Devices used to support biomedical devices during extracorporeal circulation

Abstract

The device (1) for supporting a biomedical device during extracorporeal circulation comprises at least one carrier (2), connectable to at least one command and control unit (3) of the at least one biomedical device, and at least one retaining element (4), the at least one retaining element (4) being provided with at least a first supporting device (5) of a first biomedical device (O) and with a second supporting device (6) of a second biomedical device (P), wherein the first supporting device (5) and the second supporting device (6) are locked to each other, and wherein the retaining element (4) comprises a removable hooking device (7) to the carrier (2).

Description

Technical Field

[0001] The present invention relates to an apparatus for supporting a biomedical device during extracorporeal circulation, in particular an apparatus for supporting an oxygenator and associated pumping components. Background Art

[0002] It is well known that during certain surgical operations, the function of the patient's heart is temporarily suspended, and it is necessary to use a so-called "heart-lung" machine to create an extracorporeal blood circulation circuit.

[0003] The heart-lung machine comprises a series of devices, including a filtering device adapted to filter the blood coming from the patient (also called a "venous reserve"), a heat exchanger adapted to regulate the temperature of the blood flowing out of the filtering device, and an oxygenator adapted to provide the correct supply of oxygen to the blood to be returned to the patient. In particular, the blood coming from the patient is sent to the oxygenator by means of an associated pumping assembly, which generally comprises a centrifugal pump of the traction or magnetic levitation type, i.e. provided with a rotor element adapted to convey the incoming blood to the oxygenator by its rotation, and a stator element adapted to drive the rotor element in rotation.

[0004] During extracorporeal circulation, many parameters must be monitored and controlled, including the number of revolutions of the rotor elements and the flow rate of blood delivered to the oxygenator.

[0005] Suitably, during the extracorporeal circulation applied to a patient, a supporting device having a carrier is usually used, which carrier is provided with first supporting means of the oxygenator, second supporting means of the associated pumping assembly, and is provided with a command and control unit connectable at least to the pumping assembly for commanding and controlling the above parameters.

[0006] Since extracorporeal circulation is also used in emergency situations, such as road rescue, where various devices need to be adequately supported in a flexible manner in a dynamic environment, the device is now also used in non-hospital environments in particular.

[0007] Known types of apparatus for supporting biomedical devices, in particular for supporting oxygenators and associated pumping components, do have some disadvantages.

[0008] Specifically, they do not allow the oxygenator and associated pumping components to be easily and practically supported and moved according to specific needs.

[0009] Another disadvantage of these known types of devices is that they are not able to adequately support the oxygenator and associated pumping components during extracorporeal circulation activities, both in non-hospital emergency situations and in hospital situations. Summary of the invention

[0010] The main purpose of the present invention is to devise a device that allows to support the oxygenator and the related pumping components in a practical and functional way during the application of extracorporeal circulation to a patient.

[0011] Within this aim, an object of the present invention is to enable medical personnel to place the oxygenator and associated pumping components in the optimal position with respect to the patient to facilitate connection with other medical equipment and to promote blood flow.

[0012] Another object is to simplify movement of the oxygenator and associated pump components when a change of position relative to the carrier is required.

[0013] Yet another object of the invention is to devise a device that is flexible in use and that effectively supports the oxygenator and the associated pumping assembly, or even just one of them, so that they can be moved independently, without interrupting the extracorporeal circulation applied to them, even if the patient has to be moved.

[0014] Another object of the present invention is to devise a device for supporting a biomedical device during extracorporeal circulation that overcomes the above-mentioned drawbacks of the prior art within the scope of a simple, rational, easy, effective use and low-cost solution.

[0015] The above mentioned object is achieved by an apparatus for supporting a biomedical device during extracorporeal circulation according to claim 1 . BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Other features and advantages of the invention will become more apparent from the description of preferred but non-exclusive embodiments of the apparatus for supporting a biomedical device during extracorporeal circulation, which are illustrated by way of example and not limitation in the table of the accompanying drawings, in which:

[0017] Figure 1 is a first isometric view of the apparatus according to the invention in a first use configuration;

[0018] Figure 2 yes Figure 1 Second axonal view of the instrument;

[0019] Figure 3 yes Figure 1 Axonometric view of the instrument in the second configuration for use;

[0020] Figure 4 yes Figure 1 an isometric view of a retaining element of the instrument; and

[0021] Figure 5 yes Figure 4 Side view of the retaining element. DETAILED DESCRIPTION

[0022] With particular reference to these figures, reference numeral 1 generally designates an apparatus for supporting a biomedical device during extracorporeal circulation, in particular an apparatus for supporting an oxygenator and associated pumping components.

