Systems for anesthetizing ear tissue
17 claims: 2 independent, 15 dependent
- 1イオントフォレシス物質をヒト又は動物患者の耳の鼓膜に送達するためのシステムであって、 イヤープラグであって、 可撓性シール要素から近位に延びている細長い管を含む可撓性シール要素であって、前記可撓性シール要素が、複数の微小孔を有する遠位シール表面を有し、前記微小孔が、圧力閾値を超えたら流体を排出するように構成されている、可撓性シール要素を含む、イヤープラグと、 前記細長い管 内で移動可能な電極装置であって、電極先端部に連結された細長いシャフトを含む電極装置と、 を含 み、 前記電極装置は、前記電極先端部が前記細長い管内の比較的近位位置にあり、流体が前記電極装置の周りを通って、前記細長い管内を通過できる第1の位置、及び、前記電極先端部が前記細長い管内の比較的遠位位置にあり、前記電極先端部が前記細長い管の内面と接触しており、流体が前記細長い管内を通過できない第2の位置の間で移動できる、 システム。
- 2前記微小孔が、静水条件下では前記流体を排出しないように構成されている、請求項1に記載のシステム。
- 3前記可撓性シール要素が内部プレナムを含み、前記微小孔が前記内部プレナムに流体連結している、請求項1に記載のシステム。
- 4前記内部プレナムが、前記細長い管の排出チャネルに流体連結されている、請求項3に記載のシステム。
- 5前記細長い管が、細長い内管の上に細長い外管を含み、それらの間に前記排出チャネルが配置されている、請求項4に記載のシステム。
- 6前記細長い管が、前記細長い管に一体化された少なくとも1つの電極を含み、前記少なくとも1つの電極が、前記電極先端部と電気的に接続可能である、請求項1に記載のシステム。
- 7前記電極が、円筒形ケージとして形成された導線を含む、請求項6に記載のシステム。
- 8前記円筒形ケージがコイルを含む、請求項7に記載のシステム。
- 9前記円筒形ケージが、軸方向に配列された複数のループを含む、請求項7に記載のシステム。
- 10前記円筒形ケージが、前記電極先端部を圧縮するように構成されている、請求項7に記載のシステム。
- 11前記可撓性シール要素が傘状の形状をしている、請求項1に記載のシステム。
- 12第2のイヤープラグ及び第2の電極装置を更に含み、前記第2のイヤープラグが前記イヤープラグと、前記第2の電極装置が前記電極装置と同一に構成されている、請求項1に記載のシステム。
- 13前記イヤープラグと前記第2のイヤープラグとを連結するヘッドセットを更に含む、請求項12に記載のシステム。
- 14前記ヘッドセットが、左及び右イヤーフックに連結されたネックループを含み、前記左及び右イヤーフックがそれぞれ、耳甲介の後ろを包むように構成されている、請求項13に記載のシステム。
- 15前記左イヤーフックが前記患者の左側頭骨上に、前記右イヤーフックが前記患者の右側頭骨上に、前記ネックループからの圧縮力を印加するように構成されている、請求項14に記載のシステム。
- 16前記ヘッドセットが、左低圧力流体チャネル及び右低圧力流体チャネルを更に含み、前記左低圧力流体チャネルが前記イヤープラグの内管に、前記右低圧力流体チャネルが前記第2のイヤープラグの内管に流体連結されている、請求項14に記載のシステム。
- 17前記ヘッドセットが、ばね式左スイングアーム及びばね式右スイングアームを更に含み、前記ばね式左スイングアームが前記左イヤーフックに、前記ばね式右スイングアームが前記右イヤーフックに、旋回する形で連結されているとともに、前記ばね式左スイングアームが前記イヤープラグに、前記ばね式右スイングアームが前記第2のイヤープラグに連結している、請求項14に記載のシステム。
Independent claims17
77 paragraphs, as filed
(Cross-reference of related applications) This application is a partial continuation of U.S. Patent Application No. 12 / 510,217 filed on July 27, 2009, and this patent application is U.S. Patent Application No. 12 filed on July 31, 2008. It claims the benefits under 61 / 085,360, which is incorporated herein by reference in its entirety.
(Field of invention) The present invention relates to drug delivery methods and systems by iontophoresis. The present invention specifically relates to novel and useful iontophoresis drug delivery methods and systems for anesthetizing ear tissue.
Iontophoresis is a method for delivering a drug through the skin or, in the case of certain ear surgery, a biofilm such as the eardrum (TM). By applying a low level of current to a similarly charged drug solution, iontophoresis repels the ions of the drug, which are transported through the skin or other membranes. In ear surgery, attempts are made to anesthetize (ie, "paralyze") the eardrum using iontophoresis prior to placing ear tubes through the eardrum to treat chronic ear infections. It has been done in the past. In tympanic membrane iontophoresis, a drug solution is put into the ear canal, and an anesthetic is permeated through the tympanic membrane and transported by passing an electric current through an electrode to the solution.
Conventional iontophoresis devices and systems have limited success rates and have not been available for all patients. Patients need to lie down and tilt their heads while performing the iontophoresis method, as conventional devices generally do not seal the drug solution into the ear canal. With the currently available iontophoresis method, the patient does not move much for 5 to 15 minutes in this lying and tilted position while the iontophoresis method provides sufficient anesthesia to the eardrum. This is especially difficult for children. Moreover, with currently available systems, only one ear can be anesthetized at a time, and anesthetizing the eardrums of a patient's ears with iontophoresis is relatively time consuming and burdensome. It's a big process.
Attempts have been made to administer the iontophoresis fluid to the eardrum using earplugs designed to retain the iontophoresis fluid in the ear canal. See, for example, US Pat. No. 5,674,196 issued by Donaldson et al. However, earplugs such as those described in Donaldson's patent, and other currently available earplugs, have many drawbacks. For example, most earplugs are designed to keep liquid out of the ear canal rather than holding it inside the ear canal. The earplugs mentioned above that are currently available generally do not match the curved anatomy of the ear canal well and therefore do not form a good seal on the ear canal of at least some (and in some cases all) patients. .. Therefore, current earplugs usually leak fluid from the ear, making it difficult, if not impossible, to deliver anesthetics by iontophoresis in patients in an upright position. Further, the ear plug device described above used in iontophoresis does not solve problems such as foaming in the chemical solution for iontophoresis, which may interfere with the contact between the iontophoresis electrode and the solution.
<p num="0006"> Therefore, it would be beneficial to provide improved devices and systems for administering iontophoresis to the eardrum. Ideally, such devices and systems can administer iontophoresis anesthesia to patients in an upright position. Ideally, such devices and systems would promote bilateral simultaneous tympanic membrane iontophoresis. At least some of these objects are achieved by embodiments of the present invention.</p>
<p num="0007"> In one aspect of the invention, the iontophoresis system for anesthetizing the eardrum of a patient's ear may include an earplug, at least one flexible sealing element, and an electrode device. The earplugs may include a distal part, a proximal part, a tube connecting the distal part and the proximal part, and a side outlet located in the tube or the proximal part. The tube may have a lower relative hardness than the distal and proximal, and this low relative hardness allows the tube to match the curvature of the ear canal. The flexible seal element may be coupled to the tube of the earplug and may be shaped to form a seal inside the ear canal. The electrode may include an electrode tip and an elongated shaft and may be slidably placed in the tube of the earplug, which fits into the distal portion and It is the size that slides in the tube.</p><p num="0008"> In one embodiment, the earplugs may include side vents that communicate fluidly with the tubing to allow air and / or liquid to escape from the tubing. In one embodiment, the distal portion has higher rigidity than the tube. In one embodiment, the distal portion may include an O-ring that seals against the electrode tip of the electrode device in the forward position. In one embodiment, the outer diameter of the electrode tip may be larger than the inner diameter of the O-ring, and the flexibility of the O-ring allows the electrode tip to pass through the O-ring to form a seal. It is possible. In one embodiment, the proximal portion may be rigid. In one embodiment, the proximal portion may include a luer fitting portion. In one embodiment, the at least one flexible sealing element may have an umbrella-like shape with the open end of the sealing element facing the proximal end of the earplug. In one embodiment, the at least one flexible sealing element may include a distal sealing element and a proximal sealing element, the diameter of the proximal sealing element being greater than the diameter of the distal sealing element. May be good. In one embodiment, each flexible sealing element may have an umbrella-like shape with the open end of each sealing element facing the proximal end of the earplug. In one embodiment, the electrode device may be malleable. In one embodiment, the electrode device may include a lumen. In one embodiment, the system may include an earhook attached to the proximal part of the earplug, which engages a portion of the ear and disengages after the earplug is placed in the ear. Includes curved members to prevent. In one embodiment, the system may include additional earplugs and additional electrodes for use in delivering iontophoresis material to the eardrum of the other ear of a human or animal patient. In one embodiment, the system may include a headset for connecting the earplugs to the additional earplugs with the earplugs and additional earplugs located inside the patient's ear.</p><p num="0009"> In one aspect of the invention, the system for use in delivering an iontophoresis fluid to the tympanic membrane of a human or animal patient's ear is an elongated flexible tube with proximal and distal parts and an ear canal. A first flexible sealing element having an umbrella-like shape that forms a seal inside the ear canal and a second flexible sealing element having an umbrella-like shape that forms a seal inside the ear canal. A distal strengthening tube located on the distal side of the seal member inside the distal part of the elongated tube and a lure fitting connected to the proximal part of the tube for fluid communication with the main lumen of the tube. It may include a lure fitting portion including a side vent and an electrode device. The flexible tubing may include a main tubule extending through the interior. The distal portion may include an inner lip located distal to the distal portion and a sealing member located on the proximal end side of the medial lip. The elongated tube may have sufficient flexibility to be bent to match the shape of the ear canal. The first flexible sealing element may be integral with the elongated tube, located outside the elongated tube, and offset by a distance from the most distal portion of the elongated tube. The second flexible sealing element is integral with the elongated tube and can be located on the outside of the elongated tube and proximal to the first sealing element. The distal reinforced tube can prevent the distal portion of the elongated tube from bending. The electrode device may include an elongated shaft. The electrode tip may have a diameter larger than the diameter of the elongated shaft. The electrode device fits between the inner lip and the sealing member inside the distal portion of the elongated tube with the tip of the electrode from a retracted position where fluid can pass through the tube and around the electrode. It may be movable within the lumen of the earplug tube to a forward position that forms a fluid-tight seal.</p><p num="0010"> In one aspect of the present invention, the method of anesthetizing the tympanic membrane of a patient's ear using iontophoresis is to deliver an anesthetic solution to the patient's ear canal and an iontophoresis device to the ear canal filled with the anesthetic solution. And while inserting the iontophoresis device and with the electrode in the first position, draining excess anesthetic solution through the lumen and inserting the electrode from the first position to the second position. It may involve moving to the position of and activating the electrode in the second position. The iontophoresis device may include electrodes that can be moved from a first position to a second position within the lumen. The first position of the iontophoresis device can ventilate the ear canal. The second position of the iontophoresis device can seal the ear canal.</p><p num="0011"> In one embodiment, the method may further include confirming that the electrodes move from the first position to the second position by auditory and / or tactile feedback. In one embodiment, the method may include repeating the method against the patient's second ear. In one embodiment, the patient's head may be placed in a lying, tilted position when delivering the drug solution to the ear canal, and may be placed in an upright position when activating the electrodes. In one embodiment, the method repeats the method for the patient's second ear and connects the earplugs to a headset worn on the patient's head before or during activation. May include. In one embodiment, the method may include deforming the electrodes to match the shape of the ear canal.