METHOD OF MANUFACTURING BALLOON CATHETER AND BALLOON CATHETER MANUFACTURED THEREFROM

Abstract

A method of fabricating a balloon catheter configuration is provided, the method comprises: preparing one catheter body, the catheter body comprises one internal tube, one external tube, and one stripping agent; the internal tube comprises one longitudinal groove and one drain passageway, wherein the longitudinal groove is configured in the exterior surface of the internal tube, the drain passageway is configured inside the internal tube, the external tube covers the internal tube, and the stripping agent is configured between the internal tube and the external tube; removing the internal tube of the catheter to allow one end of the external tube of the catheter body beyond one end of the internal tube adjacent to the external tube; folding the end of the external tube toward the axial center of the catheter; and attaching the end of the external tube to one part of the inner wall of the drain passageway.

Claims

1. A method for fabricating one balloon catheter, the method comprising the following steps: applying one silicone-based material into one extruder to configure one catheter body, the catheter body comprises one internal tube, one external tube, and one stripping agent; wherein the internal tube comprises one longitudinal groove and one drain passageway, the longitudinal groove, along the axial direction of the internal tube, is configured on the exterior surface of the internal tube, and extending from one end of the internal tube to the other end of the internal tube; and the drain passageway, along the axial direction of the internal tube, is configured inside the internal tube, and extending from one end of the internal tube to the other end of the internal tube; wherein the external tube covers the internal tube; and wherein the stripping agent, configured at the first end part of the catheter body, is applied between one part of the exterior surface of the internal tube and one part of the interior surface of the external tube; at the first end part of the catheter body, separating the part of the interior surface of the external tube configured from the part of the exterior surface of the internal tube; forming one working space above the part of the exterior surface of the internal tube; wherein, in the working space, applying one procedure of removing one part of the internal tube so that one end of the external tube at the first end part of the catheter body exceeds one end of the internal tube; after the procedure of removing the part of the internal tube is completed, toward the axial center of the internal tube, folding the end of the external tube beyond the end of the internal tube inwardly into the drain passageway of the internal tube; and adhering the end of the external tube to one part of the inner wall of the drain passageway, so as to configure one balloon configuration to be inflated.

2. The method according to claim 1, wherein the method of separating the part of the interior surface of the external tube configured at the first end part of the catheter body from the part of the exterior surface of the internal tube, the method comprising steps of: at the first end part of the catheter body, away from the axial center of the catheter body, folding the end of the external tube to expose one part of the internal tube of the catheter body; and applying the procedure of removing the part of the internal tube configured in the catheter body.

3. The method according to claim 1, wherein the method of adhering the end of the external tube to the part of the inner wall of the drain passageway, the method comprising the use of applying adhesive attachment, heat welding treatment, pressure treatment, ultrasonic bonding process, or a combination of thereof.

4. The method according to claim 3, further comprising steps of: applying one surface treatment on the part of the inner wall of the drain passageway, wherein the surface treatment method comprises of roughening, heating, applying one intermediary layer, or a combination of thereof.

5. The surface treatment method according to claim 4, prior to applying the surface treatment on the part of the interior surface of the drain passageway, wherein the surface treatment further comprises the procedures of configuring one concave-convex surface, one spiral surface, a combination of thereof, or other approach applied to increase the surface area of the interior surface of the drain passageway.

6. The method according to claim 1, the method further comprising steps of: configuring one infusion connector at the other end of the catheter body relative to the first end part of the catheter body, where is arranged to configure the balloon configuration to be inflated; wherein the infusion connector comprises one air inlet and one feeding pipe, the air inlet and the longitudinal groove configured in the internal tube are in communication mutually; and the drain passageway of the feeding pipe and the internal tube are in communication mutually and the air inlet and the feeding pipe are not in communication with each other.

7. The method according to claim 1, wherein, in the step of applying the silicone-based material into the extruder to configure the catheter body, the diameter of the internal tube and the diameter of the external tube are configured in the catheter body and are reduced respectively toward the first end part of the catheter body.

8. The method according to claim 1, wherein, in the step of applying the silicone-based material into the extruder to configure the catheter body, the diameter of the internal tube and the diameter of the external tube are configured in the catheter body and are increased respectively toward the first end part of the catheter body.

9. The method according to claim 1, further comprising steps of configuring one separation structure in the drain passageway of the internal tube and the separation structure is configured connectedly to the interior surface of the drain passageway, wherein the separation structure extends in the axial direction of the internal tube and shunts the flow volume configured inside the drain passageway of the internal tube.

10. The method according to claim 9, further comprising step of retracting one end of the separation structure into the internal tube, wherein the length of the internal tube in the axial direction is greater than the length of the separation structure in the axial direction.

