WO2024025499A2 - Système d'accès vasculaire - Google Patents

Système d'accès vasculaire Download PDF

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Publication number
WO2024025499A2
WO2024025499A2 PCT/TR2023/050704 TR2023050704W WO2024025499A2 WO 2024025499 A2 WO2024025499 A2 WO 2024025499A2 TR 2023050704 W TR2023050704 W TR 2023050704W WO 2024025499 A2 WO2024025499 A2 WO 2024025499A2
Authority
WO
WIPO (PCT)
Prior art keywords
vascular access
access according
cannula
conduit
valve
Prior art date
Application number
PCT/TR2023/050704
Other languages
English (en)
Other versions
WO2024025499A3 (fr
Inventor
Yavuz Selim BUHARALIOGLU
Original Assignee
Buharalioglu Yavuz Selim
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Buharalioglu Yavuz Selim filed Critical Buharalioglu Yavuz Selim
Publication of WO2024025499A2 publication Critical patent/WO2024025499A2/fr
Publication of WO2024025499A3 publication Critical patent/WO2024025499A3/fr

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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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter

Definitions

  • the present invention relates to a system for vascular access, required especially for dialysis of patients with chronic kidney disease.
  • vascular access is required to deliver medicaments, serum and fluids such as fresh blood directly into the vessel or to collect blood therefrom.
  • vascular access is achieved using plastic pieces with needles, also called as vascular access.
  • Said vascular access is in the form of a conduit, one part of which is left outside of the patient’s body and another part of which is inserted into at least one vessel of the patient.
  • the vascular access in conventional applications provides access to the vessel for a short period of time (for example, at most 10-15 days). At the end of said period of time, the vascular access must be removed in order to avoid infection.
  • high-flow blood flow is required for the dialysis process, and the high-flow blood flow can only be obtained from arteries or central veins. However, access to these vessels is difficult and serious complications may occur even when access is provided.
  • Patients suffering from chronic kidney disease must be dialyzed at certain intervals (for example, every 2-3 days).
  • the dialysis machines are for example connected to a vessel of the patient in order to collect blood from the vessel it is connected and clean it so as to be re-introduced into the vessel of the patient. Therefore, every 2-3 days, vascular access is necessary for the patients who will be dialyzed. Since the vascular access system in conventional applications is maintained in the body of the patient for a short period of time, a new vascular access is required practically for every dialysis process. This, however, is painful for the patient and also, since it results in permanent damages on vessels, it is not possible to use it for a long period of time.
  • arteriovenous fistula disclosed in DE3604151A1.
  • AVF arteriovenous fistula
  • dialysis catheters may be used as an alternative to arteriovenous fistula application.
  • dialysis catheter may cause problems such as infections, blockage, and constriction of the vessel.
  • a system for vascular access allowing for external access to a vessel.
  • Said system for vascular access comprises at least one body; at least one delivery conduit provided in the body; at least one connecting portion provided on a side of the body and suitable for being connecting to at least one vessel; at least one inner conduit, with at least one side communicating into the connecting portion and at least another side connected to the delivery conduit; at least a first valve provided between the delivery conduit and the inner conduit; at least one expansion conduit surrounding the inner conduit and suitable for being filled with at least one fluid; at least one closure member in the expansion conduit, which stretches if a fluid is filled into the expansion conduit, so that the inner conduit is closed; at least one passage opening in the first valve, which provides fluid passage between the delivery conduit and the expansion conduit; at least one inlet port provided at a side of the body distal to the connecting portion, the inlet port having at least one inlet opening for receiving at least one needle or dialysis cannula into the body.
  • a vessel of a patient can be easily accessed if desired, as well as interrupting access to the vessel in an easy manner if desired. Therefore, reliable and practical access to the vessel is ensured, especially in patients who require vascular access at certain intervals, such as dialysis patients.
