JPH02128769A - Integrally formed blood deaerator, storage bin, heat exchanger and heart-operating filter - Google Patents

Abstract

PURPOSE: To reduce damages on blood corpuscles when cold heart incision blood flow guided to a vein or an artery with heating by installing a means to guide filtered heart incision blood flow from a heart incision filter to above the winding of a heat exchange coil. CONSTITUTION: This device includes a saving tank, defoamer, heat exchanger, and heart incision filter device 30 mounted on top of a membrane-typed oxygenater 22. The upper unit consists of an outer hard shell housing 24 which forms a saving tank, a defoamer 26, a heat exchange coil 28 with a coil which is vertically set, and a heart incision filter 30. A cyclic vein blood entrance 32 is formed on top of the unit 20 to guide entering blood to the upper winding 32 of the heat exchange coil 28. A central heart incision blood entrance 34 is also formed on top of the unit to guide heart incision blood into the filter 30. The tank 24 includes a thermoplastic pot-shaped casing part 40, and a cover made of thermoplastic parts 42, 44, 46, 48, and 50.

Description

[Detailed description of the invention] Five minutes! The present invention relates to an apparatus for sifting, temperature controlling, defoaming and storing blood in an in vitro circuit, and in particular to an integrated apparatus for processing and handling cardiotomy flow that is combined with venous flow.

In surgical operations such as open-heart surgery, an external circuit containing a pump and oxygenator oxygenates blood flow from the veins and pumps the oxygenated blood to the arteries. and used to replace heart function.

This external circuit generally stores blood flow to accommodate perturbations in venous blood flow, defoams blood to remove bubbles generated or induced within the external circuit, and compensates for heat losses in the external circuit. It includes equipment for controlling the temperature of the blood, either to lower it over time and to raise it to body temperature. In addition, this surgical manipulation results in bleeding and suction from these incision sites to form a cardiotomy blood flow. This cardiotomy flow is typically sifted to remove particulate matter aspirated from the incision site, stored, and combined with venous or arterial flow in the external circuit.

U.S. Patent Nos. 4.205.042 and 4.490.
The prior art, represented by No. 331, includes a cardiotomy filter that passes the cardiotomy flow, and an integrated device that incorporates a reservoir, a defoaming device, a blood temperature control device, and a bubble-type or membrane-type oxygenator. I'm here. The cardiotomy flow is combined with venous blood (before oxygenation) or arterial blood (after oxygenation) after passing through the mouth. The blood temperature control device includes a heat exchanger for the venous flow or combined flow.

In general, prior art blood oxygenators with integrated cardiotomy filters create restrictions to blood flow, requiring excessive blood pressure and blood cell damage, and separate storage space for the cardiotomy flow. It has drawbacks such as requiring a large amount of carbon, is difficult to manufacture, and has an expensive structure.

Main Features ■ Overview The present invention comprises a bowl-shaped housing that forms a blood reservoir and has a bottom with a blood outlet, a top with a venous blood inlet, and a central cardiotomy blood inlet, and is mounted within the housing. a heat exchange coil having a plurality of turns formed around a vertical axis; a facility for directing blood flow from the venous inlet in an annular pattern over the upper turns of the heat exchange coil; and a housing. a deaerator mounted internally and interposed between the heat exchanger and the blood outlet for removing air bubbles in the blood passing to the blood outlet; a cardiotomy filter mounted within the housing extending from the top downwardly into the turns of the heat exchange coil for directing the passed cardiotomy blood flow onto the turns of the heat exchange coil; Facilities include reservoir, heating, degassing and cardiotomy devices for ex-vivo blood systems.

One object of the present invention is to construct a new and improved device that combines suffocation and temporary storage of cardiotomy flow with temporary storage, heating and defoaming of venous flow.

Another object of the present invention is to provide a reservoir that integrates heating of the cardiotomy flow;
It is heated, degassed and provided in a heart incision device.

An advantage of the present invention is that - a blood oxygenator with temporal storage and defoaming can include a cardiotomy filter with relatively little modification and additional cost.

Another benefit of the present invention is that heating the cardiotomy flow reduces blood cell damage that occurs when cold, unheated cardiotomy flow is introduced into a vein or artery.

