A tympanic membrane treatment device

Abstract

A treatment device (1) having a stem (3) with a distal end (60) configured to be inserted into a patient's ear canal, locked to the eardrum by suction so that there is no relative movement regardless of whether the patient's head moves. After suction is applied by negative pressure through a cavity (66), a needle (63) pierces the membrane. The needle tip is located within a suction cup that grips the membrane. A hand-held control device (2) for coupling to the stem and having a user-actuated controller (8) for controlling the application of negative pressure (7) to the suction cavity.

Description

TECHNICAL FIELD

[0001] The present invention relates to the treatment of the eardrum or "tympanic membrane" of a patient. The main field of the invention is the intratympanic delivery of a drug to the middle ear. Other fields of the invention include, but are not limited to, the deployment of a tympanostomy tube (or "grommet") or the aspiration of fluid from the middle ear. BACKGROUND

[0002] The ear is affected by a variety of conditions or diseases for which therapeutic delivery of a drug to the middle ear is required. One example is Ménière's disease, a chronic condition characterized by acute attacks of vertigo, tinnitus, fluctuating hearing loss, and aural fullness. Another example is tinnitus, which is often described as a ringing in the ear, but can also sound like a roar, click, hiss, or hum. People with severe tinnitus can have difficulty with hearing, work, and sleep. Another example is Otitis Media, which often leads to a demand for antibiotics.

[0003] The ear is particularly sensitive to invasive treatments involving the eardrum, because the eardrum is very thin and easily damaged, especially as the patient moves his or her head during the treatment. This problem is particularly acute in the case of children.

[0004] It is an object of the present invention to achieve an effective, safe and repeatable treatment at or near the eardrum, with or without delivery of fluid or devices. SUMMARY

[0005] We describe a treatment device as recited in the appended claims.

[0006] Furthermore, we describe a treatment device comprising:

[0007] a shaft having a distal end configured for insertion into the ear canal of a patient, the shaft comprising:

[0008] a cavity for applying suction and having a suction source or a coupling for connecting to a suction source at its proximal end,

[0009] a needle having a tip configured for puncturing the eardrum, and

[0010] a suction cup in which the needle tip is located, the suction cup being coupled to the cavity and configured for engaging the eardrum and grasping the membrane by suction.

[0011] Preferably, the device further comprises a hand-held control device for coupling to the shaft and having a user-actuated controller for controlling the application of negative pressure to the suction cavity. Preferably, the needle is mounted at an acute angle to the longitudinal axis of the shaft.

[0012] Preferably, the distal tip of the stem comprises a support cup and a needle. Preferably, the support cup comprises a conduit for receiving the cavity and is surrounded by a flexible sleeve that holds the support cup in place. Preferably, the flexible sleeve is integrally formed with the cup. Preferably, the flexible sleeve is a silicone (or similar flexible material) overmold.

[0013] Preferably, the hand-held control device comprises a housing for coupling to the stem and a handle with a trigger button for user actuation. Preferably, the hand-held control device comprises a coupler for connecting to a suction source.

[0014] Preferably, the stem comprises a cavity coupled with the needle for delivering a therapeutic fluid, the cavity having a coupler at its proximal end for connecting to a fluid source, the needle being configured for piercing the eardrum and for delivering the therapeutic fluid through the needle.

[0015] Preferably, the device comprises a housing comprising a syringe pusher for mounting a syringe, the syringe having a therapeutic fluid in fluid communication with the delivery cavity.

[0016] In one example, the needle and the cup are movable relative to each other to pierce the eardrum and withdraw from the eardrum.

[0017] Preferably, the needle is fixed and the cup is retractable relative to the needle in a manner that ensures piercing by the needle. Preferably, the cup is mounted on a sleeve that is retractable relative to the needle. Preferably, the sleeve comprises a tension cable operably connected to a controller.

