HK1027048A - Blood evacuating system and method of use thereof - Google Patents

Description

Blood drawing device and method of use

The present invention relates generally to an apparatus and method for collecting and returning fluid to a patient, and more particularly to a blood drawing device suitable for autotransfusion. More particularly, the present invention is directed to a blood drawing device that allows a disposable inner drawing bag to be separated from an outer container for reinfusion so that another drawing bag can be inserted into the container for continued blood drawing.

Blood drawing devices are commonly used in autotransfusion to draw and collect autologous blood from the collection chamber of a chest drainage device. Autotransfusion refers to the transfusion of the patient's own blood called autologous blood. Autotransfusion is the best method for transfusion, because the transported blood is the patient's own blood, thus eliminating the problems of blood group incompatibility and blood-borne diseases such as hepatitis, AIDS, etc. Moreover, autologous blood is fresher than stored blood provided by a donor and contains the patient's own antibodies.

One type of autotransfusion, known as "post-operative", is the post-operative return of the patient's own blood draw, which is collected and returned to the patient. Postoperative autotransfusion has limitations in use due to strict regulations on the type of blood that can be returned. Currently, the only postoperative blood considered suitable for autotransfusion is mediastinal blood, i.e., blood from an anatomical cavity or chamber in the chest.

Currently, chest drainage devices are commonly used in post-operative care of patients undergoing surgery in the chest. The chest drainage device uses a tube attached to the chest of the patient to drain fluid and air from the chest, which tube drains fluid and air into a collection chamber in the chest drainage device. The chest drainage device is connected to a vacuum source which causes the tubes to draw in and draw liquid and air collected from the chest chamber into the collection chamber. Once collected, the blood may be withdrawn from the collection chamber using an autologous blood transfer pump or blood bag.

The use of blood drawing bags in autotransfusion is a well-known technique. For example, U.S. patent No.5,380,314 to Herweck et al discloses a blood collection bag having an internal spring that biases the bag into a fixed shape prior to use and simultaneously creates a negative pressure therein to manually draw blood from a collection chamber of a chest drainage device. One disadvantage of the device of the above patent No.5,380,314, however, is that a gravity device must be used for the return, wherein the bag is suspended near the patient and gravity can drain the collected blood from the bag back into the patient. Unfortunately, the device of the above-mentioned patent cannot be properly drained unless the user takes additional steps to flow ambient air into the blood collection bag prior to infusion back. This flow step must be performed to force the blood collected in the rigid blood collection bag out, otherwise gravity alone will not be sufficient to force the blood out of the bag during the return process.

Another example of a blood drawing device is known from U.S. Pat. No.5,201,703 to Gentelia et al, which discloses a device for collecting blood from a chest drainage device and returning the blood to a patient. The above patent No.5,201,703 is directed to a self-contained, fully disposable device comprising a rigid outer container containing an integral flexible bag for use with a chest drainage device. A negative pressure is applied or maintained between the rigid container and the inner flexible bag so that blood stored in the collection chamber can be drawn into the bag. As the drawn blood passes through the tube connecting the device of patent No.5,201,703 with the chest drainage device, the blood begins to fill the flexible inner bag. Once the bag is filled with the desired amount of blood, the entire apparatus, including the outer rigid container and the inner bag filled with blood, is removed from the chest drainage device and hung by a suitable hanging device near the patient for the purpose of recovering the collected blood.

One disadvantage of the No.5,201,703 device, however, is that the entire device must be used during the return process. In particular, both the outer rigid container and the inner flexible bag are utilized during the infusion process because the device is of a unitary design in which the inner flexible bag cannot be separated from the outer rigid container. As a result, the entire apparatus-a container and an extraction bag-must be replaced in order to continue autotransfusion to the same patient. Accordingly, it is too costly for the user to replace the entire apparatus after each transfusion.

