WO1999025259A1

WO1999025259A1 - Method and device for tympanic membrane shrinkage

Info

Publication number: WO1999025259A1
Application number: PCT/US1998/023127
Authority: WO
Inventors: Hugh Sharkey
Original assignee: Hugh Sharkey
Priority date: 1997-11-13
Filing date: 1998-10-29
Publication date: 1999-05-27

Abstract

A device for tightening a defect area of a tympanic membrane. The device has an energy delivery device which is maneuvrable within an ear canal. The energy delivery device includes a proximal section and a distal section with an energy delivery surface. At least a portion of the energy delivery surface has a geometry configured to deliver continually along a band of tissue which at least partially surrounds a section of the defect area. The energy delivery surface delivers an energy to the band to effect a contraction within at least a portion of the band so as to cause the defect area to become tighter. The invention also relates to a method for tightening a defect area of a tympanic membrane.

Description

METHOD AND DEVICE FOR TYMPANIC MEMBRANE

SHRINKAGE

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to a method and device for improving hearing and more particularly to a method and device for tightening the tympanic membrane.

Description of the Related Art

Loose areas of the tympanic membrane, commonly called the ear drum, are a common source of hearing problems. The tympanic membrane facilitates hearing by transferring pressure variations in the air to pressure variations in the cochlea fluids of the inner ear. To perform this function, the tympanic membrane has a particular tension across the membrane. This tension allows the membrane to vibrate at certain frequencies in response to pressure variations in the air. When sections of the tympanic membrane becomes loose, the tension across the membrane is altered. The altered tension changes the vibration response of the tympanic membrane and hearing loss results.

Areas of the tympanic membrane or the entire membrane can be congenitally defective become or can become defective over time. Examples of defect areas are retraction pockets, depressions and loose areas. These defect areas can result from heredity, a puncture in the tympanic membrane, some surgical procedures, loud noises, or aging. Defect areas may shift the resonant frequency of the middle ear to a lower frequency and/or decrease efficiency of the middle ear structures, both of which can cause a hearing loss in the range of 1 .kHz to 6 kHz, which is a crucial one for the hearing of human voices.

Underlying the tympanic membrane is a collagen matrix layer. Collagen demonstrates unique characteristics not found in other tissues. A previously recognized property of collagen is shrinkage of collagen fibers when elevated in temperature. Collagen fibrils are at their greatest length in the native state of a triple helix. Thermal energy delivered to the collagen molecules disrupts the bonds which stabilize the triple helix. The loss of the triple helix structure causes the fibrils to decrease in length or contract, giving the collagen containing tissue the appearance of contracting. The degree of contraction is a function of both the height of temperature elevation as well as the length of temperature elevation. Thus, the same degree of contraction may be achieved by a high temperature elevation of short duration or by a lower temperature elevation for an extended duration. The presence of the collagen matrix layer in the tympanic membrane means chosen sections of the tympanic membrane may be contracted. For instance, applying energy to a chosen section of the tympanic membrane causes that section of the tympanic membrane to increase in temperature and correspondingly causes the underlying collagen matrix to also increase in temperature. A sufficient temperature increase causes at least a portion of the underlying collagen layer to contract and correspondingly causes at least a portion of the chosen section to contract. As a result, a chosen section of a tympanic membrane can be shrunk by delivering energy to that section of the tympanic membrane. Much of the hearing loss caused by defect areas could be restored by tightening the defect area. Tightening the tympanic membrane improves the pressure gain of the middle ear structures, particularly in the frequency range of 1 kHz to 6 kHz. This improvement may be caused by a shifting of the resonant frequency response of the tympanic membrane to a higher frequency and/or improvement in efficiency of the tympanic membrane. By shrinking the layer of collagen, the tympanic membrane can be tightened. Shrinking can be caused by rasing the temperature of the tympanic membrane so that thermal energy is transferred to the collagen layer causing the collagen layer to contract.

