WO2024062497A1

WO2024062497A1 - Triple function catheter system and implementation method thereof

Info

Publication number: WO2024062497A1
Application number: PCT/IN2023/050873
Authority: WO
Inventors: Ajay NEHRA; Sumit Mhaddolkar; Nalin Kumar
Original assignee: Biorad Medisys Private Limited
Priority date: 2022-09-21
Filing date: 2023-09-21
Publication date: 2024-03-28

Abstract

In one embodiment, a stent catheter assembly is disclosed. The stent catheter assembly comprises a catheter having a distal end. In example, the catheter comprises an outer braided catheter surrounding the middle catheter which, in turn, surrounds the inner catheter. Further stent catheter assembly comprises, a tip disposed at the distal end of the catheter, a plurality of tubes, connected to the catheter. Further the stent catheter assembly comprises, a balloon, wherein the balloon is disposed around the distal end of the catheter; a stent, wherein the stent is mounted on the balloon, a plurality of radiopaque marker bands, wherein the plurality of radiopaque marker bands is positioned proximal and distal to the stent on the catheter.

Description

TRIPLE FUNCTION CATHETER SYSTEM AND IMPLEMENTATION METHOD THEREOF

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of Indian Provisional Application No. 202221054010 filed 2022/09/21, which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

[0002] This invention is generally in the field of medical devices. More particularly, the invention relates to opening and maintaining patency within vessels of the human body, more particularly a stent delivery device having a balloon for accurate positioning of a stent in the region of a dilated stenosis.

BACKGROUND

[0003] The biliary system delivers bile produced by the liver to the duodenum where the bile assists other gastric fluids in digesting food. The biliary system includes the liver, as well as a plurality of bodily channels and organs that are disposed between the liver and the duodenum. Within the liver lobules, there are many fine “bile canals” that receive secretions from the hepatic cells. The canals of neighboring lobules unite to form larger ducts, and these converge to become the “hepatic ducts.” They merge, in turn, to form the “common hepatic duct.” The “common bile duct” is formed by the union of the common hepatic and the cystic ducts. It leads to the duodenum, where its exit is guarded by a sphincter muscle. This sphincter normally remains contracted until the bile is needed, so that bile collects in the common bile duct and backs up to the cystic duct. When this happens, the bile flows into the gallbladder and is stored there. Sometimes, however, lesions may grow in portions of the biliary system, for example, one of the biliary ducts, that impede bile from properly flowing through the system. In some cases, the lesions may completely prevent the bile flow. This is undesirable as it interrupts the regular digestive process and may even cause damage to the channels and organs of the biliary system.

[0004] In order to properly treat the lesions, it is sometimes necessary to acquire a balloon dilation and stent deployment method. Balloon dilation is a method in which a catheter consisting of a thin tube with a balloon is pushed into the vessel from the outside, and the balloon is inflated to expand the narrowed or occluded area to treat it. It is well known to use balloon catheters for the dilatation of various vessels of the human body.

[0005] It is also well known to place stents into vessels to maintain patency of that vessel. Stents and stent delivery assemblies are utilized in a number of medical procedures and situations. A stent is generally a cylindrical prosthesis that is introduced via a catheter into a lumen of a body cavity or vessel. The stent is introduced into the cavity or vessel with a generally reduced diameter and then is expanded to the diameter of the cavity or vessel. Balloon dilatation often results in a so-called 'recoil' phenomenon in which the stenosis is narrowed over a long period after the procedure. In order to solve this problem, the stent implantation is done which is basically the same as the balloon dilation, and by stably deploying a balloon equipped with a stent, the lesion is stabilized by recoil of the stenosis after the balloon dilation, as in expanded configuration of the stent, it supports and reinforces the cavity/vessel walls while maintaining the cavity/vessel in an open, unobstructed condition.

[0006] Conventionally, a guidewire is introduced into the body cavity of interest through a working lumen defined in an endoscope to ensure proper placement. A physician advances an endoscope to identify the stricture or lesion location by observing an image received from the distal end of the endoscope. A dilation device basically a balloon catheter is introduced through the scope to pre-expand the lesion position. The dilation device is then withdrawn from the endoscope. Thereafter, a stent delivery catheter is introduced to the lesion location, using fluoroscopy (x-ray imaging of a moving object), to deploy the stent. In addition, fluoroscopy is often used to ensure proper placement and deployment of the stent, which is known in the art. Furthermore, the balloon catheter is reintroduced into the area of interest to expand the stent and sometimes to be securely held at the surface of the stricture.

[0007] The dilation device needs to be inserted into the vessel alternately for many times, which is likely to cause complications and increase the operation time. In addition, the exposure time of the patient and the operator under radiation rays is increased, thereby influencing the physical health of the patient and the operator. Still further, use of fluoroscopy to confirm proper positioning of a stent is a relatively cumbersome procedure and requires additional safety mechanisms for the patients as well as the doctors and their assistants. Furthermore, using the stent deployer or delivery and the dilation device multiple times creates biodegradable waste.

