Novel esophagus dilating balloon catheter
Technical Field
The invention relates to a novel esophageal dilatation balloon catheter, in particular to a design and use method of a novel dilatation balloon, and belongs to the technical field of medical biomaterials.
Background
Esophageal atresia is a common congenital malformation of the digestive tract, with a prevalence of about 1/3000-4000 in live newborns. With the progress of surgical operation technology, perioperative intensive care technology, infant endoscopic technology and perioperative nutrition support, the survival rate of infants is obviously improved. However, postoperative complications such as stoma stenosis, stoma leakage, gastroesophageal reflux and the like still affect the quality of life of the infant patient. Among them, anastomotic stenosis is a common complication, and the incidence rate is reported to be 18% -50% in literature. In addition, the esophageal stenosis caused by various reasons comprises congenital stenosis, and the postnatal stricture such as erosive esophagitis, postoperative anastomotic stenosis and the like needs to be repeatedly dilated for many times.
There are two main expansion modes: a hard bougie and a soft balloon. The hard bougie plays a role in expansion under a gastroscope by moderately tearing the esophageal muscle layer through the bougie. However, studies have shown that the force generated by a rigid bougie when dilating the oesophagus is only a longitudinal axial shear force, which may cause damage to the oesophageal lining or even perforation. The force generated by balloon expansion is annular radial expansion force, thereby greatly reducing the possibility of esophageal injury caused by over-concentrated force. The balloon dilatation catheter is made of a nylon material with good plasticity, has good bending performance, effectively reduces damage to the cavity channel when passing through, is provided with the developing mark, can accurately judge the position of the catheter when in use, has good balloon permeability, can clearly observe the expansion, tearing and bleeding conditions, and has good safety. However, in any expansion mode, the expansion needs to be completed under an endoscope or under X-ray radiography, the treatment procedure is complicated, and the radiation exposure of medical workers and patients is increased. Partial or multiple dilations are required, which causes them to be hospitalized for many times, increasing the cost of treatment, and therefore, there is an urgent need for a new solution to the above technical problems.
Disclosure of Invention
Aiming at the problems in the prior art, the invention provides a novel esophageal dilatation balloon catheter, and the technical scheme realizes multiple intermittent dilatation of the stenosed esophagus through a specially-made three-cavity two-balloon catheter, so that multiple endoscopic or radiography operations are avoided. Meanwhile, the esophagus restenosis caused by gastroesophageal reflux after the patient eats is reduced through the intragastric anti-reflux bag.
In order to achieve the purpose, the technical scheme of the invention is that the novel esophageal dilatation balloon catheter comprises an esophageal dilatation balloon at the upper end, an anti-reflux balloon at the lower end, a central nasogastric tube, a guide wire in the central catheter and a water injection port with a valve at the tail end, wherein the esophageal dilatation balloon is positioned at the upper end of the novel dilatation balloon and is placed at the esophageal stenosis part in an esophagus, the anti-reflux balloon is positioned at the lower end of the novel dilatation balloon and is placed at the cardia part in the stomach, and the central nasogastric tube is positioned at the central part of the novel esophageal dilatation balloon and is hollow, so that gastrointestinal decompression or nasogastric feeding can be performed. The tail end water injection interface with the valve is positioned at the tail end of the novel esophagus expansion balloon catheter, and expansion pressure adjustment is respectively carried out on the esophagus expansion balloon and the anti-reflux balloon by controlling the water injection amount. The central nasal feeding tube can be used for fluid diet nasal feeding, and early enteral nutrition is realized. When the esophageal dilatation catheter is not inflated, the main pipeline body extends smoothly from the three end cavities without obvious bulges, so that the difficulty of intubation is reduced, and the pharyngeal response during intubation is reduced. The main pipeline is a high-elasticity pipeline, the esophagus dilating sac and the anti-reflux sac are both compressed water (gas) sacs, and the esophagus dilating sac is expanded into an olive shape and the anti-reflux sac is expanded into a mushroom head shape after being filled with water (gas). After water (gas) is pumped out, the air bag is compressed again under the elastic restoring force of the high-elasticity main body, and the iatrogenic risk of rebleeding is reduced during tube drawing.
