The present invention relates to devices and methods for treating soft tissue regions for clearing or reducing tissue obstructions. More particularly, the present invention relates to laser devices and methods for clearing obstructed tissue regions by treating areas within the tissue.
Treatments for chronically obstructed airway passages of a patient vary greatly. They typically range from the administration of medications to surgical interventional procedures. Examples of typical medication include such types as protriptyline, medroxyprogesterone, acetazolamide, theophylline, nicotine, and other medications. Although helpful at times, they are rarely completely effective. Moreover, such medications frequently have undesirable side effects.
Examples of typical surgical interventions include uvulopalatopharyngoplasty, tonsillectomy, surgery to correct severe retrognathia, and tracheostomy. Other surgical procedures include pulling the tongue as forward as possible and surgically cutting and removing sections of the tongue and other structures which can close off the upper airway passage. These procedures may be effective but the risk of surgery in these patients can be prohibitive and the procedures are often unacceptable to the patients.
As shown in
Pharmaceuticals such as anti-histamines and anti-inflammatory drugs have been developed for reducing the size of the turbinates. However, pharmaceuticals are not always completely efficacious and generally do not provide a permanent reduction in turbinate size. In addition, pharmaceuticals can have adverse side effects.
Opening of obstructed nasal airways 18, 20, 22 by reducing the size of the turbinates 24, 26, 28 has been performed using surgical and pharmaceutical treatments. Such surgical procedures include anterior and posterior ethmoidectomy, an example of which is a procedure known as the Wigand procedure which involves transecting a portion of the middle turbinate 26. Other procedures have included inserting an electro-surgical probe, such as a radio-frequency (RF) energy probe, directly into a portion of the inferior turbinate 24. Once inserted, RF energy is applied to ablate the tissue interior of the turbinate 24. However, complications, such as excessive hemorrhaging, infection, perforation, scarring, adhesion of the turbinate, and intra-operative and post-operative pain may be present.
Accordingly, there exists a need for devices and methods which are efficacious and safe in clearing obstructed nasal passageways, at least for an extended period of time.
By reducing the size of a nasal turbinate, particularly the inferior nasal turbinate, obstruction of a nasal meatus such as the inferior nasal meatus can be reduced thereby improving the air flow through the nasal meatus. One method for reducing the size of the inferior nasal turbinate involves applying ultrasound energy to the tissue regions beneath the surface of the inferior turbinate. Ultrasound energy may be particularly advantageous in damaging the tissues beneath the turbinate surface layer by enabling the delivery of energy to a predetermined distance through the tissue without damaging the tissue surface while injuring the underlying tissue to create scarring. Moreover, because ultrasound energy may leave the turbinate tissue surface undisturbed, the need for surgical cutting is obviated.
One variation of a treatment instrument which may be used to deliver ultrasound energy to the underlying turbinate tissue may also be configured to provide an infusion or injection of a fluid directly into the turbinate being treated by the ultrasound energy. The fluid injected into the turbinate may be used to bulk up the physical size of the turbinate by injecting the fluid to present a larger surface area to the ultrasound transducers positioned along the instrument. The enlarged surface area may help to ensure that the ultrasound energy is properly delivered directly into the intended turbinate tissue rather than surrounding tissues.
The injected fluid may also be used for drug delivery directly into the treated turbinate tissue. For instance, anesthetic fluids or other fluids infused with analgesics may be injected into the turbinate tissue to provide for pain management during and after the application of the ultrasound energy. Additionally, other drugs for injection may include any number of medications, such as non-steroidal drugs, anti-inflammatory drugs, anti-bacterial drugs, etc. which may be injected to control excessive post-operative swelling as well as infection. Additionally, the one or more injection needles may be utilized as a positioning tool for ensuring that the ultrasound energy, which is directional, is delivered into the intended turbinate tissue. For example, the injection needle(s) may be initially positioned directly within the turbinate tissue prior to application of the ultrasound energy since the ultrasound transducer(s) along the probe may be aligned with the injection needle(s). Accordingly, if the needle(s) is positioned directly within the turbinate tissue to be treated, the operator may be assured that the ultrasound energy will be directionally aligned with the appropriate turbinate tissue region.
