CA1036884A

CA1036884A - Aseptic suction collection system and method

Info

Publication number: CA1036884A
Application number: CA203,218A
Authority: CA
Inventors: Gordon S. Reynolds; Karl A. Pannier (Jr.)
Original assignee: Sorenson Research Co Inc
Current assignee: Sorenson Research Co Inc
Priority date: 1973-10-23
Filing date: 1974-06-24
Publication date: 1978-08-22
Also published as: AU7273574A; JPS5147993B2; NL179787B; FR2248424A1; IT1022699B; NL179787C; US3866608A; BE819972A; JPS5073481A; DE2439392A1; NL7413017A; GB1483207A; DE2439392C2; FR2248424B1

Abstract

Abstract of Disclosure A dual chamber aseptic suction collection system and method employing separable blood and collection reservoirs one of which retains withdrawn blood capable of reinfusion into the patient.
The collection system provides an automatic sealing mechanism to completely seal the blood reservoir upon detachment from the collection reservoir. The invention furthermore encompasses a method for using the dual chamber system which includes the isolation of collected blood in a sealable container.

Description

`

103U;&~34 ASEPTIC SUCTION COLLECTION SYSTEM AND METHOD

Specification The invention relates to suction collection systems which employ a flexible reservoir contained within a rigid cannister, and more particularly to a dual chamber reservoir wherein one chamber primarily retains blood and may be separated from the other chamber to be used with a catheter for reinfusion of the collected blood.
It is presently conventional to employ a suction collection device in medical practice when a patient is bleeding from a wound or when an internal cavity or incision must be kept free from blood and other materials during the course of examination or surgery.
A conventionally used suction collection system includes a rigid plastic cannister with a flexible reservoir suspended within the cannister from a lid. The space between the cannister and the reservoir is evacuated in order to prevent collapse of the reservoir and the internal cavity of the reservoir is con-nected to a suction line and also is in fluid communication through a second tube to the site where tissue and liquid are ~o be collected. That type of prior art suction device is advant-ageous because of its low cost and aseptic disposability. One such device is shown in U. S. Patent 3,719,197, issued to K.A. Pannier et al, on March 6, 1973.
A major deficiency recognized in the previously described prior art device is the fact that all fluids collected, parti-cularly pure blood, can only be disposed of and no provision is made for reinfusion of any uncontaminated collected blood into the patient. Often the suction device is used in connection with surgical operations where blood is collected in a form which may be suitable for direct infus on back into the cardiovascular system of the patient.