To achieve the best possible hearing recovery, the defect area should be tightened to maximize the uniformity of the tension across the defect area. The tension should be substantially uniform in order to restore the defect area to near its original condition. Tension uniformity is maximized when the forces on a defect area increase evenly at each point around the defect area. Prior investigators have attempted to tighten the tympanic membrane by using techniques which shrink a plurality of different spots around a defect area (Hennings et. al., U.S. Pat. No. 5,591,157 ). This technique creates a force on the defect area which originates from each spot. As a result the force on the defect area does not increase evenly around the defect area decreasing tension uniformity. An additional problem can arise when different spots contract different degrees. As a result each spot can create a different amount of force on the defect area further compromising tension uniformity. Further, this technique encourages cell necrosis. To achieve a high tension across the defect area, a high degree of contraction is required at the points. High degrees of contraction result from high sustained temperatures which cause cell necrosis. Thus, it is desirable to have a method and device which effects shrinkage of a band of tissue which at lest partially surrounds a section of a defect area while minimizing cell necrosis.

SUMMARY OF THE INVENTION It is an object of the present invention to provide a method and device configured to at least partially restore hearing by contracting at least a portion of a tympanic membrane.

Another object of the present invention is to provide a method and device configured to deliver sufficient energy along a band of tissue on a tympanic membrane to effect an increase in the temperature of the band.

Another object of the present invention is to provide a method and device configured to deliver sufficient energy along a band of tissue on a tympanic membrane to effect an increase in the temperature of the band while minimizing cell necrosis. Still another object of the present invention is to provide a method and device configured to deliver sufficient energy along a band of tissue on a tympanic membrane to effect a contraction of at least a portion of the band.

Still another object of the present invention is to provide a method and device configured to deliver sufficient energy along a band of tissue at least partially suirounding a section of a defect area on the tympanic membrane to increase the tension across the defect area.

Yet another object of the present invention is to provide a method and device configured to deliver sufficient energy along a band of tissue at least partially surrounding a section of a defect area on the tympanic membrane to effect an increase in the tension across the defect area such that the tension uniformity is maximized.

The above objects and others can be achieved with a device for tightening a defect area of a tympanic membrane. The device has an energy delivery device with dimensions which allow it to be maneuvered within an ear canal. The energy delivery device further has a proximal section and a distal section with an energy delivery surface. The energy delivery surface has a geometry configured such that at least a portion of the energy delivery surface delivers energy continuously along a band of tissue which has an at least partially surrounding relationship to a section of the defect area.

The invention also relates to a method for tightening a defect area of a tympanic membrane. A device is provided with a proximal section and a distal section having an energy delivery surface. Sufficient energy is delivered continuously along a band of tissue which at least partially surrounds a section of the defect area to produce a contraction within the band.

In one embodiment only a portion of the energy delivery surface delivers energy continuously along the band. The device is configured such that this portion of the energy delivery surface can be varied. The energy delivery surface can have a geometry configured to deliver energy along a band of tissue which partially or completely surrounds a section of the defect area. The energy delivery surface can also have a geometry configured to deliver energy along a band comprised of smaller semi-bands. The energy delivery device can have a lumen which encompasses at least one of a tension sensor, a cooling fluid and a viewing scope. The energy delivery device can be a composite construction where one material of the composite is the energy delivery surface. The energy delivery device can also have an insulative coating such that the sections of the energy delivery device which are not coated define the energy delivery surface.

DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective plan view of an embodiment of the present invention illustrating a device for contracting a tympanic membrane.

Figure 2A is a side view of a tympanic membrane within an ear canal.

Figure 2B illustrates an energy delivery surface configured to be adjacent to a band of tissue on a tympanic membrane.

Figure 3 A illustrates a defect area with a continuous band of tissue completely surrounding a defect area. Figure 3B illustrates the effect of shrinking the band of tissue on the tympanic membrane.

Figure 4A illustrates a band of tissue which has a surrounding relationship to the entire defect area.

Figure 4B illustrates a band of tissue which has a surrounding relationship to a section of the defect area.

Figure 4C illustrates a possible sequence of bands which may be treated when the defect area requires multiple treatments.

Figure 5 A illustrates a band of tissue with a partially surrounding relationship to the defect area. Figure 5B illustrates an energy delivery surface configured to be adjacent to the band of tissue in Figure 5 A. Figure 6A illustrates a band of tissue composed of smaller semi- bands.

