WO2024005748A1 - A balloon stent catheter with an occluded tip - Google Patents

A balloon stent catheter with an occluded tip Download PDF

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Publication number
WO2024005748A1
WO2024005748A1 PCT/TR2023/050442 TR2023050442W WO2024005748A1 WO 2024005748 A1 WO2024005748 A1 WO 2024005748A1 TR 2023050442 W TR2023050442 W TR 2023050442W WO 2024005748 A1 WO2024005748 A1 WO 2024005748A1
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Prior art keywords
balloon
stent
cut
catheter
balloon catheter
Prior art date
Application number
PCT/TR2023/050442
Other languages
French (fr)
Inventor
Mustafa Tarik AĞAÇ
Ersan TATLI
Mehmet Bülent VATAN
Original Assignee
Sakarya Üni̇versi̇tesi̇ Rektörlüğü
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Publication of WO2024005748A1 publication Critical patent/WO2024005748A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image

Definitions

  • the invention relates to a balloon stent catheter with an occluded tip that enables either occlusion or flow limitation of blood vessels or the lumens of a tubular organ within the body. It is applied by sending it through the guide wire used in the standard angioplasty procedure to the blood vessel or to the lumen of a tubular organ where the obstruction or flow limitation is desired.
  • occlusive devices can be implanted by approaching the blood vessels or the lumens of tubular organs, by entering through a peripheral blood vessel with guide wires and catheters advancing within the vessel. Thanks to the implantable occlusive devices, the flow is cut off or limited in the relevant structure, and the treatment goal is achieved.
  • Blood vessel or organ lumen occlusion procedure can basically be performed by two interventional angiographic methods.
  • One method is “Coil Embolization” and the other is “Vascular Plug”.
  • coil embolization the structure that is desired to be occluded is approached with a microcatheter and when the coil is pushed out of the microcatheter, due to its metallic memory, it becomes a three-dimensional helical mass within the vessel or lumen and thus the occlusion is achieved.
  • a vascular plug which is another method, the vessel, or a lumen, which is desired to be blocked is approached with a catheter.
  • the vascular plug which is actually a nitinol network, that has three-dimensional metallic memory and contains medical textiles that limit fluid permeability, is released within the vessel by pushing it out of the catheter, and thus, the occlusion of the vessel can be achieved.
  • the said method of coil embolization and the use of vascular plugs has various disadvantages. Microcatheter, an expensive material, is needed in the coil embolization method. In addition, in this method, it takes time for the flow in the blood vessel to stop completely.
  • the use of vascular plugs requires approaching the relevant vessels or lumens with bulky delivery catheters, which is not always technically possible in small and tortuous vessels. In addition, in the vascular plug method, it takes a while for the flow in the vessel or the lumen to stop completely.
  • the present invention relates to an endo-luminal occlusive device which, when implanted in a body lumen such as arteries, veins, or fallopian tubes, facilitates immediate occlusion of the lumen.
  • a body lumen such as arteries, veins, or fallopian tubes
  • the document in question provides the sudden blocking of the Fallopian tubes and the migration of sperm that prevents the fertilization of the egg.
  • the models defined in the said document cannot be advanced over the guide wire, that feature severely restricts the use of the proposed model in small tortuous blood vessels.
  • the present invention relates to a balloon stent catheter with an occluded tip to eliminate the above-mentioned disadvantages and to bring new advantages to the related technical field.
  • An object of the invention is to provide a balloon stent catheter that is inexpensive, effective, easy to use, and allows either occlusion or flow limitation in a blood vessel or a body lumen.
  • the flow cessation in the blood vessel or in the body lumen can be immediate or delayed according to the porosity of the balloon membrane used.
  • Another object of the invention is to provide a flow-occlusive or flow-limiting stent catheter that can be used easily without any undesirable conditions, especially in tortuous and small -diameter vessels.
  • the present invention is a balloon stent catheter with an occluded tip that allowseither occlusion or flow limitation of the relevant blood vessel by sending it over at least one guide wire to the vessel to be occluded or flow limited during the angioplasty procedures applied in human and animals.