The ultrasound and infusion probe may have an elongate shaft which is sufficient to allow for insertion and advancement into the nasal cavity and against the appropriate turbinate tissue surface. The distal end portion may be angled relative to the elongate shaft or it may be straight depending upon the desired configuration. The distal end portion may have an end effector assembly which has one or more hollow infusion/injection needles which are retractably disposed within the distal end portion. During advancement into the nasal cavity and positioning against the turbinate tissue, the infusion/injection needles may be positioned within the distal end portion so as to present a smooth atraumatic surface to the tissue. When a fluid is to be injected into the tissue after the probe has been desirably positioned against the tissue surface, a control or advancement mechanism on handle, which is connected to a proximal end of the shaft, may be actuated to advance the needles at least partially out of the distal end portion. Between or adjacent to the needles are one or more ultrasound transducers along the body of the distal end portion.
An electronic/fluid cable is electrically and fluidly connected to the handle and is further connected to a power/infusion assembly, which may hold a fluid reservoir and a pump electrically coupled to a controller or central processor. Any of the above-mentioned fluids, e.g., analgesics, anesthetics, anti-inflammatory drugs, water, saline, etc., may be filled within the reservoir for delivery through the cable and through the one or more infusion/injection needles for delivery into the turbinate tissue.
In use, the elongate shaft and distal end portion may be advanced through the patient's nostril and through the inferior nasal meatus against the tissue surface of the inferior nasal turbinate. The distal end portion of the elongate shaft may be positioned anywhere against the inferior nasal turbinate and the infusion/injection needles may be deployed from the distal end portion and pierced into the turbinate tissue, where the fluid may be injected and/or infused from the needles into the turbinate. As the fluid is injected into the tissue, the infused inferior turbinate may begin to expand in size thereby pressing against the distal end portion. The fluid may be stopped and the focused ultrasound energy may then be transmitted from the transducers into the underlying expanded turbinate tissue.
Once the injection and ultrasound treatment has been concluded, the damaged underlying turbinate tissue may scar and eventually reduce a size of the inferior turbinate, thereby resulting in an unobstructed inferior nasal meatus. The treatments may be performed periodically between extended time periods while the turbinate tissue regenerates or on an as-needed basis.
In alternative configurations, the distal end effectors may include a mechanism for securely pressing the surface of the elongate shaft against the turbinate tissue surface to be treated to ensure piercing of the needles into the tissue as well as sufficient contact for the ultrasound transmission. For instance, expandable balloons and wires or ribbon members which may be reconfigured from a low-profile configuration against the elongate shaft to an expanded shape may be utilized.
Moreover, the ultrasound and infusion probe may optionally include an additional radio-frequency energy generator to deliver RF energy to one or more needles to ablate the pierced tissue. The ultrasound and infusion probe may also optionally include a cooling unit fluidly connected via a fluid line to the power/infusion assembly. Cooled fluid may be fluidly connected through the elongate shaft to a cooling fluid port positioned along the distal end portion.
Additionally, aside from the use of ultrasound transducers for delivering energy to the turbinate tissue, laser energy may alternatively be used to facilitate turbinate tissue reduction while achieving hemostasis and minimizing tissue injury to surrounding tissue regions.
As described above in
By reducing the size of a nasal turbinate, particularly the inferior nasal turbinate 24, obstruction of a nasal meatus such as the inferior nasal meatus 18 can be reduced. By reducing an obstruction of a nasal meatus, air flow through the nasal meatus is improved. One method for reducing the size of the inferior nasal turbinate 24 involves the application of ultrasound energy to the tissue regions beneath the surface of the inferior turbinate 24. Ultrasound energy may be particularly advantageous in damaging the tissues beneath the turbinate surface layer by enabling the delivery of energy to a predetermined distance through the tissue without damaging the tissue surface while injuring the underlying tissue to create scarring. Moreover, because ultrasound energy may leave the turbinate tissue surface undisturbed, the need for surgical cutting is obviated. The affected targeted tissue may scar and atrophy and eventually shrink and/or prevent the enlargement of the turbinate 24.
Although reference is made particularly to treatment of the inferior turbinate 24, this is done so for illustrative purposes. The procedures and devices described herein may easily be applied to any of the nasal turbinates 24, 26, 28 and are intended to be so.
However, because the size of the turbinate to be treated may vary greatly between patients, there is variability in the application of ultrasound energy that an ultrasound energy delivery device needs to compensate for. Additionally, even the application of ultrasound energy may produce pain and discomfort in the patient being treated due to the highly vascularized structure of the turbinates.
