BLOOD GAS EXCHANGER WITH RESTRICTION ELEMENT OR ELEMENTS TO REDUCE GAS EXCHANGE
20240358903 ยท 2024-10-31
Assignee
Inventors
Cpc classification
B01D63/031
PERFORMING OPERATIONS; TRANSPORTING
B01D2313/08
PERFORMING OPERATIONS; TRANSPORTING
B01D63/034
PERFORMING OPERATIONS; TRANSPORTING
A61M1/3623
HUMAN NECESSITIES
International classification
A61M1/36
HUMAN NECESSITIES
Abstract
Described is a gas exchanger with a restriction element or elements to reduce gas exchange as desired to avoid hypo-capnia and hyper-oxygenation in small patients. The gas exchanger includes a gas exchanger housing with an outer wall and a core which defines an inner wall and having a blood inlet for receiving a blood supply and a blood outlet. The gas exchanger also includes: a hollow fiber bundle disposed within the housing between the core and the outer wall; and a gas inlet compartment for receiving an oxygen supply and directing the oxygen supply to first ends of the hollow fiber bundle, wherein the gas inlet compartment includes at least one restriction element configured to allow the oxygen supply to reach only a portion of the hollow fiber bundle.
Claims
1. A gas exchanger comprising: a housing including an outer wall, the housing having a blood inlet and a blood outlet, and a gas inlet and a gas outlet, the gas inlet configured for receiving a gas supply including oxygen; a hollow fiber bundle disposed within the housing and comprising a number of hollow gas permeable fibers extending between the gas inlet and the gas outlet; and at least one restriction element configured to reduce the number of hollow gas permeable fibers that receive gas from the gas supply.
2. The gas exchanger of claim 1, wherein the at least one restriction element is configured to allow the gas supply to selectively reach and flow through a first portion of the hollow gas permeable fibers, and to prevent the gas supply from reaching a second portion of the hollow gas permeable fibers.
3. The gas exchanger of claim 1, wherein the at least one restriction element is moveable between a first position and a second position, wherein in the first position, the at least one restriction element allows the gas supply to reach and flow through a first portion of the hollow gas permeable fibers, and in the second position the restriction element allows the gas supply to reach and flow through a second portion of the hollow gas permeable fibers, wherein the first and second portions include a different number of hollow gas permeable fibers.
4. The gas exchanger of claim 3, wherein the first position is an open position and the first portion includes all of the hollow gas permeable fibers, and the second position is a closed position and the second portion includes only a portion of the hollow gas permeable fibers.
5. The gas exchanger of claim 4, further comprising a handle coupled to each of the at least one restriction element, the handle configured to move the at least one restriction element between the open position and the closed position.
6. The gas exchanger of claim 2, wherein the housing includes a first end cap at a first end of the housing and the gas inlet is positioned near a center of the first end cap, wherein the housing includes a second end cap at a second end of the housing opposite the first end, wherein the hollow gas permeable fibers extend along a longitudinal axis of the housing between the first end and the second end, wherein the at least one restriction element is positioned such that the first portion of the hollow gas permeable fibers extends centrally along the longitudinal axis within the housing, and the second portion of the hollow gas permeable fibers are positioned radially outward of the first portion.
7. The gas exchanger of claim 1, wherein the at least one restriction element surrounds the gas inlet.
8. The gas exchanger of claim 7, wherein the at least one restriction element includes a gasket.
9. The gas exchanger of claim 3, wherein the hollow fiber bundle includes a potting on first ends of the hollow gas permeable fibers, wherein when in the first position, the at least one restriction element is spaced apart from the potting, and when in the second position, the at least one restriction element is in contact with the potting.
10. The gas exchanger of claim 9, wherein when the gas inlet is positioned within the at least one restriction element and the at least one restriction element is in the second position, then only the hollow gas permeable fibers located interior of the at least one restriction element receive the gas supply.
