WO2022101904A1 - A dual lumen cannula and methods of use - Google Patents
A dual lumen cannula and methods of use Download PDFInfo
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- WO2022101904A1 WO2022101904A1 PCT/IL2021/051335 IL2021051335W WO2022101904A1 WO 2022101904 A1 WO2022101904 A1 WO 2022101904A1 IL 2021051335 W IL2021051335 W IL 2021051335W WO 2022101904 A1 WO2022101904 A1 WO 2022101904A1
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- WIPO (PCT)
- Prior art keywords
- lumen
- cannula
- inner lumen
- connector unit
- outer lumen
- Prior art date
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- 230000009977 dual effect Effects 0.000 title claims abstract description 81
- 238000000034 method Methods 0.000 title claims description 20
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- 210000004369 blood Anatomy 0.000 claims description 86
- 230000002792 vascular Effects 0.000 claims description 31
- 230000037452 priming Effects 0.000 claims description 30
- 241001631457 Cannula Species 0.000 claims description 19
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- 238000007789 sealing Methods 0.000 claims description 2
- 238000001802 infusion Methods 0.000 description 42
- 230000017531 blood circulation Effects 0.000 description 16
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- 238000003780 insertion Methods 0.000 description 11
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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
- 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
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- A—HUMAN NECESSITIES
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- 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
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1698—Blood oxygenators with or without heat-exchangers
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- 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
- A61M1/3661—Cannulae pertaining to extracorporeal circulation for haemodialysis
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- 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
- A61M25/0026—Multi-lumen catheters with stationary elements
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- 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
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
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- A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
- A61M2025/0006—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system which can be secured against axial movement, e.g. by using a locking cuff
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- A61M25/00—Catheters; Hollow probes
- A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
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- 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
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
- A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
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- 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
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0039—Multi-lumen catheters with stationary elements characterized by lumina being arranged coaxially
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- A—HUMAN NECESSITIES
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/0286—Holding devices, e.g. on the body anchored in the skin by suture or other skin penetrating devices
Definitions
- This invention is directed to a dual lumen cannula assembly in general, and more specifically, this invention is directed to a dual lumen cannula in which the outer lumen and the inner lumen are connected within the body in real time and having opposite flow directions through a novel flow router connector.
- dual lumen cannula is also challenging, for multiple reasons.
- One particular challenge of dual lumen cannulas relates to the manner in which the dual lumen cannulas are inserted and primed.
- a dual lumen cannula is inserted as a standalone device, with a distal end within the vascular system, and a proximal end outside the body.
- the proximal end includes two tubes, which may be branched in a Y-shape.
- the present invention is aimed to provide a dual lumen cannula, composed of an outer lumen and an inner lumen separated thereof that are being assembled into a dual lumen cannula in real time, in vivo, upon insertion of the inner lumen into the outer lumen that is first being inserted into the patient’s body in a simple standard procedure as a single lumen cannula.
- Both lumens are assembled within the patient’s body by a novel connector assembly that further determines the flow direction in each of the lumens of the dual lumen cannula as will be described in detail below.
- the outer lumen and the inner lumen are preferably connected reversibly by the novel connector assembly that allows opposite flow directions within the outer and inner lumens of the dual lumen cannula while one cannula is being inserted within the other cannula.
- the outer lumen cannula is being inserted to the patient’s vascular system with minimal exertion of force on the cannula when it is positioned within the patient's vascular system as a single lumen cannula.
- the cannulation of the outer cannula is preferably performed by standard cannulation procedure (
- the inner lumen When the outer lumen is positioned within the patient’s body, the inner lumen is first being connected to a desired device or system, such as but not limited to, a blood treatment system, and being primed, such that it is ready to be inserted into the outer.
- a desired device or system such as but not limited to, a blood treatment system
- this invention is directed to a dual lumen cannula, the cannula comprising: at least one inner lumen having at least two ends, an inner lumen proximate end and an inner lumen distal end, a hollow intermediate extent between said two ends having one or more openings at the inner lumen distal end, and at least one inner lumen connector unit at the inner lumen proximate end; at least one outer lumen having at least two ends, an outer lumen proximate end and an outer lumen distal end, a hollow intermediate extent between said two ends having one or more openings, said intermediate extent further comprising one or more openings at the outer lumen distal end, and at least one outer lumen connector unit at the outer lumen proximate end; and at least one flow router; wherein the inner lumen is configured to be inserted into said outer lumen until said inner lumen connector unit is in coupling contact with said outer lumen connector unit.
- the flow router connects to the inner lumen connector unit, wherein the connection from the flow router to one or more medical devices is preferably but not necessarily colinear to the inner lumen and the outer lumen.
- the intermediate extent of the inner lumen further comprises one or more holes located between the distal end and the proximate end of the outer lumen, and within a region of the inner lumen which is within the outer lumen when assembled.