[0023] The device 1 comprises at least one carrier 2, preferably of a transportable type and positionable on a reference surface, at least one command and control unit 3 operably connected to at least one biomedical device to control its functions, and at least one retaining element 4 associated with the carrier 2 and provided with a first supporting device 5 for a first biomedical device O and a second supporting device 6 for a second biomedical device P.

[0024] More specifically, the first biomedical device O is of the oxygenator type and the second biomedical device P corresponds to an associated pumping assembly, for example of the centrifugal pump type. In the embodiment shown in the figures, the centrifugal pump P, which is not part of the present invention, is of the traction or magnetic levitation type and comprises at least one hollow body, inside which a rotor element (impeller) is housed, which is adapted to convey venous blood from a patient to the oxygenator O, and at least one motor adapted to at least control the rotation of the rotor element.

[0025] The command and control unit 3 is connectable to the centrifugal pump P, comprises at least one microprocessor programmed to control the associated motor and is suitably provided with a plurality of actuators 3a operable by one operator, and at least one display 3b for displaying the parameters that can be controlled by the actuators 3a. In more detail, the actuators 3a are able to control at least the number of revolutions of the rotor elements and the flow rate delivered.

[0026] Suitably, the carrier 2 has a front portion 2a intended to face the patient, a rear portion 2b opposite the front portion 2a and operable by an operator to actuate the drive 3a, and two side portions 2c between the front portion 2a and the rear portion 2b.

[0027] According to the invention, the first supporting means 5 and the second supporting means 6 are locked to each other and the retaining element 4 comprises removable hooking means 7 connected to the carrier 2 .

[0028] Advantageously, the retaining element 4 is produced in one piece.

[0029] In the preferred embodiment shown in the figures, the retaining element 4 has a substantially plate-like configuration, ie its thickness is significantly lower than the other dimensions.

[0030] Preferably, the retaining element 4 has at least one first retaining wall 4a associated with the first supporting means 5 and at least one second retaining wall 4b associated with the second supporting means 6, wherein the first retaining wall 4a and the second retaining wall 4b are arranged transversely to each other.

[0031] In more detail, in use, i.e. during use of the device 1 when extracorporeal circulation is applied to a patient, the first retaining wall 4a is arranged generally (i.e., with smaller machining tolerances and / or positioning on non-planar reference surfaces) vertically and the second retaining wall 4b is arranged generally (i.e., with smaller machining tolerances and / or positioning on non-planar reference surfaces) horizontally.

[0032] Advantageously, the first supporting device 5 is arranged at a higher height relative to the second supporting device 6 .

[0033] It thus results that, in use, the oxygenator O is arranged on top of the associated pumping assembly P, thus facilitating the transfer of blood from the pumping assembly P to the oxygenator O from a fluid dynamics point of view.

[0034] Suitably, the retaining element 4 comprises at least one intermediate wall 4c adjacent to the first retaining wall 4a, arranged substantially transversely to the first retaining wall 4a and adapted to be arranged below the oxygenator O in use.

[0035] In detail, the intermediate wall 4c is arranged substantially (ie, with a smaller processing tolerance) in parallel with the second retaining wall 4b, and is arranged at a higher height relative to the second retaining wall 4b.

[0036] In the embodiment shown in the figures, the first retaining wall 4a is arranged substantially perpendicular to the second retaining wall 4b and the intermediate wall 4c.

[0037] Therefore, the second retaining wall 4b and the intermediate wall 4c actually define two substantially parallel and staggered planes.

[0038] Preferably, the first supporting means 5 comprise at least one housing seat 8 associated with the oxygenator O and configured to hold the oxygenator itself suspended on the first holding wall 4a. More specifically, the housing seat 8 has a curvilinear extension so as to at least partially wrap around the body of the oxygenator O. The housing seat 8 is configured to receive the oxygenator O by interlocking and / or to define at least one bearing surface on which the oxygenator itself rests.

[0039] Advantageously, the first supporting means 5 are associated in a removable manner with the retaining element 4. More specifically, the first supporting means 5 comprise removable fixing means 5a connected to the retaining element 4, for example of the type of one or more interlocking elements.

[0040] Suitably, the first supporting means 5 are of disposable type and are intended to be applied to the oxygenator O before the oxygenator O is sterilized.

[0041] Alternatively, the second supporting means 6 are arranged at the second retaining wall 4b and are configured to hold the centrifugal pump P in position on the second retaining wall itself.