As an improvement of the invention, the novel esophagus dilating sacculus catheter is a specially-made three-cavity two-sac catheter, the esophagus dilating sacculus is an olive-shaped or sac-shaped sacculus, the anti-reflux sacculus is a mushroom head-shaped sacculus, and the mushroom head shape is designed to prevent the pipeline from falling off in clinic.
As an improvement of the invention, the water injection interface with the valve at the tail end comprises an esophagus expansion balloon water injection pipe and an anti-reflux balloon water injection pipe, and the esophagus expansion balloon water injection pipe and the anti-reflux balloon water injection pipe are respectively communicated with the esophagus expansion balloon and the anti-reflux balloon.
As an improvement of the invention, the tail ends of the esophagus dilating sac water injection pipe and the anti-reflux sac water injection pipe are respectively provided with a threaded anti-reflux valve, and an indicating saccule is arranged between the anti-reflux valve and the water injection pipe. The balloon used by the indicating balloon is harder than the esophagus dilating balloon and the anti-reflux balloon, and whether the esophagus dilating balloon and the anti-reflux balloon are in a water injection state or are broken and leaked can be judged according to the hardness of the indicating balloon.
As an improvement of the invention, the threaded anti-backflow valve is a one-way valve and comprises a water injection funnel, a sealing plug, a supporting rod, a spring, a sealing ring, a baffle and a tail end threaded connector, wherein the diameter of the top of the water injection funnel is larger than that of a syringe nipple, the diameter of the bottom of the water injection funnel is smaller than that of the syringe nipple, the bottom of the funnel is provided with a hole, the sealing plug and the supporting rod are of an integrally formed structure, the supporting rod is inserted on the baffle in a sliding mode, the spring is located between the sealing plug and the baffle, the inner diameter of the sealing ring is smaller than that of the sealing plug, the sealing ring is fixed on the inner side wall of the tail end of the anti-. The one-way valve can free hands of medical staff or patients after water injection (gas injection) and avoid applying a water injection port of a forceps holder of a hemostatic forceps. Conventional hemostats may cause damage to the vessel or the hemostats may loosen causing the balloon to collapse. The tail end of the anti-backflow valve is provided with threads, and the anti-backflow valve can be stably connected with a pressure measuring pump with a thread design to detect the pressure in the expansion sacculus.
As an improvement of the invention, the upper end and the lower end of the esophagus dilating balloon and the anti-reflux balloon are both provided with metal markers (16), which can be developed under X-ray and are convenient for positioning.
As an improvement of the invention, the surface of the dilatation balloon catheter is provided with length scale marks, so that the catheterization depth can be accurately controlled in the catheterization process.
As an improvement of the invention, the catheter of the central nasal feeding tube is of a hollow structure, has certain strength and does not have obvious internal diameter reduction caused by water injection and extrusion of the saccule. The inner diameter of which is larger than the diameter of the guide wire. When the catheter is placed, the guide steel wire plays a role in guiding and supporting, and the catheter placing operation is facilitated. The tail end of the nasogastric feeding tube is provided with a threaded interface, and gastrointestinal decompression can be carried out by connecting a heparin cap to close the nasogastric feeding tube or connecting a decompression bag.
As an improvement of the invention, the esophagus dilating saccule can be respectively positioned at the upper section, the middle section and the lower section of the esophagus to dilate strictures at different parts, the distance between the esophagus dilating saccule and the anti-reflux saccule is 2cm-30cm, and 2cm is an interval. The length of the expansion capsule is 4cm-8cm, and 2cm is an interval. The diameter of the expansion capsule is 6mm-20mm, and 2mm is an interval. The diameters are serialized in length. The diameter of the anti-backflow balloon is 2-6cm, 1cm is an interval, the length of the anti-backflow balloon is 1-2cm, and 1cm is an interval. The diameters are serialized in length. The diameter of the outer tube of the novel esophageal dilatation balloon catheter is less than 4mm under the state of no water injection. The main pipeline is a high-elasticity silica gel or rubber pipe, the balloon is made of high polymer such as polyurethane, silica gel and the like, and the indicating balloon is made of PVC material with smaller adaptability than the expanding and anti-backflow balloon. The pressure indication bag is a simple PVC plastic bag, whether the expansion bag or the anti-backflow bag is in a water injection state or damaged is judged through the filling degree of the pressure indication bag, the operation is simple, the cost is low, and the pressure indication bag can be accurately measured through the water injection tail end connection pressure measuring pump.