Another disadvantage of No.5,201,703 is that the conventional method of obtaining a quick return using the blood drawing device described above is sometimes not possible. Existing blood evacuation bags that are fixedly attached to an external container or made of an integral rigid container design are not suitable for use in rapid infusion techniques. For example, it is well known in the art to create a rapid infusion back around a pressure jacket of a flexible blood bag by applying pressure to a vesicle around the pressure jacket of the container. However, if the extraction container is of a rigid design, the pressure jacket surrounding the container cannot exert sufficient pressure to depress the inner flexible bag and create a high speed feedback. Because of these cost and performance disadvantages, it is desirable to have only the inner flexible bag in a blood drawing device for infusing blood back while the rigid outer container remains connected to a vacuum source for further blood collection from the chest drainage device.

Accordingly, it is desirable that the inner flexible bag in the blood drawing device be separable from the outer rigid container prior to infusion so that another flexible bag can be used in the same container for further collection of blood from the collection chamber. Therefore, there is a need for a blood drawing device that provides a cost effective means of returning blood to a patient using multiple removable blood drawing bags to continue drawing blood while returning it.

It is a primary object of the present invention to provide a cost effective device for returning blood to a patient.

It is another object of the present invention to provide an effective method for returning autologous blood to a patient.

It is a further object of the present invention to provide a blood bag set including an inner flexible bag which is separable from its outer container during the infusion process.

It is a further object of the present invention to provide a removable extraction package adapted to contain a pressure sleeve for producing high speed infusions.

These and other objects of the present invention are achieved in a presently preferred embodiment thereof, described by way of example and not of limitation, the present invention is directed to an apparatus and a method for drawing and returning blood to a patient using a blood drawing device that includes a detachable inner flexible bag in an outer rigid container for returning drawn blood drawn from a collection chamber of a chest drainage device. The outer rigid container includes a suction port connected to a vacuum source for applying negative pressure in the interstitial cavity between the rigid container and the inner flexible bag. The negative pressure maintained in the interstitial cavity of the container draws blood in the collection chamber of the chest drainage device into the bag through the tube that maintains fluid communication between the bag and the collection chamber. After the blood bag is filled to a predetermined amount, the inner flexible bag is removed from the outer rigid container and hung near the patient to return the collected blood.

FIG. 1 is a simplified block diagram illustrating a blood drawing device according to the present invention;

FIG. 2 is a perspective view of the rigid outer container and transfer tube of the present invention;

FIG. 3 is a partial cross-sectional view of the rigid outer container showing the blood collection bag of the present invention; while

Fig. 4 is a perspective view of the blood bag of the present invention.

Referring to fig. 1, a simplified block diagram of an autotransfusion device 11 is shown in which the components of the device 11 are shown. The autotransfusion device 11 includes a patient 10 in fluid communication with a drainage device 12, using the transfer tube 24 to maintain fluid flow therebetween in the A direction. The autotransfusion device 11 also includes a blood drawing device 14 of the present invention in fluid communication with the drainage device 12 using the same type of transfer tube 24 used between the patient 10 and the device 12. Preferably, the transfer tube 24 is made of a flexible plastic material, although any flexible material suitable for transporting liquids such as blood falls within the scope of the present invention.

Referring to fig. 2 and 3, the blood drawing device 14 of the present invention is shown. The blood drawing device 14 includes a rigid container 16 in which a flexible blood drawing bag 38 is disposed. Preferably, the container 16 has a substantially circular shape, although any shape of container suitable for storing liquids is within the scope of the present invention. The container 16 includes a lid 18 attached to the container housing 21 by a hinge 34, the lid 18 being free to rotate about the hinge 34 when the container 16 is opened and closed. The container 16 also includes a labeling area 20 on the outer surface. Preferably, the labeling area 20 comprises a surface area that indicates to the user how the blood drawing device 14 is to be used. The lid 18 of the container 16 has a dome shape with a suction port 32 communicating with an interior chamber 46 within the container 16, the lid 18 further including a channel 22 along the periphery of the lid 18 and a spike cover aperture 28 formed in the middle of the lid 18 for storing a spike cover (not shown) therein. The channel 22 provides an opening through which the delivery tube 24 attached to the bag 38 can be inserted and attached to the bag 38 to create a fluid flow communication with the collection chamber of the drainage device 12. Although channel 22 does not maintain a seal within container 16, sufficient negative pressure can be maintained in interstitial space 50 between container 16 and bag 2, 8 to create sufficient negative pressure within bag 2, 8 to draw blood into bag 38.

