Condensed perfusion circuit for cardiopulmonary bypass and cardioplegia

• US 6,852,280 B2
• Filed: 03/31/2003
• Issued: 02/08/2005
• Est. Priority Date: 03/31/2003
• Status: Expired due to Fees

• Current Assignee: Medici Life Sciences Licensing Company LLC (The Medici Portfolio LLC)
• Original Assignee: Kevin Mccusker, Venkataramana Vijay
• Inventors: Vijay, Venkataramana, McCusker, Kevin
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US10/403,567
• Publication Number:
  US 20040191117A1
• Time in Patent Office: 680 Days
• Field of Search: 604/6.13, 604/4.01, 604/5.01, 604/6.01, 604/6.09, 604/6.1, 604/6.11, 604 614- 616, 604/131, 604/141, 604/151, 604/19, 422/47, 422/48, 261 1- 5, 261/75, 261158-159, 96/4, 96 6- 8, 96/10, 962/43, 435/2, 435/283.1, 435/284.1, 424 44- 46, 600/16
• US Class Current: 422/45
• 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 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3664 for preparing cardioplegia solutions
• CPC Class Codes: A61M 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 2202/047 cardioplegic

Abstract

A total condensed circuit for cardiopulmonary bypass and cardioplegia are provided, as well as methods of using the same. The total circuit includes a cardiopulmonary bypass portion including tubing and components which together have a substantially short path length and priming volume preferably under 800 ml. Thus, the opportunity for an inflammatory response caused by blood contacting plasticizers is minimized. The bypass circuit includes a shunt which bypasses a blood reservoir of the total circuit. The cardioplegia circuit infuses cardioplegia fluid into blood pulled from an oxygenator of the bypass circuit. According to the method, either or both of heart-lung bypass and cardioplegia can be performed with only minimal or no isotonic priming solution circulated into the patient. In addition, use of the shunt and reservoir together eliminate the possibility of air entering the circulation system upon kinking of the circuit.

Claims

1. A cardiopulmonary bypass circuit for oxygenating blood outside a patient and circulating oxygenated blood through the patient, said circuit comprising:

a) a blood reservoir;

b) a perfusion pump in fluid communication with said reservoir;

c) a blood oxygenator in fluid communication with said pump;

d) an arterial filter in fluid communication with said oxygenator;

e) a first length of tubing located to place said reservoir in venous-side fluid communication with the patient;

f) a second length of tubing located to place said arterial filter in arterial-side fluid communication with the patient;

g) a shunt placing said first length of tubing and said pump in fluid communication and bypassing said blood reservoir;

h) manual selecting structure which permits selection of one of said shunt and said blood reservoir to be included in said circuit and the other of said shunt and said blood reservoir to be excluded from said circuit; and

i) structure external said reservoir which prevents any store of blood in said blood reservoir from being pulled by said perfusion pump when said blood reservoir is excluded from said circuit such that said perfusion pump pulls blood from said first length of tubing while bypassing the any store of blood in said blood reservoir,

wherein said circuit has a priming volume of less than approximately 800 ml.

2. A circuit according to claim 1, further comprising:

j) a second perfusion pump;

k) a tubular member coupling said second perfusion pump and said oxygenator; and

l) an infusion pump adapted to infuse an injectate into fluid circulated by said second perfusion pump.

3. A circuit according to claim 2, wherein:

said second perfusion pump, said tubular member and said infusion pump define an infusion circuit with a priming volume of less than approximately 40 ml.

4. A circuit according to claim 1, wherein:

said priming volume of said circuit is less than approximately 700 ml.

5. A circuit according to claim 1, wherein:

said circuit has a priming volume of between 567 and 700 ml.

6. A cardiopulmonary bypass circuit for oxygenating blood outside a patient and circulating oxygenated blood through the patient, said circuit comprising:

a) a blood reservoir;

b) a perfusion pump;

c) a blood oxygenator;

d) an arterial filter in fluid communication with said oxygenator;

e) a first length of tubing located to place said blood reservoir in venous-side fluid communication with the patient;

f) a second length of tubing placing said blood reservoir and said pump in fluid communication;

g) a third length of tubing placing said pump and said oxygenator in fluid communication;

h) a fourth length of tubing placing said oxygenator and said arterial filter in fluid communication;

i) a fifth length of tubing located to said arterial filter in arterial-side fluid communication with the patient;

j) a shunt placing said first length of tubing and said pump in fluid communication and bypassing said blood reservoir;

k) manual selecting structure which permits selection of one of said shunt and said blood reservoir to be included in said circuit and the other of said shunt and said blood reservoir to be excluded from said circuit; and

l) structure external said reservoir which prevents any store of blood in said blood reservoir from being pulled by said perfusion pump when said reservoir is excluded from said circuit such that said perfusion pump pulls blood from said first length of tubing while bypassing the any store of blood in said blood reservoir,

wherein a pathway through said circuit has a priming volume of less than approximately 800 ml.

