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WO2024177941A1 - Système de canule comprenant une pointe de forme variable - Google Patents

Système de canule comprenant une pointe de forme variable Download PDF

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Publication number
WO2024177941A1
WO2024177941A1 PCT/US2024/016401 US2024016401W WO2024177941A1 WO 2024177941 A1 WO2024177941 A1 WO 2024177941A1 US 2024016401 W US2024016401 W US 2024016401W WO 2024177941 A1 WO2024177941 A1 WO 2024177941A1
Authority
WO
WIPO (PCT)
Prior art keywords
tip
cannula
shape
lumen
blood vessel
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2024/016401
Other languages
English (en)
Inventor
Christopher C. Gregory
Jeff Kiersh
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vitara Biomedical Inc
Original Assignee
Vitara Biomedical Inc
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 Vitara Biomedical Inc filed Critical Vitara Biomedical Inc
Priority to AU2024226929A priority Critical patent/AU2024226929A1/en
Priority to CN202480025189.1A priority patent/CN121038831A/zh
Publication of WO2024177941A1 publication Critical patent/WO2024177941A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • 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
    • 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
    • A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M2025/0024—Expandable catheters or sheaths
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0462—Placental blood, umbilical cord blood
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0266—Shape memory materials
    • 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
    • A61M2240/00—Specially adapted for neonatal use
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes

Definitions

  • Cannula systems can facilitate cannulation of veins, arteries, and the like, of a patient such as a neonate.
  • Cannula systems typically include a trocar or needle for puncturing a patient body and a cannula for insertion into the patient via the puncturing.
  • some cannula systems may include a dilator that is used to position the cannula. The needle and dilator must be inserted into the cannula from a proximal position to extend out through the cannula tip a precise amount. During use, the needle is used to penetrate the vessel wall and advanced until the tip of the dilator passes through the opening.
  • the needle is then retracted, and the dilator is further advanced until the cannula is within the vessel the proper depth and then the dilator is retracted.
  • a device must be engaged with the vessel to secure the cannula.
  • the dilator must then be removed from the cannula to open the passage for blood.
  • the relatively large outside diameter of the dilator requires a large opening in the side of the cannula to allow the dilator to pass into and out of the cannula lumen.
  • the securement device is complex and results in a large amount of space around or within the cannula being occupied. As a result, the blood vessels may be unduly occupied and stretched. Also, there is a need to make the attachment between a cannula and anatomical vessel more secure.
  • a cannula system for cannulating a blood vessel.
  • the cannula system includes a cannula having a distal end and a proximal end.
  • the cannula defines a cannula lumen.
  • the cannula system also includes a tip on the distal end of the cannula.
  • the tip defines a tip lumen connected to the cannula lumen.
  • the tip is variable between a first shape and a second shape.
  • the first shape has a first width sized to fit through a lumen of the blood vessel.
  • the second shape has a second width larger than the first width and sized to engage the lumen of the blood vessel and secure the tip in position within the lumen of the blood vessel.
  • a method of cannulating a blood vessel in a tissue includes inserting a needle through the blood vessel wall to form a passage into the blood vessel.
  • the needle extends through a tip on a distal end of a cannula.
  • the method also includes inserting the tip and the cannula through the passage into a lumen defined by the blood vessel, and switching the tip from a first shape to a second shape.
  • the first shape has a first width sized to fit through the lumen of the blood vessel.
  • the second shape has a second width larger than the first width and sized to engage the lumen of the blood vessel and secure the tip in position within the lumen of the blood vessel.
  • a tip for a cannula system for cannulating a blood vessel defines a tip lumen connected to a cannula lumen.
  • the tip is variable between a first shape and a second shape.
  • the first shape has a first width sized to fit through a lumen of the blood vessel.
  • the second shape has a second width larger than the first width and sized to engage the lumen of the blood vessel and secure the tip in position within the lumen of the blood vessel.
  • FIG. 1 depicts a schematic of an extracorporeal support system.
  • FIG. 2 depicts a schematic of a portion of an extracorporeal support system.
  • FIG. 3 depicts an isometric view of a portion of an extracorporeal support system.
  • FIG. 4 depicts a cannula system implementing a variable tip according to an embodiment of the present disclosure, with the variable tip in a first shape.
  • FIG. 5 depicts an isometric view of a portion of the cannula system of FIG. 4, with the variable tip in the second shape.
  • FIG. 6 depicts an enlarged isometric view of the variable tip of the cannula system of FIG. 4, and illustrating surface features on the variable tip.
  • Ranges provided herein are understood to be shorthand for all of the values within the range.
  • a range of 1 to 50 is understood to include any number, combination of numbers, or sub-range from the group consisting 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 (as well as fractions thereof unless the context clearly dictates otherwise).
  • a cannula system includes a tip having a variable shape.
  • the cannula systems do not require a dilator and are simpler than prior systems.
  • cannulas described herein do not require a slit port on a side of the cannula or a collet clamp.
  • the cannula systems simplify or eliminate the tools and methods required to coordinate and position the cannula.
  • the cannula may have a reduced diameter and, therefore, be easier to position in smaller vessels than prior cannulas.
  • described embodiments reduce the number of steps in methods of using a cannula and simplify the cannulation process.
  • FIGS. 1-6 one aspect of the disclosure provides cannula systems for implementation with an extracorporeal support system particularly useful for neonates.
  • a system 10 is configured to provide extracorporeal support to a neonate.
  • the system 10 may be configured to provide a system environment that is similar to an environment the neonate would experience in utero. Viability of a neonate that is removed from the uterine environment (c. ., due to preterm birth) and that is, for example, between about 23 weeks to about 24 weeks gestation, may be increased by placing the neonate in the system 10 environment.
  • the system environment may be configured to accomplish any one of the following: (1) limit exposure of the neonate to light; (2) limit exposure of the neonate to sound; (3) maintain the neonate submerged within a liquid environment; (4) maintain the neonate within a desired temperature range; (5) minimize exposure to environmental contaminants; or (5) any combination thereof.
  • the system also permits neonatal activities (e.g., neonatal breathing movements, neonatal swallowing of fluid) necessary for organ growth and development.
  • the system 10 may be configured to treat neonates (e.g., less than 37 weeks estimated gestational age, particularly 28 to 32 weeks estimated gestational age), or extreme premature neonates (23 to 28 weeks estimated gestational age).