A blood collection bag 38 disposed in the container 16 has a plurality of ports located at the top of the bag 38. One of the return ports 42 is closed and capped by a cap 52 and provides a location for draining collected blood from the blood evacuation bag 38 after the bag 38 is separated from the container 16 during the return process. Another collection port 40 is connected to the delivery tube 24 leading from the drainage device 12 for drawing blood therefrom.

Referring to fig. 4, the blood collection bag 38 is illustrated in detail. The blood evacuation bag 38 includes an expandable lumen 46 for drawing the evacuated blood from the drainage device 12. As the drained blood collects in the lumen 46 of the blood evacuation bag 38, the lumen 46 expands until the bag 38 is filled to a desired amount. The hole 44 in the bottom of the blood evacuation bag 38 below the internal cavity 46 acts as a suspension point for the bag 38 during the infusion process. A clip 30 is also provided to prevent fluid flow through the delivery tube 24 when the user wishes to stop blood flow into the blood collection bag 38 and to prevent fluid flow from the bag 38 prior to reinfusion. Preferably, the blood bag 38 of the present invention may be made of any colorless, flexible plastic material, but any material suitable for collecting and returning a liquid, such as blood, is within the scope of the present invention.

When fluid communication is established between the blood evacuation bag 38 and the drainage device 12, the user engages a spike holder (not shown) from the collection chamber of the drainage device 12 with a blood spike 26. The blood spike 26 is attached to a spike holder (not shown) attached to the distal end of the delivery tube 24 leading from the blood collection bag 38. The dust cap 56 that covers the blood spike 26 during post-manufacture storage and transport is removed prior to attachment to the spike holder. Once the user attaches the blood spike 26 to the spike holder, a vacuum source is applied to the suction port 32. When a vacuum is applied to the interior of the container 16, a negative pressure is created in the interstitial space between the interior surface of the container 16 and the exterior surface of the blood evacuation bag 38 within the container 16. As the pressure is reduced, blood collected in the drainage device 12 flows through the delivery tube 24 and into the lumen 46 of the blood bag 38.

Once the blood bag 38 is filled to the desired amount, blood return may be performed. The infusion step is initiated by the user clamping the clip 30 to the transfer tube 24 and turning off the vacuum source of the container 16, thereby preventing fluid from flowing out of the drainage device 12. After clamping the transfer tube 24, the blood spike 26 is removed from the spike holder and properly enclosed with a spike cover (not shown) stored in the bore 28 of the container 16 to protect the contaminated tip 31 of the spike 26 after use. After enclosing the blood spike 26, the lid 18 is opened and the blood bag 38 is removed from the container 16 and suspended adjacent the patient using a suitable suspension device, such as an IV pole. After hanging, the user establishes fluid communication between the patient and the blood drawing bag 38 by removing the cover 48 from the infusion back port 42 and attaching the delivery tube 24 between the patient and the port 42.

