CN109045454B - Middle ear repeated drug delivery device and artificial cochlea implantation electrode - Google Patents
Middle ear repeated drug delivery device and artificial cochlea implantation electrode Download PDFInfo
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- CN109045454B CN109045454B CN201811248653.6A CN201811248653A CN109045454B CN 109045454 B CN109045454 B CN 109045454B CN 201811248653 A CN201811248653 A CN 201811248653A CN 109045454 B CN109045454 B CN 109045454B
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- bag
- drug delivery
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- middle ear
- delivery device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0526—Head electrodes
- A61N1/0541—Cochlear electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36036—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear
- A61N1/36038—Cochlear stimulation
Abstract
The invention relates to the field of otology medical equipment, in particular to a middle ear repeated drug delivery device and an artificial cochlea implantation electrode. The middle ear repeated drug delivery device comprises a hollow bag and a connecting pipe connected below the bag, wherein a one-way valve is arranged at the joint of the bag and the connecting pipe; wherein, the upper part of the bag is opened and a biological semipermeable membrane is arranged at the opening. The bag is arranged between the hammer and the long leg of the incus, the upper part of the bag is contacted with the tympanic membrane, a groove is transversely arranged above the bag, and the groove of the bag is blocked on the hammer handle. The invention creates a safe, convenient and economic new technical method for relieving the wound reaction of cochlear electrode implantation, inducing regeneration, replacing auditory nerve cells, optimizing the implantation effect of artificial cochlea and improving the speech recognition capability of patients.
Description
Technical Field
The invention relates to the field of otology medical equipment, in particular to a middle ear repeated drug delivery device and an artificial cochlea implantation electrode.
Background
The artificial cochlea implant is widely applied to clinic, and when a cochlea implant electrode is opened, medicines, neurotrophic factors, genes and intracellular inner ear injection therapy are given, so that the injury of the inner ear can be relieved, the nerve repair of the inner ear is promoted, and the regeneration of auditory nerve cells is supplemented and induced. Thereby improving the effect of artificial cochlea implantation and improving the speech recognition ability of the patient.
Since the us FDA officially approved the use of multi-lead cochlear implants in adults in 1984, 30 thousands of deaf people worldwide have regained hearing by implanting them. Intra-cochlear electrodes restore partial hearing by direct electrical stimulation of the neural tissue (spiral ganglion cells) near the electrode contacts. Electrical stimulation is achieved by electrodes inserted into the scala tympani of the cochlea with an implanted stimulator connected thereto. However, insertion of the electrodes can cause varying degrees of trauma within the cochlea, and inner ear trauma can subsequently cause apoptosis and/or necrosis of neural tissue (i.e., hair cells and spiral ganglion cells).
Currently, it is clinically accepted that injection of corticosteroids can reduce the post-operative impedance rise through the open scala tympani or round window when performing cochlear implants. There have also been studies that injecting neurotrophic factors into the cochlea may improve the response of the implanted electrodes, possibly contributing to the patient's speech recognition ability. However, one-time administration intervention cannot maintain the therapeutic effect. Multiple administrations are required to achieve a long-term therapeutic effect.
MED-EL Electrical medical devices, Inc. in 2007 filed an invention patent, "implantable neurostimulation electrode with fluid reservoir" (patent application No.: CN 200780027561.9). The patent discloses an implantable cochlear electrode array for electrically stimulating cochlear tissue, comprising a drug eluting portion of polymeric material adapted to release over time a therapeutically effective amount of a pharmaceutical agent for the inner ear. And an implantable electrode carrier comprising a fluid reservoir containing a volume of therapeutic fluid.
The drug delivery materials used in the prior art are all disposable, either with polymer drug elution or fluid reservoirs, and carry a limited amount of drug, which is not therapeutically effective once released. Furthermore, the fluid reservoir needs to be implanted subcutaneously or fixed to the cochlea, some of which require additional fenestrations in the cochlea. Increasing trauma to the patient and risking additional damage to the cochlea. The drug in the fluid reservoir requires a micro-pump to provide pressure to deliver the drug to the inner ear, which also requires implantation and is expensive.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a middle ear repeated drug delivery device, and further provides a cochlear implant electrode comprising the middle ear repeated drug delivery device.
The specific technical scheme of the invention is as follows:
the invention provides a middle ear repeated drug delivery device, which comprises a hollow bag and a connecting pipe connected below the bag, wherein a one-way valve is arranged at the joint of the bag and the connecting pipe;
wherein, the upper part of the bag is provided with an opening, a biological semipermeable membrane is arranged at the opening, and a groove is transversely arranged above the bag.
