SURGICAL FLUID MANAGEMENT SYSTEMS AND METHODS

• US 20130079702A1
• Filed: 09/21/2012
• Published: 03/28/2013
• Est. Priority Date: 09/22/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Arqos Surgical, Inc.
• Inventors: Klein, Kyle, Germain, Aaron, Truckai, Csaba, Walker, Michael D.
• Granted Patent: US 9,084,847 B2
• Time in Patent Office: Days
• US Class Current: 604/22
• CPC Class Codes: A61B 1/012 characterised by internal passages or accessories therefor
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/00625 Vaporization
• CPC Class Codes: A61B 2018/1213 creating an arc
• CPC Class Codes: A61B 2018/162 located on the probe body
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61M 1/774 Handpieces specially adapted for providing suction as well as irrigation, either simultaneously or independently
• CPC Class Codes: A61M 1/777 Determination of loss or gain of body fluids due to suction-irrigation, e.g. during surgery
• CPC Class Codes: A61M 1/79 Filters for solid matter specially adapted for dental use A61C17/065
• CPC Class Codes: A61M 2202/0021 removed from and reintroduced into the body, e.g. after treatment
• CPC Class Codes: A61M 2202/0028 fluid entering a filter
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/75 : with filters
• CPC Class Codes: A61M 2205/7545 : for solid matter, e.g. microaggregates
• CPC Class Codes: A61M 2210/1433 : Uterus
• CPC Class Codes: A61M 3/0208 : before use
• CPC Class Codes: A61M 3/0212 : after use
• CPC Class Codes: A61M 3/022 : Volume; Flow rate
• CPC Class Codes: A61M 3/0229 : Devices operating in a closed circuit, i.e. recycling the irrigating fluid
• CPC Class Codes: A61M 3/0266 : Stands, holders or storage means for irrigation devices containers with storage means for cannula A61M3/0245

Abstract

A surgical fluid management system delivers fluid for distending a uterine cavity to allow cutting and extraction of uterine fibroid tissue, polyps and other abnormal uterine tissue. The system comprises a fluid source, fluid deliver lines, one or more pumps, and a filter for re-circulating the distension fluid between the source and the uterine cavity. A controller can monitor fluid retention by the patient.

Claims

1. A medical fluid management system, comprising:

a filter module which includes hollow fibers having lumens therethrough;

a first fluid line configured to carry distention fluid from a fluid source to a body space;

a second fluid line configured to carry fluid and body material from the body space to the filter module;

a third fluid line configured to carry filtered fluid back from the filter to the fluid source;

wherein the hollow fibers having a total lumen surface area of at least 0.10 m².

2. The system of claim 1 wherein the total lumen surface area is at least 0.25 m².

3. The system of claim 1 wherein the total lumen surface area is at least 0.50 m².

4. The system of claim 1 wherein the total lumen surface area is at least 1 m².

5. The system of claim 1 wherein the filter module further includes an additional filter element for capturing resected tissue, wherein the additional filter element has a pore size less than the diameter of the lumens of the hollow fibers.

6. The system of claim 5 wherein the pore size of the additional filter is less than 150 microns.

7. The system of claim 6 wherein the lumens of the hollow fibers have a diameter of less than 200 microns.

8. The system of claim 1 wherein the hollow fibers have a nominal molecular weight limit (NMWL) of less than 40 kDa.

9. The system of claim 1 wherein the hollow fibers have a nominal molecular weight limit (NMWL) of less than 30 kDa.

10. The system of claim 1 wherein the hollow fibers have a nominal molecular weight limit (NMWL) of less than 20 kDa.

11. The system of claim 1 further comprising a pump for pumping fluid through the filter module and back to the fluid source.