11. A balloon catheter configuration, the balloon catheter configuration comprising: one catheter body, the catheter body comprising: one internal tube incorporating one longitudinal groove and one drain passageway; wherein the longitudinal groove, along the axial direction of the internal tube, is configured on the exterior surface of the internal tube, and extending from one end of the internal tube to the other end of the internal tube; and wherein the drain passageway, along the axial direction of the internal tube, is configured inside the internal tube, and extending from one end of the internal tube to the other end of the internal tube; one external tube covering the internal tube; and one balloon configuration to be inflated is configured at the first end part of the catheter body, and the balloon configuration to be inflated comprises one part of the internal tube and one part of the external tube; wherein, in the outer radial direction of the internal tube, and the part of the internal tube and the part of the external tube are not combined mutually so that the part of the external tube forms one overcoat sheath of the balloon configuration to be inflated, and wherein, in the inner radial direction of the drain passageway configured in the internal tube, one part of the interior surface of the drain passageway and one part of the interior surface of the external tube are combined mutually; wherein one end of the balloon configuration to be inflated starts at the distal end of the catheter body.

12. The balloon catheter configuration according to claim 11, wherein further comprising one stripping agent formed at the interface between the internal tube and the external tube and is configured at the first end part of the catheter body.

13. The balloon catheter configuration according to claim 11, wherein the part of the interior surface of the drain passageway is one rough surface.

14. The balloon catheter configuration according to claim 13, wherein the rough surface comprises one concave-convex surface, one spiral surface, or a combination of thereof.

15. The balloon catheter configuration according to claim 11, wherein the balloon catheter further comprises one infusion connector configured at the other end of the catheter body, relative to the first end part of the catheter body, wherein the infusion connector comprising one air inlet and one feeding pipe, the air inlet communicates with the longitudinal groove of the internal tube mutually; the feeding pipe and the drain passageway of the internal tube are in communication mutually; and the air inlet and the feeding pipe are not in communication with each other.

16. The balloon catheter configuration according to claim 11, wherein the diameter of the internal tube and the diameter of the external tube configured in the catheter body are reduced respectively toward the first end part of the catheter body.

17. The balloon catheter configuration according to claim 11, wherein the diameter of the internal tube and the diameter of the external tube configured in the catheter body are increased respectively toward the first end part of the catheter body.

18. The balloon catheter configuration according to claim 11, wherein the internal tube further comprises one separation structure configured in the drain passageway of the internal tube, the separation structure is configured connectedly to the interior surface of the drain passageway; and wherein the separation structure extends in the axial direction of the internal tube and shunts the flow volume configured inside the drain passageway of the internal tube.

19. The balloon catheter configuration according to claim 18, wherein one end of the separation structure is retracted into the internal tube, and the length of the internal tube in the axial direction is greater than the length of the separation structure in the axial direction.

20. The balloon catheter configuration according to claim 18, wherein the separation structure further comprising: one sheet-plate structure, one triangular-pyramid structure, one polygonal structure, one herringbone structure, one H-shaped structure, one cross structure, or a combination of thereof.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0040] FIG. 1 is a flow chart showing certain steps associated with the fabrication process of providing a balloon catheter in accordance with the first embodiment of the present disclosure.

[0041] FIG. 2 is a top view of the first balloon catheter configured in accordance with procedure S1 associated with the method of fabricating a balloon catheter in the first embodiment of the present disclosure.

[0042] FIG. 3 is a cross-sectional view of the first balloon catheter configured in accordance with procedure 51 associated with the method of fabricating a balloon catheter in the first embodiment of the present disclosure.

[0043] FIG. 4 is a top view of the balloon catheter configured in accordance with procedure S2 associated with the method of fabricating a balloon catheter in the first embodiment of the present disclosure.

[0044] FIG. 5A is a top view of the balloon catheter to be inflated and configured in accordance with procedure S3 associated with the method of fabricating a balloon catheter in the first embodiment of the present disclosure.

[0045] FIG. 5B is a top view of another balloon catheter to be inflated and configured in procedure S3 associated with the method of fabricating a balloon catheter of the first embodiment of the present disclosure.

[0046] FIG. 6 is a perspective view of a balloon catheter configured by applying the method of fabricating a balloon catheter in accordance with the first embodiment of the present disclosure.

[0047] FIG. 7A is a top view of a balloon catheter configured by applying the method of fabricating a balloon catheter in accordance with the first embodiment of the present disclosure after the balloon configuration in balloon catheter is inflated.

[0048] FIG. 7B is a top view of another balloon catheter configured by applying the method of fabricating a balloon catheter in accordance with the first embodiment of the present disclosure after the balloon configuration in balloon catheter is inflated.

