US20210259772A1 - Apparatus for endo fistula laser therapy - Google Patents
Apparatus for endo fistula laser therapy Download PDFInfo
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- US20210259772A1 US20210259772A1 US17/318,014 US202117318014A US2021259772A1 US 20210259772 A1 US20210259772 A1 US 20210259772A1 US 202117318014 A US202117318014 A US 202117318014A US 2021259772 A1 US2021259772 A1 US 2021259772A1
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- Prior art keywords
- fistula
- insertion tube
- coupler
- coupler device
- waveguide
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- 206010016717 Fistula Diseases 0.000 title claims abstract description 54
- 230000003890 fistula Effects 0.000 title claims abstract description 54
- 238000002647 laser therapy Methods 0.000 title claims description 7
- 238000003780 insertion Methods 0.000 claims abstract description 49
- 230000037431 insertion Effects 0.000 claims abstract description 49
- 238000010926 purge Methods 0.000 claims description 14
- 230000006835 compression Effects 0.000 claims description 4
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 12
- 230000005855 radiation Effects 0.000 abstract description 7
- 239000008223 sterile water Substances 0.000 abstract description 6
- 208000004680 Rectal Fistula Diseases 0.000 abstract description 5
- 206010002156 anal fistula Diseases 0.000 abstract description 5
- 238000013532 laser treatment Methods 0.000 abstract description 4
- 210000001519 tissue Anatomy 0.000 description 23
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- 238000011282 treatment Methods 0.000 description 5
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- 238000002679 ablation Methods 0.000 description 2
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- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- 229910052691 Erbium Inorganic materials 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
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- 229910052775 Thulium Inorganic materials 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
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- 210000001217 buttock Anatomy 0.000 description 1
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00641—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closing fistulae, e.g. anorectal fistulae
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00646—Type of implements
- A61B2017/00663—Type of implements the implement being a suture
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00482—Digestive system
- A61B2018/005—Rectum
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00625—Vaporization
Definitions
- the present invention relates generally to treatment of rectal fistula in normal, Crohns and IBS patients, to an improved method using CO2 laser, more efficient and flexible waveguide and coupling device that targets the H2O chromophore in tissues thereby vaporizing and ablating more efficiently without any surgical cutting to promote healing and closure of fistula.
- thermal or other energy is administered to a patient with beneficial effects.
- energy can be used to detect a tumor or a region of the body, or to destroy or denature diseased or malfunctioning body tissue.
- U.S. Pat. No. 6,095,149 issued Aug. 1, 2000, which describes the treatment of in-verbal disc abnormalities with thermal energy.
- U.S. Pat. No. 5,628,762 issued May 12, 1007 to Moshin Al-Tameen discloses a method of using a device having a cutting tool for excising a fistula track and also discloses a laser emitting device to dissect the fistula track from surrounding tissue.
- this prior art does not disclose the simplified structure and improved results of the present invention.
- U.S. Patent Application Publication No. 2011/0282334 discloses a device and method for fistula treatment comprising a laser source, fiber optics device and an imaging system. Radiation is delivered to fistula until shrinkage and closure are observed. However, the waveguide elements of the present invention are not disclosed.
- a method of providing laser therapy to a fistula of a patient comprising the steps of (a) preparing the patient rectal fistula site and inserting a line such as a surgical silk line into said fistula until the line extends into and exits from an anal canal of the patient, (b) inserting an insertion tube extending from a first end of a coupler into the fistula extending from a coupler into the fistula using said line as a guide and removing the line after the insertion tube is positioned within the fistula, (c) purging the insertion tube using a purge tube attached to the coupler to remove any tissue or debris, (d) inserting a waveguide into the coupler including the insertion tube, the insertion tube being positioned within the fistula, (e) locking the waveguide to the insertion tube end of the coupler using a lock nut of the coupler and (f) applying laser energy via the waveguide to the fistula and slowly
- the step of purging the insertion tube positioned within the fistula comprises the step of inserting at least one of sterile water and forced air into the purging tube.
- the step of inserting an optical waveguide into the coupler including the insertion tube, the insertion tube being positioned within the fistula further comprises the step of exposing the waveguide in the range of 1-3 mm from a distal end of the insertion tube.
- the method comprises the step of inserting a beam block into the anal canal of the patient opposite a distal end of the waveguide extending from the insertion tube positioned in the fistula of the patient.
