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Title:
APPARATUS FOR THE DETECTION OF AT LEAST ONE PARAMETER, IN PARTICULAR KINETIC, IN RELATION TO THE HEART, OR THE MYOCARDIUM, OF A HUMAN BEING OR AN ANIMAL
Document Type and Number:
WIPO Patent Application WO/2022/064390
Kind Code:
A1
Abstract:
An apparatus (10) for the detection of at least one parameter, in particular kinetic, in relation to the heart, or the myocardium (11) of a human being (13) or an animal, especially the apparatus (10) being usable during surgical operations, in particular performed on the heart, or myocardium, (11) itself, inside a corresponding operating theatre (15); comprising a detection means (12) for the detection of spatial or mechanical, movements of said heart, or myocardium, (11), and a control means, or processor, (14) of the apparatus, in particular adapted to, or configured to, process the signals, or data, provided by said detection means (12) for providing at least one corresponding parameter, in particular kinetic, in relation to the heart, or myocardium, (11) of a human being (13) or animal. Said detection means (12) for the detection of the spatial, or mechanical, movements of said heart, or myocardium, (11) is adapted to detect the distance, or depth, i.e. the variation in distance, or depth, of one or more points of said heart, or myocardium, (11), in particular of one or more points of a corresponding surface or wall of said same heart, or myocardium, (11), by the detection means (12) for detecting the spatial, or mechanical, movements of said heart, or myocardium, (11).

Inventors:
ROZZI GIACOMO (IT)
LA ROSA ENRICO (IT)
BARRESI FRANCESCO (IT)
Application Number:
PCT/IB2021/058650
Publication Date:
March 31, 2022
Filing Date:
September 22, 2021
Export Citation:
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Assignee:
ROZZI GIACOMO (IT)
LA ROSA ENRICO (IT)
BARRESI FRANCESCO (IT)
International Classes:
A61B5/00; A61B5/107
Domestic Patent References:
WO2019186768A12019-10-03
Foreign References:
US20160100095A12016-04-07
Other References:
ROZZI GIACOMO ET AL: "CONCLUSIONS", vol. 29, no. 4, 9 June 2019 (2019-06-09), pages 625 - 631, XP055773422, Retrieved from the Internet [retrieved on 20210208], DOI: 10.1093/icvts/ivz120
UEMATSU M ET AL: "Development of "Patient Robot"; Measurement System of Myocardial Behaviors for the Quantitative Evaluation of the Surgical Robot Technology", BIOMEDICAL ROBOTICS AND BIOMECHATRONICS, 2006. BIOROB 2006. THE FIRST IEEE/RAS-EMBS INTERNATIONAL CONFERENCE ON PISA, ITALY FEBRUARY 20-22, 2006, PISCATAWAY, NJ, USA,IEEE, PISCATAWAY, NJ, USA, 20 February 2006 (2006-02-20), pages 655 - 660, XP010922584, ISBN: 978-1-4244-0040-9, DOI: 10.1109/BIOROB.2006.1639164
WATANABE ET AL: "Three-dimensional quantification of cardiac surface motion: A newly developed three-dimensional digital motion-capture and reconstruction system for beating heart surgery", THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, MOSBY-YEAR BOOK, INC., ST. LOUIS, MO, US, vol. 132, no. 5, 1 November 2006 (2006-11-01), pages 1162 - 1171, XP005711889, ISSN: 0022-5223, DOI: 10.1016/J.JTCVS.2006.07.017
LORENZO FASSINA ET AL: "Cardiac kinematic parameters computed from video of textitin situ beating heart", ARXIV.ORG, CORNELL UNIVERSITY LIBRARY, 201 OLIN LIBRARY CORNELL UNIVERSITY ITHACA, NY 14853, 5 February 2020 (2020-02-05), XP081592937, DOI: 10.1038/SREP46143
LO MUZIO FRANCESCO PAOLO ET AL: "In-situ optical assessment of rat epicardial kinematic parameters reveals frequency-dependent mechanic heterogeneity related to gender", PROGRESS IN BIOPHYSICS AND MOLECULAR BIOLOGY, ELSEVIER, AMSTERDAM, NL, vol. 154, 21 May 2019 (2019-05-21), pages 94 - 101, XP086193859, ISSN: 0079-6107, [retrieved on 20190521], DOI: 10.1016/J.PBIOMOLBIO.2019.05.003
BOGATYRENKO E ET AL: "Simultaneous state and parameter estimation for physics-based tracking of heart surface motion", MULTISENSOR FUSION AND INTEGRATION FOR INTELLIGENT SYSTEMS (MFI), 2010 IEEE CONFERENCE ON, IEEE, PISCATAWAY, NJ, USA, 5 September 2010 (2010-09-05), pages 109 - 114, XP031777441, ISBN: 978-1-4244-5424-2
EVGENIYA BOGATYRENKO ET AL: "Efficient physics-based tracking of heart surface motion for beating heart surgery robotic systems", INTERNATIONAL JOURNAL OF COMPUTER ASSISTED RADIOLOGY AND SURGERY, vol. 6, no. 3, 6 August 2010 (2010-08-06), pages 387 - 399, XP055202161, ISSN: 1861-6410, DOI: 10.1007/s11548-010-0517-5
HAYASHIBE ET AL: "Robotic surgery setup simulation with the integration of inverse-kinematics computation and medical imaging", COMPUTER METHODS AND PROGRAMS IN BIOMEDICINE, ELSEVIER, AMSTERDAM, NL, vol. 83, no. 1, 1 July 2006 (2006-07-01), pages 63 - 72, XP005543789, ISSN: 0169-2607
Attorney, Agent or Firm:
FANZINI, Valeriano et al. (IT)
Download PDF:
Claims:
CLAIMS

