WO2012093322A4 - Portable blood salvage system - Google Patents

Portable blood salvage system Download PDF

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Publication number
WO2012093322A4
WO2012093322A4 PCT/IB2011/056000 IB2011056000W WO2012093322A4 WO 2012093322 A4 WO2012093322 A4 WO 2012093322A4 IB 2011056000 W IB2011056000 W IB 2011056000W WO 2012093322 A4 WO2012093322 A4 WO 2012093322A4
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WO
WIPO (PCT)
Prior art keywords
blood
salvage system
chamber
filtration chamber
filtered
Prior art date
Application number
PCT/IB2011/056000
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French (fr)
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WO2012093322A1 (en
Inventor
Nainesh Sumanbhai DESAI
Original Assignee
Desai Nainesh Sumanbhai
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Publication date
Application filed by Desai Nainesh Sumanbhai filed Critical Desai Nainesh Sumanbhai
Publication of WO2012093322A1 publication Critical patent/WO2012093322A1/en
Publication of WO2012093322A4 publication Critical patent/WO2012093322A4/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3627Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3692Washing or rinsing blood or blood constituents

Definitions

  • the present invention relates to portable blood salvage system for recovery, purification and reinfusion of blood lost during surgery or accident patient.
  • transmissible disease such as hepatitis B , hepatitis C , HIV /AIDS, West Nile virus (WNV), and transfusion-transmitted bacterial infection .
  • Human errors such as misidentifying patients ' blood group and drawing blood samples from the wrong person present much more of a risk than transmissible diseases.
  • US Patent No. 585238 describes a method and apparatus for salvaging blood from a patient having a blood salvaging circuit coupled to a cardiopulmonary bypass circuit, which includes a hemoconcentrator and a sorbent-containing plasma separator.
  • a combination device for salvaging blood includes a closed plasma chamber containing a plasma chamber solution, a hollow fiber plasma-separating membrane for receiving blood and permitting plasma to be transported there through into the plasma chamber solution and for refiltering the treated plasma back into the blood salvaging circuit, a selective sorbent for contacting the selected solute in the plasma and binding the selected solute and an ultrafiltration membrane for removing water, fluids and low molecular weight components from the plasma.
  • US Patent No 5876611 describes a blood salvaging apparatus which includes suction means, admixing means for admixing aspirated blood with a washing fluid, filtering means for filtering the admixture through an emboli filter, monitoring means for measuring the amount of cellular component volume in the aspirated, filtered blood, filtration means for removing excess fluid and impurities from blood and reinfusion means for introducing the washed and filtered blood to the patient free of emboli.
  • Another object of the invention is to provide a system which is disposable and provides contamination free handling of blood from surgical site to Collection, filtration, concentration and online delivery or storage of blood
  • the present invention provides a blood salvaging and a purification system which removes blood from the wound or surgical site, filters and purifies the blood by addition thereto of washing fluid such as saline and returns the blood to the patient.
  • the system comprises of a means for removing blood from the surgery site and means for mixing the blood with the washing fluid.
  • the system also comprises of means of filtration of the salvaged blood and concentration of the blood.
  • the blood salvaging system further includes structural means for delivering filtered and purified blood back to the patient or to store the blood for delivering the purified blood after the surgery.
  • the current invention can be operated manually and is free of any heavy machinery set up.
  • the means for removing blood from the surgery site and means for mixing the blood with the washing fluid is suction and vacuum tubing sets.
  • the means of filtration used in the present invention is a filtration chamber with micro aggregate filter which is hung from an i.v. pole.
  • the filtration chamber is made from transparent material.
  • the filtered blood is continuously directed from the filtration chamber to a blood collection chamber for reinfusion to the patient in a single pass.
  • FIG. 1 is schematic diagram illustrating the blood salvaging and purification system of the present invention.
  • the invention according to the first embodiment is in the form of a system (10) for blood salvaging and purification at the casualty site or in ambulance during the transfer of patient from casualty site to hospital