- the step of applying laser energy via the waveguide comprises the step of providing laser dosimetry in the range of approximately 15 watts and slowly removing from the fistula the locked together insertion tube/waveguide at a rate of approximately 1 mm per second.
- the method further comprises the step of suturing an internal distal opening of the fistula in the anal canal.
- FIG. 1 depicts a diagram of a preferred embodiment of the present invention for performing rectal fistula laser treatment
- FIG. 2 is a block diagram of the steps of the method for performing fistula laser therapy according to the present invention
- FIG. 3 illustrates the step of the method of inserting a surgical silk line into a fistula site for guiding the insertion of an insertion tube into the fistula;
- FIG. 4 illustrates the step of the method of using a purge tube of a coupler to provide sterile water held in a syringe for purging the insertion tube to remove any tissue or debris;
- FIG. 5 is an exploded perspective view of the coupler having a flexible insertion tube extending at one end and a removable lock nut at the other end.
- FIG. 1 a method and apparatus for performing endo fistula laser therapy 10 is shown.
- a fistula 12 is an abnormal passage or infected tunnel that develops between a hollow organ such as an anal canal 18 and a body skin or surface 21 .
- FIG. 1 shows an improved method 10 for treating the fistula 12 , a distal end of which extends from the anal canal 18 through a patient tissue or buttocks 14 to a proximal end at the body skin 21 .
- the method 10 includes the use of laser energy provided by a CO2 laser 54 having an optical waveguide 52 for delivering the laser energy for treating the fistula 12 .
- the tip of the optical waveguide 52 could cause trauma to good soft tissue, so for some invasive applications, it is not desirable to insert the optical waveguide 52 directly into body tissue.
- the optical waveguide 52 is inserted into a flexible insertion tube 50 which extends from a coupler 30 , as shown in FIG. 5 , and also includes a locking nut 34 , a cap 38 and a purge tube 40 .
- a beam block 20 is inserted into the anal canal 18 and positioned opposite a distal end of the optical waveguide 52 .
- FIG. 2 shows a block diagram 60 of the steps of the method for performing the endo fistula laser therapy for the fistula 12 as shown in FIG. 1 and the steps are further described as follows:
- Step 62 is preparing a patient's rectal fistula 12 site which includes cleaning and site preparation according to generally accepted medical practice methods and inserting a surgical silk line 26 (or a line of similar characteristics) into the fistula 12 from proximal end 22 to distal end 24 and then the surgical silk line exits the anal canal 18 of the patient.
- a surgical silk line 26 or a line of similar characteristics
- the next Step 64 is inserting the insertion tube 50 into the fistula 12 using the surgical silk line 26 as a guide as the insertion tube 50 moves within the fistula 12 , and then removing the surgical silk line 26 after the insertion tube 50 is positioned in the fistula 12 .
- Step 65 is illustrated in FIG. 4 and includes purging the insertion tube 50 before inserting a waveguide 52 using a syringe 28 , containing sterile water, which is attached to the purge tube 40 of the coupler 30 to remove any tissue or debris via the anal canal 18 .
- a cap 38 of the coupler 30 Prior to injecting the sterile water, a cap 38 of the coupler 30 is inserted into an open end of the coupler 30 when the lock nut 34 is removed.
- air under pressure may be used to remove any tissue or debris.
- Step 66 consists of inserting the optical waveguide 52 extending from a CO2 laser 54 into the coupler 30 (with the locking nut unlocked) and through the insertion tube 50 to a selected depth wherein 1-3 mm of the waveguide 52 is exposed from the distal end of the insertion tube positioned within the fistula 12 as shown in FIG. 1 .
- Step 67 is locking together the waveguide 52 to the insertion tube 50 by tightening the locking nut 34 of the coupler 30 to secure the waveguide within the coupler 30 by means of a compression washer 36 of the coupler 30 .
- Step 68 consists of inserting a beam block 20 into the anal canal 18 to be positioned opposite a distal end of the waveguide 52 within the fistula 12 to protect good tissue from laser treatment of unwanted tissue.
- the CO2 laser 54 is set to standby with approximately 15 watts of power to be delivered to the fistula tissue.
