Surgical instrument, system, and method for biofilm removal

• US 9,326,665 B2
• Filed: 04/09/2007
• Issued: 05/03/2016
• Est. Priority Date: 01/09/2007
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: Slenker, Dale E., Prisco, John R., Lewis, Cecil O., Norman, Gerould W., Vaccaro, Robert K., Perry, Isaac C.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US11/697,789
• Publication Number:
  US 20080249483A1
• Time in Patent Office: 3,312 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 1/0055 Constructional details of insertion parts, e.g. vertebral elements
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/2275 with controlled air pressure
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 2017/00314 Separate linked members
• CPC Class Codes: A61B 2017/242 for bronchial passages
• CPC Class Codes: A61B 2217/007 with irrigation system
• 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 2210/0618 Nose
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 3/0202 with electronic control means or interfaces
• CPC Class Codes: A61M 3/0208 before use
• CPC Class Codes: A61M 3/022 Volume; Flow rate
• CPC Class Codes: A61M 3/0258 by means of electric pumps
• CPC Class Codes: A61M 3/0279 Cannula; Nozzles; Tips; their connection means

Abstract

Systems and methods for removal of bacterial biofilm from a target site of a human patient includes a surgical instrument having an introducer for bodily insertion and maintaining an irrigation duct and a nozzle. A distal portion of the introducer is transitionable between a plurality of bend angles relative to a proximal portion thereof. In particular, the instrument is adapted to independently maintain the distal portion at each of the plurality of bend angles relative to the proximal portion. The nozzle is maintained relative to the distal portion of the introducer and is adapted to dispense pressurized irrigant from the irrigation duct toward a layer of bacterial biofilm.

Claims

1. A system for removal of bacterial biofilm from a target site of a human patient, the system comprising:

a surgical instrument for removing bacterial biofilm from the target site, the instrument comprising;

an elongate introducer adapted for minimally invasive surgical insertion into a human patient, the introducer including a proximal portion and a distal portion terminating at a distal end, the distal portion being transitionable between a plurality of bend angles relative to the proximal portion, wherein the instrument is adapted to independently maintain the distal portion at each of the plurality of bend angles relative to the proximal portion;

an irrigation duct for conveying irrigant;

a nozzle rotatably mounted to the introducer and in fluid communication with the irrigation duct, the nozzle being maintained relative to the distal end of the introducer and being adapted to dispense pressurized fluid from the irrigation duct toward a layer of bacterial biofilm to disrupt the bacterial biofilm from the target site;

a first actuator assembly adapted to selectively rotate the nozzle relative to the introducer;

wherein the instrument further includes a handle maintaining the introducer, and further wherein the first actuator assembly includes;

a first wheel rotatably secured to the handle;

a rigid irrigation duct segment connected to and extending from the wheel; and

a flexible irrigation duct segment extending between the rigid irrigation duct segment and the nozzle.

2. The system of claim 1, further comprising:

an endoscope system including an endoscope and an imaging device.

3. The system of claim 1, further comprising:

a vacuum source; and

an aspiration duct in fluid communication with the vacuum source, the aspiration duct extending through the introducer and terminating at an aspiration inlet for aspirating matter from the target site.

4. The system of claim 1, wherein the proximal portion of the introducer is substantially rigid, the distal portion of the introducer is substantially flexible, and the instrument further comprises:

a second actuator assembly adapted to transition the distal portion of the introducer between the plurality of bend angles.

5. The system of claim 4, wherein:

the second actuator assembly comprises;

a first wire and a second wire each secured to the distal portion of the introducer;

a second wheel rotatably secured relative to the handle;

wherein the distal portion defines a first side and a second side opposite the first side; and

further wherein, the first wire mechanically connects the second wheel and the first side of the distal portion, and the second wire mechanically connects the second wheel and the second side of the distal portion.

