Patent Application
20240131235
The present invention relates generally to blood reinfusion systems and methods. More particularly, the present invention relates to systems, apparatus and methods for processing autologous blood for reinfusion into a patient.
As is well established, blood loss is an inevitable aspect of many invasive surgical procedures and, if not managed or accounted for, can lead to various significant adverse physiological conditions.
Indeed, a loss of over 20% of blood volume (˜900 cc to 1000 cc) during a surgical procedure can cause hypovolemic shock and a loss of over 50% of blood volume (2250 cc to 3500 cc) can cause cardiac arrest.
Blood loss during a surgical procedure can also result in post-procedure anemia, which can, and often will, hinder recovery.
Various means have thus been employed to manage blood loss during a surgical procedure. The most common means is transfusion of blood during and after the procedure.
As is well established, there are, however, several significant drawbacks and disadvantages associated with transfusion of blood to a patient during and after a surgical procedure.
A major problem associated with a typical blood transfusion, is that such blood is typically non-autologous (i.e., donated by another person), and thus, can induce various adverse physiological events, such as antigen reactions and disease transfer, if not properly screened.
Various blood recycling or reinfusion systems have thus been developed to address blood loss during a surgical procedure. Such systems include the Cell Saver® Elite®+ autotransfusion system developed by Haemonetics, the CATSmart® continuous autotransfusion system developed by Fresenius Kabi, the XTRA® autotransfusion system developed by Livallova, and the autoLog® autotransfusion system developed by Medtronic.
The noted systems typically include means for collecting blood from a patient during a surgical procedure, means for processing the collected blood and means for reinfusing the blood into the patient.
As discussed below, there are similarly numerous drawbacks and disadvantages associated with the noted “blood reinfusion” systems.
A major disadvantage associated with the noted blood reinfusion systems is that the blood processing means of the systems can, and often will, damage the erythrocytes (i.e., red blood cells) in the collected “autologous” blood, which can, and often will, compromise the quality of the blood.
A further major disadvantage associated with the noted blood reinfusion systems is that the blood processing means typically includes mixing the collected “autologous” blood with a physiological solution (e.g., saline or Ringer's Solution) and centrifuging the mixed blood to isolate and recover the erythrocytes for reinfusion into the patient. The lighter portion of centrifuged mixed blood (i.e., the lighter plasma and buffy coat of the whole blood), which contains platelets, white blood cells, plasma proteins, and antibodies, are typically discarded as waste. The reinfused blood is thus devoid of the highly important platelets, white blood cells, plasma proteins, and antibodies.
A further disadvantage associated with the noted blood reinfusion systems is that such systems typically comprise large, complex equipment that is very difficult to operate and require multiple specialized technicians to operate. The systems thus often require advanced planning prior to use, including scheduling specialized technicians trained to set up and use the systems, and, hence, are also suboptimal for emergency use, e.g., instances of unexpected blood loss during a medical procedure or military combat.
A further disadvantage associated with the noted blood reinfusion systems is that they are typically not configured and/or adapted for use in sterile environments.
A further disadvantage associated with the noted blood reinfusion systems is the high costs associated with reinfusing blood into a patient therewith, i.e., reinfusion system acquisition and labor costs. As a result, such systems are typically not economically feasible for use during surgical procedures in developing countries.
It would thus be desirable to provide improved blood reinfusion systems that substantially reduce or eliminate the drawbacks and disadvantages associated with conventional blood reinfusion systems.
It is therefore an object of the present invention to provide improved blood reinfusion systems that substantially reduce or eliminate the drawbacks and disadvantages associated with conventional blood reinfusion systems.
It is another object of the present invention to provide improved blood reinfusion systems adapted to process autologous blood with minimal, if any, effect on the quality of the blood.
It is another object of the present invention to provide improved blood reinfusion systems adapted to process autologous blood without damaging the erythrocytes in the blood.
It is another object of the present invention to provide improved blood reinfusion systems adapted to process autologous blood with minimal blood component loss; specifically, platelet, white blood cell, plasma protein, and antibody, loss.
It is another object of the present invention to provide improved blood reinfusion systems configured and adapted for use in sterile environments.
It is another object of the present invention to provide improved blood reinfusion systems that are simple to use and can be easily operated manually by a single operator.
It is another object of the present invention to provide improved blood reinfusion systems that can be promptly employed in emergency situations.
It is another object of the present invention to provide improved blood reinfusion systems that can be readily employed in a multitude of surgical and interventional medical procedures.
The present invention is directed to systems, apparatus and methods for processing autologous blood for reinfusion into a patient. In some embodiments of the invention, there are thus provided systems for processing autologous blood for reinfusion into a patient (referred to hereinafter as “blood reinfusion systems”).
In one embodiment of the invention, the blood reinfusion system comprises a suction canister, a blood filter assembly and a blood collection container, the suction canister comprising first filter means adapted to extract impurities from the autologous blood, whereby first processed autologous blood is obtained, the blood filter assembly comprising second filter means adapted to extract excess impurities from the first processed autologous blood, whereby purified autologous blood, i.e., autologous blood substantially devoid of blood clots, emboli, tissue debris, foreign particles, etc., is obtained, the blood collection container adapted to receive the purified autologous blood from the blood filter assembly.
In some embodiments, the first filter means comprises a first filter comprising a pore size less than 5.0 mm.
In some embodiments, the second filter means comprises a second filter comprising a pore size less than 500.0 micron.
In some embodiments, the second filter comprises a pore size in the range of 10.0 micron to 40.0 micron.
In one embodiment of the invention, the blood reinfusion system comprises a suction canister, a blood filter assembly and a blood collection container,
In some embodiments, the first filter comprises a pore size less than 5.0 mm.
In some embodiments, the second filter comprises a pore size less than 500.0 micron.
