WO2019043722A1 - Oxygénateur sans échangeur de chaleur intégré, avec échangeur de chaleur commun pour système de circulation sanguine systémique et d'administration de cardioplégie d'un patient, et procédés associés - Google Patents

Oxygénateur sans échangeur de chaleur intégré, avec échangeur de chaleur commun pour système de circulation sanguine systémique et d'administration de cardioplégie d'un patient, et procédés associés Download PDF

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Publication number
WO2019043722A1
WO2019043722A1 PCT/IN2017/050487 IN2017050487W WO2019043722A1 WO 2019043722 A1 WO2019043722 A1 WO 2019043722A1 IN 2017050487 W IN2017050487 W IN 2017050487W WO 2019043722 A1 WO2019043722 A1 WO 2019043722A1
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WO
WIPO (PCT)
Prior art keywords
blood
fibers
outlet
housing
oxygenator
Prior art date
Application number
PCT/IN2017/050487
Other languages
English (en)
Inventor
Mahendran Rajalakshmi
Original Assignee
Mahendran Rajalakshmi
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 Mahendran Rajalakshmi filed Critical Mahendran Rajalakshmi
Publication of WO2019043722A1 publication Critical patent/WO2019043722A1/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
    • 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
    • A61M1/3664—Extra-corporeal blood circuits for preparing cardioplegia solutions
    • 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
    • A61M1/14—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
    • 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
    • A61M1/3623—Means for actively controlling temperature of 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
    • 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
    • A61M1/3643—Priming, rinsing before or after 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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02—Hollow fibre modules
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02—Hollow fibre modules
    • B01D63/025—Bobbin units
    • 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
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/366—General characteristics of the apparatus related to heating or cooling by liquid heat exchangers
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/44—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for cooling or heating the devices or media
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2313/00—Details relating to membrane modules or apparatus
    • B01D2313/02—Specific tightening or locking mechanisms
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2313/00—Details relating to membrane modules or apparatus
    • B01D2313/90—Additional auxiliary systems integrated with the module or apparatus
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2313/00—Details relating to membrane modules or apparatus
    • B01D2313/90—Additional auxiliary systems integrated with the module or apparatus
    • B01D2313/901—Integrated prefilter

Definitions

  • the invention relates to a medical device which facilitates the gas exchange and heat energy exchange in the fluid medium, generally blood.
  • the membrane oxygenators known in the art mostly, have inbuilt heat exchanger, utilize the heat exchanger for change in temperature in the patient's systemic blood circulation only.
  • an invention embodiment of the invention comprising of a plurality of microporous, hollow, capillary, membrane fibers which are oven tightly, each fiber at 5 to 10 degrees angle to the central longitudinal axis of, elliptic cylindrical housing, the oxygenator, crossover on the one layer to the other layer, the each layer consists the said oxygenating fibers arranged side by side in parallel direction to each other.
  • the layers of the fibers are wound around the central longitudinal axis of the said housing, progressing towards the wall of the said housing.
  • the blood medium as a thin film passes evenly and substantially at any given pressure across and over, around, the outer surface of the said fibers; additionally the blood medium flow path is, from the space provided at the blood medium inlet port compartment of oxygenator, perpendicular to the longitudinal axis of the oxygenator towards the blood medium outlet port(s) in the said housing.
  • the invention consists concentric elliptic cylindrical shape forms a plurality of layers of the oxygenating fibers which are embedded in the potting, material, means within the elliptic cylindrical housing.
  • a filter is provided in the blood medium outlet port(s) compartment.
  • the filter along with the said bundle of fibers is embedded within the said housing.
  • the wall of the said housing is having inlets and outlets for the blood medium; upper cap having inlet for sweep gas; lower cap having outlet for sweep gas.
  • the device defining a plurality of individual layer of blood medium pathways in the said bundle of fibers and allows the blood medium to pass through the filter.
  • the orientation of the said fibers, blood medium pathways and the filter facilitate the blood medium to converge evenly and constantly from all directions of the said spaces in the said bundle of fibers oriented towards the blood medium outlet (s) .
  • a heat exchanger that comprises of an inner cylindrical structure surrounded by middle cylindrical structure with a space between them to define flow path for the heat exchanging fluid medium.
  • the middle cylindrical structure has inlet at one end and the outlet at the other end for fluid medium flow passage.
  • the middle cylindrical structure surrounded by the outer cylindrical structure with a space between them to define flow path for the blood medium or cardioplegia medium.