1. Apparatus (10) for the detection of at least one parameter, in particular kinetic, in relation to the heart, or the myocardium, (11) of a human being (13) or an animal, especially the apparatus (10) being usable during surgical operations, in particular performed on the heart, or myocardium, (11) itself, inside a corresponding operating theatre (15); comprising a detection means (12) for the detection of spatial or mechanical, movements of said heart, or myocardium, (11), and a control means, or processor, (14) of the apparatus, in particular adapted to, or configured to, process the signals, or data, provided by said detection means (12) for providing at least one corresponding parameter, in particular kinetic, in relation to said heart, or myocardium, (11) of a human being (13) or animal; characterized in that said detection means (12) for the detection of the spatial, or mechanical, movements of said heart, or myocardium, (11) is adapted to detect the distance, or depth, (z), i.e. the variation in distance, or depth, of one or more points of said heart, or myocardium, (11), in particular of one or more points of a corresponding surface or wall of said same heart, or myocardium, (11), by the detection means (12) for detecting the spatial, or mechanical, movements of said heart, or myocardium, (11).

2. Apparatus according to claim 1 or according to the pre-characterizing part of claim 1, characterized in that said detection means of said heart, or myocardium, (11) is adapted to detect the movement, or displacement, of one or more points of said heart, or myocardium, (11), i.e. one or more points of said heart, or myocardium, (11), in a corresponding plane, i.e. with respect to corresponding Cartesian reference axes (x, y) in said plane, particularly perpendicular to the detection direction of said depth (z) by the detection means (12) for detecting the spatial or mechanical, movements, of said heart, or myocardium, (11).

3. Apparatus according to any one of the preceding claims or according to the pre-characterizing part of claim 1, characterized in that said detection means (12) for detecting the spatial, or mechanical, movements of said heart, or myocardium, (11), comprises, or is in the form of, a corresponding television camera.

4. Apparatus according to any one of the preceding claims, characterized in that said detection means (12) for detecting the spatial, or mechanical, movements of said heart, or myocardium, (11), comprises, or is in the form of, a corresponding 3D television camera (12), in particular adapted to detect images of said heart, or myocardium, (11), i.e. of a corresponding surface of wall of said same heart, or myocardium, (11), in a corresponding plane (x, y), with detection of the perpendicular depth (z) of the same points of the image according to said plane (x, y).

5. Apparatus according to any one of the preceding claims, characterized in that said detection means (12) for detecting the spatial, or mechanical, movements of said heart, or myocardium, (11), or television camera, (12), i.e. in particular the respective objective thereof, is placed at a distance from said heart, or myocardium, (11), i.e. from the respective surface or wall thereof, which is comprised between 10 cm and 80 cm, preferably between 30 cm and 50 cm.

6. Apparatus according to any one of the preceding claims, characterized in that said detection means (12) for detecting the spatial, or mechanical, movements of said heart, or myocardium, (11), detects the same heart, or myocardium, (11) for a time interval comprised between 12s and 30s, preferably around 20s.

7. Apparatus according to any one of the preceding claims or according to the pre-characterizing part of claim 1, characterized in that a support means (16) of said detection means (12) for detecting the spatial, or mechanical movements, of said heart, or myocardium, (11) is provided.

8. Apparatus according to claim 7, characterized in that said support means (16) of said detection means, or television camera, (12) for detecting the spatial, or mechanical movements, of said heart, or myocardium, (11), is adapted to move the same detection means (12) for detecting the spatial, or mechanical movements, of said heart, or myocardium, (11) with respect to said heart, or myocardium, (11), or to a corresponding surface, or wall, of the same heart, or myocardium, (11).

9. Apparatus according to claim 8, characterized in that said support means (16) of said detection means, or television camera, (12) for detecting the spatial, or mechanical movements, of said heart, or myocardium, (11), is adapted to move said detection means, or television camera, (12) for detecting the spatial, or mechanical movements, of said heart, or myocardium, (11) perpendicularly with respect to said heart, or myocardium, (11), or to the corresponding surface, or wall, thereof.