Figure 6B illustrates an energy delivery surface configured to be adjacent to the band of tissue in Figure 6 A. Figure 7 A is a side view of a device where the portion of the energy delivery surface configured to be adjacent to the band of tissue is variable when the energy delivery surface is in the contracted position.

Figure 7B is a side view of a device where the portion of the energy delivery surface configured to be adjacent to the band of tissue is variable with the energy delivery surface in the expanded position.

Figure 7C is a side view of a device where the portion of the energy delivery surface configured to be adjacent to the band of tissue is variable with the energy surface in the expanded position and adjacent to a band of tissue. Figure 8 is a side view of the device where the portion of the energy delivery surface configured to be adjacent to the band of tissue is variable.

Figure 9 is a side view of a device with a tension sensing mechanism.

Figure 10 is a cross section of a device which has a lumen for transporting cooling fluids to the tympanic membrane.

Figure 11 is a cross section of a device with a lumen enclosing a viewing scope.

Figure 12 is a schematic illustrating an energy source coupled to the device. Figure 13 is a side view of the distal section of the device having a three part composite construction where a material which conducts the type of energy being transferred defines the energy delivery surface. Figure 14 is a side view of the distal section of the device having a composite construction where an insulator is placed between two materials which conduct the type of energy being transferred.

Figure 15A is a side view of a device where an insulative coating defines the energy delivery surface.

Figure 15B is a side view of a device where an insulative coating defines the energy delivery surface on a helix.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention relates to a device for tightening a defect area of a tympanic membrane. The device tightens the defect area such that the uniformity of the tension across the defect area is maximized while cell necrosis is minimized. The device delivers energy continuously along a band with an at least partially surrounding relationship to a section of the defect area. The delivery of energy to the band causes the band to contract. The contraction of the band causes the outward forces across the tympanic membrane to increase since the tympanic membrane is fixed to the ear canal. Because the band has an at least partially suixounding relationship to the defect area, the increased outward forces resulting from the shrinkage have an at least partially surrounding relationship to the defect area. As a result the uniformity of the tension increase across the defect area is maximized.

An embodiment of the device is shown in Figure 1. The device 10 includes a handpiece 12 that is preferably made of a thermal insulating material or an electrode that is electrically insulated. An energy delivery device 14 is coupled to handle 12 at a proximal section 16 of energy delivery device 14. A distal section 18 of the energy delivery device 14 includes an energy delivery surface 20 configured to deliver energy to a band of tissue on a tympanic membrane.

A tympanic membrane 22 within an ear canal 24 is illustrated in Figure 2A. A band of tissue 26 surrounds a defect area 30. Hearing loss can be caused by the presence of defect areas 30 on the membrane 22 which are loose or have a reduced tension. Sample defect areas 30 are retraction pockets, depressions or other types of loose areas. Defect areas 30 can be a small section of the membrane 22 or the entire membrane 22. Defect areas 30 can be found using a tension sensor, viewing scope, otoscope, operating microscope, vibrometer or the like.

Figure 2B illustrates the energy delivery surface 20 adjacent to the band 26 in order to deliver energy along the band 26. The band 26 absorbs at least a portion of the delivered energy and the temperature of the band 26 increases. As the temperature of the band 26 increases, thermal energy is conducted to the collagen fibers within the band 26. Collagen fibers exposed to sufficient thermal energy lose their triple helix shape. Since the triple helix shape of collagen fibers is the longest shape for collagen fibers, fibers which lose their triple helix shape will contract. Thus, the delivery of energy continuously along the band 26 causes the temperature and thermal energy content of the band 26 to increase and effects collagen fibre contractions within the band 26. The collagen fiber contraction effectively causes a contraction of the band 26.