Other objects, advantages and features of the invention will become apparent from the following description with reference to the accompanying drawings.

FIG. 1 is a vertical cross-sectional view of a blood oxygenator including a reservoir, heating, defoaming and cardiotomy device in accordance with the present invention. 2 is a top view of the oxygenator of FIG. 1; FIG.

FIG. 3 is a top view of the cardiotomy filter holder of the oxygenator of FIG. 1;

FIG. 4 is a bottom view of the oxygenator of FIG. 1.

FIG. 5 is a front view of the holder of FIG. 3.

FIG. 6 is a perspective view of filter material pleated for assembly into a tubular filter for insertion into the holder of FIGS. 3 and 5 to form a cardiotomy filter configuration; FIG.

FIG. 7 is an enlarged cross-sectional view of a broken portion of the filter material of FIG. 6;

8 is a top view of the holder of FIG. 3 with the pleated filter of FIG. 6 installed therein; FIG. 9 is a top view of the filter of FIG. 6 shown in assembled tube form for insertion into the holder of FIGS. 3 and 5; FIG.

That's great! As shown in FIG. 2, one embodiment according to the present invention includes a storage tank, generally designated at 20, mounted on top of a membrane type oxygenator, generally designated at 22, for defoaming, heat exchange, and heat exchange. Includes a dissection filter device. The upper device has an outer hard shell housing 24, generally 2, forming a reservoir.
It is formed from a nested structure of a deaerator, indicated generally at 6, a heat exchanger coil, indicated generally at 28, having vertically oriented coils, and a cardiotomy filter, indicated generally at 30. A circular venous blood inlet facility, indicated generally at 32, is formed at the top of the unit 20 for directing incoming blood flow to the upper turns 32 of the heat exchanger coil 28. generally 34
A central cardiotomy blood inlet facility, shown at , is formed at the top of the unit for directing cardiotomy blood into the filter 30.

The storage tank 24 includes a molded thermoplastic pot-shaped container portion 40;
and includes a cover formed by molded thermoplastic parts 42, 44, 46, 48 and 50. Parts 42, 44, 46, 48 and 50 are joined together by conventional means such as induction bonding, solvent bonding, adhesive bonding, radio frequency bonding, ultrasonic bonding, vibration bonding, etc. using commercially available iron-containing bonding agents. Fixed. Components 42, 44, 46, and 48 have mating tongue and groove structures formed thereon to enhance strength and bond strength. Part 42 is shown mounted on housing 40 using a rotating seal of the type disclosed in U.S. Pat. No. 4,440.723, so that the relative orientation of the upper assembly is adjusted with respect to housing 40. However, a fixed joint such as that used between parts 42, 44, 46 and 48 may be used instead of a rotating seal.

As shown in FIG. 2, the venous blood inlet facility 32 is formed by a component 46 having tangential connectors 54 and 56 (shown with a sealing cap disposed thereon). Sampling ports 58 and 60 are provided on connectors 54 and 56, and a thermometer 6
2 is provided on the connector 54. Entrances 54 and 5
6 opens tangentially into an inlet chamber 64 (FIG. 1) which communicates with a lower annular opening 66 formed by parts 44 and 50. Component 50 is mounted on a central tubular projection 68 extending downwardly from the top of component 46 and has a downwardly and outwardly flared skirt portion 70 defining the inner edge of annular opening 66 at its upper end. The skirt portion 70 includes a downwardly directed vertical cylindrical portion 72, as disclosed in more detail in U.S. Pat.
, which extends thereto to direct blood flow to the top center of the surface of the tube forming the upper turn of coil 28 . Part 44 has an inwardly and upwardly sloping flange 74 forming an outer edge of annular opening 66 and extending outwardly and downwardly to a vertical cylindrical portion 76 , which includes a downwardly extending cylindrical portion. It cooperates with the vertical cylindrical portion 72 of the member 50 to form a narrow interannual lower 8 of about 0.0000000000000000000000000000000000000000000 002 0.0000000000 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 being to be co-operated with the vertical cylindrical portion 72 of the member 50 to create a film-like flow that continues from the coil 28 to the top winding of the coil 28.