- the outer lumen preferably comprises a narrow area at its distal end for centralizing the position of the inner lumen toward a target area.
- the openings on the intermediate extent of the outer lumen are at least one drainage opening.
- the inner lumen connector unit Upon connection of the outer lumen connector unit to the inner lumen connector unit, the inner lumen connector unit provides a flow path from the flow router to both said outer lumen and said inner lumen.
- the flow router further comprises an inlet port for connecting to one or more connector tubing connected to at least one medical device.
- the outer lumen may further comprise at least one suturing element that allows fixating the outer cannula to the patient’s body once it is cannulated and may further comprise one or more calibration marks.
- the flow router of the dual lumen cannula may further comprise a first internal flow channel position connection area from the outer cannula through the outer lumen connector unit then inner lumen connector unit to the medical device.
- the flow router further comprises a second internal flow channel from the medical device through the inner lumen connector unit to the inner lumen.
- the blood flow is reversed such that the first internal flow channel provides a flow path from the medical device through the inner lumen connector unit to the outer lumen connector unit, then to the outer lumen.
- the blood flow is reversed such that the second internal flow channel provides a flow path from the inner cannula through the inner lumen connector unit to the medical device.
- the outer lumen connector unit further comprises one or more barbs.
- the outer lumen and the outer lumen connector unit may be formed as a single piece.
- the inner lumen connector unit further comprises one or more flexible connectors for connecting and sealing to one or more barbs from the outer lumen connector unit.
- the inner lumen connector unit further comprises a vertical separating wall and chambers for creating a separate flow channel via one or more lumen opening to the inner lumen and a separate flow channel to the outer lumen through the outer lumen connector unit.
- This invention is further directed to a process for introducing a cannula to a patient vascular system, the process comprising at least the following steps: inserting a first outer lumen cannula into a patient’s vascular system through use of an introducer, and optionally a guide wire, drawn through the outer lumen up to its distal end; withdrawing the introducer and guidewire causing a small vacuum to form in the outer lumen, which is back filled with blood; priming a second inner lumen cannula through use of a priming cap connected to a priming system, whereupon following completion of the priming, the priming cap is removed; and inserting the second inner lumen cannulas within said first outer lumen cannula until inner lumen connection unit fastens to an outer lumen connection unit.
- the said first outer lumen cannula may be sutured to the skin of the patient by stitching regular sutures through butterfly.
- the one or more flow router is connected to the inner lumen connection unit, and the medical device is connected to the flow router.
- FIG. 1A is an isometric view of at least one embodiment of the inventive dual lumen cannula in an assembled, ready to use form comprising a drainage outer lumen and an infusion inner lumen connected therethrough by a connector assembly according to optional embodiments of the invention.
- FIG. IB is a schematic side view of at least one embodiment of the drainage outer lumen of the dual lumen cannula of FIG. 1A in accordance with some optional embodiments of the invention.
- FIG. 1C is a schematic isometric view of at least one embodiment of the infusion inner lumen of the dual lumen cannula of FIG. 1A in accordance with some optional embodiments of the invention.
- FIG. ID is a schematic isometric partial view illustrations of the connection area between the inner lumen and the outer lumen of the dual lumen cannula of FIG. 1A according to some optional embodiments of the invention.
- FIG. IE is a schematic cross section partial view of the connection area between the inner lumen and the outer lumen of the dual lumen cannula of FIG. 1A including the flow router connector, according to some optional embodiments of the invention.
- FIG. 2A is an isometric view of at least one another embodiment of the inventive dual lumen cannula in an assembled, ready to use form comprising a drainage outer lumen and an infusion inner lumen connected therethrough by a connector assembly according to optional embodiments of the invention.
- FIG. 2B is a schematic isometric close up view illustration of the overlapping area at the distal end of the outer drainage cannula and the extended inner infusion cannula out from the outer cannula of dual lumen cannula of FIG. 2A.
- FIG.s 3A-3B are schematic top view and isometric view illustrations respectively of the drainage outer lumen of dual lumen cannula of FIG. 2A in accordance with some optional embodiments of the invention.
- FIG.s 4A-4B are schematic isometric back view and isometric side view illustrations of the infusion inner lumen of the dual lumen cannula of FIG. 2A in accordance with some optional embodiments of the invention.
- FIG. 5A is a schematic exploded view illustration of the dual lumen cannula of FIG. 2A illustrating major components of the dual lumen cannula of the invention.
- FIG.s 5B-5C are schematic back and front isometric partial view illustrations of the connection area between the inner lumen and the outer lumen of the dual lumen cannula of FIG. 2A according to some optional embodiments of the invention.
- FIG.s 6A-6B are schematic top view and cross section partial views of the connection area between the inner lumen and the outer lumen of the dual lumen cannula of FIG. 2A including the flow router connector, according to some optional embodiments of the invention.