In some embodiments, the third filter comprises a pore size less than 40.0 micron.
In one embodiment of the invention, the blood reinfusion system comprises a suction canister, a blood filter assembly and a blood collection container,
In some embodiments, the first filter comprises a pore size less than 10.0 mm.
In some embodiments, the second filter comprises a pore size less than 5.0 mm.
In some embodiments, the third filter comprises a pore size less than 500.0 micron.
In some embodiments, the third filter comprises a pore size less than 200.0 micron.
In some embodiments, the fourth filter comprises a pore size less than 50.0 micron.
In a preferred embodiment, the blood reinfusion systems comprise modular units, wherein the suction canister is detachably coupled to the blood filter assembly.
In some embodiments of the invention, the blood reinfusion system further comprises aspiration means adapted to couple to the suction canister, aspirate the autologous blood from an incision site of a patient and deliver the autologous blood into the suction canister.
In some embodiments, the suction canister further comprises sensor means adapted to monitor volume of autologous blood contained in the suction canister.
In some embodiments, the blood filter assembly further comprises sensor means adapted to monitor flow of the processed autologous blood through the blood filter assembly.
In some embodiments of the invention, there are also provided apparatus for processing blood (referred to herein as “blood processing apparatus”).
In some embodiments, the blood processing apparatus comprises a top housing portion, a plurality of interconnected filter modules and a bottom housing portion,
In some embodiments, the first filter means comprise a first filter comprising a pore size less than 5.0 mm.
In some embodiments, the second filter means comprises a second filter comprising a pore size less than 500.0 micron.
In some embodiments, the blood processing apparatus comprises a top housing portion, a plurality of interconnected filter modules and a bottom housing portion,
In some embodiments, the first filter means comprise a first filter comprising a pore size less than 5.0 mm.
In some embodiments, the second filter means comprises a second filter comprising a pore size less than 500.0 micron.
In some embodiments, the third filter means comprises a third filter comprising a pore size less than 50.0 micron.
In some embodiments of the invention, there are also provided methods for processing autologous blood for reinfusion into a patient.
In one embodiment of the invention, the method for processing autologous blood comprises the steps of:
Further features and advantages will become apparent from the following and more particular description of the preferred embodiments of the invention, as illustrated in the accompanying drawings, and in which like referenced characters generally refer to the same parts or elements throughout the views, and in which:
Before describing the present invention in detail, it is to be understood that this invention is not limited to particularly exemplified systems, apparatus, structures or methods as such may, of course, vary. Thus, although a number of systems, apparatus, structures and methods similar or equivalent to those described herein can be used in the practice of the present invention, the preferred systems, apparatus, structures and methods are described herein.
It is to be understood that the terminology used herein is for the purpose of describing particular embodiments of the invention only and is not intended to be limiting. The present invention is thus to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed.
It is also to be understood that language used in this specification should not be interpreted as a general disavowal of any one specific embodiment or used to limit the claims beyond the meaning of the terms used therein.
Further, unless defined otherwise, all technical and scientific terms used in this specification have the same meaning as commonly understood by one having ordinary skill in the art to which the invention pertains.
It is also understood that the general principles defined herein can be applied to other embodiments and applications without departing from the spirit and scope of the invention.
It is also understood that any feature or component described in association with a specific embodiment may be used and implemented with any other embodiment unless clearly indicated otherwise.
Further, all publications, patents and patent applications cited herein, whether supra or infra, are hereby incorporated by reference in their entirety.
The term “surgical procedure”, as used herein, means an invasive medical procedure characterized by purposeful/deliberate access to the body via an incision or percutaneous puncture, where blood can, and often will be exhibited.
The term “surgical procedure”, as used herein, thus includes, without limitation, the following surgical procedures: cardiac surgery procedures, such as coronary artery bypass grafting (CABG), valve replacement and repair, and aortic aneurysm repair; orthopedic surgery procedures; spinal surgery procedures; neurosurgery procedures, such as craniotomy; tumor resection procedures; organ transplant procedures; and trauma surgery procedures, such as trauma resuscitation and emergency surgical hemostasis.
The term “surgical procedure”, as used herein, also includes, without limitation, interventional cardiology procedures, such as coronary angiography, percutaneous coronary intervention (PCI), angioplasty, coronary stent placement, atherectomy, and transcatheter aortic valve replacement (TAVR); interventional vascular surgery procedures, such as endovascular aneurysm repair; interventional neurosurgery procedures, such as aneurysm coiling and arteriovenous malformation (AVM) procedures; and interventional trauma procedures.
The term “impurity”, as used herein in connection with blood, means and includes, without limitation, blood clots, tissue debris, hair, foreign particles, activated coagulation factors, denatured proteins, plasma free hemoglobin, and any other fluid (e.g., irrigation fluid) introduced into the surgical site by medical personnel.
The terms “thrombus” and “occlusion” are used interchangeably herein and mean and include unwanted or undesired material disposed in a patient's veins or arteries that is partially or completely obstructing the flow of blood.
The term “purified blood”, as used herein, means whole blood substantially devoid of impurities and unwanted cellular and blood components.
The terms “one embodiment”, “one aspect”, “an embodiment” and “an aspect”, as used herein, mean that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment and not that any particular embodiment is required to have a particular feature, structure or characteristic described herein unless set forth in the claim.
The phrase “in one embodiment” or similar phrases employed herein do not limit the inclusion of a particular element of the invention to a single embodiment. The element can thus be included in other, or all embodiments discussed herein.
The term “substantially”, as used herein, means and includes the complete or nearly complete extent or degree of an action, characteristic, property, state, structure, item, or result to function as indicated. For example, an object that is “substantially” enclosed would mean that the object is either completely enclosed or nearly completely enclosed. The exact allowable degree of deviation from absolute completeness may in some cases depend on the specific context, such that enclosing nearly all the length of a lumen would be substantially enclosed, even if the distal end of the structure enclosing the lumen had a slit or channel formed along a portion thereof.