11. The gas exchanger of claim 9, wherein when the gas inlet is positioned exterior of the at least one restriction element and the at least one restriction element is in the second position, then only the hollow gas permeable fibers located exterior of the at least one restriction element receive the gas supply.
12. The gas exchanger of claim 1, wherein the at least one restriction element includes a first restriction element surrounding the gas inlet and a second restriction element surrounding the first restriction element.
13. The gas exchanger of claim 1, wherein the housing further comprises a purge port configured to purge air bubble from an interior of the housing.
14. A gas exchanger comprising: a housing including an outer wall, the housing having a blood inlet and a blood outlet, and a gas inlet and a gas outlet, the gas inlet configured for receiving a gas supply including oxygen, wherein the housing includes a first end cap at a first end of the housing and the gas inlet extends through the first end cap, wherein the housing includes a second end cap at a second end of the housing opposite the first end; a hollow fiber bundle disposed within the housing and comprising a number of hollow gas permeable fibers extending along a longitudinal axis of the housing between the first end and the second end; and at least one restriction element positioned proximate the gas inlet and configured to reduce the number of hollow gas permeable fibers that receive gas from the gas supply.
15. The gas exchanger of claim 14, wherein the at least one restriction element is moveable between a first position and a second position, wherein in the first position, the restriction element allows the gas supply to reach and flow through a first portion of the hollow gas permeable fibers, and in the second position the restriction element allows the gas supply to reach and flow through a second portion of the hollow gas permeable fibers, wherein the first and second portions include a different number of hollow gas permeable fibers.
16. The gas exchanger of claim 15, wherein the first position is an open position and the first portion includes all of the hollow gas permeable fibers, and the second position is a closed position and the second portion includes only a portion of the hollow gas permeable fibers.
17. The gas exchanger of claim 15, wherein the hollow fiber bundle includes a potting on first ends of the hollow gas permeable fibers, wherein when in the first position, the at least one restriction element is spaced apart from the potting, and when in the second position, the at least one restriction element is in contact with the potting.
18. The gas exchanger of claim 17, wherein when the gas inlet is positioned within the at least one restriction element and the at least one restriction element is in the second position, then only the hollow gas permeable fibers located interior of the at least one restriction element receive the gas supply.
19. The gas exchanger of claim 17, wherein when the gas inlet is positioned exterior of the at least one restriction element and the at least one restriction element is in the second position, then only the hollow gas permeable fibers located exterior of the at least one restriction element receive the gas supply.
20. A method of oxygenation comprising: providing a gas exchanger comprising: a housing including an outer wall, the housing having a blood inlet and a blood outlet, and a gas inlet and a gas outlet, the gas inlet configured for receiving a gas supply including oxygen; a hollow fiber bundle disposed within the housing and comprising hollow gas permeable fibers extending between the gas inlet and the gas outlet; and at least one restriction element configured to be activated to reduce the number of hollow gas permeable fibers that receive gas from the gas supply; activating the at least one restriction element; causing the gas supply to flow through only a first portion of the hollow gas permeable fibers; delivering blood to the gas exchanger through the blood inlet; causing the blood to flow over an exterior of the hollow gas permeable fibers; and discharging the blood through the blood outlet.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0027]
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[0036] While the disclosure is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the disclosure to the particular embodiments described. On the contrary, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure.
DETAILED DESCRIPTION
[0037] The disclosure pertains to an oxygenator (also commonly referred to as a gas exchanger). In some embodiments, an oxygenator may be used in an extracorporeal blood circuit. An extracorporeal blood circuit, such as may be used in a bypass procedure, may include several different elements such as a heart-lung machine, a blood reservoir, a heat exchanger, as well as an oxygenator. In various embodiments, the gas exchanger, or oxygenator, includes one or more restriction elements that allow for a reduction in gas transfer performance of the oxygenator in order to avoid hypo-capnia and hyper-oxygenation in patients, particularly small or neonatal patients. In various embodiments, one or more restriction elements are configured to be activated to allow an oxygen supply to reach only a portion of hollow gas permeable fibers, thereby reducing the amount of gas exchange performed by the oxygenator.
