Saccule conveying device
Technical Field
The invention relates to the field of medical instruments, in particular to a balloon conveying device.
Background
With the increasing aging of the population, vascular diseases are increasingly threatening the health of people, wherein arterial vascular stenosis directly endangers the life safety of patients. The balloon dilation technology can effectively treat arterial stenosis, and is characterized in that under the guidance of medical imaging equipment, a balloon catheter is inserted into a stenosis part of a vessel by using a percutaneous puncture technology, and the balloon dilation and the dilation are carried out under strict monitoring, so that the stenosis part of the vessel is dilated, and the lumen diameter is recovered. However, some patients after surgery have restenosis due to vascular endothelial injury, intimal hyperplasia, and lack of support for the dilated vessel.
On this basis, balloons with drug coatings are presented. The balloon is coated with a drug with therapeutic effect on the outer surface of the balloon, namely, a drug coating is formed on the outer wall of the balloon. After the balloon reaches the lesion site in the blood vessel, the drug coating on the surface of the balloon is contacted with the inner wall of the blood vessel by expanding the balloon. The medicine is released and acts on the lesion site, thereby achieving the purpose of treating vascular restenosis. Although the drug coated balloon has positive therapeutic effect, it was found that during actual use, there is a certain amount of drug loss during the balloon production folding process because the drug coating is directly attached to the balloon surface; in addition, in the process of the medicine balloon entering the blood vessel, the medicine on the surface of the balloon can fall off due to friction with the inner wall of the blood vessel, so that the medicine balloon can not well send the medicine to the lesion part completely.
Patent application publication number CN 115920210A discloses a double-layer saccule conveying device, which comprises a catheter seat, a middle rod and a tip, wherein the far end of the middle rod is of a single-cavity tubular structure and is connected with the tip, and the near end of the middle rod is of a three-cavity tubular structure to form a guide wire channel, a filling channel and a conveying channel which are respectively connected with three joints of the catheter seat; the balloon body consisting of an inner balloon and an outer balloon is arranged outside the single-lumen tube at the far end of the middle rod.
According to the double-layer balloon conveying device, after filling liquid conveyed through the conveying channel passes through micropores of the outer-layer balloon, the drug coating of the outer-layer balloon is released or falls off. However, the double-layer balloon delivery device still has a certain amount of loss of drug on the surface of the outer balloon during the balloon production folding process.
Disclosure of Invention
The invention aims to solve the problems, and provides a balloon conveying device which does not adopt a drug coating mode, but infuses the drug when the drug balloon reaches the lesion site, so that the drug acts on the lesion site through the micropores of the outer balloon, and the drug loss of the drug balloon in the production folding and using expanding processes is reduced.
The technical scheme for solving the problems is as follows:
a balloon delivery device, comprising:
a multi-lumen catheter body including a guidewire lumen for receiving a guidewire, an inflation lumen for inflating an inner balloon, and a delivery lumen for delivering a drug;
the balloon body is arranged at the far end of the catheter body and comprises an inner balloon and an outer balloon with micropores on the surface.
Preferably, the inner balloon and the outer balloon each comprise a middle straight portion and tapered portions at both ends; the diameter of the inner balloon is 2-12 mm; the diameter of the outer balloon is larger than that of the inner balloon; the diameter difference is 1-2 mm, and a gap is reserved between the two layers of balloons.
Preferably, the straight part and the tapered part of the outer balloon are respectively provided with micropores for medicament to exude, and the diameter of each micropore is 0.5-10 nm.
Preferably, the catheter body comprises an outer tube, an inner tube and a guide wire tube which are coaxial; the inner balloon proximal end is connected with the inner tube distal end, and the inner balloon distal end is connected with a wire guide tube inside the inner balloon; the outer balloon proximal end is connected with the outer tube distal end, and the outer balloon distal end is connected with the guide wire tube.
Preferably, the inner cavity of the guide wire tube is a guide wire cavity for accommodating a guide wire; the conveying cavity is formed between the inner wall of the outer tube and the outer wall of the inner tube; and the filling cavity is formed between the inner wall of the inner tube and the outer wall of the guide wire tube.
Preferably, the catheter body comprises a guide wire tube, a delivery tube and a filling tube which are independent; the distal end of the inner balloon is connected with the distal end of the guide wire tube, one side of the proximal end of the inner balloon is connected with the distal end of the conveying tube, and the other side of the proximal end of the inner balloon is connected with the distal end of the filling tube; the outer balloon distal end is connected with the guide wire tube, one side of the outer balloon proximal end is connected with the distal end of the conveying tube, and the other side is connected with the distal end of the filling tube.