- the CO2 laser may be embodied by Model No. MD 30 ULTRA, Manufactured by LEI (Laser Engineering, Inc.) of Arlington, Tenn.
- Step 69 is applying the laser energy via the waveguide 52 to fistula 12 in a continuous or repetitive manner.
- Laser radiation is delivered to the inner wall of the fistula 12 and the radiation is absorbed and thermally restructures the walls of the fistula 12 .
- the insertion tube 50 has graduated markings 51 for assisting a surgeon to withdraw the secured together insertion tube 50 /waveguide 52 at a desired rate which in this method is a distance per unit of time.
- the insertion tube 50 and the optical waveguide 52 which are secured together are slowly removed from the fistula 12 at a rate of approximately 1 mm per second while a laser energy dose at approximately 15 watts is emitted from the distal end of the optical waveguide 52 .
- Preferred Radiation Wavelength is 10.6 microns.
- An alternate source of laser energy includes the use of a Thulium Yag laser at a wavelength of 2 microns or 10.6 microns and an Erbium: yag laser at a wavelength of 2.9 micro
- the CO2 laser energy is ceased.
- a visual and/or audible indicator may be provided to give an indication of how fast the insertion tube 50 /waveguide 52 is withdrawn. The withdrawal rate is determined by the surgeon and the pathology of the fistula 12 .
- the CO2 wavelength of 10.6 microns is readily absorbed by H2O.
- H2O 70+ percent water
- tissue absorption at this wavelength is high.
- the tissue readily absorbs the light which subsequently causes the H2O chromophore in the cells to increase its energy level to a vaporization event.
- the target tissue mainly infected muscle, epithelial, fat, scar and collagen are readily vaporized with the incidence of the 10.6-micron energy at determined energy levels. The ablation of this infected tissue and the subsequent destruction of the resident infected cells promotes the patient's body to heal the fistula properly.
- Step 70 is where the surgeon decides repeating steps 64 - 69 as needed depending on the patient case pathology.
- Step 71 provides suturing of an internal distal end opening 24 of the fistula 12 in the anal canal 18 .
- the Physician may determine that the internal opening is not suturable.
- an exploded perspective view of the coupler 30 shows the flexible insertion tube 50 extending away from and forming a first end of the coupler 30 and a removable lock nut 34 forming a second end of the coupler 30 .
- the insertion tube 50 may be molded or glued within the coupler 30 .
- a flexible purge tube 40 extends from a side 32 of the coupler 30 and is approximately six inches long and connects to the syringe 28 as shown in FIG. 4 during the fistula purge step 65 .
- Through the center of the coupler 30 is a cylindrical cavity 33 for receiving the waveguide 52 , and the waveguide 52 passes through the coupler 30 including the insertion tube 50 .
- a cap 38 is attached at the end of a flexible plastic cord 39 which extends from the surface of the coupler 30 .
- the cap cord 39 is long enough for the cap 38 to be inserted into the open end of the coupler 30 when the lock nut 34 is removed, such as during the purging step 65 .
- the diameter of the cap 38 is approximately 1.5 mm ID and 3-4 mm OD).
- the coupler 30 has a compression washer 36 so that when the lock nut 34 is attached, the waveguide 52 within the coupler 30 , becomes secured to the coupler 30 , and the waveguide 52 cannot move inside the coupler 30 including the insertion tube 50 .
- the lock nut 34 compress or squeezes the washer 36 to a level of gripping the waveguide 52 sufficiently to lock it in place.
- the insertion tube 50 has an inside diameter of approximately 1.5-2 mm which is sufficient for the waveguide to pass within. It is made of a flexible plastic/polyethylene tube approximately 10-15 cm long with an outside diameter of approximately 1.7-2.2 mm.
- the insertion tube 50 has external graduated markings 51 in 1 mm increments for use during the withdrawal dosimetry monitoring of the waveguide 52 which is locked to the insertion tube 50 during the application of laser energy.
- the coupler 30 which includes insertion tube 50 integrated into one end may be obtained from G-Tech, Inc. of Riverside, Mass.