[0038]
[0039] In some embodiments, a blood inlet 18 extends into the housing 12 and a blood outlet 20 exits the housing 12. As noted, the oxygenator 10 includes a fiber bundle inside where gas exchange takes place, and thus includes a gas inlet 22 and a gas outlet 24. In some embodiments, the oxygenator 10 may include one or more purge ports 30 that may be used for purging air bubbles from the interior of the oxygenator 10.
[0040] The positions of the blood and gas inlets and outlets, and the purge port 30 in
[0041] The housing 12 is preferably made of a rigid plastic in order for the oxygenator 10 to be sturdy yet lightweight. The oxygenator is also preferably mainly transparent, in order to allow the user to see through the oxygenator. Therefore, a preferred material for the oxygenator is a transparent, amorphous polymer. One exemplary type of such a material is a polycarbonate, an ABS (Acrylonitrile Butadiene Styrene), or a co-polyester. Other suitable materials for the housing are also contemplated.
[0042] The fiber bundle (not shown in
[0043] In some embodiments, the hollow fibers are made of semi-permeable membrane including micropores. Preferably, the fibers comprise polypropylene, polyester, or any other suitable polymer or plastic material. According to various embodiments, the hollow fibers may have an outer diameter of about 0.25 to about 0.3 millimeters. According to other embodiments, the microporous hollow fibers may have a diameter of between about 0.2 and 1.0 millimeters, or more specifically, between about 0.25 and 0.5 millimeters. The hollow fibers may be woven into mats that can range from about 50 to about 200 millimeters in width. In some embodiments, the mats are in a criss-cross configuration. The fiber bundle may be formed of hollow fibers in a variety of winding patterns or structures.
[0044] The hollow fibers are embedded, or sealed, at their ends, in rings of polyurethane resin, for example, which is known as potting. The fiber bundle of hollow fibers is preferably in a cylindrical shape, but other shapes are also contemplated. The hollow fibers, at first ends, are connected to the first end cap 14 through the potting, with the gas inlet 22 being located in the first end cap 14. At second ends, the hollow fibers are connected to the second end cap 16 through the potting with the gas outlet 24 being located in the second end cap 16. The internal lumens of the fibers are part of the gas pathway that is determined by the first end cap 14, the potting at the first end, the fibers, the second potting and the second end cap 16. The oxygenator chamber is thus defined by the housing as an outer wall and an inner wall or core, together with the pottings at each end of the hollow fibers.
[0045] Oxygen, or a mixture of oxygen and air, known as an oxygen supply, enters through gas inlet 22, passes through the microporous hollow fibers within the fiber bundle, and exits the oxygenator 10 through the gas outlet 24. In some embodiments, the pressure or flow rate of oxygen through the oxygenator may be varied in order to achieve a desired diffusion rate of, for example, carbon dioxide diffusing out of the blood and oxygen diffusing into the blood. In some embodiments, as illustrated, the oxygen flows through the hollow fibers while the blood flows around and over the hollow fibers.
[0046] Differences in concentration of gases between the blood and the oxygen supply produce a diffusive flow of oxygen toward the blood and of carbon dioxide from the blood in the opposite direction. The carbon dioxide reaches the gas outlet 24 and is discharged from the oxygenator 10.
[0047] Any suitable gas supply (or oxygen supply) system may be used with the oxygenator 10 of the disclosure, in order to deliver an oxygen supply to the fiber bundle or hollow fibers of oxygenator 10. Such a gas supply system may also include, for example, flow regulators, flow meters, a gas blender, an oxygen analyzer, a gas filter, and a moisture trap. Other alternative or additional components in the gas supply system are also contemplated.
[0048] As shown in
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[0053] Fiber bundle 40, made up of a plurality of hollow fibers (not shown individually), is shown with a potting 42 on first ends of the hollow fibers. A gas inlet compartment 44 is formed within first end cap 14 between the gas inlet 22 and potting 42. The gas-holding capacity or size of the gas inlet compartment 44 is determined by whether the restriction elements 32, 34 are activated or not.