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1~36B84 An apparatus providing for immediate reinfusion of withdrawn blood in an essentially aseptic form is not known in the prior art. Although in conventional systems withdrawn blood in a suction reservoir could conceivably be manually transferred to a second reservoir for infusion, the danger of contamination would be extremely high and time and expense of handling are prohi-bitive.
Accordingly, it has become desirable to use a suction col-lection system which is capable of collecting the withdrawn blood in a separable reservoir which may be automatically sealed essen-tially aseptically.
The present invention comprises novel apparatus and method for collecting blood through suction collection in a first reser-voir of a dual reservoir system, for transferring the blood to a second reservoir and for sealing and seParating the second reser-voir from the first. The present invention furthermore provides an automatic sealing mechanism to immediately and aseptically 9eal the second reservoir upon detachment rom the first. The apparatus accommodates selective formation of a pressure differ-ential between the first and second reservoir to facilitate ; pumping of blood from the first to the second reservoir.
It is, therefore, a primary object of the present invention to provide a dual reservoir aseptic suction collection system wherein one reservoir is completely separable from the remainder of the system.
It is another primary object of the present invention to provide an automatic sealing mechanism to completely seal the separated blood reservoir upon detachment f~om the collection reservoir.
Still another object of the invention is to provide a dual chamber suction collection device wherein the collected fluid is 103~
pneumatically pumped from a collection reservoir to a bloodreservoir.
Yet another object o~ the invention is to provide a dual reservoir suction collection system wherein one reservoir may be used directly for reinfusion of blood into the patient.
One more object of the invention is to provide an imProved method for suction collection.
According to one aspect of the present invention, a suction collection system is provided which comprises: first reservoir means and means for evacuating the first reservoir means; means for transferring a fluid to the first reservoir means; second reser-voir means selectively separable from the first; connecting means disposed between the first and second reservoir means providing fluid communication therebetween and alternately accommodating pressure differential and pressure equalization between the first and second reservoir means; and sealing means associated with the connecting means which, in a first position accommodates fluid communication between the first and second .
reservoir means and.in a second position seals the second reservoir from the first said sealing means moving from the first to the second position for automatically sealing the second reservoir means upon removal of the connecting means.
According to another aspect of the present invention, a method is provided of isolating a fluid in a suction collection system having an evacuated rigid exterior cannister, two : separable reservoirs contained therein and fluid communication means between the reservoirs, the method comprisinq the stePs of:
evacuating the first and second reservoirs with a single vacuum source; transferring a fluid from a remote location for accumulation in the first reservoir; intermittently creating a pressure differential between the first and second reservoir by altering the magnitude of the vacuum in the first reservoir ~ ~ 3 so as to facilitate flow of the fluid from the first reservoir to the second; and removing the separable reservoirs from the cannister, separating the second reservoir from the first and sealing the second reservoir so as to isolate the fluid therein.
Okher obj~cts and features of the present invention will become more fully apparent from the following description and appended claims taken in conjunction with the accompanying drawin~s.
Figure 1 is a cross-sectional view of a presently preferred embodiment of the invention particularly showing the internal structure while fluid is being drawn into the unit;
Figure 2 is a cross-sectional view of a presently preferred embodiment of the invention particularly showing the internal structure while fluid is being pumped into the blood reservoir;
Figure 3 is a perspective illustration of one preferred embodiment of the automatic sealing plug;
Figure 4 is a perspective illustration of a second preferred embodiment of an automatic sealing plug; .
Figure 5 is a schematic cross-sectional view of the embodi-ment of Figures 1 and 2 as the dual reservoir assembly is in theprocess of separation;
Figure 6 is a perspective illustration of the separated blood reservoir as it is used to reinfuse blood into a patient;
Figure 7 is a fragmentary perspective illustration of another preferred embodiment of the dual chamber reservoir particularly illustrating the use of a separable heat seal strip to unite the two chambers.
A preferred embodiment of the invention is set forth in the drawings. In the embodiment illustrated in Figure 1, a cannister - 3~ -~o.36~
20 is utilized. The cannister 20 may be made of relatively rigid essentially transparent plas~ic material and is open at the top but closed at the bottom. The cannister does not become con-taminated by fluids which may be highly infectious or even con-tagious, and so may be repeatedly used without sterilization each time. The cannister 20 is conveniently cylindrical, although its shape is not critical and has a port 22 in the side wall and a nipple 24 which is secured within the port 22 in the cannister wall.
