PLEURAL DRAINAGE SYSTEM AND METHOD OF USE

• US 20110071415A1
• Filed: 03/12/2010
• Published: 03/24/2011
• Est. Priority Date: 03/13/2009
• Status: Active Grant

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Want, Nicholas, Croteau, James, Gillis, Ralph, KARWOSKI, THEODORE, Krawczyk, Joanne
• Granted Patent: US 8,882,678 B2
• Time in Patent Office: Days
• US Class Current: 600/529
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61L 2420/00 Materials or methods for coatings medical devices
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61M 1/0031 Suction control A61M1/0013, A61M1/0041 take precedence
• CPC Class Codes: A61M 1/0037 Intermittent or pulsating suction A61M1/0005, A61M1/0062 take precedence
• CPC Class Codes: A61M 1/008 Drainage tubes; Aspiration tips
• CPC Class Codes: A61M 1/69 Drainage containers not being adapted for subjection to vacuum, e.g. bags devices worn by the patient for reception of urine A61F5/44
• CPC Class Codes: A61M 1/73 comprising sensors or indicators for physical values
• CPC Class Codes: A61M 1/732 Visual indicating means for vacuum pressure
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/75 Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2202/0492 Pleural
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment
• CPC Class Codes: A61M 2210/101 Pleural cavity
• CPC Class Codes: A61M 25/0045 : multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 27/00 : Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202

Abstract

A pleural drainage system having an inflatable membrane and a method of using the system are disclosed. The pleural drainage system includes a pleural drainage catheter system. The pleural drainage catheter system includes an inflatable membrane and a drainage catheter integrally coupled to the inflation membrane, the drainage catheter defining a drainage lumen through which fluid is drawn from the pleural cavity, and an inflation lumen coupled for flow of inflation fluid to and from an interior of the inflatable membrane. The pleural drainage system further includes a suction system coupled to the drainage catheter and a fluid collector coupled to receive fluid from the drainage catheter. The pleural drainage system further includes an inflation system connected to deliver inflation fluid to the interior of the inflatable membrane. The pleural drainage system may be used to monitor an associated airleak in the pleural cavity of a patient.

Claims

1. A pleural drainage catheter system configured to extend into a pleural cavity of a patient and to drain fluid from the pleural cavity of the patient, said pleural drainage catheter system comprising:

an inflatable membrane comprising two opposed layers formed from a bio-compatible material, the inflatable membrane having a deflated state in which the layers are positioned substantially adjacent one another and an inflated state in which at least portions of the respective layers are spaced from one another, an external surface of the inflatable membrane defining one or more passages that facilitate the movement of fluid along the external surface for removal from the pleural cavity when the inflatable membrane is in the inflated state; and

a drainage catheter integrally coupled to the inflatable membrane, the drainage catheter defining a drainage lumen, a plurality of drainage openings through which fluid is drawn into the drainage lumen from the pleural cavity, and an inflation lumen coupled for flow of inflation fluid to and from an interior of the inflatable membrane.

2. The pleural drainage catheter system of claim 1, said drainage catheter further defining a delivery lumen through which a medicament can be introduced to the external surface of the inflatable membrane.

3. The pleural drainage catheter system of claim 2, wherein the inflation lumen defines the delivery lumen, and the medicament is introduced through the inflatable membrane when the inflatable membrane is pressurized via the inflation lumen.

4. The pleural drainage catheter system of claim 1, wherein portions of the layers of the inflatable membrane define one or more tubelets when the inflatable membrane is in the inflated state.

5. The pleural drainage catheter system of claim 4, wherein the one or more tubelets extend in a direction angled with respect to an axis of the drainage catheter.

6. The pleural drainage catheter system of claim 5, wherein the one or more tubelets extend in a direction substantially perpendicular to an axis of the drainage catheter.

7. The pleural drainage catheter system of claim 4, further comprising plural tubelets,

wherein at least two of the tubelets have different cross-sectional areas when the inflatable membrane is in the inflated state.