  • Fig. 1 the location of surgery is designated at 20.
  • the shed blood is aspirated from the surgery site (20) by suction means comprising suction cannulae (11) and suction machine (12) .
  • Suction cannulae (11) is connected to length of suction tubing (5) having air tight valve I (13) at the suction cannulae (11) side, the other end of which is connected to Filtration chamber (16).
  • the suction tubing (5) is also connected to I.V. Line which connect to N Saline bottle (15) having capacity of about 500ml.
  • Suction machine (12) is connected to vacuum tubing (8) having air tight valve II (14), the other end of which is connected to Filtration chamber (16).
  • the filtration chamber (16) having capacity of about 2000ml, consist of micro aggregate filter (18), generally made of non-woven polypropylene having pore size of 37 micron.
  • the filter (18) assures the removal of debris, small particles and clot blood cell from blood.
  • the filtered blood from filtration chamber (16) to blood collection chamber (17) having blood flow path (3) and a blood outlet (6) at its bottom end.
  • the filtered blood is delivered to patient (21) through delivery path (3) and has airtight valve III (19) which aid in online delivery of blood to patient (21).
  • the shed blood is aspirated from the surgery site (20) by suction means which generally include a conventional method of suction by creating vacuum.
  • suction means which generally include a conventional method of suction by creating vacuum.
  • the valve I (13) and valve II (14) is opened.
  • the suction machine (12) creates a vacuum pressure of 0mmHg to negative pressure till the blood from the surgery site (20) comes to filtration chamber (16).
  • the system (10) is usually operated under maximum vacuum pressure of -110mmHg.
  • the aspirated blood is mixed with normal saline and small amount of anticoagulant such as Heparin before coming to the filtration chamber (16).
  • the diluted blood moves through the micro aggregate filter (18) in the filtration chamber (16).
  • the debris, small particles and clot blood cell from blood is removed and the filtered blood moves from filtration chamber (16) to blood collection chamber (17) through blood outlet (6) at its bottom end to the patient (21) through delivery path (3) having airtight valve III (19).
  • the valve I (13) and valve III (19) are kept in open position for online delivery of blood to the patient during the surgery.
  • the shed blood filtered by using blood salvage system (10) can be stored and delivered at the bedside or after sometime.
  • the concentration chamber (31) is connected to concentrated blood storage chamber (32) via valve III (34) and waste bag (33) via valve IV (35).
  • the filtered blood moves from the filtration chamber (16) to concentration chamber (31) through passageway (30) wherein the passageway (30) includes filter of 0.3 microns.
  • valve III (34) and valve IV (35) both are open while the valve VII (38) of blood circulation line (6) meant for delivery of filtered blood to patient is kept in closed position.
  • the concentrated blood from the concentrated blood storage chamber (32) is recirculated to filtration chamber (16) through blood circulation line (9) having valve VI (37).
  • valve II (14) and valve VI (37) are kept in open position and suction machine (12) creates negative pressure till the concentrated blood from the concentrated blood storage chamber (32) comes to filtration chamber (16).
  • valve V (36) of the vacuum tubing (7) is also opened alongwith valve VI (37) and valve II (14).
  • the recirculated concentrated blood from filtration chamber (16) is delivered to the patient through blood circulation line (6) having valve VII (38).
  • the blood salvage system of the present invention is advantageous over prior blood salvage systems known.
  • the blood salvaging system of the present invention may be used for humans as well as animals, with some variations.
  • reference herein to specific details of the illustrated embodiments is by way of example and not by way of limitation. It will be apparent to those skilled in the art that many modifications of the basic illustrated embodiment may be made without departing from the spirit and scope of the invention as recited by the claims.

Abstract

A portable blood salvage system is disclosed for salvaging a patient's own blood during intraoperative surgical procedures and reinfusing the blood, washed and filtered, to the patient online or at bedside. The apparatus comprises suction means, admixing means for admixing aspirated blood with a washing fluid, filtering means for filtering the admixture through micro aggregate filter (18) and reinfusion means for introducing the washed and filtered blood to the patient free of debris, small particles and clot blood cell.

