CN118079212A - 耳导管 - Google Patents
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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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F11/00—Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
- A61F11/20—Ear surgery
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
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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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
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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
- A61M2210/00—Anatomical parts of the body
- A61M2210/06—Head
- A61M2210/0662—Ears
- A61M2210/0668—Middle ear
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Abstract
本发明涉及一种用于插入咽鼓管的非侵入性耳导管(1),其包括导管管子(2),用于封闭咽鼓管的可膨胀球囊(3)以及用于将药物引入中耳区域的注射通道(5)。
Description
本申请是申请号为201980012555.9、申请日为2019年2月7日、发明名称为“耳导管”的发明专利申请的分案申请。
技术领域
本发明涉及一种用于非侵入性地引入到咽鼓管中的耳导管,该耳导管使得药物能够在更长的时间段内被输送到中耳区域。
背景技术
已知许多中耳和内耳疾病都需要用药物治疗。在需要局部治疗的情况下,一方面可以通过耳膜,另一方面可以通过咽鼓管进行局部治疗。内耳的治疗也可以通过中耳区域进行。但是,由于药物通过咽鼓管排入鼻咽腔,因此通常以液体形式将药物给药到咽鼓管或中耳中并没有持久的作用。
一系列感染、炎症以及急性听力损失或梅尼埃病的治疗需要长期治疗,可能持续数天甚至数周。通常,在这种情况下,会不断添加新的药物,例如皮质类固醇。这种治疗既费时,又需要定期和永久的医学监督和护理。
由于这个原因,希望有一种可用的设备,通过该设备可以将药物施加到中耳中,在其中可以保持更长的时间。这样的应用应该尽可能地是非侵入性的,即不应该对耳膜有害或损坏。在这种情况下,只能诉诸通过鼻咽和咽鼓管的自然通路。
发明内容
该目的借助于上述类型的一种耳导管来实现,该耳导管包括导管管子、用于封闭咽鼓管的可膨胀球囊以及用于将药物引入中耳区域的注射通道。
可以将这种耳导管无创地穿过鼻子和鼻咽腔插入到咽鼓管中,并以使球囊在膨胀后密封咽鼓管的方式放置在那里。该闭塞中断了位于球囊远侧的中耳区域与鼻咽之间的连接。在本文中,远侧是指耳导管指向听觉系统和中耳的部分,而近侧是指背离听觉系统和中耳的部分。
本发明提出的耳导管是球囊导管,其原理上类似于用于血管舒张的球囊导管而构造。然而,所述导管不能用来扩张咽鼓管,而只能用来闭塞它。在这方面,耳导管的球囊仅以使得形成密封咽鼓管的袖带(低压袖带)的方式受到最小的超压。为此,单个球囊就足够了。耳导管的管子长约为15厘米,该长度足够长,可以将导管穿过一个鼻孔和鼻咽腔插入咽鼓管,而近侧管端仍留在患者的脸颊区域。
除了其近端从耳导管侧向突出之外,注射通道基本上在耳导管内延伸。耳导管和注射通道均配有用于常规注射器的连接器,该连接器允许用压力介质填充耳导管并将药物溶液引入内耳。方便地,所述连接器是鲁尔锁式连接器,因为它们通常用于医疗目的,可以使用适当的设备将各种注射器钩接到其上。
通常用于球囊导管技术目的的常规材料可以用于球囊、导管和注射通道。这些是批准用于医疗应用的塑料材料,例如PVC、聚乙烯、聚丙烯等。材料应具有足够的弹性/柔韧性,以允许插入到咽鼓管中。
有利地,导管应当配备有用于控制的操纵辅助件。此外,有利的是,在导管上设置弯曲的远端,这使得能够容易地将球囊和导管的端部控制和定位在咽鼓管中和咽鼓管内。这种弯曲的端部在导管和导线中被称为“猪尾”,并且被广泛使用。
不言而喻,耳导管设有密封装置,该密封装置在填充后保持施加的压力介质,从而确保维持系统的膨胀状态。类似地,注射通道在其远端或近端具有封闭装置,该封闭装置防止注射的药物从注射通道中排出。利用闭塞咽鼓管的充气球囊,可以将可能由软塑料管组成的注射通道用力地压在一起,从而将其密封。