  • the outer cylindrical structure has inlets and outlets so as to define the flow passage for the blood medium and cardioplegia medium.
  • Inner and middle cylindrical structures are attached together at the window array of pins, keeping both the ends of middle cylindrical structure opened.
  • the outer cylindrical structure and the middle cylindrical structure, along with attached inner cylindrical structure, are attached at the ends and edges of outer cylindrical structure.
  • the middle cylindrical structure acts as heat exchanging barrier between the blood medium or cardioplegia medium and the heat exchanging fluid medium.
  • the outer surface of the middle cylindrical structure defines smooth helical shape.
  • the outer cylindrical structure defines the inlets and outlets for blood medium and cardioplegia medium according to the purpose of the invention.
  • the middle cylindrical structure defines the inlet and outlet for heat exchanging fluid medium according to the purpose of the invention.
  • the present invention defines the ratio of the volume of heat energy exchanging fluid medium to the volume of the blood medium or cardioplegia medium, the highest rate of replacing the heat energy exchanging fluid medium per unit time and the counter current flow of blood medium or cardioplegia medium to the heat energy exchanging fluid medium, to maximize the heat energy exchange between the blood medium or cardioplegia medium and the heat energy exchanging fluid medium.
  • FIG. 1 Another aspect of the invention illustrates outer cylindrical structure has a substantially round cross sectional co-axial, along the central longitudinal axis of the heat exchanger, with the middle cylindrical structure, and in such a way the middle cylindrical structure has a substantially round cross sectional co ⁇ axial, along the central longitudinal axis of the heat exchanger, with the inner cylindrical structure.
  • the middle and inner cylindrical structures are opaque and the outer cylindrical structure is transparent.
  • Middle cylindrical structure is a good heat conductor.
  • Inner cylindrical structure and attached circumferential pins with the same are non-heat conductors .
  • Fig.l is a longitudinal cross-sectional view of a vertically oriented first embodiment of a blood/gas medium oxygenator in accordance with the present invention
  • Fig.2 is a longitudinal cross-sectional view of the vertically oriented blood/gas medium oxygenator of Fig.l showing the flow of two different mediums, generally blood medium and gas medium, through the oxygenator;
  • FIG.3 is an exploded, perspective view of the oxygenator of Fig.l;
  • Fig. a is a transverse cross-sectional view at the level of blood medium purge port and the blood medium recirculation port of a second embodiment of a blood/gas medium oxygenator in accordance with the present invention
  • Fig. b is a transverse cross-sectional view at the mid level of the elliptic cylindrical housing of a first embodiment of a blood/gas medium oxygenator in accordance with the present invention
  • Fig. c is a transverse cross-sectional view at the level of blood medium inlet port and the blood medium outlet port of a third embodiment of a blood/gas medium oxygenator in accordance with the present invention.
  • Fig.5 is a longitudinal cross-sectional view of a vertically oriented first embodiment of a blood/fluid medium heat exchanger in accordance with the present invention
  • Fig.6 is a longitudinal cross-sectional view of the vertically oriented blood ⁇ fluid medium heat exchanger of Fig.5 showing the flow of two different mediums, generally blood medium and water medium, through the heat exchanger.
  • Fig.7a and Fig.7b are transverse cross- sectional, perpendicular to the central longitudinal axis of the heat exchanger, view at the pins of upper and lower levels, of a second embodiment of the heat exchanger in accordance with the present invention.
  • Fig.8 is a longitudinal cross-sectional, along the central longitudinal axis of the heat exchanger, view of inner cylindrical structure of a blood/fluid heat exchanger of Fig.5 in accordance with the present invention .
  • Fig.9 is a longitudinal cross-sectional, along the central longitudinal axis of the heat exchanger, view of middle cylindrical structure of a blood/fluid heat exchanger of Fig.5 in accordance with the present invention .
  • Fig.10 is a longitudinal cross-sectional, along the central longitudinal axis of heat exchanger, view of outer cylindrical structure of a blood/fluid heat exchanger of Fig.5 in accordance with the present invention .
  • Fig.11 is a schematic diagram of the heat exchanger with connectors which connects the oxygenator, in accordance with the present invention.
  • Fig.12 is a schematic diagram for blood cardioplegia delivery, option 1.
  • Fig.13 is a schematic diagram for blood cardioplegia delivery, option 2.
  • Fig.14 is a schematic diagram for crystalloid cardioplegia delivery, option 3.
  • Fig.l illustrates a preferred embodiment of a blood medium oxygenator 25 in accordance with the present invention.