6. The system of claim 5, wherein the distal portion includes a plurality of pivotably connected links.

7. The system of claim 6, wherein each link includes a frame and opposing flanges.

8. The system of claim 1, wherein at least a portion of the introducer is substantially articulatable such that the distal portion is adapted to be transitioned between, and independently maintained at, the plurality of bend angles relative to the proximal portion.

9. The system of claim 1, wherein the nozzle is configured to generate a fan-type spray pattern.

10. The system of claim 1, wherein the introducer terminates at a distal face, and further wherein the nozzle projects from the distal face and is arranged to direct irrigant from the irrigation duct in a direction away from the distal face.

11. A method of disrupting bacterial biofilm from a target site of a human patient, the method comprising:

providing a bacterial biofilm removal system including;

a surgical instrument for removing the bacterial biofilm from the target site having an elongate introducer adapted for minimally invasive surgical insertion into the human patient including a proximal portion and a distal portion terminating at a distal end, the distal portion being articulatable and transitionable between a plurality of bend angles relative to the proximal portion, wherein the instrument is adapted to independently maintain the distal portion at each of the plurality of bend angles relative to the proximal portion, wherein the introducer maintains an irrigation duct for conveying irrigant and a nozzle in fluid communication with the irrigation duct, wherein the nozzle is positioned at the distal end and is rotatably mounted to the introducer and adapted to dispense pressurized fluid from the irrigation duct toward a layer of bacterial biofilm to disrupt the bacterial biofilm from the target site;

the surgical instrument further comprising a first actuator assembly adapted to selectively rotate the nozzle relative to the introducer; and

wherein the instrument further includes a handle maintaining the introducer, and further wherein the first actuator assembly includes;

a first wheel rotatably secured to the handle;

a rigid irrigation duct segment connected to and extending from the first wheel; and

a flexible irrigation duct segment extending between the rigid irrigation duct segment and the nozzle;

surgically inserting the distal portion of the introducer into the patient;

delivering the nozzle proximate the target site, the target site including a layer of bacterial biofilm adhered to a surface;

rotating the nozzle relative to the introducer following delivering of the nozzle proximate the target site; and

dispensing a pressurized flow of irrigant through the nozzle toward the target site to mechanically remove a substantial portion of the layer of bacterial biofilm from the surface.

12. The method of claim 11, the method further comprising:

spatially articulating the distal end relative to the handle of the instrument to adjust an angle of attack of the nozzle.

13. The method of claim 12, wherein spatially articulating the distal end includes:

delivering the nozzle to a first location relative to the target site to define a first angle of attack of the nozzle relative to the target site;

evaluating an effectiveness of the first angle of attack;

actuating a second actuator external the patient to effectuate a bend in the distal portion to adjust the angle of the nozzle from the first angle of attack to a second angle of attack.

14. The method of claim 11, wherein the fluid is dispensed from the nozzle while rotating the nozzle.

15. The method of claim 11, wherein the instrument has an aspiration duct extending through the introducer and terminating at an aspiration inlet adjacent the nozzle, the method further comprising:

aspirating the removed bacterial biofilm and the dispensed irrigant through the aspiration inlet.

16. The method of claim 11, wherein substantially all of the layer of bacterial biofilm is removed from the target site with the dispensed irrigant.

17. The method of claim 11, further comprising:

delivering the working end of an endoscope proximate the target site;

imaging the target site with the endoscope; and

positioning the nozzle relative to the target site based upon the imaging.

18. The method of claim 11, further comprising applying a medicament to the target site through the irrigation duct, the medicament adapted to interfere with bacterial biofilm regrowth.

19. The method of claim 18, wherein the medicament is selected from the group consisting of:

a surfactant, a gel, an antimicrobial, a steroid, a growth hormone, and combinations thereof.

20. The method of claim 11, wherein the flow of irrigant is directed through the nozzle at a flow rate from about 2 ml/s to about 12 ml/s.

21. The method of claim 11, wherein the target site is within a sinus cavity.

22. The method of claim 11, wherein the target site includes ciliated epithelium.

23. The method of claim 11, wherein the method is performed in treating chronic rhinosinusitis.