[0049] FIG. 8 is a top view of a balloon catheter configured by applying the method of fabricating a balloon catheter in accordance with the second embodiment of the present disclosure.

[0050] FIG. 9 is a top view of a balloon catheter configured by applying the method of fabricating a balloon catheter in accordance with the third embodiment of the present disclosure.

[0051] FIG. 10 shows a balloon catheter fabricated in accordance with a conventional prior art.

[0052] The implementations disclosed herein are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings. Like reference numerals refer to corresponding parts throughout the drawings.

DETAILED DESCRIPTION

[0053] Referring to FIGS. 1 to 7A, and 7B, the fabrication method of the balloon catheter is provided in accordance with the first embodiment of the present disclosure comprises steps:

[0054] Step S1: Apply a silicone-based material into an extruder for fabrication to form a catheter body 10. By referring to FIGS. 2 and 3, the catheter body 10 comprises an internal tube 11, an external tube 12 and a stripping agent 13; and the internal tube 11 comprises a longitudinal groove 111 and a drain passageway 112, wherein the longitudinal groove 111 is configured on the exterior surface of the internal tube 11, and, along the axial direction of the internal tube 11, extending from one end of the internal tube 11 to the other end of the internal tube 11; and wherein the drain passageway 112 is configured inside the internal tube 11, along the axial direction of the internal tube 11, and extends from one end of the internal tube 11 to the other end of the internal tube 11; in addition, the drain passageway 112 is configured in parallel with the longitudinal groove 111 and not in communication with each other, wherein the external tube 12 covers the internal tube 11 and the tubular length of the external tube 12 is equivalent to the tubular length of the internal tube 11. Furthermore, the stripping agent 13, configured in the section B of the catheter body 10, is arranged in one interface part between the internal tube 11 and the external tube 12, and volatilizes in the process of step 51, wherein the section B is configured in the first part of the catheter body 10.

[0055] Step S2: Referring to FIG. 4, one end of the external tube 12 in the section B of the catheter body 10 is preferably separated from the internal tube 11 and thus a working space is formed and preferably configured above the internal tube 11 in the section B. In the working space, in the axial direction, the internal tube 11 in the section C configured of the catheter body 10 is partially (or fully) removed (i.e. one part of the internal tube is removed), and a cross-sectional surface of the internal tube is formed, consequently, in this regard, in the axial direction, the end of the external tube 12 of the catheter body 10 exceeds the end of the internal tube 11, which is adjacent to the external tube 12; that is, in the region of the catheter body configured close to the section C of the catheter body 10, the length of the external tube 12 of the catheter body 10 is longer than the length of the internal tube 11 of the catheter body 10.

[0056] Step S3: Referring to FIGS. 4, 5A, and 5B, upon completion of a procedure of removing the internal tube partially, the end of the external tube 12 in the section C configured in the catheter body 10 is moved toward the axial center of the catheter body 10 and folded inwardly toward the inner radial direction of the drain passageway 112 of the internal tube 11; wherein the position P4 as well as the interior surface of the drain passageway 112 of the internal tube 11 are incorporated to form a balloon configuration to be inflated in accordance with using an adhesion procedure. The adhesion procedure is applied preferably by using an adhesive glue, a heat welding, a pressure treatment, an ultrasonic bonding process, or a combination of the above procedures: wherein the position P4 is configured at vicinity of the end part of the catheter body 10 and one part of the interior surface of the drain passageway 112.

[0057] Referring to FIGS. 5A, 5B, and 6, in the process of clinical procedure, relative to the end of the catheter body 10, users preferably configures an infusion connector 20 coupled to the other end of the catheter body 10, relative to the end of the catheter body 10 where is arranged to configure the balloon configuration to be inflated; wherein the infusion connector 20 comprises an air inlet 21 and a feeding pipe 22, and the air inlet 21 communicates with the longitudinal groove 111 of the internal tube 11 mutually; in addition, the feeding pipe 22 communicates with the drain passageway 112 of the internal tube 11; and the air inlet 21 and the feeding pipe 22 are not coupled in communication with each other.

[0058] Referring to FIGS. 5A, 6, and 7A, in the process of a medical procedure, when applying a balloon catheter configured in accordance with the method of fabricating a balloon catheter in the first embodiment of the present disclosure, first of all, the balloon configuration to be inflated is preferably configured at one end of the catheter body 10 and applied in a living body. In addition, a syringe is coupled to the air inlet 21 of the infusion connector 20, and air is injected into the balloon configuration to be inflated through the syringe by supplying the air through the longitudinal groove 111 of the internal tube 11 and entering the end of the catheter body 10, wherein the end of the catheter body 10 is arranged to equip with the balloon configuration to be inflated, so that the external tube 12 configured in the section D of the catheter body 10 expands away from the internal tube 11 and an inflated balloon configuration 30 is formed accordingly. Through the function of the inflated balloon configuration 30 provided, the space required in the living body can be expanded, thereby facilitating and improving medical operation efficiency. Furthermore, it is applied to inject a nutrient or a medication into the balloon catheter by coupling an injector to the feeding pipe 22 of the infusion connector 20, so that the nutrient or the medication passes through the internal tube 11. The drain passageway 112 is used and applied to enter the living body and supplies nutrition or medicine into a living body.