[0042] In more detail, the second supporting means 6 can be of the type of threaded members passing through the second retaining wall 4b and adapted to engage with the housing of the motor of the centrifugal pump P (the embodiment shown in the figure), or they can be of the interlocking type, the sliding type or other types known to experts in the field.

[0043] Advantageously, the hooking device 7 can be moved from at least one engagement configuration to a release configuration together with the carrier 2. In the preferred embodiment shown in the figures, the hooking device 7 comprises two hooking elements 7a, which can be moved in the direction of moving towards / away from each other. More specifically, in the engagement configuration, these hooking elements 7a are close to each other and can be moved in the direction of moving away from each other, resisting elastic means (not visible in detail in the figures) in order to reach the release configuration.

[0044] Suitably, the hooking device 7 comprises at least one activation element 7b which can be activated by an operator to bring the hooking element 7a from the engaged configuration to the released configuration.

[0045] Next, the device 1 comprises at least one clamping element 9 associated with the carrier 2 and the hooking means 7 are adapted to engage therewith in a removable manner.

[0046] In the preferred embodiment shown in the figures, the clamping element 9 is of the element type having an elongated shape and protrudes from the carrier 2 so as to define a profile engageable by the hooking element 7a in the engagement configuration.

[0047] Conveniently, the clamping element 9 is of the connection type, ie its configuration and dimensions are made according to prescribed and standard rules.

[0048] In particular, the clamping element 9 corresponds to a profile also found on stretchers used in hospitals.

[0049] Advantageously, the device 1 comprises at least two clamping elements 9 separated from one another so as to allow positioning of the retaining element 4 on the carrier 2 in at least two different positions which can be selected by the operator according to specific needs.

[0050] In more detail, at least one clamping element 9 is associated with the front 2a of the carrier 2, while another clamping element 9 is associated with at least one side 2c of the carrier itself. In this way, the operator can position the holding element 4 on the carrier 2 at least two substantially mutually orthogonal positions.

[0051] Preferably, the apparatus 1 comprises a first protection device 10 of a first biomedical device, namely an oxygenator O. More specifically, the first protection device 10 is associated with the carrier 2 and is shaped to surround the oxygenator O. In the preferred embodiment shown in the figures, the first protection device 10 is of the type of a curved rod, for example. Suitably, the first protection devices 10 are movable between a working position, in which they are arranged to surround the oxygenator O, and a home position, in which they are displaced relative to the working position, in order to facilitate the application or removal of the retaining element 4 to the carrier 2. In the embodiment shown in the figures, the first protection device 10 is hinged to the carrier 2 at the front part 2a and is rotated upwards to be displaced from the working position to the home position. More specifically, the first protection device 10 is associated with the carrier 2 in a removable manner, in order to reduce the overall dimensions of the apparatus 1.

[0052] Advantageously, the apparatus 1 also comprises a second protection means 11 of the second biomedical device, namely the pumping assembly P. More specifically, the second protection means 11 is associated with the carrier 2 and is shaped so as to surround the pumping assembly P.

[0053] Suitably, the second protection means 11 are movable between a working position, in which they are arranged around the pumping assembly P, and a home position, in which they are displaced from the working position in order to reduce the overall dimensions of the apparatus 1. In the embodiment shown in the figures, the second protection means 11 are hinged to the carrier 2 at the front part 2a and rotate upwards to move from the working position to the home position. Specifically, the second protection means 11 is of the type of curved rod, shaped so that in the home position it resumes the contour of the front part 2a on which it rests.

[0054] The operation of the present invention is as follows.

[0055] Depending on the specific requirements, ie depending on the position of the patient and the positions of other devices forming the apparatus for extracorporeal circulation, the operator positions the holding element 4 at the front part 2 a or at the side part 2 c of the carrier 2 .

[0056] In particular, the operator operates the activation element 7 b to bring the hooking elements 7 a to the release configuration and, after they have been positioned at the associated clamping element 9 , releases the activation element itself so that it engages with the clamping element 9 .

[0057] In this way, the retaining element 4 is locked with the carrier 2 .

[0058] Then, the operator positions the oxygenator O and the pumping assembly P on the holding element 4 by means of the first supporting device 5 and the second supporting device 6, respectively.

[0059] As mentioned above, the oxygenator O is preferably associated with the first supporting means 5 before sterilization thereof. The first supporting means 5 are therefore of disposable type.

[0060] In more detail, the oxygenator O is mounted in the accommodation seat 8 , while the centrifugal pump P is located at the second retaining wall 4 b and is blocked relative to the second retaining wall 4 b by the threaded member 6 .