Compared with the prior art, the invention has the advantages that 1) the technical scheme provides the esophageal dilatation balloon catheter which has the function of repeatedly and discontinuously dilating for many times by placing the catheter once; 2) the anti-reflux sac in the technical scheme can reduce the incidence of esophageal restenosis caused by gastroesophageal reflux in the early stage after operation; 3) the central nasal feeding tube can be used for nasal feeding of nutrient solution or gastrointestinal decompression operation; when in use, the guide wire is arranged in the nasal feeding tube, so that the hardness of the catheter is increased, and the difficulty index of the medical care personnel in operation can be reduced; 4) the design reduces the times of gastroscopy and radiography of patients through the intermittent expansion of the esophageal dilatation balloon; the expansion of the lower anti-reflux balloon avoids reflux esophagitis and esophageal restenosis caused by gastroesophageal reflux after eating; the central nasal feeding tube can be used for fluid diet nasal feeding, and early enteral nutrition is realized. The design of the central nasal feeding tube can realize enteral nutrition in the early stage of operation, and the effect of placing the esophagus in the early stage of operation can be realized by combining the application of the anti-reflux sac, so that the effects of gastroesophageal reflux on healing of an anastomotic stoma are avoided, meanwhile, enteral nutrition is restored as soon as possible, the integrity of the cell structure and the function of the intestinal mucosa is maintained, the intestinal mucosa barrier is maintained, and the intestinal bacteria displacement and the intestinal infection are reduced. In addition, the negative pressure sac is connected with the tail end of the central nasal feeding tube during flatulence so as to play a role in gastrointestinal pressurization, improve blood circulation of gastrointestinal walls and promote recovery of functions of digestive tracts.
Drawings
FIG. 1 is a schematic structural view of the present invention;
FIG. 2 is a schematic view of a check valve of the present invention;
in the figure: the novel esophagus dilating balloon catheter comprises a novel esophagus dilating balloon catheter 1, an anti-reflux valve 2, an indication balloon 3, an esophagus dilating balloon 11, an anti-reflux balloon 12, a central nasal feeding catheter 13, a guide wire 14, water injection interfaces 151 and 152, a metal mark 16, an anti-reflux valve 2, a water injection funnel 21, a sealing plug 22, a support rod 23, a spring 24, a sealing ring 25, a baffle 26 and a threaded interface 27.
The specific implementation mode is as follows:
for the purpose of enhancing an understanding of the present invention, the present embodiment will be described in detail below with reference to the accompanying drawings.
Example 1: referring to fig. 1, a novel esophageal dilatation balloon catheter comprises an esophageal dilatation balloon 11 at the upper end, an anti-reflux balloon 12 at the lower end, a central nasogastric tube 13, a guide wire 14 in the central catheter and a tail end water injection connector 15 with a valve, wherein the esophageal dilatation balloon 11 is positioned at the upper end of the novel dilatation balloon and is placed at the esophageal stenosis position in the esophagus, the anti-reflux balloon 12 is positioned at the lower end of the novel dilatation balloon and is placed at the cardia position in the stomach, and the central nasogastric tube 13 is positioned at the central part of the novel esophageal dilatation balloon 1 and is hollow, so that gastrointestinal decompression or nasal feeding can be performed. The tail end water injection interface 15 with the valve is positioned at the tail end of the novel esophagus expansion balloon catheter 1, and expansion pressure adjustment is respectively carried out on the esophagus expansion balloon 11 and the anti-reflux balloon 12 by controlling water injection amount. The central nasal feeding tube can be used for fluid diet nasal feeding, and early enteral nutrition is realized. When the esophageal dilatation catheter is not inflated, the main pipeline body extends smoothly from the three end cavities without obvious bulges, so that the difficulty of intubation is reduced, and the pharyngeal response during intubation is reduced. The main pipeline is a high-elasticity pipeline, the esophagus dilating sac and the anti-reflux sac are both compressed water (gas) sacs, and the esophagus dilating sac is expanded into an olive shape and the anti-reflux sac is expanded into a mushroom head shape after being filled with water (gas).