Use of the term “substantially” is equally applicable when used in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result. For example, a structure which is “substantially free of” a bottom would either completely lack a bottom or so nearly completely lack a bottom that the effect would be effectively the same as if it completely lacked a bottom.
The term “comprise” and variations of the term, such as “comprising” and “comprises,” means “including, but not limited to” and is not intended to exclude, for example, other components, elements or steps.
The following disclosure is provided to further explain in an enabling fashion the best modes of performing one or more embodiments of the present invention. The disclosure is further offered to enhance the understanding and appreciation for the inventive principles and advantages thereof, rather than to limit in any manner the invention. The invention is defined solely by the appended claims, including any amendments made during the pendency of this application, and all equivalents of those claims as issued.
As indicated above, described herein are blood reinfusion systems, apparatus and methods for processing autologous blood for reinfusion into a patient.
It is, however, to be understood that, although the systems, apparatus and methods are primarily described in connection with processing autologous blood for reinfusion into a patient, the systems, apparatus and methods are not limited to such application. According to the invention, the systems, apparatus and methods of the invention can also be readily employed to process non-autologous blood for transfusion into a patient.
As discussed in detail herein, the blood reinfusion systems, apparatus and methods of the invention provide numerous significant advantages over conventional blood reinfusion systems. Among the advantages are the following:
A further advantage of the blood reinfusion systems, apparatus and methods of the invention is that they can be promptly and readily employed during a multitude of surgical and interventional medical procedures, including, without limitation, invasive cardiac procedures, such as coronary artery bypass grafting (CABG), valve replacement and repair, and aortic aneurysm repair; orthopedic surgery procedures; spinal surgery procedures; neurosurgery procedures, such as craniotomy; tumor resection procedures; organ transplant procedures; thrombectomy procedures; interventional cardiology procedures, such as percutaneous coronary intervention (PCI) and transcatheter aortic valve replacement (TAVR); interventional vascular procedures, such as endovascular aneurysm repair; interventional neurosurgery procedures, such as aneurysm coiling and arteriovenous malformation (AVM) procedures; and various trauma procedures.
The blood reinfusion systems, apparatus and methods of the invention can also be readily employed at temporary trauma sites, such as a field hospital or trauma center in a combat zone, and permanent trauma treatment facilities and centers, such as in an emergency room or an intensive care unit (ICU).
As discussed in detail below, in a preferred embodiment, the blood reinfusion systems of the invention comprise (i) first blood collection means adapted to receive aspirated autologous blood from a patient, (ii) blood processing means in communication with the first blood collection means adapted to process the autologous blood, and (iii) second blood collection means in communication with the processing means adapted to receive the autologous blood after processing.
As also discussed in detail herein, in some embodiments, the blood reinfusion systems of the invention comprise multiple separate first blood collection means and/or multiple separate second blood collection means.
In some embodiments, the blood reinfusion systems of the invention comprise modular systems, i.e., the blood collection means is detachably coupled to the blood processing means.
In some embodiments, the blood reinfusion systems of the invention further comprise sensor means adapted to monitor the volume of blood (and impurities mixed therewith) in the first blood collection means.
In some embodiments, the blood reinfusion systems of the invention further comprise sensor means adapted to monitor blood flow through the blood processing means.
In some embodiments, the blood reinfusion systems of the invention further comprise (i) aspiration means configured and adapted to collect autologous blood from a surgical site of a patient and (ii) control means programmed to control the aspiration means.
In some embodiments of the invention, the blood reinfusion systems further comprise integral transfusion means for reinfusing the processed (i.e., purified) autologous blood into the patient.
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Each of the noted system components is described in detail below.
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According to the invention, the internal filter 220 can comprise any pore size.
Preferably, the internal filter 220 comprises a pore size less than approximately 10.0 mm.
Thus, in some embodiments, the internal filter 220 comprises a pore size less than approximately 5.0 mm.
In some embodiments, the internal filter 220 comprises a pore size in the range of approximately 3.0 mm to 5.0 mm.
In some embodiments, the internal filter 220 comprises a pore size in the range of approximately 1.0 mm to 2.0 mm.
In some embodiments, the internal filter 220 comprises a pore size in the range of approximately 40.0 micron to 1000.0 micron.
In some embodiments, the internal filter 220 comprises a pore size in the range of approximately 100.0 micron to 500.0 micron.
In some embodiments, the internal filter 220 comprises a pore size in the range of approximately 200.0 micron to 300.0 micron.
In some embodiments, the internal filter 220 comprises a pore size less than approximately 250.0 micron.
In some embodiments, the internal filter 220 comprises a pore size in the range of approximately 170.0 micron to 260.0 micron.
In some embodiments, the internal filter 220 comprises a pore size in the range of approximately 150.0 micron to 225.0 micron.
In some embodiments, the internal filter 220 comprises a pore size in the range of approximately 50.0 micron to 100.0 micron.
In some embodiments, the internal filter 220 comprises a pore size less than approximately 50.0 micron.
In some embodiments, the internal filter 220 comprises a pore size in the range of approximately 10.0 micron to 40.0 micron.
In a preferred embodiment, the internal filter 220 comprises a pore size of approximately 4.0 mm.
In a preferred embodiment, the internal filter 220 comprises a domed (or convex) or cone shape and is positioned in the suction canister 200a in an upward trajectory.
According to the invention, the suction canister 200a can comprise additional filters comprising any of the pore sizes referenced above. Thus, in some embodiments, the suction canister 200a comprises at least one additional filter comprising a pore size of approximately 500.0 microns or smaller.
According to the invention, the suction canister 200a is thus configured and adapted to receive autologous blood from a patient and isolate and extract first impurities from the autologous blood, whereby first processed autologous blood is obtained.