8. The pleural drainage catheter system of claim 4, further comprising plural tubelets,

wherein at least two of the tubelets have different cross-sectional shapes when the inflatable membrane is in the inflated state.

9. The pleural drainage catheter system of claim 4, wherein a cross-sectional shape of at least one of the one or more tubelets is cylindrical.

10. The pleural drainage catheter system of claim 4, wherein at least one of the one or more tubelets includes an enlarged portion having a larger cross-sectional area than the at least one tubelet when the inflatable membrane is in the inflated state.

11. The pleural drainage catheter system of claim 4, wherein the drainage catheter is configured to move within the pleural cavity by a staged inflation and deflation of the one or more tubelets.

12. The pleural drainage catheter system of claim 1, the drainage lumen of the drainage catheter having an open distal end and the inflation lumen of the drainage catheter having a closed distal end.

13. The pleural drainage catheter system of claim 1, the inflatable membrane defining a drainage opening for the flow of fluid from one side of the inflatable membrane to an opposite side of the inflatable membrane.

14. The pleural drainage catheter system of claim 1, wherein the one or more passages defined by the external surface of the inflatable membrane each provides a channel that facilitates the movement of fluid along the external surface when the inflatable membrane is in the inflated state.

15. The pleural drainage catheter system of claim 1, further comprising a coating on the external surface of the inflatable membrane, the coating being configured to resist adhesion to tissue in the pleural cavity or to provide therapy to the tissue.

16. The pleural drainage catheter system of claim 1, the inflatable membrane comprising a radiopaque marker positioned to facilitate visualization of the inflatable membrane during and after its insertion into the pleural cavity of the patient.

17. The pleural drainage catheter system of claim 1, the inflatable membrane having a preferential curve when it is in the inflated state.

18. The pleural drainage catheter system of claim 1, the inflation lumen of the drainage catheter being formed integrally with a wall of the drainage lumen of the drainage catheter.

19. A method for monitoring an airleak in a pleural cavity of a patient, the method comprising the steps of:

measuring a rate of pressure decay in the pleural cavity of the patient;

correlating the rate of pressure decay to an associated airleak of the pleural cavity of the patient according to the following formula;

Q_Airleakα

∫

Pdt

where;

Q_Airleak is an extrapolated airleak

P is a measured pressure

t is time; and

generating an indicator showing a trend in the magnitude of the airleak of the pleural cavity.

20. The method of claim 19, wherein said generating step comprises generating a progressive Red to Yellow to Green light indication of the trend in the magnitude of the airleak.

21. A pleural drainage system configured to deliver a therapeutic treatment to the pleural cavity of a patient, said system comprising:

a pleural drainage catheter system including an inflatable membrane having a deflated state and an inflated state, the pleural drainage catheter system also including a drainage catheter coupled to the inflation membrane, the drainage catheter defining a drainage lumen, a plurality of drainage openings through which fluid is drawn into the drainage lumen from the pleural cavity, and an inflation lumen coupled for flow of inflation fluid to and from an interior of the inflatable membrane;

a suction system coupled to the drainage catheter of the pleural drainage catheter system and connected to apply suction to the drainage lumen of the drainage catheter and to draw fluid into the drainage lumen of the drainage catheter through the drainage openings defined by the drainage catheter;

a fluid collector coupled to receive fluid from the drainage lumen of the drainage catheter; and

an inflation system coupled to the drainage catheter of the pleural drainage catheter system and connected to apply pressure to the inflation lumen of the drainage catheter and to deliver inflation fluid to the interior of the inflatable membrane through the inflation lumen defined by the drainage catheter.

22. The pleural drainage system of claim 21, said suction system being configured to monitor the suction applied to the drainage lumen of the drainage catheter.

23. The pleural drainage system of claim 21, further comprising an electronic controller coupled to at least one of the suction system and the inflation system.

24. The pleural drainage system of claim 21, said inflation system comprising a pump configured for active inflation and active deflation of the inflatable membrane.