- FIG.s 6C-6D are schematic isometric view and cross section view, respectively, of the connector unit of inner lumen cannula and the flow router of the dual lumen cannula of FIG. 2A according to some optional embodiments of the invention.
- FIG.s 6E-6F are schematic isometric front view and isometric back view respectively, of the connector unit of inner lumen cannula and the flow router of the dual lumen cannula of FIG. 2A according to some optional embodiments of the invention.
- FIG. 6G is a schematic isometric side view of the flow router of FIG. 2A in a position simulating the position of the unit while the dual lumen cannula of the invention is in use with the housing of the flow router transparent showing the inner components according to some optional embodiments of the invention.
- the present invention is aimed to provide a convenient and safe solution that allows practitioners to insert a dual lumen cannula as simple and safe as inserting a single lumen cannula. Beside the simplicity of inserting the cannula into the target area and advantage to the medical team, the novel solution is also beneficial to the patient as it allows to thread the second lumen through the first lumen in vivo, one into the other, after insertion of the first single lumen, without the need to create an additional incision at the entrance area as required when regular dual lumen cannula is used, and save the patient inconvenient that may occur, possible contamination and additional scar.
- Both lumens are connected in vivo by a proprietary novel connector assembly that is configured to connect the two lumens and further to route the opposite flows at the inner lumen and the outer lumen.
- the outer lumen is inserted into the vascular system of a patient, and the inner lumen is inserted through the outer lumen to a desired location.
- the term “cannula” refers to a thin tube inserted into a blood vessel that permits extraction or infusion of blood therethrough from/into the blood vessel.
- a “dual lumen cannula”, in the disclosed embodiments, is a cannula that includes an inner lumen enveloped by an external lumen, thus enabling simultaneous, physically separated inflow and outflow of blood via a single dual lumen cannula inserted into the patient vascular system.
- proximal refers to a direction closer to the blood treatment system or any other machine to which the dual lumen cannula is connected, and the term “distal” refers to a direction toward or within the patient body /vascular system.
- lumen refers to the inner spaces in tubes for the transport of liquids or gases.
- drainage lumen or “outer lumen” refers to the lumen that is responsible for draining or transporting the blood from the body of a subject into a machine before treatment.
- outer lumen the terms “outer lumen”, “outer cannula”, “outer drainage cannula”, “drainage cannula” and “drainage lumen” are all used interchangeably and directed to the same component.
- infusion lumen refers to the lumen that infuse the blood back to the body from the machine after the treatment.
- inner lumen refers to the lumen that infuse the blood back to the body from the machine after the treatment.
- infusion lumen refers to the lumen that infuse the blood back to the body from the machine after the treatment.
- infusion lumen refers to the lumen that infuse the blood back to the body from the machine after the treatment.
- the outer lumen may be used to infuse blood toward the body and the inner lumen may be used to drain blood out from the body.
- the inner lumen may be used to drain blood out from the body.
- FIG. 1A is a schematic isometric view illustration of dual lumen cannula 100 of the invention in an assembled, ready to use form.
- the dual lumen cannula 100 comprises a drainage outer lumen configured to drain blood through drainage openings 112 of cannula 106 from the body of a treated patient toward an extracorporeal machine for treating the drained blood, and an infusion inner lumen configured to infuse blood through infusion opening 122 of cannula 127 from the extracorporeal machine back into the body of the treated patient, the inner and outer lumens are connected to each other by a connector assembly that connect the two lumens and route the blood flow in each of them as will be described in details below.
- Cannula 106 of the outer lumen may comprise calibration marks 190 to thereby provide the medical team indication about the penetration length.
- cannula 127 of the inner lumen may also contain calibration marks 190 to monitor the penetration length of the inner lumen.
- the inner lumen comprises a connector unit 132 that is preferably but not necessarily, an integral part of the inner lumen.
- connector unit 132 is connected to a butterfly with suturing holes 116 that may be fixed to a patient's skin with standard sutures, to stabilize the position of the dual lumen cannula during the medical treatment. It should be clear that other means to stabilize and fasten the cannula to the patient’s body may be used and butterfly 116 is only one none-limiting exemplary implementation.
- Connector unit 132 of the inner lumen is functionally connected at its proximal end to a connector unit 136 also referred hereinafter as “flow router” 136.
- Flow router 136 is the connecting unit between the dual lumen cannula and the extracorporeal machine, and it is configured and operable to set the blood flow in opposite directions between the inner and outer lumens and preferable from a flow at two separated parallel tubes into a flow within two insertable one into the other lumens.
- Connector unit 132 is further connected to a connecting configuration of cannula 106 as will be described with reference to figs.1C- ID hereinbelow.
- connection between the inner lumen and the outer lumen is performed in vivo, within the patient’s body, as the outer lumen is first inserted into the patient as a single lumen cannula and only afterward, the inner lumen is threaded into the outer lumen until they are coupled into a dual lumen cannula.
