Patent Application
20220001151
The present application is a non-provisional application which claims the benefit of priority of Taiwanese Patent Application No. 109122558, filed on Jul. 3, 2020.
The present disclosure relates to a method of fabricating a balloon catheter, in particular, to provide a simplified method associated with the fabrication process for a balloon catheter. In addition, the present disclosure relates to a balloon catheter configuration in accordance with the method of the fabrication process therefrom.
In the process of certain medical treatments, users have to insert a balloon catheter into a living body in order to expand a lumen or create a space inside the living body to be treated, or increase the function of a support force to improve the efficiency in the process of a medical operation. Moreover, it provides the convenience and flexibility for medical users to transmit a nutrient or medicine into the living body by applying the balloon catheter so as to secure a nutrient supply or operate a treatment in the living body.
Referring to
(1) A silicone-based material is applied in an extruder to form a conduit 90 by using a heating and an extrusion process;
(2) Drilling and forming hole configuration on the side wall close to one end of the conduit 90 to form hole configuration 91 by penetrating through the sidewall of the conduit 90, and the hole configuration 91 is configured in the section A of the conduit 90;
(3) In the conduit 90, a peeling layer 92 is formed on the inner and outer walls of section A; and
(4) Place another silicone-based material at positions P1 , P2, and P3 of section A, and, by using a glue attachment, make the silicone-based material and the interior surface as well as the exterior surface of the conduit 90 are glued three times or more, thereby forming a balloon structure on the conduit 90.
From this perspective, it is obvious that the fabrication process of the balloon catheter in accordance with the prior art has to perform certain steps of drilling holes on the side surface of the conduit 90 as well as at least three times necessary associated with attachment procedures, so that the balloon structure can be formed on the conduit 90.
Therefore, the fabrication method of the balloon catheter in accordance with conventional technology has to go through sophisticated procedures associated with the fabrication process of the balloon catheter, resulting in the increase of time consumption in the manufacturing process. Furthermore, the use of multiple adhesions leads to excessive residual concentration associated with the frequently use of glue and increase the risk of contamination in the medical environment and the manufacturing cost.
In view of the foregoing, a method of fabricating a balloon catheter is provided in order to minimize fabrication steps efficiently and reduce manufacturing time consumption, and a balloon catheter configuration is fabricated in accordance with the method therefrom.
The present disclosure preferably provides a fabrication method of a balloon catheter and additionally, a balloon catheter is formed in accordance with the method hereof. The balloon catheter is configured and applied in the clinical applications such as a urinary catheter, a hematuria catheter, an endotracheal tube, a gastrostomy tube, unique catheters in vivo for pyeloplasty, nephrostomy, tubal reshaping, and etc. The main part of the balloon catheter comprises an internal tube having a tubular wall, and a longitudinal groove configured on the tubular wall of the internal tube incorporating a drain passageway. The longitudinal groove of the internal tube is covered by an overcoat sheath. In a catheter body of the balloon catheter, wherein, in one part, the stripping agent is configured between the overcoat sheath and the tubular wall of the internal tube, the overcoat sheath and the tubular wall are not combined, and in other part, no stripping agent is applied, the overcoat sheath and the tubular wall of the internal tube are combined mutually. Throughout of the time underlying certain steps in the fabrication process, the stripping agent preferably volatilizes through the channels coupled to the external ambience, and the degree of volatilization (totally or partially) differs in accordance with the types of stripping agents applied in the fabrication process. Therefore, in the present disclosure, if the balloon catheter is applied to insert into or pull out of the human body, the pain and injury of the patient can be further alleviated. In addition, the present disclosure is configured according to an integral assembly process and in this way, avoids the accumulation of waste fluids (eg. urine) inside the body effectively, due to the input distance gap between the balloon configuration and the drain passageway is further minimized, thereby it eliminates effectively the waste fluid that will be possibly retained inside the body (eg. bladder). Furthermore, it can be applied to nutrient delivery systems (eg. gastrostomy tube) efficiently, in the case of penetrating deeply into the human tissue, the distal end part of balloon catheter, incorporating the balloon configuration, can be appropriately sustained between the tissue and the opening so as to improve and facilitate the function of an internal securement module inside the human body in process of the medical application.
