HK1135051B - Adaptable perioperative cell-salvage system and methods and disposable units for same - Google Patents

Description

Self-adaptive perioperative cell recovery system and method and disposable unit thereof

This patent application claims priority from the following provisional united states patent applications:

application No. 60/864,905, filed on 8.11.2006 entitled "adaptive perioperative cell recovery system and method and disposable unit therefor," attorney docket No. 1611/a46, and inventor's name Alec d.

Technical Field

The present invention relates to blood processing systems, and more particularly to those systems that process blood collected during or after surgery, as well as to disposable units for use in such systems and methods of using such systems.

Background

Prior art systems for reinfusion of blood from surgical sites and wound drains often utilize disposable units that include a reservoir for collecting blood-containing fluid and a separation device (e.g., centrifuge bowl or tray) for separating and flushing Red Blood Cells (RBCs). RBCs recovered using these systems can be automatically transfused back into the patient, thereby reducing the need for heterologous blood transfusions. Examples of such blood recovery systems include those described in the following patents: lamphere et al, U.S. patent No.6,251,291, published 26.6.2001, and Bobroff et al, U.S. patent application publication No.2005/0203469, published 15.9.2005. Both of these patents and published applications are incorporated herein by reference. Commercial examples of such systems include OrthoPATSurgical blood recovery system and CardioPATSurgical blood recovery systems, both sold by Haemonetics, inc.

Fig. 1 shows a disposable set 20 that can be used in a prior art cell recovery system used during surgery. The kit 20 includes a centrifuge disk 35 connected to an inlet tube 18 and an outlet tube 38. The inlet tube 18 is connected to a reservoir 22 for collecting blood and other fluids from the surgical site. The inlet tube 18 forms a permanent connection between the reservoir 22 and the centrifuge disk 35. The reservoir may be of the type described in the above-referenced U.S. patent No.6,251,291. The reservoir 22 includes a port line 11 through which blood and other fluids are collected from the surgical site and a vacuum inlet port 14 through which a partial vacuum is provided to the reservoir for drawing blood and other fluids through the port line. The inlet tube 18 is also connected to a saline air removal filter 53 and a saline spike 52 which may be connected to a source of saline which may be used during flushing of RBCs in the centrifuge disk 35. The outlet tube 38 is connected to an RBC bag 59 and a waste bag 58.

Blood and other fluids are aspirated from the surgical site and into reservoir 22. This fluid is drawn from the reservoir 22 into the centrifuge disk 35, which then rotates to separate the RBCs from the plasma and other fluids. Plasma and other fluids may be directed to the waste bag 58. The RBCs can then be rinsed in the centrifuge disk 35 with saline from a saline source. After flushing, saline may be separated from the RBCs and directed to a waste bag 58, and the flushed RBCs directed to an RBC bag 59. RBCs can then be reinfused into the patient.

The amount of blood collected in the reservoir is often insufficient to perform the separation and wash procedure. In such a case, since the reservoir and separation chamber are permanently connected by the tube 18, the entire disposable set 20 must be discarded after the procedure, even if the centrifuge disk 35, RBC bag 59, and waste bag 58 are not used. Discarding the entire disposable set even if the separation chamber is not used is wasteful and adds unnecessary expense to the surgical procedure that ultimately does not result in flushing and reinfusing blood into the patient.

Disclosure of Invention

In various embodiments of the present invention, an adaptive system is provided such that certain disposable components of the system do not need to be discarded when they are not being used.

In one embodiment of the invention, a blood collection system is configured to allow selection of: (a) collecting and disposing of shed blood from the patient or (b) collecting and processing shed blood for autologous transfusion back into the patient. The system includes an automated blood processing machine; a blood collection reservoir engageable with said blood processing machine such that said machine can identify and report the presence of blood in said reservoir; a separation chamber engageable with the blood processing machine; and a fluid conduit configured to selectively couple the reservoir to the separation chamber through a quick-connect coupling.

In another embodiment, a first disposable set of components is provided for use in a blood recovery system. The first disposable-set component preferably comprises a reservoir for collecting the shed blood; a collection port for allowing shed blood to be drawn from a site into the reservoir; an outlet port for allowing blood to be drawn from the reservoir; and a quick-connect coupling for connecting the outlet port to the separation chamber. The reservoir, collection port, outlet port and coupler are preferably stored in a sealed package separate from the separation chamber. The reservoir may include a vacuum port for connecting the reservoir to a vacuum source to provide a vacuum to draw shed blood from a surgical site or wound drain into the reservoir.