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[0057] The oxygenator 100 includes a heat exchanger core 116, a heat exchanger element 118 disposed about the heat exchanger core 116, a cylindrical shell 120 disposed about the heat exchanger element 118 and a gas exchanger element 122, all disposed inside the outer shell or housing 102. The heat exchanger element 118 and the gas exchanger element 122 may each include a number of hollow fibers as discussed with respect to oxygenator 10 (
[0058] In use, blood enters the blood processing apparatus or oxygenator 100 through the blood inlet 108 and passes into the heat exchanger core 116. The blood fills the heat exchanger core 116 and exits through an elongate core aperture 126 and thus enters the heat exchanger element 118. In some embodiments, the heat exchanger core 116 includes a single elongate core aperture 126, while in other embodiments, the heat exchanger core 116 may include two or more elongate core apertures 126. In some embodiments, the elongate aperture 126 allows or directs blood to flow through the heat exchanger element 118 in a circumferential direction.
[0059] As shown in
[0060] After blood passes through the heat exchanger element 118, it collects in the channel 127 and flows into an annular shell aperture 128. The shell aperture 128, in various embodiments, extends entirely or substantially around the circumference of the cylindrical shell 120, such that blood exits the inner cylindrical shell 120 around the entire or substantially the entire circumference of the cylindrical shell 120. In some embodiments, the radially disposed shell aperture 128 may be located near an end of the oxygenator 100 that is opposite the blood outlet 110, thereby causing the blood to flow through the heat exchanger element 118 in a longitudinal direction. Blood then collects in the annular portion 124 before exiting the oxygenator 100 through the blood outlet 110.
[0061] At least one restriction element 132, as in the embodiment shown in
[0062] The embodiment shown in
[0063]
[0064] The present disclosure allows the use of one device for a range of sizes of neonatal patients. The device allows for ease in setting appropriate gas exchange performances based on specific patient dimensions, thereby avoiding excess carbon dioxide removal, particularly for very small patients (size 5 kg or less, for example). Gas exchange may be set based on the amount of fiber bundle that is active or used, based on whether or not a restriction element is activated or not. With no restriction elements activated, the percentage of the fiber bundle that is active or used is about 100%. If one restriction element is activated, the percentage of the fiber bundle that is active or used is about 50%, for example. If there are two restriction elements included in the device, then the percentage of active fiber bundle could be either about 33% or about 66%, for example, depending on which restriction element is activated. The percentages of fiber bundle that may be active or used may be varied as well as the number and location of the restriction element or elements.
[0065] Another embodiment of the disclosure is a method of oxygenation or oxygenating blood. The steps may comprise providing an oxygenator comprising: an oxygenator housing including an outer wall and a core which defines an inner wall and having a blood inlet for receiving a blood supply and a blood outlet, the oxygenator housing defining an oxygenator volume; a hollow fiber bundle disposed within the housing between the core and the outer wall, the hollow fiber bundle comprising hollow gas permeable fibers, each fiber having first and second ends and a hollow interior; a gas inlet compartment for receiving an oxygen supply and directing the oxygen supply to the first ends of the hollow gas permeable fibers; wherein the gas inlet compartment includes at least one restriction element configured to allow the oxygen supply to reach only a portion of the hollow gas permeable fibers. The oxygenator may alternatively be any embodiment as described, suggested or shown herein, or any other suitable oxygenator. The method may further comprise: activating at least one restriction element; causing an oxygen supply to flow through the hollow interior of the portion of the hollow gas permeable fibers; delivering blood to the oxygenator through the blood inlet; causing the blood to flow through the oxygenation housing over the exterior of the hollow gas permeable fibers; and discharging the blood through the blood outlet. Other methods of oxygenation are also contemplated by the disclosure.
[0066] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present disclosure. For example, while the embodiments described above refer to particular features, the scope of this disclosure also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present disclosure is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.