  • its novelty includes at least one cut balloon catheter shaft through which said guide wire passes, the cut balloon membrane attached to this shaft, at least one stent-loaded balloon catheter shaft through which said cut balloon catheter shaft is inserted, at least one balloon element provided on said stent loaded balloon catheter shaft, the stent element that covers said balloon element and secures the membrane of the cut balloon catheter to the vessel wall after implantation.
  • liquid impermeable balloon membrane when used, it is to provide a stent catheter that is inexpensive, effective, easy to use, and allows the flow in the vessel to stop in a shorter time compared to the systems in the current art.
  • a possible embodiment of the invention is characterized in that it comprises at least one balloon membrane attached to the stent element at one end to the said cut balloon shaft at the other end.
  • this membrane is made of either liquid impermeable plastic or partially liquid permeable porous/perforated plastic or medical textile, and when implanted, it will either fully occlude the lumen, or it will limit liquid flow in the lumen at the desired rate according to the density of the porous/hole or the filter feature of the medical textile.
  • ring element comprises a radio-opaque material.
  • the radiopaque rings allow the visibility of the balloon stent catheter under the X-ray.
  • Figure 1 balloon stent catheter with an occluded tip
  • Figure 2 balloon stent catheter with an occluded tip in a representative vessel.
  • balloon stent catheter with an occluded tip of the invention is described only by way of non-limiting examples for a better understanding of the subject matter.
  • Embolization is the process of stopping the blood flow in the blood vessels by delivering foreign materials inside the vessel for medical reasons. In other words, this procedure causes occlusion of the blood vesselss for medical reasons.
  • the need for vessel occlusion has an important role in interventional angiographic treatment methods. The most common area of application is to control the bleeding for life threatening hemorrhage..
  • embolization has been used to treat many different diseases. The most important procedures in the art are chemoembolization and radioembolization, especially in the treatment of liver cancer. In addition to all these, embolization of uterine fibroids in the uterus prevents the nutrition of uterine fibroids, and reduces, or destroys uterine fibroids.
  • Figure 1 and 2 shows the said invention of the balloon stent catheter with an occluded tip (100).
  • the said balloon stent catheter with an occluded tip is characterized in that it comprises a cut balloon catheter and a stent catheter attached with connection elements.
  • Cut balloon catheter comprises a cut shaft (20) and a cut balloon membrane (30). The cut shaft of the cut balloon catheter is inserted into the distal end of the larger shaft (40) of the stent catheter. The cut balloon membrane is in connection with the cut shaft to form a blunt end.
  • the cut balloon shaft and stent catheter shaft form a continuous shaft where the standard angioplasty guidewire (10) passes in so that the said balloon stent catheter with occluded tip can be advanced and reach the blood vessel or to the lumen of a tubular organ where the treatment is planned.
  • the stent catheter component of the said invention has a larger shaft (40) so that the cut balloon shaft (20) can pass in and a balloon element (50) to be inflated to expand the stent element (60) provided.
  • the stent element Since the stent element is firmly attached to the cut balloon catheter’s membrane by a connection element (70) either by glue, stitch, or molding; when the stent element (60) is implanted by inflating the balloon, the stent fixes the balloon membrane to the luminal surface of a blood vessel (90) or a tubular organ and finally remains occluded tip stent inside the lumen.
  • the shaft of the cut balloon catheter and the shaft of the stent catheter is characterized by radiopaque rings (80) to increase the visibility under X-ray, for some safety reasons.
  • the balloon stent catheter with an occluded tip (100) of the invention is obtained by following the production steps below;
  • the balloon section of the standard balloon catheter which is mainly used in angioplasty procedures and is state of the art, is cut with remaining the distal part.
  • the shaft (20) of the cut angioplasty balloon catheter has to be shortened at the inner end.
  • a one-way valve mechanism is added to the shortened inner end of the cut balloon catheter shaft so that the shaft will not permit liquid flow when the occluded tip stent finally remained inside the lumen.
