Method and device for the vascular pressure-controlled selective perfusion of fluids through blood vessels

• US 6,458,323 B1
• Filed: 12/29/1997
• Issued: 10/01/2002
• Est. Priority Date: 04/20/1995
• Status: Expired due to Fees

• Current Assignee: Peter Boekstegers
• Original Assignee: Peter Boekstegers
• Inventors: Boekstegers, Peter
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): BIANCO, PATRICIA
• Application Number:
  US08/945,488
• Time in Patent Office: 1,737 Days
• Field of Search: 624/4-6, 128/898, 128/DIG.5, 128/DIG.20, 604/4.01, 604/5.01, 604/6.01, 604/6.09, 604/6.1, 604/6.11, 604/6.14, 604/19, 604/30, 604/28, 604/65-67, 604/93.01, 604/131, 604/151, 604/31, 422/44-45, 422/82.13, 600/301, 600/334, 600/363, 600/366, 600/368, 600/500-502, 600/504-505, 600/437-439, 600/454, 600/459-468, 600/485-486, 600/493, 600/16-18, 417/1, 417/63, 417/212, 417/279, 417/282, 417/321, 417/378, 417/383, 417/428, 417/253, 606/191, 606/194
• US Class Current: 422/44
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure

Abstract

A method for selective perfusion of fluids through blood vessels is controlled by the pressure in the blood vessels. A tubing line open at the proximal end for the perfusion of fluids through a tissue region is introduced into a patient'"'"'s blood vessel in which perfusion is to be performed. The vessel is sealed off from the line in the area of its proximal end, and fluid is pumped into the vessel. The method is characterized in that a specific set value for the internal pressure of the vessel is measured, and the perfused flow of fluid is regulated during pumping in such a way that the set value for the internal pressure of the vessel is kept as closely as possible.

Claims

1. Method for the selective perfusion of fluids through blood vessels, controlled by the pressure in said blood vessels, comprising:

introducing a tubing line into a patient'"'"'s vein in which perfusion is to be performed, said tubing line being open at its proximal end for perfusing fluids through a tissue region,

sealing off said vein from the line in the area of its proximal end,

performing the following steps while maintaining said vein in the sealed-off condition;

(1) pumping said fluid periodically at intervals into said vein via said tubing line and suctioning blood from said vein via said tubing line, said pumping and suctioning intervals being synchronized with the patient'"'"'s heartbeat,

(2) measuring the internal pressure of said vein, and

(3) regulating said perfused flow of fluid during pumping in step (1) in such a way that a predefined set value for the internal pressure of said vein is maintained as closely as possible.

2. Method according to claim 1, wherein said infused fluid is an oxygen carrier.

3. Method according to claim 2 wherein said oxygen carrier comprises blood or a blood substitute.

4. Method according to claim 3, further comprising the step of withdrawing arterial blood from said patient, cleaning said blood and freeing said blood of air bubbles and reintroducing said blood into said vessel.

5. Method according to claim 1, wherein said predefined set value for the internal pressure of said vein is determined with said vein being sealed off and in the absence of venous blood flow, and by performing the steps of infusing fluid while increasing the flow of fluid at each pumping interval, measuring the internal pressure of the vein, and selecting a plateau pressure being created in said vein as said predefined set value.

6. Method according to claim 1, wherein said set value for the internal pressure of said vein is determined with said vein being sealed off and in the presence of venous blood flow, and by performing the steps of measuring the internal pressure of the vein, selecting a plateau pressure of the peak venous pressures being created in said vein in this process as said set value.

7. Method according to claim 1, wherein said fluid contains substances selected from the group of substances consisting of therapeutic and diagnostic active substances.

8. Method according to claim 6, further comprising the step of defoaming said blood which has been suctioned and, if appropriate, freeing said blood of air bubbles and returning said blood to said patient via another vein.

9. Device for the selective perfusion of a fluid through blood vessels, controlled by the pressure in said blood vessels, comprising:

a tubing line which can be introduced into a patient'"'"'s vein, said tubing line open at its proximal end thereof and being chargeable with a fluid under pressure which is to be pumped into said vein, said proximal end of said tubing line being provided with an enlargeable sealing means for sealing said vein off from said tubing line,

a suction device connected to said tubing line for withdrawing blood from said vein of said patient, said control unit receiving signals from the patient'"'"'s heartbeat and defining pumping and suction intervals which are synchronized with the patient'"'"'s heart cycle,

a control unit,

means for measuring the internal pressure of said vein, said measuring means being connected to said control unit,

means for regulating the perfused flow of fluid, said regulation means being operated by said control unit during a period when said enlargeable sealing means seals off said vein such that a defined set value for the internal pressure of the vein is maintained as constant as possible during pumping of said fluid.

10. Device according to claim 9 wherein said means for regulating the perfused flow of fluid comprise a flow regulator cooperating with said tubing line.

11. Device according to claim 10, wherein said tubing line is formed by an elastically yielding tubing in the area of said flow regulator, said flow regulator comprising a clamping member which is driven by an electric motor in order to press said elastic tubing together to a greater or lesser extent thereby controlling the flow of said fluid into said blood vessel.

