Traction Device for Curved Balloon Catheter and Traction Method

Abstract

Provided is a traction device for curved balloon catheter, which is characterized by comprising: a catheter (5) with a handle (2) at one end, a locator (3) and a traction balloon (4) arranged outside the catheter (5), which one or more cavities are arranged in the catheter (5), the catheter part is provided with at least one hole, at least one cavity fills and discharges the traction balloon (4) with fluid through the hole, the traction balloon (4) bends to one side when filled with fluid, and the handle (2) can drive the catheter (5) and the traction balloon (4) to rotate, thus realizing a simple and reliable traction.

Claims

1. The device is characterized by comprising a catheter with a handle at one end, a positioner and a pulling bag arranged outside the catheter, wherein a plurality of lumina are formed in the catheter, at least one first hole is formed in the connecting part of the catheter portion and the pulling bag, at least one first lumen is used for fluid filling the traction bag through the first hole, and when the pulling balloon is filled with fluid, one side is bent; The catheter portion is further provided with at least one second hole which is not connected with the pulling balloon, the at least one second lumen can be used for extracting gas or liquid in the esophagus through the second hole, so that the whole to-be-pulled section of the esophagus is better attached to the outside of the balloon catheter, and the whole pull is easy and effective; the handle can drive the catheter and the pulling balloon to rotate.

2. The device of claim 1, wherein said positioner is a device employing a developer that is capable of viewing its position within the body by X-ray.

3. The balloon catheter retractor of claim 1, wherein the positioner is one or more balloons positioned at a fixed location of the catheter, the balloon being filled with fluid to catch the interior lumen of the human body.

4. The balloon catheter retractor of claim 1, wherein the handle comprises a portion that is held stationary, and a rotatable angle portion.

5. The balloon catheter distraction device of claim 4, wherein the handle has an angular dimension indicated thereon, and when the handle is rotated, the handle is used to mark the relative azimuthal angle of the pulling bladder.

6. The balloon catheter retractor of claim 1, wherein the catheter is made of a material that is not susceptible to self-twisting; when the catheter is left in the outside portion of the body cavity, the pulling balloon is rotated to the same extent as the catheter rotated.

7. The balloon catheter retractor of claim 1, wherein the catheter has a length of scale for marking the depth of insertion of the catheter.

8. The balloon catheter retractor of claim 3, wherein one or more of said first lumina are used to fill the balloon with fluid.

9. The balloon catheter retractor of claim 1, wherein at least one of said second lumina is used for drainage of effusion.

10. The balloon catheter retractor of claim 9, wherein an aperture of the lumen of the drainage fluid is located at the upper end of the pulling balloon on the catheter; if there is a positioning balloon, then the aperture of the lumen is positioned at the upper end of the positioning balloon.

11. The balloon catheter retractor of claim 1, wherein at least one of the second lumina is adapted to spray a developer; an aperture of the developer is located at an upper end of the pulling balloon; if there is a positioning balloon, then the aperture of the lumen is positioned between the pulling balloon and the upper positioning balloon.

12. The balloon catheter retractor of claim 1, wherein at least one of said second lumina is adapted to provide a negative pressure, the apertures of which is located between the two ends of the positioning balloons, and the apertures used to suction the negative pressure may have one or more.

13. The device of claim 1, wherein said pulling balloon is made of a material mixed with a developer such that it has the function of being fully developed under X-rays.

14. The balloon catheter retractor of claim 3, wherein the pulling balloon is used for esophageal pulling, the pulling balloon is located between the second and third stenosis of the esophagus, and the diameter of the balloon after filling the fluid is greater than the diameter of the esophagus at the stenosis.

15. A curved balloon catheter retractor is used for pulling the esophagus and is characterized by comprising a handle, a multi-lumen catheter, two positioning balloons, and a pulling balloon; The three lumina in the multi-lumen catheter are respectively provided with apertures at the positions where the three balloons are located and are used for respectively filling the three balloons with fluid; the two positioning balloons are located at the two ends of the pulling balloon and are respectively clamped with the esophagus for fixation; when the pulling balloon is filled with fluid, the pulling balloon is bent to drive the esophagus to bend, so that the esophagus is pulled away from the original position.