[0008] Accordingly, there is a need for a means that is integral with the stent delivery and dilation system that dilates the lesions and deploys the stents accurately. It is an urgent technical problem to be solved by those skilled in the art to provide a balloon stent integrated system capable of simplifying the surgical procedure.

[0009] This invention is therefore directed towards providing an improved method and device, which is relatively simple in design and structure, and is highly effective for its intended purpose.

SUMMARY

[0010] Embodiment of the present disclosure present technological improvements as solutions to one or more of the above-mentioned technical problems recognized by the inventor(s) in conventional systems.

[0011] In one embodiment, a stent catheter assembly is disclosed. The stent catheter assembly comprises a catheter having a distal end. In example, the catheter comprises an outer braided catheter surrounding the middle catheter which, in turn, surrounds the inner catheter. Further stent catheter assembly comprises, a tip disposed at the distal end of the catheter, a plurality of tubes, connected to the catheter. In one example, the plurality of tubes comprises an SS tube for enhancing structural support. Further the stent catheter assembly comprises , a balloon, wherein the balloon is disposed around the distal end of the catheter; a stent, wherein the stent is mounted on the balloon, a plurality of radiopaque marker bands, wherein the plurality of radiopaque marker bands is positioned proximal and distal to the stent on the catheter; and an inner catheter, wherein the inner catheter is housed within the catheter and wherein the inner catheter comprises multiple openings at its distal end of the inner catheter.

[0012] Further in the embodiment, the stent catheter assembly comprises a sheath handle connected to the catheter to facilitate manipulation of the catheter.

[0013] Further stent catheter assembly comprises a locking knob operatively connected to the outer braided catheter to secure the relative position of the catheters. Further in the embodiment, he stent catheter assembly a pusher handle attached to the catheter to aid in advancing the stent to a desired location within a body vessel.

[0014] Further, the stent catheter assembly comprises a stent recapture device positioned at the distal side of said catheter, located approximately 2 mm from the middle catheter, and situated between the middle catheter and the inner catheter. Further, the stent recapture device is configured to enable a surgeon to recapture the deployed stent and the stent recapture device has a length ranging from 2 to 3 mm. Additionally, the balloon is configured to be reinflated for post dilation after stent deployment.

[0015] It will be appreciated that features of the present disclosure are susceptible to being combined in various combinations without departing from the scope of the present disclosure as defined by the below mentioned detailed description and drawings.

BRIEF DESCRIPTION OF THE FIGURES

[0016] The summary above, as well as the following detailed description of illustrative embodiment, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, example constructions of the disclosure are shown in the drawings. However, the present disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in art will understand that the drawings are not to scale. Wherever possible, like elements have been indicated by identical numbers.

[0017] Embodiment of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein:

[0018] Figure 1. Illustrates a perspective view of the integrated stent and balloon catheter device in accordance with an exemplary embodiment of the present disclosure; [0019] Figure 2. illustrates enlarged view of the distal end of the integrated stent and balloon catheter device.

[0020] Figure 3 illustrates the enlarged view of the middle portion of the integrated stent and balloon catheter device.

[0021] Figure 4. illustrates the enlarged view of the proximal end of the integrated stent and balloon catheter device.

[0022] Figure 5, Figure 6 and Figure 7 illustrates various embodiments of the stent recapture device

[0023] In the above accompanying drawings, a number relates to an item identified by a line linking the number to the item. When a number is accompanied by an associated arrow, the number is used to identify a general item at which the arrow is pointing.

[0024] Further the figures depict various embodiments of the present subject matter for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiment of the structures and methods illustrated herein may be employed without departing from the principles of the present subject matter described herein.

DETAIEED DESCRIPTION OF EMBODIMENTS

[0025] The following detailed description illustrates embodiment of the present disclosure and manners by which they can be implemented. The words "comprising," "having," "containing," and "including," and other forms thereof, are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items or meant to be limited to only the listed item or items. It must also be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Pre-dilation' means pre-dilation of the stenosis of blood vessels prior to stent deployment in stent implantation. 'Inflation fluid' refers to a liquid that is introduced into the balloon to inflate the balloon, and those skilled in the art are more commonly referred to as 'contrast diluted in saline'.

[0026] The person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. It should be understood that this invention is not limited to the particular methodology, protocols, and the like, described herein and as such may vary. The terminology used herein is for the purpose of describing particular embodiment only and is not intended to limit the scope of the present invention, which is defined solely by the claims.

[0027] Currently, multiple devices are needed with multiple steps of introducing and removing various devices or systems, in order to complete a procedure of placing a stent at a stricture point in the vessel. The embodiments described herein eliminate the complication of multiple devices and multiple introductions.