  • An object of the present invention is to provide a system for vascular access, required especially for dialysis of patients with chronic kidney disease.
  • Another object of the present invention is to provide a system for vascular access that can be used for a long period of time.
  • a further object of the present invention is to provide a system for vascular access which is easy-to use and practical.
  • Figure 1 is a perspective view of the system for vascular access according to the invention.
  • Figure 2 is a perspective view of an alternative embodiment of the system for vascular access according to the invention.
  • Figure 3 is a perspective view of another alternative embodiment of the system for vascular access according to the invention.
  • Figure 4 is a perspective view of a further alternative embodiment of the system for vascular access according to the invention.
  • Figure 5 is a perspective view of the system for vascular access according to the invention, in a semi-assembled state.
  • Figure 6 is a perspective view of a different alternative embodiment of the system for vascular access according to the invention.
  • Figure 7 is a perspective view of the system for vascular access according to the invention, in another semi-assembled state.
  • Figure 8 is a perspective view of the system for vascular access according to the invention, in a further semi-assembled state.
  • Figure 9 is a sectional perspective view of the system for vascular access according to the invention.
  • Figure 10 is a perspective view of an inlet port of the system for vascular access according to the invention.
  • Figure 11 is a perspective view of an upper valve of the system for vascular access according to the invention.
  • Figure 12 is a perspective view of a third valve of the system for vascular access according to the invention.
  • Figure 13 is a perspective view of an alternative embodiment of the system for vascular access according to the invention.
  • Figure 14 is a side view of a cannula and guide structure used in the system for vascular access according to the invention.
  • Figure 15 is a side view of the cannula used in the system for vascular access according to the invention.
  • Figure 16 is a side view of the guide used in the system for vascular access according to the invention.
  • the patient's blood should be drawn at regular intervals such that the blood is filtered and given to the patient again.
  • the mentioned processes are improved by vascular access devices that provide access to the vessel.
  • the vascular access devices used in conventional applications may result in undesired situations such as limited use, infection, blockage, heart failure, ischemia, and arterialization. Therefore, with the present invention, a system for vascular access is provided which is free of said drawbacks.
  • the system for vascular access comprises at least one body (1); at least one delivery conduit (2) provided in the body (1); at least one connecting portion (6) provided on a side of the body (1) and suitable for being connecting to at least one vessel; at least one inner conduit (3), with at least one side communicating into the connecting portion (6) and at least another side connected to the delivery conduit (2); at least a first valve (8) provided between the delivery conduit (2) and the inner conduit (3); at least one expansion conduit (4) surrounding the inner conduit (3) and suitable for being filled with at least one fluid; at least one closure member (5) in the expansion conduit (4), which stretches if a fluid is filled into the expansion conduit (4), so that the inner conduit (3) is closed; at least one passage opening (7) at the first valve (8), which provides fluid passage between the delivery conduit (2) and the expansion conduit (4); at least one inlet port (9) provided at a side of the body (1) distal to the connecting portion (6), the inlet port (9) having at least one inlet opening (12) for receiving at least
  • the system for vascular access is connected to a patient such that the connecting portion (6) is connected (e.g. stitched) to a vessel of the patient.
  • all components, including the inlet port (9), may remain under the skin of the patient.
  • a line is created to provide access to the vessel by means of the inlet port (9), the delivery conduit (2), the inner conduit (3) and the connecting portion (6), respectively.
  • a needle or a dialysis cannula is inserted through the inlet port (9) and passed through the delivery conduit (2), the inner conduit (3) and the connecting portion (6).
  • the line that can communicate between the vessel and the external environment must be closed.
  • a fluid e.g. a serum fluid