16. The balloon catheter retractor of claim 15, wherein the multi-lumen cavity comprises an intermediate large lumen and surrounding small lumina; the surrounding small lumina has apertures located at where the respective balloons are located, respectively, to fill the balloons with fluid, respectively; the intermediate larger lumen has aperture on the upper end of the positioning balloon at the upper end for drainage of the effusion.

17. The balloon catheter retractor of claim 15, wherein the other lumen has aperture between two ends of the positioning balloon and is used to vacuum air so that the entire to-be-pulled section of the esophagus is better attached to the exterior of the balloon catheter, facilitating a more effective overall pulling.

18. The balloon catheter retractor of claim 15, wherein said further lumen can be used to spray a developer to the inner wall of the esophagus for displaying bending condition of the esophagus.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG. 1 is a schematic view of the structure of the present invention.

[0020] FIG. 2 is a cross-sectional view of a catheter portion of the present invention.

[0021] FIG. 3 is a schematic view of a handle portion of the present invention.

[0022] FIG. 4 is a schematic diagram of one embodiment of the present invention.

[0023] FIG. 5 is a schematic diagram of another embodiment of the present invention.

[0024] FIG. 6 is a cross-sectional view of the catheter portion of the embodiment of FIG. 5.

[0025] FIG. 7 is a schematic view of yet another embodiment of the present invention.

[0026] FIG. 8 is a cross-sectional view of the catheter portion of the embodiment of FIG. 7.

[0027] FIG. 9 is a schematic drawing of a curved balloon catheter distraction device retractor.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] The invention will be described in further detail below in conjunction with the appended drawings and examples:

[0029] Please refer to FIG. 1, which is a schematic view of the structure of the present invention. As shown in FIG. 1, A curved balloon catheter retractor of the present invention, The following parts were made up: One end has a flow guide tube and a handle 2 of valve 1, A positioner 3 and a pulling balloon 4 are arranged outside the catheter 5, one or more lumina are formed in the catheter 5, at least one hole is formed in the portion of the catheter 5 in the positioner 3, the at least one lumen is provided with at least one hole through the flow guiding pipe and the valve 1, the at least one lumen is filled with fluid through the hole to the positioner 3 and the pulling balloon 4, and the fluid is generally a liquid and a gas which is bent towards one side when the pulling balloon 4 is filled with fluid. In one embodiment, the gas is injected into the intake port by a syringe. Closing the flow guide tube and valve 1 after injecting the gas may cause the pulling balloon 4 to hold the gas pressure. In general, the pulling balloon 4 is located near the middle or the end of the catheter 5, and the upper and lower ends of the pulling balloon 4 are closed on the catheter 5 by laser welding or bonding. The advantage of using laser welding is that the pulling requires a large pressure inside the capsule to create sufficient rigidity, sometimes up to 10 atmospheres, with only laser welding ensuring reliable sealing. The pulling balloon 4 material of the present invention is semi-compliant or non-compliant, that is, within a larger pressure range, the change in volume and profile after expansion of the pulling balloon 4 is small, thereby protecting the organ from excessive extrusion. The positioner 3 can be two compliant balloon balloons 3 which are respectively fixedly arranged on the catheter 5 at the two ends of the pulling balloon 4 The balloon 3, in some embodiments, is one or more, when one, can be placed at the proximal or distal end of the retractor balloon 4. Balloon 3 is a compliant balloon or non-compliant balloon, which is relatively small in length. Where the number of balloon 3 is multiple, some of the balloon inflation fluid (gas or liquid) may be selected as well during use. The pulling balloon 4 is a non-compliant balloon, and the length-diameter is relatively large. The balloon 3 and the pulling balloon 4 can be made from a raw material mixed with a developer so that it has the function of being fully developed under X-rays.