  • the oxygenator 25 comprises a housing 26 , which has elliptic cylindrical shape, outermost peripheral wall, opened at both ends prior to assembly of the oxygenator 25 .
  • the central longitudinal axis 40 of the elliptic cylindrical housing 26 acts as the core of the oxygenator 25 .
  • the housing 26 encloses the bundle of oxygenating fibers 44 , wound around the core 40 of the oxygenator 25 , which is also elliptic cylindrical in shape.
  • the filter 45 is incorporated in the bundle of fibers facing the blood medium outlet ports compartment.
  • a space 46 lies between the bundle of fibers 44 and the wall, along with the blood medium inlet port 48 and the blood medium purge port 52 , of the elliptic cylindrical housing 26 .
  • Another space 47 lies between the filter 45 along with the bundle of fibers 44 and the wall, along with the blood medium outlet ports 49 and 53 , of the elliptic cylindrical housing 26 .
  • a bundle of oxygenating fibers 44 is wrapped around the core 40 in elliptic cylindrical shape with 5 to 10 degrees angle to the central longitudinal axis of the elliptic cylindrical housing. Further the filter 45 is incorporated with the bundle, facing the space 47 , of oxygenating fibers 44 .
  • the bundle of oxygenating fibers 44 comprises a number of microporous hollow membrane fibers wound around the core 40 in elliptic cylindrical shape.
  • the core 40 along with the filter 45 and bundle of oxygenating fibers 44 , the first end 42 of bundle of fibers at the upper potting material 34 and the second end 43 of bundle of fibers at the lower potting material 35 , has an axis extending from the first end 42 to the second end 43 .
  • the bundle of oxygenating fibers 44 extends from the space 46 towards the filter 45 and the space 47 within the elliptic cylindrical housing 26 .
  • Each of the fibers in the bundle 44 preferably includes a first end and a second end, a hollow interior and a semi-permeable, microporous, membrane wall.
  • the filter 45 means, generally screen filter 45 with the pore size of 40 to 80 microns, the pore size may be altered, is incorporated with the bundle of oxygenating fibers 44 facing the space 47 .
  • Potting means 34 , 35 are located at the ends of oxygenating fibers and filter. These potting means 34 , 35 are generally adhesive means that seal the fibers at the ends. Potting means 34 are located adjacent to the first end 42 of the core 40 and preferably seal the first ends 42 of the oxygenating fibers and filter. Potting means 35 are located adjacent to the second end 43 of the core 40 and preferably seal the second ends 43 of the oxygenating fibers 44 and filter 45 .
  • the upper potting means 34 is adhereto the upper portion of elliptic cylindrical housing 26 along with the upper gas inlet cap 32 via the mating feature 36 and the lower potting means 35 is adhere to the lower portion of elliptic cylindrical housing 26 along with the lower gas outlet cap 33 via the mating feature 37 .
  • potting means 34 , 35 serve to separate the blood phase from the gas phase 41 , provided in the gas inlet cap 32 and the gas outlet cap 33 , within the oxygenator 25 .
  • a gas inlet cap 32 is fitted at the top of the oxygenator 25, in other words at top of the elliptic cylindrical housing 26, and generally includes a gas inlet port 50 and in such a way a gas outlet cap 33 is fitted at the bottom of the oxygenator 25, in other words at bottom of the elliptic cylindrical housing 26, and generally includes a gas outlet port 51.
  • the blood medium inlet port 48 and the blood medium purge port 52 are incorporated on the body portion of the elliptic cylindrical housing 26 facing the space 46. In such a way the blood medium outlet port 49 and the blood medium recirculation port 53 are incorporated on the body portion of the elliptic cylindrical housing 26 facing the space 47.
  • the inlet/outlet ports, 48, 49, 52 and 53 are incorporated on the elliptic cylindrical body/housing 26 in such a way that there will not be any gap between the opening of the inlet/outlet ports, 48, 49, 52 and 53, and the potting means, 34 and 35, when fusing the elliptic cylindrical body/housing 26, by potting means, 34 and 35, via mating features, 36 and 37, with gas inlet/outlet caps, 32 and 33, to keep the blood medium in dynamic motion, thereby avoiding the stagnation of the blood medium and micro bubbles at the levels of the potting means 34 and 35.
  • the blood medium purge port 52 and the blood medium recirculation port 53 may be suitably located on the oxygenator 25, for example, as shown in Fig.l & Fig.2, adjacent gas inlet cap 32 and through the elliptic cylindrical housing 26.