12. The system of claim 11 wherein the pump consists of a single pumping unit.

13. A medical fluid management system, comprising:

a filter comprising a plurality of hollow fibers having lumens and an additional filter element;

a first fluid line configured to carry distension fluid from a fluid source to a body space;

a second fluid line configured to carry fluid from the body space to the filter; and

a third fluid line configured to carry filtered fluid from the filter back to the fluid source;

wherein the filter element has a pore size which is less than a diameter of the lumens of the hollow fibers.

14. The system of claim 13 wherein the pore size of the additional filter is less than 150 microns.

15. The system of claim 14 wherein the lumens of the hollow fibers have a diameter of less than 200 microns.

16. The system of claim 13 wherein the hollow fibers have a nominal molecular weight limit (NMWL) of less than 40 kDa.

17. The system of claim 13 wherein the hollow fibers have a nominal molecular weight limit (NMWL) of less than 30 kDa.

18. The system of claim 13 wherein the hollow fibers have a nominal molecular weight limit (NMWL) of less than 20 kDa.

19. The medical system of claim 13 further including a tissue-cutting tool and wherein the second fluid line is configured to carry fluid and cut tissue through the tissue-cutting tool from the body space.

20. The medical system of claim 13 wherein the first filter is configured for de-coupling from the system to transport cut tissue.

21. A medical fluid management system, comprising:

a first fluid line;

a pump configured to carry distension fluid from a fluid source through the first line to a body space;

a second fluid line;

a third fluid line;

a second pump configured to deliver fluid through the second fluid line from the body space, through the filter, and through the third fluid line from the filter back to the fluid source;

a controller; and

a pressure sensor in a flow path communicating with the body cavity for providing intra-cavity pressure signals to the controller, wherein the controller is configured to control the first and second pumps to maintain a selected pressure in the body cavity in response to the intra-cavity pressure signals.

22. The system of claim 21 wherein the controller operates the first pump at a variable rate and the second pump at a fixed rate.

29. The system of claim 21 further comprising a fourth fluid line joining the first tissue-capture filter and the second hollow fiber filter, wherein the check valve is present in the fourth line.

23. A medical fluid management system, comprising:

a fluid source having an initial volume;

a filter having a fluid retention volume;

a first fluid line configured to carry distention fluid from the fluid source to a body space, said first fluid line having a fluid retention volume;

second and third fluid lines configured to re-circulate fluid from the body space through the filter and back to the fluid source, said second and third fluid lines having a fluid retention volume; and

a controller which monitors a difference between (1) the initial volume of the fluid source and (2) a sum of the volume of fluid in the fluid source present at a given time and the combined fluid retention volumes of the first line, second line, third line, and filter, wherein a difference that exceeds a preselected volume indicates a risk of intravasion.

24. The system of claim 23 wherein the preselected volume is 2.5 liters.

25. The system of claim 24 wherein the combined fluid retention volumes of the first line, second line, third line, and filter is at least 0.5 liters.

26. The system of claim 23 wherein the filter includes hollow fibers having a total lumen surface area of at least 0.10 m^2..

27. The system of claim 23 wherein said filter includes hollow fibers having a nominal molecular weight limit (NMWL) of less than 40 kDa.

28. A medical fluid management system, comprising:

a filter assembly including a first tissue-capture filter and a second hollow fiber filter;

a first fluid line configured to carry distention fluid from a fluid source to a body space;

second and third fluid lines configured to re-circulate fluid from the body space through the filter assembly and back to the fluid source; and

at least one check valve intermediate the first and second filters to prevent backflow of fluid from the hollow fiber filter to the first filter.

30. The system of claim 28 wherein the first filter is configured for de-coupling from the system to allow removal of cut tissue.

31. The system of claim 30 wherein the first filter is configured to allow transport of cut tissue after having been de-coupled from the system.

32. The system of claim 28 further comprising at least one additional check valve in the second line carrying fluid back from the body to the first filter to prevent backflow of fluid from the first filter to the body.

33. The system of claim 28 further comprising at least one additional check valve in the first fluid line carrying fluid back from the fluid source to the body to prevent backflow of fluid from the body to the fluid source.