DEVICE FOR PERFORMING DIAGNOSTICS AND/OR THERAPY

• US 20140336743A1
• Filed: 11/30/2012
• Published: 11/13/2014
• Est. Priority Date: 12/02/2011
• Status: Abandoned Application

• Current Assignee: Rainer Zotz
• Original Assignee: Rainer Zotz
• Inventors: Zotz, Rainer
• Application Number:
  US14/361,658
• Publication Number:
  US 20140336743A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2560/066 catheters therefor
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/33 specially adapted for cooperation with other devices
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/13 Tomography A61B8/10, A61B8/12 take precedence; tomography for radiation diagnosis A61B6/02
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/483 involving the acquisition of a 3D volume of data
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/2481 : Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/82 : Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 : Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61M 2205/058 : with ultrasound therapy
• CPC Class Codes: A61M 2205/8243 : by induction
• CPC Class Codes: A61M 2210/1014 : Diaphragm
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 60/191 : mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
• CPC Class Codes: A61M 60/289 : Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/468 : the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/473 : generated by an electromotor
• CPC Class Codes: A61M 60/515 : Regulation using real-time patient data
• CPC Class Codes: A61M 60/839 : of devices for mechanical circulatory actuation
• CPC Class Codes: A61M 60/876 : Implantable batteries
• CPC Class Codes: A61N 2007/0043 : intra-cavitary
• CPC Class Codes: A61N 2007/0078 : with multiple treatment transducers
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

The disclosure relates to a device for performing diagnostics and/or therapy and related kit, system, computer program, methods and computer readable mediums. The device of this disclosure has the advantages that the device does not need access to the pericardium and that the whole system including kit and device can be removed after diagnostics/therapy. A device for performing diagnostics and/or therapy of an organ in the thoracic cavity, comprising an organ support (10), which organ support (10) is devised to be arranged exterior to an organ, and comprises: a flexible structure (14), such as a fabric, net, coil, bag or mesh, which is configured to cover a region of the organ, the region comprising at least the surface at an apex of the organ; at least one actuator (16), such as a motor, for actuating a movement of the flexible structure (14) for the therapy, and optionally at least one transducer (18), is provided.

Claims

1. A device for performing diagnostics and/or therapy of an organ in the thoracic cavity, comprising an organ support (10), which organ support (10) is devised to be arranged in contact with, but exterior to a pericardial sack (12) of a heart, and comprises:

a flexible structure (14), such as a fabric, net, coil, bag or mesh, which is configured to cover a region of said heart, said region comprising at least the surface at an apex of said heart;

at least one actuator (16), such as a motor, for actuating a movement of said flexible structure (14) for said therapy, and

a plurality of transducers (18).

2. The device according to claim 1, said device comprising said at least one transducer (18), such as a temperature sensor, accelerometer, ultrasound transmitter, ultrasound receiver, voltage sensor, potential sensor, current sensor or pH sensor for said diagnosis, wherein said at least one transducer (18) is preferably integrated with said flexible structure (14).

3. The device according to claim 1 or 2, wherein said device is collapsible and transluminally deliverable to said heart in a collapsed state, and operative in an expanded state, as well as removable from said heart when returned to said collapsed state.

4. The device according to any of claims 1 to 3, wherein said flexible structure (14) is configured to cover a region of the pericardial surface of said heart, said region comprising the pericardial surface at least at an apex of said heart and wherein said at least one actuator is adapted to actuate a movement of said flexible structure (14) in order to aid heart contractions of said heart.

5. The device according to any of claims 1-4, wherein said flexible structure (14) is a hollow structure, which hollow structure has the shape of a sock.

6. The device according to any of claims 1-5, wherein

said flexible structure (14) is resilient, so that said flexible structure (14) will regain its original shape after said movement of said flexible structure (14).

7. The device according to any of claims 1-6, comprising a plurality of ultrasound transducers (18), which are distributed on said flexible structure (14) and wherein at least one of said ultrasound transducers 18 are used for therapy.

8. The device according to claim 7, wherein said plurality of ultrasound transducers (18) are controlled so that at least one group of ultrasound transducers (18) are used for therapy.

9. The device according to any of claims 1-8, wherein said at least one transducer (18) is configured to provide a measurement signal for an electrical activity of a heart, and wherein at least one electrocardiogram (ECG) is computed from said measurement signal.

10. The device according to claim 9, further comprising a calculating unit for computing at least one electrocardiogram so that analysis can be performed in four dimensions.

11. The device according to any of claims 1-10, wherein said at least one transducer (18) is adapted to measure alpha radiation, beta radiation and/or gamma radiation.

12. The device according to any of claims 1-11, wherein said flexible structure (14) comprises an internal electromagnetic coil, and wherein said internal electromagnetic coil is a transceiver of signals related to magnetic resonance imaging MRI.