  • the blood medium inlet port 48 and the blood medium outlet port 49 may be suitably located on the oxygenator 25, for example, as shown in Fig.l & Fig.2, adjacent gas outlet cap 33 and through the elliptic cylindrical housing 26.
  • the central longitudinal axis is being the same for the elliptic cylindrical housing 26 as well as the oxygenator 25.
  • the oxygenator 25 is in a typical vertical orientation, parallel to central longitudinal axis, of the oxygenator 25, the blood medium purge port 52 and the blood medium recirculation port 53 facilitate the de-airing of the oxygenator 25 at ease.
  • the gas inlet cap 32 with gas inlet port 50 is mated, via mating feature 36, to the potting means 34 which holds one end of the bundle of fibers along with the filter and the elliptic cylindrical housing 26 and thereby attached to the oxygenator 25 as a whole.
  • the gas outlet cap 33 with gas outlet port 51 is mated, via mating feature 37, to the potting means 35 which holds the other end of the bundle of fibers along with the filter and the elliptic cylindrical housing 26 and thereby attached to the oxygenator 25 as a whole as shown in Fig.l.
  • the oxygenator 25 is further connected to a reservoir, not shown in the picture, which provides blood medium to the oxygenator 25.
  • the pumping means not shown in the picture, generally a peristaltic or centrifugal pump, generates sufficient pressure to supply the blood medium from the reservoir, to the oxygenator 25 and eventually, oxygenated blood, back to the patient.
  • the oxygenator 25 may be generally operated in a vertical position, such as that depicted in Fig.l and Fig.2. Referring to Fig.2, the path of the blood and the path of the gas are illustrated.
  • Solid black arrows 56 indicate the path of the blood medium to be oxygenated.
  • Dotted solid arrows 57 indicate the path of the gas, generally oxygen or air with higher content of oxygen .
  • the blood medium, to be oxygenated, is supplied into the space 46, flows across the bundle of fibers 44 in a transverse direction, perpendicular to the longitudinal axis of the oxygenator 25, then through the filter 45 between the upper potting means 34 and the lower potting means 35 and eventually, oxygenated blood, exits the oxygenator 25 via the blood medium outlet port 49, 53 and 55.
  • the pre-membrane pressure can be monitored.
  • the inner diameter of the blood medium purge port 52 may be provided sufficient enough to drive the sufficient quantity of blood to additional devices like hemoconcentrator, hemodialysis, cell saver, etc if connected.
  • the purge line, from purge port 52, can have the one way valve to prevent the air, inadvertently, pumping into the oxygenator 25.
  • Fig.2 describes the gas medium, to provide oxygenation, flows alongwith the blood medium, indicated by the solid dotted arrows 57 and the blood medium, to be oxygenated, flows along with the gas medium, indicated by the solid black arrows 56.
  • the gas such as oxygen rich air, enters the oxygenator 25 through the gas inlet port 50 and flows through hollow fibers 44 and finally exits via the gas outlet port 51.
  • Gas exchange takes place via diffusion through micro-porous membrane of hollow fibers. This occurs as the blood is flowing across and over the fibers 44 in a transverse direction, perpendicular to the axis of the oxygenator 25 and the gas flowing in a direction, generally, perpendicular to the blood flow.
  • FIG.3 illustrates the exploded detailed individual sections of the oxygenator 25, a gas inlet cap 32 with gas inlet port 50 and mating feature 36,
  • Fig.4a illustrates the embediment of the said fibers and the filter at the level of the blood medium purge port 52 and the recirculation port 53.
  • Fig.4b illustrates the embediment of the said fibers and the filter at the mid level of the said housing 26.
  • Fig.4c illustrates the embediment of the said fibers and the filter at the level of the blood medium inlet port 48 and outlet port 59.
  • Fig.5 illustrates a preferred embodiment of the heat exchanger 75 in accordance with the present invention.
  • the heat exchanger 75 comprises a outer cylindrical structure 77, acts as housing 77, which has a long cylindrical, generally transparent, outer most peripheral wall, having inlet and outlet ports.
  • the outer cylindrical structure 77 surrounds middle cylindrical structure 78, generally opaque, middle wall, opening at both ends, upper and lower as shown in Fig.5 & Fig.6.
  • the middle cylindrical structure 78 surrounds inner cylindrical structure 79, generally opaque, non-heat conducting inner wall as shown in Fig.6.
