U.S. patent application number 10/553174 was filed with the patent office on 2007-03-08 for device and machine for regenerating a human liver.
Invention is credited to Antonino Cavallari, Domenico Cianciavicchia, Bruno Pasquale Franco Nardo.
Application Number | 20070051681 10/553174 |
Document ID | / |
Family ID | 33187364 |
Filed Date | 2007-03-08 |
United States Patent
Application |
20070051681 |
Kind Code |
A1 |
Nardo; Bruno Pasquale Franco ;
et al. |
March 8, 2007 |
Device and machine for regenerating a human liver
Abstract
Device (10) and machine (1000) for regeneration of a human liver
(L). The device (10) comprises at least two catheters (11, 12) and
a three-way connection (13) between the two catheters (11, 12).
Inventors: |
Nardo; Bruno Pasquale Franco;
(Bologna, IT) ; Cavallari; Antonino; (Ponticella
Di San Lazzaro Di Savena, IT) ; Cianciavicchia;
Domenico; (Cavuccio, IT) |
Correspondence
Address: |
DARBY & DARBY P.C.
P. O. BOX 5257
NEW YORK
NY
10150-5257
US
|
Family ID: |
33187364 |
Appl. No.: |
10/553174 |
Filed: |
April 15, 2004 |
PCT Filed: |
April 15, 2004 |
PCT NO: |
PCT/IB04/01142 |
371 Date: |
October 13, 2006 |
Current U.S.
Class: |
210/645 ;
623/1.11 |
Current CPC
Class: |
A61M 1/3496 20130101;
A61M 1/3659 20140204; A61M 1/3621 20130101; A61M 1/3653
20130101 |
Class at
Publication: |
210/645 ;
623/001.11 |
International
Class: |
B01D 61/00 20060101
B01D061/00; A61F 2/06 20060101 A61F002/06 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 18, 2003 |
IT |
BO2003A000239 |
Claims
1. A device for arterialization of the portal vein comprising at
least two catheters and connection means between said two
catheters.
2. The device as claimed in claim 1, wherein said connection means
comprise a three-way connection.
3. The device as claimed in claim 1, wherein said three-way
connection comprises a tap.
4. The device as claimed in claim 2, wherein said three-way
connection comprises elements, each of which is suitable to produce
coupling of said three-way connection with the respective
catheter.
5. The device as claimed in claim 1, wherein said catheters are
heparinized and radiopaque.
6. A kit for application to the body of a patient of a device as
claimed in claim 1; the kit comprising: (i) two radiopaque and
heparinized catheters; (ii) two metal guides to insert said
catheters into the body; (iii) two syringes each having a
respective needle; (iv) two feed devices to move said guides
forward inside the body; (v) a three-way connection; and (vi) a
syringe.
7. The kit as claimed in claim 6, wherein there are various needles
having different dimensions according to the system chosen for
insertion of said catheter.
8. The kit as claimed in claim 7, wherein the dimensions of said
needle vary from 15 cm to 30 cm.
9. Use of a kit for application to the body of a patient of a
device as claimed in claim 1; said kit comprising: (i) two
radiopaque and heparinized catheters; (ii) two metal guides to
insert said catheters into a body; (iii) two syringes each having a
respective needle; (iv) two feed devices to move said guides
forward inside the body; (v) a three-way connection; and (vi) a
syringe.
10. A pack comprising at least a kit as claimed in 6.
11. A machine for regeneration of a human liver; machine comprising
at least two catheters, an extracorporeal circuit designed to
connect said two catheters and at least an oxygenation device
connected to said extracorporeal circuit, said oxygenation device
being suitable to introduce oxygen into the blood in extracorporeal
circulation in said circuit.
12. The machine as claimed in claim 11, wherein there are also
means designed to control introduction of oxygen into the blood in
extracorporeal circulation.
13. The machine as claimed in claim 12, wherein there are also
means for hemofiltration of the blood in extracorporeal
circulation.