Description

PORTABLE BLOOD SALVAGE SYSTEM
FIELD OF THE INVENTION
[0001] The present invention relates to portable blood salvage system for recovery, purification and reinfusion of blood lost during surgery or accident patient.
BACKGROUND OF THE INVENTION
[0002] There is a significant loss of multiple units of blood during a traumatic injury, during serious and traumatic surgeries such as open heart surgery, spinal surgery, Neurosurgery etc. Such loss of blood may result in decreased blood pressure, decreased cardiac output and decreased oxygen delivery to brain cells. Thus the blood lost during the surgery must be compensated by blood transfusion as soon as possible.
[0003] Providing safe blood for transfusion remains a challenge despite advances in preventing transmissible disease such as hepatitis B , hepatitis C , HIV /AIDS, West Nile virus (WNV), and transfusion-transmitted bacterial infection . Human errors such as misidentifying patients ' blood group and drawing blood samples from the wrong person present much more of a risk than transmissible diseases.
[0004] For every unit of donated blood the patient receives, his immune system is further compromised. This reduction in immune response reduces his ability to fight off infection thus increasing the amount of time it may take one to recover from a surgical procedure.
[0005] When multiple units of donated blood is transfused to patient during surgery or post surgery all the above complications are indirectly delivered to the patient.
[0006] At times, it is difficult to find the necessary blood needed for transfusions, and it can be very expensive. As a result reuse of a patient's own blood has been receiving significant attention. American Red Cross also advices to use OWN blood or use blood processing device which transfuses all blood components.
[0007] There are many existing blood salvage systems which vary in design and operation.
[0008] US Patent No. 585238 describes a method and apparatus for salvaging blood from a patient having a blood salvaging circuit coupled to a cardiopulmonary bypass circuit, which includes a hemoconcentrator and a sorbent-containing plasma separator. A combination device for salvaging blood includes a closed plasma chamber containing a plasma chamber solution, a hollow fiber plasma-separating membrane for receiving blood and permitting plasma to be transported there through into the plasma chamber solution and for refiltering the treated plasma back into the blood salvaging circuit, a selective sorbent for contacting the selected solute in the plasma and binding the selected solute and an ultrafiltration membrane for removing water, fluids and low molecular weight components from the plasma.
[0009] US Patent No 5876611 describes a blood salvaging apparatus which includes suction means, admixing means for admixing aspirated blood with a washing fluid, filtering means for filtering the admixture through an emboli filter, monitoring means for measuring the amount of cellular component volume in the aspirated, filtered blood, filtration means for removing excess fluid and impurities from blood and reinfusion means for introducing the washed and filtered blood to the patient free of emboli.
[0010] These apparatus as described above and most of blood salvage system which is present in the market today are machine dependent such as Heart lung machine and are very cumbersome, Heart lung machine available in market weight 150 Kg, such machines which are available in the market due to heavy machine set up, cannot be even transferred to other operation theatres and hence are not portable. Also, the systems available in the market are very expensive and unaffordable for common man.
[0011] The problem of the immobility of such blood salvage system due to complex machine set up requires the development of portable blood salvage system which can be easily used at any casualty site and even in an ambulance. Use of such portable blood salvage system would drastically help in reducing the mortality caused due to blood loss at casualty site and also during the transfer of patient from casualty site to the hospital.
OBJECT OF THE INVENTION
[0012] It is thus an object of this invention to provide a blood salvage system which is portable which can be easily used at any casualty site and even in an ambulance and is cost effective.
[0013] Another object of the invention is to provide a system which is disposable and provides contamination free handling of blood from surgical site to Collection, filtration, concentration and online delivery or storage of blood
SUMMARY OF THE INVENTION
[0014] The present invention provides a blood salvaging and a purification system which removes blood from the wound or surgical site, filters and purifies the blood by addition thereto of washing fluid such as saline and returns the blood to the patient.
[0015] The system comprises of a means for removing blood from the surgery site and means for mixing the blood with the washing fluid. The system also comprises of means of filtration of the salvaged blood and concentration of the blood. The blood salvaging system further includes structural means for delivering filtered and purified blood back to the patient or to store the blood for delivering the purified blood after the surgery.
[0016] In contrast to the prior art, the current invention can be operated manually and is free of any heavy machinery set up.
[0017] In the present invention, the means for removing blood from the surgery site and means for mixing the blood with the washing fluid is suction and vacuum tubing sets. The means of filtration used in the present invention is a filtration chamber with micro aggregate filter which is hung from an i.v. pole. The filtration chamber is made from transparent material.