The middle ear repeat drug delivery device according to the present invention, wherein the capsular bag is placed between the malleus and the long leg of the incus, the upper side of the capsular bag is in contact with the tympanic membrane, a groove is transversely formed above the capsular bag, and the groove of the capsular bag is caught on the malleus handle.
The middle ear repeat drug delivery device according to the present invention, wherein preferably the bladder is a collapsible cylindrical structure, such as but not limited to a cylinder with an accordion bellows structure.
The middle ear repeated drug delivery device according to the present invention, wherein it is further preferred that the outer diameter of the outer ring of the capsular bag is 3-5 mm, the height is not more than 1.5mm when compressed to the tightest, and not more than 2.5mm in the natural relaxed state.
The middle ear repeated drug delivery device according to the present invention, wherein the length of the connection tube is preferably 10 to 15 mm.
According to the middle ear repeat drug delivery device of the present invention, preferably, the upper center of the bag is opened and a groove is provided in the middle and transverse direction above the bag.
The invention also provides a cochlear implant electrode comprising the middle ear repeated drug delivery device as described in any one of the above.
The cochlear implant electrode according to the present invention is provided with an expanded part behind the last stimulating electrode foil in the cochlear implant, and the expanded part is connected with the end of the connecting tube of the middle ear repeated drug delivery device.
A cochlear implant electrode according to the present invention, wherein a stimulation electrode within the cochlear implant has at least one drug delivery port thereon.
The invention provides a novel artificial cochlea implanting electrode, which is characterized in that: 1. having a biocompatible storage device (i.e., the middle ear repeat drug delivery device of the present invention) that allows for repeated drug delivery, the device being implantable in the middle ear cavity; it is connected with the cochlear implant electrode through a connecting pipe with a one-way valve; 2. an implant electrode has at least one drug delivery port connecting the reservoir device to an outer surface of the electrode carrier for delivering therapeutic drug from the reservoir device to the implant electrode outer surface.
The invention fixes and positions the fluid storage device capable of repeatedly feeding by depending on the natural physiological structures of the tympanic membrane and the ossicular chain. The biological treatment liquid such as a drug in the fluid storage device is injected into the cochlea by the vibration of the tympanic membrane and the pressure of the stapedius muscle reflex twitch. The device such as a micro pump and the like is not required to be additionally implanted, the wound of a patient is reduced, the manufacturing cost is low, and the economic burden of the patient is avoided. Can be injected with therapeutic drugs or biological therapeutic fluids of inner ear such as genes, stem cells and the like for a plurality of times and repeatedly through the routine outpatient treatment of tympanic membrane puncture. The method creates a safe, convenient and economic new technical method for relieving the wound reaction of cochlear electrode implantation, inducing regeneration, replacing auditory nerve cells, optimizing the implantation effect of artificial cochlea and improving the speech recognition capability of patients.
Drawings
FIG. 1 is a schematic diagram of a middle ear repeat delivery device of the present invention, wherein the left side is a top view of the device and the right side is a front view of the device;
FIG. 2 is a schematic diagram of a cochlear implant electrode including a middle ear repeat drug delivery device of the present invention;
fig. 3 is a schematic diagram of middle ear implantation of a cochlear implant electrode comprising a middle ear repeated drug delivery device according to the present invention.
Reference numerals
1. A capsular bag 11, a biological semipermeable membrane 12, a groove 2, a connecting pipe 3, an implantation electrode 31, an expansion part 4 and an implant.
Detailed Description
The present invention will now be described in further detail with reference to the accompanying drawings.
As shown in figure 1, the middle ear repeated drug delivery device comprises a hollow bag 1 and a connecting pipe 2 connected below the bag, wherein a one-way valve is arranged at the joint of the bag and the connecting pipe; wherein, the upper part of the bag is provided with an opening, the opening is provided with a biological semipermeable membrane 11, and a groove 12 is transversely arranged above the bag and can be conveniently connected with the malleus handle. The middle ear repeated drug delivery device (comprising the bag, the connecting pipe and the like) adopts the same biocompatible material (such as silica gel, polyethylene, Teflon and the like) as the outer surface of the cochlear implant.
The biological semipermeable membrane (collodion film, cellophane and the like) arranged at the opening above the bag can cover the opening and can also be lined at the inner side of the opening.
As shown in fig. 3, the capsular bag is placed between the malleus and the long leg of the incus, the upper part of the capsular bag is in contact with the tympanic membrane, and the groove of the capsular bag is caught on the manubrium.
Wherein preferably, the bag is of a telescopic cylindrical structure, so that the bag has a certain telescopic space, and preferably adopts a cylindrical structure with an organ bellows structure. Further preferably, the diameter of the outer ring of the bag is 3-5 mm, the height of the bag is not more than 1.5mm when the bag is compressed to be tightest, and the height of the bag is not more than 2.5mm in a natural relaxation state. Preferably, the length of the connection pipe is 10 mm.