Abstract
A method and apparatus for rectal fistula laser treatment wherein an insertion tube of a coupler is inserted into a fistula from proximal to distal end. The insertion tube is then purged using sterile water and/or air. A flexible optical waveguide is then inserted through the coupler including the insertion tube until the end of the optical waveguide protrudes 1-3 mm from the distal end of the insertion tube. The optical waveguide is secured to the coupler by a lock nut of the coupler. The insertion tube locked to the optical waveguide is withdrawn through the fistula while CO2 laser radiation is passed down the optical waveguide so that laser radiation is delivered to the inner wall of the fistula at a specific rate as the laser radiation treats the fistula.
Description
- This application is a divisional of U.S. application Ser. No. 16/285,357, filed Feb. 26, 2019, which claims the benefit of U.S. Provisional Application No. 62/635,914, filed Feb. 27, 2018. Each of these applications is herein incorporated by reference in their entirety for all purposes.
- The present invention relates generally to treatment of rectal fistula in normal, Crohns and IBS patients, to an improved method using CO2 laser, more efficient and flexible waveguide and coupling device that targets the H2O chromophore in tissues thereby vaporizing and ablating more efficiently without any surgical cutting to promote healing and closure of fistula.
- In certain invasive medical procedures thermal or other energy is administered to a patient with beneficial effects. For example, energy can be used to detect a tumor or a region of the body, or to destroy or denature diseased or malfunctioning body tissue. One example of this type of treatment is disclosed in U.S. Pat. No. 6,095,149, issued Aug. 1, 2000, which describes the treatment of in-verbal disc abnormalities with thermal energy.
- U.S. Pat. No. 5,628,762 issued May 12, 1007 to Moshin Al-Tameen discloses a method of using a device having a cutting tool for excising a fistula track and also discloses a laser emitting device to dissect the fistula track from surrounding tissue. However, this prior art does not disclose the simplified structure and improved results of the present invention.
- U.S. Patent Application Publication No. 2011/0282334 discloses a device and method for fistula treatment comprising a laser source, fiber optics device and an imaging system. Radiation is delivered to fistula until shrinkage and closure are observed. However, the waveguide elements of the present invention are not disclosed.
- Accordingly, it is therefore an object of this invention to provide a more efficient and flexible method and apparatus for performing endo fistula laser treatment with a CO2 laser that treats the targeted tissue more efficiently resulting in less treatment time, better tissue ablation and no or reduced recurrence.
- It is another object of this invention to vaporize and ablate more efficiently unwanted fistula tissue due to tissue absorption coefficient characteristics at the laser wavelength of approximately 10.6 microns wherein the CO2 laser light targets the H2O chromophone in the tissue to be treated.
- It is a further object of this invention to provide less collateral trauma into surrounding tissues using the method and apparatus of this invention.
- These and other objects are accomplished by a method of providing laser therapy to a fistula of a patient comprising the steps of (a) preparing the patient rectal fistula site and inserting a line such as a surgical silk line into said fistula until the line extends into and exits from an anal canal of the patient, (b) inserting an insertion tube extending from a first end of a coupler into the fistula extending from a coupler into the fistula using said line as a guide and removing the line after the insertion tube is positioned within the fistula, (c) purging the insertion tube using a purge tube attached to the coupler to remove any tissue or debris, (d) inserting a waveguide into the coupler including the insertion tube, the insertion tube being positioned within the fistula, (e) locking the waveguide to the insertion tube end of the coupler using a lock nut of the coupler and (f) applying laser energy via the waveguide to the fistula and slowly removing the locked together insertion tube/waveguide through the fistula at a predetermined rate.
- The step of purging the insertion tube positioned within the fistula comprises the step of inserting at least one of sterile water and forced air into the purging tube. The step of inserting an optical waveguide into the coupler including the insertion tube, the insertion tube being positioned within the fistula, further comprises the step of exposing the waveguide in the range of 1-3 mm from a distal end of the insertion tube.
- The method comprises the step of inserting a beam block into the anal canal of the patient opposite a distal end of the waveguide extending from the insertion tube positioned in the fistula of the patient. The step of applying laser energy via the waveguide comprises the step of providing laser dosimetry in the range of approximately 15 watts and slowly removing from the fistula the locked together insertion tube/waveguide at a rate of approximately 1 mm per second. The method further comprises the step of suturing an internal distal opening of the fistula in the anal canal.
- Additional objects, features and advantages of the invention will become apparent to those skilled in the art upon consideration of the following detailed description of the preferred embodiment exemplifying the best mode of carrying out the invention as presently perceived.