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According to the invention, the suction canister 200a can comprise any configuration and size. In a preferred embodiment, the suction canister 200a is sized and configured to receive and contain in the range of 200.0 ml to 1000.0 ml of fluid, e.g., autologous blood. In some embodiments of the invention, the suction canister 200a is sized and configured to receive and contain approximately 500.0 ml of fluid.
As indicated above and discussed in detail below, in some embodiments of the invention, the blood reinfusion system 100a comprises two suction canisters; each canister being in communication with the blood filter 300, discussed below.
As depicted in
Referring now to
In a preferred embodiment, the blood filter assembly 300 comprises one embodiment of the filter assembly disclosed in priority U.S. application Ser. No. 18/220,373, which, as depicted in
According to the invention, the blood filter assembly 300 can also comprise a two-stage filter system comprising the top housing portion 306, first intermediate housing portion 308 and a bottom housing portion 312; the top housing portion 306 and first intermediate housing portion 308 similarly comprising at least one filter.
The blood filter assembly 300 can also comprise additional intermediate housing portions, such as a third and fourth intermediate housing portion, wherein each additional intermediate housing portion would similarly comprise at least one filter.
The intermediate housing portions of the blood filter assembly 300, e.g., first intermediate housing portion 308, are also referred to herein as “filter modules”.
As set forth in priority U.S. application Ser. No. 18/220,373 and depicted in
In some embodiments, the first reservoir 314 preferably comprises a volume in a range of approximately 60.0 ml to 300.0 ml and the second reservoir 316 preferably comprises a volume in a range of approximately 100.0 ml to 400.0 ml.
As set forth in priority U.S. application Ser. No. 18/220,373, the top housing portion 306 of the blood filter assembly 300 comprises a first filter 320a, the first intermediate housing portion 308 comprises a second filter 320b, and the second intermediate housing portion 310 comprises a third filter 320c.
According to the invention, the first, second and third filters 320a, 320b, 320c can similarly comprise any suitable pore size.
Preferably, the first filter 320a and/or second filter 320b and/or third filter 320c comprises a pore size less than approximately 10.0 mm.
Thus, in some embodiments, the first filter 320a and/or second filter 320b and/or third filter 320c comprises a pore size less than approximately 5.0 mm.
In some embodiments, the first filter 320a and/or second filter 320b and/or third filter 320c comprises a pore size in the range of approximately 3.0 mm to 5.0 mm.
In some embodiments, the first filter 320a and/or second filter 320b and/or third filter 320c comprises a pore size in the range of approximately 1.0 mm to 2.0 mm.
In some embodiments, the first filter 320a and/or second filter 320b and/or third filter 320c comprises a pore size in the range of approximately 40.0 micron to 1000.0 micron.
In some embodiments, the first filter 320a and/or second filter 320b and/or third filter 320c comprises a pore size in the range of approximately 100.0 micron to 500.0 micron.
In some embodiments, the first filter 320a and/or second filter 320b and/or third filter 320c comprises a pore size in the range of approximately 200.0 micron to 300.0 micron.
In some embodiments, the first filter 320a and/or second filter 320b and/or third filter 320c comprises a pore size less than approximately 250.0 micron.
In some embodiments, the first filter 320a and/or second filter 320b and/or third filter 320c comprises a pore size in the range of approximately 170.0 micron to 260.0 micron.
In some embodiments, the first filter 320a and/or second filter 320b and/or third filter 320c comprises a pore size in the range of approximately 150.0 micron to 225.0 micron.
In some embodiments, the first filter 320a and/or second filter 320b and/or third filter 320c comprises a pore size in the range of approximately 50.0 micron to 100.0 micron.
In some embodiments, the first filter 320a and/or second filter 320b and/or third filter 320c comprises a pore size less than approximately 50.0 micron.
In some embodiments, the first filter 320a and/or second filter 320b and/or third filter 320c comprises a pore size in the range of approximately 10.0 micron to 40.0 micron.
In a preferred embodiment, the first filter 320a comprises a pore size in the range of approximately 1.0 mm to 5.0 mm, more preferably, a pore size of approximately 4.0 mm, even more preferably, a pore size of approximately 2.0 mm.
In a preferred embodiment, the second filter 320b comprises a pore size in the range of approximately 40.0 micron to 1000.0 micron, more preferably, a pore size less than approximately 500.0 micron, even more preferably, a pore size in the range of approximately 170.0 micron to 260.0 micron.
In a preferred embodiment, the third filter 320c comprises a pore size less than 50.0 micron, more preferably, a pore size in the range of approximately 10.0 micron to 40.0 micron, even more preferably, a pore size of approximately 40.0 micron.
In a preferred embodiment of the invention, the first filter 320a is configured and adapted to receive the first processed autologous blood from the suction canister 200a and isolate and extract first excess, i.e. remaining, impurities from the first processed autologous blood, whereby second processed autologous blood is obtained, the second filter 320b is adapted to receive the second processed autologous blood from the first filter 320a and isolate and extract second excess impurities from the second processed autologous blood, whereby third processed autologous blood is obtained, and the third filter 320c is adapted to receive the third processed autologous blood from the second filter 320b and isolate and extract third excess impurities from the third processed autologous blood, whereby purified autologous blood, i.e., whole autologous blood substantially devoid of blood clots, emboli, tissue debris, foreign particles, etc., is obtained.
According to the invention, the first, second and third filter 320a, 320b, 320c can comprise any acceptable surgical material, e.g., stainless steel, and form. In a preferred embodiment, the first filter 320a comprises a perforated filter and the second and third filters 320b, 320c comprise mesh filters.
In some embodiments of the invention, the first intermediate portion 308 or the second intermediate portion 310 of the blood filter 300 comprises or includes a membrane filter, comprising a pore size in the range of approximately 0.0001 micron to 100.0 micron.