13. The device according to claim 12, comprising:

an external electromagnetic coil (22);

a computer (20) for sending control signals to and/or for receiving measurement signals from said external electromagnetic coil (22), wherein said external electromagnetic coil (22) is configured to work in pair with said internal electromagnetic coil so that said signals related to magnetic resonance imaging can be conveyed via said pair and a diagnosis based on MRI can be obtained.

14. The device according to claim 13, further comprising an internal control unit (24) for receiving said control signals from and/or for sending said measurement signals to said internal electromagnetic coil.

15. The device according to claim 14, wherein said internal control unit (24) is adapted to control said internal electromagnetic coil so that a varying electromagnetic field for MRI is generated.

16. The device according to claim 14 or 15, wherein said internal control unit (24) is connected to said at least one transducer (18) for obtaining a signal related to detected electromagnetic signals, such as electromagnetic signals emanated from photons.

17. The device according to any of claims 1-16, wherein said at least one actuator (16), is a motor, or at least one pneumatic and/or hydraulic actuator, such as a pump, connected to said flexible structure (14), and wherein said actuator (16) is adapted to assist a movement of said heart, in contracting and/or expanding.

18. The device according to claim 17, wherein said at least one actuator (16), is a motor and said motor is subcutaneously implantable in the region of the left shoulder.

19. The device according to claim 18, wherein said motor and a battery for the motor is implanted subcutaneously, in a single implantable device, in the region of the left shoulder.

20. The device according to claim 19, wherein said single implantable device further comprises an internal power supply (30).

21. The device according to claim 17, wherein said flexible structure (14) is resilient and said heart is assisted in expanding by said flexible structure (14).

22. The device according to any of claims 17-21, further comprising:

a component (40) arranged at a voltage supply (44) of said motor;

a measuring device (42), connected to said component (40) for measuring a value related to said component (40), and thereby sensing a load of said motor;

a comparison unit (46), connected to said measuring device (42) for making a comparison between said value and at least one expected value; and

a decision unit (48) for determining a condition of a heart based on said comparison.

23. The device according to any of claims 17-22, wherein said motor is provided with an internal power supply (30), comprising a battery (32), and wherein said internal power supply (30) can be recharged from an external power supply (34) through a wireless energy transfer.

24. The device according to claim 23, wherein said internal power supply (30) further comprises a radio frequency transceiver (36) and wherein said external power supply (34) comprises a radio frequency transceiver (38) and wherein said radio frequency transceivers (36, 38) are adapted to perform said wireless energy transfer.

25. The device according to claim 24, wherein said radio frequency transceivers (36, 38) also are adapted to transfer radio signals related to measurements.

26. The device of any of claims 1-25, further comprising:

a stent (1602), comprising a section (1604), which section comprises at least one compartment (1802), said compartment (1802) being configured to hold at least one piece of instrumentation, such as said plurality of transducers, and wherein said stent (1602) is implantable into the aorta of a patient.

31. A kit for delivery of a device according to any of claims 1-26, comprising:

a flexible protecting catheter for bringing said flexible structure of said removable device to a target site in a body, exterior and/or interior to the pericardial sack of a heart;

a guide wire for guiding said flexible protecting catheter to said target site in said body, exterior to the pericardial sack of said heart;

a tool (52) for facilitate lifting of said heart;

a surgical tool for putting said flexible structure around the pericardial sack of said heart, so that said flexible structure surrounds part of said heart; and

a surgical tool (140), such as three-arm-pliers or four-arm-pliers, for bringing said flexible structure back to its collapsed state.

32. A removable system comprising:

said kit of claim 31; and

said device of any of claims 1-26.

33. A method for delivery of a device according to any of claims 1-26, said method comprising:

gaining epicardial access by puncturing an intercostal space;

bringing said flexible structure into a collapsed state;

placing said collapsed flexible structure inside a protecting catheter;

delivering said collapsed flexible structure with said protecting catheter to a target site exterior to the pericardial sack;

optionally lifting said heart with a tool 52; and

sliding said flexible structure around the pericardial sack of a heart, so that said flexible structure surrounds part of said heart.

34. A method for delivery of a device according to any of claims 1-26, said method comprising:

gaining epicardial access through the use of the epicardial access approach via the left internal mammary puncture from the left arm;

bringing said flexible structure into a collapsed state;

placing said collapsed flexible structure inside a protecting catheter;

delivering said collapsed flexible structure with said protecting catheter to a target site exterior to the pericardial sack;

optionally lifting said heart with a tool 52; and

sliding said flexible structure around the pericardial sack of a heart, so that said flexible structure surrounds part of said heart.

35. A method of temporary treatment of an organ in a thoracic cavity, said method comprising:

providing a device of any of claims 1-26; and

activating a therapy program for an organ, wherein activating is regulated in a control loop based on a control signal based on sensor measurement.