After water (gas) is pumped, the air bag is compressed again under the elastic restoring force of the high-elasticity main body, the iatrogenic risk of rebleeding is reduced during tube drawing, the novel esophagus dilating balloon catheter 1 is a specially-made three-cavity two-balloon catheter, the esophagus dilating balloon 11 is an olive-shaped or balloon-shaped balloon, the anti-reflux balloon 12 is a mushroom head-shaped balloon, the specific shape can be properly adjusted in normal use, the tail-end valved water injection interface 15 comprises an esophagus dilating balloon water injection tube 151 and an anti-reflux balloon water injection tube 152, the esophagus dilating balloon water injection tube 151 and the anti-reflux balloon water injection tube 152 are respectively communicated with the esophagus dilating balloon 11 and the anti-reflux balloon 12, the tail ends of the esophagus dilating balloon water injection tube 151 and the anti-reflux balloon water injection tube 152 are respectively provided with a threaded anti-reflux valve 2, and an indicating balloon 3 is arranged between the anti-reflux valve and the water injection tube. The balloon used by the indication balloon 3 is harder than the esophagus dilation balloon 11 and the anti-reflux balloon 12, whether the esophagus dilation balloon 11 and the anti-reflux balloon 12 are in a water injection state or are broken and leak water can be judged by indicating the hardness of the balloon, the threaded anti-reflux valve 2 is a one-way valve and comprises a water injection funnel 21, a sealing plug 22, a support rod 23, a spring 24, a sealing ring 25, a baffle 26 and a tail end threaded connector 27, the diameter of the top of the water injection funnel 21 is larger than that of an injector nipple, the diameter of the bottom of the water injection funnel is smaller than that of the injector nipple, the bottom of the funnel is provided with a hole, the sealing plug 22 and the support rod 23 are of an integrated structure, the support rod 23 is inserted and connected onto the baffle 26 in a sliding manner, the spring 24 is positioned between the sealing plug 22 and the baffle 26, the inner diameter of the, the supporting baffle 26 is provided with a hole and fixed on the inner side wall of the injection anti-backflow valve, metal markers 16 are arranged at the upper end and the lower end of the esophagus dilating saccule 11 and the anti-backflow saccule 12 and can be developed under X-rays to facilitate positioning, length scale marks are arranged on the surface of the dilating saccule conduit to facilitate accurate control of the depth of the conduit in the conduit arranging process, the conduit of the central nasal feeding tube 13 is of a hollow structure and has certain strength, and the obvious inner diameter reduction caused by water injection extrusion of the saccule does not occur. Its inner diameter is larger than the guide wire diameter 14. When the catheter is placed, the guide steel wire plays a role in guiding and supporting, and the catheter placing operation is facilitated. The tail end of the nasogastric feeding tube is provided with a threaded interface, the nasogastric feeding tube can be closed by connecting a heparin cap or is connected with a decompression bag for gastrointestinal decompression, the esophageal dilatation balloons 11 can be respectively positioned at the upper section, the middle section and the lower section of the esophagus to dilate strictures at different parts, the distance between the esophageal dilatation balloon 11 and the anti-reflux balloon 12 is 2cm-30cm, and 2cm is an interval. The length of the expansion capsule is 4cm-8cm, and 2cm is an interval. The diameter of the expansion capsule is 6mm-20mm, and 2mm is an interval. Serialization of diameter and length; the diameter of the anti-reflux balloon 12 is 2-6cm, 1cm is an interval, the length is 1-2cm, and 1cm is an interval. The diameters are serialized in length. The diameter of the outer tube of the novel esophageal dilatation balloon catheter 1 is less than 4mm under the state of no water injection. The main pipeline is a high-elasticity silica gel or rubber pipe, the balloon is made of high polymer such as polyurethane, silica gel and the like, and the indicating balloon is made of PVC material with smaller adaptability than the expanding and anti-backflow balloon.