The feedback can be formed in a number of ways. The blood evacuation bag 38 is preferably suspended above the patient such that gravity alone can drain the evacuated blood from the bag 38 to allow the blood to flow into the patient 10 through the delivery tube 24. A modified method of infusion is to apply a pressure cuff around the blood bag 38 while the bag 38 is suspended. When the user applies pressure through a bladder of the pressure jacket, blood in the blood bag 38 is expressed and a high rate of return is created due to the increased pressure. Preferably, a hanging means 19 is provided on the outer surface of the container housing 21 and the hanging means 19 comprises a hook integrally formed on the top for hanging the blood drawing device 14. Alternatively, a "VELCRO" (VELCRO) support and corresponding "VELCRO" ring may be provided on the bottom of the container housing 21 for suspending the blood bag 38 from a suitable suspension device.

When an infusion is made, the user may continue to draw blood from the drainage device 12 by inserting another blood drawing bag 38 into the container 16 and reestablishing fluid communication between the bag 38 and the drainage device 12 as described above. Thus, a "batch" autotransfusion can be performed by simply replacing the blood drawing bag 38 in the container 16 each time the bag 38 is removed for export.

From the foregoing it will be appreciated that, although specific embodiments of the invention have been shown and described, various modifications may be made without departing from the spirit and scope of the invention. Accordingly, the invention is not limited by this description, but instead the scope of the invention is defined only by the claims.

Claims (24)

1. An extraction device (14) for collecting fluids from a drainage device (12) and returning the fluids to a patient, comprising:

a container (16), said container (16) including an open top and a lid (18) for sealing said open top of said container (16), said lid (18) including a port (32) on the top thereof, said port (32) adapted to be connected to a source of negative pressure for applying and maintaining a negative pressure in said container (16) to draw liquid into said container (16), and,

a flexible bag (38) disposable in the container (16) and separable from the container (16), the flexible bag (38) having a plurality of openings (42, 40, 54), one of the plurality of openings (40) in fluid communication with a drainage device (12) for withdrawing fluid from the drainage device (12) and collecting fluid in the flexible bag (38) when the vacuum source is applied, another of the openings (42) adapted to return the collected fluid to the patient,

the method is characterized in that: the flexible bag (38) can be withdrawn from the container (16) for returning the liquid to the patient.

2. The extraction device (14) according to claim 1, wherein the negative pressure is applied to a interstitial space between an inner surface of the container (16) and an outer surface of the flexible bag (38), the negative pressure causing liquid to be drawn from the drainage device (12) and into the flexible bag (38).

3. The extraction device (14) according to claim 1 wherein one of said openings (40, 42, 54) is adapted to act as a gravity drain during the infusion back process to drain fluid from said flexible bag (38).

4. The extraction device (14) according to claim 4, wherein the port (32) is formed in the lid (18), the port (32) communicating with the interior of the container (16).

5. The extraction device (14) according to claim 4, wherein the lid (18) is hingeable about the container (16).

6. The extraction device (14) according to claim 1 wherein said fluid communication between said drainage device (12) and one of said plurality of openings (40, 42, 54) is maintained by a tube (29) connected therebetween.

7. A method of returning fluid to a patient (10), the method comprising the steps of:

a) establishing fluid communication between a receptacle (38) contained in a container (16) and a source of fluid, collecting said fluid into said receptacle (38) to a predetermined amount;

b) closing the liquid communication between the receptacle (38) and the liquid source after a predetermined amount of liquid has been collected in the receptacle (38);

c) disconnecting the receptacle (38) from the liquid source and opening a lid (18) of the container (16);

d) -removing the receptacle (38) from the container (16) and hanging the receptacle (38) near the patient (10); and

e) establishing fluid communication between the patient (10) and the receptacle (38) and returning the fluid to the patient (10).

8. The method of claim 7, wherein the step of establishing fluid communication between the receptacle (38) and the source of fluid further comprises applying a vacuum source in the lumen (46) to separate the receptacle (38) from the container (16).

9. The method of claim 7, wherein the step of establishing fluid communication between the receptacle (38) and the source of fluid further comprises connecting a tube (24) connected to the receptacle (38) to a tube (24) connected to the source of fluid.

10. The method of claim 7, wherein the step of separating the receptacle (38) from the source of liquid further comprises closing a free end of a tube (24) attached to the receptacle (38) after separation.