In another embodiment, a second disposable kit component is provided for use in a blood recovery system. The second disposable kit part comprises a separation chamber in which the blood component (preferably RBCs) can be separated from the other fluids; and a quick-connect coupling for connecting the separation chamber to the coupling of the collection reservoir. The separation chamber is stored in a sealed package separate from the collection reservoir. The second disposable set of components may also include a blood component container for receiving blood components separated from the separation chamber and/or a waste container for receiving waste fluid from the separation chamber. These containers may be stored in the same sealed package as the separation chamber.

In another embodiment, a method for salvage of blood includes the steps of: (i) removing the first disposable-set component from its sealed package, (ii) collecting a volume of shed blood into a reservoir of the first disposable-set component, (iii) monitoring the volume of shed blood in the reservoir, and if the volume of shed blood reaches a threshold value, performing the following additional steps: (iv) removing the second disposable set component from its sealed package, (v) connecting the coupler of the first disposable set component to the coupler of the second disposable set component, (vi) drawing the shed blood from the reservoir into the separation chamber of the second disposable set component, and (vii) separating blood components from other fluids in the separation chamber.

In another embodiment, a method for collecting shed blood from a patient into a disposable reservoir while retaining a selected mode of processing shed blood in a disposable separation chamber for autologous transfusion back to the patient comprises: providing an automated blood processing machine, a blood collection reservoir engageable with the blood processing machine such that the blood processing machine can identify and report the presence of blood in the blood collection reservoir, a separation chamber engageable with the blood processing machine, and a fluid conduit configured to selectively couple the blood collection reservoir to the separation chamber through a quick-connect coupling; collecting blood from a patient into the reservoir and operating the processor; to monitor the amount of blood collected; coupling the separation chamber to the reservoir by securing the quick-connect coupling in the conduit; transferring blood from the reservoir to the separation chamber; operating the processor to separate unwanted substances from the blood to provide purified blood; and returning the purified blood to the patient.

Drawings

The foregoing features of the invention will become more apparent by reference to the following detailed description when taken in conjunction with the accompanying drawings, wherein:

fig. 1 shows a prior art disposable set for use in an intra-operative blood recovery system.

Fig. 2 and 3 show a first disposable kit component and a second disposable kit component, respectively, according to a preferred embodiment of the present invention.

Fig. 4 shows the first and second disposable set components of an alternative embodiment mounted on or in the base unit.

Fig. 5 shows a flow diagram of a method according to an embodiment of the invention.

Detailed Description

And (4) defining. As used in this specification and the appended claims, the following terms shall have the indicated meanings, unless the context indicates otherwise:

as used herein, "perioperative" describes an article or method that is used during or shortly after surgery. The term includes the aspiration of blood from a surgical site operation (along with other fluids such as perfusion solutions) and the post-operative collection of blood from a wound drain.

As used herein, "intraoperative blood recovery" describes a system that collects shed blood during surgery, typically by suctioning from the surgical site. Separating out RBCs from intraoperatively collected shed blood and flushing the separated RBCs can be performed after the surgery is completed.

As used herein, "post-operative blood recovery" describes a system that typically collects shed blood from a wound drain after surgery.

It will be appreciated that the present invention may be adapted for use in intra-operative or post-operative blood recovery or a combination of both.

Fig. 2 and 3 show two disposable cartridge components retrofitted from the prior art disposable cartridge of fig. 1. Fig. 2 shows a first disposable set of components 31 comprising the reservoir 22, the collection port 11, the outlet tube 28 and other elements. The reservoir 22 may be of a design according to U.S. patent No.6,251,291 (which is incorporated herein by reference as noted above). The outlet tube 28 comprises a releasable coupling 25 for allowing the first disposable set component 31 to be releasably connected to the second disposable set component 32 of fig. 3. Preferably, the releasable coupling 25 is designed to not allow air to enter the outlet tube 28 when the coupling 25 is not attached.

The second disposable kit part 32 includes the centrifuge disk 35, the inlet tube 29, the disk outlet tube 38, the RBC collection bag 59, and the waste bag 58 (as well as other elements, such as a valve mechanism). (centrifugal disk 35 may be of the variable volume design described in U.S. Pat. No.5,733,253 to Headley et al, published 3/31 in 1998, and U.S. Pat. No.5,651,766 to Kingsley et al, published 7/29 in 1997, both of which are incorporated herein by reference, although it will be understood that other types of separation chambers, such as centrifuge bowls, may also be used in the blood recovery system of the present invention.) Inlet tube 29 includes a releasable coupling 26 that is designed to be easily and quickly connectable to releasable coupling 25 of the first disposable set component. Preferably, the releasable coupling 26 of the second disposable kit part may also be designed not to allow air to enter the inlet tube 29 when the coupling 26 is not attached.

