ, and pancreatogastrostomy. In our study, animal experiments confirmed the advantages of ductal PJ in reducing the incidence of PF.

[0003] First, after the cut surface of the pancreatic stump is sutured, a silicone rubber tube with a diameter of 4-5 cm is inserted into the pancreatic duct if the pancreatic duct is dilated and fixed to the pancreatic duct wall with 4 / 0 absorbable suture. Then the jejunal seromuscular layer is sutured continuously to the posterior lip of the pancreatic stump (including part of the pancreatic parenchyma) with 4 / 0 ene. The probe should not be cut to allow for suturing of the anterior part. A small hole is punctured in the jejunal mucosa, and its posterior edge is sutured to the posterior wall of the pancreatic duct with a thin 3 / 0 absorbable suture. The stent tube is fixed in the anastomosis with sutures, and 3 interrupted sutures are added at the 3, 6, and 9 o'clock positions. Finally, the cut edge in front of the jejunal seromuscular layer is sutured continuously to the anterior lip of the pancreatic stump. Antibiotics and octreotide are routinely used in all patients with Parkinson's disease.

[0004] Deficiencies of existing technology:

[0005] Since the interface diameters of the pancreatic and jejunal insertion catheters of different patients are different, catheters of different diameters are required. Usually, larger catheters are used and sutured with absorbable sutures. Larger catheters may cause discomfort to patients, and medical staff are required to select appropriate catheters on site. In addition, since the catheter specifications are usually larger than the actual interface, it is more cumbersome to remove the catheter after it hardens in the human body. Summary of the invention

[0006] The object of the present invention is to provide an insertion catheter for mucosal jejunostomy to solve the problems mentioned in the above background technology.

[0007] To achieve the above object, the present invention provides the following technical solution: an insertion catheter for mucosal jejunostomy, comprising a tube body, a positioning blocking mechanism for inserting from the jejunum into the pancreas is provided on the outer surface of the tube body, and the positioning blocking mechanism comprises:

[0008] A gyro-shaped tube sleeve, wherein the gyro-shaped tube sleeve is arranged on the outer surface of the tube body, the outer surface of the gyro-shaped tube sleeve is an inwardly concave arc, and the diameter of the gyro-shaped tube sleeve varies in the range of 1-5CM;

[0009] A plurality of support blocks, wherein the support blocks are arranged on one side of the larger diameter of the gyro-shaped tube sleeve, and one side of the support blocks is arranged on the outer surface of the tube body;

[0010] The gyro-shaped tube sleeve is provided with a contraction mechanism for facilitating the removal of the tube body.

[0011] As a further improvement of the present invention, the contraction mechanism comprises:

[0012] An absorbable biofilm is coated on the through grooves provided on the surface of the gyro-shaped tube sleeve, and an air-filled cavity is formed between the gyro-shaped tube sleeve, the absorbable biofilm and the tube body;

[0013] A plurality of absorbable gauze, two ends of which are respectively connected to the outer surface of the tube body and the inner surface of the gyro-shaped tube sleeve, and the absorbable gauze is distributed at equal intervals;

[0014] A plurality of elastic ropes, the two ends of which are respectively arranged on the gyro-shaped tube sleeve and the outer surface of the tube body.

[0015] As a further improvement of the present invention, both ends of the tube body are conical structures, and both ends of the tube openings are arc surfaces, and a plurality of guide holes are arranged on both sides of the positioning and blocking mechanism on the tube body.

[0016] As a further improvement of the present invention, one side of the support block is set as a concave arc surface, and the support block is composed of absorbent material, and the absorbent material includes any one or more of collagen, gelatin or polylactic acid.

[0017] As a further improvement of the present invention, a plurality of grooves are arranged on the surface of the absorbable biofilm between the absorbable gauze, and the depth of the grooves is one third of the absorbable biofilm.

[0018] As a further improvement of the present invention, the absorbable gauze is provided with a plurality of hollow holes.

[0019] As a further improvement of the present invention, the inflation chamber is filled with a mixed gas, and the mixed gas is a mixture of oxygen and carbon dioxide.

[0020] As a further improvement of the present invention, the diameter of the tube body is 1-1.5CM.

[0021] As a further improvement of the present invention, the gyro-shaped tube sleeve is made of soft silicone.

[0022] As a further improvement of the present invention, the support block is provided with a plurality of notches, and the diameter of the notches is 0.15-0.25CM.

[0023] Compared with the prior art, the present invention has the following beneficial effects:

[0024] 1. The present invention is provided with a positioning blocking mechanism, which includes a gyro-shaped tube sleeve and a plurality of support blocks. The outer surface of the gyro-shaped tube sleeve is an inwardly concave arc. The diameter of the gyro-shaped tube sleeve varies in the range of 1-5CM, which can be applied to different patients without selecting catheters of different diameters for blocking. It is applicable to different patients without selecting a suitable catheter on site.