27. A computer-readable medium having embodied thereon a computer program (60) for processing by a computer (20), said computer program (60) performing diagnostics of an organ in the thoracic cavity and comprising:

a code segment (62) for receiving at least one measurement signal from at least one transducer (18);

a code segment (64) for computing a diagnosis of an organ based on said at least one measurement signal;

a code segment (66) for searching a database for therapy methods corresponding to said diagnosis;

a code segment (68) for computing a score for each therapy method according to a criterion;

a code segment (70) for selecting a therapy method with the highest score as a best matched therapy method;

a code segment (72) for comparing said score of said best matched therapy method to a threshold value;

a code segment (74) for displaying a plurality of therapy methods having a score, which is higher than a threshold value with corresponding score, and if no therapy method gives a higher score than said threshold not displaying any therapy method.

28. A non-transitory computer-readable storage medium encoded with programming instructions, said storage medium being loaded into a computerized control system of an apparatus for performing diagnostics of an organ in the thoracic cavity, and said programming instructions causing said computerized control unit to control said apparatus during operation by:

receiving (80) at least one measurement signal from at least one transducer (18) at an internal control unit (24);

transmitting (82) said at least one measurement signal from said internal control unit (24) to a computer (20);

computing (84) in said computer (20) a diagnosis of an organ based on said at least one measurement signal;

searching (86) in said computer (20) a database for therapy methods corresponding to said diagnosis;

computing (88) a score for each therapy method according to a criteria;

selecting (90) a therapy method with the highest score as a best matched therapy method;

comparing (92) said score of said best matched therapy method to a threshold value; and

controlling said apparatus to display (94) a plurality of therapy methods having a score, which is higher than a threshold value with corresponding score, and if no therapy method gives a higher score than said threshold controlling said apparatus to not display any therapy method.

29. A method of performing diagnostics of an organ in the thoracic cavity, comprising:

receiving (80) at least one measurement signal from at least one transducer (18) at an internal control unit (24);

transmitting (82) said at least one measurement signal from said internal control unit (24) to a computer (20);

computing (84) in said computer (20) a diagnosis of an organ based on said at least one measurement signal;

searching (86) in said computer (20) a database for therapy methods corresponding to said diagnosis;

computing (88) a score for each therapy method according to a criterion;

selecting (90) a therapy method with the highest score as a best matched therapy method;

comparing (92) said score of said best matched therapy method to a threshold value; and

displaying (94) a plurality of therapy methods having a score, which is higher than a threshold value with corresponding score, and if no therapy method gives a higher score than said threshold not displaying any therapy method.

30. A computer program enabling carrying out a method according to claim 29.

36. A stent (1602), comprising a section (1604), which section comprises at least one compartment (1802), said compartment (1802) being configured to hold at least one piece of instrumentation, and wherein said stent (1602) is implantable into the aorta of a patient.

37. The stent of claim 36, wherein said instrumentation and/or said stent are insertable into and/or removable from the aorta of a patient by means of a catheter.

38. The stent of any of claims 36-37, wherein a pump is reversibly connected to said stent.

39. A system comprising:

said stent (1602) of any of claims 36-38; and

a transcutaneously chargable battery for delivering energy to said instrumentation of said stent (1602), and

wherein said battery is implantable in the left shoulder region of a patient.

40. A device for performing diagnostics and/or therapy of an organ in the thoracic cavity, comprising an organ support (10), which organ support (10) is devised to be arranged exterior to a lung, and comprises:

a flexible structure (14), such as a fabric, net, coil, bag or mesh, which is configured to cover a region of said lung, said region comprising at least the surface at an apex of said lung;

at least one actuator (16), such as a motor, for actuating a movement of said flexible structure (14) for said therapy, and

at least one transducer (18).

41. The device according to claim 40, said device comprising said at least one transducer (18), such as a temperature sensor, accelerometer, ultrasound transmitter, ultrasound receiver, voltage sensor, potential sensor, current sensor or pH sensor for said diagnosis, wherein said at least one transducer (18) is preferably integrated with said flexible structure (14).

42. The device according to claim 40 or 41, wherein said device is collapsible and transluminally deliverable to said lung in a collapsed state, and operative in an expanded state, as well as removable from said lung when returned to said collapsed state.

43. The device according to any of claims 40 to 42, wherein said organ support (10) is devised to be arranged exterior to said lung and wherein said flexible structure (14) is configured to cover a region of the surface of said lung, said region comprising at least the surface at an apex of said lung and wherein said at least one actuator (16) is adapted for actuating a movement of said flexible structure (14) so that said flexible structure (14) will assist lung contractions and/or expansion.

44. The device according to any of claims 40-43, wherein said organ support (10) is adapted to assist in diaphragmatic breathing.

45. The device according to claim 44, wherein said assisting in diaphragmatic breathing comprises an internal movement of the whole thorax, with or without the diaphragm, so that negative pressure breathing can be performed.