10. Apparatus according to any one of the preceding claims 8 and 9, characterized in that said support means (16) of said detection means, or television camera, (12) for detecting the spatial, or mechanical movements, of said heart, or myocardium, (11), is adapted to move said detection means, or television camera, (12) for detecting the spatial, or mechanical movements, of said heart, or myocardium, (11), in a corresponding plane parallel to said heart, or myocardium, (11), i.e. to the corresponding surface or wall thereof, in particular to the support plane of said patient (13), or to the floor of said operating theatre (15).

11. Apparatus according to any one of the preceding claims or according to the pre-characterizing part of claim 1, characterized in that said support means (16) of said detection means, or television camera, (12) for detecting the spatial, or mechanical movements, of said heart, or myocardium, (11), is adapted to position

18 said means, or television camera, (12) of the spatial, or mechanical movements, of said heart, or myocardium, (11) above and distanced from the same heart, or myocardium, (11), in particular perpendicularly aligned with said heart, or myocardium, (11).

12. Apparatus according to any one of the preceding claims or according to the pre-characterizing part of claim 1, characterized in that said control means, or processor, (14) of the apparatus is configured to position said detection means, or television camera, (12) for detecting the spatial, or mechanical movements, of said heart, or myocardium, (11), in a corresponding and predetermined position with respect to said heart, or myocardium, (11), or with respect to a corresponding surface, or wall thereof.

13. Apparatus according to claim 12, characterized in that said control means, or processor, (14) of the apparatus is configured to store the position of said detection means, or television camera, (12) for detecting the spatial, or mechanical movements, of said heart, or myocardium, (11), in a predetermined position with respect to said heart, or myocardium, (11), or to a corresponding surface, or wall thereof, and to reposition, in particular selectively or automatically, said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements of said heart, or myocardium, (11) in said stored position.

14. Apparatus according to any one of the preceding claims or according to the pre-characterizing part of claim 1, characterized in that, in particular in the apparatus (10), a detection means is provided for detecting the position of said support means (16) of said detection means, or television camera, (12) for detecting the spatial, or mechanical movements, of said heart, or myocardium, (11), which is in communication with said control means, or processor, (14) of the apparatus for

19 determining the position of said detection means or television camera, (12) of the spatial, or mechanical movements, of said heart, or myocardium, (11).

15. Apparatus according to any one of the preceding claims, characterized in that said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11) is adapted to detect said heart, or myocardium, (11) in a first and in a second operating condition, i.e. in particular in a pre-operating step (40) and in a post-operating step (50).

16. Apparatus according to any one of the preceding claims or according to the pre-characterizing part of claim 1, characterized in that said control means, or processor, (14) of the apparatus is configured to determine, starting from corresponding signals, or data, received from said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), one or more of the following parameters, in particular kinetic, of the heart, or myocardium, (11) of a human being (13) or animal: force of contraction, cardiac fatigue, kinetic energy of contraction, contraction speed, punctiform displacement of the trajectory, area and perimeter of the trajectory, analysis of the systole and diastole times of the individual beat.

17. Apparatus according to any one of the preceding claims or according to the pre-characterizing part of claim 1, characterized in that said control means, or processor, (14) of the apparatus is configured to determine, starting from corresponding signals, or data, received from said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), evaluate one or more of the following parameters, in particular kinetic, of the heart, or myocardium, (11) of a human being (13) or animal: the ejection fraction, the fractional shortening, the ventricular hemodynamic load of said

20 heart, or myocardium, (11).

18. Apparatus according to any one of the preceding claims from 7 to 17, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), comprising an elongated support arm (18), in particular at the respective free end, of said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11).

19. Apparatus according to claim 18, characterized in that said elongated support arm (18) of said means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), extends, in particular backwards, from said apparatus (10), especially, during use, towards the patient and/or beyond a separation (19) between the sterile area of the operating theatre (15) and the non-sterile area, for housing technical equipment to assist with the operation (17).

20. Apparatus according to any one of the preceding claims 18 and 19, characterized in that said elongated support arm (18) of said means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), is axially extensible, or telescopic.

21. Apparatus according to any one of the preceding claims from 18 to 20, characterized in that said elongated support arm (18) of said detection means, or television chamber, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), is rotatable, in particular with respect to a corresponding perpendicular, or vertical, axis according to opposite angular directions, especially for an angular portion around 180°.

22. Apparatus according to any one of the preceding claims from 18 to 21, characterized in that said elongated support arm (18) of said detection means, or

21 television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), can be perpendicularly or vertically raised and lowered, in particular with respect to said heart, or myocardium, (11).

23. Apparatus according to any one of the preceding claims from 7 to 22, characterized in that said support means (16) of said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), comprises an upright (20) that supports said elongated support arm (18) of said detection means, or television camera (12) and from which the same extends, for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11).

24. Apparatus according to claim 23, characterized in that said upright (20) for supporting said elongated support arm (18) of said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), extends perpendicularly or vertically.