[0028] Although this invention could be used for any vessel of the human body including but not limited to arteries, veins, vascular grafts, urethras, fallopian tubes, bronchial tubes, etc., the descriptions herein will highlight the use of this device for biliary ducts.

[0029] An object of the present invention is to provide a single integrated catheter capable of performing vessel dilatation and delivering the stent at accurate position.

[0030] Another object of the present invention is to deploy a self-expanding stent by means of pulling back a slide able integrated catheter while holding the stent at a position which allows it to expand radially outward into a dilated stenosis.

[0031] Yet another object of the invention is to provide a balloon stent integrated system and method for deploying self-expandable stents in a quick and efficient way. [0032] The present invention overcomes the disadvantages of prior art devices by integrating a balloon and a stent into an integrated catheter system which can perform both pre-dilation of the strictures and stent delivery. A single, integrated catheter is capable of performing pre-dilation followed by delivery of a stent and further post dilation to ensure the proper placement of the stent without removing the catheter from the patient's body. Aspects of the present disclosure provide a deployer system for delivering a stent in a target vessel. The system comprises a guide wire which is intended to be guided along with the tip of the catheter into the target vessel. The balloon is moved forward by alternately inflating and deflating by introducing saline solution into the channel formed by the inner catheter and a nylon tube to dilate the strictures or lesions. Once the stricture is dilated enough to pass the outer braided catheter, and the balloon has reached the other end of the stricture, the rotating knob in the sheath handle is rotated; the sheath handle is pulled to deploy the self-expanding stent in the intended area. As the compressed stent is moved distally from stent containment cavity, the stent begins expanding and radially expands until contact is made between the outer surface of the stent and the inner surface of the wall of a vessel. After the stent is deployed completely, the balloon is retracted through the stricture or lesion in the same way by alternately inflating and deflating it leaving the stent to keep the target vessel open.

[0033] In one embodiment, in one embodiment, a stent catheter assembly is disclosed. The stent catheter assembly comprises a catheter having a distal end. In example, the catheter comprises an outer braided catheter surrounding the middle catheter which, in turn, surrounds the inner catheter. Further stent catheter assembly comprises, a tip disposed at the distal end of the catheter, a plurality of tubes, connected to the catheter. In one example, the plurality of tubes comprises an SS tube for enhancing structural support. Further the stent catheter assembly comprises , a balloon, wherein the balloon is disposed around the distal end of the catheter; a stent, wherein the stent is mounted on the balloon, a plurality of radiopaque marker bands, wherein the plurality of radiopaque marker bands is positioned proximal and distal to the stent on the catheter; and an inner catheter, wherein the inner catheter is housed within the catheter and wherein the inner catheter comprises multiple openings at its distal end of the inner catheter.

[0034] Further in the embodiment, the stent catheter assembly comprises a sheath handle connected to the catheter to facilitate manipulation of the catheter. The catheter comprises an outer braided catheter surrounding the middle catheter which, in turn, surrounds the inner catheter. In one example, the inner catheter is made of a nylon tube material.

[0035] Further comprising a locking knob operatively connected to the outer braided catheter to secure the relative position of the catheters. Further in the embodiment, he stents catheter assembly a pusher handle attached to the catheter to aid in advancing the stent to a desired location within a body vessel.

[0036] The deployed stent can be recaptured by the surgeon by the help of a stent recapture device that is positioned at the distal side of the device/catheter preferably at a distance of 2 mm from middle catheter i.e., in between middle catheter and inner catheter. The stent recapture device can be 2-3 mm in length. Further the balloon can be inflated again in case post dilation is required.

[0037] These and other features and advantages of the present invention will become apparent from the following description of the invention that is provided in connection with the accompanying drawings and illustrated embodiments of the invention. In the table below the nomenclature used is provided.

[0038] Referring now to the drawings, Figure 1 illustrates an integrated balloon and stent catheter 100 which includes a catheter tip 102, a plurality of tubes 104 (a catheter tube, a nylon tube, a middle catheter, a braided outer catheter (all explained later in description in Figure(2-4)),an expandable balloon 106 (explained later in description in Figure2), a stent 108 located in a stent containment cavity (explained later in description in Figure3) , a plurality of radiopaque marker bands 110, a sheath handle 112 having Mid Y-Port and a rotating knob 114 , a SS tube 116 deployed between sheath handle and a pusher hub 118 having multiple openings 120. [0039] Referring to Figure2, the tip 102 of the catheter 100 is advanced to penetrate the constriction or lesions of the vessel and the guide wire is run through the inner catheter 202 to locate and measure the lesions. The inflatable balloon 106 is mounted near the catheter's distal end 204 which is initially used for dilation of a vessel. One extremity of the balloon is connected to the inner catheter 202; the other extremity is connected to the Nylon Tube 206. The saline solution is introduced in between the channel created by the inner catheter 202 and the nylon tube 2O6.This saline solution inflates or deflates the balloon to pre-dilate the strictures or lesions within the vessel.