- The appended claims particularly point out and distinctly claim the subject matter of this invention. The various objects, advantages and novel features of this invention will be more fully apparent from a reading of the following detailed description in conjunction with the accompanying drawings in which like reference numerals refer to like parts and, in which:
-
FIG. 1 depicts a diagram of a preferred embodiment of the present invention for performing rectal fistula laser treatment; -
FIG. 2 is a block diagram of the steps of the method for performing fistula laser therapy according to the present invention; -
FIG. 3 illustrates the step of the method of inserting a surgical silk line into a fistula site for guiding the insertion of an insertion tube into the fistula; -
FIG. 4 illustrates the step of the method of using a purge tube of a coupler to provide sterile water held in a syringe for purging the insertion tube to remove any tissue or debris; -
FIG. 5 is an exploded perspective view of the coupler having a flexible insertion tube extending at one end and a removable lock nut at the other end. - Referring to
FIG. 1 , a method and apparatus for performing endofistula laser therapy 10 is shown. As is well-known afistula 12 is an abnormal passage or infected tunnel that develops between a hollow organ such as ananal canal 18 and a body skin orsurface 21.FIG. 1 shows an improvedmethod 10 for treating thefistula 12, a distal end of which extends from theanal canal 18 through a patient tissue orbuttocks 14 to a proximal end at thebody skin 21. - The
method 10 includes the use of laser energy provided by aCO2 laser 54 having anoptical waveguide 52 for delivering the laser energy for treating thefistula 12. The tip of theoptical waveguide 52 could cause trauma to good soft tissue, so for some invasive applications, it is not desirable to insert theoptical waveguide 52 directly into body tissue. Instead, theoptical waveguide 52 is inserted into aflexible insertion tube 50 which extends from acoupler 30, as shown inFIG. 5 , and also includes alocking nut 34, acap 38 and apurge tube 40. Furthermore, to protect good tissue, abeam block 20 is inserted into theanal canal 18 and positioned opposite a distal end of theoptical waveguide 52. -
FIG. 2 shows a block diagram 60 of the steps of the method for performing the endo fistula laser therapy for thefistula 12 as shown inFIG. 1 and the steps are further described as follows: -
Step 62 is preparing a patient'srectal fistula 12 site which includes cleaning and site preparation according to generally accepted medical practice methods and inserting a surgical silk line 26 (or a line of similar characteristics) into thefistula 12 fromproximal end 22 to distalend 24 and then the surgical silk line exits theanal canal 18 of the patient. - The
next Step 64 is inserting theinsertion tube 50 into thefistula 12 using thesurgical silk line 26 as a guide as theinsertion tube 50 moves within thefistula 12, and then removing thesurgical silk line 26 after theinsertion tube 50 is positioned in thefistula 12. -
Step 65 is illustrated inFIG. 4 and includes purging theinsertion tube 50 before inserting awaveguide 52 using asyringe 28, containing sterile water, which is attached to thepurge tube 40 of thecoupler 30 to remove any tissue or debris via theanal canal 18. Prior to injecting the sterile water, acap 38 of thecoupler 30 is inserted into an open end of thecoupler 30 when thelock nut 34 is removed. As an alternative to sterile water, air under pressure may be used to remove any tissue or debris. -
Step 66 consists of inserting theoptical waveguide 52 extending from aCO2 laser 54 into the coupler 30 (with the locking nut unlocked) and through theinsertion tube 50 to a selected depth wherein 1-3 mm of thewaveguide 52 is exposed from the distal end of the insertion tube positioned within thefistula 12 as shown inFIG. 1 . -
Step 67 is locking together thewaveguide 52 to theinsertion tube 50 by tightening thelocking nut 34 of thecoupler 30 to secure the waveguide within thecoupler 30 by means of acompression washer 36 of thecoupler 30. -
Step 68 consists of inserting abeam block 20 into theanal canal 18 to be positioned opposite a distal end of thewaveguide 52 within thefistula 12 to protect good tissue from laser treatment of unwanted tissue. Now that theinsertion tube 50 and thewaveguide 52 are secured in position within thefistula 12 and thebeam block 20 is inserted, theCO2 laser 54 is set to standby with approximately 15 watts of power to be delivered to the fistula tissue. The CO2 laser may be embodied by Model No. MD 30 ULTRA, Manufactured by LEI (Laser Engineering, Inc.) of Nashville, Tenn. -
