Intraoperative autotransfusion device

• US 6,632,190 B2
• Filed: 03/27/2001
• Issued: 10/14/2003
• Est. Priority Date: 04/03/2000
• Status: Expired due to Term

• Current Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Original Assignee: Dideco SPA
• Inventors: Benatti, Francesco, Simonini, Giampaolo
• Primary Examiner(s): Look, Edward K.
• Assistant Examiner(s): FRISTOE JR, JOHN K
• Application Number:
  US09/819,004
• Publication Number:
  US 20010044601A1
• Time in Patent Office: 931 Days
• Field of Search: 604/4.01, 604/5.01, 604/5.02, 604/5.03, 604/5.04, 604/6.01, 604/6.09, 604/6.11, 604/6.14, 604/6.19, 210/252, 210/253, 210/254, 210/255, 210/256, 210/645, 210/646, 210/647
• US Class Current: 604/5.01
• CPC Class Codes: A61M 1/02 Blood transfusion apparatus blood infusion by syringes A61M5/14
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/3692 Washing or rinsing blood or blood constituents
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 39/223 Multiway valves
• CPC Class Codes: A61M 39/28 Clamping means for squeezing flexible tubes, e.g. roller clamps tube strippers A61M1/83

Abstract

An intraoperative autotransfusion system and method of use. The system includes an autotransfusion device, a removable cassette, a cardiotomy reservoir, a container for holding washing fluid, and a reservoir for containing processed blood. The removable cassette includes a centrifugal cell, a peristaltic pump, and multiple clamps, each having fixed and sliding elements. The cassette has a housing and multiple ducts for connection to the cardiotomy reservoir.

Claims

1. A cassette configured for removable attachment in an operational position on an intraoperative autotransfusion device, which includes a centrifugal cell, a peristaltic pump and first, second, and third clamps, each clamp having a fixed element and a sliding element, the first, second and third clamps having first, second and third channels respectively, defined between their respective fixed and sliding elements, the cassette comprising:

a housing;

first, second, and third ducts at least partially contained within the housing, the first, second and third ducts having first, second, and third lumens respectively, each duct having a first end and a second end, the first end of the first duct being adapted for connection to a cardiotomy reservoir, the first end of the second duct being adapted for connection to a container for holding washing liquid, the first end of the third duct being adapted for connection to a reservoir for containing blood processed by the autotransfusion device, the first, second and third ducts being secured within the housing at a location such that when the cassette is attached to the autotransfusion device in the operational position, the first, second and third ducts are positioned within the first, second and third channels, respectively; and

a tube at least partially contained within the housing and fluidly connected to the second ends of the first, second, and thirds ducts, the tube having an end adapted for connection to the centrifugal cell.

2. The cassette according to claim 1 wherein the portions of first, second and third ducts contained within the housing are co-planar.

3. The cassette according to claim 1 wherein a portion of the tube is looped and sized to fit around a raceway of the peristaltic pump.

4. An autotransfusion system comprising:

(i) a an autotransfusion device comprising;

a centrifugal cell;

a pump for causing fluid flow into and out of the centrifugal cell; and

first, second and third clamps, each clamp including a sliding element and a fixed element defining a channel therebetween, including first, second and third channels through the first, second, and third clamps, respectively; and

(ii) a cassette configured for removable attachment in an operational position on the autotransfusion device,

the cassette comprising;

a housing;

first, second, and third ducts at least paritally contained within the housing, the first, second and third ducts having first, second, and third lumens respectively, each duct having a first end and a second end, the first end of the first duct being adapted for connection to a cardiotomy reservoir, the first end of the second duct being adapted for connection to a container for holding washing liquid, the first end of the third duct being adapted for connection to a reservoir for containing blood processed by the autotransfusion device, the first, second and third ducts being secured within the housing at a location such that when the cassette is attached to the autotransfusion device in the operational position, the first, second and third ducts are positioned within the first, second and third channels, respectively; and

a tube at least partially contained within the housing and fluidly connected to the second ends of the first, second and third ducts, the tube having an end adapted for connection to the centrifugal cell.

5. The system according to claim 4 wherein the autotransfusion device further comprises movement-limiting elements to limit the movement of the sliding elements.

6. The system according to claim 4 wherein the autotransfusion device further comprises a cam, the cam having a first portion including a plurality of extending members adapted to simultaneously contact and move the first, second and third sliding elements from the first position to the second position when the cam is rotated to a first position.

7. The system according to claim 6 wherein the cam has a second portion having an oblong shape adapted to selectively and individually contact the first, second and third sliding elements upon rotation of the cam.