  • the outer surface of the middle cylindrical structure 78 is provided with helical shape 80 to create gentle turbulence in the blood /cardioplegia medium.
  • the blood medium inlet port 82, the blood medium outlet port 83, the cardioplegia inlet port 84 and the cardioplegia outlet port 85 with temperature monitoring probe port 88 are formed in the outer, generally transparent, cylindrical structure 77.
  • the outer cylindrical structure 77 is provided with elevated dome shape like inverted cup 92, at top end above the blood medium outlet port 83.
  • the blood medium or cardioplegia medium purge port 81 of the heat exchanger 75 can be used for monitoring the cardioplegia pressure.
  • the purge line, from the purge port 81 of the heat exchanger 75 can have the one way valve to prevent the air, inadvertently, pumping into the heat exchanger 75.
  • the heat exchanger75 may be operated, generally, in a vertical position, parallel to central longitudinal axis of its own as shown in Fig.5 & Fig.6.
  • Fig.6 illustrates the path of the blood medium or cardioplegia medium and the path of the heat exchanging fluid.
  • Solid black arrows 93 indicate the path of the blood medium, to be oxygenated, or cardioplegia medium.
  • Solid white arrows 94 indicate the path of the heat energy exchanging fluid medium. Further the flow direction of blood medium/cardioplegia medium is opposite to heat exchanging fluid medium, counter current flow, and hence provides maximum energy transfer .
  • the space 89 between outer cylindrical structure 77 and middle cylindrical structure 78 provides the path for the blood medium.
  • the space 90 between middle cylindrical structure 78 and inner cylindrical structure 79 provides the path for heat exchanging fluid.
  • Fig.7a & Fig.7b illustrate the transverse cross sectional, perpendicular to the central longitudinal axis of the heat exchanger 75, views at the point of circumferential pins 91a & 91b, upper circumferential pins 91a and lower circumferential pins 91b, of the inner cylindrical structure 79.
  • Fig.8 shows the longitudinal cross-sectional, open at a plane which is parallel and passing through the central longitudinal axis of the heat exchanger75, view of two parallel halves 79a & 79b of inner cylindrical structure 79, with pins 91a & 91b attached to its outer surface. Parallel two halves 79a & 79b are attached together, at their edges 79c & 79d, at parallel plane to make the inner cylindrical structure 79 as shown in Fig.6.
  • the inner cylindrical structure 79 with pins, as a whole, as shown in Fig.6, may be molded in one step process itself.
  • Fig.9 shows the longitudinal cross-sectional, open at a plane which is parallel and passing through the central longitudinal axis of the heat exchanger 75, open at both ends along the central longitudinal axis of the heat exchanger 75, view of two parallel halves 78a & 78b of middle cylindrical structure 78.
  • Two halves 78a & 78b of middle cylindrical structure 78 are attached together, at their edges 78c & 78d and pins 91a & 91b by enclosing inner cylindrical structure 79 at the centre and along the central longitudinal axis of the heat exchanger 75, as shown in Fig.6.
  • Fig.10 shows the longitudinal cross-sectional, open at a plane which is parallel and passing through the central longitudinal axis of the heat exchanger 75, view of two parallel halves 77a & 77b of outer cylindrical structure 77.
  • the blood medium inlet port 82, blood medium outlet port 83 and the purge port 81 of the heat exchanger 75 are incorporated with one half 77a, parallel to central longitudinal axis of the heat exchanger 75, of outer cylindrical structure77.
  • the cardioplegia medium inlet port 84 and the cardioplegia medium outlet port 85 with temperature monitoring probe port 88 are incorporated with the other half 77b, parallel to the central longitudinal axis of the heat exchanger 75, of outer cylindrical structure 77.
  • Fig.11 explains the feasibility of connecting the heat exchanger 75, along with the connectors, with the oxygenator 25 to utilize the heat exchanger 75 either for patient's blood circulation or cardioplegia delivery in accordance with the present invention. Priming technique of the present invention for blood cardioplegia delivery, option 1:
  • Fig.12 illustrates the detailed cardiopulmonary bypass circuit for blood cardioplegia delivery option 1 according to the present invention.
  • Priming fluid medium either blood medium or crystalloid medium, generally crystalloid solution is added in the reservoir till sufficient level.
  • the blood medium outlet port 49 of the oxygenator 25 and cardioplegia outlet port 85 of the heat exchanger 75 are kept closed and other ports are kept opened.