Step 69 is applying the laser energy via thewaveguide 52 tofistula 12 in a continuous or repetitive manner. Laser radiation is delivered to the inner wall of thefistula 12 and the radiation is absorbed and thermally restructures the walls of thefistula 12. Theinsertion tube 50 has graduatedmarkings 51 for assisting a surgeon to withdraw the secured togetherinsertion tube 50/waveguide 52 at a desired rate which in this method is a distance per unit of time. Theinsertion tube 50 and theoptical waveguide 52 which are secured together are slowly removed from thefistula 12 at a rate of approximately 1 mm per second while a laser energy dose at approximately 15 watts is emitted from the distal end of theoptical waveguide 52. Preferred Radiation Wavelength is 10.6 microns. An alternate source of laser energy includes the use of a Thulium Yag laser at a wavelength of 2 microns or 10.6 microns and an Erbium: yag laser at a wavelength of 2.9 microns. - When the secured together
insertion tube 50/waveguide 52 reach theproximal end 22 of thefistula 12, the CO2 laser energy is ceased. A visual and/or audible indicator may be provided to give an indication of how fast theinsertion tube 50/waveguide 52 is withdrawn. The withdrawal rate is determined by the surgeon and the pathology of thefistula 12. - The CO2 wavelength of 10.6 microns is readily absorbed by H2O. With the understanding that the human body is comprised of 70+ percent water (H2O) it is understood that tissue absorption at this wavelength is high. The tissue readily absorbs the light which subsequently causes the H2O chromophore in the cells to increase its energy level to a vaporization event. The target tissue mainly infected muscle, epithelial, fat, scar and collagen are readily vaporized with the incidence of the 10.6-micron energy at determined energy levels. The ablation of this infected tissue and the subsequent destruction of the resident infected cells promotes the patient's body to heal the fistula properly.
-
Step 70 is where the surgeon decides repeating steps 64-69 as needed depending on the patient case pathology. When laser energy treatment of the fistula is ended,Step 71 provides suturing of an internal distal end opening 24 of thefistula 12 in theanal canal 18. However, the Physician may determine that the internal opening is not suturable. - Referring now to
FIG. 5 , an exploded perspective view of thecoupler 30 shows theflexible insertion tube 50 extending away from and forming a first end of thecoupler 30 and aremovable lock nut 34 forming a second end of thecoupler 30. Theinsertion tube 50 may be molded or glued within thecoupler 30. Aflexible purge tube 40 extends from aside 32 of thecoupler 30 and is approximately six inches long and connects to thesyringe 28 as shown inFIG. 4 during thefistula purge step 65. Through the center of thecoupler 30 is acylindrical cavity 33 for receiving thewaveguide 52, and thewaveguide 52 passes through thecoupler 30 including theinsertion tube 50. Acap 38 is attached at the end of aflexible plastic cord 39 which extends from the surface of thecoupler 30. Thecap cord 39 is long enough for thecap 38 to be inserted into the open end of thecoupler 30 when thelock nut 34 is removed, such as during the purgingstep 65. The diameter of thecap 38 is approximately 1.5 mm ID and 3-4 mm OD). Thecoupler 30 has acompression washer 36 so that when thelock nut 34 is attached, thewaveguide 52 within thecoupler 30, becomes secured to thecoupler 30, and thewaveguide 52 cannot move inside thecoupler 30 including theinsertion tube 50. Thelock nut 34 compress or squeezes thewasher 36 to a level of gripping thewaveguide 52 sufficiently to lock it in place. - The
insertion tube 50 has an inside diameter of approximately 1.5-2 mm which is sufficient for the waveguide to pass within. It is made of a flexible plastic/polyethylene tube approximately 10-15 cm long with an outside diameter of approximately 1.7-2.2 mm. Theinsertion tube 50 has external graduatedmarkings 51 in 1 mm increments for use during the withdrawal dosimetry monitoring of thewaveguide 52 which is locked to theinsertion tube 50 during the application of laser energy. Thecoupler 30 which includesinsertion tube 50 integrated into one end may be obtained from G-Tech, Inc. of Westminster, Mass. - This invention has been disclosed in terms of a certain embodiment. It will be apparent that many modifications can be made to the disclosed method and apparatus for endo fistula laser therapy without departing from the invention. Therefore, it is the intent of the appended claims to cover all such variations and modifications as come within the true spirit and scope of this invention.