11. The method of claim 10, wherein the step of closing the free end of the tube (24) attached to the receptacle (38) further comprises enclosing a spike (26) attached to the free end of the tube (24) attached to the receptacle (38).

12. The method of claim 7, wherein said separating step further comprises separating a spike (26) attached to a free end of a tube (24) connected to said receptacle (38) from a seat attached to a free end of a tube (24) connected to said source of liquid.

13. The method of claim 7, wherein said separating step further comprises separating a spike (26) attached to a free end of a tube (24) connected to said source of liquid from a seat attached to a free end of a tube (24) connected to said receptacle (38).

14. The method of claim 7, wherein said step of establishing fluid communication between the patient (10) and said receptacle (38) further comprises connecting a free end of a tube (24) attached to said receptacle (38) to a free end of a tube (38) attached to the patient (10).

15. The method of claim 14, wherein said step of establishing fluid communication further comprises applying a pressure device about said receptacle (38) to force fluid out of said receptacle (38) and into the patient (10) during the return.

16. A method of returning fluid to a patient (10), the method comprising the steps of:

a) establishing fluid communication between a first reservoir (38) contained in a container (16) and a source of fluid, collecting said fluid into said first reservoir (38) to a predetermined volume;

b) closing the liquid communication between the first receptacle (38) and the liquid source after a predetermined amount of liquid has been collected in the first receptacle (38);

c) disconnecting the first receptacle (38) from the liquid source and opening a lid (18) of the container (16);

d) -removing the first receptacle (38) from the container (16) and hanging the first receptacle (38) near the patient (10); and

e) establishing fluid communication between the patient (10) and the first receptacle (38) and returning the fluid to the patient (10);

f) inserting a second receptacle (38) into the container (16) and closing the lid (18);

g) establishing fluid communication between the second reservoir (38) and the source of fluid, collecting the fluid into the second reservoir (38) to a predetermined amount;

h) repeating said steps (a) - (g) when multiple reservoirs (38) are required to deliver fluid back into the patient (10).

17. The method of claim 16, wherein the step of establishing fluid communication between the desired plurality of receptacles (38) and the source of fluid further comprises applying a vacuum source in the interior chamber (46) to separate the desired plurality of receptacles (38) from the container (16).

18. The method of claim 16, wherein the step of establishing fluid communication between the desired plurality of receptacles (38) and the source of fluid further comprises connecting a tube (24) connected to the desired plurality of receptacles (38) to a tube (24) connected to the source of fluid.

19. The method of claim 16, wherein the step of separating the plurality of desired receptacles (38) from the liquid source further comprises closing a free end of a tube (24) connected to the plurality of desired receptacles (38) after separation.

20. The method of claim 19, wherein the step of closing the free end of the tube (24) associated with each of the plurality of desired receptacles (38) further comprises enclosing a spike (26) associated with the free end of the tube (24) associated with each of the desired plurality of receptacles (38).

21. The method of claim 16, wherein said separating step further comprises separating a spike (26) connected to a free end of a tube (24) connected to said plurality of desired receptacles (38) from a seat connected to a free end of a tube (24) connected to said source of liquid.

22. The method of claim 16, wherein said separating step further comprises separating a spike (26) connected to a free end of a tube (24) connected to said source of liquid from a seat connected to a free end of a tube (24) connected to said plurality of desired receptacles (38).

23. The method of claim 16, wherein said step of establishing fluid communication between the patient (10) and said plurality of desired receptacles (38) further comprises connecting a free end of a tube (24) connected to said plurality of desired receptacles (38) to a free end of a tube (24) connected to the patient (10).

24. The method of claim 14, wherein said step of establishing fluid communication further comprises applying a pressure device about the outside of said plurality of desired receptacles (38) to force fluid out of said plurality of desired receptacles (38) and into the patient during the procedure.