  • the cut balloon catheter shaft (20) is inserted inside the larger stent-loaded balloon catheter's shaft (40) from the front.
  • the cut balloon's membrane (30) is fixed to the stent element (60) with the stitches or adhesive connection (70) in a way that provides a fixed union with the stent element.
  • the balloon stent catheter with an occluded tip (100) is obtained.
  • the balloon stent catheter with an occluded tip (100) is sent to the blood vessel (90) where the occlusion or flow limitation process is desired over the guide wire (10) used in the standard angioplasty process.
  • the guide wire (10) is 0.014 inches in size, however for larger blood vessels a larger diameter guidewire could be chosen.
  • the structure consists of a distally cut half balloon catheter with a shaft (20) through which the guide wire (10) passes, and a stent-loaded balloon catheter shaft (49) through which said cut balloon catheter shaft (20) is inserted.
  • a balloon element (50) is provided on the stent-loaded balloon catheter shaft (40).
  • the stent element (60) is firmly crimped over the balloon (50) element.
  • the balloon element provided is inflated and expanded inside the blood vessel (90). Since the stent element (60) is in connection (70) with the cut balloon membrane (30), during the inflation process, the stent element (60) also expands and allows the balloon membrane (30) of the cut half balloon catheter to be fixed to the vessel wall (90).
  • the balloon membrane (30) of the cut balloon catheter shaft (20) either allows the partial passage of liquid (semipermeable) or is liquid-proof.
  • This balloon membrane (30) is at least partially wrapped over the stent element (60) and firmly attached to the stent element with connections (70).
  • the balloon membrane (30) can be connected to the stent element (60) by either stitches or an adhesive method.
  • This balloon membrane (30) may be long to cover some or the whole length of the stent (60) element.
  • the balloon membrane (30) may be made of monolithic plastic or medical textile to provide sealing, or of porous/perforated plastic or medical textile to provide partial fluid permeability.
  • rings (80) positioned on the cut balloon catheter shaft (20) and the stent-loaded balloon catheter shaft (40). Said rings (80) allow visibility of the balloon stent catheter with an occluded tip (100) at least under X-ray.
  • the rings (80) are made of radio-opaque metal material in a preferred embodiment of the invention.
  • the balloon stent catheter with an occluded tip (100) of the invention After the balloon stent catheter with an occluded tip (100) of the invention is expanded in the blood vessel (90), it provides a plug formation that either interrupts or limits the flow.
  • the occluded tip balloon membrane (30) By expanding the stent (60) in the appropriate blood vessel (90), the occluded tip balloon membrane (30) is fixed to the blood vessel (90), and either the occlusion or flow limitation process is performed in the vessel (90).
  • the stent and balloon technology existing in the current art are revised with a novel method to develop a successful, effective, and inexpensive occlusive catheter.
  • another possible embodiment of the invention is characterized in that there is a valve mechanism at the inner tip of the cut balloon catheter shaft (20), thereby preventing fluid passage from the cut balloon catheter shaft after the implantation.
  • another possible embodiment of the invention is characterized in that it comprises a cut balloon catheter with defined features, which is front-loaded and fixed to the self-expanding nitinol stent elements (60)..
  • the selfexpanding nitinol stent element (60) is released and the membrane of the cut balloon catheter at the front of the stent element (60) fixed to the vessel lumen (90) together with the stent element (60).
  • the flow is either completely interrupted or the liquid flow is limited.
  • the balloon stent catheter with an occluded tip (100) is provided with simple and inexpensive materials such as the stent element (60) and the balloon membrane (30) and can be delivered to all kinds of blood vessels or the lumens of tubular organs (90) using the guide wire (10).
  • the invention in question is particularly conical in structure and can be advanced without encountering resistance up to all kinds of distal blood vessels (90), and the occlusion of the vessel (90) or flow limitation process is carried out.
  • the vessel (90) occlusion process occurs immediately after the device is released.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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Abstract