- tube connection platform 50 that is one of two tube connector platforms that are connected to flow router 136 and allow the connection of the dual lumen cannula of the invention to tubes for transporting blood from the patient’ s body toward the extracorporeal machine and for transporting blood on the opposite direction, from the extracorporeal machine towards the patient’s body.
- FIG. IB is a schematic side view of the drainage outer lumen 110 of the dual lumen cannula of fig. 1A in accordance with some optional embodiments of the invention.
- outer lumen 110 comprises at least a cannula 106, also denoted interchangeably “inner cannula” and “infusion cannula”, having a diameter that is larger than the diameter of the inner lumen 120 to thereby allow the insertion of inner lumen 120 through it.
- Cannula 106 has a narrow area 111 at its distal end mainly for centralizing the position of the inner lumen toward the target area, and at least one drainage opening 112.
- cannula 106 contain calibration marks on it that may further be marked with numbers 190 to indicate the penetration length of outer lumen 110 into the patient’s body.
- Cannula 106 comprise at its proximal end a connector unit 108.
- connector unit 108 is made of subsequent barbs that are continuous to cannula 106.
- Upon connection of the inner lumen to the outer lumen connector unit 108 is configured to be inserted to a complementary niche or socket at inner lumen connector unit as will be described with reference to figs 1C-1D.
- Other connecting solutions such as Luer lock, snap connection, and the like can be used alternatively.
- FIG. 1C is a schematic isometric view of an infusion inner lumen 120 of the dual lumen cannula of fig. 1A in accordance with some optional embodiments of the invention.
- Inner lumen cannula 120 comprises cannula 127, inner lumen connector unit 132 that in the example illustrated herein is attached to flow router 136 and connected as one piece to the proximal end of cannula 127.
- Cannula 127 has smaller diameter relative to cannula 106 that functionally allow to insert it through cannula 106 and bigger length that allow it to extend beyond cannula 106 to the target area.
- Cannula 127 comprises at least one infusion opening 122 at its distal end that allow to return treated blood from the extracorporeal machine back to the patient’ s vascular system.
- Cannula 127 may further comprise a pressure regulation hole 128 that is formed along the perimeter of the inner lumen.
- Pressure regulation hole 128 is located at a location along cannula 127 such that, when inner lumen 120 is inserted into outer lumen 110, pressure regulation hole 128 is covered by outer lumen 110.
- Pressure regulation hole 128 functions to alleviate high pressure situations in the infusion lumen, which may lead to cavitation. Cavitation is a phenomenon in which rapid changes of pressure in a liquid lead to formation of small vapor-filled cavities in places where the pressure is relatively low.
- Connector unit 132 may comprise a butterfly with suture holes 116 to allow stitching the dual lumen cannula of the invention to the patient’s skin during the medical process.
- Inner lumen 120 may further comprise at its distal end a priming cap (not shown).
- the priming cap is removable and may be connected to a priming system for priming inner lumen 120.
- the priming cap may be connected to a source of saline and may be removed after priming is completed.
- inner lumen 120 comprises infusion openings 122 for fluidic connection to the patient’s vascular system. These openings form a gateway for treated blood to flow back into the cardiovascular system. Also shown in these drawings, calibration marks 190 and tubes 50 and 50’ that transport the blood into and from the medical machine.
- FIG. ID is a schematic isometric partial view illustrations of the connection area between inner lumen 120 and the outer lumen 110 of the dual lumen cannula 100 of fig. 1A according to some optional embodiments of the invention.
- cannula 127 is connected at its proximal end to inner lumen connector unit 132 and is being inserted through its distal end into the proximal end of cannula 106 through outer connector unit 108.
- Connector unit 108 is then being pushed into the inner space of inner lumen connector unit 132, such that its barbs are hooked and covered by connector unit 132.
- FIG. IE is a schematic cross section partial view of the connection area between the inner lumen 120 and the outer lumen 110 of the dual lumen cannula 100 of fig. 1A including the flow router connector, according to some optional embodiments of the invention.
- Flow router 136 gathers all the drained blood that flows in chambers 1326 together into one tube that will be connected to tube connector platform 50 to transport the blood into the extracorporeal machine for treatment.
- treated blood from the extracorporeal machine is infused back into the vascular system of the treated patients through a tube that will be connected to tube connector platform 50’ to transports the treated blood through flow router 136 into cannula 127 toward the patient’s body.
- FIG. 2A is a schematic isometric view illustration of dual lumen cannula 200 of the invention in an assembled, ready to use form.
- the dual lumen cannula 200 comprises a drainage outer lumen comprising cannula 106 configured to drain blood through drainage openings 112 from the body of a treated patient toward a machine for treating the drained blood, and an infusion inner lumen comprising cannula 127 configured to infuse blood through infusion opening 122 from the machine back into the body of the treated patient, the inner and outer lumens are connected to each other by a connector assembly that connect the two lumens and route the blood flow in each of them as will be described in details below.