  • the gestation periods are provided for humans, though corresponding preterm neonates of other animals may be used.
  • the neonate has no underlying congenital disease.
  • the term or preterm neonate may have limited capacity for pulmonary gas exchange, for example, due to pulmonary hypoplasia or a congenital anomaly affecting lung development, such as congenital diaphragmatic hernia.
  • the subject may be a preterm or term neonate awaiting lung transplantation, for example, due to congenital pulmonary disease (e.g., bronchoalveolar dysplasia, surfactant protein B deficiency, and the like).
  • congenital pulmonary disease e.g., bronchoalveolar dysplasia, surfactant protein B deficiency, and the like.
  • Such transplantation surgeries are currently rarely performed in the United States. However, the number of transplantation surgeries may be increased with the more stable method for pulmonary support provided by embodiments of the disclosure.
  • the neonate 5 may also be a candidate for ex utero intrapartum treatment (EXIT) delivery, including patients with severe airway lesions and a long- expected course before definitive resection.
  • the neonate 5 may also be a neonatal surgical or fetoscopic procedure patient, particularly with preterm labor precipitating early delivery.
  • the system 10 may be configured such that the neonate 5 is maintained in the system 10 for as long as needed (for example, for days, weeks or months, until the neonate 5 is capable of life without the system 10).
  • the system 10 should be operable to maintain the neonate 5 for at least 7 days, at least 14 days, at least 21 days, at least 28 days, at least 35 days, at least 42 days, at least 49 days, or at least 56 days.
  • the system 10 includes a neonatal chamber 100 configured to house a neonate 5, a physiologic saline solution (PSS) circuit configured to provide a flow (e.g., a constant flow) of PSS through the neonatal chamber 100, and an oxygenation circuit 400 (e.g., extracorporeal membrane oxygenation system) configured to remove carbon dioxide from the neonate's blood and supply oxygen to the neonate's blood.
  • PSS physiologic saline solution
  • an oxygenation circuit 400 e.g., extracorporeal membrane oxygenation system
  • the system 10 is configured to maintain the neonate 5 in the neonatal chamber 100 immersed in PSS.
  • the system 10 is further configured such that the oxygenation circuit 400 provides adequate gas exchange for the neonate 5 to sustain life.
  • the system 10 provides an environment similar to an intrauterine environment to facilitate continued growth and development of the neonate 5.
  • the system 10 may include a cart or similar device that facilitates monitoring, caring for, and transporting the neonate 5 within a medical facility.
  • the system 10 may be as described in U.S. Patent No. 11,471,351 entitled “System and Method Configured to Provide Extracorporeal Support for Premature Fetus”.
  • the oxygenation circuit 400 can be connected with the neonate 5 in a venous/venous arrangement (e.g., with a mechanical pump included in the system 10). Alternatively, the oxygenation circuit 400 may be connected with the neonate 5 in an arterial/venous arrangement.
  • Cannulas may be placed in the great neck vessels (e.g., carotid, jugular) of the neonate 5 to connect the circulatory system of the neonate 5 to the oxygenator 500. The placement in the great neck vessels may avoid issues of vasospasm and cannula instability in umbilical vessels.
  • An external portion of the cannulas may be fitted with a sleeve (e.g., to permit increased tension of the stabilizing sutures).
  • the sleeve may be made of silicone and may be, for example, about 1 - 10 cm in length, particularly about 3-5 cm in length.
  • the cannulas may be sutured to the neonate 5 (for example via the fitted sleeve) to secure the cannulas to the neck of the neonate 5.
  • the oxygenation circuit 400 may be connected to the neonate 5 via the neonate’s umbilical cord.
  • cannulas may be sutured into the veins and arteries of the umbilical cord. It will be appreciated that other connection arrangements may be utilized.
  • a non-suturing device is described in United States Provisional Application No. 63/017,204.
  • the oxygenation circuit 400 may include an oxygenator 500 for providing gas exchange functionality, particularly of oxygen (to) and carbon dioxide (from), to the neonate 5.
  • the oxygenator 500 can be removably connected to the neonate 5 and, optionally, to other components of the oxygenation circuit 400 and the system 10.
  • the oxygenator 500 is connected with the neonate 5 via two or more fluid lines and includes at least a drain line 440 and an inlet line 445. Blood flows from the neonate 5 though the drain line 440 to the oxygenator 500. The blood then flows through the oxygenator 500 and returns to the neonate 5 via the inlet line 445.
  • the oxygenator 500 may be configured to be disconnected and replaced while the oxygenation circuit 400 is operational. If the oxygenator 500 is damaged or has surpassed its expected life cycle (typically 8 hours based on regulatory approvals), the oxygenation circuit 400 may be temporarily configurable to bypass the oxygenator 500 so that the oxygenator 500 may be disconnected from the oxygenation circuit 400 and a new, primed, oxygenator 500 connected in its place without interruption of blood flow.
  • the oxygenation circuit 400 may be temporarily configurable to bypass the oxygenator 500 so that the oxygenator 500 may be disconnected from the oxygenation circuit 400 and a new, primed, oxygenator 500 connected in its place without interruption of blood flow.
  • a heating and/or cooling element 600 may be connected to the system 10 and arranged to regulate a temperature of one or more components of the system 10.
  • FIG. 4 depicts a cannula system 200 according to embodiments of the present disclosure.
  • the cannula system may be integrated into the oxygenation circuit 400 with reference to FIGS. 1-3.
  • the cannula may be integrated into the cannula insertion system described with reference to U.S. Patent Publication No. 2021/0338270 Al.