Further preferably, the pocket is centrally open above and a groove is provided centrally and laterally above the pocket, which opening may be, but is not limited to, a circular mouth.
As shown in fig. 2 and 3, the present invention also provides a cochlear implant electrode including the middle ear repeat drug delivery apparatus as set forth in any of the above. The cochlear implant electrode 3 is provided with an expansion part 31 behind the last stimulating electrode foil in the cochlear implant, wherein the expansion part is the contact part between the cochlear implant electrode and a round window or a scala tympani window, and is connected with the tail end of a connecting pipe of a middle ear repeated drug administration device at the expansion part. A stimulation electrode within the cochlear implant has at least one drug delivery port thereon. The signal receiving end of the cochlear implant electrode is connected with a known implant 4, and the implant is used for receiving signals and transmitting the signals to the implant electrode.
The middle ear repeated drug delivery device and the artificial cochlea implant electrode have the following specific using processes:
(1) manufacturing a novel implanted electrode: as shown in fig. 1 and 2, the cochlear implant electrode of the present invention has the same implant, electrode array, as the conventional electrode. In contrast, a biocompatible reservoir device (i.e., the middle ear repeat drug delivery device of the present invention) is attached at the intersection of the electrode lead and the electrode array, which is capable of repeated drug delivery, and is implantable in the middle ear cavity. The outer surface of the implanted electrode array has at least one drug delivery port for delivering a therapeutic drug from the reservoir device to the outer surface of the implanted electrode.
(2) The specific implantation mode of the cochlear implant electrode with the middle ear repeated drug delivery device is as follows: after completion of the conventional cochlear implant, as shown in fig. 3, the middle ear repeat drug delivery device connected to the cochlear electrode is placed between the malleus and the long leg of the incus, taking care that the front (i.e., upper) of the capsular bag is in contact with the tympanic membrane and the groove of the front is caught on the malleus handle. The implanted capsular bag is then bonded to the ossicles on both sides with a bio-organic glue, which may be, but is not limited to, a cyanoacrylate adhesive, such as the quick-drying glue series available from Permabond.
(3) Administration pressure generation mode: as shown in fig. 3, the drug or biological treatment fluid stored in the capsular bag implanted in the middle ear, in the absence of pressure, is unable to open the one-way valve at the end of the capsular bag into the cochlea. The pressure for promoting the medicine to enter the cochlea comes from the force for driving the auditory ossicle chain to move by the motion of the tympanic membrane, and a micro pump is not needed to be implanted to provide the pressure at all, and the electric power maintenance is not needed. The tympanic membrane can be pushed to move by a tympanic membrane pressing device (such as a pressing otoscope, a Boehringer bulb or a Mernit instrument with controllable frequency and pressure) which is widely used in clinic, and the pressure generated by pressing the capsular bag is enough to open the valve and inject the liquid medicine into the cochlea. Alternatively, electrical stimulation via a cochlear electrode induces a reflex of the stapedius muscle, which drives movement of the stapedius bone through the ossicular chain to the capsular bag implanted between the ossicles, squeezing the capsular bag to create a pressure sufficient to open the valve and inject the liquid drug into the cochlea. Or a combination of both, to achieve optimal dosing pressure.
(4) The repeated administration mode comprises the following steps: the middle ear implanting device manufactured by the invention forms a mark area on the umbilicus of the tympanic membrane after being connected with the malleus and the tympanic membrane. Within a circle of radius of 1mm around the umbilicus, drugs and biotherapeutic fluids can be precisely injected into the capsular bag implanted between the ossicles by fine needle penetration.
Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and are not limited. Although the present invention has been described in detail with reference to the embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the spirit and scope of the invention as defined in the appended claims.
Claims (5)
1. A cochlear implant electrode, comprising a middle ear repeat drug delivery device; the middle ear repeated drug delivery device comprises a hollow bag and a connecting pipe connected below the bag, a one-way valve is arranged at the joint of the bag and the connecting pipe, and the bag is of a telescopic cylindrical structure;
wherein, the upper part of the bag is provided with an opening and a biological semipermeable membrane is arranged at the opening;
the bag is arranged between the hammer and the long leg of the incus, the upper part of the bag is contacted with the tympanic membrane, a groove is transversely arranged above the bag, and the groove of the bag is blocked on the hammer handle;
the cochlear implant electrode is provided with an expansion part behind the last stimulating electrode metal sheet in the cochlear implant, and the expansion part is connected with the tail end of a connecting pipe of the middle ear repeated drug delivery device.