</p><p num="0012"> In one aspect of the invention, the method for anesthetizing the eardrum of a patient's ear using iontophoresis is to deliver an anesthetic solution to the patient's ear canal and to insert an iontophoresis device into the patient's ear canal. That and the actuation of the electrodes can be included. The iontophoresis device may include electrodes inside the lumen. The iontophoresis device can seal the anesthetic solution and at the same time drain excess anesthetic solution beyond the electrodes and through the sealing portion inside the lumen.</p><p num="0013"> In one embodiment, the method may include repeating the method against the patient's second ear. In one embodiment, the patient can be in a lying position during delivery of the drug solution and in an upright position during operation. In one embodiment, the method may include deforming the electrodes to match the shape of the ear canal.</p><p num="0014"> In one aspect of the invention, a kit for anesthetizing the eardrum of a human or animal patient's ear using iontophoresis may include an earplug and a controller. The earplugs are distal, proximal, tubing extending from the distal to proximal, and at least one extending from the outer surface of the tubing and located closer to the distal end than the proximal end. It may have one flexible sealing element and an electrode device. The tube may have a hardness lower than that of the proximal and distal parts of the earplug. The electrode device may include an elongated shaft and an electrode tip having a diameter larger than the diameter of the elongated shaft. The electrode device ears from a retracted position where the fluid can pass through the tube and around the electrode to a forward position where the tip of the electrode contacts the inner surface of the tube and prevents the fluid from flowing through the tube. It can move inside the tube of the plug. The controller can be electrically connected to the electrode device.</p><p num="0015"> In one embodiment, the kit may include an additional earplug for the patient's other ear and an additional electrode device for the additional earplug. In one embodiment, the controller may be connected to an electrode device and additional electrode devices. In one embodiment, the kit may include a headset that is placed on the patient's head to hold the electrodes and earplugs. In one embodiment, the kit may contain a sufficient amount of drug solution to provide iontophoresis anesthesia to the eardrums of both ears of the patient. In one embodiment, the kit may include a drug delivery device for delivering the drug solution into the patient's ear canal.</p><p num="0016"> One embodiment of the present invention provides a method of delivering an iontophoresis substance to the eardrum of a human or animal patient's ear. The earplugs can be inserted into the patient's ear canal. A portion of the flexible sealing element of the earplug can be liquid-tightly sealed into the ear canal to create a space between the earplug and the eardrum. Iontophoresis material can be injected into the earplugs to fill the space between the earplugs and the eardrum. This space can be pressurized with an iontophoresis material during injection. The fluid in the space is drained through the micropores of the flexible sealing element to relieve pressure.</p><p num="0017"> In one aspect, the micropores are configured to drain the fluid when the pressure threshold is exceeded. In one aspect, the fluid is drained into the plenum of the earplug. In one aspect, the micropores are configured to not drain fluid under hydrostatic conditions. In one aspect, the electrode device may be inserted into an earplug and the electrode tip of the electrode device may be brought into contact with an iontophoresis substance. A voltage can be applied to this electrode device to anesthetize the eardrum with an iontophoresis substance. In one aspect, the electrode tip may be electrically connected to the electrode of the earplug, in which case a voltage is applied to the electrode of the earplug by an electrode device. In one aspect, inserting the earplugs may include placing the headset attached to the earplugs behind the patient's neck. In one aspect, the headset includes a left ear hook and a right ear hook, in which case placing the headset corresponds to the right ear hook with the corresponding portion of the left ear hook over the patient's left skull. Includes placing the portion on the patient's right skull. In one aspect, the headset may be connected to a second earplug, which may be configured identically to the earplug, and the headset may apply an independent force to the earplug. , The earplugs can be held in the corresponding ear canal. In one aspect, the headset may include a fluid channel fluidly connected to an earplug and a second earplug, respectively, and injecting iontophoresis material may impose fluid channels on the headset under low pressure. May include filling. In one aspect, the fluid discharged from the earplugs can be observed, and once the fluid is observed draining from the earplugs, the infusion of the iontophoresis material may be stopped.</p><p num="0018"> One embodiment of the present invention provides a system for delivering an iontophoresis substance to the eardrum of a human or animal patient's ear. This system may include earplugs. The earplugs may include a flexible sealing element that includes an elongated tube, the elongated tube extending proximally from the flexible sealing element. The flexible seal element may have a distal seal surface with multiple micropores. The micropores may be configured to drain the fluid when the pressure threshold is exceeded. The system may include an electrode device that is movable within the inner tube. The electrode device may include an elongated shaft connected to the tip of the electrode.</p><p num="0019"> In one aspect, the micropores are configured to not drain fluid under hydrostatic conditions. In one aspect, the flexible sealing element may include an internal plenum, and the micropores are fluid connected to the internal plenum. In one aspect, the internal plenum may be fluid connected to the drainage channel of the elongated tube. In one aspect, the elongated tube may include an elongated outer tube on top of the elongated inner tube, with drain channels located between them. In one aspect, the elongated tube may include at least one electrode integrated into the elongated tube, the at least one electrode of which may be electrically connectable to the electrode tip. In one aspect, the electrode may include a wire formed as a cylindrical cage. In one aspect, the cylindrical cage may be a coil. In one aspect, the cylindrical cage may be a plurality of loops arranged in the axial direction. In one aspect, the cylindrical cage may be configured to compress the electrode tip. In one aspect, the flexible sealing element may have an umbrella-like shape. In one aspect, the system may include a second earplug and a second electrode device, the second earplug being configured identically to the earplug above and the second electrode device to be identical to the electrode device above. Has been done. In one aspect, the headset may connect an earplug and a second earplug. In one aspect, the headset may include a neck loop connected to a left ear hook and a right ear hook, the left ear hook and the right ear hook, respectively, which may be configured to wrap behind the concha. In one aspect, the left ear hook may be configured to apply compressive force from the neck loop onto the patient's left skull and the right ear hook onto the patient's right skull. In one aspect, the headset may further include a left low pressure fluid channel and a right low pressure fluid channel, with the left low pressure fluid channel in the inner tube of the earplug and the right low pressure fluid channel in the second earplug. It can be fluidly connected to the inner tube. In one aspect, the headset may further include a spring-loaded left swing arm and a spring-loaded right swing arm, the spring-loaded left swing arm being a left ear hook.</p><p num="0020"> For a better understanding of the essence and benefits of the different aspects and embodiments, see description and accompanying drawings below. Each figure is given for the purpose of illustration and explanation only, and is not intended to limit the scope of the embodiment of the present invention.</p>
<figref num="1A">Front view of the outer ear.</figref><figref num="1B">Partial cross-sectional view of the outer ear, middle ear, and inner ear.</figref><figref num="2A">Sectional drawings of a system for anesthetizing the eardrum according to various embodiments of the present invention.</figref><figref num="2B">Sectional drawings of a system for anesthetizing the eardrum according to various embodiments of the present invention.</figref><figref num="2C">Sectional drawings of a system for anesthetizing the eardrum according to various embodiments of the present invention.</figref><figref num="2D">Perspective view of the distal end of an earplug according to an embodiment of the present invention.</figref><figref num="2E">A side view of an earplug according to an embodiment of the present invention.</figref><figref num="2F">A side view of a system for anesthetizing the eardrum according to various embodiments of the present invention.</figref><figref num="2G">A side view of a system for anesthetizing the eardrum according to various embodiments of the present invention.</figref><figref num="2H">A usage state of the system according to an embodiment of the present invention.</figref><figref num="3A">Partial cross-sectional view of the working state of the system for anesthetizing the eardrum according to various embodiments of the present invention.</figref><figref num="3B">Partial cross-sectional view of the working state of the system for anesthetizing the eardrum according to various embodiments of the present invention.</figref><figref num="3C">Partial cross-sectional view of the working state of the system for anesthetizing the eardrum according to various embodiments of the present invention.</figref><figref num="4">A kit for anesthetizing the eardrum according to an embodiment of the present invention.</figref><figref num="5A">Front view of the flexible sealing element according to one embodiment of the present invention.</figref><figref num="5B">A side view of a flexible sealing element according to an embodiment of the present invention.</figref><figref num="5C">Front view of the flexible sealing element according to one embodiment of the present invention.</figref><figref num="5D">A side view of a flexible sealing element according to an embodiment of the present invention.</figref><figref num="5E">FIG. 3 is a perspective view of a flexible sealing element according to an embodiment of the present invention.</figref><figref num="5F">Front view of the flexible sealing element according to one embodiment of the present invention.</figref><figref num="6A">The front view of the ear plug including the ear hook according to one Embodiment of this invention.