  • the cannula system may be arranged for cannulating a blood vessel.
  • the cannula system 200 includes a cannula 202 having a distal end 204 and a proximal end 206.
  • the cannula 202 defines a cannula lumen 208 extending from the proximal end 206 to the distal end 204.
  • the cannula 202 includes a rigid section 205 extending proximally from the distal end 204, and a flexible section 207 extending from the rigid section to the proximal end 206.
  • the cannula system 200 includes a tip 210 on the distal end 204 of the cannula 202.
  • the tip 210 defines a tip lumen 212 connected to the cannula lumen 208.
  • the tip 210 is variable between a first shape (shown in FIG. 4) and a second shape (shown in FIGS. 5 and 6).
  • the first shape has a first width sized to fit through a lumen of the blood vessel.
  • the second shape has a second width that is larger than the first width and is sized to engage the lumen of the blood vessel and secure the tip 210 in position within the lumen of the blood vessel.
  • the cannula system 200 includes a needle 214 sized to fit through the cannula lumen 208 and the tip lumen 212.
  • the tip 210 defines a distal opening 216 arranged for the needle 214 to extend through and engage the blood vessel.
  • the cannula 202 includes a septum seal 218 that is proximal of the tip 210 and is arranged for the needle 214 to enter into or exit the cannula lumen 208.
  • the septum seal 218 is located on the flexible section 207 of the cannula. The septum seal 218 facilitates the insertion of the needle 214 and allows simple removal of the needle without a slit port.
  • the cannula is composed of biocompatible materials such as stainless steel, cobalt chrome alloy, titanium, nickel -titanium alloy, tantalum, tungsten plated nickel, tungsten plated brass, polycarbonate, PEEK, PES, fiber-reinforced plastic, or a combination thereof.
  • biocompatible materials such as stainless steel, cobalt chrome alloy, titanium, nickel -titanium alloy, tantalum, tungsten plated nickel, tungsten plated brass, polycarbonate, PEEK, PES, fiber-reinforced plastic, or a combination thereof.
  • the tip 210 is variable between a first shape and a second shape.
  • the second shape may be a different size and/or geometric shape than the first shape.
  • the tip 210 is a perforated, flexible sleeve or stent.
  • the first shape of the tip 210 is a tapered frustum.
  • the second shape of the tip 210 is a cylinder having a diameter. The diameter defines a width of the second shape and is larger than the width of the first shape.
  • the first shape may have a width about 1 mm or less, and the second width of the second shape may be in a range of 3 mm to 6 mm.
  • the tip 210 may have length in a range of 6 mm to 11 mm. In other embodiments, the tip 210 may have other shapes. For example, in some embodiments, the tip 210 may be cuboid, spherical, rectangular cuboid, and/or any suitable shape.
  • the tip 210 tapers from a larger diameter at the proximal end 204 to a smaller diameter that matches the outside diameter of the needle at the distal end.
  • the smaller diameter defines a minimum width of the first shape.
  • the tip 210 defines the distal opening 216 arranged for a needle to extend through and engage the blood vessel at the distal end.
  • the tapered shapes provides a smooth transition between the outside diameter of the needle 214 and the outside diameter of the cannula 202.
  • the tip 210 comprises features 220 that are disposed on an outer surface of the tip and are arranged to engage an inner surface of the blood vessel.
  • the features may comprise ribs or protrusions and facilitate the tip 210 engaging and securing to the blood vessel.
  • the features may be arranged in an irregular pattern (e.g. non-symmetric with respect to a transverse axis of the cannula) on the outer surface of the tip 210 such that the features facilitate engaging the blood vessel but do not hinder introduction of the tip 210 into the vessel.
  • the features are omitted.
  • the tip 210 is composed of a shape memory alloy such as a nickeltitanium (nitinol) alloy.
  • the shape memory alloy may facilitate the tip 210 switching shapes.
  • the tip is composed of biocompatible materials such as stainless steel, cobalt chrome alloy, titanium, nickel-titanium alloy, tantalum, tungsten plated nickel, tungsten plated brass, polycarbonate, PEEK, PES, fiber-reinforced plastic, or a combination thereof.
  • a retainer may be provided to secure the tip in the first shape or the second shape.
  • the retainer may be a separate component that engages the tip 210 in the first or second shape.
  • the retainer is incorporated into the tip 210 and/or the cannula 202.
  • the retainer may be removed or adjusted to switch the tip between the first shape and the second shape.
  • the retainer is a bias member, a latch, a catch, and/or any other suitable retainer.
  • the tip 210 may have the first shape or the second shape when the tip 210 is in a neutral position and require a force to be retained or held in the other of the first and second shape.
  • the retainer may retain the tip 210 in the first and/or second shape. In some embodiments, the retainer is omitted.
  • the tip 210 has the second shape when in the neutral state, and the retainer is incorporated with the needle 214.
  • the needle 214 engage and retain the tip 210 in the first shape, which is a collapsed state of the tip 210.
  • the restraint on the tip 210 is removed, and the tip 210 expands to the second shape.
  • the tip 210 has the second shape when in the neutral state, and the retainer is a sheath.
  • the sheath is positioned over the tip 210 to secure the tip 210 in the first, collapsed shape.
  • the sheath can be removed from the tip 210 when the cannula 202 and the tip are in position within the vessel. When the sheath is removed, the tip 210 expands to the second, expanded shape.
  • the tip has the second shape when in the neutral state, and the retainer is a restraining filament that engages the tip 210.
  • the retainer is a restraining filament that engages the tip 210.
  • the retainer is not needed.