25. Apparatus according to any one of the preceding claims 23 and 24, characterized in that said support upright (20) of said elongated support arm (18) of said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), is axially extensible, i.e. it can be raised and lowered, in particular for raising and lowering said elongated support arm (18) of said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11).

26. Apparatus according to any one of the preceding claims, characterized in that said apparatus (10) comprises a display screen (22) in particular supported on a corresponding support surface (26) of the apparatus (10).

27. Apparatus according to any one of the preceding claims, characterized in

22 that said apparatus (10) comprises an input means (24), especially said control means, or processor, (14) of the apparatus, in particular comprising a joystick (241) for controlling said support arm (18) and/or a keyboard (242) and/or a trackpad or mouse (243), in particular supported on a corresponding support surface (26) of the apparatus (10).

28. Apparatus according to any one of the preceding claims, characterized in that said apparatus (10) comprises a support structure (28), in particular of said support means (16) of said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11) and/or of said support surface (26) of the apparatus (10).

29. Apparatus according to claim 28, characterized in that said support structure (28) comprises a lower base (281) in particular on which said control means, o processor, (14) of the apparatus is supported and/or from which a corresponding column (282) extends, in particular for supporting said support surface (26) of the apparatus (10).

30. Apparatus according to any one of the preceding claims 28 and 29, characterized in that on said support structure (28), said control means, or processor, (14) of the apparatus is positioned in front of said support upright (20) of said elongated support arm (18) of said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11).

31. Apparatus according to any one of the preceding claims from 28 to 30, characterized in that said support upright (20) of said elongated support arm (18) of said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), is provided in the rear

23 area of said support structure (28) and backwards.

32. Apparatus according to any one of the preceding claims from 28 to 31, characterized in that said support structure (28) comprises a roller means, in particular swivelling, (30), in particular fixed to said lower base (281) of said support structure (28) and being provided with a locking means of the movement of said apparatus (10), i.e. for locking the rotation of said roller means, in particular of the swivelling type, (30).

33. Apparatus according to any one of the preceding claims or according to the pre-characterizing part of claim 1, characterized in that said control means, or processor, (14) of the apparatus is configured to position perpendicularly, or vertically, said detection means or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), in particular as a function of corresponding signals, or data, received from said detection means (12) of the distance, or depth, (z), of said heart, or myocardium, (11), i.e. using the depth parameter of said 3D television camera.

34. Apparatus according to any one of the preceding claims or according to the pre-characterizing part of claim 1, characterized in that said control means, or processor, (14) of the apparatus is configured to define the means for the positioning in perpendicular, or vertical, alignment of said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), of the patient, and in particular defined by an image in transparency of said heart, or myocardium, (11), to collimate by the operator manoeuvring said elongated support arm (18) of said detection means, or television camera, (12) for detecting the spatial, or mechanical, movements, of said heart, or myocardium, (11), i.e. automatically, and that is preferably displayed on said display

24 screen of the apparatus (10).

35. Apparatus according to any one of the preceding claims or according to the pre-characterizing part of claim 1, characterized in that said control means, or processor, (14) of the apparatus is configured, or has corresponding software, for performing, in particular in both of said steps, preferably in said pre-operative step (40) and/or in said post-operative step (50), particularly in sequence and preferably automatically, a tracking step, (41, 51) of the spatial, or mechanical, movements, of said heart, or myocardium, (11), or of corresponding points thereof to be tracked, an extraction step (42, 52) of the coordinates (x, y, z) of said tracked movement (, in 41, 51,) of said heart, or myocardium, (11), and an evaluation or calculation step (43, 53) of said one or more parameters, in particular kinetic, in relation to said heart, or myocardium, (11), in particular starting from said coordinates (x, y, z) extracted from said tracked movement (in 41, 51) of said heart, or myocardium, (11), as well as a possible implementation (44, 54) of a statistic, in particular weighted according to the number of recordings or detections performed, for said one or more parameters, in particular kinetic, evaluated, or calculated, in relation to said heart, or myocardium, (11).

36. Apparatus according to any one of the preceding claims or according to the pre-characterizing part of claim 1, characterized in that said control means, or processor, (14) of the apparatus is configured, or has corresponding software, to display, in particular once said post-operative verification procedure (50) has been performed, in particular in sequence therewith and preferably automatically following it (60), in particular on said display (22) of the apparatus (10), the differences between said one or more parameters, in particular kinetic, evaluated, or calculated, in relation to said heart, or myocardium, (11) in said first and second step,

25 i.e. in said pre-operative (40) and post-operative steps (50).

37. Apparatus according to any one of the preceding claims or according to the pre-characterizing part of claim 1, characterized in that said control means, or processor, (14) of the apparatus is configured, or has corresponding software, to perform, in particular following said post-operative step (50), and especially in sequence with said display step (60), preferably automatically, an artificial intelligence procedure for the recognition of the state of said heart, or myocardium, (11), and to obtain corresponding results or outcomes, respectively positive (70) or negative (80) and, following the respective outcome, to control the emission of a corresponding signal (71), e.g. of the visual type, and preferably shown on said display (22), for consent for the continuation of the operation, i.e. consent to close the patient’s chest, or to control the emission of a warning signal (81) of the presence of a problem for said patient.