The invention is characterized in that during angioplasty procedures on individuals, it comprises a balloon stent catheter with an occluded tip (100) that is sent through at least one guide wire (10) to the blood vessel or a tubular organ (90) that is to be occluded or flow-limited, at least one cut balloon catheter shaft (20) with an inner end valve through which said guide wire (10) passes, at least one balloon membrane (30), at least one stent loaded balloon catheter shaft (40) through which said cut balloon catheter shaft (20) is inserted, at least one balloon element (50) provided on said stent-loaded balloon catheter shaft (40), at least onestent element (60) which covers the said balloon element (50) and which fixes the cut balloon membrane (30) to the wall of the vessel (90), at least one connection element (70) to ensure stable integrity of the balloon membrane (30) and the stent element (60).

Description

A BALLOON STENT CATHETER WITH AN OCCLUDED TIP
TECHNICAL FIELD
The invention relates to a balloon stent catheter with an occluded tip that enables either occlusion or flow limitation of blood vessels or the lumens of a tubular organ within the body. It is applied by sending it through the guide wire used in the standard angioplasty procedure to the blood vessel or to the lumen of a tubular organ where the obstruction or flow limitation is desired.
BACKGROUND
Today, in some diseases, it is necessary to embolize or occlude the blood vessels or the lumen of a tubular organ for treatment purposes, and in some cases, the flow in the relevant structures should be limited. These procedures can be performed surgically or by interventional angiographic methods. In interventional angiographic methods, occlusive devices can be implanted by approaching the blood vessels or the lumens of tubular organs, by entering through a peripheral blood vessel with guide wires and catheters advancing within the vessel. Thanks to the implantable occlusive devices, the flow is cut off or limited in the relevant structure, and the treatment goal is achieved.
Blood vessel or organ lumen occlusion procedure can basically be performed by two interventional angiographic methods. One method is “Coil Embolization” and the other is “Vascular Plug”. In coil embolization, the structure that is desired to be occluded is approached with a microcatheter and when the coil is pushed out of the microcatheter, due to its metallic memory, it becomes a three-dimensional helical mass within the vessel or lumen and thus the occlusion is achieved. In the use of a vascular plug, which is another method, the vessel, or a lumen, which is desired to be blocked is approached with a catheter. The vascular plug, which is actually a nitinol network, that has three-dimensional metallic memory and contains medical textiles that limit fluid permeability, is released within the vessel by pushing it out of the catheter, and thus, the occlusion of the vessel can be achieved.
The said method of coil embolization and the use of vascular plugs has various disadvantages. Microcatheter, an expensive material, is needed in the coil embolization method. In addition, in this method, it takes time for the flow in the blood vessel to stop completely. The use of vascular plugs requires approaching the relevant vessels or lumens with bulky delivery catheters, which is not always technically possible in small and tortuous vessels. In addition, in the vascular plug method, it takes a while for the flow in the vessel or the lumen to stop completely.
A document with application number US2014163599 is available in the literature. The present invention relates to an endo-luminal occlusive device which, when implanted in a body lumen such as arteries, veins, or fallopian tubes, facilitates immediate occlusion of the lumen. Thus, blood flow to tumors, necrotic tissues, and aneurysms can be stopped instantly and the healing of the affected areas can be helped. Similarly, the document in question provides the sudden blocking of the Fallopian tubes and the migration of sperm that prevents the fertilization of the egg. The models defined in the said document cannot be advanced over the guide wire, that feature severely restricts the use of the proposed model in small tortuous blood vessels.
As a result, all the above-mentioned problems have made it imperative to innovate in the relevant technical field.
BRIEF DESCRIPTION OF THE INVENTION
The present invention relates to a balloon stent catheter with an occluded tip to eliminate the above-mentioned disadvantages and to bring new advantages to the related technical field.
An object of the invention is to provide a balloon stent catheter that is inexpensive, effective, easy to use, and allows either occlusion or flow limitation in a blood vessel or a body lumen. The flow cessation in the blood vessel or in the body lumen can be immediate or delayed according to the porosity of the balloon membrane used. Another object of the invention is to provide a flow-occlusive or flow-limiting stent catheter that can be used easily without any undesirable conditions, especially in tortuous and small -diameter vessels.