  • the tip 210 is in the first shape in a neutral state.
  • a bladder is inflated inside of the tip 210 and the bladder expands the tip 210 by plastic deformation to the second shape and the bladder is removed.
  • the retainer is incorporated into the tip 210 and the cannula such that the tip 210 is held in the first shape by the position of the tip 210 relative to the cannula.
  • twisting of the distal end of the tip 210 relative to the cannula causes the distal end of the tip 210 to be positioned in the first shape.
  • the distal end of the tip is twisted relative to the cannula in an opposite direction to change the tip to the second shape.
  • the tip 210 and at least a portion of the cannula 202 are a single piece.
  • the tip 210 and the cannula 202 may be the same material, e.g., Nitinol memory shape alloy, to facilitate operation of the cannula and the tip .
  • a flexible section of the cannula proximal to the tip 210 is a deformable stent structure and facilitates the tip 210 and/or an introduced element such as a balloon to expand in size.
  • the system may include a deformable liquid tight cover around or inside of the deformable cannula 202 to affect a liquid tight structure.
  • an exterior collet mechanism is incorporated into the cannula 202 and clamps over the vessel tissue around the cannula to facilitate securing the cannula in position, in conjunction with the tip 210.
  • the cannula tip can be implemented in a cannula system, such as the cannula system depicted in FIG. 4.
  • the cannula system can be configured to penetrate a targeted blood vessel, expand the opening in the vessel wall, connect a cannula to the vessel (e.g., by inserting a portion of the cannula into the blood vessel through the created opening), and secure the cannula to the vessel via the tip described herein.
  • the cannula system can include a needle assembly and a cannula.
  • the needle assembly can include a needle.
  • the needle is configured to extend through an opening in a tip on a distal end of a cannula, and pierce a vessel thereby creating a passage into the vessel.
  • the tip and the cannula can be inserted through the passage into the lumen defined by the blood vessel.
  • the cannula insertion system does not require a dilator assembly.
  • the needle is housed in the tip instead of within a dilator assembly.
  • the tip is arranged to facilitate manipulation of the needle and facilitate insertion of the cannula within the blood vessel lumen.
  • the tip expands to secure the cannula in position and create a larger opening in the blood vessel after the end of the needle pierces the wall of the blood vessel.
  • the tip is switched between a first shape having a first width sized to fit through the lumen of the blood vessel, and a second shape having a second width larger than the first width and sized to engage the lumen of the blood vessel and secure the tip in position within the lumen of the blood vessel.
  • the cannula is configured to fluidly connect to the vessel to be cannulated at one end and to a circulation system at another end.
  • the cannula and the tip can define a lumen that extends the length of the cannula and the tip.
  • the cannula system provides a method for a clinician to securely attach the cannula to the cannulated region such as, without limitation, a blood vessel.
  • a needle is passed though the septum seal, through the inside of a cannula lumen and out a tip on a distal end of the cannula.
  • the tip has a first shape in which the tip tapers from a larger diameter at the distal end to a smaller diameter that matches the outside diameter of the needle.
  • the tapered shapes provides a smooth transition between the needle outside diameter and the cannula outside diameter.
  • the needle is used to penetrate the vessel wall.
  • the cannula is advanced such that the distal end of the tip passes through the opening and into the inside of the vessel.
  • the needle is retracted within the lumen defined by the tip.
  • the cannula assembly is advanced until the entirety of the tip and at least a portion of the rigid section of the cannula is inside the lumen of the vessel.
  • the cannula is inserted into a lumen defined by the blood vessel.
  • the method includes switching the tip on the distal end of the cannula from the first shape to a second shape.
  • the second shape has a second width that is larger than the first width of the first shape and is sized to engage the lumen of the blood vessel and secure the tip in position within the lumen of the blood vessel.
  • the expanded, second shape presses into an inner surface of the vessel inside and provides an open path from the vessel lumen to the cannula lumen.
  • the needle can be removed from the vessel and the tip through the cannula lumen when the tip is in the second, expanded shape.
  • the cannula system can include a septum seal for insertion and removal of the needle from the cannula.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Biophysics (AREA)
  • External Artificial Organs (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Système de canule pour canulation d'un vaisseau sanguin comprenant une canule ayant une extrémité distale et une extrémité proximale. La canule définit une lumière de canule. Le système de canule comprend également une pointe sur l'extrémité distale de la canule. La pointe définit une lumière de pointe reliée à la lumière de canule. La pointe est variable entre une première forme et une seconde forme. La première forme a une première largeur dimensionnée pour s'ajuster à travers une lumière du vaisseau sanguin. La seconde forme a une seconde largeur plus grande que la première et est dimensionnée pour venir en prise avec la lumière du vaisseau sanguin et fixer la pointe en position à l'intérieur de la lumière du vaisseau sanguin.
PCT/US2024/016401 2023-02-20 2024-02-19 Système de canule comprenant une pointe de forme variable Ceased WO2024177941A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2024226929A AU2024226929A1 (en) 2023-02-20 2024-02-19 Cannula system including variable shape tip
CN202480025189.1A CN121038831A (zh) 2023-02-20 2024-02-19 包括可改变形状的末梢的插管系统

