Method for reducing biofilm formation

Patent metadata

Field	Value
Publication number	US-2016128708-A1
Application number	US-201514939552-A
Country	US
Kind code	A1
Filing date	Nov 12, 2015
Priority date	Nov 12, 2014
Publication date	May 12, 2016
Grant date	—

Abstract

A two phase method for reducing the formation of biofilm includes an evacuation of ambient air from a region about the surgical or treatment site, to extract airborne or aerosolized bacteria ejected from the site by the treatment. The extracted bacteria are prevented from settling back onto the cleansed tissue surface, thus at least reducing colonial bacteriological growth and concomitantly exuded biofilm material. A second phase involves the attachment of one or more ultrasonic transducers to the patient over or near a surgical treatment site after the surgery is terminated. Each applied ultrasonic transducer is used to vibrate the patient's tissues at the treatment site to disrupt biofilm formation.

First claim

What is claimed is:

1 . A medical therapeutic method comprising:
providing an ultrasonic debridement instrument having an operative tip and a suction channel; manipulating said instrument to place said operative tip against a patient's tissues at a preselected surgical site; during contact of said operative tip with the patient's tissues, generating an ultrasonic standing wave in said instrument, to thereby fragment necrotic tissue and other undesired organic material at said surgical site; during the generating of said ultrasonic standing wave, disposing a suction inlet at a distal end of said suction channel proximate the surgical site; during the generating of said ultrasonic standing wave, applying vacuum or negative pressure to said suction channel to remove tissue debris fragmented organic material from said surgical site via said suction inlet; disposing a suction port at a position spaced from said surgical site; and during and/or after the generating of said ultrasonic standing wave and the fragmenting of tissue and material, sucking ambient air from a region about said surgical site through said suction port at said position.

2 . The method defined in claim 1 wherein said suction port is on said instrument, further comprising operating an actuator to enable the sucking of air through said suction port.

3 . The method defined in claim 2 wherein the operating of said actuator includes shifting a sheath or sleeve in a proximal direction along said instrument.

4 . The method defined in claim 2 wherein said suction port is different from said suction inlet, said suction port being located proximally along said instrument from said suction input, the operating of said actuator including directing suction under-pressure to said suction port.

5 . The method defined in claim 2 wherein said instrument includes a longitudinally shiftable sheath or sleeve, said suction channel being located between said sheath or sleeve and a shaft or horn of said instrument, further comprising shifting said sheath or sleeve in a proximal direction after the applying of a vacuum or negative pressure and prior to the sucking of the ambient air through said suction port, a distal tip of said sheath or sleeve defining said suction inlet in a distal position of said sheath or sleeve, said distal tip defining said suction port in a proximal position of said sheath or sleeve.

6 . The method defined in claim 1 , further comprising:
placing at least one ultrasonic transducer on the patient at least proximate the surgical site after terminating of a debridement process and while the surgical site is free of discernible bacteria; and after the placing of said transducer and while said transducer is in effective vibration-transmitting contact with the patient, conducting an electrical energization waveform of an ultrasonic frequency to said transducer at least intermittently during a period of approximately one day or longer to at least reduce biofilm formation on the patient at the surgical site and facilitate a healing of the patient's tissue at the surgical site.

7 . The method defined in claim 6 wherein said transducer is affixed to a carrier pad, the placing of said transducer on the patient including attaching said pad to the patient.

8 . The method defined in claim 6 , further comprising utilizing said instrument at a lower energy setting to pre-condition the tissues at the surgical site for disrupting adherence or starting the formation of biofilm.

9 . The method defined in claim 1 , further comprising applying vacuum or negative pressure to said suction channel prior to the generating of said ultrasonic standing wave to remove irrigant from said surgical site.

10 . A medical therapeutic method comprising:
removing necrotic tissue and other undesired organic material from a surgical site on a patient; after the removal of all discernible necrotic tissue and other undesirable organic material from the surgical site and while the surgical site is free of discernible bacteria, placing at least one ultrasonic transducer on the patient at least proximate the surgical site; and after the placing of said transducer and while said transducer is in effective vibration-transmitting contact with the patient, conducting an electrical energization waveform of an ultrasonic frequency to said transducer at least intermittently during a period of approximately one day or longer, said waveform having frequency, amplitude and duration to effectively reduce biofilm formation on the patient at the surgical site and thereby facilitate a healing of the patient's tissue at the surgical site.

11 . The method defined in claim 10 wherein the placing of said transducer includes removably attaching said transducer to the patient.

12 . The method defined in claim 11 wherein the placing of said transducer includes removably attaching said transducer atop tissues at the surgical site.

13 . The method defined in claim 11 wherein said transducer is affixed to a carrier pad, the placing of said transducer on the patient including attaching said pad to the patient.

14 . The method defined in claim 10 wherein the removing of necrotic tissues includes operating an ultrasonic debrider instrument at a first energy setting, further comprising utilizing said instrument at a lower second energy setting to pre-condition the tissues at the surgical site for disrupting adherence or starting the formation of biofilm.

15 . A surgical device comprising:
an ultrasonic probe having an operative tip; an electromechanical transducer operatively connected to said probe for generating an ultrasonic standing wave in said probe; and at least one sheath or sleeve disposed about said probe and defining at least a first suction port at a distal end of said probe, proximate said operative tip, and a second suction port spaced from said distal end of said probe.

16 . The surgical device defined in claim 15 wherein said at least one sheath or sleeve is exactly one sheath or sleeve longitudinally slidable relative to said probe to shift between a distal position and a proximal position, wherein a distal end of said sheath or sleeve is alternately locatable (i) proximate said operative tip to define said first suction port and (ii) at a predetermined distance from said operative tip to define said second suction port.

17 . The surgical device defined in claim 15 wherein said first suction port and said second suction port are different openings in said at least one sheath or sleeve.

18 . The surgical device defined in claim 17 wherein said at least one sheath or sleeve defines a first suction channel extending to said first suction port and a separate second suction channel extending to said second suction port, said first suction channel and said second suction channel being subjectable to different negative pressures.

19 . The surgical device defined in claim 15 wherein said ultrasonic probe is cannulated.

20 . An ultrasonic debridement instrument assembly comprising: a probe including a proximal body section, a smaller-diameter horn section, and a probe head, the horn section extending distally of said body section, said head being formed at a distal end of said horn section; a rigid sheath shiftable relative to said probe for assuming a continuous range of longitudinal positions relative to the probe, said probe having a longitudinal channel for the delivery of liquid irrigant to an outlet in a distal end face of said probe head, said probe

Assignees

• Misonix Inc

Inventors

• Mikus Paul
• Isola Scott
• Voic Dan
• Ludecker Scott
• Darian Alexander

Classifications

• A61B17/320068

  using mechanical vibrations, e.g. ultrasonic (A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745) · CPC title

• A61B2217/005

  with suction drainage system · CPC title

• A61B17/22004 Primary

  using mechanical vibrations, e.g. ultrasonic shock waves (A61B17/225 takes precedence) · CPC title

• A61B2017/22005

  Effects, e.g. on tissue · CPC title

• A61M1/85

  with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants (for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208) · CPC title