14. The machine as claimed in claim 12, wherein said means are
designed to measure the hematocrit and the partial pressure of the
oxygen present in the blood in extracorporeal circulation.
15. The machine as claimed in claim 11, wherein there are also
means designed to heat the blood in extracorporeal circulation.
16. The machine as claimed in claim 11, wherein there are also
means designed to introduce anticoagulating substances into the
blood in extracorporeal circulation.
17. The machine as claimed in claim 11, wherein there are also
means to detect and eliminate any air bubbles present in the blood
in extracorporeal circulation.
18. A process for regeneration of a human liver, process
characterized in that oxygenated blood is sent to said liver.
19. The process as claimed in claim 18, wherein the oxygenated
blood undergoes a further hemofiltration process.
20. The process as claimed in claim 18, wherein said oxygenated
blood is sent to the portal vein.
21. The process as claimed in claim 18, wherein said oxygenated
blood is arterial blood taken from the body of the patient and
channeled towards the liver of the patient.
22. A process for regeneration of a human liver; process comprising
the following phases: (a1) filling a syringe, provided with a
needle, with a saline solution; after inserting the needle into the
right jugular vein of the patient, aspiration is performed with the
syringe until venous blood is visible; (a2) detaching the body of
the syringe and inserting a metal guide into the lumen of the
needle; making the metal guide slide, utilizing in this operation a
device; (a3) making the metal guide move through the inferior vena
cava, the right suprahepatic vein; and the portal vein; the metal
guide being blocked with one of its ends at the portal vein; (a4)
removing the needle by sliding it towards the outside on the metal
guide; (a5) inserting the metal guide into a first catheter and
making the latter slide on the metal guide until one end of the
first catheter reaches the portal vein; as the first catheter is
radiopaque, it is possible to constantly monitor its route through
the body of the patient using radiological observation; (a6)
removing the metal guide from the first catheter; (a7) connecting
the first catheter to a three-way connections, suitably positioning
a respective tap; (a8) connecting the three-way connection to a
syringe and aspirating the blood to confirm that it is effectively
portal blood; and (a9) inserting a second catheter into the femoral
artery with the system described in the previous phases and
connecting it with the three-way connection.
23. A process for regeneration of a human liver; process comprising
the following phases: (a1) piercing the skin and hepatic parenchyma
with a needle until portal blood of the patient is aspirated by
means of a syringe; (a2) detaching the body of the syringe and
inserting a metal guide into the lumen of the needle; making the
metal guide slide utilizing in this operation a device; (a3)
blocking the metal guide with one of its ends at the portal vein;
(a4) removing the needle by sliding it towards the outside on the
metal guide; (a5) inserting the metal guide into a first catheter
and making the latter slide on the metal guide until one end of the
first catheter reaches the portal vein; as the first catheter is
radiopaque, it is possible to constantly monitor its route through
the body of the patient using radiological observation; (a6)
removing the metal guide from the first catheter; (a7) connecting
the first catheter to a three-way connection, suitably positioning
a respective tap; (a8) connecting the three-way connection to a
syringe and aspirating the blood to confirm that it is effectively
portal blood; and (a9) inserting a second catheter in the femoral
artery with the system described in the previous phases and
connecting it with the three-way connection.
Description
TECHNICAL FIELD
[0001] The present invention relates to a process, and to a machine
implementing said process, for regeneration of a human liver
through treatment with oxygenated blood. This treatment may
comprise hyperoxygenation of the portal venous blood.
[0002] The present invention also relates to a device for
arterialization of the portal vein and to a relative kit for its
application to the body of a patient.
BACKGROUND ART
[0003] It is known that acute hepatic insufficiency is a serious
clinical syndrome that may be caused by various etiologic factors
(toxic, viral, vascular occlusion, low flow rate, etc.). These
factors all have the common characteristic of causing variable
degrees of necrosis of the hepatocytes. In the massive form in
which over 80% of the hepatocytes are destroyed the prognosis is
unfavourable unless a liver transplant is performed quickly. On the
other hand, it is known that a liver transplant cannot always be
performed (for example, due to sepsis, or to the advanced age of
the patient, etc.) and, even when a transplant is indicated, it
cannot always take place due to the shortage of donors.