[0018] In the present invention, the filtered blood is continuously directed from the filtration chamber to a blood collection chamber for reinfusion to the patient in a single pass.
BREIF DESCRIPTION OF DRAWING
[0019] In the drawings, which illustrate what is currently considered to be best mode for carrying out the invention:
[0020] FIG. 1 is schematic diagram illustrating the blood salvaging and purification system of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0021] Referring to figure 1, the invention according to the first embodiment is in the form of a system (10) for blood salvaging and purification at the casualty site or in ambulance during the transfer of patient from casualty site to hospital
[0022] In Fig. 1 the location of surgery is designated at 20. The shed blood is aspirated from the surgery site (20) by suction means comprising suction cannulae (11) and suction machine (12) .Suction cannulae (11) is connected to length of suction tubing (5) having air tight valve I (13) at the suction cannulae (11) side, the other end of which is connected to Filtration chamber (16). The suction tubing (5) is also connected to I.V. Line which connect to N Saline bottle (15) having capacity of about 500ml. Suction machine (12) is connected to vacuum tubing (8) having air tight valve II (14), the other end of which is connected to Filtration chamber (16).
[0023] The filtration chamber (16) having capacity of about 2000ml, consist of micro aggregate filter (18), generally made of non-woven polypropylene having pore size of 37 micron. The filter (18) assures the removal of debris, small particles and clot blood cell from blood. The filtered blood from filtration chamber (16) to blood collection chamber (17) having blood flow path (3) and a blood outlet (6) at its bottom end. The filtered blood is delivered to patient (21) through delivery path (3) and has airtight valve III (19) which aid in online delivery of blood to patient (21).
[0024] In accordance with the present invention, the shed blood is aspirated from the surgery site (20) by suction means which generally include a conventional method of suction by creating vacuum. The valve I (13) and valve II (14) is opened. The suction machine (12) creates a vacuum pressure of 0mmHg to negative pressure till the blood from the surgery site (20) comes to filtration chamber (16). The system (10) is usually operated under maximum vacuum pressure of -110mmHg. The aspirated blood is mixed with normal saline and small amount of anticoagulant such as Heparin before coming to the filtration chamber (16).
[0025] The admixture of the normal saline and the aspirated blood flows into filtration chamber (16). When the diluted blood volume in the filtration chamber is 1000 ml the suction machine (12) if required can be stopped and valve I (13) and valve II (14) is closed.
[0026] The diluted blood moves through the micro aggregate filter (18) in the filtration chamber (16). As blood passes through the micro aggregate filter (18) the debris, small particles and clot blood cell from blood is removed and the filtered blood moves from filtration chamber (16) to blood collection chamber (17) through blood outlet (6) at its bottom end to the patient (21) through delivery path (3) having airtight valve III (19). The valve I (13) and valve III (19) are kept in open position for online delivery of blood to the patient during the surgery.
[0027] According to the second embodiment of the said invention, the shed blood filtered by using blood salvage system (10) can be stored and delivered at the bedside or after sometime.The concentration chamber (31) is connected to concentrated blood storage chamber (32) via valve III (34) and waste bag (33) via valve IV (35). The filtered blood moves from the filtration chamber (16) to concentration chamber (31) through passageway (30) wherein the passageway (30) includes filter of 0.3 microns. As filtered blood moves through passageway (4) washing fluid is separated from the blood and concentrated blood moves towards the concentrated blood storage chamber (32) via valve III (34) whereas the separated washing fluid goes to waste bag (33) via valve IV (35). It should be noted that during the filtration of blood in concentration chamber valve III (34) and valve IV (35) both are open while the valve VII (38) of blood circulation line (6) meant for delivery of filtered blood to patient is kept in closed position.
[0028] The concentrated blood from the concentrated blood storage chamber (32) is recirculated to filtration chamber (16) through blood circulation line (9) having valve VI (37). For recirculation of concentrated blood to filtration chamber (16), valve II (14) and valve VI (37) are kept in open position and suction machine (12) creates negative pressure till the concentrated blood from the concentrated blood storage chamber (32) comes to filtration chamber (16). However, sometime in order to increase the speed of the said recirculation of the concentrated blood, valve V (36) of the vacuum tubing (7) is also opened alongwith valve VI (37) and valve II (14). The recirculated concentrated blood from filtration chamber (16) is delivered to the patient through blood circulation line (6) having valve VII (38).
[0029]
The blood salvage system of the present invention is advantageous over prior blood salvage systems known. The blood salvaging system of the present invention may be used for humans as well as animals, with some variations. Thus, reference herein to specific details of the illustrated embodiments is by way of example and not by way of limitation. It will be apparent to those skilled in the art that many modifications of the basic illustrated embodiment may be made without departing from the spirit and scope of the invention as recited by the claims.