- cannulas 106 and 127 comprise calibration marks 190 to thereby provide the medical team indication about the penetration length
- the outer lumen comprise at its proximal end outer connector unit 131 that is preferably but not necessarily an integral part of a connector assembly 130 and configured to allow the physical connection of the outer lumen with the inner lumen.
- the outer lumen may optionally contain a butterfly with suturing holes 116 that may be fixed to a patient's skin with standard sutures, to allow fixation of the outer cannula to the patient’s body so as to stabilize its position before insertion of the inner cannula through it.
- connecter unit 131 is connecter to butterfly 116. It should be clear that other means to stabilize and fasten the outer cannula to the patient’s body are also within the scope of this invention and the example provided herein is only one exemplary optional implementation.
- inner lumen connector unit 132 that is preferably but not necessarily, an integral part of the inner lumen. Upon threading the inner lumen into the outer lumen, outer lumen connector unit 131 and inner lumen connector unit 132 are coupled as will be described in detail with reference to figs. 5A-5B. Also shown in this drawing flow router 136. Flow router 136 is the connecting unit between the dual lumen cannula and the extracorporeal machine, and it is configured and operable to set the blood flow in opposite directions between the inner and outer lumens. Connector units 131, 132, and 136 compose together connector assembly 130. Also shown in this drawing tube connector platform 50 that has the same role as described with reference to fig. 1A above.
- FIG. 2B is a schematic isometric close up view illustration of the overlapping area at the distal end of the outer drainage cannula 106 and the inner infusion cannula 127 extended out from the tip of the distal portion of outer cannula 106 of the dual lumen cannula of fig. 2A.
- the distal tip of outer cannula 106 is narrow relative to the diameter of the outer lumen dimensions at other areas. This narrow area 111 at the distal end of outer cannula 106 forces centralization of inner cannula 127 when it passes through it toward the target area within the patient’s body.
- Inner cannula 127 is preferably longer than outer cannula 106 in a manner that allows to infuse the treated blood through infusion openings 122 away from the drained blood through drainage openings 112.
- the distance that the inner cannula 127 extends beyond outer cannula 106 is preferably a fixed length.
- calibration marks 190 on both outer cannula 106 and inner cannula 127 are optional features only and other methods to estimate the penetration length may be used.
- pressure regulation hole 128 positioned on inner lumen 120.
- FIG.s 3A-3B are schematic top view and isometric view illustrations respectively of the drainage outer lumen 110 of dual lumen cannula 200 of fig. 2A in accordance with some optional embodiments of the invention.
- Outer lumen 110 comprises at least a cannula 106 having a fixed diameter that is larger than the diameter of the inner lumen 120 to thereby allow the insertion of inner lumen 120 through it.
- Cannula 106 has a narrow area 111 at its distal end mainly for centralizing the position of the inner lumen toward the target area, and at least one drainage opening 112.
- cannula 106 contain calibration marks on it that may further be marked with numbers to indicate the penetration length of outer lumen 110 into the patient’s body.
- Cannula 106 is attached at its proximal end to outer connector unit 131 that comprises in the specific example illustrated herein at least two protruding elements 1312 configured to be inserted to a complementary niche or socket at inner lumen connector unit 132 of inner lumen 120.
- outer lumen 110 further comprise a suturing element that allows to fixate outer cannula 110 to the patient’s body once it is cannulated, to ensure minimal movement and undesired pulling of the cannula from the patient’s body. Fixation of the outer drainage cannula to the body before insertion of the inner cannula through it, further ensure stable drainage and infusion of the blood from the patient’s body and back into it.
- FIG.s 4A-4B are schematic isometric back view and isometric side view illustrations of infusion inner lumen 120 of dual lumen cannula 200 of FIG. 2A in accordance with optional embodiments of the invention.
- inner lumen connector unit 132 and flow router 136 are attached to each other and connected as one piece to the proximal end of cannula 127.
- Cannula 127 has smaller diameter relative to cannula 106 that functionally allow to insert it through cannula 106 and bigger length that allow it to extend beyond cannula 106 to the target area.
- Cannula 127 comprises at least one infusion opening 122 at its distal end that allow to return treated blood from the extracorporeal machine back to the patient’s vascular system.
- Cannula 127 further comprises pressure regulation hole 128 that is formed along the perimeter of the inner lumen.
- Pressure regulation hole 128 is located at a location along cannula 127 such that, when inner lumen 120 is inserted into outer lumen 110, pressure regulation hole 128 is covered by outer lumen 110.
- Pressure regulation hole 128 functions to alleviate high pressure situations in the infusion lumen, which may lead to cavitation. Cavitation is a phenomenon in which rapid changes of pressure in a liquid lead to formation of small vapor-filled cavities in places where the pressure is relatively low. Cavitation in blood vessels may cause the formation of liquid jets, and potentially may cause vessel rupture.