Couplings manufactured by cooler Products of St.Paul, Minn, particularly part numbers SMF0291 and SMM0291, may be used for couplings 25 and 26.

Each of the first disposable set component 31 and the second disposable set component 32 is preferably stored in a separate sealed container. Thus, the first disposable set component 31 is first removed from its sealed container and used for collection of the shed blood. Preferably, the second disposable set component 32 is removed from its sealed container only when sufficient shed blood is collected in the reservoir 22 of the first disposable set component to allow the shed blood to be processed in the separation chamber to produce reinfused RBCs.

Fig. 4 shows an alternative pair of disposable kit components connected to each other with couplings 25 and 26 and used with base unit 50. The reservoir 22 is shown connected to the base unit 50. Unfiltered fluid obtained from the fluid source 10 is directed into the reservoir 22 through the unfiltered fluid inlet 12. The fluid source 10 may be in communication with a surgical site that produces blood, debris, and other fluids. During surgical procedures, it is critical to remove blood and other fluids and debris from the surgical site as quickly as possible as such products are produced. The reservoir 22 is designed to efficiently collect and filter fluids from various procedures. A vacuum source 15 on the base unit 50 is connected to the reservoir 22 through a vacuum port 14. A pressure differential is established causing fluid to flow from the fluid source 10 into the reservoir 22. The base unit 50 may utilize a partial vacuum to draw filtered effluent blood from the system's filtration outlet 13 into the inlet 16 of the centrifuge disk 35. In this embodiment, the reservoir 22 is divided into an inlet chamber 2 and an adjacent outlet chamber 3. The filter element 17 is shown arranged to physically separate the inlet chamber 2 and the outlet chamber 3.

Initially, only the first disposable-set component comprising the reservoir 22 is attached to the base unit 50. If the software controlling the base unit needs to insert a disk into the cartridge of the base unit before the shed blood can be collected, a virtual disk (dummy disk) can be inserted into the base unit 50. The amount of shed blood collected in the reservoir may be monitored by the base unit 50. (procedures and base unit configurations described in U.S. patent application publication No.2005/0203469, which is incorporated by reference above, may be used in some embodiments of the invention to monitor the amount of shed blood collected in a reservoir.)

Once the base unit 50 determines that a sufficient amount of shed blood has been collected, the base unit provides an indication to the operator that a threshold volume has been collected. Depending on the indication, several steps may occur: the second disposable cartridge component can be removed from its sealed container; the dummy disc may be removed from the base unit so that the actual centrifugal disc 35 may be inserted into the base unit 50; and the couplings 25 and 26 of the two disposable cartridge components are connected to each other. At this point, the shed blood may be transferred from the reservoir 22 into the centrifuge disk 35, and the shed blood may then be processed to produce RBCs according to known procedures for recovering RBCs. The waste product and recovered RBCs exit the centrifuge disk 35 through outlet tube 38 to pass to a waste bag and RBC bag, respectively.

If the base unit does not detect that a sufficient volume of fluid has been collected, the second disposable set of components is not removed from its sealed container and can therefore be stored for later use in a different patient procedure. Thus, significant cost savings can be achieved if insufficient shed blood is collected for a complete salvage procedure. In addition, the physician may avoid guessing that those procedures are likely or unlikely to produce sufficient volume of shed blood to avoid wasting all disposable kits, such as the kit shown in fig. 1, in procedures where it is deemed unlikely that all disposable kits will be used. Conversely, the physician may simply use a first disposable kit component (e.g., the kit component of fig. 2) for all procedures, and if sufficient volume is collected, the physician may utilize a second disposable kit component, e.g., the kit component of fig. 3. Thus, some patients may reduce the risks associated with allogenic transfusions if the procedure produces an unexpectedly high volume of shed blood. Thus, the present invention may help reduce costs while reducing patient risk.