Preferably, the inner cavity of the guide wire tube is a guide wire cavity for accommodating a guide wire; the inner cavity of the conveying pipe is the conveying cavity; the filling pipe inner cavity is the filling cavity.
Preferably, the proximal end of the catheter body is provided with a catheter seat, and the catheter seat comprises a medicine injection port, a filling port and a guide wire cavity inlet; the guide wire cavity inlet is connected with the guide wire cavity; the filling port is connected with the filling cavity; the medicine injection port is connected with the conveying cavity.
Preferably, the proximal end of the catheter body is sleeved with a stress buffer piece; the distal end of the guide wire tube in the catheter body is provided with a sharp end; two developing rings are embedded on the wall of the wire guide tube in the inner balloon.
Preferably, the drug delivered by the balloon delivery device is a paclitaxel solution.
In the technical scheme, the near end refers to one end of a medical instrument operated by a doctor; distal refers to: one end of the medical instrument firstly extends into the patient; balloon diameter refers to: balloon is inflated to the diameter of the balloon body at the recommended pressure.
The invention has the following beneficial effects:
1. according to the balloon conveying device, a medicine coating mode is not adopted, and medicine is injected when the medicine balloon reaches a lesion part, so that the medicine acts on the lesion part through the micropores of the outer balloon, and the medicine loss of the medicine balloon in the production folding and using expanding processes is reduced;
2. in the use process of the balloon conveying device, the high-pressure balloon is not required to be used in advance for pre-expanding in order to enable the medicine to reach the inner membrane of the blood vessel, and the medicine can reach the inner membrane of the blood vessel by direct use, so that the operation time is shortened, and the efficiency is improved;
3. the balloon conveying device comprises the coaxial multi-cavity catheter body with good flexibility and the catheter body with the independent cavity and strong pushing capability, can be selected according to different use scenes, and has a wide application range.
Drawings
FIG. 1 is a schematic structural view of a balloon delivery device of the present invention incorporating a coaxial multi-lumen catheter body;
FIG. 2 is a cross-sectional view of a coaxial multi-lumen catheter body of the present invention;
FIG. 3 is a cross-sectional view of a balloon of the present invention;
FIG. 4 is a schematic structural view of a balloon delivery device of the catheter body of the present invention having independent lumens;
fig. 5 is a cross-sectional view of a catheter body of the independent lumen of the present invention.
In the figure, 1-catheter body, 11-outer tube, 12-inner tube, 13-wire guide tube, 14-delivery tube, 15-filling tube, 2-balloon body, 21-inner balloon, 22-outer balloon, 3-catheter hub, 31-drug injection port, 32-filling port, 33-wire guide cavity inlet, 4-delivery cavity, 5-filling cavity, 6-wire guide cavity, 7-stress buffer, 8-tip, 9-developing ring.
Detailed Description
The following describes the embodiments of the present invention further with reference to the drawings and examples. The following examples are only for more clearly illustrating the technical aspects of the present invention, and are not intended to limit the scope of the present invention.
To more clearly describe embodiments of the present invention, the terms "proximal" and "distal" are defined. The end of the medical instrument that the physician manipulates is defined as the "proximal end" and the end of the medical instrument that first protrudes into the patient is defined as the "distal end". The above definitions of "proximal" and "distal" are provided for convenience in describing embodiments of the present invention only and are not limiting on the structure of the present invention.
Example 1
As shown in figure 1, the proximal end of a catheter body 1 is connected with a catheter seat 3, a stress buffer piece 7 is fixedly sleeved on the proximal end of the catheter body 1 and connected with the distal end of the catheter seat 3, and the distal end of the catheter body 1 is connected with a balloon body 2.