</figref><figref num="6B">The front view of the ear plug including the ear hook according to one Embodiment of this invention.</figref><figref num="6C">FIG. 2 is a facing view of a usage state of an ear plug including an ear hook according to an embodiment of the present invention.</figref><figref num="6D">A side view of an integrated earbud according to an embodiment of the present invention.</figref><figref num="6E">Facing views of the usage state of the integrated earbuds according to various embodiments of the present invention.</figref><figref num="6F">Facing views of the usage state of the integrated earbuds according to various embodiments of the present invention.</figref><figref num="7A">The perspective view of the ear plug according to one Embodiment of this invention.</figref><figref num="7B">A perspective view of an extension portion used in an earplug according to an embodiment of the present invention.</figref><figref num="7C">FIG. 6 is a cross-sectional view of an extension portion used in an earplug according to an embodiment of the present invention.</figref><figref num="7D">Perspective view of an extension portion used in an earplug according to various embodiments of the present invention.</figref><figref num="7E">Perspective view of an extension portion used in an earplug according to various embodiments of the present invention.</figref><figref num="7F">Perspective view of an extension portion used in an earplug according to various embodiments of the present invention.</figref><figref num="7G">Perspective view of an extension portion used in an earplug according to various embodiments of the present invention.</figref><figref num="7H">Perspective view of an extension portion used in an earplug according to various embodiments of the present invention.</figref><figref num="7I">Perspective view of an extension portion used in an earplug according to various embodiments of the present invention.</figref><figref num="7J">Exploded view of an extension portion used in an earplug according to an embodiment of the present invention.</figref><figref num="8A">A side view of an expandable earplug according to an embodiment of the present invention.</figref><figref num="8B">FIG. 5 is a side view of a usage state of an expandable ear plug according to an embodiment of the present invention.</figref><figref num="9A">FIG. 6 is a cross-sectional view of a foam plug device according to an embodiment of the present invention.</figref><figref num="9B">FIG. 6 is a cross-sectional view of the foam balloon device according to an embodiment of the present invention.</figref><figref num="10A">Sectional drawing of the microscope port according to one Embodiment of this invention.</figref><figref num="10B">FIG. 3 is a cross-sectional view of an alternative distal port according to an embodiment of the invention.</figref><figref num="10C">Perspective view of an alternative distal port according to an embodiment of the invention.</figref><figref num="10D">A usage state of the speculum port according to an embodiment of the present invention.</figref><figref num="10E">A usage state of the speculum port according to an embodiment of the present invention.</figref><figref num="10F">A usage state of the speculum port according to an embodiment of the present invention.</figref><figref num="10G">A usage state of the speculum port according to an embodiment of the present invention.</figref><figref num="10H">A usage state of the speculum port according to an embodiment of the present invention.</figref><figref num="11">Simplified support structures attached to the head of a patient according to various embodiments of the present invention that support an iontophoresis system.</figref><figref num="12">Simplified support structures attached to the head of a patient according to various embodiments of the present invention that support an iontophoresis system.</figref><figref num="13A">Perspective side view of an earplug according to an embodiment of the present invention.</figref><figref num="13B">FIG. 3 is a perspective sectional view of an ear plug according to an embodiment of the present invention.</figref><figref num="13C">Sectional drawing of the ear plug according to one Embodiment of this invention.</figref><figref num="14A">FIG. 3 is a perspective view of a system for delivering an iontophoresis substance according to an embodiment of the present invention.</figref><figref num="14B">Perspective view of an electrode integrated with an earplug according to various embodiments of the present invention.</figref><figref num="14C">Perspective view of an electrode integrated with an earplug according to various embodiments of the present invention.</figref><figref num="15A">Perspective view of a headset for delivering an iontophoresis substance according to an embodiment of the present invention.</figref><figref num="15B">Perspective view of a headset for delivering an iontophoresis substance according to an embodiment of the present invention.</figref><figref num="15C">FIG. 15A is a perspective view of the headset used in the method for delivering an iontophoresis material according to an embodiment of the present invention.</figref><figref num="15D">FIG. 15B is a perspective view of the headset used in the method for delivering an iontophoresis material according to an embodiment of the present invention.</figref>
Figure 1A shows a diagram of the outer ear. The outer ear contains the main element known as the pinna or pinna 100. The outer ear functions as a funnel to direct sound to each part of the ear. The main physical elements of the outer ear include the earlobe 102, the concha 104, the ring leg 106, the helix 108, the scaphoid fossa 110, the triangular fossa 112, the ear canal 114, the tragus 116, and the tragus 118.
FIG. 1B shows a cross-sectional view of the inner ear portion and the outer ear portion. It is shown that the auricle 100 is connected to the ear canal 118 (external auditory meatus or ear canal). The ear canal 118 is shown as a relatively short passage, but is often a more curved and winding passage. The ear canal 118 is connected to the middle ear 120, which contains the eardrum 122. The middle ear 120 is connected to the inner ear 124. The ear drum 122 is usually a tympanic It has an air pocket behind an outer part called a membrane). When the middle ear 120 is infected, fluid collects inside the eardrum 122. The swelling of the fluid causes severe pain in patients with otitis media. Otitis media is common in children. Pain can be relieved by puncturing the eardrum and draining fluid, a treatment known as eardrum puncture. Patients may be given general anesthesia prior to tympanic puncture, which is not preferred due to cost and health concerns. As a preferred alternative, the eardrum can be locally anesthetized using drug delivery by iontophoresis. In this case, the patient can be treated while awake. Devices and methods for local anesthesia of the eardrum are disclosed in U.S. Patent Applications No. 11 / 962,073 and No. 11 / 749,729 assigned to the same applicant as this application, the entire application of which is by reference. set to herein are incorporated seen.
FIG. 2A shows an iontophoresis system 200 for anesthetizing the eardrum according to an embodiment of the present invention. The system 200 includes an earplug 202 and an electrode device 206. The earplug 202 may include a flexible sealing element 204, a distal portion 208, a proximal portion 210, and a tube 212 connecting the two. The tube 212 is relatively more flexible than the distal 208 and the proximal 210 in terms of resistance to bending. This is especially beneficial as the ear canal is often a winding passage and the distal 208 and proximal 210 need to be located at opposite ends of this winding passage. The earplug 202 preferably bends without blocking the tube 212 and matches the shape of the winding passage. Also, the earplug 202 may be pre-bent or pre-formed into a predetermined suitable shape that matches the winding passage of the ear canal. The earplug 202 can be made of a flexible polymeric material such as silicone to obtain the desired flexibility.
The distal portion 208 may include a rigid member 214. The rigid member 214 may generally be cylindrical or tubular and includes an inner lip 216 that prevents the electrode device from escaping from the distal portion 208. The rigid member 214 can be made of a metal or polymer that provides structural integrity to the distal portion 208. By providing the distal portion 208 with higher rigidity than the tube 212 by the rigid member 214, the distal portion 208 can maintain its shape even when passed through a winding passage. The rigid member 214 can be glued to the distal portion 208 or molded into the distal portion 208. Alternatively, the rigid member 214 may be integrated with the distal portion 208 as a portion having a wall thickness greater than the wall thickness of the pipe 212.
The distal part 208 may also include an O-ring 218. The O-ring 218 liquidally seals the electrode device 206 inside the distal portion 208. The O-ring can be glued to the distal 208 or molded into the distal 208, or integrally formed between the distal 208 and the tube 212. The O-ring 218 can be designed to allow fluid to pass under pressure loads above atmospheric pressure, such as the pressure generated when inserting the system 200 into a fluid-filled ear. For example, the O-ring 218 can be configured as a duck bill seal that opens towards the proximal end. Studies have shown that a good value for the pressure release threshold of the O-ring is 0.125 kPa (2.2 cm water column).
The proximal 210 can be stiffer than the tube 212 so that the shape of the proximal 210 is maintained when inserted into the winding passage. The proximal portion 210 may be provided with a side vent 220. The side vent 220 functions to allow excess fluid to escape from the ear, and excess fluid is released from the proximal 208 through the tube 212. Further, the side vent 220 may be located around the pipe 212. The proximal portion 210 may include a luer fitting portion having a liquid tight fitting portion 222 so as to border the electrode device 206, as shown. The proximal portion may include a hook portion 222 that borders the tube 212. Alternatively, the proximal portion 210 can be formed integrally with the tube 212 and the rigidity can be maintained by using a molded reinforcing insert or thick portion.
The flexible seal element 204 is used to form a liquidtight seal between the system 200 and the ear canal. The flexible seal element 204 is usually flexible and deforms to form a liquidtight seal that matches the shape of the ear canal. Two flexible sealing elements 204 are shown, but only one is required and more than two can be used. The first sealing element 204a is shaped like an elliptical umbrella and can be integrally formed with the tube 212 and the distal portion 208 as shown in the figure. Alternatively, the flexible seal element 204 may have a pyramidal shape (having three sides) or a triangular shape. The ear canal is often found to have an elliptical or triangular cross section. It is preferred that there is an offset 226 between the first flexible sealing element 204a and the most distal portion of the system 200. The offset 226 provides an additional volume inside the ear that allows air bubbles to be present, preventing the air bubbles from blocking the distal 208. The second flexible sealing element 204b may be larger than the first flexible sealing element and may be formed integrally with the tube 212 as shown in the figure.