The band 26 can have a surrounding relationship to a section of the defect area 30 as illustrated in Figure 3 A. Figure 3B illustrates how this band 26 geometry maximizes tension uniformity by showing the effects of shrinking the band 26 of Figure 3 A. The shrinking causes a reduction in the width of the band 26. Since the periphery of the tympanic membrane 22 is fixed, the shrinking of the band 26 causes increased forces in the direction of the illustrated arrows. These increased forces cause the increased tension across the defect area 30. Because the arrows are 360 degrees around the defect area 30, the tension uniformity across the defect area 30 is maximized. As discussed later, it is often not desirable for the band 26 to completely surround the defect area 30 due to the presence of tissues which may be damaged. As a result the, band 26 can also have a partially surrounding relationship to the defect area 30. Thus, the present invention maximizes tension uniformity by delivering energy continuously along the band 26 with an at least partially surrounding relationship to the defect area 30.

The energy delivery surface 20 can have a nearly even energy distribution across the energy delivery surface 20 which further maximizes tension uniformity. The even energy distribution encourages the band 26 to evenly absorb the energy which further encourages similar degrees of contraction along each point within the band 26. The similar degrees of contraction cause the outward forces on the defect area 30 to have similar magnitudes. As a result, uniform tension across the defect area 30 is even further encouraged.

The energy delivery surface 20 also has a geometry allowing it to be placed substantially concentric with the defect area 30. The energy delivery surface 20 being concentric with the defect area 30 further maximizes tension uniformity. This relationship encourages the forces resulting from the shrinking to be substantially centered within the defect area 30, further maximizing the tension uniformity. The geometry of energy delivery surface 20 further minimizes cell necrosis. The degree of collagen contraction is a function of the height of the temperature as well as the duration of the heat. When applying energy continuously along the band 26, a small degree of contraction at each point along the band 26 can cause a substantial increase in the tension across the defect area 30. To achieve the same increase in tension by heating a plurality non-continuous points around the defect area 30, the points must have a higher degree of contraction. As a result the temperature at the points must be increased to higher levels for longer times. High temperatures and extended exposures can cause cell necrosis. Since the band 26 reduces the need for high temperatures and extended exposures, cell necrosis is minimized.

In one embodiment the band 26 surround the entire defect area 30 as illustrated in Figure 4A. An embodiment with the energy delivery surface 20 illustrated in Figure 1 has a geometry configured to deliver energy continuously along the band 26 of Figure 4 A. This embodiment is especially useful when the defect area 30 is a retraction pocket. Retraction pockets are known to be missing the collagen matrix layer. As a result, applying heat within the pocket will not cause contractions and may ablate the tissue.

Figure 4B illustrates an embodiment where the band 26 has a surrounding relationship to only a section of the defect area 30. This arrangement is effective when the defect area 30 is adjacent to an obstruction such as the ear canal as illustrated in Figure 4B. This arrangement is also effective when a plurality of treatments must be performed to effectively tighten the defect area 30 as illustrated in Figure 4C. In another embodiment the band 26 has a partially surrounding relationship to the defect area 30 as illustrated in Figure 5A. An embodiment of the device with the energy delivery surface 20 illustrated in Figure 5B has a geometry configured to deliver energy continuously along the band of Figure 5 A. As a result, the energy delivery surface 20 has a horseshoe like shape similar to the band 26. This embodiment is advantageous when the band 26 partially sits over tissue which can be damaged as illustrated in Figure 5A. For instance, a defect area 30 can be partially located over the Malleus which lies on the inside of the membrane 22 as shown in Figure 2A. During a sustained treatment, heat may pass through the membrane 22 and damage the Malleus. As a result, the band 26 can have a partially surrounding relationship to the defect area 30 in order to minimize damage to surrounding tissues.

In another embodiment the band 26 has a partially surrounding relationship to the defect area 30 and the band 26 is comprised of a plurality of semi-bands 32 (Figure 6A). An embodiment with the energy delivery surface 20 illustrated in Figure 6B is comprised of semi-energy delivery surfaces 33. The energy delivery surface has a geometry configured to deliver energy continuously along the band 26 of Figure 6 A. This embodiment is most advantageous when the defect area 30 is located over tissues which can be damaged and which extend entirely under the defect area 30. For instance, in Figure 6 A the malleus extends under the entire width of the defect area 30. By dividing the band 26 into smaller selected semi-bands 32 the amount of energy which passes through to the damageable tissue is reduced.

