Multipurpose machine for monitoring and control of locoregional therapies in oncology

• US 6,610,024 B1
• Filed: 01/14/2000
• Issued: 08/26/2003
• Est. Priority Date: 11/16/1999
• Status: Expired due to Fees

• Current Assignee: Rand SRL
• Original Assignee: Luigi Benatti
• Inventors: Benatti, Luigi
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US09/481,443
• Time in Patent Office: 1,320 Days
• Field of Search: 604/4.01, 604/5.01, 604/5.04, 604/6.07, 604/6.09, 604/6.1, 604/6.11, 604/6.13, 604/19, 604/27, 604/29, 604/30, 604/31, 604/65-67, 604/80-83, 604/890.1, 424/140.1, 424/145.1, 424/529, 210/645-646, 210/739, 210/741, 210/198.1
• US Class Current: 604/4.01
• CPC Class Codes: A61M 1/1698 Blood oxygenators with or without heat-exchangers intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3451 the difference in weight between both ultra-filtrate and substitution reservoir being used as control signal
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3615 Cleaning blood contaminated by local chemotherapy of a body part temporarily isolated from the blood circuit
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment

Abstract

The multipurpose machine for monitoring and control of locoregional therapies in oncology comprises a head which has a box-like structure, is supported by a stand provided with means for modifying its dimensions, and is provided with adsorbent and/or filtering means and with means for controlling and regulating chemotherapy and chemofiltration which are arranged along a first set of duct circuits accommodated in the head; the first set of circuits is divided into at least two loops, each of which has its own pumping means; the loops are mutually interactive or separable, and the first loop is provided for the infusion of the chemotherapeutic agents and the second loop is provided for the filtration of the chemotherapeutic agents; an emergency electronic circuit is inserted between the two loops in order to detect malfunctions of the pumping means and functionally restore at least the infusion loop; the head furthermore accommodates a second main set of circuits which can be activated alternately with respect to the first one and is meant to perform intraperitoneal hyperthermal perfusion therapy.

Claims

1. A multipurpose machine for monitoring and control of locoregional therapies in oncology, comprising:

a head having a box-like structure;

a base for supporting said head;

dimension adjustment means for modifying overall dimensions of the machine;

adsorbent/filtering means, accommodated within said head, for chemofiltration;

perfusion chemotherapy and chemofiltration controlling and regulating means accommodated within said head for controlling and regulating chemotherapy and chemofiltration;

at least one set of duct circuits accommodated within said head and forming at least first and second loops defining, respectively, first and second extracorporeal blood circuits, said first and second loops being connected to each other so as to selectively enable fluid circulation in a separate perfusion configuration for chemotherapy fluid perfusion along the first extracorporeal blood circuit and an interactive chemofiltration configuration for fluid chemofiltration along the second extracorporeal blood circuit, said adsorbent/filtering means and said perfusion chemotherapy and chemofiltration controlling and regulating means being arranged along said at least one set of duct circuits;

and wherein said perfusion chemotherapy and chemofiltration controlling and regulating means includes fluid flow control valve means for interrupting fluid circulation between said first and second loops in said separate perfusion configuration and for enabling fluid flow circulation between said first and second loops in said interactive chemofiltration configuration.

2. The multipurpose machine of claim 1, comprising a second set of duct circuits, accommodated within said head, said second set of duct circuits activated alternatively with respect to said first set of duct circuits in order to perform intraperitoneal hyperthermal perfusion therapy.

3. The multipurpose machine of claim 2, wherein said second set of duct circuits is provided with a closed loop, with a series of dispensers/detection sensors, to which said closed loop leads, which can be introduced in a peritoneal region of a patient, with a branch loop for feeding solution containing chemotherapeutic agents, with a weighing means for containing and weighing the solution, fitted along said branch loop, with a heating means, with a pumping means, said heating and pumping means being further provided in series on said closed loop, and with infusion and circulation pressure sensing means being arranged upstream and, respectively, downstream of said heating and pumping means.

4. The multipurpose machine of claim 3, wherein said second set of duct circuits comprises respective inlet and outlet ends of said branch loop arranged upstream and downstream of said series of dispensers/sensors, and corresponding clamp means, located on said inlet and outlet ends, which control connection to said weighing means.

5. The multipurpose machine of claim 3, wherein said pumping means and said heating means are provided so as to be selectively connectable for operation with both said second main loop and said second set of duct circuits.

6. The multipurpose machine of claim 3, wherein said weighing means include a pouch/ampoule supported by a load cell.

7. The multipurpose machine of claim 2, wherein said first loop includes at least three mutually sequential duct segments:

a first segment for drawing blood from a patient and for introducing the chemotherapeutic agents;

a second intermediate segment for blood control; and

a third segment for returning the blood to the patient.