7. A circuit according to claim 6, further comprising:

m) a second perfusion pump;

n) a tubular member coupling said second perfusion pump and said oxygenator; and

o) an infusion pump adapted to infuse an injectate into fluid circulated by said second perfusion pump.

8. A circuit according to claim 7, wherein:

said second perfusion pump, said tubular member and said infusion pump define an infusion circuit with a priming volume of less than approximately 40 ml.

9. A circuit according to claim 6, wherein:

said circuit has a priming volume of between 567 and 700 ml.

10. A cardiopulmonary bypass circuit for oxygenating blood outside a patient and circulating oxygenated blood through the patient, said circuit comprising:

a) a venous line;

b) a blood reservoir in fluid communication and in series with said venous line;

c) a perfusion pump in fluid communication and in series with said blood reservoir;

d) a blood oxygenator in fluid communication and in series with said pump;

e) an arterial filter in fluid communication and in series with said oxygenator;

f) a shunt placing said first length of tubing and said pump in fluid communication and bypassing said blood reservoir;

g) manual selecting structure which permits selection of one of said shunt and said blood reservoir to be included in said circuit and the other of said shunt and said blood reservoir to be excluded from said circuit; and

h) structure external said reservoir which prevents any store of blood in said blood reservoir from being pulled by said perfusion pump when said blood reservoir is excluded from said circuit such that said perfusion pump pulls blood from said first length of tubing while bypassing the any store of blood in said blood reservoir,

wherein said circuit has a priming volume of less than approximately 800 ml.

11. A circuit according to claim 10, further comprising:

i) an infusion system configured to infuse an injectate directly into blood oxygenated by said circuit.

12. A circuit according to claim 11 wherein:

said priming volume of said circuit is less than approximately 700 ml.

13. A circuit according to claim 11, wherein:

said circuit has a printing volume of between 567 and 700 ml.

14. A circuit according to claim 11, wherein:

said infusion system includes,

(i) a second perfusion pump,

(ii) a tubular member coupling said second perfusion pump and said oxygenator, and

(iii) an infusion pump adapted to infuse an injectate into fluid circulated by said second perfusion pump.

15. A cardiopulmonary bypass circuit for oxygenating blood outside a patient and circulating oxygenated blood through the patient, said circuit comprising:

a) a blood reservoir;

b) a perfusion pump;

c) a blood oxygenator;

d) a filter in fluid communication with said oxygenator;

e) an approximately one to two foot long ⅜

inch diameter tubing located to place said blood reservoir in venous-side fluid communication with the patient;

f) an approximately six inches of ⅜

inch diameter tubing placing said blood reservoir and said pump in fluid communication;

g) an approximately six inches of ⅜

inch diameter tubing placing said pump and said oxygenator in fluid communication;

h) an approximately one to two foot long ⅜

inch diameter tubing in fluid communication with said arterial filter; and

i) a shunt located to place said perfusion pump in venous-side fluid communication with the patient and bypassing said blood reservoir.

16. A circuit according to claim 15, further comprising:

j) an infusion system configured to infuse an injectate directly into blood oxygenated by said circuit.

17. A circuit according to claim 16, wherein:

said infusion system includes,

(i) a second perfusion pump,

(ii) a tubular member coupling said second perfusion pump and said oxygenator, and

(iii) an infusion pump adapted to infuse an injectate into fluid circulated by said second perfusion pump.

18. A circuit according to claim 15, wherein:

wherein said circuit has a priming volume of less than approximately 800 ml.

19. A circuit according to claim 15, wherein:

said circuit has a priming volume of less than approximately 700 ml.

20. A circuit according to claim 15, wherein:

said circuit has a priming volume of between 567 and 700 ml.

21. A circuit according to claim 15, further comprising:

j) manual selecting structure which permits selection of one of said shunt and said blood reservoir to be included in said circuit and the other of said shunt and said blood reservoir to be excluded from said circuit; and

k) structure external said reservoir which prevents any store of blood in said blood reservoir from being pulled by said perfusion pump when said blood reservoir is excluded from said circuit such that said perfusion pump pulls blood from the patient while bypassing the any store of blood in said blood reservoir.