A cover 26 has a circumferential depending flange 28 that engages the open end of the cannister 20 in order to provide an air-tight seal. The cover 26 is formed from a rigid plastic material similar to that of the cannister 20. Two fluid communi-cation nipples 30 and 32 pass through the cover 26 in order to couple with a vacuum system (nipple 30) and a suction wand (nipple 32) respectively. A collecting reservoir 34 is suspended from and sealed to the cover 26. Therefore, the cover 26 serves as one end of the collecting reservoir 34, and the nipples 30 and 32 are in fluid communication with the inside of the reservoir 34.
A filter 36 is also suspended from the cover 26 and is placed between the nipple 32 and the remainder of the reservoir in order to filter the fluid which enters the chamber through nipple 32. The filter may be composed of a wide variety of materials. A fine weave nylon net material in the form of a bag having one closed end has been found desirable in the practice of the invention. It has also been found desirable to attach only a portion of the open end of the filter bag 36 to the cover 26 leaving segment 37 of the nylon filter separated from the cover 26. The air passageway thus created provides a vent which allows air mixed with the entering fluid to escape while passing the entering fluid through the filter. The end 38 of the collection 1036~
reservoir 34 contains an aperture 40 which is fitted with a short length of plastic tubing 42. The plastic tube 42 is integral with the reservoir 34.
A blood reservoir 44 occupies the lower part of the cannister 20 and is made from the same flexible plastic material as the collection reservoir 34. The blood reservoir 44 has an inter-nally projecting sleeve 46 which tightly receives the extending tube 42 from the collection reservoir 34 in telescopic relation.
Tube 42 normally projects somewhat beyond the end of the sleeve 46.
In the embodiment of Figures 1 and 2, a orce distribution extractor 45 is interposed along the length of tube 42 and between the reservoirs 34 and 44. The extractor is used to exert force on the blood reservoir 44 when it is desirable to separate the two reservoirs.
The tube 42 may be provided with one or more apertures 48 at a point slightly above the open end of the tube 42 (see Figure 4). An automatic sealing plug 50 i8 inserted in the open end of the tube 42 within the confines of the blood reservoir 44.
Figure 4 presents a more detailed view of the automatic sealing plug 50. The plug 50 is formed in a three-tier cylin-drical configuration. The smallest cylindrical segment 52 is of a diameter that will rictionally engage the inside diameter of the tube 42. The next largest segment 54 of the plug 50 is the same diameter as the outside of the tube 42 and therefore is capable of being snugly telescopically mated within the sleeve 46 of the blood reservoir 44. The largest cylindrical tier 56 of the plug 50 may be of any convenient size or shape and need only be slightly larger than the second tier 54 so as to prevent the plug 50 from being drawn through the sleeve 46 when the reser-voirs 34 and 44 are separated.
It should be observed that when the plug 50, as shown in .j -103~
Figure 4, is inserted in the end of the tube 42, fluid communi-cation between the collection reservoir 34 and the blood reser-voir 44 is maintained through the apertures 48 in the sides of the tube 42.
A second embodiment of the automatic sealing plug 51 is shown in Figure 3. The principal difference in construction between the automatic sealing plug of Figure 3 and that of Figure 4 is that the tube insertion ends 58 (Figure 3) are generally flat rigid extensions from the intermediate cylindrical portion 62. A flange 60 is formed on each side of the flat extension 58 spaced somewhat above the juncture between the extension 58 and the intermediate diameter cylinder 62. The flange 60 does not extend diametrally beyond the width of the intermediate cylinder 62.
Use of the plug 51 shown in Figure 3 permits elimination of the apertures 48 in the sides of the tube 42. The extension 58 is inserted into the tube 42. The flange 60 prevents the tube 42 from abutting cylinder 62. Accordingly, a pathway for fluid communication between the collection reservoir 34 and the bLood reservoir 44 is provided through the tube 42, along the flat sides of extension 58, and into chamber 44 through the space maintained by the flange 60.
The extension 58 presen~s, at its free end, opposed out-wardly directed projections 59 which engage the interior surface of the tube 42. Accordingly, when the tube 42 is drawn through the corresponding sleeve 46, projections 59 will maintain the plug 51 within tube 42 until forced out of tube 42 by the leading edge 47 of sleeve 46.
The blood reservoir 44 is also provided with an infusion withdrawal tube 64 (see Figure 6~. The infusion tube 64 is mounted upon the blood reservoir 44 but the reservoir end of the tube 64 is normally sealed to prevent fluid communication with the reservoir.
As shown in Figure 6, the tube 64 is designed to friction-ally accept and retain the infusion set 66. The spike 70 of the infusion set punctures the reservoir surface at the end of the infusion withdrawal tube 64. A sterile cap 72 (see Figure 5) is fitted over the exterior end of the infusion tube in order to preserve the sterile nature of the tube 64 until it is used for infusion of blood into the patient. A bail 73 of flexible plastic material is attached diametrally across the bottom of the blood reservoir 44. The bail 73 serves the dual function of a handle to be used in separating the two reservoirs and as a hanger for suspending the reservoir 44 in the inverted position for redelivery of blood to the patient.
In the embodiment shown in Figure 5, the blood reservoir 44 ic physically attached to the collection reservoir 34 only through the interconnecting tube 42. Alternatively, in order to aid in the assembly and disassembly of the suction collection unit, and to prevent inadvertent disconnection of the two reser-voirs, a connecting seam 74 formed by heat seal (see Figure 7)may be made along the periphery of the adjoining ends of the two reservoirs. A separation tab 76 is also preferably sealed to the - blood reservoir 34. The sealing of the units together may be readily accomplished through any suitable conventional technique accommodating separation of the reservoirs 34 and 44 without adversely affecting the integrity of the reservoir.
