MEDICAL SYSTEMS AND METHODS

• US 20140303551A1
• Filed: 04/08/2014
• Published: 10/09/2014
• Est. Priority Date: 04/08/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Arqos Surgical, Inc.
• Inventors: Germain, Aaron, Klein, Kyle, Walker, Michael D., Bek, Robin
• Granted Patent: US 9,907,563 B2
• Time in Patent Office: Days
• US Class Current: 604/30
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/162 located on the probe body
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• 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 2210/1433 Uterus
• CPC Class Codes: A61M 3/0208 before use
• CPC Class Codes: A61M 3/0212 after use
• CPC Class Codes: A61M 3/0216 Pressure
• CPC Class Codes: A61M 3/022 Volume; Flow rate

Abstract

A fluid management system for use in a tissue resection procedure includes a controller. An inflow pump is operated by the controller and configured to provide fluid inflow through a flow path to a site in patient'"'"'s body. An outflow pump is operated by the controller and configured to provide fluid outflow through a flow path from the site in patient'"'"'s body. A motor driven resecting device may be provided for resecting tissue at the site. The controller is configured to actuate an inflow pump and an outflow pump in response to various signals and various algorithms are provided to provide malfunction warnings and assure safe operation.

Claims

1. A fibroid treatment system, comprising:

a controller;

an inflow pump operated by the controller and configured to provide fluid inflow through a flow path to a patient'"'"'s uterine cavity;

an outflow pump operated by the controller and configured to provide fluid outflow through a flow path to the uterine cavity; and

a motor driven resecting device operated by the controller, the device comprising an elongate introducer having (i) a tissue extraction channel therein with a diameter of no less than 2.4 mm and (ii) an outside diameter of no more than 3.8 mm such that the device is adapted to remove fibroid tissue at a rate of at least 2 gm/min;

wherein the controller is configured to actuate the inflow and outflow pumps in response to signals of fluid pressure in the uterine cavity to maintain a target pressure therein.

2. The fibroid treatment system of claim 1, wherein the controller is configured to operate the resecting device in response to at least one parameter selected from a group consisting of an inflow pump speed, an outflow pump speed and signals of fluid pressure in the uterine cavity.

3. The fibroid treatment system of claim 1, wherein said signal of fluid pressure in the site is provided by a pressure sensor coupled to a static fluid column communicating with the uterine cavity.

4. The fibroid treatment system of claim 1, wherein the controller is configured to provide a fluid loss signal in response to at least one parameter selected from a group consisting of an inflow pump speed, an outflow pump speed and signals of fluid pressure in the uterine cavity.

5. A fluid management system, comprising:

a controller;

a first pump operated by the controller and configured to provide fluid inflow to a site in patient'"'"'s body;

a second pump operated by the controller and configured to provide fluid outflow from the site in patient'"'"'s body;

wherein the controller is configured to provide at least one operating parameter selected from a group consisting of a first pump speed, a second pump speed, and a targeted pressure in the site rate; and

wherein the controller is configured to provide a fluid loss warning if the first pump speed exceeds a predetermined level for a pre-selected time interval.

6. The fluid management system of claim 5 wherein the first pump speed provides a fluid loss warning at a first predetermined level when operating in a resection mode of operation and provides a fluid loss warning at a second predetermined level when operating in a non-resection mode of operation.

7. The fluid management system of claim 6 wherein the pre-selected time interval is at least 1 second.

8. The fluid management system of claim 6 wherein the pre-selected time interval is at least 5 seconds.

9. The fluid management system of claim 6 wherein the pre-selected time interval is at least 10 seconds.

10. The fluid management system of claim 6 wherein the controller is further configured to de-activate at least one pump if the first pump speed exceeds the predetermined level for the pre-selected time interval.

11. The fluid management system of claim 6 wherein the controller is further configured to de-activate a powered resecting device positioned in the site if the first pump speed exceeds the predetermined level for the pre-selected time interval.

12. A fluid management system, comprising:

a controller;

an inflow pump operated by the controller and adapted to provide a fluid inflow through a flow path to a site in a patient'"'"'s body; and

an outflow pump operated by the controller and adapted to provide a fluid outflow through a flow path from the site in the patient'"'"'s body;

wherein the controller is configured to provide at least one operating parameter selected from a group consisting of a first pump speed, a second pump speed, and a targeted pressure in the site; and

wherein the controller is configured to provide a blocked flow warning if a calculated power for driving the inflow pump exceeds a predetermined level for a pre-selected time interval.