[0004] On the other hand, current support systems, among which the
"bio-artificial liver", are essentially purifying and do not
promote hepatic regeneration, but are only useful while waiting for
an organ to become available or until the necrotic liver undergoes
a process of self-regeneration which would avoid transplant.
[0005] Instead, to promote hepatic regeneration the present
invention proposes (in a particular embodiment) arterialization of
the portal vein, or, in other words, oxygenation of portal blood
with arterial blood.
[0006] Surgical arterialization of the portal vein has proved
efficacious both clinically, where it has been used to solve
massive hepatic necrosis secondary to arterial thrombosis after
transplant, and in an experimental model in the rat in which
massive hepatic necrosis was induced by means of administering
carbon tetrachloride.
[0007] As will be explained in greater detail hereunder,
oxygenation of the portal blood is performed by means of a specific
device that can be marketed equipped with a relative kit to be
implanted in the body of the patient (see below).
[0008] Moreover, on the basis of experimental data, by oxygenating
the portal vein according to the present invention, hepatic
necrosis is resolved completely within forty-eight hours, although
a great improvement can already be observed after twenty-four
hours.
[0009] It is known that all the blood of the intestine flows
through the portal vein. The portal vein (also called "portal
trunk") originates from the union of its roots represented by the
superior mesenteric vein and the inferior mesenteric vein, which
collect blood from the intestine, and by the splenic vein which
instead conveys the blood coming from the spleen. Being venous
blood, it is therefore poorly oxygenated. This blood, which, as
mentioned, comes from the intestine and the spleen, is metabolized
by the liver and returned to the vena cava. Therefore, in the liver
as well as the arterial flow route (hepatic artery), there is also
a venous flow route (portal vein) and a discharge route (the
suprahepatic veins which discharge into the vena cava). The blood
reaches the right heart through the vena cava.
[0010] It has been experimentally observed that hyperoxygenation of
the portal blood stimulates hepatic regeneration. In other words,
the liver is an organ capable of regeneration. Therefore, in the
presence of necrosis caused by the action of toxic agents, of viral
agents or by mushroom poisoning, if oxygenated blood reaches the
portal system hepatic necrosis is resolved in 48 hours through
triggering of cellular regeneration.
[0011] There are two routes through which the liver can be
reached:
(1) through the jugular vein; or
(2) by direct injection of the liver.
[0012] It is known that the jugular vein carries blood to the right
heart. To reach the portal vein it is possible, through the jugular
vein and the right atrium, to reach the suprahepatic vena cava and
the suprahepatic veins (usually right or middle). Therefore, a
direct link is created with the portal branch (usually right) and
the portal trunk.
[0013] Arterial blood, taken for example from the femoral artery at
the groin, is at high pressure (100-120 mm of mercury) and ends up
in a low pressure portal venous system (15-20 mm of mercury), so
that a sort of "natural pumping" of arterial blood towards the
portal vein is obtained.
DISCLOSURE OF INVENTION
[0014] Therefore, the principal object of the present invention is
a device for arterialization of the portal vein according to the
characteristics claimed in claim 1.
[0015] A further object of the present invention is a kit for
application of this device to the body of a patient according to
the characteristics claimed in claim 6.
[0016] Moreover, further objects of the present invention are a
method for regeneration of a human liver and a relative machine to
carry out said method. The innovative method and the machine are
claimed in corresponding independent claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The present invention shall now be described with reference
to the accompanying drawings, which show some non-limiting
embodiments, in which:
[0018] FIG. 1 shows a device according to the present invention
applied to a human body;
[0019] FIG. 2 shows a first method of reaching the portal vein also
shown in FIG. 1;
[0020] FIG. 3 shows a second alternative way of reaching the portal
vein;
[0021] FIGS. 4 and 5 shows some components of the device according
to the present invention and of the kit designed for application of
this device to the body of a patient;
[0022] FIG. 6 shows a further component, enlarged, of the kit for
application of the device for arterialization shown in FIG. 1 to
the body of a patient; and
[0023] FIG. 7 represents a machine to efficaciously induce
regeneration of a human liver through the supply of oxygenated
blood thereto.