In some embodiments of the invention, the second intermediate portion 310 of the blood filter 300 comprises or includes an emboli filter adapted to remove residual air, if any, from the processed autologous blood.
In a preferred embodiment, the top housing portion 306, first intermediate housing portion 308, and second intermediate housing portion 310 are detachably coupled in succession, whereby the autologous blood is successively filtered through filters 320a, 320b, and 320c by gravity, i.e., a gravitational force.
In some embodiments of the invention, as discussed below, the blood filter assembly 300 includes means for providing negative pressure therein, wherein the autologous blood is successively filtered and, hence, processed through filters 320a, 320b, and 320c via the negative pressure in the blood filter assembly 300.
In a preferred embodiment, the top housing portion 306, the first intermediate housing portion 308, the second intermediate housing portion 310, and the bottom housing portion 312 are readily detachable from one another for ease of access and cleaning of the respective housing portions and cleaning and replacing the filters 320a, 320b, and 320c.
As set forth in priority U.S. application Ser. No. 18/220,373 and depicted in
In a preferred embodiment, the inlet port 330 comprises a luer connector to facilitate releasable connection of the suction canister 200a to the blood filter assembly 300.
As depicted in
In a preferred embodiment, the outlet port 332 similarly comprises a luer connector to facilitate releasable connection of the blood filter assembly 300 to the blood collection container 400a.
As further set forth in priority U.S. application Ser. No. 18/220,373, in some embodiments, the inner walls of the top housing portion 306 comprise channels that allow for the first filter 320a, when inserted into the top housing portion 306 from the bottom of the top housing portion 306 (when the top housing portion 306 is detached from the first intermediate housing portion 308), to be twisted in a first direction and be locked in place, and twisted in a second direction (opposite to the first direction) to unlock.
As also set forth in priority U.S. application Ser. No. 18/220,373, in some embodiments, a flow redirector element is positioned above and proximate each of the filters 320a, 320b, 320c, to bias and control the blood flow thereto, e.g., blood flow towards a side or portion of the filters. By configuring the flow redirector element in such manner, impurity accumulation is focused to a portion of the filters while the remaining portion(s) of the filters remains open and unobstructed.
According to the invention, the plane of the flow redirector element can be inclined at any desired predefined angle, e.g., 30.0 degrees to 45.0 degrees from a horizontal plane.
In some embodiments, the predefined angle of the flow redirector element ranges from approximately 0.0 degrees to 60.0 degrees from the horizontal plane.
As further set forth in priority U.S. application Ser. No. 18/220,373 and depicted in
Further features and embodiments of the blood filter assembly 300 are set forth in U.S. application Ser. No. 18/220,373, which is expressly incorporated by reference herein in its entirety.
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According to the invention, the valve assembly 304 can comprise any suitable valve assembly including, without limitation, a passive (one-way) valve assembly, an active valve assembly and a multi-way valve assembly.
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In some embodiments of the invention, the top housing portion 306 of the blood filter 300 further comprises an agent inlet configured and adapted to deliver blood processing agents and compositions into blood filter assembly 300, when it is desired to mix such agents and/or compositions with the autologous blood. In some embodiments, the blood processing agents and compositions are pre-loaded in the top housing portion 306 and/or bottom housing portion 312 in a powdered or lyophilized form.
Exemplar blood processing agents and compositions include, without limitation, anticoagulants, such as heparin or coumadin; thrombolytics, such as tissue plasminogen activator (tPA), streptokinase, or urokinase; and hormones, such as erythropoietin (EPO).
As indicated above, the blood collection containers of the invention are configured and adapted to receive and contain the processed autologous blood from the blood filter assemblies of the invention.
According to the invention, the blood collection containers can comprise any configuration and size. In one preferred embodiment, the blood collection containers comprise a blood collection (or transfer) bag, such as a blood transfer or transfusion bag, to facilitate reinfusion of the processed autologous blood into a patient.
In the noted preferred embodiment, the blood collection bag preferably comprises a size or capacity in the range of 200 ml to 1000 ml.
In a preferred embodiment, the blood collection containers of the invention are also configured and adapted to receive blood processing agents and compositions, including, without limitation, the aforementioned blood processing agents and compositions, therein.
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In some embodiments, one or more of the aforementioned blood processing agents and compositions are pre-loaded in the blood collection container 400a in a powdered or lyophilized form.
As indicated above, the blood reinfusion system 100a can further comprise two (2) blood collection containers; each adapted to couple to the blood filter assembly 300.
As indicated above, according to the invention, the blood reinfusion system 100a can also comprise a modular system, wherein the suction canister 200a and blood filter assembly 300 are detachably coupled and thus the blood filter inlet line 302 of the blood filter assembly 300 is eliminated, or the suction canister 200a, blood filter assembly 300 and blood collection container 400a are detachably coupled and thus the blood filter inlet line 302 and blood filter outlet line 305 of the blood filter assembly 300 are eliminated.
According to the invention, the noted modular systems can further comprise on-off switches at the interconnections between the suction canister 200a and blood filter assembly 300, and the blood filter assembly 300 and bag(s) 400a, if part of the modular system.
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In a preferred embodiment, the negative pressure means, i.e., means for providing the suction force though the aspiration catheter 606, comprises a conventional pump assembly 602.
In a preferred embodiment, the pump assembly 602 is configured and adapted to generate and provide a negative pressure in the suction canister 200a via negative pressure line 604, which provides the suction force though the aspiration catheter 606 connected thereto.
In a preferred embodiment, the pump assembly 602 is configured and adapted to provide a negative pressure up to −400 mm Hg.
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According to the invention, blood reinfusion systems 100b and 100c can also comprise modular systems, such as the modular blood reinfusion system 100a, described above.