[0030] Please refer to FIG. 2, which is a cross-sectional view of a catheter portion of the present invention. In FIG. 2, the cross-section of the catheter 5 has three lumina, two of which are used to inflate the balloon 3, and the other lumen 51 is for inflating the balloon 4

[0031] FIG. 3 is a schematic view of a handle portion of the present invention. The handle 2 is used for inflating, injecting, holding, rotating and the like. The inflation and/or injection port 1, determined according to a particular design, has one or more. The handle 2 includes a portion that is held stationary, and a rotatable angle. The handle 2 has a graduated scale 21 on the handle 2 which, when rotated, is used to mark the relative angular orientation of the pulling bladder relative to the organ of the human body or where the tissue needs to be pulled

[0032] Please refer to FIG. 4, which is a schematic diagram of one embodiment of the present invention. In FIG. 4, the positioner or balloon 3 has a positioning mark 31, which may be a developing material, such as a barium sulfate contrast agent. Other positioning devices such as infrared or radio frequency (RF) tags or the like can also be used to enable the physician to measure the specific location of the positioner or balloon 3 in the body outside of the patient's body. In some embodiments, the catheter 5 has a developed line on the catheter 5 for development as X-rays.

[0033] Please refer to FIG. 5 and FIG. 6, which are schematic diagrams of another embodiment of the present invention. FIG. 6 is a cross-sectional view of the catheter portion of the embodiment of FIG. 5. The balloon catheter retractor includes a handle 2, a four-lumen catheter 5, two compliant balloon balloons 3, a semi-compliant or non-compliant pulling balloon 4 with four lumina, respectively, an intermediate large lumen 53, and surrounding three small lumina 51 and 52; three small lumina are provided with holes 511, 521, 522 at the three bladders, respectively, for inflating the three bladders, respectively. The intermediate larger lumen 53 opens up the upper opening 531 of the balloon at the upper end for drainage of saliva.

[0034] The catheter 5 is a hollow catheter with one or more lumina inside the catheter 5. At least one lumen 51 in the lumen is dedicated to filling the pulling bladder 4 with fluid. One or more of the lumina are used to inflate the balloon 3. At least a lumen 53 in the lumen has a lumen 53 for draining saliva; the lumen 53 of the drainage saliva is located at the upper end of the pulling balloon 4 at the location of the opening 531 on the catheter 5; if the balloon 3 is provided, the upper end of the balloon 3 is located at the upper end of the balloon 3

[0035] Please refer to FIGS. 7 and 8, which are schematic diagrams of yet another embodiment of the present invention. FIG. 8 is a cross-sectional view of the catheter portion of the embodiment of FIG. 7. Unlike the previous embodiment, there is no apparent size of the lumen in the present embodiment. The three lumina 51 and 52 of the four-lumen catheter 5 are open at the locations of the three balloons, respectively, to inflate the three balloons, respectively. Another lumen 54 is used to spray a developer (meal; barium sulfate); the hole 541 of the developer is located at the upper end of the pulling balloon 4; as with the balloon 3, between the pulling balloon 4 and the upper balloon 3. The effect of the spray developer is to enable the inner wall of the esophagus to develop, clearly knowing the distance of the distraction.

[0036] In other embodiments, the lumen 54 is used to suction a negative pressure, the open position of which is located in the middle of the two balloon 3, and the holes used to suction the negative pressure may have one or more. In particular, the balloon 3 is inflated first, then air is drawn through the lumen 54 with negative pressure, and finally the pulling balloon 4 is distracted, so that the purpose of bending the esophagus is achieved.

[0037] The catheter is made of a material which is not easy to twist; when the catheter is left outside the human body cavity, a certain proportion of angle is rotated at the same time. At the same time, there is a length of scale on the catheter to mark the depth of catheter insertion.

[0038] The invention also provides a pulling method, which can be inserted into a single-lumen/multi-lumen catheter pipeline in an animal body and can be expanded into an arc-shaped pulling balloon after being injected into the fluid, the pulling balloon is linked to the outside of the catheter, and the catheter can be offset towards the protruding direction of the pulling balloon and can be combined with an operating handle and other related accessories. Tissue traction for use in surgery is accomplished by either natural lumen intervention or open surgical intervention. Procedures include, but are not limited to, various laparoscopic procedures, cardiovascular major surgery, brain surgery, digestive tract surgery, urinary disease surgery, and the like. The retractor tissue includes, but is not limited to, the gastrointestinal tract, the esophagus, the airway, the urethra, the vagina, the bladder, and the like. Distraction objectives include, but are not limited to, protecting a particular tissue, removing a particular tissue to facilitate a surgical procedure.