Application embodiment and working process: a special three-cavity two-sac catheter is shown in figure 1 and comprises an upper esophageal dilatation balloon 11, a lower anti-reflux balloon 12, a central nasogastric tube 13, a guide wire 14 in the central catheter and a water injection interface 15 with a valve at the tail end. The esophagus dilating balloon 11 is positioned at the upper end of the novel dilating balloon and is placed at the esophageal stenosis position in the esophagus. The anti-reflux balloon 12 is positioned at the lower end of the novel expansion balloon and is placed at the cardia in the stomach. The central nasal feeding tube 13 is positioned in the central part of the novel esophageal dilatation balloon 1, is hollow and can be used for gastrointestinal decompression or nasal feeding. The tail end water injection interface 15 with the valve is positioned at the tail end of the novel esophagus expansion balloon catheter (1), and expansion pressure adjustment is respectively carried out on the esophagus expansion balloon 11 and the anti-reflux balloon 12 by controlling water injection amount.
Before operation, medical workers determine the position and range of esophageal stenosis through the results of gastrointestinal radiography, endoscopy or intraoperative measurement, and select an esophageal dilatation balloon catheter with an appropriate size (including indexes such as balloon diameter, length, distance between an dilatation balloon and an anti-reflux balloon and the like). An esophageal dilatation balloon is placed under the guidance of the guide wire 14. The position relationship of the two balloons is determined by X-ray examination according to the metal mark 16. The esophageal stenosis caused by scar hyperplasia can be prevented by intermittently injecting water into the expansion capsule for multiple times for expansion in the early stage after operation. During the expansion process, attention needs to be paid to the expansion duration and the balloon tension, so that esophageal mucosa ischemia caused by excessive compression is avoided. The specific pressure is 0.5-3 atm, the expansion time is 3-5 minutes, and the expansion is performed 3-5 times per day. After nasal feeding, the anti-reflux sac is injected with water, the dilation catheter is properly pulled to enable the anti-reflux sac to be tightly attached to the cardia opening, and the condition that the reflux stimulates the anastomotic orifice to cause anastomotic orifice leakage or stenosis due to early gastroesophageal reflux after operation is prevented. The anti-reflux balloon is evacuated after gastric emptying to avoid compression of the gastric fundus mucosa by the balloon. The central nasal feeding tube 13 and the catheter are of a hollow structure, have certain strength, and are not obviously reduced in inner diameter due to water injection and extrusion of the balloon. Its inner diameter is larger than the guide wire diameter 14. The tail end is provided with a threaded interface, and gastrointestinal decompression can be carried out by connecting a heparin cap to close a nasogastric tube or connecting a decompression bag.
According to fig. 2, the one-way anti-backflow valve 2 is disposed at the water injection ports 151 and 152, and includes a water injection funnel 21, a sealing plug 22, a support rod 23, a spring 24, a sealing ring 25, a baffle 26, and a tail end screw connector 27. The diameter of the top of the water injection funnel 21 is larger than that of the injector nipple, the diameter of the bottom of the water injection funnel is smaller than that of the injector nipple, and the bottom of the funnel is provided with a hole. The sealing plug 22 and the support rod 23 are of an integrally formed structure, the support rod 23 is inserted on the baffle 26 in a sliding mode, and the spring 24 is located between the sealing plug 22 and the baffle 26. The inner diameter of the sealing ring 25 is smaller than the diameter of the sealing plug 22, and the sealing ring 25 is fixed on the inner side wall of the tail end of the anti-backflow valve. The support baffle 26 is provided with a hole and fixed on the inner side wall of the injection-resisting backflow valve. In the operation process, an injector or a water injection pump with pressure detection is connected with the anti-backflow valve threaded interface, and a nipple of the injector or the pressure pump pushes a water injection funnel to enable a sealing plug and a support rod complex to move downwards so as to enable a one-way valve to be opened for water injection or water pumping. After the operation is finished, the injector or the pressure pump is pulled out, the complex rebounds under the action of the spring, so that the sealing plug and the sealing ring are tightly attached to close the valve, and the backflow resisting effect is achieved.
According to the illustration in fig. 1, an indication balloon 3 is arranged at the lower end of the anti-reflux valve, and the anti-reflux valve is characterized in that: the used balloon is harder than the esophagus dilating balloon 11 and the anti-reflux balloon 12, and whether the esophagus dilating balloon 11 and the anti-reflux balloon 12 are in a water injection state or are broken and leaked can be judged by indicating the hardness of the balloon.
It should be noted that the above-mentioned embodiments are not intended to limit the scope of the present invention, and all equivalent modifications and substitutions based on the above-mentioned technical solutions are within the scope of the present invention as defined in the claims.