38. Apparatus characterized in that it is made according to any one of the preceding claims and/or as described and illustrated with reference to the appended drawings.

26

Description:
DESCRIPTION

TITLE: APPARATUS FOR THE DETECTION OF AT LEAST ONE PARAMETER, IN PARTICULAR KINETIC, IN RELATION TO THE HEART, OR THE MYOCARDIUM, OF A HUMAN BEING OR AN ANIMAL.

Field of annlication of this invention

The present invention refers to an apparatus for the detection of at least one parameter, in particular kinetic, in relation to the heart, or myocardium, of a human being or an animal.

In particular, the apparatus can be used during surgical operations, in particular performed on the heart, or myocardium itself, inside a corresponding operating theatre.

Background

An apparatus for the detection of at least one parameter, in particular kinetic, in relation to the heart, or myocardium, of a human being or an animal, especially for use during surgical operations, in particular performed on the heart, or myocardium itself, inside a corresponding operating theatre, is known.

Said already known apparatus comprises a detection means for the detection of spatial or mechanical, movements of said heart, or myocardium, and a control means, or processor of the apparatus, in particular adapted to, or configured to, process the signals, or data, provided by said detection means for providing at least one corresponding parameter, in particular kinetic, in relation to said heart, or myocardium, of said human being or animal.

This already known apparatus uses a 2D television camera for the detection of the patient's heart, but this has many limitations and does not allow a good kinetics of the patient's heart to be obtained, which cannot therefore be conveniently assessed by the clinician.

In addition, due to the fact that there are very bright lights in the operating theatre that the surgeon needs in order to have a good view at all times during the operation, however, light refractions occur that can lead to problems in processing the 2D images detected, with the risk of obtaining totally misleading data.

Moreover, said already known apparatus is manually positioned, with difficulty and discomfort on the part of the operator, at the patient's heart, in the preoperating step, then removed and repositioned, again at the same heart of the patient, in the post-operating step, which leads, for obvious reasons, to positions that will never be perfectly coincident with each other and which consequently lead to clinical comparisons that are invalidated by such a technical distortion.

In particular, according to the prior art, it is not possible to obtain a particularly accurate detection of the kinetics of the heart, and in particular it is not possible to assess the ejection fraction, the fractional shortening and the ventricular hemodynamic load of said heart, or myocardium, without resorting to particularly invasive techniques for the patient.

Summary of the invention

With the present invention it is therefore wished to propose a new solution and an alternative to the solutions known up to now and in particular it is proposed to overcome one or more of the drawbacks or problems referred to above, and/or to satisfy one or more requirements referred to above and/or in any case experienced in the art, and in particular which can be deduced from the above.

An apparatus is therefore provided for the detection of at least one parameter, in particular kinetic, in relation to the heart, or the myocardium, of a human being or an animal, especially the apparatus being usable during surgical operations, in particular performed on the heart, or myocardium, itself, inside a corresponding operating theatre; comprising a detection means for the detection of spatial or mechanical, movements of said heart, or myocardium, and a control means, or processor, of the apparatus, in particular adapted to, or configured to, process the signals, or data, provided by said detection means for providing at least one corresponding parameter, in particular kinetic, in relation to said heart, or myocardium, of a human being or animal; characterized in that said detection means for the detection of the spatial, or mechanical, movements of said heart, or myocardium, is adapted to detect the distance, or depth, i.e. the variation in distance, or depth, of one or more points of said heart, or myocardium, in particular of one or more points of a corresponding surface or wall of said same heart, or myocardium, by the detection means for detecting the spatial, or mechanical, movements of said heart, or myocardium.

In this way, a particularly accurate detection of the kinetics of the heart is obtained, in particular it is possible to assess the ejection fraction, the fractional shortening and the ventricular hemodynamic load of said heart, or myocardium, all with an apparatus that is in itself non-invasive for the patient.

Brief description of the drawings

This and other innovative aspects or respective advantageous embodiments, are however, set forth in the appended claims, the technical characteristics of which can be found, together with corresponding advantages achieved, in the following detailed description, illustrating a purely non-limiting example of the embodiment of the invention, which is made with reference to the appended drawings, in which: figure 1 A illustrates a schematic front perspective view of a preferred embodiment of the apparatus according to the present invention; figure IB illustrates a schematic rear perspective view of the preferred embodiment of the apparatus according to the present invention; figure 2 illustrates a schematic view of the operating theatre configured for an advantageous use of the preferred embodiment of apparatus according to the present invention; figure 3 illustrates a flow diagram of the operation of the preferred embodiment of apparatus according to the present invention.

Detailed description of preferred embodiments of the invention

A preferred embodiment 10 of apparatus for the detection of at least one parameter, in particular kinetic, in relation to the heart, or the myocardium, 11 of a human 13 or an animal is illustrated in the attached figures.