Fig. 5 is a flow chart showing the basic steps involved in a method according to one embodiment of the invention. In step 61, the shed blood is collected (e.g., from the surgical site and/or wound drain) in a reservoir. In step 62, the volume of fluid in the reservoir is preferably monitored by the base unit to which the reservoir is attached. Preferably, the base unit can determine or estimate the actual amount of blood in the reservoir (as opposed to the total amount of all fluid) and use this information to determine whether a complete salvage procedure should be performed. Alternatively, the base unit may simply measure the total volume of all fluid in the reservoir and instead make a decision as to whether to perform a complete reclamation procedure based on this information. The base unit may be configured to activate a visual or audible alarm when a set threshold is reached.

In step 63, a threshold amount of fluid is collected in the reservoir, and at this point the separation chamber is attached to the reservoir. Up to this point, the separation chamber and other elements of the second disposable cartridge component may remain unused in its own sealed container. If a threshold amount of fluid is not collected during the procedure, the second disposable set component is saved for a later procedure (step 67) and the first disposable set component is simply disposed of at the end of the current procedure (step 68). It should be noted that the threshold amount of fluid worth processing needed in the reservoir is determined by the health care professional on a case-by-case basis. The value may be preset into the base unit electronics or through a user interface. Various factors may be considered such as patient size, volume of blood and fluid collected, hematocrit, and other factors.

After the separation chamber is attached to the reservoir in step 63, fluid is transferred from the reservoir to the separation chamber (step 64). In step 65, a blood component, typically RBCs, are separated from the remainder of the fluid in a separation chamber. The separation is preferably achieved by the base unit rotating the separation chamber at a sufficiently high speed for a sufficient period of time. At which point the blood components may optionally be rinsed with saline. Preferably, after being separated and flushed, the blood components are directed to a bag or other container from which they may be reinfused 66 back to the patient.

While the foregoing discussion discloses various exemplary embodiments of the invention, it will be apparent to those skilled in the art that various modifications can be made which will achieve some of the advantages of the invention without departing from the true scope of the invention.

Claims (6)

1. A disposable cartridge component for use in a blood recovery system, the disposable cartridge component comprising:

reservoir for collecting shed blood, the reservoir comprising

A collection port for allowing shed blood to be drawn from a site into the reservoir, and

an outlet port for allowing blood to be drawn from the reservoir via an outlet tube; and

a first speed coupling for connecting the outlet port and an outlet tube to a centrifugal rotor, the first speed coupling being adapted to connect with a second speed coupling, the second speed coupling being connected to an inlet tube to the centrifugal rotor, the first speed coupling preventing air from entering the outlet tube when disconnected from the second speed coupling, the second speed coupling preventing air from entering the inlet tube when disconnected from the first speed coupling,

wherein the reservoir and the first quick connect coupling are stored in a sealed package separate from the centrifuge rotor, the disposable set being configured to allow the blood salvage system to operate in a collection mode, in which the blood salvage system collects shed blood into the reservoir, not in a separation and return mode, in which the blood salvage system separates first blood components from other fluids in the centrifuge rotor and returns the first blood components to the patient, and to allow connection of the centrifuge rotor for operation in a separation and return mode after a threshold amount of blood has been collected.

2. The disposable kit component of claim 1 wherein the reservoir includes a vacuum port for connecting the reservoir to a vacuum source.

3. A disposable cartridge component for use in a blood recovery system, the disposable cartridge component comprising:

a centrifugal rotor for separating blood components from other fluids; and

a second speed coupling for connecting the centrifugal rotor to a collection reservoir via an inlet pipe and an outlet pipe, the second speed coupling being connected to the inlet pipe and adapted to connect with a first speed coupling connected to an outlet pipe leading to the collection reservoir, the second speed coupling preventing air from entering the inlet pipe when disconnected from the first speed coupling, the first speed coupling preventing air from entering the outlet pipe when disconnected from the second speed coupling,

wherein the centrifuge rotor is stored in a sealed package separate from the collection reservoir, the disposable set being configured to allow the blood reclamation system to transition from a first configuration in which the system collects and processes the collected blood to a second configuration in which the system collects and processes the collected blood after collecting a threshold amount of blood.

4. The disposable kit component of claim 3, further comprising a blood component container for receiving blood components separated from the centrifuge rotor, wherein the blood component container is stored in the same sealed package as the centrifuge rotor.

5. The disposable kit component of claim 3 or claim 4, further comprising a waste container for receiving waste fluid from the centrifuge rotor, wherein the waste container is stored in the same sealed package as the centrifuge rotor.

6. The disposable kit component of claim 3, wherein the centrifuge rotor is a variable volume centrifuge rotor.