本发明提出的耳导管以无创的方式穿过鼻子和鼻咽腔插入到咽鼓管中。插入可以通过耳镜检查来监测。一旦可膨胀球囊到达要被闭塞的咽鼓管的部分,就会以通常的方式将液体注入到球囊上,从而使其膨胀。认为将球囊设计为低压袖带并提供压力限制器是可取的,通过该压力限制器方便地将压力保持在最大值1巴(表压)。为了使球囊膨胀,使用液体,优选生理盐溶液。为了引入盐溶液,耳导管的近侧连接件装配有常规的鲁尔锁,可以将用于盐溶液的注射器附接到该鲁尔锁。为了使球囊保持加压,导管管子装有单向阀。
注射通道,通常是注射管,延伸穿过导管管子和球囊并到达中耳区域。在其近端,还为注射器配备了鲁尔锁连接件,通过该连接器可以将药物注入中耳区域。在远端有一个出口,该出口可以无创伤地设计并装有单向阀。使用单向阀,出口在注入溶液的压力下打开。如果管子由柔软的弹性材料制成,则即使球囊施加的压力也足以将其密封。在这种情况下,球囊压力导致注射管被迫压在一起并密封,并且仅当注射液与注射器一起插入时由注射液施加的压力才打开管。作为将单向阀布置在远侧的一种替代方案,也可以将它定位在近侧。
如本发明所提供的,耳导管特别适合于对中耳区域施用抗生素溶液,这在治疗持续性细菌感染中是可取的。皮质类固醇激素治疗可导致听力严重丧失的标准治疗也可以通过这种耳导管适当地进行。标准的治疗方法要求这种皮质类固醇需要更长的时间(通常约两周)给药,因为药物会流到鼻咽腔,因此必须每天重新施用。在这里,通常的治疗期为14天。使用本发明提出的耳导管,由于导管确保了在需要的地方不断存在药物,因此可以实现更密集和更短的治疗。这大大缩短了治疗时间,可能缩短到几天。特别地,导管适当地使药物在中耳区域中保持更长的时间段,尤其是几天。
另外,抗炎药也可以通过耳导管引入。
耳导管通过一个鼻孔放置在适当的位置,在施加压力并注入药物后,用合适的贴片将其固定在脸颊上。在治疗期间,它保留在咽鼓管中。患者可以保持活动状态,不需要在诊所停留更长的时间,定期的医疗监督就足够了。耳镜可用于监督。
完成治疗后,可以在释放压力后轻松移出耳导管。
耳导管还可以治疗内耳疾病,因为药物通常可以穿过圆形窗口的膜并进入内耳区域。这是由于扩散过程引起的。
附图说明
通过附图更详细地解释本发明。
图1示出了本发明的耳导管。
具体实施方式
根据图1的本发明的耳导管1包括导管管子2,该导管管子在远侧终止于可膨胀的球囊3(袖带)中。在近端,有一个用于常规注射器的鲁尔锁连接件4,通过它可以引入生理盐溶液以使球囊3膨胀。插入的压力计(未显示)用于监控压力并将其限制为1巴。
注射管5延伸穿过导管的中心,所述管还设有鲁尔锁连接件6,通过其可以使用注射器注射药物溶液。注射通道5终止于无创伤设计的出口开口或尖端7,其在注射流体的压力下打开,并在注射完成后自动关闭。
耳导管1的总长度约为15cm;导管管子的直径为3mm,注射管的直径约为1mm。
套筒8摩擦地安装在导管上,用作操纵和处理辅助。套筒优选地由塑料制成并且适当地开槽以便可以被安装或移除。
在治疗急性听力丧失的情况下,在适当地放置导管之后,并通过使用例如2ml注射器,将可的松溶液填充到中耳中并放置所需的时间。中耳的填充通过耳镜检查来监测。该程序最好在局部麻醉下进行,但在特殊情况下,建议使用全身麻醉。给药后,将敷贴导管的近侧部分用贴片粘在脸颊上。压力从注射通道释放。导管球囊保留在咽鼓管中,并防止注入的溶液排出。在治疗结束时,从球囊释放压力,并拔出导管。
Claims (14)
1.一种用于引入咽鼓管的非侵入性耳导管,包括导管管子(2),用于闭塞咽鼓管的可膨胀球囊(3)以及用于将药物引入中耳区域的注射通道(5)。
2.根据权利要求1所述的耳导管,其特征在于,所述注射通道(5)在所述导管的内部延伸。
3.根据权利要求1或2所述的耳导管,其特征在于,所述可膨胀球囊(3)被设计作为低压袖带。
4.根据权利要求1至3中任一项所述的耳导管,其特征在于,最大压力为1巴的压力限制器。
5.根据前述权利要求中任一项所述的耳导管,其特征在于,所述注射通道(5)设有用于容纳注射材料的注射器的鲁尔锁连接件(6)。
6.根据前述权利要求中任一项所述的耳导管,其特征在于,所述导管管子(2)设置有用于液体介质的鲁尔锁连接件(4),以使所述球囊(3)膨胀。
7.根据权利要求6所述的耳导管,其特征在于,用于使所述球囊(3)膨胀的液体是生理NaCl溶液。
8.根据前述权利要求中任一项所述的耳导管,其特征在于,所述注射通道(5)从所述球囊(3)向远侧终止。
9.根据前述权利要求中任一项所述的耳导管,其特征在于,所述注射通道(5)设有无创伤设计的出口(6)。
10.根据权利要求9所述的耳导管,其特征在于,所述出口(6)具有自闭合设计。
11.根据前述权利要求中任一项所述的耳导管,其特征在于,操纵辅助件(8)。
12.根据权利要求11所述的耳导管,其特征在于,所述操纵辅助件(8)是摩擦安装在所述导管管子上的塑料套筒。
13.根据前述权利要求中任一项所述的耳导管,用于将药物非侵入性地施加到患者的中耳中。
14.根据权利要求13所述的耳导管,其特征在于,其适合于将药物在中耳中保留几天。
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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DE102018102937.3 | 2018-02-09 | ||
DE102018102937.3A DE102018102937A1 (de) | 2018-02-09 | 2018-02-09 | Ohrkatheter |