The present invention is a balloon stent catheter with an occluded tip that allowseither occlusion or flow limitation of the relevant blood vessel by sending it over at least one guide wire to the vessel to be occluded or flow limited during the angioplasty procedures applied in human and animals. Accordingly, its novelty includes at least one cut balloon catheter shaft through which said guide wire passes, the cut balloon membrane attached to this shaft, at least one stent-loaded balloon catheter shaft through which said cut balloon catheter shaft is inserted, at least one balloon element provided on said stent loaded balloon catheter shaft, the stent element that covers said balloon element and secures the membrane of the cut balloon catheter to the vessel wall after implantation. Thus, when liquid impermeable balloon membrane is used, it is to provide a stent catheter that is inexpensive, effective, easy to use, and allows the flow in the vessel to stop in a shorter time compared to the systems in the current art. A possible embodiment of the invention is characterized in that it comprises at least one balloon membrane attached to the stent element at one end to the said cut balloon shaft at the other end. Thus, this membrane is made of either liquid impermeable plastic or partially liquid permeable porous/perforated plastic or medical textile, and when implanted, it will either fully occlude the lumen, or it will limit liquid flow in the lumen at the desired rate according to the density of the porous/hole or the filter feature of the medical textile.
Another possible embodiment of the invention is characterized in that said ring element comprises a radio-opaque material. Thus, the radiopaque rings allow the visibility of the balloon stent catheter under the X-ray.
FIGURES
Figure 1 : balloon stent catheter with an occluded tip
Figure 2: balloon stent catheter with an occluded tip in a representative vessel.
100 Balloon Stent Catheter with an Occluded Tip
10 Guide Wire
20 Cut Balloon Catheter Shaft
30 Balloon Membrane
40 Stent Loaded Balloon Catheter Shaft
50 Balloon Element
60 Stent Element
70 Connection
80 Ring
90 Blood vessel
DETAILED DESCRIPTION OF THE INVENTION
In this detailed description, the balloon stent catheter with an occluded tip of the invention is described only by way of non-limiting examples for a better understanding of the subject matter.
Embolization is the process of stopping the blood flow in the blood vessels by delivering foreign materials inside the vessel for medical reasons. In other words, this procedure causes occlusion of the blood vesselss for medical reasons. The need for vessel occlusion has an important role in interventional angiographic treatment methods. The most common area of application is to control the bleeding for life threatening hemorrhage.. Over the past 20 years, embolization has been used to treat many different diseases. The most important procedures in the art are chemoembolization and radioembolization, especially in the treatment of liver cancer. In addition to all these, embolization of uterine fibroids in the uterus prevents the nutrition of uterine fibroids, and reduces, or destroys uterine fibroids.
Figure 1 and 2 shows the said invention of the balloon stent catheter with an occluded tip (100). The said balloon stent catheter with an occluded tip is characterized in that it comprises a cut balloon catheter and a stent catheter attached with connection elements. Cut balloon catheter comprises a cut shaft (20) and a cut balloon membrane (30). The cut shaft of the cut balloon catheter is inserted into the distal end of the larger shaft (40) of the stent catheter. The cut balloon membrane is in connection with the cut shaft to form a blunt end. The cut balloon shaft and stent catheter shaft form a continuous shaft where the standard angioplasty guidewire (10) passes in so that the said balloon stent catheter with occluded tip can be advanced and reach the blood vessel or to the lumen of a tubular organ where the treatment is planned. The stent catheter component of the said invention has a larger shaft (40) so that the cut balloon shaft (20) can pass in and a balloon element (50) to be inflated to expand the stent element (60) provided. Since the stent element is firmly attached to the cut balloon catheter’s membrane by a connection element (70) either by glue, stitch, or molding; when the stent element (60) is implanted by inflating the balloon, the stent fixes the balloon membrane to the luminal surface of a blood vessel (90) or a tubular organ and finally remains occluded tip stent inside the lumen. The shaft of the cut balloon catheter and the shaft of the stent catheter is characterized by radiopaque rings (80) to increase the visibility under X-ray, for some safety reasons.
The balloon stent catheter with an occluded tip (100) of the invention is obtained by following the production steps below;
• The balloon section of the standard balloon catheter, which is mainly used in angioplasty procedures and is state of the art, is cut with remaining the distal part.