As shown in fig. 1 and 2, the catheter body 1 is made of polyamide, and includes an outer tube 11, an inner tube 12 and a guide wire tube 13 which are coaxial. The balloon body 2 connected to the distal end of the catheter body 1 includes an inner balloon 21 and an outer balloon 22. The proximal end of the inner balloon 21 is connected to the distal end of the inner tube 12, and the distal end of the inner balloon 21 is connected to the guidewire tube 13 inside the inner balloon 21. The proximal end of the outer balloon 22 is connected to the distal end of the outer tube 11 and the distal end of the outer balloon 22 is connected to the guidewire tube 13. The inner wall of the outer tube 11 and the outer wall of the inner tube 12 form a delivery cavity 4 for delivering the drug between the outer balloon 22 and the inner balloon 21; the inner wall of the inner tube 12 and the outer wall of the guide wire tube 13 form a filling cavity 5 for filling the inner balloon 21, and the inner cavity of the guide wire tube 13 is a guide wire cavity 6 for containing guide wires. The distal end of the guide wire tube 13 is connected with a tip head 8. Two developing rings 9 are embedded on the wall of the wire guide tube 13 in the inner balloon 21, and the two developing rings 9 are respectively arranged near the proximal end and the distal end of the inner balloon 21 and used for positioning the balloon conveying device in the input and use processes.
The catheter holder 3 is provided with three inlets, namely a guidewire lumen inlet 33, a filling port 32 and a drug injection port 31. The guide wire cavity inlet 33 is connected with the guide wire cavity 6 of the catheter body 1 and is an inlet of a guide wire; the filling port 32 is connected with the filling cavity 5 of the catheter body 1 and is used for expanding the inner balloon 21; the drug injection port 31 is connected to the delivery lumen 4 of the catheter body 1 for delivering a drug.
The inner balloon 21 and the outer balloon 22 each include a straight portion in the middle and tapered portions at both ends, and the straight portion is integrally connected with the tapered portions at both ends. The inner balloon 21 is a high-pressure balloon, is made of a nylon and Pebax mixed material, and can bear the pressure of more than 30 atm; the diameter of the inner balloon 21 is 12mm. The outer balloon 22 is a permeable membrane balloon, and is made of cellulose acetate membrane; the diameter of the outer balloon 22 is 14mm. Micropores are formed in the middle straight part and the two tapered ends of the outer balloon 22, and the diameter of micropores on the surface of the outer balloon 22 is 9nm. The relative positions of the guidewire tube 13, the inner balloon 21, and the outer balloon 22 can be seen in fig. 3.
The balloon delivery device is assembled as follows: the tip 8 is welded with the distal end of the guide wire tube 13, then the distal end of the inner balloon 21 is welded with the guide wire tube 13, the proximal end of the inner balloon 21 is welded with the distal end of the inner tube 12, and the inner balloon 21 is folded; placing the folded inner balloon 21 into the outer balloon 22; the outer balloon 22 is folded by welding the distal end of the outer balloon 22 to the guidewire tube 13, and welding the proximal end of the outer balloon 22 to the distal end of the outer tube 11. The lengths of the outer tube 11, the inner tube 12 and the guide wire tube 13 are cut, the delivery cavity 4 is connected with the medicine injection port 31, the filling cavity 5 is connected with the filling port 32, and the guide wire tube 13 is connected with the guide wire cavity inlet 33.
The balloon conveying device comprising the coaxial multi-cavity catheter body 1 has better flexibility and trafficability, and is suitable for the conditions of longer path and less bending. In use, a guidewire is inserted from the guidewire lumen inlet 33, the balloon body 2 is pushed to the stenosed vessel site under the direction of the guidewire and the developing ring 9, the inner balloon 21 is rapidly expanded through the filling lumen 5 to fill to 30atm to a diameter of 12mm, the outer balloon 22 is supported to a diameter of 14mm, and a gap exists between the inner balloon 21. At this time, the paclitaxel solution is injected through the drug injection port 31 of the catheter holder 3, so that the paclitaxel solution reaches between the outer balloon 22 and the inner balloon 21 through the delivery cavity 4 of the catheter body 1, and permeates onto the vessel wall through the micropores on the surface of the outer balloon 22, thereby realizing the effect of resisting the proliferation of the intima of the vessel.
Example 2
As shown in fig. 4, the proximal end of a catheter body 1 is connected with a catheter seat 3, a stress buffer piece 7 is fixedly sleeved on the proximal end of the catheter body 1 and connected with the distal end of the catheter seat 3, and the distal end of the catheter body 1 is connected with a balloon body 2.