[0040] Referring Figure 3 now, a self-expanding stent 108 is located in a stent containment cavity in the compressed state. When the stent is deployed, the middle catheter 302 acts like a stopper and holds the stent 108 to expand it radially. The middle catheter 302 is made up of thermoplastic polymer such as Polypropylene. The radio opaque markers 110 are positioned at a difference of certain distance to let the physician know under fluoroscopy as to how much the tubes/catheter are inside the patient. The self-expandable stent 108 can be marked with material of high-density, highly corrosion-resistant metals such as tantalum or the like for the better visibility. Sometimes, instead of radio opaque markers, coating of fine metal powder such as tungsten or the like material can be done on the catheters for radiopacity.

[0041] Referring to Figure 4 now, the outer braided catheter 402 covers all the inner catheters and tubes and prevents them from kinking. The integrated balloon and stent catheter may also comprise of a sensor or an imaging device while using for the current application or for alternative application.

[0042] Referring to Figure 5, 6, 7 now illustrates various embodiments of the stent recapture device.

[0043] In operation once the guide wire is introduced, the balloon is moved forward by alternately inflating and deflating by introducing saline solution to dilate the strictures or lesions. Once the stricture is dilated enough to pass the outer braided catheter, and the balloon has reached the other end of the stricture, the rotating knob in the sheath handle is rotated, the sheath handle is pulled to deploy the self-expanding stent in the intended area. As the compressed stent is moved distally stent containment cavity, the stent begins expanding and radially expands until contact is made between the outer surface of the stent and the inner surface of the wall of a vessel. After the stent is deployed completely, the balloon is retracted through the stricture or lesion in the same way by alternately inflating and deflating it leaving the stent to keep the target vessel open. [0044] It is observed that use of multiple devices and multiple introductions of the devices into the patient’s body has been eliminated. Along with this advantage, the single integrated balloon and stent catheter has provided efficiency, cost reduction, reduction in biodegradable waste as well as elimination of time-consuming surgery as described in the present invention.

[0045] The present invention has both technical as well as economic significance with respect to the conventional devices for deploying stents.

[0046] While a particular embodiment of the invention has been illustrated and described, modifications thereof will readily occur to those skilled in the art. It is understood that the various embodiments, details and constructions and their features described above and illustrated in the attached figures may be interchanged among the various embodiments while remaining within the scope of the invention. Additionally, it is understood that various modifications could be made to any of the elements described herein above while remaining within the scope of the invention.

Claims

CLAIMS:

1. A stent catheter assembly, wherein the stent catheter assembly comprising: a catheter (100) having a distal end (204) a tip (102), wherein the tip (102) is disposed at the distal end (204) of the catheter (100); a plurality of tubes (104), wherein the plurality of tubes (104) are connected to the catheter (100); a balloon (106), wherein the balloon is disposed around the distal end (204) of the catheter (100); a stent (108), wherein the stent (108) is mounted on the balloon (106); a plurality of radiopaque marker bands (110), wherein the plurality of radiopaque marker bands (110) is positioned proximal and distal to the stent (108) on the catheter (100); and an inner catheter (202), wherein the inner catheter (202) is housed within the catheter (100) and wherein the inner catheter (202) comprises multiple openings (120) at its distal end of the inner catheter (202)

2. The stent catheter assembly of claim 1, further comprising a sheath handle (112) connected to the catheter (100) to facilitate manipulation of the catheter (100).

3. The stent catheter assembly of claim 1, wherein the catheter (100) comprises an outer braided catheter (402) surrounding the middle catheter (302) which, in turn, surrounds the inner catheter (202).

4. The stent catheter assembly of claim 3, further comprising a locking knob (114) operatively connected to the outer braided catheter (402) to secure the relative position of the catheters.

5. The stent catheter assembly of claim 1, wherein the plurality of tubes (104) comprise an SS tube (116) for enhancing structural support.

6. The stent catheter assembly of claim 1, further comprising a pusher handle (118) attached to the catheter (100) to aid in advancing the stent (108) to a desired location within a body vessel.

7. The stent catheter assembly of claim 1, wherein the inner catheter (202) is made of a nylon tube (206) material.

8. The stent catheter assembly of claim 1, further comprising: a stent recapture device positioned at the distal side of said catheter (100), located approximately 2 mm from said middle catheter (302), and situated between said middle catheter (302) and said inner catheter (202), wherein said stent recapture device is configured to enable a surgeon to recapture the deployed stent (108), wherein said stent recapture device has a length ranging from 2-3 mm, and wherein said balloon (106) is configured to be reinflated for post dilation after stent deployment.