In an alternative embodiment, the flexible seal element 204 can include an adhesive element to facilitate a liquidtight seal between the surface of the flexible seal element 204 and the ear canal. For example, an adhesive layer can be used on the outer surface of the first sealing element 204a and / or the second sealing element 204b (ie, the surface facing the ear canal). The adhesive layer may be covered with lining tape, which can be peeled off prior to insertion into the ear canal. Various adhesives, such as temperature-dependent adhesives, which exhibit only weak adhesiveness at room temperature, but which exhibit stronger adhesiveness due to the heat of the ear canal after insertion, can be used. It may be possible to place and replace within the complex anatomy of the ear with a temperature-dependent adhesive to reduce the burden on the patient. The earplug 202 can be taken out by cooling the earplug 202 with a cold compress to reduce the adhesiveness. Examples of adhesive elements are Eakin Cohesive® seals and Landec manufactured by CovaTec, Inc. Pre-Po® drapes manufactured by Labs, Inc. can be mentioned. Alternatively, a temperature-dependent adhesive that exhibits strong adhesiveness at body temperature but becomes less adhesive when heated to a temperature higher than body temperature can also be used. In this embodiment, the earplug 202 can be removed by applying heat with a warm compress to reduce its adhesiveness.
The electrode device 206 includes an electrode tip portion 228, an elongated shaft 230, and a proximal end side connector 232. The electrode tip 228 can have a cylindrical shape that matches the interior of the distal 208. The electrode tip portion 228 is generally formed in a shape that forms a seal between the inner lip 216 inside the distal portion 208 and the O-ring 218. Further, the electrode tip portion 228 has a size that allows it to be slidably arranged in the tube 212. The electrode tip 228 is preferably made of silver (purity 99.9%). The pure silver electrode tip 228 may include an oxide layer and has been shown to promote the iontophoresis method. Conventional devices use stainless steel or gold electrodes that tend to cause electrolysis of iontophoresis solutions such as lidocaine, and such electrolysis lowers the pH value and causes discomfort. The silver electrode relatively reduces electrolysis and suppresses such discomfort. Alternatively, the electrode tip 228 may include a silver coating covering a different metal such as stainless steel.
Although the electrode tip 228 is shown as a cylindrical metal block, in another embodiment the electrode tip 228 may have a different form that increases the surface area and promotes iontophoresis. For example, a plurality of silver wires having a shape similar to a brush can be used. In another embodiment, a plurality of concentric hypotubes arranged with different diameters can be used. In another embodiment, a mass of silver mesh in a form similar to steel wool can be used. In another embodiment, a molded polymer matrix plug that has a relatively large surface area (eg, sponge-like) and is plated or vapor-deposited with gold or silver can be used. In another embodiment, the metal-coated woven fabric can be used with or without insulation on the outside, depending on the size. In another embodiment, a cylindrical body in which the honeycomb structure is arranged internally and is exposed to the distal side can be used. In another embodiment, a silver foil coil can be used. In another embodiment, a recess plug sized (ie, small diameter) to have exposed sides can be used. In another embodiment, a proximal seal can be used within the tube 212 and the elongated shaft 230 can be used as an electrode in the form of a tube or conductor. In another embodiment, a (ie, flower-like) mass having a plurality of petals or branched elements integrated on the surface of the flexible seal element 204 can be used. In another embodiment, a flexible flexible bag-like element having an insulating outer surface and a silver-coated inner surface, which is flexible and flexible extending distally from distal 208. Bag-shaped elements can be used. In another embodiment, one or more cavities may be used that include a metal coated surface and are located distally 208. In another embodiment, the electrode tip 228 may include pore and / or textured surfaces (eg, crosshatch, etched, sandblasted surfaces) to increase surface area. In another embodiment, the electrode tip 228 can contain multiple types of metals, of which One metal of is the sacrificial anode (eg zinc). In another embodiment, a conveyor system (eg, a metal-coated flexible belt) that can be actuated to provide a fresh electrode surface throughout iontophoresis can be used. In another embodiment, the tube 212 may include a wipe element that cleans the surface of the electrode when rotated to provide a new surface of the electrode throughout the iontophoresis method. In another embodiment, the electrode tip 228 may include a protective coating that helps prevent corrosion.
The electrode tip 228 can be attached to the elongated shaft 230 by soldering or welding. The elongated shaft 230 can be made of the same material as the electrode tip 228. The elongated shaft 230 may further include a lumen through which the liquid passes. The elongated shaft 230 is preferably malleable so that the user can pre-bend the elongated shaft prior to inserting the system 200 into the ear canal. The earplug 202 may also be installed before the electrode device 206, so that the electrode device 206 can be shaped to match the shape of the pre-inserted and deformed earplug 202. The proximal connector 232 is shaped to hermetically seal the proximal 210. The proximal connector 232 is further electrically connected to the conductor 234 to supply energy to the electrode device 206.
FIG. 2B shows a state in which the iontophoresis system 200 is placed in the first position according to an embodiment of the present invention. The electrode device 206 shows a state in which the electrode tip 228 is located proximal to the inside of the tube 212. In the first position, the distal 208 is in fluid communication with the tube 212. In the first position, fluid can flow out through the distal part 208 and through the vent 220, as indicated by the arrows in the figure.
FIG. 2C shows a state in which the iontophoresis system 200 is placed in a second position according to an embodiment of the present invention. The electrode device 206 shows a state in which the tip of the electrode is located at the distal position inside the distal portion 208. The electrode device 206 may be forced to pass through the O-ring 218, which can cause a "click" audible sound. As a result, the electrode device 206 can be moved from the first position to the second position while confirming by sound. In the second position, the open distal position 208 is closed and no fluid communication with the tube 212. In another embodiment, the O-ring 218 may allow the fluid to pass when the pressure of the fluid in the ear canal exceeds a threshold.
FIG. 2D shows an alternative embodiment of the iontophoresis system 200. In this embodiment, the offset portion 226 and the distal portion 208 each include a plurality of aligned pores 236 located in close proximity to the back of the medial lip 216. Four pores 236 are shown, but in other embodiments more or less pores can be used. The size of the small hole 236 may be any of many suitable sizes, for example, in one embodiment, the small hole diameter may be about 0.0635 cm (0.025 inch). The pores 236 reduce the volume of the drug solution to be trapped and expose a larger surface area of the electrode tip 228, thus reducing the voltage required by the iontophoresis method. Since the iontophoresis method gradually corrodes the electrode tip 228, more voltage is required from the iontophoresis system as the electrical efficiency of the electrode tip decreases. Tests on the corpse have experimentally shown that the small hole 236 can reduce the required voltage by about two-thirds over 10 minutes compared to the system 200 without the small hole 236. Therefore, the use of the small holes 236 prevents system interference and the generation of voltage noise. System disruption is when the iontophoresis system fails to meet the voltage demand of the corroded electrode tip 228 and the iontophoresis method is unintentionally interrupted. Voltage noise can cause discomfort to the patient.
FIG. 2E shows an alternative embodiment of the iontophoresis system 200. In this embodiment, the system 200 remains largely as described above, but with a bag-like element 238 attached to the distal end of the system 200. The bag-like element 238 can be made of a flexible material such as a thin polymer or woven material. The bag-shaped element 238 may have an outer adhesive material such as an adhesive member as described herein. During insertion and / or iontophoresis processes, skin flakes or organic debris such as earwax may come off. Such debris can adhere to the electrodes of the system 200 and reduce the active surface area of the electrodes. At the time of use, the system can be inserted into the ear and the pouch-shaped element 238 adhered to the surface of the ear canal, which extends to the eardrum 122. The sac-like element 238 can be inflated with respect to the ear canal by physically pushing it with a probe such as a cotton swab, or it can be inflated with an inflatable foam or balloon. In some embodiments, the bag-like element 238 can be a double-walled balloon. The sac-like element 238 prevents debris from adhering to the electrodes by providing a physical barrier between the ear canal and the electrodes. The sac-like element can further reduce the loss of the drug solution by blocking the absorption of the drug solution by the wall of the ear canal.
2F-2H show alternative embodiments of the iontophoresis system 200. In these embodiments, the system 200 remains largely as described above, but the flexible electrode 240 extends from the distal end of the system 20. The flexible electrode 240 may include an insulating side surface 242 and a conductive side surface 244 having an exposed metal (eg, silver) portion. The flexible electrode 240 is made of a flexible polymer material such as polyimide and can be co-extruded with a metal strip. The flexible electrode 240 can be configured as a single loop-shaped band such that the exposed metal portion is the inner portion of the loop. Alternatively, more than one band can be used, as shown by the flexible electrode 246 in FIG. 2G. The length of the extension of the flexible electrode 240 can be adjusted according to the anatomical shape of the particular patient. Since the conductive side surface 244 does not contact the ear canal during use, the flexible electrode 240 can contact the ear canal without shock, as shown in FIG. 2H. The flexible electrode 204 can be deflected from the ear canal due to its flexibility. The flexible electrode 240 provides a large electrode surface area for increasing the efficiency of the iontophoresis method. The large electrode surface area can further reduce the formation of bubbles in the chemical solution.