  • Priming fluid medium is withdrawn from the reservoir outlet port 65 by pumping means and supplied to the blood medium inlet port 48 of the oxygenator 25 via connector 73, the heat exchanger 75, bypass line BL (Bypass Line) and connector 74. Further the priming fluid medium travels through fiber bundle 44 and filter 45 of the oxygenator 25, then exits via the recirculation port 53 of the oxygenator 25.
  • Air bubbles in the circuit are emptied, via blood medium purge port 52 of the oxygenator 25, recirculation port 53 of the oxygenator 25, the purge port 81 of the heat exchanger 75, the cardioplegia inlet port 84 of the heat exchanger 75 and the blood medium line BLC2 (Blood Line to Cardioplegia) into the reservoir simultaneously.
  • the blood medium outlet port 49 is opened and filled the A- V (Arterial to Venous) loop without air.
  • the pumping means is stopped, once de-air is done.
  • Option 1 The bypass line BL is kept opened.
  • the reservoir inlet port 66, blood medium inlet port 82 of the heat exchanger 75 and blood medium outlet port 83 of the heat exchanger 75 and blood medium purge port 52 of the oxygenator 25 are kept closed.
  • Blood medium is allowed, by pumping means, to travel from the reservoir outlet port 65 to blood medium outlet port 49 of the oxygenator 25 via pumping means, connector 73, bypass line BL and connector 74 , bypassing the heat exchanger 75 in the circuit, blood medium inlet port 48 of the oxygenator 25 , membrane compartment and eventually oxygenated blood is supplied to the patient from blood medium outlet port 49 of the oxygenator 25 . Thereby maintaining the patient's oxygenated blood circulation.
  • the cardioplegia outlet port 85 of the heat exchanger 75 is kept closed. Oxygenated blood is allowed, from the recirculation port 53 of the oxygenator 25 , to enter the heat exchanger 75 via cardioplegia inlet port 84 . Eventually oxygenated blood medium, from the heat exchanger 75 , allowed to drain into the reservoir via the purge port 81 of the heat exchanger 75 . Once the heat exchanger 75 is filled with oxygenated blood without air, the purge port 81 of the heat exchanger 75 is closed.
  • Fig.13 illustrates the detailed cardiopulmonary bypass circuit for blood cardioplegia delivery option 2according to the present invention.
  • Priming fluid medium either blood medium or crystalloid medium, generally crystalloid solution, is added, sufficient level, in the reservoir.
  • the blood medium outlet port 49 of the oxygenator 25, the blood medium line to cardioplegia BLCl from recirculation line RL (Recirculation Line) , cardioplegia inlet port 84 of the heat exchanger 75 and cardioplegia outlet port 85 of the heat exchanger 75 are kept closed and other ports are kept opened.
  • Priming fluid medium is withdrawn from the reservoir outlet port 65 by pumping means and supplied to the blood medium inlet port 48 of the oxygenator 25 via connector 73, the heat exchanger 75, bypass line BL to the heat exchanger 75 and connector 74.
  • the priming fluid medium travels through bundle of fibers 44 and filter 45 of the oxygenator 25, and eventually exits via the recirculation port 53 of the oxygenator 25. Air bubbles in the circuit are emptied, via the purge port 81 of the heat exchanger 75, blood medium purge port 52 of the oxygenator 25 and recirculation port 53 of the oxygenator 25, into the reservoir simultaneously. Gravity prime may, instead of pumping means, also be used. Once the oxygenator 25 is de-aired completely, the blood medium outlet port 49 is opened and the A-V loop is filled without air for patient's blood circulation. The pumping means is stopped, once de-aired the system.
  • the cardioplegia solution line CSL is connected with the cardioplegia solution bag without air.
  • the blood medium line BLC1 and the cardioplegia solution line CSL, parallel to each other, are running through the cardioplegia pump head and joining together at the output of the cardioplegia pumping means .
  • the continuity of priming fluid medium flow from the reservoir outlet port 65 to reservoir inlet port 66 of recirculation line RL, via pumping means, bypass line BL, blood medium inlet port 48 of the oxygenator25, membrane compartment is maintained. All other ports are kept closed.
  • Shunt Line SLBC, Cardioplegia inlet port 84 and the purge port 81 of the heat exchanger 75 are kept opened.
  • the cardioplegia solution line CSL and the cardioplegia outlet port 85 are kept closed.
  • the prime is allowed, by cardioplegia pumping means, to travel through the heat exchanger75, thereby expelling the air from the tubes which are passing through the cardioplegia pumping means, the cardioplegia tube attached with the cardioplegia inlet port 84 and the heat exchanger 75 via the purge port 81of the heat exchanger 75 into reservoir.