Cardiotomy blood inlet facility 34 has an inlet 82.8 open into a chamber 88 formed between members 46 and 48.
4 and 86 (FIG. 2). Chamber 88 communicates with a passageway 90 at its bottom through a tubular protrusion 68 that directs blood flow from chamber 88 to filter 30 . Boats 92 and 94 are provided for inlets 82 and 86, with boat 96 provided to the center of chamber 88.

The cover part 42 includes a raised portion 98 into which a boat or vent 100 is mounted to provide an outlet for removing gases carried or generated by the blood flow input from the reservoir.

Heat exchanger coil 28 is a coiled concertina aluminum heat exchange tube having respective inlet and outlet openings 102 and 104 secured by appropriate mating openings in parts 42, 44 and 50. The outer surface of the aluminum is preferably anodized and/or coated with a thin coating of commercially available urethane-based, epoxy-based or other biocompatible material applied by a suitable technique such as electrostatic powder coating. 0 Alternatively, the coil 28 may be stainless steel, and the coil may be smooth,
It may be formed from a tube provided with pleated or alternating surfaces.

Rigid housing 106 has a helical groove that engages the outside of heat exchange coil 28 to maintain blood flow over heat exchange coil 28. Housing 106 has an outwardly extending lip 108 that engages a projection 110 formed on inner wall 112 of top member 42 .

U.S. Patent Application No. 06 filed on July 14, 1986
The defoamer 26, described in more detail in U.S. Pat. An open cell polyurethane sock 116 is placed over the lattice support 114 and has a woven polyester stocking sock secured onto its lower three quarters. socks 116
An outer sock 120 of open cell polyurethane with larger pores surrounds the inner socks 116 and 118 and is secured by a knitted polyester sock 122, which is attached to the support 1 to secure it on the grid 114.
14 is secured by a tie 124 at its upper edge at the top of an outwardly extending lip 126.

Filter 30 includes a support, shown generally at 140 in FIGS. 3 and 5, that includes a bottom tray section 142 and a top ring section 144 joined by a vertical panel section 146. This heats the bottom winding of the coil at fluid outlet 1
It is suitable for accommodating a vertical section 148 (FIG. 1) of heat exchange tubing that extends vertically through the coil 28 for connection to the coil 28. As shown in FIGS. 1 and 8, the filter has a perforated inner vertical tube 150 that extends into the raised portion 144 of the tray 144 at its lower end.
52 and receives a tubular projection 68 at its upper end. Open cell polyurethane foam 154
A tubular defoaming layer, such as a tubular defoaming layer, surrounds the tube 150.

A pleated filter 156 supported by upper ring 144 and lower tray 142 surrounds defoaming member 154 . Filter 156 is formed from a pleated material having a central filter layer 160 sandwiched between two support layers 162 and 164, as shown in FIGS. Filter material 160 is preferably a woven polyester material with an approximately 20 micron mesh, and outer layers 162 and 164 are suitable support materials to hold inner filter layer 160, such as extruded mesh. Sheets of material 160, 162 and 164 are
Assembled and shirred with care taken to avoid breaking layers 160, 162 and 164 as shown, the shirred structure generally keeps the layers in place, the shirred sheet of FIG. It is folded into a tube shape as shown in Figure 9.
The overlapping end portions 170 are then joined together by heat sealing, hot melt adhesive, or other securing means to secure the pleated sheet in a tube shape. This pleated tube configuration of FIG. 9 is then inserted into the holder 140 of FIGS. 3 and 5 over the defoamer 154.

As shown in FIG. 1, the lower end of filter 156 is sealed by potting material 172, and the upper end of filter 156 and upper ring 144 are secured and sealed in member 50 by potting material 174. Potting materials 172 and 174 are preferably hot melt adhesives or other suitable potting materials.

A flexible disc, such as polyurethane foam 176 (FIG. 1), is secured to the bottom of support tray 142 by hot melt adhesive or other securing means.

Disc 176 has a diameter that extends from filter 30 into engagement with coil 28 to direct the flow of cardiotomy flow from filter 30 to the coil 2 turns.