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US202363447017P 2023-02-20 2023-02-20
US63/447,017 2023-02-20

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WO2024177941A1 true WO2024177941A1 (fr) 2024-08-29

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CN (1) CN121038831A (fr)
AU (1) AU2024226929A1 (fr)
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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030040736A1 (en) * 1991-07-16 2003-02-27 John H. Stevens Endovacular cardiac venting catheter and method
US20040030319A1 (en) * 2001-06-29 2004-02-12 A.B. Korkor Medical, Inc. Catheter introducer having an expandable tip
US20080188806A1 (en) * 2006-09-01 2008-08-07 Giorgio Cattaneo Device for cannulation of a hollow organ
WO2010149168A1 (fr) * 2009-06-25 2010-12-29 Ingeniørhøjskolen I Århus Diffuseur extensible
US20120053485A1 (en) * 2010-09-01 2012-03-01 Salient Surgical Technologies, Inc. Catheter Having Needle And Expandable Support Member And Methods Of Use
US20160175003A1 (en) * 2013-03-05 2016-06-23 Ronny Kafiluddi Compound needle
US20210338270A1 (en) 2020-04-29 2021-11-04 The Children's Hospital Of Philadelphia Cannula Insertion System And Methods Of Using The Same
US11471351B2 (en) 2016-12-14 2022-10-18 The Children's Hospital Of Philadelphia System and method configured to provide extracorporeal support for premature fetus

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030040736A1 (en) * 1991-07-16 2003-02-27 John H. Stevens Endovacular cardiac venting catheter and method
US20040030319A1 (en) * 2001-06-29 2004-02-12 A.B. Korkor Medical, Inc. Catheter introducer having an expandable tip
US20080188806A1 (en) * 2006-09-01 2008-08-07 Giorgio Cattaneo Device for cannulation of a hollow organ
WO2010149168A1 (fr) * 2009-06-25 2010-12-29 Ingeniørhøjskolen I Århus Diffuseur extensible
US20120053485A1 (en) * 2010-09-01 2012-03-01 Salient Surgical Technologies, Inc. Catheter Having Needle And Expandable Support Member And Methods Of Use
US20160175003A1 (en) * 2013-03-05 2016-06-23 Ronny Kafiluddi Compound needle
US11471351B2 (en) 2016-12-14 2022-10-18 The Children's Hospital Of Philadelphia System and method configured to provide extracorporeal support for premature fetus
US20210338270A1 (en) 2020-04-29 2021-11-04 The Children's Hospital Of Philadelphia Cannula Insertion System And Methods Of Using The Same

Also Published As

Publication number Publication date
CN121038831A (zh) 2025-11-28
AU2024226929A1 (en) 2025-09-18

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