- the dimensioned of hole 128 is determined such that when pressure in the inner lumen 120 increases beyond a predetermined level, the blood passes through the pressure regulation hole 128 from the inner lumen to the outer lumen, thereby bypassing the patient vascular system.
- blood flows into hole 128 based on the principle of fluid dynamics that a liquid always flows along a path of least resistance. The blood continues to flow through hole 128 until the pressure in the infusion lumen 120 decreases, to the point that the infusion lumen 120 again becomes the path of least resistance.
- Inner lumen 120 may further comprise at its distal end a priming cap (not shown).
- the priming cap is removable and may be connected to a priming system for priming inner lumen 120.
- the priming cap may be connected to a source of saline and may be removed after priming is completed.
- inner lumen 120 comprises infusion openings 122 for fluidic connection to the patient’s vascular system. These openings form a gateway for treated blood to flow back into the cardiovascular system. Also shown in these drawings, calibration marks 190 and tube connector platforms 50 and 50’ for transporting the blood into and from the medical machine.
- FIG. 5A is a schematic exploded view illustration of the dual lumen cannula 200 of fig. 2A illustrating the major components of the device.
- dual lumen cannula 200 is composed of three main functional components: the outer lumen 110, the inner lumen 120 and the flow router 136 that comprise at its proximal end tube connection platforms 50 and 50’ to thereby allow transport of the blood into and from the medical machine.
- flow router 136 is an integral part of inner lumen connector unit 132 and both are connected as one unit to the external end of a lumen so as to create inner lumen 120.
- inner lumen together with inner lumen connector unit 132 and optionally further with connector unit 136 are designed to be threaded through outer lumen 110 that is pre cannulated as a single lumen cannula into the patient’s body.
- connectors units with the connecting elements between the three connector units will be described in detail hereinafter.
- the connecting elements described herein should be construed as one non limiting implementation of the invention as other connecting means are also optional embodiments that may be implemented to connect between the connector assembly units of the invention. The following elements are also shown in this view:
- outer connector unit 131 outer connector unit 131, protruding elementsl312 , cannula 106, calibration marks 190, drainage openings 112, narrow area of outer cannula 111, and butterfly with suturing holes 116.
- inner lumen connector unit 132 For inner lumen cannula 120: inner lumen connector unit 132, cannula 127, calibration marks 190, infusion openings 122, Pressure regulation hole 128, vertical separating wall 1324, and chambers 1326.
- FIG.s 5B-5C are schematic back and front isometric partial view illustrations of the connection area between inner lumen 120 and outer lumen 110 of dual lumen cannula 200 of fig. 2A according to some optional embodiments of the invention.
- cannula 127 is connected at its proximal end to inner lumen connector unit 132 and is being inserted through its distal end into the proximal end of outer connector unit 131 in a manner that protruding elements 1312 of outer connector unit 131 are embracing cannula 127 and functionally create a mechanical support to centralize the positioning of cannula 127 within outer cannula 106 at its proximal end in addition to the narrowing structure of cannula 106 at its distal end.
- Protruding elements 1312 are then being inserted into the inner space of inner lumen connector unit 132.
- cannula 127 is extended into inner lumen connector unit 132 until it reaches its proximal end.
- cannula 127 is connected to the outer circumference of inner lumen connector unit 132 by at least one vertical separating wall (septum) 1324.
- inner lumen connector unit 132 contains four separating walls 1324 and the drained blood flows from the patient’ s vascular system through outer lumen 110 into chambers 1326 that are created between the separating walls 1324 and cannula 127, while the infused blood flows back unto the body via lumen (opening) 1270 of cannula 127.
- butterfly with suturing holes 116 also denoted “suturing element” that is used to fixate outer cannula 110 to the patient’s skin with standard sutures, for safer usage of the dual lumen cannula 200 of this invention.
- suturing holes 116 also denoted “suturing element”
- other fastening means such as rubber band, external fixation device, and the like, may be used additionally or alternatively.
- the inner cannula 127 is extended only until the distal end of inner lumen connector unit 132 and a central hollow tube-like structure within connector unit 132 function as an extension of inner cannula 127 and replacing it.
- FIG.s 6A-6B are schematic top view and cross section partial views of the connection area of inner lumen cannula 120 and outer lumen cannula 110 of dual lumen cannula 200 of fig. 2A.
- Outer connector unit 131 is attached to cannula 106 at its distal end and to suturing element 116 at the bottom side.
- Outer connector unit 131 having protruding elements 1312 at its proximal side ready to be inserted into a complementary space within inner lumen connector unit 132 and embracing cannula 127 of inner lumen cannula 120.
- Flow router connector 136 is also shown in these drawings, while it is being attached to inner lumen connector unit 132.