In particular, the apparatus 10 can be used during surgical operations, in particular performed on the heart, or myocardium 11 itself, inside a corresponding operating theatre 15.

As is particularly clear from Figures 1 A, IB and 2, the apparatus 10 comprises a detection means 12 for the detection of spatial or mechanical, movements of said heart, or myocardium, 11, and a control means, or processor, 14 of the apparatus, in particular adapted to, or configured to, process the signals, or data, provided by said detection means 12 for providing at least one corresponding parameter, in particular kinetic, in relation to said heart, or myocardium, 11 of a human being 13 or animal.

Advantageously, said detection means 12 for the detection of the spatial, or mechanical, movements of said heart, or myocardium, 11 is adapted to detect the distance, or depth, z, i.e. the variation in distance, or depth, of one or more points of said heart, or myocardium, 11, in particular of one or more points of a corresponding surface or wall of the same heart, or myocardium, 11, by said detection means 12 for detecting the spatial, or mechanical, movements of said heart, or myocardium 11.

In this way, a particularly accurate detection of the kinetics of the heart is obtained, in particular it is possible to assess the ejection fraction, the fractional shortening and the ventricular hemodynamic load of said heart, or myocardium, 11, all with an apparatus that is in itself non-invasive for the patient.

In particular, the distance, or depth, z from said heart, or myocardium, 11, or from the respective surface or wall thereof, means the distance of the objective of the same television camera from said heart, or myocardium, 11, i.e. from the respective surface or wall thereof.

Advantageously, said detection means of said heart, or myocardium, 11, is adapted to detect the movement, or displacement, of one or more points of said heart, or myocardium, 11, i.e. one or more points of said heart, or myocardium, 11, in a corresponding plane, i.e. with respect to corresponding Cartesian reference axes x, y in said plane, particularly perpendicular to the detection direction of said depth z by the detection means 12 for detecting the spatial or mechanical, movements, of said heart, or myocardium, 11.

Advantageously, said detection means 12 for the detection of the spatial, or mechanical, movements of said heart, or myocardium, 11 comprises, or is in the form of, a corresponding television camera.

With advantage, said detection means 12 for detecting the spatial, or mechanical, movements of said heart, or myocardium, 11, comprises, or is in the form of, a 3D television camera, in particular adapted to detect images of said heart, or myocardium, 11, i.e. of a corresponding surface of wall of said same heart, or myocardium, 11, in a corresponding plane x, y, with detection of the perpendicular depth z of the same points of the image according to said plane x, y.

Advantageously, as can be seen from said figures, said detection means 12 for detecting the spatial, or mechanical, movements of said heart, or myocardium, 11, or television camera, 12, i.e. in particular the respective objective thereof, is placed at a distance from said heart, or myocardium, 11, i.e. from the respective surface or wall thereof, which is comprised between 10 cm and 80 cm, preferably between 30 cm and 50 cm.

With advantage, as can be seen from said figures, said detection means 12 for the detection of the spatial, or mechanical, movements of said heart, or myocardium, 11, detects the same heart, or myocardium, 11 for a time interval comprised between

I second and 30 seconds, preferably around 15-20 seconds.

As can be seen from said figures, advantageously, support means, or station, 16 of said detection means 12 for the detection of the spatial, or mechanical, movements of said heart, or myocardium, 11, is provided.

With particular advantage, said support means 16 of said detection means, or television camera, 12 for detecting the spatial, or mechanical movements, of said heart, or myocardium, 11, is adapted to move, or displace, the same detection means 12 for detecting the spatial, or mechanical movements, of said heart, or myocardium,

I I with respect to said heart, or myocardium, 11, or to a corresponding surface, or wall, of the same heart, or myocardium, 11.

With particular advantage, said detection means 16, or television camera, 12 for detecting the spatial, or mechanical movements, of said heart, or myocardium, 11, is adapted to move said detection means, or television camera, 12 for detecting the spatial, or mechanical movements, of said heart, or myocardium, 11 perpendicularly with respect to said heart, or myocardium, 11, or to the corresponding surface, or wall, thereof.

As can be seen from said figures, advantageously, said support means 16 of said detection means, or television camera, 12 for detecting the spatial, or mechanical movements, of said heart, or myocardium, 11, is adapted to move said detection means, or television camera, 12 for detecting the spatial, or mechanical movements, of said heart, or myocardium, 11, in a corresponding plane parallel to said heart, or myocardium, 11, i.e. to the corresponding surface or wall thereof, in particular to the support plane of said patient 13, or to the floor of said operating theatre 15.

Advantageously, as can be seen from said figures, said support means 16 of said detection means, or television camera, 12 for detecting the spatial, or mechanical movements, of said heart, or myocardium, 11, is adapted to position said means, or television camera, 12 of the spatial, or mechanical movements, of said heart, or myocardium, 11 above and distanced from the same heart, or myocardium, 11, in particular perpendicularly aligned with said heart, or myocardium, 11.