22. A cardiopulmonary bypass circuit for oxygenating blood outside a patient and circulating oxygenated blood through the patient, said circuit comprising:

a) a blood reservoir;

b) a perfusion pump;

c) a blood oxygenator;

d) a filter in fluid communication with said oxygenator;

e) a first tubing not exceeding approximately two feet in length and approximately ⅜

inch in diameter located to place said blood reservoir in venous-side fluid communication with the patient;

f) a second tubing not exceeding approximately six inches and approximately ⅜

inch in diameter and placing said blood reservoir and said pump in fluid communication;

g) a third tubing not exceeding approximately six inches in length and ⅜

inch in diameter and placing said pump and said oxygenator in fluid communication.

h) a fourth tubing not exceeding approximately two feet in length and approximately ⅜

inch in diameter and in fluid communication with said arterial filter; and

i) a shunt located to place said perfusion pump in venous-side fluid communication with the patient and bypassing said blood reservoir.

23. A cardiopulmonary bypass circuit for oxygenating blood outside a patient and circulating oxygenated blood through the patient, said circuit comprising:

a) a blood reservoir;

b) a perfusion pump in fluid communication with said reservoir;

c) a blood oxygenator in fluid communication with said pump;

d) an arterial filter in fluid communication with said oxygenator;

e) a first length of tubing located to place said reservoir in venous-side fluid communication with the patient;

f) a second length of tubing located to place said arterial filter in arterial-side fluid communication with the patient;

g) a shunt placing said first length of tubing and said pump in fluid communication and bypassing said blood reservoir;

h) manual selecting structure which permits selection of one of said shunt and said blood reservoir to be included in said circuit and the other of said shunt and said blood reservoir to be excluded from said circuit; and

i) structure external said reservoir which prevents any store of blood in said blood reservoir from being pulled by said perfusion pump when said blood reservoir is excluded from said circuit such that said perfusion pump pulls blood from said first length of tubing while bypassing the any store of blood in said blood reservoir.

24. A circuit according to claim 23, further comprising:

j) a second perfusion pump;

k) a tubular member coupling said second perfusion pump and said oxygenator; and

l) an infusion pump adapted to infuse an injectate into fluid circulated by said second perfusion pump.

25. A cardiopulmonary bypass circuit for oxygenating blood outside a patient and circulating oxygenated blood through the patient, said circuit comprising:

a) a venous line;

b) a blood reservoir in fluid communication and in series with said venous line;

c) a perfusion pump in fluid communication and in series with said blood reservoir;

d) a blood oxygenator in fluid communication and in series with said pump;

e) an arterial filter in fluid communication and in series with said oxygenator;

f) a shunt placing said venous line and said pump in fluid communication and bypassing said blood reservoir;

g) manual selecting structure which permits selection of one of said shunt and said blood reservoir to be included in said circuit and the other of said shunt and said blood reservoir to be excluded from said circuit; and

h) structure external said reservoir which prevents any store of blood in said blood reservoir from being pulled by said perfusion pump when said blood reservoir is excluded from said circuit such that said perfusion pump pulls blood from said venous line while bypassing the any store of blood in said blood reservoir.

26. A circuit according to claim 25, further comprising;

i) an infusion system configured to infuse an injectate directly into blood oxygenated by said circuit.

27. A cardiopulmonary bypass circuit for oxygenating blood outside a patient and circulating oxygenated blood through the patient, said circuit comprising:

a) a venous line;

b) a blood reservoir in fluid communication and in series with said venous line;

c) a perfusion pump in fluid communication and in series with said blood reservoir;

d) a blood oxygenator in fluid communication and in series with said pump;

e) an arterial filter in fluid communication and in series with said oxygenator;

f) a shunt placing said venous line and said pump in fluid communication and bypassing said blood reservoir; and

g) structure external said reservoir which prevents any store of blood in said blood reservoir from being pulled by said perfusion pump when said blood reservoir is excluded from said circuit and said perfusion pump draws blood from the patient through said shunt such that said perfusion pump pulls blood from said venous line while bypassing the any store of blood in said blood reservoir.

28. A circuit according to claim 27, further comprising:

h) an infusion system configured to infuse an injectate directly into blood oxygenated by said circuit.

31. A circuit according to claim 27, wherein:

said circuit has a priming volume of between 567 and 700 ml.

29. A circuit according to claim wherein:

said circuit has a priming volume of less than approximately 800 ml.

30. A circuit according to claim wherein:

said priming volume of said circuit is less than approximately 700 ml.