13. The fluid management system of claim 12 wherein the controller is further configured to de-activate at least one pump if the calculated power for driving the inflow pump exceeds the predetermined level for the pre-selected time interval.

14. The fluid management system of claim 12 wherein the controller is further configured to de-activate a powered resecting device positioned in the site if the calculated power for driving the inflow pump exceeds the predetermined level for the pre-selected time interval.

15. A fluid management system, comprising:

a controller;

a first pump operated by the controller and configured to provide fluid inflow to a site in patient'"'"'s body;

a second pump operated by the controller and configured to provide fluid outflow from the site in patient'"'"'s body;

wherein the controller is configured to provide at least one operating parameter selected from a group consisting of a first pump speed, a second pump speed, and a targeted pressure in the site; and

wherein the controller is configured to provide a blocked flow warning if an input voltage to the inflow pump motor is below a predetermined threshold voltage for a pre-selected time interval during which the outflow pump is operating.

16. The fluid management system of claim 15 wherein the pre-selected time interval ranges from 5 seconds to 120 seconds.

17. The fluid management system of claim 15 wherein the controller is further configured to de-activate at least one pump if the input voltage to the inflow pump falls below the predetermined level for the pre-selected time interval.

18. The fluid management system of claim 15 the controller is further configured to de-activate a powered resecting device positioned in the site if the voltage to the inflow pump motor exceeds the predetermined level for the pre-selected time interval.

19. A fluid management system, comprising:

a controller;

an inflow pump operated by the controller and configured to provide fluid inflow through a flow path to a site in patient'"'"'s body;

an outflow pump operated by the controller and configured to provide fluid outflow through a flow path from the site in patient'"'"'s body;

wherein the controller is configured to maintain at least one operating parameter selected from a group consisting of a first pump speed, a fluid inflow rate, a second pump speed, and a fluid outflow rate; and

wherein the controller is further configured to provide a blocked flow warning if a measured current to the outflow pump exceeds a predetermined threshold voltage for a pre-selected time interval.

20. A fluid management system for use in a tissue resection procedure, comprising:

a controller;

an inflow pump operated by the controller and configured to provide fluid inflow through a flow path to a site in patient'"'"'s body;

an outflow pump operated by the controller and configured to provide fluid outflow through a flow path from the site in patient'"'"'s body; and

a motor driven resecting device for resecting tissue at the site;

wherein the controller is configured to actuate an inflow pump and an outflow pump in response to signals of actual pressure at the site in the patient'"'"'s body to provide respective fluid inflow and fluid outflow to maintain a target pressure at the site; and

wherein the controller is configured to de-activate the motor driven resecting device upon sensing that the actual pressure in the site falls below a predetermined threshold pressure level.

21. The fluid management system of claim 20 wherein the controller is further configured to de-activate a motor that drives the resecting device if actual pressure in the site falls below a predetermined threshold pressure level.

22. The fluid management system of claim 20 wherein the controller is further configured to de-activate at least one tissue resecting electrode if actual pressure in the site falls below a predetermined threshold pressure level.

23. The fluid management system of claim 20 wherein the threshold pressure level is 100 mmHg or less.

24. The fluid management system of claim 20 wherein the threshold pressure level is 50 mmHg or less.

25. The fluid management system of claim 20 wherein the threshold pressure level is 25 mmHg or less

26. A fluid management system for use in tissue resection, comprising:

a controller configured to;

(a) actuate an inflow pump and an outflow pump in response to signals of actual pressure in a site in patient'"'"'s body to thereby provide respective fluid inflows and fluid outflows to maintain a target pressure at said site;

(b) send a tissue-engagement signal to the controller after sensing a predetermined steady pressure state within a pre-selected interval resulting from a resecting tool engaging targeted tissue in the site;

(c) send a tissue-disengagement signal to the controller after sensing a predetermined change in the actual pressure within a pre-selected interval resulting from a resecting tool subsequently disengaging from the tissue; and

(d) modulate an operating parameter of the fluid management system in response to a tissue-engagement signal or a tissue-disengagement signal.

27. The fluid management system of claim 26 wherein the controller is further configured to place the inflow pump in a ready state to provide a selected high inflow rate in response to a tissue-engagement signal.

28. The fluid management system of claim 26 wherein the controller is further configured to lower the inflow pump speed in response to a tissue-engagement signal.

29. The fluid management system of claim 26 wherein the controller is further configured to actuate the inflow pump to provide a selected high inflow rate in response to a tissue dis-engagement signal.