BEST MODE FOR CARRYING OUT THE INVENTION
[0024] In the accompanying FIGS. 1-5, the number 10 indicates a
device for arterialization of the portal vein according to the
present invention.
[0025] To fully understand the present invention it is firstly
necessary to describe some parts of the human body B.
[0026] Therefore, in the human body B the liver L, the heart H, the
portal vein VP, the vena cava VC, the jugular vein VG and the
femoral artery AF can be distinguished.
[0027] In this first particular embodiment, to reach the portal
vein VP a catheter 11 has been used which, with means to be
described in more detail hereunder, is inserted into the jugular
vein VG and reaches the heart H after passing through the vena cava
VC. From the heart H the catheter 11 is then made to advance
towards the portal vein VP.
[0028] The device also comprises a second catheter 12, which
reaches the femoral artery AF with a three-way connection 13,
represented in greater detail in FIG. 6.
[0029] As shown again in FIG. 1, by means of the device 10 the
arterial blood coming from the femoral artery AF is conveyed
towards the portal vein VP running through the catheters 12 and 11
positioned in succession with each other, according to a direction
identified by an arrow F.
[0030] For the reasons mentioned previously, oxygenation of the
portal vein VP by arterial blood taken from the femoral artery AF
induces rapid regression of necrosis of the liver L.
[0031] As shown again in FIG. 1 the device 10 is not provided with
pumping means as blood is pumped naturally, being delivered from
the femoral artery AF with a pressure of 100-120 mm of mercury to
flow towards a zone, the portal vein VP, with a pressure of 10-15
mm of mercury.
[0032] As shown in greater detail in FIG. 6, the three-way
connection 13 comprises three tubular elements 13a, 13b, 13c which
may be obtained in one piece. In particular, the tubular element
13a is, so as to speak, the ideal continuation of the tubular
element 13b, while the tubular element 13c is positioned
perpendicularly to the first two so that the three-way connection
13 is in the shape of a T. The tubular elements 13a, 13b and 13c
are connected to one another hydraulically.
[0033] Moreover, the tubular elements 13a, 13b are each provided
with a relative threaded connection capsule 14a, 14b that can be
screwed onto a respective threaded connection element 15a, 15b
positioned at one end of the respective catheter 11, 12 (see FIGS.
4-6). In other words, by screwing a respective threaded capsule
14a, 14b onto the respective threaded connection element 15a, 15b
the catheters 11, 12 are fixed to the three-way connection 13. In
this way the catheters 11, 12 are connected hydraulically to the
connection 13.
[0034] The end of a syringe S1 is inserted into the tubular element
13c, to allow the operator to ensure the catheters 11, 12 have been
inserted correctly into the portal vein VP and femoral artery AF
respectively, as shall be seen below.
[0035] As shown in FIG. 6 the three-way connection 13 also has a
tap 15, which is positioned by the operator to allow according to
choice: [0036] hydraulic connection in series of the two catheters
11, 12; [0037] hydraulic connection of the sole catheter 11 to the
syringe S1; or [0038] hydraulic connection of the sole catheter 12
to the syringe S1.
[0039] The operator will choose the position of the tap 15 as a
function of the treatment phases of the patient (see below). FIG. 3
shows, as an example, a further means of reaching the portal vein
VP. In this case the portal vein VP has been reached using a needle
A1 of a syringe S2.
[0040] FIGS. 4 and 5 show other elements that are part of a kit 100
for application of the device 10 to the body of a patient.