3A-3C show a method of using the iontophoresis system 200 for anesthetizing the eardrum of a patient's ear according to an embodiment of the present invention. A cross section of the patient's ear 300 is shown. The patient is first laid sideways with the ear to be treated facing up. The iontophoresis solution 302 is then injected into the ear canal as shown. Then, the ear plug 304 is inserted into the ear filled with the solution to seal the iontophoresis solution in the ear canal. The earplug 304 is generally as described in the embodiments herein. The earplug 304 may optionally be primed with iontophoresis solution 302 prior to insertion into the ear canal.
In FIG. 3B, the electrode device 306 is inserted into the inserted ear plug 304. The electrode device 306 is malleable and may optionally be pre-bent prior to insertion. The electrode device 306 provides the user with an audible signal confirming that the electrode device is properly placed by producing an audible sound when fully inserted into the earplug 304. When the electrode device 306 is fully inserted, pressure builds up inside the ear canal 308, allowing excess liquid 308 to escape from the rear of the plug as shown, immediately equilibrating the liquid pressure with atmospheric pressure. This is a great advantage, as even a slight increase in pressure can cause great pain in the infected ear. After the electrode device 306 is fully inserted, a voltage can be applied to the electrode device 306 to treat the patient. The other ear can also be treated as described herein.
In another embodiment, the electrode device 306 may be partially inserted into the earplug 304 upon initial insertion into the ear canal, for example to a first position such that the electrode tip 228 is located within the tube 212. it can. After placing the earplug 304, the electrode device 306 can be moved from the first position to a second position (eg, working position) that is fully inserted into the earplug 304.
In yet another alternative embodiment, the electrode device 306 may be fully inserted into the earplug 304 prior to insertion into the ear canal. As the earplug 304 is inserted into the ear canal, the pressure inside the ear increases, but at the same time the pressure is released through the seal inside the earplug 304, which allows excess fluid to escape when the pressure exceeds a certain threshold. Be removed. This embodiment is advantageous because the user does not need to move the electrodes with the earplugs placed inside the ear.
Figure 3C shows the ear in an upright position, the patient. The device 304 includes an offset 310 from the electrode, which moves the bubble 312 to the position shown in the figure. Offset 310 prevents direct or partial placement of air bubbles on the electrodes leading to incomplete or ineffective treatment. The offset 310 allows the system 200 to be used in an upright position, which is advantageous because both ears can be treated at the same time.
In another embodiment, the patient can be in an upright position prior to insertion of the iontophoresis solution 302 or earplug 304. First, the ear plug 304 is inserted into the ear canal with the electrode 306 completely inserted. In this embodiment, the electrode device 306 includes another lumen for filling the ear canal. The iontophoresis solution 302 is injected through the electrode device 306 to fill the ear canal. When the ear canal is filled with iontophoresis fluid 302, the pressure inside the ear increases, but at the same time the pressure is relieved through the seal inside the earplug 304. Therefore, when the pressure exceeds a predetermined threshold, excess liquid is released. This embodiment is advantageous because one or both ears can be filled simultaneously as needed, which can be done in an upright position by the patient.
In another embodiment, the proximal sealant can be applied after the device 304 has been arranged as shown in FIG. 3C. The sealing material can be made from a soft putty-like substance, for example bone wax (eg beeswax, paraffin, or iropropyl palmitate) can be used. The sealant can be used separately or as a sealable member attached to device 304, eg, as a disc placed proximally (eg, between the seal member 204b in FIG. 2A and the side outlet 220). it can. The sealing material can be molded when heated to body temperature. In use, after the device 304 has been placed as shown in FIG. 3C, the sealant can be pushed into the anatomy of the concha and outer ear to form its shape. The sealing material matches the complex anatomical structure of the outer ear and can be firmly fixed. Also, the sealant can provide a liquid-tight seal, and the sealant provides a primary seal instead of the device 304, so this liquid-tight seal provides a device that is slightly smaller in size than the ear canal. The 304 can be used, which means that the device can be inserted into the ear canal in a faster and less painful manner.
Alternatively, a fabric patch can be used in place of or in combination with the sealant. The fabric patch can have the shape of a disc and can be sealably attached to device 304 as a disc placed proximally (eg, between the seal member 204b in FIG. 2A and the side outlet 220). it can. The fabric patch may include an adhesive such as the temperature dependent adhesive described herein. Alternatively, the fabric patch can use conventional adhesives such as those used in Nexcare Tegaderm Transparent Dressing from 3M, Inc. In use, after the device 304 has been placed as shown in FIG. 3C, the fabric patch can be pushed into the anatomy of the concha and outer ear to form its shape. The fabric patch can provide both a liquidtight seal and a firm fixation. Therefore, the fabric patch can also be used with a smaller than standard device 304.
FIG. 4 shows a kit 400 for anesthetizing the eardrum of a patient's ear using iontophoresis according to an embodiment of the present invention. The kit includes system 402 similar to the equipment disclosed herein. Each system 402 includes an earplug 404 and an electrode device 406. As shown in the figure, earplugs of various sizes are possible. Kit 400 also includes a counter electrode 410 and a controller 408 that is electrically compatible with the system 402. Controller 412 supplies system 402 with power to perform the iontophoresis method. An example of a compatible controller is shown in US Patent Application No. 11 / 962,063, which has already been incorporated by reference and assigned to the same applicant as this application.
FIG. 5A shows a front view of the umbrella-shaped flexible seal element 500 according to an embodiment of the present invention, and FIG. 5B shows a side view thereof. The flexible seal element 500 includes integrally formed ribs 502 or spokes. The integral rib 502 allows the remaining portion 504 of the flexible seal element 500 to be formed thinner than the rib portion, which makes the flexible seal element 500 extremely easily deformed. Thus, in a device incorporating a flexible seal element 500, such as the system 200, it is possible to form a seal inside the ear canal with a weaker force than a seal element without an integral rib 502. Alternatively, the integral rib 502 may be located on the inner portion of the flexible sealing device 500.
FIG. 5C shows a front view of the flexible sealing element 506 according to an embodiment of the present invention, and FIG. 5D shows a side view thereof. The flexible seal element 506 includes a notch 508. The notch 508 features a web of thin material. Since the notch portion 508 is thinner than the remaining portion 510 of the flexible seal element 506, the flexible seal element 506 is highly deformable. Thus, a device incorporating the flexible seal element 506, such as the system 200, can form a seal inside the ear canal with less force than a seal element without a notch 508. Alternatively, the notch portion 508 may be located on the inner portion of the flexible sealing device 506.
FIG. 5E shows a perspective view of the flexible sealing element 510 according to an embodiment of the present invention, and FIG. 5F shows a front view thereof. As shown in the figure, the flexible seal element 506 has a pyramid or triangular shape. Flexible sealing element 506 includes three sides for sealing the ear canal. The ear canal does not have a circular cross section and is often triangular in shape. As such, the flexible sealing element 510 can fit within the ear canal very effectively and seal the ear canal.
FIG. 6A shows a rear view of the ear plug 600 according to an embodiment of the present invention, and FIG. 6B shows a side view thereof. The earplug 600 includes a body 602 that may include a tubular element and at least one flexible sealing element as generally described herein. The earplugs further include an earhook 604. Conventional devices have used earmuffs or headphone-type holding mechanisms to hold the earplugs. These conventional devices can be painful and uncomfortable for the user (eg, a child) and the iontophoresis treatment may be disturbed by the patient. The ear hook 604 can be formed of a flexible polymer such as silicone and can be integrally formed with the ear plug 600. The earhook 604 may also contain a flexible polymer with a skeleton-like structure wrapped around a core (eg, wire). This core may be malleable so that the ear hook 604 is shaped to the contour of a particular ear. Alternatively, the core may be made elastic to help apply a constant force from the outer ear to the earplug 600.
FIG. 6C shows the usage state of the earplug 600 according to the embodiment of the present invention. The earhook 604 is designed to be wrapped around the helix leg 606 of the ear. The earhook 604 is relatively unbulky and does not feel overly disturbing to the patient, which is an advantage over other conventional devices.
FIG. 6D shows an integrated earbud 608 according to an embodiment of the present invention. The earbud includes a body 610 that includes a power supply and a control unit. This control unit can have the function of the control unit 412 of FIG. The body 610 may include a control button for starting or stopping the iontophoresis method. The body 610 may include one or more adhesive patches. The earbud 608 further includes a malleable bridge 612 with a curved shape. The malleable bridge 612 may have a malleable metal core made of a flexible polymer such as rubber. The earplug 614 can be swivelly connected to the malleable bridge 612. The earplug 614 can have a structure generally common to the earplugs disclosed herein. The cable 616 extends from the main body 610 and is connected to the counter electrode plate 618. The counter electrode plate 618 may include a snap element that allows connection with other counter electrode plates.
FIG. 6E shows the usage state of the integrated earbud 608 according to the embodiment of the present invention. The body 610 can be placed behind the helix and can be temporarily adhered to the patient's skin, as shown. A malleable bridge 612 is wrapped around the helix and an earplug 614 is inserted into the ear canal. The integrated earbud 608 supports the earplug 614 to prevent unwanted movement and provide a constant mounting force that helps ensure a liquidtight seal. The malleable bridge 612 can be adjusted to provide greater or lesser mounting force. The earplug 614 can be rotated so that the integrated ear bug 608 can be used with either ear. The return electrode 618 can be glued to a portion of the patient's skin to provide a return path for electricity to the control unit. The integrated earbud 608 includes an integrated control unit that allows the patient to move freely during the procedure.
FIG. 6F shows the usage state of the integrated earbud 620 according to the embodiment of the present invention. The integrated earbud 620 has the same configuration as the earbud 608 in Figure 6D, but the control unit 622 is housed separately from the counter electrode patch. The integrated earbud 620 further includes a malleable body 624 that completely surrounds the helix of the ear. The malleable body 624 can be made of a flexible polymer such as rubber and may have a malleable metal core. The malleable body 624 is adjusted to fit various ear anatomy to prevent unwanted movement and provide a constant fit that helps ensure a liquidtight seal. Can be done.
