Variable ratio blood-additive solution device and delivery system

• US 5,322,500 A
• Filed: 03/04/1993
• Issued: 06/21/1994
• Est. Priority Date: 05/09/1991
• Status: Expired due to Fees

• Current Assignee: Cardio Pulmonary Supplies Incorporated
• Original Assignee: Cardio Pulmonary Supplies Incorporated
• Inventors: Straus, Stephen R., Giordano, Joseph D., Johnson, Gilbert H.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): ZUTTARELLI, ANTHONY
• Application Number:
  US08/026,277
• Time in Patent Office: 474 Days
• Field of Search: 128/DIG. 6, 128/12, 128/13, 604/4, 604/7, 604/21, 604/27, 604/30-31, 604/43, 604/56, 604/65-67, 604/81-83, 604/113, 604/131, 604/141, 604/143, 604/151, 604/207, 604/246
• US Class Current: 604/6.11
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3664 for preparing cardioplegia solutions
• CPC Class Codes: A61M 1/369 Temperature treatment
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: Y10S 128/12 Pressure infusion
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

A variable ratio, blood-additive solution, mixing device and delivery system that permits the varying of the ratio of blood to solution from either all blood to pure solution and any ratio of the two, either continuously or intermittently, prior to or during cardiovascular and cardiac perfusion procedures, particularly warm or cold cardioplegia procedures for open heart surgery.

Claims

1. A device for mixing a solution with blood to form a mixture and for delivering the mixture to a site of perfusion, said device comprising:

a. a source of blood and a source of solution;

b. a mixing means interconnected with said source of blood and said source of solution for mixing the blood and the solution to form a mixture, said mixing means having a plurality of inlets and a dispensing means for delivering said mixture to the site of perfusion;

c. a first path means interconnecting said source of blood and said mixing means for defining a blood flow path between said source of blood and one of said inlets of said mixing means;

d. a second path means interconnecting said source of solution and said mixing means for defining a solution flow path between said source of solution and one of said inlets of said mixing means;

e. a third path means interconnected to said dispensing means for delivering said mixture to the site of perfusion for defining a mixture flow path between said dispensing means and the site of perfusion;

f. a first pump disposed in said first path means for moving the blood along said first path means;

g. a second pump disposed in said third path means for moving said mixture along said third path means;

h. varying means in communication with said source of blood and said source of solution for selectively varying a ratio of blood to solution in said mixture;

i. monitoring means in communication with said mixing means for continuously and instantaneously monitoring the ratio of blood to solution in said mixture, said monitoring means comprising;

(a) computer means for calculating the ratio of blood to solution in said mixture;

(b) pressure measuring means connected to said third path means for continuously measuring an instantaneous pressure of said mixture in said third path means, said pressure measuring means being adapted to provide an electronic signal to said computer means representing the pressure in said third path means; and

(c) flow measuring means disposed in at least two of said first, second and third path means for determining an instantaneous rate of fluid flow therethrough, said flow measuring means being adapted to provide an electronic signal to said computer means representing the rate of fluid flow determined; and

j. means in communication with said first path means for diverting along a fourth flow path leading to the site of perfusion a portion of blood flowing in said first path means.

2. The mixing device as defined in claim 1 in which said varying means comprises a fluid regulating means for selectively controlling the fluid flow.

3. The mixing device as defined in claim 1 in which said solution comprises cardioplegia.

4. The mixing device as defined in claim 1 further comprising an oxygenator disposed in said second path means.

5. A variable ratio mixing device for dispensing a mixture of blood and solution toward a site of perfusion, said device comprising:

a. a source of blood and a source of solution;

b. a mixing means interconnected with said source of blood and said source of solution for mixing blood and solution, said mixing means having a plurality of inlets and including dispensing means for dispensing a mixture of blood and solution;

c. a first path means interconnecting said source of blood and said mixing means for defining a blood path between said source of blood and one of said inlets of said mixing means;

d. a second path means interconnecting said source of solution and said mixing means for defining a solution path between said source of solution and one of said inlets of said mixing means;

e. a third path means interconnected to said dispensing means for delivering said mixture to the site of perfusion for defining a blood and solution mixture path between said dispensing means and the site of perfusion;

f. a first pump disposed in said first path means for moving said blood along said first path means;

g. a second pump disposed in said third path means for moving said mixture of blood and solution along said third path means;

h. varying means in communication with said source of blood and said source of solution for selectively varying a ratio of blood to solution in said mixture of blood and solution;

i. monitoring means in communication with said mixing means for continuously and instantaneously monitoring the ratio of blood to solution in said mixture of blood and solution, said monitoring means comprising;

(a) a computer means having;

(i) a plurality of input means for receiving electronic signals;

(ii) means for calculating the ratio of blood to solution based on said electronic signals; and

(iii) display means for displaying said ratio;

(b) a plurality of flow measuring means for determining an instantaneous ratio of fluid flow, each of said flow measuring means being adapted to generate and transmit to said computer means an electronic signal representative of the rate of fluid flow, said flow measuring means being disposed in at least any two of said first path means, said second path means and said third path means; and

j. a means in communication with said first path means for diverting a portion of the blood flow from said first path means along a fourth path means to the site of perfusion.