Membrane oxygenator 22 is described in detail in U.S. patent application Ser. 18
0, through which a number of hollow membrane fibers 188 extend, and an upper end secured into seal 122;
A chamber 186 is formed with a lower end secured into the chamber 84. The upper cap 190 has a threaded retaining ring 19
2 to the top side of the seal 184 and has a tangential population 194 (FIG. 4) for receiving blood and distributing it to the open upper end of the hollow membrane line 1i 18B. The upper cap 190 also receives a flange 195 for attaching the membrane oxidizer unit 22 to the bottom of the upper apparatus 20.
and has a groove fixed to it, for example by adhesive. An outlet 196 is provided at the top of the cap 190 for removing gas from the cap 190. Entrance 1
98 and outlet 200 communicate with chamber 186 for passing air, oxygen, or oxygen-rich gas through chamber 186 to oxygenate and remove carbon dioxide from the blood flowing through membrane fibers 188. The lower cap 202 receives blood flow and directs the blood flow to the outlet 20.
6 and 208 (FIG. 4) and is secured and sealed to the outer periphery of lower seal 184 by threaded ring 204. A thermometer boat 210 and sample or sample ports 212 and 214 are provided on the main outlet 206.

Reservoir shell 40, top parts 42, 44, 46, 48 and 50, housing 106, support 140, perforated tube 150, tubular housing 180, upper and lower caps 190 and 202, and retaining ring 1
Various molded parts such as 92 and 204 are made from transparent polymeric materials such as polycarbonate, acrylic, ABS, SAN or other suitable materials. If appropriate, container shell 40, cover parts 42, 44, 46.
48 and 50, housing 106, support 140, tube 150, caps 190 and 202, membrane fiber 1
Various parts, such as 88, seals 182 and 184, and other components, can be coated with conventional antithrombotic materials to avoid creating blood flow in the blood being processed. Preferably, the defoaming sleeve 154 and defoaming socks 11
The upper one third of 6 is coated with a conventional silicone antifoam compound.

In use of the oxygenator of FIG. 1, the upper and lower units first supply a priming fluid, such as a patient's blood or other compatible fluid, to one or more venous populations 54 and 56 and one or more cardiac It will be primed by feeding into the incisions 82, 84 and 86. After flowing down heating coil 28, the priming fluid flows through deaerator 26 and to the bottom of reservoir 40, where it is removed through a pump (not shown) through connector 132, which pumps the fluid is returned to the inlet 194 (FIG. 4) of the membrane oxygenator 22. The priming fluid passes into the inlet cap 190;
and the gas to the membrane fibers 188 and the outlet cap 202,
and expelled from exits 206 and 208. The system is then connected for operation and venous blood flow is inlet 5 in FIG.
4 into chamber 64 of FIG. 1 and then distributed over the lower turns of coil 28 and flowing down over each lower turn to obtain the desired blood temperature. Water is heated or cooled and the inlet 102 and outlet 1
04.

Cardiotomy flow from one or more suction pumps (not shown) enters one or more inlets 82, 84 and 86 and is routed through passageway 90 into central tube 150 of filter 30. The cardiotomy flow passes through a hole in tube 150 and is then defoamed by contact through defoaming material 154 .

The blood then passes through a fluted filter 156 to remove particles and other materials having dimensions greater than about 20 microns. After passing through filter material 156, the blood is directed onto coil turns 28 by disk 176. This ensures that the cardiotomy flow is maintained at the desired temperature along with the venous flow. The cardiotomy flow removed from the incision site may be substantially cooler than the venous flow. Ensuring that the cardiotomy flow is in direct contact with the heating coil before being thoroughly mixed with the venous flow occurs when the cardiotomy flow is added to the venous or arterial flow. obtain,
Ensure that the desired temperature is raised to avoid shock due to sudden temperature changes in the fluid surrounding the blood cells in the vein or venous flow.

The nested configuration of the cardiotomy filter 30 in the coil 28 nested in the deaerator 26 nested in the reservoir 40 provides a relatively compact unit that avoids large altitude changes in blood passing through the extracorporeal circuit. This helps maintain blood pressure at a minimum level that avoids blood damage that can be caused by such pressure.