Another purpose is for drug delivery directly into the treated turbinate tissue. For instance, anesthetic fluids or other fluids infused with analgesics (e.g., lidocaine with or without epinephrine, marcaine with or without epinephrine, etc.) may be injected into the turbinate tissue to provide for pain management during and after the application of the ultrasound energy. Additionally, other drugs for injection may include any number of medications, such as steroidal drugs (e.g., corticosteroids, dexamethasone, beclomethasone, etc.), non-steroidal drugs (e.g., non-steroidal anti-inflammatory drugs, etc.), anti-inflammatory drugs, anti-histamines (e.g., diphenhydramine, etc.), anti-bacterial drugs, etc. which may be injected to control excessive post-operative swelling as well as infection.
Yet another purpose may be to utilize the one or more injection needles as a positioning tool for ensuring that the ultrasound energy, which is directional, is delivered into the intended turbinate tissue. For example, the injection needle(s) may be initially positioned directly within the turbinate tissue prior to application of the ultrasound energy since the ultrasound transducer(s) along the probe may be aligned with the injection needle(s). Accordingly, if the needle(s) is positioned directly within the turbinate tissue to be treated, the operator may be assured that the ultrasound energy will be directionally aligned with the appropriate turbinate tissue region.
Returning now to
The distal end portion 34 may be angled relative to the elongate shaft 32 or it may be straight depending upon the desired configuration. The distal end portion 34 may have an end effector assembly 38 which has one or more hollow infusion/injection needles 40 which are retractably disposed within the distal end portion 34. During advancement into the nasal cavity and positioning against the turbinate tissue, the infusion/injection needles 40 may be positioned within the distal end portion 34 so as to present a smooth atraumatic surface to the tissue. When a fluid is to be injected into the tissue after the probe 30 has been desirably positioned against the tissue surface, a control or advancement mechanism on handle 42, which is connected to a proximal end of shaft 32, may be actuated to advance needles 40 at least partially out of distal end portion 34.
The illustration of
An electronic/fluid cable 44 is electrically and fluidly connected to handle 42 and is further connected to a power/infusion assembly 46. Within assembly 46 is a fluid reservoir 48 and a pump 50 electrically coupled to controller or central processor 54. Any of the above-mentioned fluids, e.g., analgesics, anesthetics, anti-inflammatory drugs, water, saline, etc., may be filled within reservoir 48 for delivery through cable 44, elongate shaft 32 and through the one or more infusion/injection needles 40 for delivery into the turbinate tissue. The infusion rate of the fluid and control of the pump 50 may be determined by the controller 54. An example of a pump which is pre-programmed to inject a fluid in a controlled injection rate and which may be utilized with the pump 50 is commercially available as the CompuDent® delivery system and Wand® handpiece (Milestone Scientific, Inc., South Orange Livingston, N.J.). Power supply 52 may also be provided within assembly 46 and may be controlled by controller 54 to control the amount of energy provided by the ultrasound transducers 41 located in distal end portion 34.
As mentioned above, during delivery and positioning of elongate shaft 32 against the turbinate tissue, the one or more needles 40 may be retracted within distal end portion 34, as shown in the partial cross-sectional detail view of
When the infusion/injection needles 40 are to be deployed into or against the turbinate tissue, they may be advanced distally through needle lumens 60 until they project from a surface of the elongate shaft 32, as shown in
In another variation,
In use, elongate shaft 32 and distal end portion 34 may be advanced through the patient's nostril 14 and through the inferior nasal meatus 18 against the tissue surface of the inferior nasal turbinate 24, as shown in
The instrument variations shown and described above in
As described above and as illustrated in
The increased size of the turbinate 24′ tissue surface presented to the transducers 41 may facilitate treatment of the underlying tissue as well as ensure that the appropriate tissue is treated. Moreover, once the ultrasound energy 72 has been applied at a first location, the needles 40 may be retracted and the distal end portion 34 may be moved to another region of the inferior turbinate 24′ to further effect treatment. Any amount of the expanded inferior turbinate 24′ may be treated, e.g., 3 to 4 cm of turbinate tissue along its length. With the infusion of anesthetics and/or anti-inflammatory drugs, any pain associated with the application of ultrasound energy and scarring of the tissue is eliminated or reduced.
Once the injection and ultrasound treatment has been concluded, the damaged underlying turbinate tissue may scar and eventually reduce a size of the inferior turbinate 24″, thereby resulting in an unobstructed inferior nasal meatus 18, as shown in
The configuration and number of infusion/injection needles 40 and ultrasound transducers 41 may be varied depending upon the desired effect.