The present disclosure provides a method of fabricating a balloon catheter, by forming a balloon catheter with an external tube covering the internal tube and forming a groove on the exterior surface of the internal tube, the process steps of the balloon catheter fabrication can be reduced efficiently. In addition, the time consumption of manufacturing the balloon catheter is minimized, and the process cost of the balloon catheter is eligible to be reduced accordingly. Furthermore, as a result of the complication of the procedures and the requirement of mass production in the fabrication process, it may cause more process variations in the process of fabricating the balloon catheter, and increase the risk such as the shrinkage rate of a product, sacrifice the accuracy of the product specification, and so on, resulting in poor yields, lack of stability and reliability, which may cause medical personnel clinical issues and health hazards to patient. For the avoidance of the above issues, the mentioned advantages can be alleviated in accordance with reducing the fabrication steps of the balloon catheter.
Another embodiment of the present disclosure provides a balloon catheter configuration in accordance with the method of fabricating the balloon catheter, apart from this, it facilitates medical users in the medical application and improves the efficacy and efficiency associated with medical operations.
For the purpose of achieving the above objectives, the present disclosure provides a method applied to fabricate a balloon catheter in accordance with one preferred embodiment, which comprises certain steps as described below: a silicone-based material is applied into an extruder to form a catheter body, and the catheter body preferably comprises an internal tube, an external tube, and a stripping agent; the internal tube preferably comprises a longitudinal groove and a drain passageway; wherein the longitudinal groove, along the axial direction of the internal tube, is preferably 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 preferably configured inside the internal tube and extending from one end of the internal tube to the other end of the internal tube; covering the internal tube by the external tube; the stripping agent is preferably configured on the distal part of the catheter body and additionally, is preferably configured between the internal tube and the external tube; wherein one partial interior surface of the external tube configured on the distal part of the catheter body is separated from one partial exterior surface of the internal tube adjacent to the external tube, and thereby a working space can be formed and preferably configured above the exterior surface of the internal tube; within the working space, in the axial direction of the catheter body, a procedure of removing one part of the internal tube configured in the catheter body is applied so that one end of the external tube of the catheter body exceeds one end of the internal tube, which is adjacent to the external tube; wherein the working space defines a space located availably above the part of the outer wall of the internal tube and is sufficient for the user to apply the procedure of removing the part of the internal tube flexibly ; and after the procedure of removing the part of the internal tube is completed, the end of the external tube configured in the catheter body, toward the axial center and the inner radial direction of the catheter body, is preferably folded in the interior surface of the drain passageway configured in the internal tube, and connected with the inner wall of the drain passageway of the internal tube by using an adhesion procedure, so as to configure a balloon configuration to be inflated.
In one embodiment, a silicone-based material is applied in an extruder to configure and form a catheter body, the catheter body comprises an internal tube, an external tube, and a stripping agent; the internal tube comprises a longitudinal groove, and a drain passageway, wherein the longitudinal groove, along the axial direction of the internal tube, is configured on the outer wall of the internal tube, and extending from one end of internal tube until the other end of 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 until the other end of the internal tube; the external tube covers the internal tube; the stripping agent, configured on the distal part of the catheter body, is formed between the internal tube and the external tube; wherein one end of the external tube configured on the distal part of the catheter body faces away from the axial center of the catheter body (i.e. axially outwardly) and toward the outer radial direction; fold axially outwardly so as to expose partially the internal tube of the catheter body and followed by applying a procedure of removing the part of the internal tube; and after the procedure of removing the part of the internal tube is completed, the end of the external tube is preferably unfolded (i.e. restored or released) toward the axial direction of the catheter body so that, along the axial direction, the end of the external tube of the catheter body extends beyond the end of the internal tube adjacent to the external tube; and toward the axial center and the inner radial direction of the catheter body, fold the end of the external tube configured at the first end part of the catheter body axially inwardly, toward the axial center of the catheter body, into the drain passageway of the internal tube. Afterwards, the folded part is attached to one part of the inner wall of the drain passageway configured in the internal tube.
In one embodiment, a silicone-based material is applied in an extruder to process and form a catheter body, the catheter body comprises an internal tube, an external tube, and a stripping agent; the internal tube comprises a longitudinal groove, and a drainage pipe, wherein the longitudinal groove, along the axial direction of the internal tube, is configured on the outer wall of the internal tube, and extends from one end of the internal tube until the other end of the internal tube; wherein the drain passageway, along the axial direction of the internal tube, is configured inside the internal tube and extends from one end of the internal tube until the other end of the internal tube; the external tube covers the internal tube; and the stripping agent, configured on the distal part of the catheter body, is formed in one part of the interface between the internal tube and the external tube; wherein the drain passageway comprises a separation structure, extending along the axial direction of the internal tube, configured connectedly to the inner wall of the internal tube, and the volume (e.g. lumen area) associated with the drain passageway is partitioned into portions configured inside the internal tube so as to provide the function of flow shunting in use.