This particular construction of the cardiotomy filter, i.e., a central inlet tube 150 surrounded by a vertical tubular filter 156 fixedly sealed at the bottom by a bottom tray 172 and fixedly sealed at the top by a botting material 174, is efficient. It is especially suitable for reliable manufacturing. In addition, the one-piece assembly only requires special production of the filter 30 and cap 48; the remaining parts are already commercially produced for devices without cardiotomy filters, so this one-piece assembly is particularly easy to manufacture. Economical and efficient.

FIG. 10 depicts a pediatric oxygenator at 220 that is substantially the same as adult oxygenator 20, except that the various dimensions of the unit have been reduced in accordance with the reduced blood flow requirements of the pediatric patient. do.

The cardiotomy filter 30 may incorporate a bubble oxygenator as disclosed in US Pat. No. 4,282,180, as shown in the variations of FIGS. 11 and 12. In this variation, a bubble oxygenation facility, indicated generally at 302, replaces the membrane oxygenation unit 22 of FIG. Various parts are identified in Figures 11 and 12 with the numbers used in Figures 1-9 to indicate that they are similar and perform similar functions. This blood oxygenation equipment includes part 30 instead of part 1 44 in FIG.
4 and 306. Part 306 connects the chamber between parts 304 and 46 to upper annular chamber 3.
08 and a lower annular chamber 310.

Venous blood populations 54 and 56 formed on component 46 open tangentially into upper chamber 308 to form an annular blood flow into chamber 308 similar to chamber 64 of FIG. The inlet 312 is connected to the chamber 31 for supplying pressurized air, oxygen or oxygen-rich gas.
It's open to 0 inside. The dividing member 306 is, for example, the coil 2
U.S. Pat.
It is porous by having pores 314 formed therethrough as disclosed in No. 8. This blood with air bubbles flows down the turns of coil 28. In the modification shown in FIG. 11, the coil 28 is shown to be formed of a smooth tube instead of the bellows tube shown in FIG.

The cardiotomy flow from the filter 30 is directed onto the inner surface of the coil 28 generally above the vertical midpoint of the coil 28 so that the cardiotomy flow is heated as it joins the venous flow.

Additionally, in the variation of FIGS. 11 and 12, the reservoir shell 40 is longer, the inner defoaming sock 116 is formed of multiple layers of knitted material instead of porous foam, and the coil housing 106 is pleated. The defoamer support grid 114 has extensions 316 instead of having smooth walls.

An annular layered member 318 is secured to the bottom of the coil housing 106 at its outer lip, and an inverted cup member 320 provides an extended passageway through which the blood bubble mixture must pass to increase oxygenation time for the blood. It has a downwardly extending annular lip secured to the bottom lip 322 of member 318 to form a . A porous polyurethane foam filler 326 coated with a conventional anti-foam material is
Support grid 11 for receiving the flow of blood and air bubble mixture
4 is supported in the central opening of the annular member 31B.

Foam fill 326 reduces the formation of small air bubbles that can pass through defoamer 26. After passing the foam padding 326 into the pool that may form in the reservoir, air bubbles are removed from the blood by contact with the deaerator 26. After passing through the deaerator 26 it is now oxygenated and passes to the outlet 132.

Numerous variations, changes in detail and modifications may be made to the embodiments described without departing from the scope and spirit of the invention. It is intended that the foregoing description and accompanying drawings be considered only as illustrative of the presently preferred embodiments of the invention, and that the invention as defined in the claims may take the form of numerous other embodiments. Ru.

[Brief explanation of the drawing]