25. The pleural drainage system of claim 21, said inflation system comprising a sensor configured to sense the pressure of the inflation fluid.

26. The pleural drainage system of claim 21, said inflation system comprising a maximum pressure check valve configured to release inflation fluid from the pleural drainage system when a predetermined pressure is achieved.

27. The pleural drainage system of claim 21, further comprising a scanner for obtaining patient identification information.

28. The pleural drainage system of claim 21, further comprising a display including at least one of a user interface and system controls.

29. The pleural drainage system of claim 21, further comprising a memory for storing at least one of patient data and backup data.

30. The pleural drainage system of claim 21, the inflatable membrane comprising two opposed layers formed from a bio-compatible material, the layers being positioned substantially adjacent one another in the deflated state and at least portions of the respective layers being spaced from one another in the inflated state.

31. The pleural drainage system of claim 21, further comprising a connection for the transfer of data to and from the pleural drainage system.

32. The pleural drainage system of claim 21, further comprising an audible alarm.

33. The pleural drainage system of claim 21, said inflation system being configured to monitor the pressure of inflation fluid in the inflatable membrane and to measure the exerted pressure within the pleural cavity.

34. The pleural drainage system of claim 33, further comprising a pressure sensor module having a pressure sensor, a processor, and a sensor access probe.

40. The pleural drainage system of claim 33, wherein the processor is further configured to selectively activate the plurality of indicators such that:

the first indicator and the second indicator of the plurality of indicators are activated together when the sensed pressure is within a fourth predefined range, and

the second indicator and the third indicator of the plurality of indicators are activated together when the sensed pressure is within a fifth predefined range.

35. A pleural drainage system comprising:

a drainage catheter defining a drainage lumen and at least one drainage opening through which fluid is drawn into the drainage lumen from a pleural cavity;

a suction system coupled to apply suction to the drainage lumen in order to draw fluid into the drainage lumen through the at least one drainage opening;

a fluid collector coupled to receive fluid from the drainage lumen of the drainage catheter;

a pressure sensor coupled to the suction system and positioned for sensing a pressure in the pleural cavity;

a processor coupled to receive a signal from the pressure sensor based on the sensed pressure in the pleural cavity; and

a plurality of indicators coupled to the processor and configured to visually indicate a status corresponding to the sensed pressure in the pleural cavity to an operator,

wherein the processor is configured to selectively activate the plurality of indicators such that;

a first indicator of the plurality of indicators is activated when the sensed pressure is within a first predefined range,

a second indicator of the plurality of indicator is activated when the sensed pressure is within a second predefined range, and

a third indicator of the plurality of indicators is activated when the sensed pressure is within a third predefined range.

36. The pleural drainage system of claim 35, wherein the first, second, and third predefined ranges are based on predefined expected pressures for the pleural cavity.

37. The pleural drainage system of claim 35, wherein the first, second, and third predefined ranges are based on predefined pressure differentials between the pressure in the pleural cavity and a pressure applied by the suction system.

38. The pleural drainage system of claim 35, further comprising a fluid-clearing device for clearing fluid from the drainage catheter of the pleural drainage system.

39. The pleural drainage system of claim 38, wherein the fluid clearing device comprises a pump and an accumulator in fluid communication with the pump.

41. A pleural drainage system comprising:

a drainage catheter defining a drainage lumen and at least one drainage opening through which fluid is drawn into the drainage lumen from a pleural cavity;

a suction system coupled to apply suction to the drainage lumen in order to draw fluid into the drainage lumen through the at least one drainage opening, the suction system including a pump, an accumulator in fluid communication with the pump, and a valve coupled between the accumulator and the drainage catheter; and

a fluid collector coupled to receive fluid from the drainage lumen of the drainage catheter;

wherein the pump is configured to generate a negative pressure in the accumulator, the valve is configured to open when there is a blockage between the pleural cavity and the fluid collector, and the opening of the valve causes the negative pressure in the accumulator to be applied to the drainage catheter such that the blockage is drawn into the fluid collector.