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To facilitate communication of the inner blood collection bag 400c with the blood filter 300 and, hence, receipt of processed blood therefrom (denoted “402” in
To facilitate the noted communication of the blood inlet 415 of the container cap 414 with the blood inlet line 424 of the inner blood collection bag 400c, the blood inlet 415 preferably extends into the inner fluid reservoir 412 of the outer container 410 when the top cap 414 is engaged thereto.
According to the invention, blood flow into and through the blood filter 300 and, thereby into the inner blood collection bag 400c is facilitated by the negative pressure (or vacuum) of the external aspiration system and, hence, catheter 1000 (and, hence, aspiration system). In addition to the processed blood transmitted through the blood filter 300, the inner blood collection bag 400c thus may, and, in all likelihood will, contain undesirable air. However, according to the invention, when the external aspiration catheter 1000 is disconnected from the blood filter 300 (and, hence, the negative pressure in the system 100d is released), the inner blood collection bag 400c relaxes and, hence, contracts, and the air in the bag 400c is released via air vent 419 when unsealed.
In a preferred embodiment, the outer container 410 of the blood collection container 400b comprises a rigid structure, such as, by way of example, a polypropylene housing or case, which secures the inner blood collection bag 400c in a sealed, sterile protective structure.
According to the invention, the blood outlet line 305 of the blood filter 300 can similarly comprise a valve assembly, such as valve assembly 304 depicted in
According to the invention, one or more of the aforementioned agents and compositions, e.g., anticoagulants, can be pre-loaded into the blood collection bag 400c in a powdered or lyophilized form.
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According to the invention, valve assemblies 425 can be disposed in the blood outlet line 305 proximate each blood collection container 400b to modulate blood flow into the containers 400b. In such embodiments, the blood reinfusion system 100e would further comprise control means programmed and configured to control the valve assemblies, such as control means 500 depicted in
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According to the invention, the purified autologous blood is reinfused into the patient via a transfusion line (i.e., conduit means) 702, which is connected directly to the blood outlet line 305 of the blood filter 300.
According to the invention, the blood reinfusion system 100d can also comprise a modular system, wherein the blood filter assembly 300 and blood collection container 400b are interconnected and thus the blood filter outlet line 305 of the blood filter assembly 300 is eliminated.
According to the invention, the noted modular systems can similarly further comprise an on-off switch at the interconnection between the blood filter assembly 300 and blood collection container 400b.
According to the invention, the suction canisters 200a, 200b of the blood reinfusion systems of the invention can further comprise integral suction canister/filter assemblies, i.e., the suction canisters comprise an internal filter system comprising a plurality of filters.
According to the invention, the plurality of filters can comprise any suitable pore size, including, without limitation, the filter pore sizes referenced above.
Thus, in some embodiments of the invention, the internal filter system comprises three (3) separate filters: a first filter comprising a pore size less than approximately 5.0 mm, a second filter comprising a pore size less than approximately 300.0 micron, and a third filter comprising a pore size less than approximately 50.0 micron.
In some embodiments of the invention, the internal filter system comprises four (4) separate filters: a first filter comprising a pore size less than approximately 5.0 mm, a second filter comprising a pore size less than approximately 3.0 mm, a third filter comprising a pore size less than approximately 300.0 micron, and a fourth filter comprising a pore size less than approximately 50.0 micron.
Referring now to
As illustrated in
Referring now to
As depicted in
In a preferred embodiment, the outlet 512 of the blood processing canister 500 comprises a one-way valve 513 that is adapted to allow blood flow into and through the outlet 512 when the blood collection container 530 is coupled thereto and automatically close and seal the outlet 512 when the blood collection container 530 is decoupled therefrom.
As further depicted in
As further depicted in
According to the invention, filters 510a, 510b, 510c and 510d can comprise any suitable pore size, including, without limitation, the filter pore sizes referenced above.
In a preferred embodiment of the invention, the first filter, i.e. filter 510a, comprises a pore size less than approximately 10.0 mm, more preferably, a pore size in the range of approximately 3.0 mm to 5.0 mm, the second filter, i.e. filter 510b, comprises a pore size less than approximately 5.0 mm, more preferably, a pore size in the range of approximately 1.0 mm to 3.0 mm, the third filter, i.e. filter 510c, comprises a pore size less than approximately 300.0 micron, more preferably, a pore size in the range of approximately 100.0 micron to 200.0 micron, even more preferably, a pore size in the range of approximately 140.0 micron to 160.0 micron, and the fourth filter, i.e. filter 510d, comprises a pore size less than approximately 100.0 micron, more preferably, a pore size in the range of approximately 30.0 micron to 60.0 micron.
In a preferred embodiment of the invention, filter 510a is configured and adapted to receive initially processed autologous blood from at least one suction canister, e.g., suction canister 200a, and isolate and extract first excess, i.e. remaining, impurities from the initially processed autologous blood, whereby first processed autologous blood is obtained, filter 510b is adapted to receive the first processed autologous blood from filter 510a and isolate and extract second excess impurities from the first processed autologous blood, whereby second processed autologous blood is obtained, filter 510c is adapted to receive the second processed autologous blood from filter 510b and isolate and extract third excess impurities from the second processed autologous blood, whereby third processed autologous blood is obtained, and filter 510d is adapted to receive the third processed autologous blood from filter 510c and isolate and extract fourth excess impurities from the third processed autologous blood, whereby purified autologous blood, i.e., whole autologous blood substantially devoid of blood clots, emboli, tissue debris, foreign particles, etc., is obtained.
According to the invention, filters 510b, 510c and 510d can also comprise a membrane filter, comprising a pore size in the range of approximately 0.0001 micron to 100.0 micron.