FIG. 1 is a vertical sectional view of the device of the present invention, FIG. 2 is a top view of the device of FIG. 1, FIG. 3 is a top view of the cardiotomy filter holder, and FIG. 4 is a bottom view of the device of FIG. 1. Figure 5 is a front view of the holder shown in Figure 3, Figure 6 is a perspective view of the pleated filter material, Figure 7 is an enlarged sectional view of the filter material in Figure 6, and Figure 8 is the same as that shown in Figure 6. 9 is a top view of the tubular assembly of the filter of FIG. 6; FIG. 10 is a vertical cross-sectional view of the device of the invention for pediatric use; FIG. 11 is a top view of the holder of FIG. The figure is a vertical sectional view of the deformed side of the device of the present invention. 20 is an upper device, 22 is a membrane type filter, 24 is a housing, 26 is a deaerator, 28 is a heat exchange coil, 32 is a venous blood inlet, and 34 is a cardiotomy blood inlet. 2≦;; Engineering, 7゛42, no change) Procedural amendment blind side Patent Application No. 282300 of 1988 2, Title of Invention: Blood defoamer, storage tank, heat exchanger and cardiotomy filter 3 , Relationship with the case of the person making the amendment Patent applicant 4, Name of agent (6036) Patent attorney Takuo Akaoka 5, Date of amendment order Attorney 6, Number of inventions increased by amendment None 7, Number of drawings subject to amendment Engraving (no change in content) Procedural amendment blind side Patent Application No. 282300 of 1982 2, Blood defoaming device, storage tank, heat exchanger and cardiotomy filter 3 with the title of the invention, relationship with the case of the person making the amendment Contents of Patent Applicant's Amendment 1, on page 26, line 6 of the specification, after "is."
FIG. 12 is a top view of the apparatus of FIG. 11. ” is inserted. 4. Agent Address: Hiroshi Building, 2-1-13 Awajicho, Nakasu-ku, Osaka Phone: (06) 222-0547 Name (603)
6) Patent attorney Takuo Akaoka 5, date of amendment order sent April 25, 1999

Claims (9)

[Claims] (1) a bowl-shaped housing having a bottom defining a blood reservoir and having blood outlet means, and a top having venous blood inlet means and midcardiotomy blood inlet means; a heat exchange coil having a plurality of vertically arranged turns, the venous blood inlet means having means for directing incoming venous blood flow in an annular pattern over the upper turns of the heat exchange coil. a deaerator mounted within the housing and interposed between the heat exchanger and the blood outlet means for removing air bubbles in the blood passing to the blood outlet; and a cardiotomy filter extending downwardly from the top into the windings of the heat exchange coil, said cardiotomy filter being connected to said cardiotomy blood inlet means for receiving and passing cardiotomy blood flow. , a reservoir, heating, defoaming and cardiac system for an extracorporeal blood system, characterized in that it comprises means for directing filtered cardiotomy blood flow from a cardiotomy filter onto a winding of a heat exchange coil. Incision filter device. (2) The device of paragraph 1 further comprising means for oxygenating the blood. (3) The apparatus of claim 2, wherein said oxygenation means includes a membrane oxygenator mounted to the bottom of said housing. (4) The apparatus of clause 1 further comprising a cardiotomy input flow deaerator interposed between the cardiotomy entry means and the cardiotomy filter. (5) the cardiotomy filter comprises a bottom support tray, an annular upper support member, a vertical porous filter tube, a means for securing the bottom end of the filter tube to the bottom support tray, and a top portion of the filter tube. 2. The device of claim 1, including means for securing the cardiotomy blood inlet means to an annular upper support member, the cardiotomy blood inlet means being in communication with the interior of the filter tube. (6) The means for directing the filtered cardiotomy blood flow onto the heat exchanger turns is a flexible member mounted horizontally to the bottom of the bottom support tray and extending into engagement with the heat exchanger coil. The device of paragraph 5, which includes a sexual disc. (7) a vertical perforated inlet tube extending from the cardiotomy inlet means to the bottom support tray and a vertical tube shape covering the outer diameter of said inlet tube for degassing the cardiotomy flow upstream of the filter; 6. The apparatus of clause 5 further comprising a defoaming pad. (8) a heated fluid inlet and a heated fluid outlet mounted on the top of said housing, one of said heated fluid inlet and outlet being connected to the topmost turn of the heat exchange coil and along the inner diameter of the heat exchange coil; a vertical tube portion extending vertically and connecting a lowermost turn of the heat exchange coil to the other of the heating fluid inlet and outlet;
6. The apparatus of claim 5, wherein said support member and said tubular fibrous filter tube are formed with a vertically extending groove that receives said vertical tube portion. 9. The apparatus of claim 2, wherein the oxygenating means includes means for forming bubbles of oxygen-containing gas in the blood flow within the annular venous blood inlet means.