12. Device according to claim 9, wherein a distal end of said tubing line is connected to a pressurized fluid reservoir having a pressure sensor for monitoring the pressure in said reservoir.

13. Device according to claim 12, further comprising a roller pump for feeding blood taken from an artery of said patient to said reservoir.

14. The device according to claim 9 wherein said tubing line comprises a multi-lumen lumen catheter, in particular an at least four-lumen catheter for retroinfusion, said multi-lumen lumen catheter comprising an admission line for said fluid, a suction line for suctioned blood, a measurement line for determining the internal pressure of a catheterised vein, and a control line for said enlargeable sealing means.

15. Device according to claim 14 wherein said measurement line communicates at one end with the inside of said vessel and has a pressure sensor arranged at its other end.

16. Device according to claim 9, wherein said sealing means comprises a pressure-controlled, inflatable balloon.

17. Device according to claim 9, wherein said means for measuring said internal pressure of said blood vessel comprises a pressure sensor arranged at the proximal end of said tubing line, said pressure sensor connected to said control unit.

18. Device according to claim 9, wherein said suction device comprises a vacuum pump and a container for suctioned blood.

19. Device according to claim 9, further comprising a reservoir, a roller pump and an air trap being connected to one another and being further connected to said suction device, for withdrawing blood from said patient, cleaning said suctioned blood and delivering said cleaned blood to a vein of said patient.

20. Method for the selective perfusion of fluids through blood vessels, controlled by the pressure in said blood vessels, comprising:

introducing a tubing line into a patient'"'"'s vein in which perfusion is to be performed, said tubing line being open at its proximal end for perfusing fluids through a tissue region,

sealing off said vein from the line in the area of its proximal end,

performing the following steps while maintaining said vein in the sealed-off condition;

(1) pumping said fluid periodically at intervals into said vein via said tubing line, the pumping intervals being synchronized with the patient'"'"'s heartbeat,

(2) measuring the internal pressure of said vein, and

(3) regulating said perfused flow of fluid during pumping in step (1) in such a way that a predefined set value for the internal pressure of said vein is maintained as closely as possible,

said predefined set value for the internal pressure of said vein being determined with said vein being sealed off and in the absence of venous blood flow, and by performing the steps of infusing fluid while increasing the flow of fluid at each pumping interval, measuring the internal pressure of the vein, and selecting a plateau pressure being created in said vein as said predefined set value.

22. The method according to claim 20, or claim 21, further comprising the steps of infusing said fluid into said vein periodically via said tubing line, and suctioning blood from said vein via said tubing line.

23. The method according to claim 22 wherein said pumping and suction steps are performed in intervals that are synchronized with the patient'"'"'s heartbeat.

21. Method for the selective perfusion of fluids through blood vessels, controlled by the pressure in said blood vessels, comprising:

introducing a tubing line into a patient'"'"'s vein in which perfusion is to be performed, said tubing line being open at its proximal end for perfusing fluids through a tissue region,

sealing off said vein from the line in the area of its proximal end,

performing the following steps while maintaining said vein in the sealed-off condition;

(1) pumping said fluid periodically at intervals into said vein via said tubing line, the pumping intervals being synchronized with the patient'"'"'s heartbeat,

(2) measuring the internal pressure of said vein, and

(3) regulating said perfused flow of fluid during pumping in step (1) in such a way that a predefined set value for the internal pressure of said vein is maintained as closely as possible,

said predefined set value for the internal pressure of said vein being determined with said vein being sealed off and in the presence of venous blood flow, and by performing the steps of measuring the internal pressure of the vein, selecting a plateau pressure of the peak venous pressures being created in said vein in this process as said set value.

24. Device for the selective perfusion of a fluid through blood vessels, controlled by the pressure in said blood vessels, comprising:

a tubing line which can be introduced into a patient'"'"'s vein, said tubing line open at its proximal end thereof and being chargeable with a fluid under pressure which is to be pumped into said vein, said proximal end of said tubing line being provided with an enlargeable sealing means for sealing said vein off from said tubing line, said tubing line comprising a multi-lumen catheter, in particular an at least three-lumen artery catheter for perfusion, said multi-lumen catheter comprising an admission line for said fluid, a measurement line for determining the internal pressure of a catheterised artery, and a control line for said enlargeable sealing means,

a control unit,

means for measuring the internal pressure of said vein, said measuring means being connected to said control unit,

means for regulating the perfused flow of fluid, said regulation means being operated by said control unit during a period when said enlargeable sealing means seals off said vein such that a defined set value for the internal pressure of the vein is maintained as constant as possible during pumping of said fluid.

25. Device according to claim 24, wherein said vessel comprises a vein and wherein said device further comprises a suction device connected to said tubing line for withdrawing blood from said vein of said patient, said control unit receiving signals from the patient'"'"'s heartbeat and defining pumping and suction intervals which are synchronized with the patient'"'"'s heart cycle.

26. The device according to claim 25, wherein said multi-lumen catheter is an at least four-lumen catheter for retroinfusion further comprising a suction line for suctioned blood.