[0041] In particular, FIG. 4 shows the elements relative to the
catheter 11, while FIG. 5 shows the elements used to insert the
catheter 12 into the body B. The elements relative to the two
catheters 11 and 12 are similar and at times may even be identical
(see below).
[0042] If, for example, we consider the elements relative to the
catheter 11 we can see that there is a metal guide 16 with
radiopaque markers. The metal guide 16 has a diameter of 0.8 mm
with a straight and soft tip at one end and in the shape of a J at
the other end.
[0043] This metal guide 16 is pushed inside the body B by means of
a feed device 17 around which the operator squeezes his/her
fingers, using the thumb to make the metal guide 16 move
forward.
[0044] FIG. 4a shows a syringe S2 provided with a needle A1,
preferably, although not necessarily, of the 18 Ga gauge.
[0045] As shown in FIG. 4d, the catheter 11 is also provided with a
clamp 18 and a supporting element 19, which may be fixed to the
skin of the patient by suture stitches. The purpose of the clamp 18
is to protect the catheter 11 and hold it to the skin at its exit
point from the body.
[0046] The catheter 11 is made of polyurethane, it is radiopaque to
allow its position in the body B to be checked, and it is
heparinized to prevent clots from forming and clogging it. The
internal gauge of the catheter must not exceed 18 Ga.
[0047] The process for introducing the catheter 11 is as
follows:
(A) Transjugular access (FIGS. 1 and 2):
[0048] (a1) the syringe S2 is filled with a saline solution
connected to an angiocath with needle; after being inserted into
the right jugular vein VG aspiration is performed until venous
blood, easily distinguished by an expert, is visible; it is
mentioned by way of parenthesis that the angiocath is a venous
catheter available on the market and used both for arterial and
venous vascular access, while saline solution is used to improve
aspiration of the blood and prevent the introduction of air
bubbles; [0049] (a2) the body of the syringe S2 is detached and the
metal guide 16 is inserted into the lumen of the needle A1; the
metal guide 16 is made to slide, utilizing in this operation the
device 17; [0050] (a3) the metal guide 16 moves through the
inferior vena cava VC, the right suprahepatic vein and the portal
vein VP; the metal guide 16 is blocked with one of its ends at the
portal vein VP; [0051] (a4) the needle A1 is removed by sliding it
towards the outside of the metal guide 16; [0052] (a5) the metal
guide 16 is inserted into the catheter 11 and the latter is made to
slide on the metal guide 16 until one end of the catheter 11
reaches the portal vein VP; as the catheter 11 is radiopaque, it is
possible to constantly monitor its route through the body B of the
patient using radiological observation; [0053] (a6) the metal guide
16 is removed from the catheter 11; [0054] (a7) the catheter 11 is
connected to the three-way connection 13, with suitable positioning
of the tap 15; [0055] (a8) the three-way connection 13 is connected
to the syringe S1 (FIG. 1) and blood is aspirated to confirm that
it is effectively portal blood. (B) Percutaneous hepatic access
(FIG. 3): [0056] (b1) a syringe filled with saline solution is
prepared connected to an angiocath with needle; [0057] (b2) the
skin and hepatic parenchyma are pierced with a needle A1 until
portal blood is aspirated; [0058] (b3) the metal guide 16 is
inserted until reaching the portal vein VP; [0059] (b4) the
catheter 11 is introduced using the set 100 with the system
described previously; [0060] (b5) aspiration is performed to ensure
that it is effectively portal blood; [0061] (b6) the three-way
catheter 13, is connected, with suitable positioning of the tap 15;
and [0062] (b7) the three-way tap 13 is connected to the syringe S1
(FIG. 1) and blood is aspirated to confirm that it is effectively
portal blood.
[0063] As well as being radiopaque and heparinized, the properties
of the catheter 11 must allow it to remain in the lumen of the
portal vein VP for at least twenty-four hours. The gauge of the
catheter 11 must be between 1.5 mm and 2.5 mm.
[0064] The length of the catheter 11 introduced percutaneously into
the abdomen and through the liver L (FIG. 3) must be at least 70
cm.