Particularly advantageously, as can be seen from said figures, said control means, or processor, 14 of the apparatus is configured to position said detection means, or television camera, 12 for detecting the spatial, or mechanical movements, of said heart, or myocardium, 11, in a corresponding and predetermined position with respect to said heart, or myocardium, 11, or with respect to a corresponding surface, or wall thereof.

As can be seen from said figures, in a particularly advantageous way, said control means, or processor, 14 of the apparatus is configured to store the position of said detection means, or television camera, 12 for detecting the spatial, or mechanical movements, of said heart, or myocardium, 11, in a predetermined position with respect to said heart, or myocardium, 11, or to a corresponding surface, or wall thereof, and to reposition, in particular selectively or automatically, said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements of said heart, or myocardium, 11 in said stored position.

Advantageously, as can be seen from said figures, in particular in the apparatus 10, a detection means is provided for detecting the position of said support means 16 of said detection means, or television camera, 12 for detecting the spatial, or mechanical movements, of said heart, or myocardium, 11, which is in communication with said control means, or processor, 14 of the apparatus for determining the position of said detection means or television camera, 12 of the spatial, or mechanical movements, of said heart, or myocardium, 11.

Advantageously, as can be seen from said figures, said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, is adapted to detect said heart, or myocardium, 11 in a first and in a second operating condition, i.e. in particular in a pre-operating step 40 and in a post-operating step 50, as can be clearly seen from the following figure 3. According to a further embodiment, however, it would also be conceivable for a detection to take place in an intra-operating step.

As can be seen from said figures, advantageously, said control means, or processor, 14 of the apparatus is configured to determine, starting from corresponding signals, or data, received from said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, one or more of the following parameters, in particular kinetic, of the heart, or myocardium, 11 of a human being 13 or animal: force of contraction, cardiac fatigue, kinetic energy of contraction, contraction speed, punctiform displacement of the trajectory, area and perimeter of the trajectory, analysis of the systole and diastole times of the individual beat.

Advantageously, as can be seen from said figures, said control means, or processor, 14 of the apparatus is configured to determine, starting from corresponding signals, or data, received from said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, evaluate one or more of the following parameters, in particular kinetic, of the heart, or myocardium, 11 of a human being 13 or animal: the ejection fraction, the fractional shortening, the ventricular hemodynamic load of said heart, or myocardium, 11.

With advantage, as can be seen from said figures, said support means 16 of said detection means, or television camera, 12 for detecting the spatial, or mechanical movements, of said heart, or myocardium, 11, comprises an elongated support arm 18, in particular at the respective free end, of said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11.

As can be seen from said figures, advantageously, said elongated support arm 18 of said means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, extends, in particular backwards, from said apparatus 10, especially, during use, towards the patient and/or beyond a separation 19 between the sterile area of the operating theatre 15 and the non-sterile area, for housing technical equipment to assist with the operation 17. In particular, said separation is defined by the drape 19, which prevents pollution of the operating field, with said arm 16 that extends above the support or underwire from which said drape 19 is hung.

Advantageously, as can be seen from said figures, said elongated support arm 18 of said means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, is axially extensible, or telescopic.

With particular advantage, as can be seen from said figures, said elongated support arm 18 of said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, is rotatable, in particular with respect to a corresponding perpendicular, or vertical, axis according to opposite angular directions, especially for an angular portion around 180°.

As can be seen from said figures, advantageously, said elongated support arm 18 of said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, can be perpendicularly or vertically raised and lowered, in particular with respect to said heart, or myocardium, 11.

Advantageously, as can be seen from said figures, said support means 16 of said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, comprises an upright 20 that supports said elongated support arm 18 of said detection means, or television camera 12 and from which the same extends, for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11.

In a particularly advantageous manner, as can be seen from said figures, said upright 20 for supporting said elongated support arm 18 of said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, extends perpendicularly or vertically.

As can be seen from said figures, advantageously, said support upright 20 of said elongated support arm 18 of said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, is axially extensible, i.e. it can be raised and lowered, in particular for raising and lowering said elongated support arm 18 of said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11.

Advantageously, as can be seen from said figures, said apparatus 10 comprises a display screen 22 in particular supported on a corresponding support surface 26 of the apparatus 10.

Advantageously, as can be seen from said figures, said apparatus 10 comprises an input means 24, especially said control means, or processor, 14 of the apparatus, in particular comprising a joystick 241 for controlling said support arm 18 and/or a keyboard 242 and/or a trackpad or mouse 243, in particular supported on a corresponding support surface 26 of said apparatus 10, or also integrated in the structure of the station.

As can be seen from said figures, advantageously, said apparatus 10 comprises a support structure 28, in particular of said support means 16 of said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11 and/or of said support surface 26 of the apparatus 10.