PCT/EP2019/052987 WO2019154902A1 (de) | 2018-02-09 | 2019-02-07 | Ohrkatheter |
CN201980012555.9A CN111698976B (zh) | 2018-02-09 | 2019-02-07 | 耳导管 |
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CN201980012555.9A Division CN111698976B (zh) | 2018-02-09 | 2019-02-07 | 耳导管 |
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CN202410206507.6A Pending CN118079212A (zh) | 2018-02-09 | 2019-02-07 | 耳导管 |
CN201980012555.9A Active CN111698976B (zh) | 2018-02-09 | 2019-02-07 | 耳导管 |
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CN201980012555.9A Active CN111698976B (zh) | 2018-02-09 | 2019-02-07 | 耳导管 |
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EP (1) | EP3749267A1 (zh) |
JP (1) | JP7361400B2 (zh) |
CN (2) | CN118079212A (zh) |
BR (1) | BR112020016110A2 (zh) |
DE (1) | DE102018102937A1 (zh) |
WO (1) | WO2019154902A1 (zh) |
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KR102222049B1 (ko) | 2018-09-27 | 2021-03-04 | 주식회사 아이센스 | 연속 혈당 측정 장치용 어플리케이터 |
DE102021105036A1 (de) | 2020-11-27 | 2022-06-02 | Auriventis Gmbh | Ohrkatheter und Einführhilfe für Katheter |
DE102022135028A1 (de) | 2022-12-30 | 2024-07-11 | Auriventis Gmbh | Verbesserter Ohrkatheter zur Medikamentenapplikation |
DE102022135027A1 (de) | 2022-12-30 | 2024-07-11 | Auriventis Gmbh | Ohrkatheter zur Applikation von Medikamenten |
DE202023106064U1 (de) | 2023-10-19 | 2025-02-10 | Jörg Schwarzbich | Ohrkathetervorrichtung |
DE202023104948U1 (de) | 2023-08-30 | 2024-12-03 | Jörg Schwarzbich | Ohrkathetervorrichtung |
DE202023105616U1 (de) | 2023-09-26 | 2025-01-09 | Jörg Schwarzbich | Ohrkathetervorrichtung |
WO2025045449A1 (de) | 2023-08-30 | 2025-03-06 | Schwarzbich Joerg | Ohrkathetervorrichtung |
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US6648873B2 (en) | 2001-09-21 | 2003-11-18 | Durect Corp. | Aural catheter system including anchor balloon and balloon inflation device |
US7410480B2 (en) * | 2004-04-21 | 2008-08-12 | Acclarent, Inc. | Devices and methods for delivering therapeutic substances for the treatment of sinusitis and other disorders |
US8764729B2 (en) | 2004-04-21 | 2014-07-01 | Acclarent, Inc. | Frontal sinus spacer |
CN2877748Y (zh) * | 2006-01-04 | 2007-03-14 | 高爱秋 | 带球囊的胃管 |