  • This fluid passes through the passage opening (7) in the first valve (8), thereby filling the expansion conduit (4).
  • said closing member (5) applies pressure on the inner conduit (3) to close the inner conduit (3).
  • the first valve (8) allows a needle or dialysis cannula to pass through the delivery conduit (2) to the inner conduit (3), while preventing the fluid in the delivery conduit (2) from passing into the inner conduit (3). Therefore, the fluid fills the expansion conduit (4) without the capability of passing into the inner conduit (3).
  • the fluid that has been previously sent into the delivery conduit (2) is received back by means of a needle.
  • the fluid in the expansion conduit (4) returns to the delivery conduit (2) through the passage opening (7).
  • the closure member (5) ceases to apply pressure on the inner conduit (3), so that the vessel can be accessed.
  • the closure member (5) comprises at least two barriers located to surround the inner conduit (3).
  • the barriers preferably in the form of flexible sheets, compress the inner conduit (3) when the expansion conduit expands, thus ensuring the closure of the inner conduit (3).
  • the first valve (8) is in the form of a duckbill, as shown in detail in Figure 5.
  • Said duckbill form comprises two surfaces located to exert pressure towards each other. While a needle or dialysis cannula can be passed between said surfaces, these surfaces close the gap after removal of the needle or dialysis cannula.
  • the connection between the delivery conduit (2) and the inner conduit (3) is interrupted.
  • the fluid sent to the delivery conduit (2) is passed through the passage opening to fill the expansion conduit (4).
  • the first valve (8) is in the form of a flexible disc with an opening in the middle section for the passage of the needle or dialysis cannula. Thanks to the aforementioned flexible form, the opening can be closed after the needle or dialysis cannula is withdrawn from the opening.
  • the system for vascular access comprises at least one inlet conduit (10) that connects the inlet port (9) and the delivery conduit (2).
  • the system for vascular access further comprises at least a second valve (11) located between the inlet conduit (10) and the inner conduit (2).
  • Said second valve (11) may be in the form of a duckbill, or a flexible disc (for example, in one of the forms of the first valve (8) described above).
  • the second valve (11) allows a needle to pass from the inlet conduit (10) to the delivery conduit (2), while preventing the fluid sent into the delivery conduit (2) from passing into the inlet conduit (10).
  • the system for vascular access comprises at least a third valve (16) provided on a side of the inlet conduit (10) distal to the delivery conduit (2).
  • Said third valve (16) may be in the form of a duckbill, or a flexible disc (for example, in one of the forms of the first valve (8) described above).
  • the third valve (16) allows a needle or dialysis cannula to be inserted into the inlet conduit (10), while preventing the fluid in the inlet conduit (10) from moving out of the inlet opening (12).
  • the third valve (16) is provided in the form of a disc
  • said third valve (16) comprises at least one valve body (16a); at least one slit (16b) provided at the middle portion of the valve body (16a); at least one flexible edge (16c) around said slit (16b), which stretches towards the valve body (16a) when a needle or dialysis cannula is passed through the slit (16b); at least one flexible obstacle (16d) provided between the flexible edge (16b) and the valve body (16a).
  • the system for vascular access further comprises at least one stretch gap (14) provided between the third valve (16) and inlet conduit (10). Said stretch gap (14) is in the form of a duckbill or disc of the third valve (16), which ensures unobstructed stretching movement when opened by stretching.
  • the system for vascular access comprises at least one upper valve (13) provided at the inlet port (9).
  • Said upper valve (13) is provided to valve the inlet opening (12).
  • Said upper valve (13) comprises at least one inclined surface (13a) for guiding a needle or dialysis cannula to the inlet opening (12).
  • the system for vascular access comprises polytetrafluorethylene (PTFE - Teflon), silicone, liquid silicone rubber (LSR), liquid silicone, or a similar biocompatible flexible material (in other words, it is made of polytetrafluorethylene, silicone or a similar biocompatible flexible material).
  • PTFE - Teflon polytetrafluorethylene
  • silicone liquid silicone rubber
  • the delivery conduit (2), inner conduit (3) and connecting portion (6) are made of liquid silicone rubber material.