In another embodiment the energy delivery surface 20 can be varied such that a portion of the energy delivery surface 20 has a geometry configured to deliver energy continuously along the band 26. As illustrated in Figure 7 A, the proximal section 16 of the energy delivery device 14 has a top 40 while the distal section 18 of the energy delivery device 14 is a helix 42 which can be expanded and compressed. The helix 42 contains the energy delivery surface 20. The energy delivery device 14 is partially enclosed within a shaft 34 of a cannula 36 having a cannula distal end 38. Before the shaft 34 is inserted into the ear canal 24, the helix 42 is compressed and completely enclosed within the shaft 34. Once the shaft 34 is inserted into the ear canal 24 and is near the membrane 22, pressure is applied to the top 40 causing the energy delivery device 14 to advance through the shaft 34. As the helix 42 passes the cannula distal end 38, the helix 42 begins to expand as shown in Figure 7B. As the helix 42 expands, the portion of the energy delivery surface 20 with a geometry configured to deliver energy along the band 26 also expands. As a result, the pressure on the top 40 is maintained until the portion of the energy delivery device 14 with a geometry configured to deliver energy continuously along the band 26 substantially matches the geometry of the band 26. As illustrated in Figure 7C, this embodiment is advantageous when the band 26 is larger than the ear canal 24 or is the entire tympanic membrane 22. The energy delivery device 14 is easily maneuvered through the ear canal with the helix

42 in the compressed state. Once the energy delivery device 14 is near the tympanic membrane 22 the helix is expanded so its diameter is greater than the diameter of the ear canal. The helix 42 can be expanded to the periphery of the tympanic membrane 22 in cases where the entire membrane 22 is the defect area 30.

In yet another embodiment, the portion of the energy delivery surface 20 with a geometry configured to deliver energy continuously along the band 26 is variable. As illustrated in Figure 8, the helix 42 is attached to the cannula distal end 38 at an attachment point 44. The energy delivery device 14 is free to rotate within the shaft 34. Because the helix 42 is fixed to the Canula distal end 38, the rotation of the energy delivery device 14 causes the circumference of the helix 42 to expand and contract. The expansion or contraction of the helix also causes the portion of energy delivery surface 20 configured to be adjacent to the defect area 30 to increase and decrease. As a result the energy delivery device 14 is rotated until the portion of energy delivery surface 20 with a geometry configured to deliver energy continuously along the band 26 matches the geometry of the band 26. Since the energy delivery surface 20 is easily and accurately varied, this embodiment is advantageous when a more than one 26 of different sizes needs to be treated as illustrated in Figure 4C.

In both of the above embodiments the helix can be flexible, this allows the helix 42 to conform to the membrane 22, thus, increasing the portion of energy delivery surface 20 which is actually in contact with the band 26.

Another embodiment includes a tension sensor 46 for measuring the tension of the defect area 30. As illustrated in Figure 9, the energy delivery device 14 has a lumen 44 which encloses a tension sensor 46. A number of tension sensors 46 are available such as a vibrometer. Most tension sensors 46 measure the frequency change of an incident and reflected wave. A large drop in the frequency indicates a loose tensions where a smaller drop indicates a higher tension. The drop in frequency can be determined with ultrasound, sonar and the like. The tension sensors 46 can be used to find the defect area 30 and can also be used during the treatment to determine when the proper tension level has been achieved in the defect area 30. Another embodiment can supply a cooling fluid to the membrane 22 as illustrated in Figure 10. The energy delivery device 14 has a lumen 50 which can have a fluid outlet 52. During operation of the device 10, the cooling fluid can be pumped through the lumen 50 to contact the membrane 22. If the energy delivery surface 20 is in contact with the band 26, the cooling fluid can become trapped within the lumen 50. However, if the fluid outlet 52 is present, the cooling fluid is can flow out of the lumen 50 to contact portions of the membrane 22 which are outside the band 26. This embodiment is advantageous because it helps to concentrate the delivered energy on the band 26. During an extended treatment it is possible for energy to be conducted away from the band 26 to other areas of the membrane 22 where it can cause stray collagen contractions. It is often desirable to limit collagen contractions to the band 26 in order to control the treatment, as a result, stray contractions can be undesirable. The presence of the cooling fluid can reduce these stray contractions by cooling sections of the membrane 22 which are not in contact with the energy delivery surface 20.