[0065] In the case in FIG. 3, the needle A1 must be around 30 cm in
length and have a thickness of 18 Ga. If the catheter 11 is
introduced from the jugular vein VG (FIGS. 1 and 2) the needle is
around 15 cm in length.
[0066] The arterial catheter 12 shown in FIG. 3 is designed to
access the arterial system by cannulating the femoral artery AF at
the groin (FIG. 1), or through the carotid (right or left).
[0067] The other elements shown in FIG. 5 that are utilized to
introduce the catheter 12 may be identical to the elements in FIG.
4 referring to the catheter 11.
[0068] Therefore, to summarize, the possible variants relative to
the arterial and venous vascular accesses are as follows:
(a) right (or left) femoral artery with right jugular vein (FIGS.
1, 2);
(b) right (or left) femoral artery with transhepatic percutaneous
catheter (FIG. 3);
(c) right (or left) common carotid artery with right jugular vein;
and
(d) right (or left) common carotid artery with transhepatic
percutaneous artery.
[0069] The kit 100 forming a further object of the present
invention may be composed of the following elements:
(i) two radiopaque and heparinized catheters 11, 12; it is
mentioned by way of parenthesis that the catheter 12, as shown in
FIG. 5, is also provided with a clamp 18a and a supporting element
19a;
(ii) two metal guides 16, 16a (FIG. 5) for insertion of the
catheters 11, 12;
(iii) two syringes S2, S3, each with a respective needle A1, A2; in
particular, the kit 100 may be provided with two needles A1 having
different diameters according to the route chosen for insertion of
the catheter 11;
(iv) two feed devices 17, 17a (see also FIG. 5) for the guides 16,
16a;
(v) a three-way connection 15; and
(vi) a syringe S1.
[0070] If necessary, the kit 100 may also be equipped with a device
(not shown) to heat the arterial blood travelling through the
catheters 11 and 12 to avoid the danger of clots.
[0071] The advantages of the device 10 and the relative kit 100 are
many.
[0072] They are essentially due to the fact that they allow rapid
positioning of the catheters 11, 12 in order to obviate in
extremely quick times occurring problems of liver necrosis.
[0073] The elements of which the kit 100 is composed may be sold in
a pack (not shown) of transparent plastic material having the
prescribed requirements relative to hygiene.
[0074] The blood travelling through the two catheters 11, 12 should
have no problems of coagulation. In any case, as mentioned, the kit
100 may be completed with a device (not shown) in the form of a
sleeve provided with heating elements, if necessary electric, to
heat the portions of the catheters 11, 12 outside the body B.
[0075] To increase the efficacy of the treatment described
hereinbefore a machine 1000, represented in FIG. 7, has been
devised.
[0076] In the embodiment in FIG. 7, the machine 1000 is connected
to the body B in the manner described with reference to FIG. 1.
[0077] The machine 1000 has an extracorporeal circuit CIR to take
arterial blood comprising, in turn, a plurality of tubes. The
machine 1000 is utilized to treat the blood and to return this
blood to the portal vein VP to obtain regeneration of the liver
L.
[0078] In the example shown in FIG. 7 the arterial blood is taken
from the femoral artery AF by means of a catheter 200, as already
described with reference to FIG. 1.
[0079] A device 201 to measure the arterial pressure is provided
immediately downstream of the catheter 200. This device 201, in a
known way, is utilized to measure the aspiration arterial pressure.
In fact, it is known that if the catheter 200 becomes attached to
the vessel wall and bursts it, this produces a very high negative
pressure. It is therefore necessary have the device 201 available
to detect any negative pressure produced in the point in which the
catheter 200 is inserted into the human body B.
[0080] Continuing to analyze the elements constituting the machine
1000 positioned in series in the extracorporeal circuit CIR, we can
see a pumping system 202 (preferably of the peristaltic type)
followed by a device 203 for introduction of an anticoagulant
fluid, such as heparin.