[0061] After the various devices have been connected to one another and to the patient, the extracorporeal circulation may be started by monitoring and possibly modifying some parameters of the centrifugal pump P, such as the number of revolutions and the delivered flow rate, through the command and control unit 3 .

[0062] If the patient is placed on the stretcher, whether in hospital or outside the hospital, it is possible to release the holding element 4 from the carrier 2 by always operating on the hooking device 7. In particular, the operator can operate the activation element 7b again to bring the hooking element 7a to the release configuration, thereby removing the holding element 4 from the carrier 2. The holding element 4 can then always be applied to the stretcher structure using the hooking device 7.

[0063] Suitably, the holding element 4 is arranged at a lower height than the patient in order to optimize the fluid dynamics of the blood circulation.

[0064] It has been established in practice that the described invention achieves the intended objects and in particular it allows an optimal positioning of the oxygenator and the associated pumping components during extracorporeal circulation applied to a patient.

[0065] In particular, the shape of the retaining element makes it possible to move the oxygenator and the centrifugal pump simultaneously so that they remain in the same mutual position.

[0066] Furthermore, the hooking device makes it possible to change the position of the holding element on the carrier and to apply it to a hospital stretcher, thereby making it flexible and practical to use.

Claims

1. An apparatus for supporting a biomedical device during extracorporeal circulation (1), comprising: At least one carrier (2), at least one command and control unit (3) connected to at least one biomedical device, and at least one holding element (4), the at least one holding element (4) being provided with at least a first supporting device (5) of a first biomedical device (O) and a second supporting device (6) provided with a second biomedical device (P), wherein the first supporting device (5) and the second supporting device (6) are locked to each other, and wherein the holding element (4) comprises a removable hooking device (7) to the carrier (2), the holding element (4) having at least a first retaining wall (4a) removably engaged with the first supporting device (5) and at least a second retaining wall (4b) engaged with the second supporting device (6), the first retaining wall (4a) and the second retaining wall (4b) being arranged transversely to each other, characterized in that: The retaining element (4) comprises at least one intermediate wall (4c) adjacent to the first retaining wall (4a) and arranged substantially transversely to the first retaining wall (4a), wherein the intermediate wall (4c) is adapted to be arranged below the first biomedical device (O) during use, wherein the intermediate wall (4c) is arranged substantially parallel to the second retaining wall (4b) and at a higher height relative to the second retaining wall (4b).

2. The device (1) according to claim 1, characterized in that: The retaining element (4) is manufactured as a single piece.

3. The device (1) according to claim 1, characterized in that: The first retaining wall (4a) and the second retaining wall (4b) are arranged vertically and horizontally respectively during use.

4. The device (1) according to any one of claims 1 to 3, characterized in that: The first supporting device (5) comprises at least one receiving seat (8) for a first biomedical device (O), and the receiving seat (8) is configured to hold the first biomedical device (O) suspended on the first holding wall (4a).

5. The device (1) according to claim 1, characterized in that: The first supporting means (5) comprises removable fixing means (5a) connected to the retaining element (4).

6. The device (1) according to any one of claims 1 to 3, characterized in that: The second supporting means (6) is configured to hold a second biomedical device (P) in place on the second retaining wall (4b).

7. The device (1) according to claim 1, characterized in that: The hooking device (7) can be moved together with the carrier (2) from at least one engaged configuration to a released configuration.

8. The device (1) according to claim 1, characterized in that: The device (1) comprises at least one clamping element (9) associated with the carrier (2), and the hooking device (7) is adapted to engage with the clamping element (9) in a removable manner.

9. The device (1) according to claim 8, characterized in that: The device (1) comprises at least two clamping elements (9) separated from each other.

10. The device (1) according to claim 9, characterized in that: The carrier (2) comprises at least one front portion (2a) and at least two side portions (2c) arranged transversely relative to the front portion (2a), and the clamping element (9) is associated with at least the front portion (2a) and at least one of the side portions (2c).

11. The device (1) according to claim 10, characterized in that: The apparatus (1) comprises at least one of a first protection device (10) of a first biomedical device (O) and a second protection device (11) of a second biomedical device (P) associated with the carrier (2).

12. The device (1) according to claim 11, characterized in that: At least one of the first protection device (10) and the second protection device (11) is movable relative to the carrier (2) between a working position and an original position, wherein at least one of the first protection device (10) and the second protection device (11) is arranged to surround the relevant biomedical device (O, P) in the working position, and is displaced relative to the working position in the original position.

13. The device (1) according to claim 11 or 12, characterized in that: At least one of the first protection device (10) and the second protection device (11) is hinged to the carrier (2) at the front portion (2a).

Images