It can be recognized, with further reference to Figure 7, that the tab 76 may be used to separate the reservoirs 34 and 44 after the blood reservoir 44 is filled with blood and ready to be used as the infusion supply container. Although the two reser-voirs may be physically attached as shown in Figure 7, the fluid connection and automatic sealing plug remains the same as that ~ 036884 shown in Figures 1, 2 and 5. Generally, however, the force dis-tribution extractor 45 is not used when the two reservoirs are sealed together.
In the contemplated use as a blood suction collection device, a vacuum line 80 is attached to nipples 24 and 30 (see Figure 1).
The vacuum at nipple 24 causes a partial vacuum in the space between the cannister 20 and the reservoirs 34 and 44. The vacuum at nipple 30 causes a continuous flow of air through nipple 30 from the interior of the collection reservoir 34. An appropriate safety valve (not shown) may be used between the vacuum supply conduit 80 and any permanently installed vacuum system which might exist in a hospital in order to prevent the possibility of entrance of fluid from the nipple 30 into the permanent vacuum system.
The nipple 32 is connected through an appropriate conduit 82 to an open end suction collection wand (not shown) which can be selectively positioned in any area from which blood or other fluid is to be collected.
Upon completion of the assembly of the invention as pre-viously described, it may then be used to collect and retainblood or other fluid. Figures 1 and 2 particularly illustrate a preferred embodiment of the invention in two primary positions while it is being used as a suction collection system. Figure 1 illustrates the invention during the time when the suction wand (not shown) connected to tube 82 is immersed in the fluid to be collected. A vacuum is produced in the collection chamber 34 and fluid is drawn into the chamber through tube 82 as indicated by the arrow 84. During the time when the tube 82 is filled with fluid, the air space in the chamber 34 is substantially evacu-ated. Accordingly, air is also drawn from the lower chamber 44as the pressure equalizes between the two chambers. During the course of fluid intake, fluid 86 accumulates within the collection chamber 34 as shown in Figure 1 and does not immediately flow into the lower blood reservoir 44.
When the suction wand, and therefore tube 82, begins to aspirate air rather than fluid (see Figure 2), there is a sudden decrease in vacuum (or increase in pressure) within the chamber 34. Accordingly, the pressure in the blood reservoir 44 is measurably lower than the pressure in the collection reservoir 34. The pressure differential between the two reservoirs causes the fluid 86 to flow into the lower blood reservoir 44 as shown by directional arrows 85.
As illustrated in Figures 1 and 2, a slight change in shape of the interface between the two reservoirs occurs as a result of the pressure differential. Of course, the pressure differential "pumping" action between the chambers would still take place even with rigid chambers and the change in shape shown in the figures is only a result of the effect of the differential pressure upon the flexible chamber walls.
It should be observed that by transferring the blood from reservoir 34 to reservoir 44, a major problem associated with blood collection devices is avoided. It has been discovered that strong air turbulence, such as that which exists within suction collection devices, causes dangerous hemolysis and may cause clotting of blood even though the blood has been previously heparinized. The transfer of blood to the relatively quiescent and turbulence-free blood reservoir 44 therefore minimizes hemolysis due to turbulence of the blood and reduces the like-lihood of harmful clot formation.
After the blood reservoir 44 has been completely filled with blood according to the previously described method, the two reservoirs along with the cover 26 may be removed from the cannister 20 as shown in Figure 5. Separation of the two reser-voirs is now possible. The extractor 45, interposed between the _ g _ 1036~4 reservoirs, serves as a handle to apply force to the reservoir 44 while the cover 26 is used to apply an opposing force to reser-voir 34.
With continued reference to Figure 5, it can be observed that as the tube 42 is withdrawn through the sleeve 46 in the top of the reservoir 44, the plug 50 or 51 will engage the leading edge 47 of the sleeve 46 causing the plug 50 or 51 to seat within the sleeve 46. Therefore, when the tube 42 has been completely disengaged, the reservoir 44 becomes a completely sealed vessel.
Of course, if the heat sealed embodiment shown in Figure 7 were used, it would be necessary to first break the connecting seam prior to withdrawing the tube 42 through the sleeve 46, but the operation of the plug 50 in sealing the reservoir 44 would be the same as previously described.
The sealed reservoir 44 (Figure 6) may be inverted for use as an infusion supply reservoir for reinfusion of blood into the patient. As previously described, an infusion set 66 having a spike 70 may be used to pierce the closed end of the blood supply tube 64 and to complete fluid communication between the suspended reservoir 44 and the delivery tube 68.
It should be recognized that although the invention has been described with reference to use in collecting blood, it is con-templated that the invention could be used for many other fluids involved in suction collection applications. An important aspect of the invention is the capability of preserving the quality of an aspirated fluid. The use of the lower reservoir as shown in Figure 6 has been described with reference to reinfusion.
However, it is completely possible for the chamber 44 to be used in a similar manner for purposes of sampling and testing the fluid within the reservoir.
The invention may be embodied in other specific forms without departing from its spirit or essential characteristics.