[0025] 2. The contraction mechanism of the present invention includes an absorbable biofilm, a plurality of absorbable gauzes and a plurality of elastic ropes. The absorbable biofilm is coated on the through grooves opened on the surface of the gyro-shaped tube sleeve. An air-filled cavity is formed between the gyro-shaped tube sleeve and the absorbable biofilm and the tube body. The catheter can automatically contract when it passes through the absorbable structure on the surface absorbed by the human body in the later stage of the human body, so as to facilitate the removal of the pipeline in the later stage. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 A schematic diagram of the catheter inserted into the pancreas and jejunum of the present invention;

[0027] Figure 2 This is a front view of the catheter of the present invention;

[0028] Figure 3 It is a schematic diagram of the local structure of the catheter of the present invention;

[0029] Figure 4 For the present invention Figure 2 A in the middle is an enlarged schematic diagram;

[0030] Figure 5 For the present invention Figure 3 B is an enlarged schematic diagram.

[0031] In the figure: 1. tube body; 101. diversion hole; 2. positioning and blocking mechanism; 21. gyro-shaped tube sleeve; 22. support block; 3. contraction mechanism; 31. absorbable biofilm; 311. inflation cavity; 312. groove; 32. absorbable gauze; 33. elastic rope. DETAILED DESCRIPTION

[0032] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0033] Example

[0034] See also Figure 1-5 The present invention provides the following technical solution: an insertion catheter for mucosal jejunostomy, comprising a tube body 1, a positioning blocking mechanism 2 for inserting from the jejunum into the pancreas is installed on the outer surface of the tube body 1, the positioning blocking mechanism 2 comprises a gyro-shaped tube sleeve 21 and a plurality of support blocks 22, both ends of the gyro-shaped tube sleeve 21 are hot-melt connected to the outer surface of the tube body 1, the outer surface of the gyro-shaped tube sleeve 21 is an inwardly concave arc, the diameter of the gyro-shaped tube sleeve 21 varies in the range of 1-5CM, and the support block 22 is hot-melt connected to the large diameter of the gyro-shaped tube sleeve 21. On the side, one side of the support block 22 is hot-melt connected to the outer surface of the tube body 1, and a contraction mechanism 3 for facilitating the removal of the tube body 1 is installed on the gyro-shaped tube sleeve 21. When the tube body 1 is inserted from the jejunum into the pancreas, the concave arc surface of the gyro-shaped tube sleeve 21 can effectively block the connection between the patient's jejunum and pancreas to prevent the inability to effectively close the interlaced part of the jejunum and pancreas. It can be suitable for the specifications of the jejunum and pancreas of different people. At the same time, the support and bending effect of the support block 22 can ensure the positioning of the tube body 1 and the adjustment of the angle of the tube body 1.

[0035] The contraction mechanism 3 includes an absorbable biofilm 31, a plurality of absorbable gauzes 32 and a plurality of elastic cords 33. The absorbable biofilm 31 is coated on the through grooves provided on the surface of the gyro-shaped tube sleeve 21. An air-filled cavity 311 is formed between the gyro-shaped tube sleeve 21 and the absorbable biofilm 31 and the tube body 1. The two ends of the absorbable gauze 32 are respectively connected by heat-melting to the outer surface of the tube body 1 and the inner surface of the gyro-shaped tube sleeve 21. The absorbable gauze 32 is evenly spaced. The two ends of the elastic cord 33 are respectively connected by heat-melting to the gyro-shaped tube sleeve 21 and the inner surface of the gyro-shaped tube sleeve 21. On the outer surface of the tube body 1, after the tube body 1 is inserted and positioned as a whole, as the absorbent thread sutured on the jejunum and the pancreas is absorbed, the absorbable biofilm 31 is also absorbed and digested by the human body, so that the mixed gas inside the inflation cavity 311 begins to be discharged. As the absorbent biofilm 31 and the absorbable gauze 32 are absorbed and lost, the diameter of the connection position between the jejunum and the pancreas becomes smaller. At the same time, under the action of the elastic rope 33, the gyro-shaped tube sleeve 21 is pulled to contract, so that the gyro-shaped tube sleeve 21 is attached to the surface of the tube body 1, which is convenient for taking out the tube body 1;

[0036] Both ends of the tube body 1 are tapered structures, and both ends of the tube openings are arc surfaces, which are convenient for the insertion of the tube body 1 and prevent discomfort to the patient. The tube body 1 is provided with a plurality of guide holes 101 on both sides of the positioning and blocking mechanism 2 to facilitate the pancreatic fluid to flow into the jejunum and prevent the tube body 1 opening from being blocked, resulting in the inability of the pancreatic fluid to flow effectively.