  • the shunt line SLBC, the purge port 81 of the heat exchanger 75 are closed by stopping the cardioplegia pumping means.
  • Option 2 The bypass line BL is kept opened.
  • the reservoir inlet port 66, blood medium inlet port 82 of the heat exchanger 75 and blood medium outlet port 83 of the heat exchanger 75, blood medium purge port 52 of the oxygenator 25, purge port 81 of the heat exchanger 75 are kept closed.
  • Blood medium is allowed, by blood medium pumping means, to travel from reservoir outlet port 65 to blood medium outlet port 49 of the oxygenator 25 via pumping means, connector 73, bypass line BL and connector 74, bypassing the heat exchanger75 in the circuit, blood medium inlet port 48 of the oxygenator 25, membrane compartment and eventually oxygenated blood is supplied to the patient from blood medium outlet port 49 of the oxygenator25. Thereby maintaining the patient's oxygenated blood circulation.
  • the oxygenated blood medium from recirculation port 53 and the cardioplegia solution, via cardioplegia solution line CSL, are supplied, by cardioplegia pumping means, to the heat exchanger 75 via cardioplegia inlet port 84.
  • Blood cardioplegia after getting heat energy exchange with heat exchanging fluid, is supplied, via the cardioplegia outlet port 85 of the heat exchanger 75, to the heart.
  • Fig.14 illustrates the detailed cardiopulmonary bypass circuit for crystalloid cardioplegia delivery according tothe present invention.
  • Priming fluid medium either blood medium or crystalloid medium, generally crystalloid solution is added, sufficient level, in the reservoir.
  • the blood medium outlet port 49 of the oxygenator 25, the blood medium inlet port 82 of the heat exchanger 75 and the blood medium outlet port 83 of the heat exchanger 75 are kept closed and other ports are kept opened.
  • Priming fluid medium is withdrawn from the reservoir outlet port 65 by blood medium pumping means and supplied to the blood medium inlet port 48 of the oxygenator 25 via connector 73, bypass line BL and connector 74. Further the priming fluid medium travels through bundle of fibers 44 and filter 45 of the oxygenator 25, and eventually exits via the recirculation port 53 of the oxygenator 25.
  • Air bubbles in the circuit are emptied, via the blood medium purge port 52 of the oxygenator 25 and recirculation port 53 of the oxygenator 25, into the reservoir simultaneously.
  • the blood medium outlet port 49 is opened and the A-V loop is filled without air for patient's blood circulation.
  • the pumping means is stopped, once the system is de-aired.
  • entire circuit is primed, except the heat exchanger 75 and its circuit .
  • the cardioplegia outlet port 85 of the heat exchanger 75 is kept closed.
  • the cardioplegia solution is allowed, by cardioplegia pumping means, to travel through the heat exchanger 75 via the cardioplegia inlet port 84 and eventually the air in the system is removed through the purge port 81 of the heat exchanger 75.
  • pumping means is stopped and the purge port 81 of the heat exchanger 75 is closed.
  • the cardioplegia outlet port 85 is opened and the cardioplegia supply line, to heart, is filled, by cardioplegia pumping means, with cardioplegia solution without air.
  • Option 3 The bypass line BL is kept opened.
  • the reservoir inlet port 66, blood medium inlet port 82 and blood medium outlet port 83 of the heat exchanger 75 , blood medium purge port 52 of the oxygenator 25 are kept closed.
  • Blood medium is allowed, by blood medium pumping means, to travel from reservoir outlet port 65 to blood medium outlet port 49 of the oxygenator 25 via pumping means, connector 73 , bypass line BL and connector 74 , bypassing the heat exchanger 75 in the circuit, blood medium inlet port 48 of the oxygenator 25 , membrane compartment and eventually oxygenated blood is supplied to the patient from blood medium outlet port 49 of the oxygenator 25 .
  • blood medium outlet port 49 of the oxygenator 25 Thereby maintaining the patient's systemic, oxygenated, blood circulation.
  • the cardioplegia outlet port 85, blood medium inlet port 82 and blood medium outletport 83 of the heat exchanger 75 are kept closed.
  • Crystalloid cardioplegia medium is supplied, by cardioplegia pumping means, to the heat exchanger 75 via cardioplegia inlet port 84 .
  • the purge port 81 is kept closed by stopping the pumping means.