US9987025B2 (en) * | 2006-05-26 | 2018-06-05 | Bruce B. Becker | Increased axial load carrying sheathed irrigating balloon catheter |
CN200984386Y (zh) * | 2006-12-18 | 2007-12-05 | 侯守智 | 一种治疗鼻炎、鼻窦炎的气囊扩张导管 |
US20100198191A1 (en) * | 2007-12-20 | 2010-08-05 | Acclarent, Inc. | Method and system for treating target tissue within the eustachian tube |
AU2012287321A1 (en) * | 2011-07-25 | 2014-02-13 | Acclarent, Inc. | Devices and methods for transnasal dilation and irrigation of the sinuses |
US20130274715A1 (en) * | 2012-04-13 | 2013-10-17 | Acclarent, Inc. | Method and System for Eustachian Tube Dilation |
CN103656843A (zh) * | 2012-09-04 | 2014-03-26 | 杭州朗佑医疗科技有限公司 | 靶向扩张成形球囊导管 |
CN203029796U (zh) * | 2013-02-05 | 2013-07-03 | 青岛市市立医院 | 咽鼓管球囊导管 |
CN203315053U (zh) * | 2013-05-24 | 2013-12-04 | 孟箭 | 上颌窦骨折用预制水囊 |
US10118012B2 (en) | 2015-10-30 | 2018-11-06 | Acclarent, Inc. | System and method for anesthetizing eustachian tube |
US20170238829A1 (en) * | 2016-02-23 | 2017-08-24 | Steven Parker | Catheter grip with hinge |
WO2018050165A1 (de) | 2016-09-16 | 2018-03-22 | David Spiggle | Katheter zur applikation eines mediums in das mittelohr |
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2018
- 2018-02-09 DE DE102018102937.3A patent/DE102018102937A1/de active Pending
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2019
- 2019-02-07 JP JP2020565531A patent/JP7361400B2/ja active Active
- 2019-02-07 CN CN202410206507.6A patent/CN118079212A/zh active Pending
- 2019-02-07 CN CN201980012555.9A patent/CN111698976B/zh active Active
- 2019-02-07 EP EP19707272.1A patent/EP3749267A1/de active Pending
- 2019-02-07 WO PCT/EP2019/052987 patent/WO2019154902A1/de unknown
- 2019-02-07 BR BR112020016110-1A patent/BR112020016110A2/pt unknown
- 2019-02-07 US US16/968,493 patent/US20200406014A1/en active Pending
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WO2019154902A1 (de) | 2019-08-15 |
BR112020016110A2 (pt) | 2021-02-02 |
CN111698976B (zh) | 2024-02-13 |
DE102018102937A1 (de) | 2019-08-14 |
US20200406014A1 (en) | 2020-12-31 |
JP2021513450A (ja) | 2021-05-27 |
JP7361400B2 (ja) | 2023-10-16 |
EP3749267A1 (de) | 2020-12-16 |
CN111698976A (zh) | 2020-09-22 |
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