[0037] One side of the support block 22 is integrally formed as an inner concave arc surface, which is convenient for the later removal of the tube body 1. The support block 22 is composed of an absorbent material, which includes any one or more of collagen, gelatin or polylactic acid, which can further reduce the diameter of the tube body 1 when it is removed later, making it easier to remove, while ensuring the toughness of the tube body 1 during the early insertion and ensuring effective blocking;

[0038] The surface of the absorbable biofilm 31 has a plurality of grooves 312 between the absorbable gauze, which is convenient for increasing the contact area of ​​the absorbable biofilm 31 and improving the absorption effect. At the same time, it can ensure that the local position of the absorbable biofilm 31 can be preferentially absorbed to produce damage, thereby improving the absorption effect. The depth of the grooves 312 is one third of the absorbable biofilm 31.

[0039] The absorbable gauze 32 is provided with a plurality of hollow holes to improve the absorption efficiency of the absorbable gauze 32;

[0040] The gas chamber 311 is filled with a mixed gas, which is a mixture of oxygen and carbon dioxide, so that the gas chamber 311 can be effectively filled, and the mixed gas is harmless after entering the human body;

[0041] The diameter of the tube body 1 is 1-1.5CM;

[0042] The gyro-shaped tube sleeve 21 is made of soft silicone to ensure softness and toughness;

[0043] The support block 22 is provided with a plurality of notches, each having a diameter of 0.15-0.25 cm, which is convenient for adjusting the curvature of the tube body 1 and for increasing the contact area and improving the absorption effect.

[0044] Working principle:

[0045] When the tube body 1 is inserted from the jejunum into the pancreas, the concave arc surface of the gyro-shaped tube sleeve 21 can effectively block the connection between the patient's jejunum and pancreas to prevent the inability to effectively close the interlaced part of the jejunum and pancreas. The tube body 1 can be suitable for the jejunum and pancreas specifications of different people. At the same time, the support and bending effect of the support block 22 can ensure the positioning of the tube body 1 and the adjustment of the angle of the tube body 1. After the tube body 1 is inserted and positioned as a whole, as the absorption line sutured on the jejunum and pancreas is absorbed, the absorbable biofilm 31 is also absorbed by the human body and begins to be digested, so that the mixed gas inside the inflation cavity 311 begins to be discharged. As the absorbable biofilm 31 and the absorbable gauze 32 are absorbed and lost, the diameter of the connection between the jejunum and pancreas becomes smaller. At the same time, under the action of the elastic rope 33, the gyro-shaped tube sleeve 21 is pulled to contract, so that the gyro The spiral tube sleeve 21 is attached to the surface of the tube body 1 to facilitate the removal of the tube body 1. The experiment was conducted on puppies, beagles, unlimited male and female, about 10-12 kg (all animal work was performed in accordance with the guidelines of the institution. The surgical procedure: after intraperitoneal injection of sodium pentobarbital (5%, 2.4ml / kg) for anesthesia, an abdominal incision was made, and group A (duct PJ) was performed. The surgical method of group B (invaginated PJ) is as follows. After PD, the pancreatic stump is separated for about 2-3cm, and the wedge-shaped section is sutured. The serum muscle layer of the posterior wall of the jejunum and the pancreatic capsule at the posterior cut end (including part of the pancreatic parenchyma) are sutured with interrupted sutures. Then the entire layer of the posterior wall of the jejunum and the posterior lip of the cut end of the pancreas are sutured. After the reverse suture between the entire anterior wall layer of the jejunum and the anterior lip of the cut end of the pancreas is completed, the pancreatic stump is invaginated into the jejunum. The serum layer of the anterior wall of the jejunum and the pancreatic capsule are sutured interruptedly.