According to the invention, filters 510a, 510b, 510c and 510d can also comprise any configuration. In a preferred embodiment, at least filters 510b, 510c and 510d comprise a domed (or convex) shape or, as depicted in
As depicted in
In a preferred embodiment, filters 510a, 510b, 510c and 510d are removably attached to the inner wall 505 of the blood processing canister 500 to facilitate removal for cleaning and replacement, if necessary.
In some embodiments, the blood processing canister 500 thus further comprises a removable bottom 507 that facilitates access to filters 510a, 510b, 510c and 510d.
In a preferred embodiment, the blood processing canister 500 (i.e., top and/or bottom collection chamber 504, 506 thereof) and/or internal chamber 532 of the blood collection container 530 is/are further configured and adapted to receive the aforementioned processing agents and compositions, e.g., thrombolytics, therein, when it is desired to mix such agents and/or compositions with the autologous blood.
Referring now to
As depicted in
According to the invention, the blood processing canister 500 can comprise any suitable internal volume. In a preferred embodiment, the top and bottom collection chambers 504, 506 comprise a volume of at least 500 cc.
As indicated above and depicted in
As depicted in
As further depicted in
As additionally depicted in
According to the invention, the internal chamber 532 of the blood collection container 530 can similarly comprise any suitable internal volume. In a preferred embodiment, the internal chamber 532 of the collection container 530 similarly comprises a volume of at least 500 cc.
According to the invention, the blood processing canister 500 can further comprise sensor means adapted to monitor the flow of fluid, e.g., autologous blood, through the blood processing canister 500 and/or volume of fluid disposed in the internal chamber 532 of the blood collection container 530.
According to the invention, the inlet 533 of the blood collection container 530 or outlet 512 of the blood processing canister 500 can comprise a further system filter to further isolate and capture impurities mixed with blood transmitted through the blood processing canister 500. The additional system filter can similarly comprise any of the aforementioned filter pore sizes, preferably, a pore size less than approximately 50.0 micron.
According to the invention, the inlet 533 of the blood collection container 530 or outlet 512 of the blood processing canister 500 can also comprise an emboli filter adapted to remove residual air, if any, from the processed autologous blood.
As indicated above, although the systems, apparatus and methods of the invention described above are primarily described in connection with processing autologous blood for reinfusion into a patient, the systems, apparatus and methods of the invention can also be readily employed to process non-autologous blood for transfusion into a patient.
In one aspect of the invention, there is provided a blood processing apparatus that is configured and adapted to process autologous and/or non-autologous blood for transfusion into a patient.
In some embodiments, the blood processing apparatus comprises a top housing portion, a plurality of interconnected filter modules and a bottom housing portion,
In some embodiments, the blood processing apparatus comprises a top housing portion, a plurality of interconnected filter modules and a bottom housing portion,
According to the invention, the first, second and third filter means of the blood processing apparatus can comprise filters comprising any of the aforementioned pore sizes.
As also indicated above, a major advantage of the blood reinfusion systems, apparatus and methods of the invention is that they can be promptly and readily employed during a multitude of surgical and interventional medical procedures, including, without limitation, invasive cardiac procedures, such as coronary artery bypass grafting (CABG), valve replacement and repair, and aortic aneurysm repair; orthopedic surgery procedures; spinal surgery procedures; neurosurgery procedures, such as craniotomy; tumor resection procedures; organ transplant procedures; thrombectomy procedures; interventional cardiology procedures, such as percutaneous coronary intervention (PCI) and transcatheter aortic valve replacement (TAVR); interventional vascular procedures, such as endovascular aneurysm repair; interventional neurosurgery procedures, such as aneurysm coiling and arteriovenous malformation (AVM) procedures; and various trauma procedures.
Exemplar procedures using a blood reinfusion system of the invention are set forth below.
A SI joint prosthesis, such as prosthesis 70, depicted and described in U.S. application Ser. No. 18/107,563 is provided.
The OR aspiration system is initially engaged to at least one suction canister 200a, 200b (or both) of blood reinfusion system 100a, as depicted in
An incision in and through tissue of the patient is made to provide posterior access to the patient's dysfunctional SI joint; preferably, a 2.0 cm to 3.0 cm incision.
The aspiration catheter, e.g., aspiration catheter 1000, is disposed proximate the incision site, i.e., body cavity formed via the incision, and engaged.
Thereafter, a guide bore is created in the dysfunctional SI joint, and a guide pin is inserted therein.
After the guide pin is inserted in the dysfunctional SI joint, a pilot opening is created in the dysfunctional SI joint with a tool assembly, the pilot opening comprising a first portion in the ilium bone structure and a second portion in the sacrum bone structure.
Thereafter, the tool assembly is removed, and the dysfunctional SI joint is flushed with a saline solution—the aspiration catheter 1000 continually aspirating the autologous blood of the patient, bone fragments, saline, etc. at the incision site and delivering the mixture of blood and other impurities into and through the blood reinfusion system 100a for processing by the blood filter assembly 300.
After the tool assembly is removed and the SI joint is flushed, the prosthesis 70 is advanced into the pilot opening in the SI joint.
After the procedure is completed and before the incision is sutured, the aspiration catheter 1000 is removed from the incision site and the aspiration system is disengaged.
The incision site is thereafter sutured and, hence, closed.
After the incision site is closed, the blood collection container 400a is disconnected from the blood filter assembly 300. A transfusion line is thereafter attached to the outlet 409 of the blood collection container 400a and the blood collection container 400a is mounted on an IV stand. Thereafter, the transfusion line is disposed in a blood vessel of the subject, wherein the processed autologous blood is reinfused into the patient.
As indicated above, the blood reinfusion systems, apparatus and methods of the invention can also be readily employed during thrombectomy procedures to remove occlusions and unwanted matter, such as thrombi or clots, from an artery or vein in a patient.