In one embodiment, the separation structure preferably comprises: a sheet-plate structure, a triangular-pyramid structure, a polygonal structure, a herringbone structure, an H-shaped structure, a cross structure, or a combination of the above structures.
In one embodiment, one end of the separation structure is preferably in undercut configuration (i.e retracted axially inwardly into the internal tube), wherein the longitudinal length of the tubular wall of the internal tube in the axial direction is greater than the longitudinal length of the separation structure in the axial direction.
In one embodiment, the inwardly folded part is preferably in adhesion to the inner wall of the drain passageway configured inside the internal tube. The adhesion process herein can be applied preferably by using an adhesive, heat welding treatment, and pressure treatment, ultrasonic bonding or enhancement process, or a combination of the above methods.
In one embodiment, the inwardly folded part is preferably in adhesion to the inner wall of the drain passageway configured inside the internal tube. Prior to the adhesion process is applied, a procedure of surface treatment is further applied on one part of the inner wall of the drain passageway and the procedure of the surface treatment process comprises: performing surface roughening, applying heating, or adding an intermediate layer.
In one embodiment, a process of surface modification is further applied on one part of the inner wall of the drain passageway. In addition, the process of surface modification is applied to roughen the part of the inner wall of the drain passageway. The surface of the inner wall is preferably configured as a concave-convex surface, a spiral surface, or other alternative approaches so as to increase the surface area of the inner wall.
In one embodiment, the concave-convex surface comprises a primary concave-convex surface and a secondary concave-convex surface configured on at least one part of the primary concave-convex surface.
In one embodiment, the method of fabricating the balloon catheter further comprises steps: an infusion connector is configured at the other end of the catheter body opposite to the first end part of the catheter body; wherein the infusion connector comprises an air inlet, and a feeding pipe; the air inlet and the longitudinal groove of the internal are in communication mutually; in addition, the feeding pipe is coupled to the drain passageway of the internal tube, and the air inlet and the feeding pipe are coupled not in communication mutually.
In one embodiment, in the step of applying the silicone-based material into the extruder for the fabrication, wherein the diameters, extending from one end of the catheter body to the other end, are preferably equivalent.
In one embodiment, in the step of applying the silicone-based material into the extruder for fabrication, the diameter of the internal tube and the diameter of the external tube of the catheter body are respectively reduced toward the distal end of the catheter body, wherein one part at vicinity of the distal end of the catheter body is arranged to form a balloon configuration to be inflated.
In one embodiment, in the step of applying the silicone-based material into the extruder for fabrication, the diameter of the internal tube and the diameter of the external tube of the catheter body are respectively increased toward the distal end of the catheter body, wherein one part at vicinity of the distal end of the catheter body is arranged to form a balloon configuration to be inflated
In one embodiment, in the step of applying the silicone-based material into the extruder for fabrication, the catheter body further comprises an X-ray indicator, and the X-ray indicator is configured at one location relative to a dent configuration of the internal tube, wherein the dent configuration is a cross-sectional structure illustrated in accordance with the cross section of the longitudinal groove of the internal tube in a perspective view.
In addition, the present disclosure provides a balloon catheter in accordance with the method of fabricating the balloon catheter, comprising: a catheter body, the catheter body comprising: an internal tube comprises a longitudinal groove and a drain passageway; wherein the longitudinal groove is configured on the outer wall of the internal tube, along the axial direction of the internal tube, and extends from the proximal end of the internal tube to the distal end of the internal tube; and wherein the drain passageway is configured inside the internal tube, along the axial direction of the internal tube, and extends from the proximal end of the internal tube to the distal end of the internal tube; an external tube covers the internal tube; and a stripping agent, which is configured in the distal end of the catheter body in the specific step of the fabrication process (certain step previously), is configured between the internal tube and the external tube; wherein the longitudinal length of the external tube in the first end part of the catheter body is longer than the longitudinal length of the internal tube and the end of the external tube configured in the first end part of the catheter body is folded inwardly to the internal tube. In addition, the end of the external tube configured in the first end part of the catheter body is preferably folded inwardly to one part of the inner wall of the internal tube and adheres to each other.
In one embodiment, the balloon catheter further comprises an infusion connector configured at the proximal end of the catheter body, wherein the distal end of the catheter body is preferably arranged to configure with the balloon configuration to be inflated. In addition, the infusion connector comprises an air inlet and a feeding pipe; wherein the air inlet communicates with the longitudinal groove of the internal tube; the air inlet communicates with the drain passageway of the internal tube; and the air inlet and the feeding pipe are not in communication with each other.