Figure 11 illustrates an embodiment including a viewing scope 53. Energy delivery device 14 can have a lumen 50 which includes a viewing scope 53. Viewing scope 53 provides a field of view 54, permitting the surgeon to view the membrane 22 while delivering energy continuously along the band 26 and tightening the defect area 30. Viewing scope 53 can include a bundle of light transmitting fibers and optical viewing elements. Alternatively, the surgeon can view the procedure under direct or otoscopic visualization. Fiber optics, an otoscopic video camera and the like may be used. Figure 12 illustrates an embodiment where energy is supplied from an energy source 56 through a cable 58 to energy delivery device 14. The amount of energy supplied to the energy delivery device 14 is adjustable at the energy source 56. Since several types of energy can cause an elevation in the temperature of a tympanic membranes 22, the type of energy delivered through energy delivery surface 20 can include but is not limited to RF, microwave, ultrasonic, coherent and incoherent light, thermal transfer, and resistive heating.

Energy delivery device 14 can be made of a number of different materials including but not limited to stainless steel, platinum, other noble metals and the like. Energy delivery device 14 can be made of a memory metal, such as nickel titanium, commercially available from Raychem Corporation, Menlo Park, California. Energy delivery device 14 can also be a composite construction whereby different sections are constructed from different materials.

Figure 13 illustrates an embodiment where energy delivery device 14 is a composite. The particular embodiment illustrated is a three piece composite. The energy delivery device 14 has two pieces made of a first material 60 which is conductive to the type of energy being delivered and another piece made of a second material 62 which is not conductive to the type of energy being delivered. The first material 60 defines the energy delivery surface 20. For instance, the embodiment of Figure 13 has a geometry configured deliver energy continuously along the band 26 of Figure 6B. If the type of energy being delivered was thermal energy from resistive heating, the first material 60 could be a resistive heater while the second material could be a thermal insulator made of a plastic. Each first material can have a pair of electrical contacts 64 and heat can be generated by connecting both pieces of the first material 60 in parallel and running a current through them as illustrated in Figure 13. If the two pieces of first material have similar sizes and resistances, the parallel connection will facilitate a substantially even energy distribution across the energy delivery surface 20. The substantially even energy distribution results because the flow of current through each piece will be similar yielding a similar thermal energy. AS described above, even energy distribution across the energy delivery surface 20 is desirable to encourage substantially even contractions along the band 26. In another embodiment, the energy delivery device 14 is a composite of a first material 66 and a second material 68 which are both conductive to the type of energy be delivered (Figure 14). An insulator 70 which is impermeable to the type of energy being delivered is disposed between the two materials. As a result, the energy delivered from the energy delivery surface 20 (the second material 68) does not pass through the insulator 70 into the first material 66. Thus, the insulator 70 defines the limits of the energy delivery surface 20. As a result the energy being delivered spreads out over the energy delivery surface 20 and is more likely to be evenly concentrated across the energy delivery surface 20. This is especially important when RF energy is being delivered since RF energy is .known to accumulate near points.

Figure 14 illustrates another embodiment where the energy delivery surface 20 is defined by an insulating coating. Distal section 18 of energy delivery device 14 includes an insulative coating 72 which is substantially impenetrable to the type of energy being delivered. Specifically, in the case of RF energy, an electrically insulative coating can be used and in the case of resistive heating a thermally insulative coating can be used. Insulative coating 72 can be formed on energy delivery device 14 to define the energy delivery surface 20 such that it is configured to be adjacent to the band 26. For instance, in Figure 15 the insulative coating is fomied to the energy delivery device 14 so that the energy delivery surface 20 has a geometry configured to deliver energy continuously along the band 26 of Figure 5 A.

