Apparatus and method for in vivo extrapulmonary blood gas exchange

• US 4,583,969 A
• Filed: 06/26/1984
• Issued: 04/22/1986
• Est. Priority Date: 06/26/1984
• Status: Expired due to Term

• Current Assignee: InnerDyne, Inc. (Medtronic Plc)
• Original Assignee: Midsix Cardiovascular/Pulmonary Incorporated
• Inventors: Mortensen, J. D.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/624,627
• Time in Patent Office: 665 Days
• Field of Search: 261/DIG. 28, 261/122, 604/4, 604/48, 604/147, 604/23-26, 604/52-53, 128/DIG. 3, 128/632, 128/635, 3/1, 422/45
• US Class Current: 604/500
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• 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: H04W 52/241 taking into account channel quality metrics, e.g. SIR, SNR, CIR, Eb/lo
• CPC Class Codes: H04W 52/248 where transmission power control commands are generated based on a path parameter

Abstract

A method and apparatus for the in vivo oxygenation of blood without using or disturbing the patient'"'"'s lungs. The apparatus comprises a plurality of small diameter gas permeable tubes connected to headers at each end. The headers in turn are connected on one end to a source of oxygen rich gas and on the other end to an exhaust means. The apparatus is positioned within the circulatory system of a patient. Particularly, an incision is made in the patient'"'"'s femoral or iliac vein and the apparatus is threaded through the venae cavae and eventually out an incision in the patient'"'"'s jugular vein. Both headers are positioned so that a source of oxygen rich gas can be attached and the gas circulated through the device.

Claims

1. A method for effecting in vivo extrapulmonary blood gas exchange comprising the steps of:

attaching a plurality of gas permeable tubes to a first header at the inlet end of said tubes and to a second header at the outlet end of said tubes;

positioning said gas permeable tubes within the venae cavae of a patient;

connecting said first header to a source of oxygen enriched gas;

connecting said second header to a means for exhausting gas carried by said tubes;

passing said oxygen enriched gas through said gas permeable tubes at a rate of from 0.6 to 1.2 liters per minute and at a pressure of from 5 to 10 mm Hg such that blood flowing through said venae cavae is oxygenated as carbon dioxide is removed from said blood into said gas permeable tubes; and

applying controlled suction to said second header.

2. A method as defined in claim 1 wherein said step of positioning said gas permeable tubes within said vena cava comprises the steps of:

preparing a first incision in said patient'"'"'s right jugular vein and a second incision at one of the right external iliac or common femoral veins of said patient;

inserting a guide catheter into said patient'"'"'s vena cava through said first incision;

attaching said second header to said guide catheter and pulling said second header through said first incision into said vena cava to the point of said second incision; and

attaching a first length of tubing to said second header and a second length of tubing to said first header.

3. A method as defined in claim 1 wherein said step of positioning said gas permeable tubes within said venae cavae comprises the steps of:

attaching a semi-rigid stylet between said headers; and

bending said stylet to form an undulating pattern followed by said tubes.

4. An apparatus for effecting in vivo extrapulmonary blood gas exchange comprising:

a plurality of gas permeable tubes adapted for insertion into the venae cavae of a patient, said gas permeable tubes allowing for the passage of oxygen from said gas permeable tubes into blood flowing through said venae cavae and allowing for the passage of carbon dioxide from said blood into said gas permeable tubes, each said gas permeable tube having an inlet end adapted for placement in the inferior vena cava of the patient and an outlet end adapted for placement in the superior vena cava of the patient;

a first header adapted for placement in the inferior vena cava and attached to the inlet ends of said gas permeable tubes, said first header having a molded base member into which the inlet ends of said gas permeable tubes are secured in spaced relation to one another;

a second header adapted for placement in the superior vena cava and attached to the outlet ends of said gas permeable tubes, said second header having a molded base member into which the outlet ends of said gas permeable tubes are secured in spaced relation to one another;

an oxygen inlet tube having one end thereof connected to said first header and the other end thereof in gaseous communication with a source of oxygen, said oxygen inlet tube being adapted for insertion through an incision formed in the inferior vena cava;

a gas outlet tube having one end thereof connected to said second header, said gas outlet tube being adapted for insertion through an incision formed in the superior vena cava so as to provide exhaust means for said gas permeable tubes; and

a semi-rigid stylet interconnecting said first and second headers so as to be positioned therebetween within said venae cavae, said stylet being bent so as to form an undulating pattern within said venae cavae to thereby minimize laminar blood flow around said gas permeable tubes within said venae cavae.