  • the system for vascular access described herein may comprise a polytetrafluorethylene coating on different parts (for example, on the interior parts intended to contact with the cannula or needle).
  • the connecting portion (6) is securely connected to the vessel.
  • the system for vascular access comprises at least one front valve (15) provided on a side of the body (1) distal to the inlet port (9).
  • the front valve (15) closes the part of the expansion conduit (4) that is distal to the delivery conduit (2), thereby allowing for creation of a closed volume.
  • Said front valve (15) has preferably a rounded form. Therefore, for example, during a subcutaneous injection of the system for vascular access for connection to the vessel, damage to the subcutaneous tissues is prevented.
  • the system for vascular access comprises at least one valve (not shown in the figures) provided at the connecting portion (6).
  • said valve allows a needle or dialysis cannula to pass through the inner conduit (3) to reach the vessel, while ensuring interruption of the connection between the vessel and the inner conduit (3) in case of removal of the needle or dialysis cannula.
  • the connection of the vessel can be interrupted in a more effective manner by means of the line formed by the inner conduit (3), the delivery conduit (2) and the inlet port (9).
  • the system for vascular access comprises at least one protrusion (17) provided on the outer side of the body (1).
  • Said protrusion (17) is preferably in the form of a spiral or disc (for example, multiple discs positioned parallel to each other), which allows the body (1) to be attached to the surrounding tissues after insertion under the skin.
  • the body (1) is prevented from moving, thereby minimizing the pushing/pulling forces that will be reflected on the vessel.
  • the system for vascular access may further comprise at least one felt (not shown in the figures) for attachment of the body (1) to the subcutaneous tissues.
  • Said felt preferably comprises a large amount of yarn pieces entangled in a dispersed manner, and provides an increase in the contact surface with the subcutaneous tissue and a better connection with said tissue.
  • Said protrusion (17) and felt are made of polytetrafluoroethylene (PTFE - teflon), silicone, liquid silicone rubber (LSR), liquid silicone, or a similar biocompatible flexible material.
  • the system for vascular access comprises at least one cannula (18).
  • Said cannula (18) can reach the vessel by passing through the inlet port (9), the delivery conduit (2), the inner conduit (3) and the connecting portion (6), respectively.
  • Said cannula (18) comprises at least one cannula body (18a) in the form of a rod; at least one cannula conduit (18b) in the cannula body (18a); at least one cannula tip (18c) provided at a side of the cannula body (18a) and suitable for being inserted through the inlet port (9); at least one cannula inlet (18d) provided at a side of the cannula body (18a) distal to the cannula tip (18c).
  • Said cannula tip (18c) preferably has a rounded form.
  • Said cannula inlet (18d) preferably comprises at least one grooved section (18e).
  • Said grooved section (18e) is, for example, screwed to components of the dialysis device, ensuring a secure connection in between.
  • Said cannula (18) comprises at least one cannula opening (not shown in the figures) provided at the cannula tip (18c) or at a side of the cannula body (18a) close to the cannula tip (18c). Said cannula opening provides access to the vessel.
  • the cannula (18) comprises at least one of the materials such as silicone, liquid silicone, liquid silicone rubber or soft medical plastic (for example, it is made of at least one of these materials) and preferably has a monolithic structure.
  • the system for vascular access comprises at least one guide (19) which is suitable for insertion into the cannula (18) and is preferably made of a harder material (such as medical plastic, metal) than the cannula (18).
  • Said guide (19) comprises at least one guide body (19a) in the form of a rod; at least one guide conduit (19b) provided in the guide body (19a); at least one guide tip (19c) provided at a side of the guide body (19a) and suitable for insertion into the cannula (18); and at least one guide inlet (19d) provided at a side of the guide body (19a) distal to the guide tip (19c).
  • Said guide (19) comprises at least one guide opening (not shown in the figures) provided at the guide tip (19c) or at a side of the guide body (19a) close to the guide tip (19c).
  • the guide inlet (19d) comprises at least one injector housing (19e) which is preferably suitable for connecting with an injector.