8. The system according to claim 6 wherein the autotransfusion device further comprises a knob coaxially positioned with respect to the cam, the knob being connected for manually turning the cam.

9. The system according to claim 4 wherein the autotransfusion device further comprises a control member configured for automatically moving at least one sliding element at a time from a first position to a second position.

10. An intraoperative autotransfusion system comprising:

a cardiotomy reservoir suitable for receiving blood from a patient;

a container suitable for holding blood washing fluid;

a reservoir suitable for containing processed blood;

an autotransfusion device including a centrifugal cell, a pump, and first, second, and third clamps, each clamp having a fixed element and a sliding element, defining first, second and third channels therebetween through the first, second and third clamps, respectively; and

a cassette configured for removable attachment in an operational position on the autotransfusion device, the cassette comprising;

a housing;

first, second, and third ducts at least partially contained within the housing, the first, second and third ducts having first, second, and third lumens respectively, each duct having a first end and a second end, the first end of the first duct being adapted for connection to the cardiotomy reservoir, the first end of the second duct being adapted for connection to the container for holding washing liquid, the first end of the third duct being adapted for connection to the reservoir for containing blood processed by the autotransfusion device, the first, second and third ducts being secured within the housing at a location such that when the cassette is attached to the autotransfusion device in the operative position, the first, second and third ducts are positioned within the first, second and third channels, respectively; and

a tube at least partially contained within the housing and fluidly connected to the second ends of the first, second, and thirds ducts, the tube having an end adapted for connection to the centrifugal cell.

11. The system according to claim 10 wherein a portion of the tube is looped and sized to fit within a raceway of the pump.

12. The system according to claim 10 wherein the pump is connected to cause bidirectional flow through the tube.

13. The system according to claim 10 further comprising movement-limiting elements to limit the movement of the sliding elements.

14. The system according to claim 10 further comprising a hematocrit sensor contained within the housing.

15. The system according to claim 10 wherein the autotransfusion device further comprises a cam, the cam having a first portion including a plurality of extending members adapted to simultaneously contact and move the first, second and third sliding elements from the first position to the second position when the cam is rotated to a first position.

16. The system according to claim 15 wherein the cam has a second portion having an oblong shape adapted to selectively and individually contacting the first, second and third sliding elements upon rotation of the cam.

17. The system according to claim 15 wherein the autotransfusion device further comprises a knob coaxially positioned with respect to the cam, the knob being connected for manually turning the cam.

18. The system according to claim 15 wherein the autotransfusion device further comprises a control member configured to automatically actuate the cam.

19. The system according to claim 15 further including a motor connected to rotate the cam.

20. The system according to claim 15 further comprising at least one optical sensor to detect the position of the cam.

21. A method of processing and re-infusing a patient'"'"'s blood comprising:

providing an intraoperative autotransfusion device which includes a centrifugal cell, a peristaltic pump and first, second, and third clamps, each clamp having a fixed element and a sliding element, defining first, second and third channels therebetween through the first, second and third clamps, respectively;

providing a cassette including a housing, first, second, and third ducts at least partially contained within the housing, and a tube at least partially contained within the housing and fluidly connected to second ends of the first, second, and thirds ducts, the tube having an end adapted for connection to the centrifugal cell, a first end of the first duct being connected to a cardiotomy reservoir suitable for receiving blood from the patient, a first end of the second duct being connected to a container suitable for holding washing fluid;

installing the cassette into the autotransfusion device such that the first, second and third ducts are positioned within the first, second and third channels, respectively;

a first end of the third duct being connected to a reservoir suitable for containing processed blood;

fitting the tube around a raceway of the peristaltic pump;

connecting the tube to the centrifugal cell;

operating the pump in a first direction;

moving the first sliding element from a first position to a second position to allow blood to flow through the first duct from the cardiotomy reservoir into the cell;

filling the centrifugal cell with blood;

operating the centrifugal cell to concentrate the cells of the blood;

moving the first sliding element from the second position to the first position to stop blood flow in the first duct;

moving the second sliding element of the second duct from a first position to a second position to allow washing liquid to flow into the centrifugal cell to wash the blood;

discontinuing the operation of the centrifugal cell;

moving the second sliding element from the second position to the first position to stop blood flow in the second duct;

operating the pump in a second direction; and

moving the third sliding element of the third duct from a first position to a second position to allow washed blood to flow to the processed blood container for reinfusion to the patient.

22. The method according to claim 21 further comprising the step of sending waste to a waste pouch.