FIG. 7A shows an earplug 700 according to an embodiment of the present invention. Different regions of the anatomy of the ear have different magnitudes of electrical resistance. The current selectively flows through the region where the resistance is low. For example, the eardrum has lower resistance than the area of cartilage in the ear canal. It is desirable to prevent unnecessary electrical contact to areas of high resistance, and for patient comfort it is desirable to limit the amount of current delivered. Placing the electrodes as close as possible to the eardrum reduces the overall current supply, resulting in favorable results. However, because the ear canal is known to be winding, it is difficult to place electrodes near the eardrum without contact with other areas of the ear. The earplug 700 solves these difficulties.
The earplug 700 includes a seal body 702 for sealing the earplug 700 in the ear canal. The seal body 702 may include other similar earplug structures disclosed herein. The seal body 702 may or may not include a lumen and a vent for filling the ear canal. The earplug 700 includes an insulator 704 that extends through the seal body 702. An electrode 708 is housed in an extension portion 706 of the insulator 704. The extension portion 706 is advantageous because it extends the electrode 708 well beyond the seal and close to the eardrum during use. The distal part 706 may also come into contact with part of the ear canal while continuing to insulate the electrode 708.
FIG. 7B is a perspective view of an alternative extension 710 that may be used with, for example, the earplug 700 shown in FIG. 7A, and FIG. 7C is a sectional view thereof. The extension portion 710 features a plurality of slits 712 that provide fluid access to the inner electrode 714. The extension portion 710 can be formed from a hypotube that has been cut out and then coated with an outer insulating barrier. This extension is beneficial because it reduces the number of components required and also reduces the current density by using a relatively large surface area for the electrode 714. It has been found that lower current densities increase patient comfort. Alternatively, the dome-shaped portion 710 may be removed and more or less slits 712 than those shown in the figure may be used.
FIG. 7D shows a perspective view of an alternative extension 710 that can be used with, for example, the earplug 700 shown in FIG. 7A. Extension portion 710 includes insulating portions 716a, 716b and electrode 718. The electrode 718 may be constructed of a superelastic alloy such as nickel titanium. This causes the electrode 718 to deflect as easily as necessary when the electrode 716a comes into contact with part of the ear canal. The electrode 718 may be longer than that shown in the figure and includes a plurality of insulating portions 716b to further extend the electrode 718 closer to the eardrum.
FIG. 7E shows a perspective view of an alternative extension 720 that can be used with, for example, the earplug 700 shown in FIG. 7A. The extension portion 720 has a hypotube structure similar to that shown in FIGS. 7B and 7C. The extension portion 720 includes a plurality of perforations 722 that allow fluid communication with the inner electrode portion 724 indicated by the shaded portion. The extension portion 720 can be formed from a hypotube that is cut out, perforated and then coated with an outer insulating barrier.
FIG. 7F shows a perspective view of an alternative extension 726 that can be used with, for example, the earplug 700 shown in FIG. 7A. The extension portion 726 can be configured as a basket-like element that is easily deformable but has elasticity. The extension 726 easily deflects when in contact with part of the ear canal. The extension portion 728 is made of an outer insulating material 728 and an inner conductive portion 730. The extension portion 726 may be made of a superelastic material such as nickel titanium and may be thin, for example 0.0127 cm (0.005 inch) thick.
FIG. 7G shows a perspective view of an alternative extension portion 732 that can be used with, for example, the earplug 700 shown in FIG. 7A. The extension portion 732 includes an outer insulating member 734 and a plurality of electrodes 736. The plurality of electrodes 736 extend inside the insulating member 734. This configuration is advantageous because it significantly increases the conductive surface area and thus helps reduce the current density. This configuration also directs a distal current towards the eardrum during use.
FIG. 7H shows a perspective view of an alternative extension 738 that can be used with, for example, the earplug 700 shown in FIG. 7A. Extension 738 is similar to the extension shown in Figure 7F. However, as shown in the figure, the electrode 742 is insulated to the most distal point. This configuration also directs a distal current towards the eardrum during use.
FIG. 7I is a perspective view of an alternative extension 744 that can be used with, for example, the earplug 700 shown in FIG. 7A, and FIG. 7J is an exploded view thereof. The extension portion 744 includes a coiled form as shown in the figure, and the coiled form further includes a laminated structure. The laminated structure includes an outer insulating member 746, a conductive member 748, and an inner insulating member 750. The inner insulating member 750 includes an opening 752 that exposes the conductive member 750. The extension 744 can be made by cutting one side of the initially coated flat conductor to form an opening 752 and then winding it into a coil.
FIG. 8A shows a side view of the expandable earplug according to an embodiment of the present invention, and FIG. 8B shows a view during its operation. The earplug 800 includes an outer extension 802 and an expander 804. The outer extension 802 and the expander can be connected inside near the distal end of the earplug as shown in the figure. The expander 804 is slidable within the expansion and by pulling the expander 804 proximally, the outer expansion is forced to expand into a second form, as shown in Figure 8B. can do. The outer extension portion 802 can be made of a soft polymer such as silicone. This configuration is advantageous because it not only fits exactly within the anatomy of a particular ear, but also allows for deeper placement.
FIG. 9A shows a foam plug device 900 according to an embodiment of the present invention. The foam plug device 900 includes an electrode 902 and a perforated tube 904 attached to the electrode 902. The foam plug 906 surrounds the electrode 902. The foam plug 906 can have a cylindrical or conical shape and can be constructed from open cell foam material. The electrode 902 can be constructed from a single or stranded wire of malleable metal (eg silver), or a solid or perforated tube and includes an insulator 908 extending from the proximal end of the perforated tube 904. Can be done. An electrical connector (not shown) can be connected to the proximal end of electrode 902. The perforated tube 904 can be made of a flexible, insulating or conductive material and is usually perforated throughout. The foam plug device 900 may further include additional sealing elements (not shown) and / or adhesives as described herein. In use, the ear canal is sealed by compressing the foam plug 906, inserting it into the ear canal, and then inflating it. Due to the open cell nature of the effervescent plug 902, the drug solution can be introduced into the ear canal before or after inserting the effervescent plug device 900. Due to the porosity of the foam plug, the chemical solution contacts over the entire length of the perforated tube 904, so that the holes in the perforated tube 904 increase the surface area of the electrode. The porosity of the spark plug further prevents pressure buildup during the iontophoresis method.
FIG. 9B shows a foam balloon device 910 according to an embodiment of the present invention. The foam balloon device 910 includes an electrode 921. The electrode 912 can be constructed from a single or stranded wire of malleable metal (eg silver), or a solid or perforated tube. In one embodiment, the electrode 912 is an outer lumen (not shown) having an inner diameter of about 0.152 cm (0.060 inch) and an outer diameter of about 0.183 cm (0.072 inch), which can be made from a polyether block amide (eg, Pebax® 55D). ) Can be included. An electrical connector (not shown) can be connected to the proximal end of the electrode. Electrode 912 may further include a distal end in which an expansion insulator surrounds a plurality of conductor strands. A foam plug 914 surrounds the electrode 912. The foam plug 914 can be constructed from open cell foam material. Foamex Innovation with a density of 5 lbs / cubic foot Inc.'s Polyether Foaming Material (EC85HDE) has been found to be suitable. The foam plug may have a cylindrical shape with an outer diameter of 5 to 15 mm and an inner diameter of 2.5 mm. 8.3 mm and 11 mm were used as the outer diameter. The foam plug may have other shapes such as a conical shape. The foam plug is wrapped in a double-walled balloon 916. The double wall balloon 916 can be constructed from flexible, semi-flexible, or inflexible materials. In one embodiment, the double-walled balloon 916 can be formed by dipping-coating the molded mandrel with a silicone such as MED10-6400 from NuSil Technology LLC. Subsequently, the double wall balloon 916 can be adhered to a part of the electrode 912 and then partially turned inside out to form a double wall. This allows the foam plug 914 to be inserted into the space between the walls. The distal portion of the balloon 916 can be connected to a suction coupler 918 such as the T connector 88207 available from Qosina Corp.
At the time of use, the foam plug 914 can be crushed by applying a vacuum to the suction coupler 918. In this state, the foam balloon device 910 can be inserted into the ear canal. After being placed in place, the vacuum state can be released, which causes the foam 914 to expand. The expansion of the foam 914 pushes the double-walled balloon 916 into contact with the ear canal wall, tightly sealing the drug solution into the ear canal. No positive air pressure is used to inflate the double-walled balloon, so there is no risk of the balloon exploding. To remove it from the ear canal, apply vacuum again to crush the foam 914 again.
FIG. 10A shows a speculum port 1000 according to an embodiment of the present invention. The speculum port 1000 may have a substantially conical shape. The speculum port 1000 can be made of a polymer or metal alloy. The speculum port 1000 may be relatively flexible or rigid. The speculum port 1000 may include a proximal port 1002 detachably connected to a distal port 1004. Proximal port 1002 can be connected to distal port 1004 with a light tightening or screw connection. The inner plug 1006 can be detachably and sealably connected to the distal port 1004. The inner plug 1006 includes an electrode 1008 configured as a looped electrode as shown in FIG. 2F. However, the electrode 1008 may generally be in any form of the electrode disclosed herein. The inner plug 1006 may include a sealing member (not shown) configured similar to the other sealing members disclosed herein. The distal port 1004 may include an adhesive layer 1010 which may be in any form of the adhesive disclosed herein. The adhesive layer 1010 may be a layer of flexible silicone putty, ostomy bag adhesive gasket material, inflatable foam material, impression material, gel, bast wax, balloon cement, or silicone gasket.