[0039] The curved balloon catheter of the retractor is regulated by a handle to be inserted into the body through a human body natural cavity or a surgical mode. The position and angle of rotation of the catheter can be adjusted with the handle with the aid of an image device to lock the position and angle with the handle. Inflation of the balloon may be accomplished by an insufflation port of the handle attachment or any other insufflation pathway. After the balloon is inflated, the balloon is inflated and exhibits a curved shape, at least one section of the catheter pipeline has at least one section of bending, and the bending part of the final balloon catheter can complete the pulling or shifting effect of the tissue.

[0040] The effect of the catheter retractor is described in terms of atrial fibrillation ablation complications. Atrial fibrillation is the most common arrhythmia, while atrial fibrillation radiofrequency (RF) ablation therapy has been gradually recognized in recent years as a better solution than drug therapy and conventional surgical procedures. The occurrence of atrial esophageal fistula complications arises from the spatial relationship between the left atrium and the esophagus. Since the esophagus is at the posterior mediastinum, the posterior wall of the left atrium is separated from the posterior wall of the left atrium by only the pericardial oblique sinus, while the posterior wall of the left atrium and the anterior wall of the esophagus are both thin, and high temperature and high energy in the ablation procedure is likely to cause excessive damage to the esophagus. Atrial esophageal fistula complications have extremely high mortality, in order for the surgical safety to be drawn away from the heart, FIG. 9 is a schematic diagram of a curved balloon catheter retractor pulling on the esophagus. In FIG. 9, a catheter which is externally provided with a balloon is inserted into a patient's natural or surgical forming cavity, the balloon portion is inserted into the cavity position needing to be pulled, the catheter is inflated to inflate the balloon, the balloon is bent to bend towards one side after inflation of the balloon, the catheter is bent and causes the patient cavity to bend, and the distraction displacement is achieved.

[0041] When in use, the catheter 5 is inserted into the esophagus from the nasal cavity, when the distal balloon 3 enters between the second stenosis and the third stenosis of the esophagus, the distal balloon 3 is opened, and the balloon 3 continues to be pushed to the third stenosis; the upper end of the balloon 3 is opened, and the balloon 3 is clamped under the second stenosis; and then the middle pulling balloon 4 is opened to bend, and the esophagus is driven to bend. During use, the catheter 5 and balloon 3, 4 are driven to rotate by rotating the handle 2 so that the esophagus changes in the direction of deflection in the body, thereby always avoiding ablation points of the ablation of the heart. After the balloon 3 is opened, the esophagus is pumped by using the opening, and after a certain negative pressure range is reached, the pulling balloon 4 is distracted, so that the purpose of bending the esophagus is achieved. The aperture can also be used to spray a developer such that the esophageal curved portion can be developed under X-rays.

[0042] In particular, when used for esophagus pulling, the catheter is inserted into the esophagus through the nasal cavity or the oral cavity, after the catheter reaches the position, the relative position of the bending direction and the heart is determined through marking on the catheter and the handle, then the pulling balloon is inflated and distracted, and the esophagus is pulled by using the pulling balloon; and when the positioning of the pulling balloon needs to be rotated and adjusted in the horizontal section (cardiac ablation is needed to replace the ablation point)) By rotating the whole catheter through the knob device on the handle, the pulling balloon is driven to rotate, so that the esophagus is pulled away from the new ablation point in the new direction. The pulling balloon is positioned between the second stenosis and the third stenosis of the esophagus when the esophagus is pulled, the diameter of the balloon is larger than the diameter of the esophagus of the stenosis, the length of the pulling balloon is 10-15 cm, the working air pressure is 2-8 atm, and the pulling distance is 2-4 cm.

[0043] Those skilled in the art will also appreciate that other variations can be made within the spirit and scope of the present invention, and that various modifications that are derived in accordance with the spirit of the invention should still be within the scope of the invention.