  • Crystalloid cardioplegia medium after getting heat energy exchange with heat energy exchanging fluid, is supplied, via cardioplegia pumping means, cardioplegia inlet port 84 and outlet port 85 , to the heart.
  • crystalloid cardioplegia is more practical for long action crystalloid cardioplegia solution since it will be delivered in initial stage of procedure, single time, alone in majority of the procedures.
  • the heat exchanger is used for systemic blood circulation.
  • the blood medium inlet port 82 and the blood medium outlet port 83 and the heat exchanger 75 are closed by keeping the bypass line BL opened during systemic circulation.
  • the blood medium in the heat exchanger 75 is flushed out through the purge port 81 of the heat exchanger 75 by pumping the crystalloid cardioplegia solution and, then the purge port 81 of the heat exchanger 75 is closed. Now the heat exchanger is ready for the crystalloid cardioplegia infusion to the heart.
  • the cardioplegia delivery pressure can be monitored by incorporating a suitable provision in cardioplegia delivery line or the purge port 81 of the heat exchanger 75 in all the above described procedures.
  • the bypass line BL, the purge port 52, the recirculation port 53 of the oxygenator 25, cardioplegia inlet port 84 of the heat exchanger 75, cardioplegia outlet port 85 of the heat exchanger 75 and the purge port 81 of the heat exchanger 75 are kept closed.
  • the blood medium is drawn from the reservoir by blood medium pumping means and supplied, via the connector 73 and the blood medium inlet port 82 of the heat exchanger 75, to the heat exchanger 75.
  • the blood medium after getting heat energy exchange in the heat exchanger 75, exits through the blood medium outlet port 83 of the heat exchanger 75 and eventually enters the oxygenator 25 through the connector 74 and the blood medium inlet port 48 of the oxygenator 25 .
  • the blood medium, after oxygenation with reduced carbon dioxide tension, from the membrane compartment, exits through the blood medium outlet port 49 of the oxygenator 25 and eventually the oxygenated blood medium with altered temperature is supplied to the patient, generally to systemic blood circulation of the patient.

Abstract

L'invention concerne un dispositif médical pour l'oxygénation, l'élimination du dioxyde de carbone, l'échange de température dans le sang du patient et, en outre, pour l'administration de cardioplégie au sang froid/chaud/cristalloïde au muscle cardiaque dans un circuit extracorporel pendant une chirurgie cardiaque. Un échangeur de chaleur unique est utilisé soit pour la circulation sanguine systémique d'un patient, soit pour l'administration de cardioplégie au cœur, chaque fois que cela est nécessaire.
PCT/IN2017/050487 2017-09-04 2017-10-23 Oxygénateur sans échangeur de chaleur intégré, avec échangeur de chaleur commun pour système de circulation sanguine systémique et d'administration de cardioplégie d'un patient, et procédés associés WO2019043722A1 (fr)

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IN201741031239 2017-09-04
IN201741031239 2017-09-04

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WO2019043722A1 true WO2019043722A1 (fr) 2019-03-07

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115624664A (zh) * 2022-11-10 2023-01-20 江苏赛腾医疗科技有限公司 小型化膜式氧合器

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1322352A2 (fr) * 2000-09-27 2003-07-02 Cobe Cardiovascular, Inc. Cartouche jetable pour systeme de perfusion sanguine
US20100262063A1 (en) * 2008-04-09 2010-10-14 O'neill William G Recirculation switch for blood cardioplegia
EP3079737A1 (fr) * 2013-12-10 2016-10-19 ResuSciTec GmbH Unité de refroidissement pour échangeur de chaleur destiné à équilibrer la température du sang circulant dans un circuit sanguin extracorporel

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1322352A2 (fr) * 2000-09-27 2003-07-02 Cobe Cardiovascular, Inc. Cartouche jetable pour systeme de perfusion sanguine
US20100262063A1 (en) * 2008-04-09 2010-10-14 O'neill William G Recirculation switch for blood cardioplegia
EP3079737A1 (fr) * 2013-12-10 2016-10-19 ResuSciTec GmbH Unité de refroidissement pour échangeur de chaleur destiné à équilibrer la température du sang circulant dans un circuit sanguin extracorporel

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115624664A (zh) * 2022-11-10 2023-01-20 江苏赛腾医疗科技有限公司 小型化膜式氧合器
CN115624664B (zh) * 2022-11-10 2024-01-30 江苏赛腾医疗科技有限公司 小型化膜式氧合器

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