[0046] Experimental methods: Intestinal physical pressure was measured 10 days after surgery in 6 beagle dogs and artificial high pressure at the anastomosis was tested at double, triple, and quadruple the above average pressure. The in vivo anastomotic strength and histopathological results were evaluated on the tenth day. To evaluate the intestinal physical pressure of the anastomotic stoma, a drainage tube was inserted into the intestinal lumen 2 cm away from the anastomosis, and the physical pressure was measured at 3 specific times (2 hours before feeding). In the beagle dogs undergoing invaginated PJ surgery, 2 dogs died after artificial anastomotic high pressure was applied on the 3rd and 5th days after surgery. Autopsy showed contrast leakage in the abdominal cavity. X-ray films showed that the other 2 deaths occurred at the fistula on the mesenteric side. However, no death was reported in group A. In addition, no abnormalities were found in the autopsy results. In all 6 cases. While in group B, 2 cases had PF on the 3rd and 5th days after surgery with artificial high pressure double the above average pressure. The fracture pressure of the anastomosis was 272.13±22.20 mmHg in group A and 141±14.51 mmHg in group B (Table 1, *P<0.05). The anastomotic strength was 9.35±0.35 N / S in group A and 6.5±0.30 N / S in group B (Table 1, *P<0.05). Histological examination was performed on the 10th day after surgery. In group A, connective tissue was used to repair the anastomosis, and the serosa adhered tightly to the pancreas. The inflammatory cells and capillaries in the granulation tissue of the pancreatic stump were significantly reduced. The proliferation of fibroblasts and collagen fibers was observed. However, in group B, pathological examination showed that the anastomosis was full of inflammatory cells and the granulation tissue was not obvious. In addition, there is also extensive cell necrosis in the pancreatic stump. By designing a blocking structure with a diameter range of 1-5CM, this device can be suitable for different patients without selecting catheters of different diameters for blocking. At the same time, the catheter can automatically shrink through the absorbable structure on the surface of the human body in the later stage, which is convenient for the removal of the pipeline in the later stage.

[0047] Group A Group B P Breaking pressure (mmHg) 272.13±22.20 141±14.51 P＜0.05 Anastomotic strength (N / S) 9.35±0.35 6.5±0.30 P＜0.05

[0048] Table 1 Comparison results of anastomotic fracture pressure and anastomotic strength

[0049] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0050] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. An insertion catheter for mucosal jejunostomy, comprising a tube body (1), characterized in that: The outer surface of the tube body (1) is provided with a positioning and blocking mechanism (2) for inserting into the pancreas from the jejunum, and the positioning and blocking mechanism (2) comprises: A gyro-shaped tube sleeve (21), wherein the gyro-shaped tube sleeve (21) is arranged on the outer surface of the tube body (1), the outer surface of the gyro-shaped tube sleeve (21) is an inwardly concave arc shape, and the diameter of the gyro-shaped tube sleeve (21) varies in the range of 1-5 cm; A plurality of support blocks (22), wherein the support blocks (22) are arranged on a side of the larger diameter of the gyro-shaped tube sleeve (21), and one side of the support blocks (22) is arranged on the outer surface of the tube body (1); The gyro-shaped tube sleeve (21) is provided with a retracting mechanism (3) for facilitating the removal of the tube body (1).

2. The insertion catheter for mucosal jejunostomy according to claim 1, characterized in that: The contraction mechanism (3) comprises: An absorbable biofilm (31), the absorbable biofilm (31) covering the through grooves provided on the surface of the gyro-shaped tube sleeve (21), and an air-filled cavity (311) being formed between the gyro-shaped tube sleeve (21), the absorbable biofilm (31) and the tube body (1); A plurality of absorbable gauzes (32), wherein two ends of the absorbable gauzes (32) are respectively on the outer surface of the tube body (1) and the inner surface of the gyro-shaped tube sleeve (21), and the absorbable gauzes (32) are distributed at equal intervals; A plurality of elastic ropes (33), both ends of which are respectively arranged on the gyro-shaped tube sleeve (21) and connected to the outer surface of the tube body (1).

3. The insertion catheter for mucosal jejunostomy according to claim 1, characterized in that: Both ends of the tube body (1) are conical structures, and both ends of the tube openings are arc surfaces. The tube body (1) is provided with a plurality of flow guide holes (101) on both sides of the positioning and blocking mechanism (2).

4. The insertion catheter for mucojejunostomy according to claim 1, characterized in that: One side of the support block (22) is configured as an inwardly concave arc surface. The support block (22) is composed of an absorbent material, and the absorbent material includes any one or more of collagen, gelatin or polylactic acid.

5. The insertion catheter for mucosal jejunostomy according to claim 2, characterized in that: The surface of the absorbable biofilm (31) is provided with a plurality of grooves (312) between the absorbable gauze (32), and the depth of the grooves (312) is one third of the absorbable biofilm (31).

6. The insertion catheter for mucosal jejunostomy according to claim 2, characterized in that: The absorbable gauze (32) is provided with a plurality of hollow holes.

7. The insertion catheter for mucosal jejunostomy according to claim 2, characterized in that: The inflation chamber (311) is filled with a mixed gas, which is a mixture of oxygen and carbon dioxide.

8. The insertion catheter for mucojejunostomy according to claim 1, characterized in that: The diameter of the tube body (1) is 1-1.5 cm.

9. The method for dilating an insertion catheter for mucosal jejunostomy according to claim 1, characterized in that: The gyro-shaped tube sleeve (21) is made of soft silica gel.

10. The insertion catheter for mucojejunostomy according to claim 1, characterized in that: The support block (22) is provided with a plurality of notches, and the diameter of the notches is 0.15-0.25 cm.

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