Claims (5)
1. A coupler device for performing laser therapy on a fistula comprising:
an insertion tube integrated into a first end of said coupler device;
a removable lock nut forming a second end of said coupler device;
a cavity extending through a center of said coupler device from said first end to said second end, said cavity extending through said insertion tube;
a purge tube attached to a side of said coupler device and engaging with said cavity for passage of fluid from said purge tube to said insertion tube, and
a compression washer positioned within said coupler device for securing in cooperation with said lock nut a waveguide passing through said cavity within said coupler device.
2. The coupler device as recited in claim 1 further comprises a cap at an end of a cord, said cord attaching to said side of said coupler.
3. The coupler device as recited in claim 1 wherein said compression washer comprises said cavity for receiving said waveguide within said coupler device.
4. The coupler device as recited in claim 1 comprises a plastic material.
5. The coupler device as recited in claim 11 wherein said insertion tube end comprises graduated markings on an external surface of said insertion tube.
Priority Applications (1)
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US17/318,014 US20210259772A1 (en) | 2018-02-27 | 2021-05-12 | Apparatus for endo fistula laser therapy |
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US201862635914P | 2018-02-27 | 2018-02-27 | |
US16/285,357 US11013558B2 (en) | 2018-02-27 | 2019-02-26 | Method and apparatus for endo fistula laser therapy |
US17/318,014 US20210259772A1 (en) | 2018-02-27 | 2021-05-12 | Apparatus for endo fistula laser therapy |
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US16/285,357 Division US11013558B2 (en) | 2018-02-27 | 2019-02-26 | Method and apparatus for endo fistula laser therapy |
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US20210259772A1 true US20210259772A1 (en) | 2021-08-26 |
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US16/285,357 Active US11013558B2 (en) | 2018-02-27 | 2019-02-26 | Method and apparatus for endo fistula laser therapy |
US17/318,014 Abandoned US20210259772A1 (en) | 2018-02-27 | 2021-05-12 | Apparatus for endo fistula laser therapy |
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US16/285,357 Active US11013558B2 (en) | 2018-02-27 | 2019-02-26 | Method and apparatus for endo fistula laser therapy |
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Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5853366A (en) * | 1996-07-08 | 1998-12-29 | Kelsey, Inc. | Marker element for interstitial treatment and localizing device and method using same |
US8936592B2 (en) * | 2010-06-03 | 2015-01-20 | Ams Research Corporation | Laser tissue ablation system |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7549424B2 (en) | 1991-10-18 | 2009-06-23 | Pro Surg, Inc. | Method and apparatus for tissue treatment with laser and electromagnetic radiation |
US5312399A (en) | 1992-09-29 | 1994-05-17 | Hakky Said I | Laser resectoscope with mechanical cutting means and laser coagulating means |
US5458595A (en) | 1993-12-16 | 1995-10-17 | The Regents Of The University Of California | Vaginal speculum for photodynamic therapy and method of using the same |
US5643305A (en) | 1994-11-18 | 1997-07-01 | Al-Tameem; Moshin | Device for excision of a fistula |
US10709896B2 (en) | 2009-12-22 | 2020-07-14 | Biolitec Unternehmensbeteiligungs Ii Ag | System and method for treating hemorrhoids |
US20110282334A1 (en) | 2010-05-11 | 2011-11-17 | Ceramoptec Industries Inc. | Device and method for fistula treatment |
EP2476460B1 (en) | 2011-01-12 | 2013-10-02 | Fotona d.d. | Laser system for non ablative treatment of mucosa tissue |
-
2019
- 2019-02-26 US US16/285,357 patent/US11013558B2/en active Active
-
2021
- 2021-05-12 US US17/318,014 patent/US20210259772A1/en not_active Abandoned
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5853366A (en) * | 1996-07-08 | 1998-12-29 | Kelsey, Inc. | Marker element for interstitial treatment and localizing device and method using same |
US8936592B2 (en) * | 2010-06-03 | 2015-01-20 | Ams Research Corporation | Laser tissue ablation system |
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US11013558B2 (en) | 2021-05-25 |
US20190262073A1 (en) | 2019-08-29 |
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