  • an injector can be connected to the guide (19) to send a fluid through the guide into the system for vascular access (for example, in order to expand the expansion conduit (4)).
  • Said guide (19) is also used to observe the blood from the vessel when the cannula (18) reach the vessel, so as to detect whether the conduit is reached.
  • Said guide tip (19c) has preferably a rounded form.
  • Said guide tip (19c) is prevented from damaging the cannula (18) while passing through the cannula (18).
  • Said guide inlet (19d) preferably comprises at least one groove to be compatible with the grooved section (18e). Therefore, the guide (19) can be connected to the cannula (18) in a practical and reliable way in the form of screwing.
  • Said injector housing (19e) may also comprise at least one groove.
  • the grooved injectors are allowed to be connected to the injector housing (19e) in a reliable manner.
  • the system for vascular access comprises at least one piercing member.
  • Said piercing member is preferably in the form of a needle (or in a different way with a pointed tip) and provides a hole to be pierced at the skin when necessary, in order to reach the system for vascular access.
  • the piercing member has preferably a length insufficient to reach the system for vascular access after piercing the skin. Thus, damage to the system for vascular access is prevented while piercing the skin.
  • said cannula (18) and/or guide (19) passes through said hole to reach the system for vascular access.
  • reliable use of the system for vascular access is ensured even if the end portions of the cannula (18) and the guide (19) are not sharp enough to pierce the skin.
  • a vessel of a patient can be easily accessed if desired, as well as interrupting access to the vessel in an easy manner if desired. Therefore, reliable and practical access to the vessel is ensured, especially in patients who require vascular access at certain intervals, such as dialysis patients.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Pulmonology (AREA)
  • External Artificial Organs (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention divulgue un système d'accès vasculaire permettant un accès externe à un vaisseau sanguin. Ledit système d'accès vasculaire comprend au moins un corps (1) ; au moins un conduit de distribution (2) disposé dans le corps (1) ; au moins une partie de connexion (6) disposée sur un côté du corps (1) et appropriée pour être connectée à au moins un vaisseau sanguin ; au moins un conduit interne (3), avec au moins un côté communiquant dans la partie de connexion (6) et au moins un autre côté connecté au conduit de distribution (2) ; au moins une première valve (8) disposée entre le conduit de distribution (2) et le conduit interne (3) ; au moins un conduit d'expansion (4) entourant le conduit interne (3) et approprié pour être rempli d'au moins un fluide ; au moins un élément de fermeture (5) dans le conduit d'expansion (4), qui s'étire si un fluide est introduit dans le conduit d'expansion (4), de telle sorte que le conduit interne (3) est fermé ; au moins une ouverture de passage (7) au niveau de la première soupape (8), qui fournit un passage de fluide entre le conduit de distribution (2) et le conduit d'expansion (4) ; au moins un orifice d'entrée (9) disposé sur un côté du corps (1) distal par rapport à la partie de liaison (6), l'orifice d'entrée (9) ayant au moins une ouverture d'entrée (12) pour recevoir au moins une aiguille ou une canule de dialyse dans le corps (1).
PCT/TR2023/050704 2022-07-28 2023-07-19 Système d'accès vasculaire WO2024025499A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2022/011967 2022-07-28
TR2022011967 2022-07-28

Publications (2)

Publication Number Publication Date
WO2024025499A2 true WO2024025499A2 (fr) 2024-02-01
WO2024025499A3 WO2024025499A3 (fr) 2024-02-29

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Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4655746A (en) * 1985-12-02 1987-04-07 Target Therapeutics Catheter device
WO2003066125A2 (fr) * 2002-02-05 2003-08-14 Yale University Aiguille de dialyse a acces unique
ITMO20020152A1 (it) * 2002-06-05 2003-12-05 Mariangela Moggi Dispositivo per il clampaggio di grandi vasi
WO2005123158A1 (fr) * 2004-06-10 2005-12-29 Orqis Medical Corporation Canules et systeme presentant une resistance reduite a l'ecoulement
US20170043086A1 (en) * 2013-02-06 2017-02-16 Liviu Popa-Simil Enhanced cannulation method and needles
TR201514922A2 (tr) * 2015-11-25 2017-06-21 Yavuz Selim Buharalioglu Bir damar erişim sistemi.
TR202015394A2 (tr) * 2020-09-28 2022-04-21 Seli̇m Buharalioğlu Yavuz Bir damar erişim sistemi.

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