The shaft (20) of the cut angioplasty balloon catheter has to be shortened at the inner end. A one-way valve mechanism is added to the shortened inner end of the cut balloon catheter shaft so that the shaft will not permit liquid flow when the occluded tip stent finally remained inside the lumen. The cut balloon catheter shaft (20) is inserted inside the larger stent-loaded balloon catheter's shaft (40) from the front. The cut balloon's membrane (30) is fixed to the stent element (60) with the stitches or adhesive connection (70) in a way that provides a fixed union with the stent element. Thus, the balloon stent catheter with an occluded tip (100) is obtained. The balloon stent catheter with an occluded tip (100) is sent to the blood vessel (90) where the occlusion or flow limitation process is desired over the guide wire (10) used in the standard angioplasty process. In a preferred embodiment of the invention, the guide wire (10) is 0.014 inches in size, however for larger blood vessels a larger diameter guidewire could be chosen. The structure consists of a distally cut half balloon catheter with a shaft (20) through which the guide wire (10) passes, and a stent-loaded balloon catheter shaft (49) through which said cut balloon catheter shaft (20) is inserted. A balloon element (50) is provided on the stent-loaded balloon catheter shaft (40). The stent element (60) is firmly crimped over the balloon (50) element. The balloon element provided is inflated and expanded inside the blood vessel (90). Since the stent element (60) is in connection (70) with the cut balloon membrane (30), during the inflation process, the stent element (60) also expands and allows the balloon membrane (30) of the cut half balloon catheter to be fixed to the vessel wall (90).
In the invention, the balloon membrane (30) of the cut balloon catheter shaft (20) either allows the partial passage of liquid (semipermeable) or is liquid-proof. This balloon membrane (30) is at least partially wrapped over the stent element (60) and firmly attached to the stent element with connections (70). The balloon membrane (30) can be connected to the stent element (60) by either stitches or an adhesive method. This balloon membrane (30) may be long to cover some or the whole length of the stent (60) element. In one embodiment of the invention, the balloon membrane (30) may be made of monolithic plastic or medical textile to provide sealing, or of porous/perforated plastic or medical textile to provide partial fluid permeability. In the invention, there are rings (80) positioned on the cut balloon catheter shaft (20) and the stent-loaded balloon catheter shaft (40). Said rings (80) allow visibility of the balloon stent catheter with an occluded tip (100) at least under X-ray. The rings (80) are made of radio-opaque metal material in a preferred embodiment of the invention.
After the balloon stent catheter with an occluded tip (100) of the invention is expanded in the blood vessel (90), it provides a plug formation that either interrupts or limits the flow. By expanding the stent (60) in the appropriate blood vessel (90), the occluded tip balloon membrane (30) is fixed to the blood vessel (90), and either the occlusion or flow limitation process is performed in the vessel (90). The stent and balloon technology existing in the current art are revised with a novel method to develop a successful, effective, and inexpensive occlusive catheter.
In addition, another possible embodiment of the invention is characterized in that there is a valve mechanism at the inner tip of the cut balloon catheter shaft (20), thereby preventing fluid passage from the cut balloon catheter shaft after the implantation.. Further, another possible embodiment of the invention is characterized in that it comprises a cut balloon catheter with defined features, which is front-loaded and fixed to the self-expanding nitinol stent elements (60).. In this embodiment, with the retraction of the catheter, the selfexpanding nitinol stent element (60) is released and the membrane of the cut balloon catheter at the front of the stent element (60) fixed to the vessel lumen (90) together with the stent element (60). Thus, according to the property of the balloon membrane (30), the flow is either completely interrupted or the liquid flow is limited.
The balloon stent catheter with an occluded tip (100) is provided with simple and inexpensive materials such as the stent element (60) and the balloon membrane (30) and can be delivered to all kinds of blood vessels or the lumens of tubular organs (90) using the guide wire (10). The invention in question is particularly conical in structure and can be advanced without encountering resistance up to all kinds of distal blood vessels (90), and the occlusion of the vessel (90) or flow limitation process is carried out. In addition, in the case when the balloon stent catheter with an occluded tip (100) is manufactured from the liquid-proof balloon membrane (30), the vessel (90) occlusion process occurs immediately after the device is released. The protection scope of the invention is specified in the appended claims and cannot be strictly limited to those explained in this detailed description for illustrative purposes. It is evident that a person skilled in the art may exhibit similar embodiments in light of the foregoing without departing from the main theme of the invention.