- flow router 136 is to be considered as the third connector unit of the connector assembly of this invention and may be a separate unit or an integral unit of inner lumen connector unit 132.
- flow router 136 is a separated independent unit it may be assembled with inner lumen connector unit 132 by any suitable connecting means known in the art.
- the operator may snap them one into the other, or lock them by Luer lock, or fasten one onto the other, for example by using fastening ring, and the like.
- the infused blood and the drained blood are transported from and machine to the patient’s body and vice versa by tubes (not shown) connected to tube connector platforms 50 and 50’ that extend from flow router 136 toward the extracorporeal machine.
- Flow router 136 gathers all the drained blood that flows in chambers 1326 together into one tube that will be connected to tube connector platform 50 to transport the blood into the extracorporeal machine for treatment.
- treated blood from the extracorporeal machine is infused back into the vascular system of the treated patients through a tube that will be connected to tube connector platform 50’ to transports the treated blood through flow router 136 into cannula 127 toward the patient’s body.
- FIG.s 6C-6D are schematic isometric view and cross section view, respectively, of inner lumen connector unit 132 and flow router 136 of dual lumen cannula 200 of fig.2A according to some optional embodiments of the invention.
- Flow router 136 gathers the drained blood from outer tube 110 through the different chambers 1326 of inner lumen connector unit 132 into a single tube connected to tube connector platform 50 transporting the drained blood into the extracorporeal machine.
- Flow router 136 also routes the blood flowing from the extracorporeal machine through a tube connected to tube connector platform 50’ in a manner that blood that flows in two separate adjacent tubes is converted to flow in two lumens inserted one within the other, while the opposite flow direction is maintained.
- inner lumen connector unit 132 and flow router 136 are connected to each other and tubes connector platforms 50 and 50’ are partially shown at the proximal end of flow router 136.
- the isometric view further illustrates cannula 127 and lumen 1270 shown at the distal end of inner lumen connector unit 132, separating walls 1324, chambers 1326, and area 131’ to which outer connector unit 131 with protruding elements 1312 are connected thereto.
- the cross-section view (Fig. 6C) shows the treated blood flow within cannula 127 from tube connected to tube connector platform 50’ toward the patient’s vascular system.
- the drained blood that flows out from the body through outer lumen 110 is entering chambers 1326 of inner lumen connector unit 132 that functionally serve as the extension of outer lumen 110 to transport the drained blood out from the body to the extracorporeal machine via a tube configured to be connected to tube connector platform 50.
- the blood from chambers 1326 is preferably gathered within flow router 136 into a single chamber 110’ that is connected at its proximal end to tube connector platform 50 that transport the drained blood into a tube connected to the extracorporeal machine.
- FIG.s 6E-6F are schematic isometric front view and isometric back view respectively, of the inner lumen connector unit 132 of inner lumen cannula 120 and flow router 136 of dual lumen cannula 200 of fig. 2A according to some optional embodiments of the invention.
- the isometric front view (fig. 6E) four chambers 1326 created at the interface of separating walls 1324 and cannula 127 are clearly shown.
- the isometric back view (fig. 6F) demonstrates the connection of flow router 136 to tube connecter platforms 50 and 50’ that transport the drained blood from the body through drainage openings 112 of outer lumen through cannula 106 into chambers 1326 of inner lumen connector unit 132 that are all collected into a single chamber 110’ of flow router 136 and transported to a tube (not shown) connected to tube connector platform 50 into the extracorporeal machine.
- cannula 127 in this optional implementation of the invention passes through the entire units of connector assembly 130, through cannula 106 until it reaches the target area and infuse the blood through infusion openings 122.
- inner cannula 127 may extend up to the distal end of connector unit 132 and from that point up to the tube connected to tube connector platform 50’ the treated blood flows through dedicated chambers within flow router 136 and connector unit 132 until they reach inner cannula 127.
- FIG. 6G is a schematic isometric side view of flow router 136 of fig. 2A in a position simulating the position of the unit while the dual lumen cannula is in use and connected to the patient’s body, with the housing of flow router 136 transparent showing the inner components according to some optional embodiments of the invention.
- tube connector platforms 50 and 50’ are positioned upward.
- tube connector platform 50’ in one optional embodiment is connected to cannula 127 at one end and to a tube (not shown) that transport blood from the extracorporeal machine into the patient’ s body, while tube connector platform 50 is connected to chamber 110’ at one end and to a tube (not shown) at the other end for transporting blood suctioned from the body into the extracorporeal machine. Also shown in this position connection area 1328 of flow router 136 and inner lumen connector unit 132, and the inner components of flow router 136 including cannula 127 and chamber 110’.
- the inner lumen is an infusion lumen, for delivering treated blood back into the patient’s vascular system
- the outer lumen is a drainage lumen, for removing untreated blood from the vascular system.