6. The mixing device as defined in claim 5 further comprising pressure measuring means for continuously measuring a pressure of blood flow in said fourth path means, said pressure measuring means being adapted to generate and transmit to said computer means an electronic signal representative of the pressure of blood flow in said fourth path means.

7. The mixing device as defined in claim 6, where said solution is cardioplegia.

8. The mixing device as defined in claim 6, further comprising an oxygenator disposed in said second path means.

9. The mixing device as defined in claim 8, further comprising a heat exchanger, disposed in said third path means.

10. A variable ratio mixing device for mixing blood and solution and for dispensing the mixture thereof toward a site of perfusion, said device comprising:

a. a source of blood and a source of solution;

b. a mixing means in communication with said source of blood and said source of solution for mixing blood and solution to form a mixture, said mixing means having first and second inlets and an outlet, said first inlet being connected to said source of blood and said second inlet being connected to said source of solution;

c. dispensing means connected to said outlet of said mixing means for dispensing said mixture toward the site of perfusion; and

d. monitoring means in communication with said mixing means for continuously and instantaneously monitoring a ratio of blood to solution in said mixture, said monitoring means comprising flow measuring means for determining an instantaneous rate of fluid flow of at least two of the fluid flows comprising blood flowing toward said mixing means, solution flowing toward said mixing means and mixture flowing toward the site of perfusion.

11. The mixing device as define din claim 10 in which said flow measuring means is adapted to generate and transmit electronic signals corresponding to the rates of fluid flow determined and in which said monitoring means further comprises computer means for receiving said electronic signals generated by said flow measuring means and for calculating the ratio of blood to solution in said mixture.

12. The mixing device as defined in claim 11 further including pressure measuring means disposed intermediate said mixing means and the site of perfusion for continuously measuring an instantaneous pressure of said mixture flowing toward the site of infusion, said pressure measuring means being adapted to provide an electronic signal to said computer means representing the pressure determined thereby.

13. The mixing device as defined in claim 11 further including means for diverting to the site of perfusion a portion of the blood flowing from said source of blood to said mixing means.

14. A variable ratio mixing device for mixing blood and solution and for dispensing the mixture thereof toward a site of perfusion, said device comprising:

a. a source of blood and a source of solution;

b. a mixing means interconnected with said source of blood and said source of solution for mixing blood and solution to form a mixture, said mixing means having first and second inlets and an outlet, said first inlet being connected to said source of blood and said second inlet being connected to said source of solution;

c. dispensing means connected to said outlet for dispensing said mixture toward the site of perfusion;

d. a first pump disposed intermediate said source of blood and said mixing means for moving said blood toward said mixing means;

e. a second pump disposed intermediate said mixing means and the site of perfusion for moving said mixture toward the site of perfusion;

f. varying means in communication with said source of blood and said source of solution for selectively varying a ratio of blood to solution in said mixture;

g. monitoring means in communication with said mixing means for continuously and instantaneously monitoring the ratio of blood to solution in said mixture, said monitoring means comprising;

(i) flow measuring means for determining an instantaneous rate of fluid flow of at least two of fluid flows comprising blood flowing toward said mixing means, solution flowing toward said mixing means and mixture flowing toward the site of perfusion, said flow measuring means being adapted to generate said transmit electronic signals corresponding to the rates of fluid flow determined; and

(ii) computer means for receiving said electronic signals generated by said flow measuring means and for calculating the ratio of blood to solution in said mixture.

15. The mixing device as defined in claim 14 further including pressure measuring means disposed intermediate said mixing means and the site of perfusion for continuously measuring an instantaneous pressure of said mixing flowing toward the site of infusion, said pressure measuring means being adapted to provide an electronic signal to said computer means representing the pressure determined thereby.

16. The mixing device as defined in claim 14 further including means for diverting to the site of perfusion a portion of the blood flowing from said source of blood to said mixing means.

17. The mixing device as defined in claim 14 further including one way valve means disposed between said source of solution and said mixing means for permitting solution flow only in a direction toward said mixing means.

18. The mixing device as defined in claim 14 wherein said solution is cardioplegia.

19. The mixing device as defined in claim 18 further comprising an oxygenator disposed intermediate said source of blood and said mixing means.

20. The mixing device as defined in claim 19 further comprising a heat exchanger, disposed intermediate said mixing means and said site of perfusion.