[0018] Preferably, the needle is arranged for delivering a tympanostomy tube across the membrane and retracting to leave the tube in place deployed in the membrane. BRIEF DESCRIPTION OF DRAWINGS

[0019] The present application will become more clearly understood from the following description of some embodiments thereof that are given, by way of example only, with reference to the accompanying drawings in which:

[0020] Figure 1 is a perspective view of a therapeutic device for delivering a medicament into an ear distal of the eardrum;

[0021] Figure 2 is a perspective view of a stem of the device;

[0022] Figure 3 is a perspective view of a distal tip of the stem;

[0023] Figure 4 and Figure 5 is a side view and a side cutaway view of the distal tip;

[0024] Figure 6is a view of the alternative device;

[0025] Figure 7 and 8 is a side cross-sectional view showing in more detail the distal tip of the other rod; and

[0026] Figure 9 is a magnified perspective view of the distal tip of the alternative rod. DETAILED DESCRIPTION

[0027] In various examples we describe a treatment delivery device which in use locks onto the tympanic membrane and pierces it for therapeutic purposes so that even with any patient head movement the tip of the rod does not move relative to the membrane. Once such a lock exists, an operation is performed, in one example drug delivery through the membrane and in another example deployment of a tympanostomy tube.

[0028] Advantageously the suction action ensures that the needle is in the optimum position and does not move during the performance of the operation, for example drug delivery or tympanostomy tube placement.

[0029] Device 1

[0030] With reference to Figure 1 discloses a device 1 for delivering a therapeutic fluid into an ear. The device 1 comprises a hand-held housing 2 and a rod 3 of flexible construction. The rod is long and pliable so that it has low 'pushability' and will accommodate unexpected patient movement. That is, if the rod is introduced into the ear canal and the physician pushes it forward so that the distal tip contacts the tympanic membrane (or any solid structure), then due to the flexible nature of the rod, the rod will collapse under the pushing force. Furthermore, if the distal tip is attached to the patient's tympanic membrane, then the rod will accommodate any unexpected movement of the patient.

[0031] The housing 2 has a handle 5 and a main body 6 containing control mechanisms. The handle 5 has a coupling 7 to couple with an external suction source and a control button 8. Within the housing 2 there is a pressure control valve to prevent excessive pressure being applied to the ear canal by the device 1 in use, even if there is an error in the pressure delivered to the coupling 7.

[0032] The housing main body 6 includes a syringe pusher 10 having a spring-loaded push member 11 arranged to push a piston 12 of a syringe 13.

[0033] The button 8 includes a lower button 15 for applying suction when coupled to an external source and an upper button 16 for drug delivery when a syringe is inserted.

[0034] With reference to Figures 2 to 5The stem 3 has a main section 50, a distal tip 60 and a proximal coupler 80 with a luer connector that is connected to the housing 6 during manufacturing assembly.

[0035] The tip 60 has a suction cup 61 with a diameter of about 3 mm and an angle of about 45° between the cup and the sidewall on the distal side (stem longitudinal axis), and this angle is generally preferably in the range of 20° to 90°; and has an outer sleeve 62 or tubular structure of the stem leading to the suction cup 61. The angle of the suction cup 61 matches the acute angle in which the ear drum is positioned relative to the ear canal. This angle can be particularly acute / severe in pediatric patients.

[0036] Within the stem, there is a delivery lumen 65 for delivery of therapeutic fluid, and an aspiration lumen 66. The needle 63 forms a continuation of the delivery lumen 65, being embedded in a plastic bushing 67 at its proximal end.

[0037] The bushing 67 forms a conduit 68, which is a distal continuation of the aspiration lumen 66, and the conduit 68 terminates distally in a mouth 69 that flares in the suction cup 61.

[0038] As Figure 5 most clearly shown in the example, the outer sleeve 62 comprises an overmolded flexible silicone (medical grade) or similar material that encases the outer multi-lumen liner 70 of the stem and the bushing 67, and that itself forms the suction cup 61 in an integral manner.

[0039] As Figure 5 shown, there is a gap, denoted by delta, between the end of the needle and the plane formed by the distal edge of the cup 61. Thus, the needle 63 does not protrude beyond the outer edge of the suction cup 61, ensuring that the needle does not inadvertently puncture vital structures during placement or removal of the device. Thus, the needle only punctures when suction is applied - otherwise the needle is effectively wrapped within the suction cup.

[0040] The tubular inner liner 70 is made of a flexible silicone material (or in other examples a suitable medical grade flexible material such as a thermoplastic elastomer, "TPE") to ensure minimal risk of injury when the stem distal tip 60 is inserted into the ear canal. However, the silicone overmold 62 is particularly pliable, and effectively contains the bushing 67, needle 63, and lumens 65 and 66 distal ends in a manner that ensures optimal support and flexibility in use of these components.