Claims (7)

1. A blood salvage system (10) comprising: a suction machine (12) for aspirating blood from a wound or surgical site; a filtration chamber (16) for receiving and filtering said aspirated blood there through; a blood collection chamber (17) connected to filtration chamber for temporary retention filtered blood from where the said filtered blood is delivered to the patient; a source of washing fluid (15) with said filtration chamber(16)for admixing washing fluid with said aspirated blood prior to entry into filtration chamber (16) characterized in that the said filtration chamber (16) consist of micro aggregate filter (18) having pore size of 37 micron for removing debris, small particles and clot blood cell from blood.
The blood salvage system (10) as claimed in claim 1, wherein the said micro aggregate filter (18) is made of non-woven polypropylene material.
The blood salvage system (10) as claimed in claim 1, wherein the said blood salvage system is operated under maximum vacuum pressure of -110mmHg.
The blood salvage system (10) as claimed in claim 1, wherein the said washing fluid can be mixture of normal saline and small amount of anticoagulant such as Heparin or normal saline without any anticoagulant.
A blood salvage system (10) as claimed in claim 1 further comprising: a suction machine (12) for aspirating blood from a wound or surgical site; a filtration chamber (16) for receiving and filtering said aspirated blood therethrough; a concentration chamber (31) connected to filtration chamber (16) through passageway (30) for removing washing fluid from the filtered blood.
A blood salvage system (10) as claimed in claim 4, wherein the concentration Chamber (31) is further connected concentrated blood storage chamber (32) and waste bag (33).
A blood salvage system substantially as herein described with reference to the accompanying drawings.
PCT/IB2011/056000 2011-01-03 2011-12-29 Portable blood salvage system WO2012093322A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2MU2011 2011-01-03
IN02/MUM/2011 2011-01-03

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WO2012093322A4 true WO2012093322A4 (en) 2012-08-30

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WO2016122007A1 (en) * 2015-01-26 2016-08-04 가톨릭관동대학교 산학협력단 Blood recirculation device

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WO1984000892A1 (en) * 1982-08-24 1984-03-15 Baxter Travenol Lab Increased yield blood component collection systems and methods
US5876611A (en) * 1997-06-16 1999-03-02 Shettigar; U. Ramakrishna Intraoperative blood salvaging system and method
CN103007367B (en) * 2006-11-08 2016-01-20 美国血液技术公司 Disposable external member, blood collection systems and blood collection methods

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