2. The cochlear implant electrode of claim 1, wherein the stimulation electrode in the cochlear implant has at least one drug delivery port thereon.
3. The cochlear implant electrode of claim 1 or 2, wherein the outer ring of the capsular bag has a diameter of 3-5 mm, a height of not more than 1.5mm when compressed to the tightest, and not more than 2.5mm in a natural relaxed state.
4. The cochlear implant electrode of claim 1 or 2, wherein the connecting tube has a length of 10 to 15 mm.
5. A cochlear implant electrode according to claim 1 or 2, wherein the capsular bag is open centrally above and a groove is provided centrally laterally above the capsular bag.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811248653.6A CN109045454B (en) | 2018-10-25 | 2018-10-25 | Middle ear repeated drug delivery device and artificial cochlea implantation electrode |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201811248653.6A CN109045454B (en) | 2018-10-25 | 2018-10-25 | Middle ear repeated drug delivery device and artificial cochlea implantation electrode |
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| CN109045454A CN109045454A (en) | 2018-12-21 |
| CN109045454B true CN109045454B (en) | 2021-02-02 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN213851263U (en) * | 2020-07-31 | 2021-08-03 | 黄建民 | Cup-shaped top plate artificial titanium auditory ossicle |
| CN115430026A (en) * | 2022-09-23 | 2022-12-06 | 南京鼓楼医院 | Integrated artificial cochlea implant repeated delivery dosing electrode and control device |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1437491A (en) * | 1999-12-27 | 2003-08-20 | 阿尔萨公司 | Osmotic beneficial agent delivery system |
| CN101489623A (en) * | 2006-07-24 | 2009-07-22 | Med-El电气医疗器械有限公司 | Implantable neuro-stimulation electrode with drug elution material |
| CN104519926A (en) * | 2012-07-13 | 2015-04-15 | Med-El电气医疗器械有限公司 | Implantable fluid delivery system with floating mass transducer driven pump |
| CN104703650A (en) * | 2012-03-15 | 2015-06-10 | Med-El电气医疗器械有限公司 | Accessory device for inner ear drug delivery |
| WO2017203397A1 (en) * | 2016-05-26 | 2017-11-30 | Cochlear Limited | Inner ear plug |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL105073A0 (en) * | 1992-03-17 | 1993-07-08 | Becton Dickinson Co | User activated iontophoretic device and method for using same |
| EP1238659B1 (en) * | 1996-02-02 | 2004-09-29 | ALZA Corporation | Sustained delivery of an active agent using an implantable system |
| DE19928611A1 (en) * | 1999-06-22 | 2000-12-28 | Lre Technology Partner Gmbh | Portable applicator for supplying fluid medicament continuously to middle ear includes detachable cover and reservoir, with tubing leading to cannula retained in ear drum |
| US20080213331A1 (en) * | 2002-04-08 | 2008-09-04 | Ardian, Inc. | Methods and devices for renal nerve blocking |
| CN101528283A (en) * | 2005-01-24 | 2009-09-09 | 纽罗赛斯特克公司 | Apparatus and method for delivering therapeutic and/or other agents to the inner ear and to other tissues |
| US20070077270A1 (en) * | 2005-03-28 | 2007-04-05 | Clemson University | Delivery devices and methods for long-term, targeted delivery of therapeutic agents to the eye and ear |
| US8956333B2 (en) * | 2005-04-22 | 2015-02-17 | Alternamedics Llc | Medication delivery device |
| JP5461427B2 (en) * | 2007-12-17 | 2014-04-02 | ニューワールド ファーマシューティカルズ，エルエルシー | Integrated intradermal delivery, diagnosis and communication system |
| CN103813766B (en) * | 2011-09-14 | 2016-01-20 | 3M创新有限公司 | Tool valvular malleation medical dressing and the external member comprising described dressing |
-
2018
- 2018-10-25 CN CN201811248653.6A patent/CN109045454B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1437491A (en) * | 1999-12-27 | 2003-08-20 | 阿尔萨公司 | Osmotic beneficial agent delivery system |
| CN101489623A (en) * | 2006-07-24 | 2009-07-22 | Med-El电气医疗器械有限公司 | Implantable neuro-stimulation electrode with drug elution material |
| CN104703650A (en) * | 2012-03-15 | 2015-06-10 | Med-El电气医疗器械有限公司 | Accessory device for inner ear drug delivery |
| CN104519926A (en) * | 2012-07-13 | 2015-04-15 | Med-El电气医疗器械有限公司 | Implantable fluid delivery system with floating mass transducer driven pump |
| WO2017203397A1 (en) * | 2016-05-26 | 2017-11-30 | Cochlear Limited | Inner ear plug |
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