The insulative coating 72 should be as even where the insulative coating 72 meets the energy delivery surface 20. If the insulative coating 72 is not even, some sections of the energy delivery device may deliver more energy to the band 26 than others. This may cause uneven distribution of contractions around the band 26 and may cause an uneven tension across the defect area 30 . Acceptable insulative coatings include, but are not limited to, thermoplastics with sufficient dielectric properties such as NyCor, PTFE, Polyamide.

The present invention also provides a method for tightening the defect area 30 of the tympanic membrane 22. The defect area 30 is tightened to a such that cell necrosis is minimized and the tension uniformity across the defect area is maximized.

The location of a defect area 30 is determined using a tension sensor, otoscope, viewing scope 51, operating microscope, vibrometer or the like. The severity of the defect and how much it needs to be tightened are determined. A band 26 of tissue is chosen for shrinkage. The band 26 has an at least partially surrounding relationship to a least a section of the defect area 30. The band 26 geometry has a partially surrounding relationship to reduce the amount of energy that can be transferred to damageable tissues. The band can also be located so that it is substantially concentric with the defect area in order to further maximize tension uniformity. As a result, the geometry and location of the band 26 maximizes the uniformity of tension across the membrane 22 while minimizing damage to any surrounding tissues.

The device 10 for shrinking the band 26 is supplied. The device 10 having an energy delivery device 14 including a proximal section 16 and a distal section 18 with an energy delivery surface 20 with a geometry configured to deliver energy continually along the band 26. The device 10 is maneuvered within the ear canal 24 until the energy delivery surface 20 is adjacent to the band 26.

Energy is delivered from the energy delivery surface 20 to the band 26 to effect a contraction in at least a portion of the band 26. The tightness of the defect area 30 can be monitored with a tension sensor, otoscope, viewing scope 51 , operating microscope, vibrometer or the like. Once the desired degree of tightness is created across the defect area 30, the delivery of energy to the band 26 is stopped. In another embodiment of the device 10 the portion of the energy delivery surface 20 configured to a adjacent to the band of tissue 26 is variable. As a result, the portion of the energy delivery surface 20 configured to be adjacent to the band 26 can be adjusted to match the band

26. This adjustment must occur before placing the portion of the energy delivery surface 20 configured to be adjacent to the band 26 adjacent to the band 26.

In embodiments of the method where the defect of the defect area 30 is substantial, a sequence of bands 26 may be treated as illustrated in Figure

4C. In each of the embodiments described above the energy delivery device 14 should be configured to be maneuverable within the ear canal 24.

The diameter of the energy delivery device 14 is preferably from 2mm to 6mm Further, the energy delivery device 14 can be coated with a lubricating material which allows the energy delivery device 14 to slide easily within the ear canal 24. Acceptable lubricants include K-Y Jelly. While embodiments and applications of this invention have been shown and described, it will be apparent to those skilled in the art that many more modifications and combinations than mentioned above are possible without departing from the invention concepts herein. The invention, therefore, is not to be restricted except in the spirit of the appended claims.

Claims

1. aAn device for tightening a defect area of a tympanic membrane, comprising: an energy delivery device including a proximal section and a distal section, the distal section having an energy delivery surface, the energy delivery device having dimensions which allow it to be maneuvered within an ear canal, the energy delivery surface having a geometry configured such that at least a portion of the energy delivery surface delivers energy continuously along a band of tissue which has an at least partially surrounding relationship to a section of the defect area.

2. The device of claim 1, wherein the band of tissue completely surrounds a section of the defect area.

3. The device of claim 2, wherein the section of the defect area is the entire defect area.

4. The device of claim 1, wherein the band of tissue partially surrounds a section of the defect area.

5. The device of claim 4, wherein the section of the defect area is the entire defect area.

6. The device of claim 1, wherein the band of tissue is comprised of a plurality of semi-bands which partially surround the defect area.

7. The device of claim 6, wherein the section of the defect area is the entire defect area.

8. The device of claim 1, wherein the portion of the energy delivery surface which delivers energy continuously along the band of tissue is the entire energy delivery surface.

9. The device of claim 1, wherein the energy delivery surface has a geometry to minimize cell necrosis.

10. The device of claim 1, wherein the band is substantially concentric with the defect area.

11. The device of claim 1 , wherein the portion of the energy delivery surface which delivers energy continuously along the band of tissue is variable.