[0041] Use of device 1

[0042] The physician connects the coupler 7 to an external suction source. The syringe pusher 10 is pulled back (spring loaded and button activated) and a standard syringe is installed into the handpiece housing 6 through the standard luer fitting on the handpiece (fitting 80). The medication line is purged by pressing the upper button 16 before use. The distal end 60 is placed in the patient's ear canal, - the tube 50 (double lumen) is soft so that it will not damage the eardrum or structures of the ear (ossicles) due to the push of the flexible rod 3 which collapses under this push force. The physician visualizes the depth or location where they are trying to deliver the medication to the tympanic membrane, preferably the anterior inferior quadrant, but due to the flexible nature of the distal end 60 and the short penetration depth of the needle 63, they can not need to specify the location where the distal end 60 is suctioned onto the tympanic membrane. Once the suction cup 61 is at the eardrum, the surgeon pushes the lower button 15 to apply suction (very low negative pressure) at the tip to grasp the tympanic membrane. The suction cup 61 locks onto the eardrum. During the locking, the needle 63 pierces the membrane of the eardrum (eardrum thickness: typically 0.05mm to 0.20mm). This piercing method will ensure that the needle 63 only penetrates to a set depth and that this depth is not so great that it can contact important structures behind the tympanic membrane, such as the ossicles or the middle ear wall containing the facial nerve. The negative suction pressure is what causes the device tip 60 to lock and pierce the tympanic membrane, however, if the device locks onto other structures such as the ear canal wall or the ossicles, there will not be enough suction force to penetrate these more rigid structures.

[0043] Once the tympanic membrane is locked and pierced, the surgeon presses the upper button 16 to administer the medication. Once finished, the physician releases the suction button 16 which opens the suction line to atmospheric pressure (or positive pressure) to unlock the suction cup. The rod 3 is removed from the patient's ear canal.

[0044] Device 200

[0045] Reference Figures 6 to 8 The alternative device 200 includes a hand control 201 and a rod 202 having a distal tip 203. The control 201 includes a handle 205 having a coupler 220 for coupling to a suction source, a trigger button 207 for applying suction, and a trigger button 208 for medication delivery. In addition, there is a trigger button 209 for user activated manipulation of the tip 203, as described in more detail below. The control 201 also includes a syringe pusher 220, as described for the device 1.

[0046] As Figure 7 and 8Most clearly shown, the shaft 202 comprises a suction channel or cavity 250 which terminates in a mouth 251 within the suction cup 252. The needle 260 extends parallel to the shaft longitudinal axis and as a more rigid cavity than the surrounding part of the shaft extends proximally for the entire length of the shaft, back to the controller 201. The needle is fixed in place and cannot move. The needle has a tip 261 configured for piercing the eardrum. In this example, the needle and the length of tube extending proximally from the needle is 300mm, long enough for the required rigidity for piercing but not so long as to provide too much push force.

[0047] The shaft 202 comprises a tubular structure 265 made of a flexible medical grade silicone material (or other suitable flexible material such as TPE) which terminates distally as the suction cup 252. There are a number of tension cables 266 and 267 which extend longitudinally through the structure 265, terminating in the vicinity of the suction cup 252.

[0048] Advantageously, there is a simultaneous action of gripping the eardrum without risk of damage, whilst delivering the drug through the needle 63 to the distal side of the membrane. The suction action ensures that the needle is in the optimum position and does not move during drug delivery.

[0049] Other advantages are that the user can see the placement of the suction cup 252 to ensure correct position and can push the trigger 209 once the physician is satisfied with the deployment.

[0050] In this case, the distal edge of the suction cup is at right angles to the longitudinal axis, however in other examples it is at an acute angle to this axis distally of the cut-out, as is the case with device 1.

[0051] Use of device 200

[0052] In use, as described for device 1, the shaft is inserted into the ear canal and suction is applied by the user pressing the button 207 to grip the eardrum. Then, with actuation of the trigger 209, the user causes the tubular structure 265 to exit relative to the needle 260 (by using the cables 266 and 267) so that the tubular structure is compressed in the rightward direction, forming Figure 7 the position shown to Figure 8 the position shown. Alternatively, the cables 266 and 267 hold the length of the flexible shaft 202 and the needle 261 moves relative to 251. This has the effect of making the needle relatively protruding, as Figure 8 shown. At this stage, the user actuates delivery of the treatment fluid through the needle 260 by pushing the button 208, whilst the needle passes through the eardrum as the eardrum is gripped by the suction cup 252.