Claims

CLAIMS A balloon stent catheter with an occluded tip (100) that enables the occlusion or flow limitation process in the relevant blood vessel (90) or tubular organ to be carried out by sending it over at least one guide wire (10) to the desired location characterized in comprising at least one cut balloon catheter shaft (20) through which said guide wire (10) passes, at least one stent-loaded balloon catheter shaft (40) through which said cut balloon catheter shaft (20) is inserted, at least one balloon element (50), at least one stent element (60) which covers the said balloon element and fixes the connected balloon membrane to the vessel wall when implanted. A method of manufacturing a balloon stent catheter with an occluded tip (100), characterized by comprising steps of
• cutting the balloon section of the standard balloon catheter near the radio-opaque rear ring (80) with sparing the distal half,
• shortening the inner shaft of the cut angioplasty balloon catheter to obtain a cut balloon catheter shaft (20),
• adding a valve mechanism to the inner tip of the shaft of the cut balloon catheter (20),
• inserting the cut balloon catheter shaft (20) into the stent-loaded balloon catheter shaft (40) from the front,
• securing the membrane of the cut balloon (30) to the stent (60) to provide a fixed union with the stent element. A balloon stent catheter with an occluded tip (100) according to claim 1, characterized by comprising at least one balloon membrane (30) which at least one end is connected to said stent element (60) via connection elements (70) and the other end connected to said cut balloon catheter shaft (20). A balloon stent catheter with an occluded tip (100) according to claim 1, wherein said ring (80) is located on the cut balloon catheter shaft (20) and the said stent-loaded balloon catheter shaft (40) is made of radio-opaque material.
PCT/TR2023/050442 2022-06-30 2023-05-15 A balloon stent catheter with an occluded tip WO2024005748A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2022/010877A TR2022010877A2 (en) 2022-06-30 2022-06-30 BALLOON STENT CATHETER WITH A CLOSED TIP
TR2022/010877 2022-06-30

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WO2024005748A1 true WO2024005748A1 (en) 2024-01-04

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6029671A (en) * 1991-07-16 2000-02-29 Heartport, Inc. System and methods for performing endovascular procedures
US20190134358A1 (en) * 2008-09-15 2019-05-09 Aeeg Ab Medical Device, Method And System For Temporary Occlusion Of An Opening In A Lumen Of A Body

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6029671A (en) * 1991-07-16 2000-02-29 Heartport, Inc. System and methods for performing endovascular procedures
US20190134358A1 (en) * 2008-09-15 2019-05-09 Aeeg Ab Medical Device, Method And System For Temporary Occlusion Of An Opening In A Lumen Of A Body

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