[0059] Referring to FIGS. 5B, 6, and 7B, when a balloon catheter configured in accordance with another fabrication method of the first embodiment in the present disclosure is applied in a medical procedure, first of all, one part of one end of the catheter body 10 incorporating the balloon configuration to be inflated is preferably applied into a living body, and a syringe is coupled to the air inlet 21 of the infusion connector 20, and air is injected into the balloon catheter through the syringe to pass the air through the longitudinal groove 111 of the internal tube 11 until the part of the end of the catheter body 10, where is delicately arranged to equip with the balloon configuration to be inflated, so that the part of the external tube 12 located in the section D of the catheter body 10 expands toward the outer radial direction of the internal tube 11. To form an inflated balloon configuration 30 in the section D, additionally, the external tube 12 configured adjacent to the end of the internal tube 11 and the balloon configuration to be inflated is further expended, including the expansion in the axial and radial direction of the internal tube 11 (i.e including the expansion at the end terminal of the internal tube 11).

[0060] Referring to FIG. 8, the fabrication method of the balloon catheter provided by the second embodiment of the present disclosure is provided, comprising; a catheter body 10A comprises an internal tube 11, an external tube 12, and a stripping agent 13A to be formed, wherein the internal tube 11 comprises a longitudinal groove 111A and a drain passageway 112A. As compared to the first embodiment of the present disclosure, the main differences between the second embodiment of the present disclosure and the first embodiment include: The catheter body 10A by step S1 forms a cone-shaped structure, toward the end of the catheter body 10A, at one end of the catheter body 10A to which the balloon configuration to be inflated is to be formed. That is, the diameter of the internal tube 11A and the diameter of the external tube 12A of the catheter body 10A respectively decrease or increase toward the end of the catheter body 10A, where the balloon configuration to be inflated is to be arranged (i.e. one part of section B). As shown in FIG. 8, the balloon catheter fabricated in accordance with the method for providing a balloon catheter in accordance with the second embodiment of the present disclosure is configured by forming a cone-shaped structure at one end part of the catheter body 10A, where is arranged to equip with the balloon configuration to be inflated. The balloon catheter can be easily and smoothly penetrated into a living body through an entrance having a small opening, or reduce the pain and injury of the patient when the catheter is inserted, removed, or pulled out, and thereby improve the efficiency of medical operation.

[0061] Referring to FIG. 9, the fabrication process of the balloon catheter provided by the third embodiment of the present disclosure is provided by referencing the first embodiment of the present application. The differences between the third embodiment and the first embodiment of the present disclosure are mainly described as below: The catheter body 10B configured in step Si further comprises an X-ray indicator 14B, wherein the X-ray indicator 14B is provided opposite to a dent 111B in term of a cross sectional view, configured in the internal tube 11B. The balloon catheter fabricated in accordance with the method of manufacturing a balloon catheter in the third embodiment of the present disclosure enables the users to identify promptly the position of the dent 111B according to the X-ray indicator 14B, thereby improves the medical operation efficiency.

[0062] In summary, as compared to the prior art, the fabrication process of the balloon catheter applied in the present disclosure, one adhesion step is required to form a balloon configuration in the balloon catheter. In addition, as shown in FIG. 2, the fabrication process of the balloon catheter in the present disclosure is applied to configure the internal tube 11 incorporating the longitudinal groove 111 in the procedure of step Si, and therefore additional efforts associated with drilling hole in the internal tube 11 is avoidable. Therefore, the fabrication process of the balloon catheter in the present disclosure not merely provides a simplified process, but effectively reduces the manufacturing cost and minimize the production time as well. Furthermore, the balloon catheter fabricated in accordance with the method of configuring a balloon catheter in the present disclosure can be efficiently penetrated into a living body through a small opening and entrance, and the X-ray indicator of the balloon catheter is applied to be promptly identified by users, respective to the position or orientation of the longitudinal groove, in this way, the balloon catheter configured in the present disclosure allows to improve the medical operation efficiently.

[0063] Although the present disclosure has been discussed in the above embodiments, they are not intended to limit the scope of the present disclosure. Any one skill in the art can make changes and embellishment without departing from the spirit and scope of the present disclosure. Therefore, the scope of the present disclosure shall be accorded to the definitions set forth in the appended claims.