[0053] Once delivery is complete, the tension is gradually released from the cables 266 and 267 so that the needle moves proximally relative to the suction cup, disengaging from the membrane.

[0054] For either of the devices 1 and 200, any of a variety of therapeutic fluids can be delivered, examples of such medications are listed in the table below. Note: the medications delivered to the middle ear are not limited to those in this table, they are mentioned by way of example only.

[0055]

[0056]

[0057] Alternative device

[0058] The device of the present invention is locked to the tympanic membrane by suction, such that the position of the distal rod tip remains fixed relative to the membrane, regardless of whether the patient’s head can move. In addition, the distal tip pierces the membrane. In the exemplary devices 1 and 200, a therapeutic fluid is delivered through the pierced membrane. In other examples, however, a different therapy can be performed. One example is suction in a special case where broad spectrum antibiotics are not appropriate, in a location with suction of infectious liquid from the middle ear.

[0059] In another example, a tympanostomy tube is deployed in a manner known in the art, for example as described in WO2014 / 075949 and WO2019 / 086608. Such a device will have a suction cavity and disc for locking to the membrane. The rod also includes a deployment needle which, in addition to piercing the membrane, carries a tube with a distal flange which is opened when it is distal to the membrane. In addition to tube deployment, such a needle can also perform a preliminary membrane piercing. The distal tube flange can be opened by being released by the holder to assume a default shape, or the tube can be deformed by pulling through the needle.

[0060] If the former arrangement, the device can include a pre-loaded tympanostomy tube comprising a proximal flange, an inter-cavity connector, and a distal flange, and wherein the proximal flange comprises a passage; and wherein in a pre-deployment position, the device holder fingers extend through the proximal flange passage and press the tube distal flange inwardly. In such an arrangement, the device can have a rod connected to a deployment mechanism or have a coupler for connection to a deployment mechanism; the needle has a tip for piercing the tympanic membrane, the needle has a longitudinal axis; and the holder has a plurality of fingers extending axially at a distance from said longitudinal axis; and the holder is movable from a pre-deployment distal position, in which the holder is adapted to press against the tube distal flange radially inwardly to hold said distal flange in a folded position, to a deployment proximal position, at which the tube distal flange is free to radially pop out to a deployed position. Preferably, there are at least two diametrically opposed holder fingers, and preferably said fingers have an arcuate cross-sectional shape with a concave inner surface.

[0061] Device 300

[0062] With reference to Figure 9 In another example, the stem 300 extends from a housing as described in any of the above embodiments. The stem 300 has an outer tubular structure 302 which terminates at its distal end in a suction cup 301 and a needle 303, similar to needle 63 and having the same purpose, at the end of the cavity. In this case, a second needle 320 is provided and it has no cavity. However, it communicates with the electronic circuit within the handpiece through a wire connection within the stem wall 302. The needle 303 also has a wire connection to this electronic board. During use, both needles pierce the tissue of the site when the device is aspirating. The circuit applies an electrical drive across both needles 303 and 320 and measures a parameter such as impedance or capacitance. The circuit within the handle of the device has an interface to an output device such as an LCD screen or LED light. The circuit is also coupled with a sensor to measure the pressure within the suction line leading to the cup 301. With these two inputs, the circuit produces an output to inform the user whether the drug can be administered to the correct location. That is, if the pressure within the suction line increases, i.e. the device sucks or attaches to the target site, then the device will subsequently measure the capacitance / impedance between the two needles. If this measurement is greater than a threshold value, then the circuit can distinguish whether the user has attached on the eardrum or on the ear canal wall. The circuit will show the user a pass or fail decision on whether to administer the drug by pressing the trigger button or to unlock from the suction and reposition the device.

[0063] In an alternative embodiment, the two electrodes required to measure the capacitance or impedance are located within a single needle coupled to the circuit by a cable, such as a coaxial insulated cable.