As shown in fig. 4 and 5, the catheter body 1 includes a guidewire tube 13, a filling tube 15, and a delivery tube 14 that are independent of each other. The balloon body 2 connected to the distal end of the catheter body 1 includes an inner balloon 21 and an outer balloon 22. The distal end of the inner balloon 21 is connected to the guidewire tube 13, and the proximal end of the inner balloon 21 is connected on one side to the distal end of the delivery tube 14 and on the other side to the distal end of the filling tube 15. The distal end of the outer balloon 22 is connected to the guidewire tube 13, and the proximal end of the outer balloon 22 is connected on one side to the distal end of the delivery tube 14 and on the other side to the distal end of the filling tube 15. The inner cavity of the delivery tube 14 is a delivery cavity 4 for delivering medicines, and the inner cavity of the filling tube 15 is a filling cavity 5 for filling the inner balloon 21; the lumen of the guidewire tube 13 is the guidewire lumen 6 that accommodates the guidewire. Two developing rings 9 are embedded on the wall of the wire guide tube 13 in the inner balloon 21, and the two developing rings 9 are respectively arranged near the proximal end and the distal end of the inner balloon 21 and used for positioning the balloon conveying device in the process of input and use.
The catheter holder 3 is provided with three inlets, namely a guidewire lumen inlet 33, a filling port 32 and a drug injection port 31. The guide wire cavity inlet 33 is connected with the guide wire tube 13 and is an inlet of the guide wire; the filling port 32 is connected with the filling cavity 5 and is used for expanding the inner balloon 21; the drug injection port 31 is connected to the delivery chamber 4 for delivering the drug.
The inner balloon 21 and the outer balloon 22 each include a straight portion in the middle and tapered portions at both ends, and the straight portion is integrally connected with the tapered portions at both ends. The inner balloon 21 is a high-pressure balloon, is made of a nylon and Pebax mixed material, and can bear the pressure of more than 30 atm; the diameter of the inner balloon 21 is 10mm. The outer balloon 22 is a permeable membrane balloon, and is made of an aromatic polyhydrazide membrane; the diameter of the outer balloon 22 is 11mm. Micropores are arranged at the middle straight part and the tapered parts of the two ends of the outer balloon, and the diameter of micropores on the surface of the balloon is 7nm. The relative positions of the guidewire tube 13, the inner balloon 21, and the outer balloon 22 can be seen in fig. 3.
The balloon delivery device is assembled as follows: the tip 8 is welded with the distal end of the guide wire tube 13, then the distal end of the inner balloon 21 is welded with the guide wire tube 13, one side of the proximal end of the inner balloon 21 is welded with the distal end of the filling tube 15, the other side is welded with the distal end of the conveying tube 14, and the inner balloon 21 is folded; placing the folded inner balloon 21 into the outer balloon 22; the outer balloon 22 is welded to the guidewire tube 13 at the distal end, the filling tube 15 is welded to one side of the outer balloon 22 at the proximal end, the delivery tube 14 is welded to the other side, and the outer balloon 22 is folded. By cutting the catheter body 1, the exposed lengths of the filling tube 15, the guide wire tube 13 and the delivery tube 14 are different, the delivery lumen 4 is connected to the drug injection port 31, the filling lumen 5 is connected to the filling port 32, and the guide wire lumen 6 is connected to the guide wire lumen inlet 33.
The balloon delivery device comprising the independent lumen catheter body 1 has better mountain turning and pushing capabilities, i.e. more capability to reach the lesion through stenosed and bent sites. In use, a guidewire is inserted from the guidewire lumen inlet 33, the balloon body 2 is pushed to the stenosed vessel site under the direction of the guidewire and the developing ring 9, the inner balloon 21 is rapidly expanded through the filling lumen 5 to a diameter of 10mm, the outer balloon 22 is supported to a diameter of 11mm, and a gap exists between the inner balloon 21 and the guidewire. At this time, the paclitaxel solution is injected through the drug injection port 31 of the catheter seat 3, so that the paclitaxel solution reaches between the outer balloon 22 and the inner balloon 21 through the delivery cavity 4, and permeates onto the wall of the blood vessel through the micropores on the surface of the outer balloon 22, thereby realizing the effect of resisting the proliferation of the intima of the blood vessel.
According to the balloon conveying device, a medicine coating mode is not adopted, and medicine is injected when the medicine balloon reaches a lesion part, so that the medicine acts on the lesion part through micropores on the surface of the outer balloon, and the medicine loss of the medicine balloon in the production folding and using expanding processes is reduced; meanwhile, the step of pre-dilating the blood vessel by using the medicine saccule is reduced, and the operation time is shortened.