FIG. 10B shows an alternative distal port 1012 according to an embodiment of the invention. The distal port 1012 is configured similarly to the distal port 1004, but the distal port 1012 contains an electrode surface 1014. The electrode surface 1014 can be a layer of metal, such as silver, bound to the inner surface of the distal port 1004. The inner plug 1016 can be detachably and sealably connected to the distal port 1012. The inner plug 1016 may include a contact surface 1018 capable of making electrical contact with the electrode surface when the inner plug 1016 is connected to the distal port 1004.
FIG. 10C shows another distal port 1020 according to one embodiment of the invention. The distal port 1012 is configured similar to the distal port 1004, but the distal port 1012 is connected to a plug with a plurality of tentacle-like electrodes 1022. The tentacle-shaped electrode 1022 is extremely flexible and provides a larger surface area. The tentacle-shaped electrode 1022 may include an insulating region and a conductive region of the exposed metal.
10D and 10E show the usage state of the speculum port 1000 according to the embodiment of the present invention. Specimen port 1000 can be processed by proximal port 1002. Due to the large diameter of the proximal port 1002, the speculum port 1000 can be operated and inserted with a finger. The speculum port can be adjusted so that the eardrum can be seen. The adhesive layer 1010 on the distal port 1004 provides a liquidtight seal and fixation between the distal port 1004 and the ear canal. After the speculum port 1000 is optimally positioned, the proximal port 1002 can be removed from the distal port 1004. The distal port 1004 can then be filled with a drug solution and the inner plug 1006 can be inserted into the distal port 1004. The inner plug 1006 can then be supplied with an electric current to complete the iontophoresis method.
10F to 10H show the usage state of the speculum port 1000 according to the embodiment of the present invention. The speculum port 1000 includes another distal port 1012 with an electrode surface 1014. The distal port 1012 is already located in the ear canal and the proximal port 1002 has been removed, according to FIGS. 10D and 10E. The distal port 1012 can be filled with a drug solution and the inner plug 1016 can be inserted into the distal port 1012. The inner plug 1016 can then be supplied with an electric current to complete the iontophoresis method.
FIG. 11 shows a simplified support structure 1100 attached to a patient's head according to an embodiment of the present invention. The simplified support structure 1100 is worn on the patient's head in an upright position with the patient awake. The support structure 1100 is configured to hold one or more of the systems described herein aligned with the patient's ear E. As shown in FIG. 11, in the support structure 1100, the first body 1110 engages the first ear, the second body 1110 engages the second ear, and one member is the first. It can have an alignment structure that extends around the patient's head between the body and the second body. Any of the earplugs of the present invention can be connected to the head by a headset similar to that shown in FIG.
FIG. 12 shows a simplified support structure 1200 mounted on a patient's head according to an embodiment of the present invention. The support structure 1200 has a structure similar to eyeglasses and can be worn in the same manner as eyeglasses. The earplug 1210 is hinged to the support structure 1200 and can be inserted into the ear canal by the support structure 1200. The earplugs 1210 can be configured similar to any of the earplugs disclosed herein. The support structure 1200 prevents unnecessary movement and can provide a sealing force against the earplug 1210. The support structure 1200 can include adjustable elements for adjusting the width and length for patients of various sizes. The support structure 1200 may include a visual panel, such as a liquid crystal panel, so that the patient can watch the video. The earplug 1210 may further include a speaker that provides audio to the patient.
13A and 13B show earplugs 1300 for delivering iontophoresis material to the eardrum, according to another embodiment. The earplug 1300 includes a flexible sealing element 1302 having an elongated tube 1304, which elongated tube 1304 extends proximally from the flexible sealing element. The earplugs 1300 can be formed from a flexible material such as silicone. The flexible seal element 1302 may have an umbrella-like shape as shown. The flexible sealing element 1302 has a distal surface 1306 that tightly seals the ear canal, the distal surface 1306 containing a plurality of micropores 1308. Micropores 1308 are configured to expel excess fluid (air and / or liquid) once a certain pressure threshold is exceeded. Micropores 1308 generally do not drain fluid under hydrostatic conditions, i.e. below the pressure threshold. In one embodiment, the diameter of the micropores 1308 may be from about 0.0051 cm (0.002 inch) to about 0.0635 cm (0.025 inch), and in some embodiments from about 0.0203 cm (0.008 inch) to about 0.0381 cm (. 0.015 inch). In another embodiment, the micropore 1308 is a self-sealing hole made within the flexible sealing element 1302 that does not allow fluid to pass through unless pressure is applied. In one embodiment, 10 to 25 micropores are provided in the flexible sealing element 1302. Absorbent inserts (not shown), such as foam inserts, may be placed behind the flexible sealing element to absorb fluid secretions from the micropores 1308. The earplugs 1300 can be connected to the electrode device 206 as described above, and the electrode device 206 can be inserted into the tube 1304.
At the time of use, the earplug 1302 is first inserted into the patient's ear canal, thereby creating a space between the flexible sealing element 1302 and the patient's eardrum. Subsequently, the iontophoresis material can be injected into the space between the flexible seal element 1302 and the eardrum via an elongated tube 1304. The injection of the iontophoresis material raises the fluid pressure in the space, and at the same time, the fluid escapes through the micropores 1308 to remove the fluid pressure. Therefore, the patient does not experience discomfort due to excessive pressurization of the space. Once the iontophoresis material is observed to be released through the micropores 1308, the user may stop injecting the iontophoresis material. Subsequently, the electrode device 206 can be inserted into the earplug 1300 as described above and a voltage can be applied to anesthetize the eardrum with the iontophoresis material.
FIG. 13C shows an earplug 1310 according to another embodiment. The earplug 1310 is configured in the same manner as the earplug 1300 described above. The earplug 1310 includes a flexible sealing element 1302 having a distal surface 1314 as well as a plenum 1316 inside. The plenum 1316 is fluid-coupled to multiple micropores 1308 on the distal surface 1314, as well as to the drainage channel 1318, which exits proximal to the earplug 1310. The earplug 1310 includes an elongated inner tube 1320 that can be connected to the electrode device 206. The drain channel 1318 lies between the elongated inner tube 1320 and the elongated tube 1304. Alternatively, the elongated inner tube 1320 may be integrated with the elongated tube 1304 to form a single tube.
When in use, the earplug 1310 is used in the same way as the earplug 1300. During the injection of the iontophoresis material, fluid can be expelled through the micropores 1308 into the plenum 1316 and subsequently through the discharge channel 1318. Once the iontophoresis material is observed to be released through the discharge channel 1318, the user may stop injecting the iontophoresis material. Alternatively, the user may inject the iontophoresis material through the discharge channel 1318 to allow the fluid to drain through the elongated inner tube 1320. In this embodiment, Plenum 1316 can function as a reservoir of iontophoresis material so that excess iontophoresis material is supplied to the ear canal as needed.
FIG. 14A shows a system 1400 for delivering iontophoresis material to the eardrum, according to another embodiment. The system 1400 includes an earplug 1402 (which may have any of the configuration of the earplugs disclosed herein) and an electrode device 206. The earplug 1402 is located distal within the lumen of the earplug 1402 and includes at least one electrode 1404 integrated with the lumen of the earplug 1402. Electrode 1404 can be formed from silver alloy wire and can be configured as a cylindrical cage. The electrode 1402 is configured to be electrically connected to the electrode tip portion 228 of the electrode device 206, and also receives energy from the electrode tip portion 228. The electrode 1404 can apply a compressive force to the electrode tip portion 228. Electrode 1404 maximizes the total surface area of the electrode available for iontophoresis treatment. Electrode 1404 also creates spatial spacing between the electrode elements to reduce the current blocking effect of the precipitate formed on the electrode surface during iontophoresis treatment.
FIG. 14B shows an electrode 1404 that is an axially wound cylindrical cage configured as a cylindrical cage forming a plurality of axially aligned fingers or loops 1406. FIG. 14C shows electrode 1408 according to another embodiment. In this figure, the electrode 1408 is configured as a coil capable of applying a compressive force to the electrode tip portion 228.
Figures 15A and 15B show a headset 1500 for delivering iontophoresis material to the eardrum, according to another embodiment. The headset 1500 includes a neck loop 1502 that is configured to be located behind the patient's neck. The neck loop 1502 is configured to apply resistance and compressive forces when expanded. The neck loop 1502 is connected to the left ear hook 1504L and the right ear hook 1504R. The earhook 1504L is configured to wrap behind the left concha of the patient's ear, and the earhook 1504R is configured to wrap behind the right concha. The earhook 1504L has a left contact area 1506L configured to be placed over the patient's left skull, and the earhook 1504R has a right contact area 1506R configured to be placed over the right skull. including.
The left swing arm 1508L is spring-loaded and is connected to the left ear hook 1504L in a swinging manner, and the right swing arm 1508R is spring-loaded and connected to the right ear hook 1504R in a swinging manner. The left ear plug 1510L is connected to the left swing arm 1508L, and the right ear plug 1510R is connected to the right swing arm 1508R. The left earplug 1510L and the right earplug 1510R may be configured similar to any of the earplugs disclosed herein. The left fluid channel 1512L runs outside along the ear hook 1504L and neck loop 1502, and the right fluid channel 1512R runs outside along the ear hook 1504R and neck loop 1502, or even inside. Good.