[0081] Downstream of the device 203 a coil heater 204 may be
provided to keep the blood at a pre-established temperature
(35-36.degree. C.) and to prevent it from coagulating. The coil
heater 204 is particularly useful if the blood flow rates are high
(around 400-500 cc/min), while for low flow rates (around 100
cc/min), as in the cases commonly taken into consideration in the
treatments contemplated in the present invention, the coil heater
204 may be omitted.
[0082] Advancing in the direction of flow of the blood, positioned
after the coil heater 204 is an oxygenation device 205 designed to
introduce oxygen in the form of 02 into the blood in extracorporeal
circulation.
[0083] Introduction of oxygen into the blood by means of the
oxygenation device 205 is controlled in feedback by means of a
control device 206 that measures both hematocrit and saturation,
expressed in terms of partial pressure of the molecular oxygen in
the blood. In a known way the control device 206 comprises a
transmitter element Tx1 and a receiver element Rx1.
[0084] In other words, the device 206 measures some important
parameters of the blood to understand the degree of oxygenation
thereof. As a function of said parameters the device 206 regulates
the quantity of oxygen flowing from a supply line 207 towards the
oxygenation device 205 by controlling the degree of aperture of a
valve 208.
[0085] The extracorporeal circuit CIR also comprises a drip chamber
209 to capture air in the form of bubbles to which a device 210 to
measure the portal vein VP pressure is connected.
[0086] The circuit CIR is completed with equipment 211 to control
gaseous embolism, a clamp 212 to interrupt blood flow towards the
body B and an infusion point 213 through which it is possible to
introduce into the circuit CIR any substances useful for the
treatment being carried out. Also in this case, in a known way, the
equipment 211 comprises a transmitter element Tx2 and a receiver
element Rx2 to detect the presence of air bubbles.
[0087] If the equipment 211 should detect the presence of air
bubbles in the blood in extracorporeal circulation, it would
immediately give the alarm and automatically close the clamp 212.
Moreover, by means of an aspiration syringe (not shown) the
operator will, in a known way, aspirate the air bubble into the
drip chamber 209 from where it will be evacuated from the circuit
CIR. Simultaneously an electronic control unit (not shown), which
will supervise all the previously described operations, will also
interrupt operation of the pumping system 202.
[0088] Obviously, the equipment 1000 is also provided with a second
catheter 214 to return treated blood to the body B, in particular
to the portal vein vP, with the procedure described hereinbefore
with reference to FIG. 1.
[0089] It is also obvious that the equipment 1000 may
advantageously be employed also in the case of blood being returned
directly to the liver L, as has already been described with
reference to FIG. 3.
[0090] Moreover, it is known how in some pathologies, also of
hepatic origin, there is an accumulation of liquid due to a
decrease in pressure in the corporeal circuit. It is therefore
necessary to remove the plasma water from the blood in
extracorporeal circulation in the circuit CIR.
[0091] For this purpose a hemofiltration device 215 has been
provided in which plasma filtration of the blood takes place. The
device 215 comprises, in turn, a filter 216, an evacuation tube
217, a peristaltic pump 218 designed to evacuate the plasma water,
which is collected in a container 219. In this way a higher
concentration of hemoglobulin is obtained, simultaneously obtaining
greater blood oxygenation. The filter 216 comprises, in a known
way, a semi-permeable membrane (not shown) through which the blood
yields the plasma water which, as already mentioned, is aspirated
by the pump 218 through the evacuation tube 217.
[0092] Therefore, in other words, in an innovative way, a
hemofiltration circuit designed to remove plasma water from the
blood in extracorporeal circulation has been added to the
previously disclosed extracorporeal oxygenation circuit for blood,
which essentially utilizes the circuit CIR.
[0093] The disposable elements of the machine 1000 may be the
catheters 200, 214, the tubes constituting the circuit CIR, the
oxygenation device 205, the filter 216, the plasma water evacuation
tube 217, the container 219 and the drip chamber 209.
* * * * *