Advantageously, as can be seen from said figures, said support structure 28 comprises a lower base 281 in particular on which said control means, o processor, 14 of the apparatus is supported and/or from which a corresponding column 282 extends, in particular for supporting said support surface 26 of the apparatus 10.

With advantage, as can be seen from said figures, on said support structure 28, said control means, or processor, 14 of the apparatus is positioned in front of said support upright 20 of said elongated support arm 18 of said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11.

As can be seen from said figures, advantageously, said support upright 20 of said elongated support arm 18 of said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, is provided in the rear area of said support structure 28 and backwards.

Advantageously, as can be seen from said figures, said support structure 28 comprises a roller means, in particular swivelling, 30, in particular fixed to said lower base 281 of said support structure 28, and preferably comprising, as illustrated in figures 1A and IB, rollers for ground support, and being provided with a locking means of the movement of said apparatus 10, i.e. for locking the rotation of said roller means, in particular of the swivelling type, 30.

With particular advantage, as can be seen from said figures, said control means, or processor, 14 of the apparatus is configured to position perpendicularly, or vertically, said detection means or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, in particular as a function of corresponding signals, or data, received from said detection means 12 of the distance, or depth, z, of said heart, or myocardium, 11, i.e. using the depth parameter of said 3D television camera.

As can be seen from said figures, advantageously, said control means, or processor, 14 of the apparatus is configured to define the means for the positioning in perpendicular, or vertical, alignment of said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, of the patient, and in particular defined by an image in transparency of said heart, or myocardium, 11, to collimate by the operator manoeuvring said elongated support arm 18 of said detection means, or television camera, 12 for detecting the spatial, or mechanical, movements, of said heart, or myocardium, 11, i.e. automatically, and that is preferably displayed on said display screen of the apparatus 10.

As can be seen from said figure 3, advantageously, said control means, or processor, 14 of the apparatus is configured, or has corresponding software, for performing, in particular in both of said steps, preferably in said pre-operative step 40 and/or in said post-operative step 50, particularly in sequence and preferably automatically, a tracking step, 41, 51 of the spatial, or mechanical, movements, of said heart, or myocardium, 11, or of corresponding points thereof to be tracked, an extraction step 42, 52 of the coordinates x, y, z of said tracked movement, in 41, 51, of said heart, or myocardium, 11, and an evaluation or calculation step 43, 53 of said one or more parameters, in particular kinetic, in relation to said heart, or myocardium, 11, in particular starting from said coordinates x, y, z extracted from said tracked movement in 41, 51 of said heart, or myocardium, 11, as well as a possible implementation 44, 54 of a statistic, in particular weighted according to the number of recordings or detections performed, for said one or more parameters, in particular kinetic, evaluated, or calculated, in relation to said heart, or myocardium, 11.

Advantageously, as can be seen from said figures, moreover, said control means, or processor, 14 of the apparatus is configured, or has corresponding software, to display, in particular once said post-operative verification procedure 50 has been performed, in particular in sequence therewith and preferably automatically following it 60, in particular on said display 22 of the apparatus 10, the differences between said one or more parameters, in particular kinetic, evaluated, or calculated, in relation to said heart, or myocardium, 11 in said first and second step, i.e. in said pre-operative 40 and post-operative steps 50. In this way, the clinician can advantageously evaluate the success of the intervention.

As can be seen from said figures, advantageously, said control means, or processor, 14 of the apparatus is configured, or has corresponding software, to perform, in particular following said post-operative step 50, and especially in sequence with said display step 60, preferably automatically, an artificial intelligence procedure for the recognition of the state of said heart, or myocardium, 11, and to obtain corresponding results or outcomes, respectively positive 70 or negative 80 and, following the respective outcome, to control the emission of a corresponding signal 71, e.g. of the visual type, and preferably shown on said display 22, for consent for the continuation of the operation, i.e. consent to close the patient’s chest, or to control the emission of a warning signal 81 of the presence of a problem for said patient.

In practice, as is evident, the technical characteristics illustrated above allow, individually or in a respective combination, achieving one or more of the following advantageous results:

- a particularly accurate detection of the kinetics of the heart is obtained, in particular it is possible to evaluate the ejection fraction, the fractional shortening, the ventricular hemodynamic load of said heart, or myocardium, all with an apparatus which is in itself non-invasive for the patient, as well as the force of contraction, cardiac fatigue, kinetic energy of contraction, contraction speed, punctiform displacement of the trajectory, area and perimeter of the trajectory, analysis of the systole and diastole times of the individual beat;

- the clinician can advantageously evaluate the success of the operation.

The present invention is susceptible to evident industrial application. The person skilled in the art will also be able to imagine numerous modifications and/or variations to be made to the same invention, while remaining within the scope of the inventive concept, as extensively explained. Moreover, the person skilled in the art will be able to imagine further preferred embodiments of the invention which include one or more of the above illustrated characteristics of the preferred embodiment.

Moreover, it must also be understood that all the details of the invention can be replaced by technically equivalent elements.