In alternative configurations, the distal end effectors may include a mechanism for securely pressing the surface of the elongate shaft against the turbinate tissue surface to be treated to ensure piercing of the needles into the tissue as well as sufficient contact for the ultrasound transmission. For instance,
Another variation of a mechanism is shown in the side and end views of
In yet another configuration, the ultrasound and infusion probe 30 may optionally include an additional radio-frequency energy generator 90, which may be configured to deliver RF energy to one or more needles to ablate the pierced tissue. Ablation of the pierced regions of tissue may help to coagulate the pierced tissue. Moreover, the ultrasound and infusion probe 30 may also optionally include a cooling unit 92 fluidly connected via fluid line 98 to power/infusion assembly 46. Cooling unit 92 may comprise a pump 94 fluidly coupled to a reservoir 96 containing cooled or chilled fluid 96, e.g., saline, water, etc. The cooled fluid 96 may be fluidly connected through elongate shaft 32 to a cooling fluid port 100 positioned along distal end portion 100. Before, during, or after ultrasound energy transmission into the turbinate tissue, the cooled fluid may be pumped from reservoir 96 through cooling fluid port 100 to cool the surface of the turbinate tissue to ensure that the turbinate tissue surface is unperturbed by the energy applied beneath its surface.
Other configurations for the ultrasound and infusion probe may be utilized. One example is shown in the top and side views of the ultrasound and infusion probe 110 shown in
In any of the variations described herein, elongate shaft may be configured to be a malleable shaft 120, or at least have a distal portion which is malleable, from which the one or more infusion/injection needles 122 may be positioned. Such a malleable shaft may be configured by the user to conform to any number of configurations prior to advancement into the nasal cavity. For instance, the malleable shaft 120 may be configured into a curved configuration, as shown in
In use, the instrument may be delivered and positioned adjacent to the tissue to be treated. During or after the injection of the needles 40 and delivery of fluids in the tissue, the laser generator 132 may be actuated to deliver laser energy through the terminal end of the optical fiber 130. The laser may be configured as any number of laser instruments. For instance laser generator 132 may be an Argon laser or CO2 laser capable of generating laser temperatures, e.g., of 750° to 900° C., to vaporize the underlying turbinate tissue.
Moreover, controller 54 may be configured to control laser generator 132 to deliver pulsed laser energy through fiber terminal end 130 for a controlled period of time and frequency.
Another variation for delivering laser energy for tissue treatment is illustrated in the detail side views of
Moreover, the laser energy passed through the optical fibers 142 may be utilized in conjunction with the ultrasound energy delivered via the one or more ultrasound transducers 41, as above, or alone. Furthermore, the optical fibers may be advanced through any of the needles described herein for laser treatment of the tissue and the use of ultrasound transducers may be omitted entirely as well.
In passing the optical fiber 144 through the needle body, the fiber 144 may be independently translatable within the needle lumen 142. In this variation, the fiber 144 may be passed through the same lumen utilized for fluid infusion through the needle, if fluid infusion is utilized. Alternatively, the optical fiber 144 may be affixed within the lumen 142 of the needle such that advancement or retraction of the needle also likewise advances or retracts the optical fiber 144 relative to the elongate shaft 34. Moreover, the optical fiber 144 in either case may be configured (if affixed) or otherwise urged (if translatable) to extend just proximal to, adjacent with, or distally beyond the lumen opening or needle tip and into the tissue during treatment.
In an exemplary method of use, the elongate shaft 34 may be advanced with the needles in their retracted position within shaft 34 and placed against the region of tissue to be treated, e.g., the inferior nasal turbinate 24, as shown in
With optical fiber 144 positioned proximate to or within the tissue 24, laser energy 162 may be passed through optical fiber 144, as described above, to ablate the tissue region 164 around the needle 140, as shown in
In alternative methods of use, other regions of the patient body may be treated with the system described herein. An example is illustrated in
The applications of the devices and methods discussed above are not limited to the treatment of the tissue regions in or around the nasal and oral cavities but may include any number of further treatment applications. Other treatment sites may include areas or regions of the body such as soft tissue bodies. Modification of the above-described assemblies and methods for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the art are intended to be within the scope of the claims.
This application claims the benefit of priority to the following U.S. Provisional Patent Application Nos. 60/820,322 and 60/820,328 both filed Jul. 25, 2006; and 60/863,018 filed Oct. 26, 2006, each of which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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60820322 | Jul 2006 | US | |
60820328 | Jul 2006 | US | |
60863018 | Oct 2006 | US |