In one embodiment, the infusion connector comprises an air inlet and at least one feeding pipe; wherein the air inlet is coupled to the longitudinal groove configured on the internal tube; wherein the at least one feeding pipe and the drain passageway of the internal tube are configured in communication mutually, and the air inlet and the at least one feeding pipe are not configured in communication with each other.
In one embodiment, the diameter within the catheter body, extending from one end until the other end, is equivalent equal.
In one embodiment, the diameter of the internal tube and the diameter of the external tube of the catheter body are respectively reduced toward the distal end of the catheter body, wherein the distal end of the catheter body is arranged to configure with the balloon configuration to be inflated, thereby preventing a round-shape module is configured at this end, additionally, as such that the patient's pain and injury can be reduced and the fabrication process is simplified when the balloon catheter is inserted or pulled out.
In one embodiment, the diameter of the internal tube and the external tube of the catheter body increase respectively toward the end of the catheter body, wherein the end of the catheter body is arranged to configure with the balloon configuration to be inflated. In the perspective of the increase in the inner diameter and outer diameter of the end part of the catheter body, when folded into the drain passageway of the internal tube, the end of the external tube configured at the first end part of the catheter body faces toward the axial center of the catheter body as well as in the inward radial direction, and the inwardly folded part is then attached to the inner wall of the drain passageway of the internal tube. Consequently, in this regard, the wrinkles or crumples possibly formed on the inwardly folded part of the external tube can be further prevented due to the increase associated with the inner diameter of the end of the catheter body as well as the mismatch of surface area for a implementation of an appropriate attachment, thereby the effect of a stable adhesion can be achieved in accordance with a simplified adhesion procedure hereof.
In one embodiment, in the step of applying the silicone-based material into the extruder for fabrication, the catheter body further comprises an X-ray indicator, and the X-ray indicator is configured at a position relative to the longitudinal groove.
In one embodiment, the catheter body further comprises an X-ray indicator, and the X-ray indicator is configured at a position relative to a dent configuration of the internal tube by looking into in terms of a cross section of the catheter body.
According to the present disclosure, in the fabrication process of the balloon catheter, one adhesion step is required to configure the balloon configuration of the balloon catheter. In addition, through the silicone-based material is applied in the extruder for fabrication, the internal tube incorporating the longitudinal groove is configured, and in this regard, additional steps underlying drilling the internal tube is avoidable. In this way, the method of fabricating the balloon catheter in accordance with the present disclosure not merely offers simplified steps, but effectively reduces manufacturing costs and reduces time consumption as well. Furthermore, the balloon catheter described in the present disclosure is preferably applied to penetrate into living organisms with small openings, and the X-ray indicator of the balloon catheter allows users to identify the dent easily and promptly. Therefore, the balloon catheter disclosed in the present disclosure enables to improve the efficiency in the process of the medical operation.
According to the description of the present disclosure and objectives, purpose, features, configures, effects, and advantages that can be more obvious and easy to understand, the present disclosure will cite specifically preferred embodiments, in conjunction with the drawings and descriptions in detail as follows. In addition, the directional terms described in the present disclosure, such as up, down, bottom, front, back, left, right, inside, outside, tubular wall, sidewall, inner wall, outer wall, center, longitudinal, axial, axis, axial center, radial, inner radial, outer radial, inward radial, outward radial, toward, or away from are for reference in the direction of the attached drawings. Therefore, the directional terms applied are not intended to limit the scope of the present disclosure.
The following preferred embodiments allow the present disclosure to be more comprehensively understood by one of ordinary skill in the art, but do not limit the spirit, coverage, and/or scope of the present disclosure in any way whatsoever. The aspects of the present disclosure and the details thereof are illustrated more fully by referring to the non-limiting embodiments and examples disclosed in conjunction with the following description and the accompanying drawings. Descriptions on known information, manufacturing tools, process technologies, and etc. are omitted, so as not to avoid obscure the present disclosure. However, it should be understood that the following description and preferred embodiments, which are provided to illustrate the aspects or concepts of the present disclosure, are by means of indicating illustration and not limitation. One of ordinary skill in the art will be able to recognize that various embodiments of the invention and numerous specific details thereof, many substitutions, alterations, modifications, additions, and/or arrangements may be configured within the spirit and/or scope of the inventive concept through the present disclosure without departing from the spirit thereof, and embodiments of the invention include all such substitutions, modifications, additions and/or rearrangements.
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.
Referring to
Step S1: Apply a silicone-based material into an extruder for fabrication to form a catheter body 10. By referring to
Step S2: Referring to
Step S3: Referring to
Referring to
Referring to
Referring to
Referring to
Referring to
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
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 109122558 | Jul 2020 | TW | national |