The left fluid channel 1512L is fluidly connected to the left earplug 1510L to supply iontophoresis material to the left earplug 1510L, and the right fluid channel 1512R is fluidly connected to the right earplug 1510R and ionized to the right earplug 1510R. Supply foresis material. The left electrical connection 1514L runs inside and outside along the ear hook 1504L and neck loop 1502, and the right electrical connection 1514R runs inside and outside along the ear hook 1504R and neck loop 1502. There is. The left electrical connection 1514L is electrically connected to the electrode of the left ear plug 1510L to supply energy to the electrode of the left ear plug 1510L, and the right electrical connection 1514R is electrically connected to the electrode of the right ear plug 1510R. To supply energy to the electrodes of the right ear plug 1510R.
Figures 15C and 15D show the usage of the headset 1500 according to another embodiment. The neck loop 1502 is located behind the patient's neck, the earhook 1504L is located behind the left concha of the patient's ear, and the earhook 1504R is located behind the right concha of the patient's ear. And supports the headset 1500. To keep the headset 1500 in place, the neck loop 1502 applies compressive force to the left and right contact areas 1506 L / R located above the patient's temporal bone. Since the temporal bone is fixed to the patient's body, the headset 1500 does not move due to movements imparted by facial movements such as conversation.
The left swing arm 1508L applies a force independent of the compressive force of the neck loop 1502 to the left ear plug 1510L, and the right swing arm 1508R applies a force independent of the compressive force of the neck loop 1502 to the right ear plug 1510R. Therefore, when placing the headset, it is not necessary to place both the left ear plug 1510L and the right ear plug 1510R, either the left ear plug 1510L or the right ear plug 1510R, depending on the needs of the procedure. Only one and the corresponding swing arm 1508L or R may be used. Further, since the force applied by the left swing arm 1508L and the right swing arm 1508R is not determined by the compressive force of the neck loop 150, the force applied by the left swing arm 1508L and the right swing arm 1508R is the patient's head. It is not determined by the width of. Therefore, the headset 1500 can be used for patients of various head sizes without compromising the sealing performance of the left ear plug 1510L and the right ear plug 1510R.
The left fluid channel 1512L and the right fluid channel 1512R can be filled with iontophoresis material at low pressure (eg, gravity feed) to fill the left ear plug 1510L and right ear plug 1510R, as well as the corresponding ear canal. Low pressure filling helps prevent the formation of air bubbles in the ear canal. It is beneficial to prevent the formation of bubbles, as bubbles in the iontophoresis solution can adversely affect the application of current to the iontophoresis solution. Subsequently, a voltage is applied to the left electrical connection 1514L and the right electrical connection 1514R to supply energy to the electrodes of the left ear plug 1510L and the right ear plug 1510R, resulting in an iontophoresis substance in the ear canal. Can be supplied with energy to anesthetize the patient's eardrum.
The present invention can be practiced in other particular embodiments without departing from its essential properties. These other embodiments shall be included in the scope of the present invention described in the "Claims" below.
[Implementation mode] (1) A method of delivering an iontophoresis substance to the eardrum of a human or animal patient's ear. Inserting the earplug into the patient's ear canal and A part of the flexible sealing element of the earplug is fluidly sealed in the ear canal to create a space between the earplug and the eardrum. Injecting an iontophoresis substance into the earplug to fill the space between the earplug and the eardrum. Including A method in which the space is pressurized by the iontophoresis substance during injection, and the fluid in the space is discharged through the micropores of the flexible sealing element to release the pressure. (2) The method according to embodiment 1, wherein the micropores are configured to drain the fluid when the pressure threshold is exceeded. (3) The method according to the second embodiment, wherein the micropores are configured so as not to discharge the fluid under still water conditions. (4) The method according to embodiment 1, wherein the fluid is discharged into the plenum of the earplug. (Five) Inserting the electrode device into the ear plug to bring the tip of the electrode of the electrode device into contact with the iontophoresis substance. Applying a voltage to the electrode device to anesthetize the eardrum with the iontophoresis substance, The method according to embodiment 1, further comprising. (6) The method according to embodiment 5, wherein the tip of the electrode is electrically connected to the electrode of the ear plug, and a voltage is applied to the electrode of the ear plug by the electrode device. (7) The method of embodiment 1, wherein inserting the earplugs comprises placing a headset coupled to the earplugs behind the patient's neck. (8) The headset includes a left ear hook and a right ear hook, and placing the headset allows the corresponding portion of the left ear hook to rest on the patient's left skull and the right ear hook to correspond. 7. The method of embodiment 7, comprising placing the portion to be placed on the right skull of the patient. (9) The headset is connected to a second earplug, the second earplug is configured identically to the earplug, and the headset applies an independent force to the earplug to The method of embodiment 7, wherein the earplugs are held in the corresponding ear canal. (10) The headset comprises a fluid channel fluidly connected to the earplug and the second earplug, respectively, and injecting the iontophoresis material lowers the fluid channel of the headset. 9. The method of embodiment 9, comprising filling under pressure.
(11) The first embodiment, further comprising observing the fluid discharged from the earplug, stopping the injection of the iontophoresis substance when the fluid is observed to be discharged from the earplug. The method described in. (12) A system for delivering iontophoresis substances to the eardrum of the ear of a human or animal patient. It s an earplug, A flexible sealing element comprising an elongated tube extending proximally from the flexible sealing element, wherein the flexible sealing element has a distal sealing surface having a plurality of micropores, said micropores. With earplugs, including flexible sealing elements, which are configured to drain fluid when the pressure threshold is exceeded, An electrode device that is movable in the inner tube and includes an elongated shaft connected to the tip of the electrode, and an electrode device that includes an elongated shaft. Including the system. (13) The system according to embodiment 12, wherein the micropores are configured not to drain the fluid under hydrostatic conditions. (14) The system according to embodiment 12, wherein the flexible sealing element comprises an internal plenum and the micropores are fluid connected to the internal plenum. (15) The system according to embodiment 14, wherein the internal plenum is fluidly connected to the discharge channel of the elongated tube. (16) The system according to embodiment 15, wherein the elongated tube comprises an elongated outer tube over an elongated inner tube in which the drainage channel is located. (17) The system according to embodiment 12, wherein the elongated tube comprises at least one electrode integrated into the elongated tube, and the at least one electrode is electrically connectable to the tip of the electrode. .. (18) The system of embodiment 17, wherein the electrode comprises a wire formed as a cylindrical cage. (19) The system according to embodiment 18, wherein the cylindrical cage comprises a coil. (20) The system according to embodiment 18, wherein the cylindrical cage comprises a plurality of loops arranged in the axial direction.
(21) The system according to embodiment 18, wherein the cylindrical cage is configured to compress the electrode tip. (22) The system according to embodiment 12, wherein the flexible sealing element has an umbrella-like shape. (23) An embodiment further comprising a second ear plug and a second electrode device, wherein the second ear plug is configured to be the same as the ear plug, and the second electrode device is configured to be the same as the electrode device. The system described in 12. (24) The system according to embodiment 23, further comprising a headset connecting the earplugs to the second earplugs. (25) The 24th embodiment, wherein the headset includes a neck loop connected to a left and right ear hook, and the left and right ear hooks are respectively configured to wrap behind the concha. system. (26) In embodiment 25, wherein the left ear hook is configured to apply a compressive force from the neck loop onto the patient's left skull and the right ear hook onto the patient's right skull. Described system. (27) The headset further includes a left low pressure fluid channel and a right low pressure fluid channel, the left low pressure fluid channel in the inner tube of the earplug and the right low pressure fluid channel in the second earplug. 25. The system according to embodiment 25, which is fluidly connected to a tube. (28) The headset further comprises a spring-loaded left swing arm and a spring-loaded right swing arm, the spring-loaded left swing arm swiveling onto the left ear hook and the spring-loaded right swing arm swiveling onto the right ear hook. 25. The system according to embodiment 25, wherein the spring-loaded left swing arm is connected to the ear plug and the spring-loaded right swing arm is connected to the second ear plug.
60 sheets
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Every citation, both ways
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| WO2007111365A1 | Cites | World Intellectual Property Organization (WIPO) |
| JP2002509474A | Cites | Japan |
| WO2009108659A1 | Cites | World Intellectual Property Organization (WIPO) |
51 members in 12 offices
Priority claims9
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| MX2011001100A | Mexico | A | |
| MX2011001100A | Mexico | A | |
| KR20110042328A | Republic of Korea | A | |
| KR20110042328A | Republic of Korea | A | |
| EP2328653A1 | European Patent Office (EPO) | A1 | |
| CN102119041A | China | A | |
| CA2786551A1 | Canada | A1 | |
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| JP2011529747A | Japan | A | |
| AU2010337214A1 | Australia | A1 | |
| MX2012007726A | Mexico | A | |
| MX2012007726A | Mexico | A | |
| EP2328653B1 | European Patent Office (EPO) | B1 | |
| KR20120099146A | Republic of Korea | A | |
| RU2011107228A | Russian Federation | A | |
| EP2519199A1 | European Patent Office (EPO) | A1 | |
| ES2393697T3 | Spain | T3 | |
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Numbers
- Publication
- 5774601
- Publication, DOCDB
- 5774601
- Publication, EPODOC
- JP5774601B
- Application
- 2012547088
- Application, DOCDB
- 2012547088
- Application, EPODOC
- JP20120547088
Titles2
- Japanese
- 耳組織を麻酔するためのシステム及び方法
- English
- Systems and methods for anesthetizing ear tissue
Classification
- CPC, 17
- A61F11/00
- A61M37/00
- A61K9/0009
- A61K9/0046
- A61M3/0279
- A61M19/00
- A61M2210/0662
- A61M2210/0668
- A61N1/303
- A61N1/36021
- A61M2205/3341
- A61F11/08
- A61N1/0526
- A61N1/325
- A61M1/90
- A61M31/002
- A61M2202/048
- IPC, 2
- A61F11 00
- A61N1 30