12. The device of claim 11 , wherein the portion of the energy delivery surface which delivers energy continuously along the band of tissue is variable after the energy delivery device has been inserted into an ear canal.

13. The device of claim 11 , wherein the portion of the energy delivery surface which delivers energy continuously along the band of tissue can be expanded to the periphery of an ear canal.

14. The device of claim 1, wherein the distal section of the energy delivery device is substantially helix shaped.

15. The device of claim 1, further comprising: a handle coupled to the proximal section of the energy delivery device.

16. The device of claim 1, wherein the energy delivery device has a lumen containing a tension sensor configured to be placed adjacent to the defect area and to detect a tension of the defect area.

17. The device of claim 1, wherein the energy delivery device has a lumen, the lumen configured to deliver a cooling fluid to the tympanic membrane.

18. The device of claim 17, wherein the lumen has a fluid outlet configured to allow the cooling fluid to exit the lumen when the energy delivery surface is in contact with the band of tissue.

19. The device of claim 1, wherein the energy delivery device has a lumen, the lumen containing a viewing scope configured to allow observation of the defect area during treatment.

20. The device of claim 1, wherein the energy delivery device is an RF energy delivery device coupled to an RF energy source.

21. The device of claim 1 , wherein the energy delivery device is a resistive heating element coupled to a resistive heating source.

22. The device of claim 1, wherein the energy delivery device is a microwave probe coupled to a microwave source.

23. The device of claim 1 wherein the energy delivery device is a composite construction, the composite being at least one first material coupled to a second material, the first material conducting a type of energy being delivered, the second material being minimally conductive to the type of energy being delivered.

24. The device of claim 1 wherein the energy delivery device is a composite construction, the composite being a first material coupled to an insulator, the insulator coupled to a second material which is minimally conductive to a type of energy being delivered and the second material conducting the type of energy being delivered.

25. The device of claim 24. wherein the insulator is an electric insulator.

26. The device of claim 24, wherein the insulator is a thermal insulator.

27. The device of claim 1 wherein at least a portion of an exterior of the energy delivery device has an insulative coating, the insulative coating being minimally conductive to a type of energy being delivered and configured to define the energy delivery surface.

28. The device of claim 27, wherein the insulative coating is a thermally insulative coating.

29. The device of claim 27, wherein the insulative coting is an electrically insulative coating.

30. The device of claim 1, wherein the energy delivery device has a lubricating coating which allows the energy delivery device to be easily maneuvered within the ear canal.

31. A method for tightening a defect area of a tympanic membrane comprising: providing a device including an energy delivery device with proximal section and a distal section having an energy delivery surface; delivering sufficient energy continuously along a band of tissue which at least partially surrounds a section of the defect area to produce a contraction within the band.

32. The method of claim 31, wherein the band of tissue is substantially concentric with the defect area.

33. The method of claim 31 , wherein the band of tissue completely surrounds a section of the defect area.

34. The method of claim 33, wherein the section of the defect area is the entire defect area.

35. The method of claim 31 , wherein the band of tissue partially surrounds a section of the defect area.

36. The method of claim 35, wherein the section of the defect area is the entire defect area.

37. The method of claim 31 , wherein the band of tissue is comprised of a plurality of semi-bands which partially surround the defect area.

38. The method of claim 37, wherein the section of the defect area is the entire defect area.

39. The method of claim 31 , wherein the delivery of sufficient energy to the band minimizes cell necrosis.

40. The method of claim 31 , wherein the delivery of sufficient energy to the band eliminates cell necrosis.

41. The method of claim 31 further comprising the step of monitoring the tension across the membrane.

42. The method of claim 31 , wherein the contraction within the band increase a tension of the defect area.

43. The method of claim 31 , wherein the contraction within the band effect a desired level of tension of the defect area.

44. The method of claim 31 , wherein the delivery of sufficient energy effects a rise in the temperature of the to a desired temperature.

45. The method of claim 45 , wherein the desired temperature is about X-Y.

46. The method of claim 45, wherein the desired temperature is about X-Y.