[0064] One major advantage of this embodiment is that the physician can use it without visualisation aids such as surgical microscope / otoscope and can be sure to deliver the drug accurately to the correct location.

[0065] The invention is not limited to the described embodiments, but can vary in structure and details. For example, in another example, the sleeve does not retract but the needle protrudes to achieve the relative longitudinal motion. Furthermore, as mentioned above, when the components have elasticity and flexibility, they can be of any suitable medical grade material such as TPE.

Claims

1. A treatment device, comprising: An ear canal rod (3) having a distal end (60) for insertion into a patient's ear canal, the rod comprising: A suction chamber (66) for applying suction, and having a suction source or a connector for connecting to the suction source at its proximal end. A delivery chamber (65) for delivering therapeutic fluid, and having a connector at its proximal end for connection to a fluid source. A needle having an end for piercing the tympanic membrane, wherein the needle is coupled to the delivery cavity (65) and configured for piercing the tympanic membrane and for delivering therapeutic fluid. A suction cup, the end of which is located within the suction cup, the suction cup being connected to the suction cavity and configured to engage the tympanic membrane and grasp it through suction. A bushing (67) is located at the distal end (60) of the rod and supports the suction cup and the needle. The bushing includes a conduit for receiving the suction cavity and is surrounded by a flexible sleeve that holds the bushing in place.

2. The apparatus according to claim 1, characterized in that, The device also includes a handheld control unit for attachment to the rod and having a user-actuated controller (8) for controlling the application of negative pressure to the suction chamber.

3. The apparatus according to claim 1 or 2, characterized in that, The needle is mounted at an acute angle to the longitudinal axis of the rod.

4. The apparatus according to claim 1, characterized in that, The flexible sleeve integrally forms the suction cup.

5. The apparatus according to claim 1 or 4, characterized in that, The flexible sleeve has a silicone resin coated structure.

6. The apparatus according to claim 2, characterized in that, The handheld control device includes a housing for attachment to the rod and a handle with a trigger button for user actuation.

7. The apparatus according to claim 2, characterized in that, The handheld control device includes a connector (7) for connecting to the suction source.

8. The apparatus according to claim 1 or 2, characterized in that, The device includes a housing that includes a syringe pusher (11) for mounting a syringe, the syringe having therapeutic fluid being in fluid communication with the delivery cavity.

9. The apparatus according to claim 1 or 2, characterized in that, The needle and the suction cup are movable relative to each other for piercing and withdrawing from the tympanic membrane.

10. The apparatus according to claim 9, characterized in that, The needle is fixed, and the suction cup ensures that the needle can be retracted relative to the needle in the manner in which it is pierced.

11. The apparatus according to claim 10, characterized in that, The suction cup is mounted on or integrated with the sleeve, and the sleeve is retractable relative to the needle.

12. The apparatus according to claim 11, characterized in that, The sleeve includes tension cables (266, 267) that are operatively connectable to a controller.

13. The apparatus according to claim 1 or 2, characterized in that, The needle is arranged to deliver a tympanic membrane perforation tube across the membrane and retracts to leave the tube in place within the membrane.

14. The apparatus according to claim 1 or 2, characterized in that, The rod also includes a plurality of sensor electrodes at the distal end, and the device further includes circuitry for applying a drive signal to the electrodes and sensor circuitry for monitoring at least one electrical parameter to determine whether the electrode is in contact with the tympanic membrane or the ear canal, and generating an output to indicate at an output device whether the electrode is in contact with the tympanic membrane.

15. The apparatus according to claim 14, characterized in that, One of the electrodes is the needle.

16. The apparatus according to claim 15, characterized in that, One of the plurality of electrodes is a cavityless needle (320) spaced apart from the needle.

17. The apparatus according to claim 1 or 2, characterized in that, The device further includes a handheld control unit for connection to the rod and having a user-actuated controller (8) for controlling the application of negative pressure to the suction chamber, wherein an output device is mounted to the handheld control unit.

18. The apparatus according to claim 1 or 2, characterized in that, Before applying suction, there is a gap along the longitudinal direction of the rod between the distal end of the needle and the plane formed by the distal edge of the suction cup.

19. The apparatus according to claim 1 or 2, characterized in that, The distal edge of the suction cup defines a plane at an acute angle relative to the longitudinal axis.

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