An exemplar thrombectomy procedure with the thrombectomy apparatus 2800 depicted in
The OR aspiration system is initially connected to the aspiration catheter 2835 of the thrombectomy apparatus 2800. The aspiration catheter 2835 is thereafter connected to a blood reinfusion system of the invention, in this instance blood reinfusion system 100a.
The delivery catheter 2848 (with the aspiration catheter 2835 disposed therein, as described in priority U.S. application Ser. No. 18/220,373) is disposed in the patient's vessel, e.g., artery, proximate the occlusion, as described in priority U.S. application Ser. No. 18/220,373.
After the delivery catheter 2848 is disposed in the patient's vessel proximate the occlusion, the occlusion (and material thereof) is dislodged from the vessel with the thrombectomy apparatus 2800 and the occlusion (and material thereof) and autologous blood proximate thereto are aspirated into the aspiration catheter 2835, as described in U.S. application Ser. No. 18/220,373, and thereafter into the blood filter 300, wherein the autologous blood is processed, in this instance, the occlusion (and material thereof) is filtered from the autologous blood.
After the occlusion (and material thereof) is dislodged from the vessel and aspirated into the aspiration catheter 2835, the delivery catheter 2848 is extracted out of the vessel.
After the delivery catheter 2848 is extracted out of the vessel, the blood collection container 400a is disconnected from the blood filter 300. A transfusion line is thereafter attached to the outlet 409 of the blood collection container 400a and the blood collection container 400a is mounted on an IV stand.
Thereafter, the transfusion line is disposed in a blood vessel of the subject, wherein the processed autologous blood is reinfused into the patient.
The following examples are provided to enable those skilled in the art to more clearly understand and practice the present invention. The examples should not be considered as limiting the scope of the invention, but merely as being illustrated as representative thereof.
Referring now to
The thrombosed blood and saline mixture was then injected into and though the blood delivery line and introduced into the suction canister 200a of the blood reinfusion system 100a and into and though filters 320a, 320b, and 320c of the blood filter assembly 300.
Another 60 cc syringe was then connected to the outlet 409 of the blood collection container 400a and the processed blood was drawn into the syringe.
A ten (10) cc portion of the blood processed with the blood filter assembly 300 was then injected into a petri dish and visually examined for impurities to determine the filtration efficacy of the blood filter assembly 300 and, hence, blood reinfusion system 100a. The remaining portion of the processed blood was then filtered through a 40 μm filter (denoted 3000 in
Referring now to
As depicted in
To evaluate the effect on erythrocyte integrity of porcine blood after processing with a reinfusion system of the invention, fifty (50) cc of untreated porcine blood was collected and divided into ten (10) cc and forty (40) cc samples. The 10 cc sample was left untreated and the 40 cc sample was processed via the blood reinfusion system 100a depicted in
The filtered 40 cc sample was then collected from the blood collection container 400a of the blood reinfusion system 100a for analysis.
The filtered 40 cc sample and the untreated 10 cc sample were then micro-histologically evaluated to determine erythrocyte integrity. Serum calcium (Ca), serum potassium (K), and hematocrit percent (Hct %) were determined for both the filtered 40 cc sample and the untreated 10 cc sample.
Micro-histologic evaluation of both the filtered 40 cc sample and the untreated 10 cc sample showed no significant differences in erythrocyte morphology. Based on the blood smear review, the erythrocytes and platelets in the filtered 40 cc sample and the untreated 10 cc sample similarly displayed no significant morphologic abnormalities.
As shown in Table I below, there also were no significant differences between the unfiltered control and the filtered sample in terms of serum potassium, serum calcium and Hct %.
The difference in platelet counts between the filtered 40 cc sample and the untreated 10 cc sample reflected in Table I were due to platelet clumping in the unfiltered sample.
To evaluate the effect on erythrocyte integrity of human blood after processing with a reinfusion system of the invention, fifty (50) cc of untreated human blood was collected and divided into ten (10) cc and forty (40) cc samples. The 10 cc sample was left untreated and the 40 cc sample was processed via the blood reinfusion system 100a depicted in
The filtered 40 cc sample was then collected from the blood collection container 400a of the blood reinfusion system 100a for analysis.
The filtered 40 cc sample and the untreated 10 cc sample were then micro-histologically evaluated to determine erythrocyte integrity. Lactate dehydrogenase (LDH), total bilirubin, aspartate aminotransferase (AST), alanine transaminase (ALT), albumin, serum potassium (K), hematocrit percent (Hct %), and platelet concentration were similarly determined for the filtered 40 cc sample and the untreated 10 cc sample.
Micro-histologic evaluation of both the filtered 40 cc sample and the untreated 10 cc sample similarly showed no significant differences in erythrocyte morphology. The erythrocytes and platelets in the filtered 40 cc sample and the untreated 10 cc sample similarly reflected no significant morphologic abnormalities.
As shown in Table II below, there were also no significant differences between the unfiltered control and the filtered sample in terms of total bilirubin, aspartate aminotransferase (AST), alanine transaminase (ALT), albumin, serum potassium (K), hematocrit percent (Hct %), and platelet concentration.
Thus, as will readily be appreciated by one having ordinary skill in the art, the present invention provides numerous significant advantages compared to prior art blood reinfusion systems and methods. Among the advantages are the following:
Without departing from the spirit and scope of this invention, one of ordinary skill in the art can make various changes and modifications to the invention to adapt it to various usages and conditions. As such, these changes and modifications are properly, equitably, and intended to be, within the full range of equivalence of the following claims.
The present application is a continuation-in-part of U.S. application Ser. No. 18/220,373, filed on Jul. 11, 2023, which claims the benefit of U.S. Pat. App. No. 63/368,325, filed on Jul. 13, 2022.
| Number | Date | Country | |
|---|---|---|---|
| 63368325 | Jul 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 18220373 | Jul 2023 | US |
| Child | 18398727 | US |