5. An apparatus as defined in claim 4 wherein the number of said tubes attached to said headers is from 30 to 500.

6. An apparatus as defined in claim 4 wherein each said tube comprises a membrane of polyakylsulfone of from 2.5 to 4 microns thick imbedded on a porous tubular framework constructed of ethyl cellulose.

7. An apparatus as defined in claim 4 wherein each said tube comprises a membrane of silicone rubber 25 microns thick imbedded on a porous tubular framework of ethyl cellulose.

8. An apparatus as defined in claim 4 wherein each tube comprises a microporous membrane of polypropylene.

9. An apparatus as defined in claim 4 wherein each tube comprises a microporous membrane of polypropylene.

10. An apparatus as defined in claim 4 wherein each tube comprises a microporous membrane of polytetrafluorethylene.

11. An apparatus as defined in claim 4 wherein each tube comprises a microporous membrane of polyethylene.

12. An apparatus as defined in claim 4 wherein said tubes are intertwined one with another along their length between said first and second headers.

13. An apparatus as defined in claim 4 wherein said tubes are from 50 cm to 250 cm in length, and from 0.25 mm to 1 mm in outside diameter.

14. A method for effecting in vivo extrapulmonary blood gas exchange comprising the steps of:

attaching a plurality of gas permeable tubes to a first header at the inlet ends of said gas permeable tubes by securing said inlet ends in a molded base member formed in said first header so as to position said inlet ends in spaced apart relationship;

attaching the outlet ends of said gas permeable tubes to a second header by putting said outlet ends into a molded base member formed in said second header so as to position said outlet ends in spaced apart relationship;

making a first incision in one of the right external iliac or common femoral veins of a patient and a second incision in the right jugular vein of said patient;

inserting a guide catheter into said patient'"'"'s inferior vena cava through said first incision;

attaching said second header to said guide catheter and pulling said second header through said first incision and through said inferior vena cava to the point of said second incision so as to position said second header in said patient'"'"'s superior vena cava and so as to position said first header in said patient'"'"'s inferior vena cava, thereby positioning said gas permeable tubes within said venae cavae;

attaching a first length of tubing to said first header and a second length of tubing to said second header, said first length of tubing extending through said first incision and into the inferior vena cava and said second length of tubing extending through said second incision and into the superior vena cava;

connecting said first length of tubing to a source of oxygen enriched gas;

connecting said second length of tubing to a means for exhausting gas carried by said gas permeable tubes;

passing said oxygen enriched gas through said gas permeable tubes so as to provide for the passage of oxygen from said gas permeable tubes into blood flowing through said venae cavae and so as to allow for the passage of carbon dioxide from said blood into said gas permeable tubes; and

minimizing laminar blood flow around said gas permeable tubes within said venae cavae by forming a semi-rigid stylet into an undulating configuration and positioning said stylet within said venae cavae between said first and second headers.

15. A method for effecting in vivo extrapulmonary blood gas exchange comprising the steps of:

securing a plurality of gas permeable tubes to a first header at the inlet ends of said tubes and to a second header at the outlet ends of said tubes such that said inlet and outlet ends are spaced one from the other to permit blood flow around and through the tubes held by each said header;

positioning said tubes and headers within the venae cavae of a patient;

forming a semi-rigid stylet into an undulating configuration and positioning said stylet within said venae cavae between said first and second headers to minimize laminar blood flow around said tubes;

connecting said first header to a source of oxygen enriched gas and connecting said second header to a means for exhausting gas carried by said tubes; and

passing said oxygen enriched gas through said tubes such that blood flowing through said vena cavae is oxygenated as carbon dioxide is removed from said blood.

16. A method as defined in claim 15 wherein said step of positioning said gas permeable tubes within said venae cavae comprises the steps of:

preparing a first incision in said patient'"'"'s right jugular vein and a second incision at one of the right external iliac or common femoral veins of said patient;

inserting a guide catheter into said patient'"'"'s venae cavae through said first incision;

attaching said second header to said guide catheter and pulling said second header through said first incision into said venae cavae to the point of said second incision; and

attaching a first length of tubing to said second header and a second length of tubing to said first header.