8. The multipurpose machine of claim 7, further comprising:

pumping means, arranged at said first and second loop, for pumping fluid in said set of duct circuits forming said first and second loops; and

an electronic emergency circuit which is inserted between said two selectively interactive and separate configuration first and second loops, for managing malfunctions of said pumping means whereupon functionally restoring operation of at least said first infusion loop.

9. The multipurpose machine of claim 8, wherein said emergency electronic circuit is connected to said pumping means of said first and second loops and to said adsorbent/filtering means for filtering the chemotherapeutic agents.

10. The multipurpose machine of claim 9, wherein said electronic circuit is connected to said pumping means so as to carry out, upon malfunction of said first loop, active functional switching between the pumping means of said second and first loops.

24. The multipurpose machine of claim 1, wherein said dimension-modifying adjustment means include a trolley which is integrated in said head, by a vertical post on which said trolley is slidingly guided, and by a base from which said post rises.

25. The multipurpose machine of claim 1, further comprising supporting elements, provided at said head for supporting said adsorbent/filtering means and said perfusion chemotherapy and chemofiltration controlling and regulating means, which include at least one plate which is retractably foldable into said head, said plate being provided with corresponding recesses for accommodating said adsorbent/filtering means and said perfusion chemotherapy and chemofiltration controlling and regulating means.

26. The multipurpose machine of claim 25, wherein said perfusion chemotherapy and chemofiltration controlling and regulating means further include:

a controller which is provided with a touch-screen, said touch-screen being foldable onto said head into a fold-away position.

11. The multipurpose machine of claim 11, wherein said chemotherapy and chemofiltration controlling and regulating means further include, arranged in a cascade arrangement along said first segment:

a first blood pressure sensor means for sensing blood pressure at withdrawal from a patient which is connected to a point of said first segment for introducing the chemotherapeutic agents;

a pumping assembly arranged downstream of said point of the first segment; and

a second sensor means for controlling inlet pressure of the chemotherapeutic agents.

12. The multipurpose machine of claim 11, wherein said pumping assembly includes a pump of a peristaltic type.

13. The multipurpose machine of claim 11, wherein said perfusion chemotherapy and chemofiltration controlling and regulating means further includes, arranged in a series arrangement along said second intermediate segment:

an oxygen pressure sensing means for sensing pressure of the oxygen in the blood in said first loop;

a heating means, provided downstream of said oxygen pressure sensing means; and

a third blood pressure sensor means for measuring the pressure of the blood returning to the patient, said fluid flow control valve means including a first throttling/connection valve means for throttling and respectively enabling fluid flow between said first and second loops.

14. The multipurpose machine of claim 13, wherein said perfusion chemotherapy and chemofiltration controlling and regulating means further includes, arranged in a series arrangement along said third segment for blood return:

a fourth air sensor means for detecting air in the blood returned to the patient; and

at least one terminal electric clamp to prevent reverse flow of the blood.

15. The multipurpose machine of claim 14, wherein said perfusion chemotherapy and chemofiltration controlling and regulating means further include:

a multiple-way valve means provided so as to control, both sequentially and with time-dependent criteria, fluid flow at said point for introducing the chemotherapeutic agent.

16. The multipurpose machine of claim 14, wherein said pumping assembly is controlled by said first blood pressure sensing means and by said third blood pressure sensor means.

17. The multipurpose machine of claim 16, wherein said fluid flow control valve means is provided so as to be controlled by said oxygen pressure sensing means.

18. The multipurpose machine of claim 17, wherein said oxygen pressure sensing means includes a probe adapted to be placed in direct contact with an organ which is target of the chemotherapeutic agents.

19. The multipurpose machine of claim 14, wherein said electric clamp is provided so as to be controlled by said fourth air sensor means for detecting air in blood being returned to the patient.

20. The multipurpose machine of claim 14, wherein said second chemotherapeutic agent filtration loop includes two sub-loops:

a first sub-loop including the adsorbent/filtering means for filtering the chemotherapeutic agents; and

a second sub-loop for controlling functionality of said adsorbent/filtering means and for maintaining a presettable water balance of the patient.

21. The multipurpose machine of claim 20, wherein said perfusion chemotherapy and chemofiltration controlling and regulating means further include:

at least one further electric clamp, said first sub-loop being connectable to said intermediate segment of said first loop, in input, through said fluid flow control valve means, and in output, directly upstream of said oxygen sensing means, through said at least one further electric clamp for throttling said connection in output.

22. The multipurpose machine of claim 21, wherein said second sub-loop includes a conventional set of circuits for hemofiltration and hemodialysis.

23. The multipurpose machine of claim 22, further comprising:

at least one fifth blood sensor means provided at said second sub-loop for detecting presence of blood in said second sub-loop;

a sixth pressure sensing means serially connected to said fifth blood sensor means for sensing pressure in output from said filtering means;

a second pumping assembly located downstream of said sixth pressure sensing means;

a weighing station provided downstream of said pumping assembly;

a third pumping assembly arranged downstream of said weighing station; and

a seventh sensing means for sensing and controlling pressure in said second sub-loop.