~ 036BB4 The described embodiments are to be considered in all respects only as illustrative and not restrictive and the scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

The embodiments of the invention in which exclusive property or privilege is claimed are defined as follows:

1. A suction collection system comprising:
first reservoir means and means for evacuating the first reservoir means;
means for transferring a fluid to the first reservoir means;
second reservoir means selectively separable from the first;
connecting means disposed between the first and second reservoir means providing fluid communication therebetween and alternately accommodating pressure differential and pressure equalization between the first and second reservoir means; and sealing means associated with the connecting means which, in a first position accommodates fluid communication between the first and second reservoir means and in a second position seals the second reservoir from the first said sealing means moving from the first to the second position for automatically sealing the second reservoir means upon removal of the con-necting means.

2. A suction collection system including an exterior cannister and means for maintaining a negative pressure there-in, a first collection reservoir, means for evacuating the reservoir and means for aspirating fluid at a remote location and means for transferring the fluid to the first collection reservoir, the improvement comprising:
a second reservoir confined within the cannister, the second reservoir comprising an aperture;
a fluid communicating conduit, telescopically uniting the second reservoir with the first; and means associated with the fluid communicating conduit normally accommodating fluid transfer to the second reservoir and sealing the aperture concomitant with the separation of the conduit.

3. A suction collection system as defined in claim 2 further comprising a fluid filter through which fluid entering the first collection reservoir passes, the fluid filter being provided with an air passageway for accommodating free flow of air between the transferring means and the interior of the first collection reservoir.

4. A suction collection system as defined in claim 2 wherein said fluid communication conduit is essentially cen-trally located on the underside of the first collection reser-voir and projects through a cylindrical sleeve integral with the second reservoir and aligned with the aperture, the fluid communicating conduit defining a fluid passageway having less fluid-transmitting capacity than the transferring means.

5. A suction collection system as defined in claim 2 wherein said sealing means comprises a plug initially mounted within the fluid communicating conduit so as to permit fluid communication between the first and second reservoirs, the plug comprising a diametrally enlarged portion which seats within the aperture of the second reservoir when the fluid communica-ting conduit is withdrawn therefrom.

6. A suction collection system as defined in claim 5 wherein said plug comprises a generally solid cylindrical body having a substantially flat face and a flat forwardly directed projection and spacers secured to the flat face for supporting one end of the fluid communicating conduit away from the flat face to permit fluid flow between the plug and the fluid com-municating conduit, the forward projection comprising secure-ment means for mounting the plug within the fluid communicating conduit.

7. A suction collection system as defined in claim 2 further comprising an essentially flat extractor circumscribing the fluid communicating conduit to facilitate separation thereof from the second reservoir.

8. A suction collection system as defined in claim 2 wherein said second reservoir comprises a bail integral with the bottom of the reservoir to accommodate suspension of the second reservoir in an inverted orientation for fluid delivery.

9. A suction collection system as defined in claim 2 wherein said second reservoir comprises an initially sealed delivery port capable of penetration by conventional infusion sets for delivering the contents of the second reservoir even when the sealing means is in place in the aperture.

10. A suction collection system as defined in claim 2 further comprising a peripheral seam joining the first and second reservoirs around the exterior circumference thereof, the seam comprising heat sealed plastic material and means for selectively breaking the heat seal and opening the seam to accommodate separation of the first and second reservoirs.

11. A method of isolating a fluid in a suction collection system having an evacuated rigid exterior cannister, two separable reservoirs contained therein and fluid communication means between the reservoirs, comprising steps of:
evacuating the first and second reservoirs with a single vacuum source;
transferring a fluid from a remote location for accu-mulation in the first reservoir;
intermittently creating a pressure differential between the first and second reservoir by altering the magnitude of the vacuum in the first reservoir so as to facilitate flow of the fluid from the first reservoir to the second; and removing the separable reservoirs from the cannister, separating the second reservoir from the first and seal-ing the second reservoir so as to isolate the fluid therein.

12. A method as defined in claim 11 wherein said pressure creating step comprises aspirating fluid into the first reser-voir and simultaneously drawing air from the second reservoir into the first, and thereafter aspirating air into the first reservoir thereby increasing the pressure therein to force the fluid into the second reservoir.

13. A method as defined in claim 11 further comprising minimizing air turbulence in the fluid by isolating fluid in the second reservoir from direct contact with air forced in a stream to the interior of the first reservoir.

14. A suction collection system comprising:
a generally rigid cannister having a separable lid;
a first reservoir connected to the lid and commun-icable therethrough with a fluid inlet port;
a second reservoir normally carried within the rigid cannister, the second reservoir being connected to the cannister only by temporary attachment to the first reser-voir, said temporary attachment comprising a fluid port communicating the interiors of the first and second reservoirs; and means accommodating separation of the first and second reservoirs so that fluid within the second reser-voir is intact upon exertion of opposed forces at the temporary attachment site.