- the outer lumen may be used to return the blood into the body, while the inner lumen is used to drain blood from the body.
- inner lumen 120 has a longer extension than outer lumen 110.
- inner lumen 120 is sized of sufficient length and diameter to be inserted into the femoral veins and/or to the superior vena cava via a major vein superior to the heart.
- the major veins are included, but not limited to, the right and left internal jugular veins, the right and left external jugular veins, and the right and left brachiocephalic veins.
- the dimensions of the inner lumen and the outer lumen may be dictated by considerations such as the size of the patient and the desired volume and flow rate of the blood through the lumens.
- inner lumen 120 has a length of between 10 and 40 mm and a diameter of between 5 and 16 Fr
- outer lumen 110 has a length of between 10 and 40 mm and a diameter of between 10 and 24 Fr.
- connection between inner lumen and outer lumen may be reversable and they can be separated thereof.
- the position of one lumen related to the other is fixed and predetermined by the connector units connected to each one of the cannulas respectively.
- Drainage lumen 110 includes openings 112 for sucking blood therethrough from the patient vascular system. Openings 112 are suction holes, and blood is drawn therethrough by the force of a pump that is part of the extracorporeal blood treatment machine. Openings 112 are preferably located at the distal end of drainage lumen 110. In some embodiment, openings 112 are sized and situated on the side of the distal end of drainage lumen 110 in order to prevent blocking of blood draining during suction. Blocking may occur due to clotting or vein adhesion to the drainage lumen due to suction forces.
- outer lumen 110 is inserted into the patient’ s vascular system.
- the outer lumen may be sutured to the skin of the patient by stitching regular sutures through butterfly 116.
- the outer lumen is inserted through use of an introducer, and optionally a guide wire, drawn through the outer lumen 110 up to its distal end according to common practice (Seidinger technique).
- common practice Seidinger technique
- the inner infusion lumen 120 is preferably pre-primed through use of a priming cap (not shown) that may be connected to a priming system.
- the priming system may be a standalone system or may be integrated with the blood extracorporeal machine.
- the priming cap is removed.
- inner lumen 120 is inserted into the outer lumen 110 through the outer lumen connector unit (either 108 or 131). The inner lumen 120 is advanced to protrude through outer lumen 110, until the connectors of each lumen are coupled. Inner lumen 120 is fixed to the outer lumen 110 when the connector assembly units are connected. Once the two lumens are connected, they function as a single dual lumen cannula 100, 200.
- the insertion of the inner lumen is performed with minimal strain on the patient.
- the inner lumen 120 is already fully primed prior to connection, there is no need to prime open connection ports during the connection process, as in other dual lumen cannulas known in the art.
- the cannulation process for the dual lumen cannula of this invention is significantly easier, and safer, than cannulation of other dual lumen cannulas available in the market.
- the described method is especially advantageous compared to an alternative dual lumen cannula system, in which the two lumens are inserted as single units separated thereof and are advanced to the desired location in the body while connected to each other, before the inner lumen is further advanced relative to the outer lumen.
- the inner diameter of outer cannula 106 at the distal end is sized to be only slightly wider than the outer diameter of inner cannula 127. This sizing enables free sliding of the inner cannula 127 through narrow area 111, while also minimizing inefficiencies resulting from the flow of blood through the area 111 instead of continuing through outer cannula 127.
- inner lumen 120 In the described embodiments, the proximal point of connection between inner lumen 120 and outer lumen 110 is fixed. Thus, inner lumen 120 always extends a specified distance beyond outer lumen 110.
- the dual lumen cannulas are designed such that, after treated blood enters the body via the infusion lumen, the blood circulates throughout the entire bloodstream before being removed via the drainage lumen.
Abstract
Description
Claims
Priority Applications (5)
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IL302851A IL302851A (en) | 2020-11-10 | 2021-11-10 | A dual lumen cannula and methods of use |
KR1020237019401A KR20230107622A (en) | 2020-11-10 | 2021-11-10 | Dual lumen cannula and method of use |
EP21891360.6A EP4199990A1 (en) | 2020-11-10 | 2021-11-10 | A dual lumen cannula and methods of use |
CN202180076037.0A CN116472077A (en) | 2020-11-10 | 2021-11-10 | Double lumen cannula and methods of use thereof |
JP2023550749A JP2023548436A (en) | 2020-11-10 | 2021-11-10 | Dual lumen cannula and how to use it |
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US63/111,803 | 2020-11-10 | ||
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US63/112,183 | 2020-11-11 |
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US20190255245A1 (en) * | 2011-12-19 | 2019-08-22 | Cardiacassist, Inc. | Method of Assisting a Heart Using a Dual Lumen Cannula |
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US20190255245A1 (en) * | 2011-12-19 | 2019-08-22 | Cardiacassist, Inc. | Method of Assisting a Heart Using a Dual Lumen Cannula |
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