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WO2022108115A1 - Balloon catheter for treating nasal passages and eustachian tube - Google Patents

Balloon catheter for treating nasal passages and eustachian tube Download PDF

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Publication number
WO2022108115A1
WO2022108115A1 PCT/KR2021/014027 KR2021014027W WO2022108115A1 WO 2022108115 A1 WO2022108115 A1 WO 2022108115A1 KR 2021014027 W KR2021014027 W KR 2021014027W WO 2022108115 A1 WO2022108115 A1 WO 2022108115A1
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WO
WIPO (PCT)
Prior art keywords
tube
balloon catheter
balloon
optical fiber
guide
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/KR2021/014027
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French (fr)
Korean (ko)
Inventor
주돈수
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Imedicom Co Ltd
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Imedicom Co Ltd
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Filing date
Publication date
Application filed by Imedicom Co Ltd filed Critical Imedicom Co Ltd
Publication of WO2022108115A1 publication Critical patent/WO2022108115A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/07—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/24—Surgical instruments, devices or methods for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • 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
    • 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
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/77—Suction-irrigation systems
    • 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
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008—Strength or flexibility characteristics of the catheter tip
    • 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
    • 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
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • 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
    • A61M25/1027—Making of balloon catheters
    • A61M25/1034—Joining of shaft and balloon
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008—Strength or flexibility characteristics of the catheter tip
    • A61M2025/0081—Soft tip
    • 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
    • A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements

Definitions

  • the present invention relates to a balloon catheter, and more particularly, to a balloon catheter used for treatment of the sinuses and otitis.
  • sinusitis There are several spaces in the facial bones of our body, and these empty spaces are called sinuses. And when bacteria or viruses penetrate into the space called the sinuses and cause inflammation, it is called sinusitis.
  • a balloon catheter operation method As a method for treating such sinusitis, a balloon catheter operation method is used, and this method has the advantage of faster recovery after the operation than the conventional surgical method.
  • Sinusitis surgery using a balloon catheter is performed by first inserting a catheter into the nasal cavity, and then expanding the balloon located at the end of the catheter at the entrance to the sinus to remove inflammation and secretions from the inside of the sinus.
  • FIG. 13 shows a balloon catheter that can be used for sinusitis surgery disclosed in Korean Patent Application Laid-Open No. 10-2018-0113660.
  • FIG. 13 corresponds to FIG. 1 of the Korean Patent Application Laid-Open, and for convenience, reference numerals and the like are indicated without modification.
  • the conventional balloon catheter is easy to insert in a straight direction, but difficult to enter in a bent direction.
  • the irrigation fluid injection tube 120 in order for the balloon catheter to enter the maxillary sinus of the sinus, the irrigation fluid injection tube 120 must be bent at least about 110° in a straight state.
  • patients with severe lesions had a problem in performing balloon catheterization because the entrance to the sinuses was narrow, making it difficult to enter the balloon 130 .
  • the present invention is to solve the problems of the prior art as described above, and an object of the present invention is to enter the sinuses while efficiently securing straightness, and to minimize the size at the time of entry. to provide a catheter.
  • the balloon catheter for sinus and ear canal treatment is provided with a body portion having a guide port mounting portion, a balloon, and relatively movable to the body portion.
  • a balloon catheter assembly coupled to the body portion, a guide port detachably coupled to the guide port mounting portion, and a first tube having one end coupled to the guide port and the other end extending in a direction away from the guide port, the first A second tube coupled to the inner wall of the tube and extending to protrude from the other end of the first tube, a guide portion having a soft tip coupled to the end of the second tube, and mounted on the body portion, comprising an optical fiber It is characterized in that it comprises an optical fiber lighting unit.
  • the hardness of the soft tip is smaller than that of the second tube, and the hardness of the second tube is smaller than that of the first tube.
  • annular groove forming a step is formed on the inner wall of the guide port, and one end of the first tube is positioned in the annular groove.
  • the second tube is characterized in that the other end is provided with a plurality of bent at different predetermined angles.
  • the second tube for maxillary sinus surgery has the predetermined angle of 110°
  • the second tube for sphenoid sinus surgery has the predetermined angle of 0°
  • the second tube for frontal sinus surgery has the predetermined angle of 70 It is characterized as °.
  • one end of the balloon catheter assembly is inserted into the balloon and fused to the distal portion of the balloon, and the other end is an inner tube extending in a direction away from the balloon, the inner tube and the inner tube with a predetermined gap and wraps around the inner tube,
  • An outer tube whose one end is fused to the proximal portion of the balloon, a guide tube that surrounds the outer tube and is fused to the outer tube, a cover tube that surrounds the guide tube and is fused to the guide tube, and an inner tube to which the other end of the inner tube is fixed
  • the body portion is characterized in that it includes an opening through which the sliding pressing portion is seated so as to slide in the front and rear directions of the body portion.
  • the balloon catheter assembly is provided with an optical fiber holding part at the rear end of the inner tube holder, the optical fiber is inserted through the optical fiber holding part, the optical fiber holding part is made of silicone, pulling or pushing with a force greater than a predetermined force When the optical fiber is characterized in that it can be moved relative to the optical fiber holding part.
  • the balloon catheter assembly is moved relative to the guide portion, characterized in that the balloon is inserted into the interior of the second tube may not be exposed to the outside.
  • the balloon catheter according to an embodiment of the present invention having the above configuration has the following effects.
  • the straightness of the balloon catheter can be secured by selecting an appropriate guide part 3 at the operation site.
  • the balloon catheter assembly when the user holds the body part equipped with the guide part and moves the sliding subscription part in the right direction (based on FIG. 1), the balloon catheter assembly also moves in the right direction in conjunction with it, and through this, the guide part into the second tube inside The balloon is inserted so that the balloon is not exposed to the outside.
  • the diameter (size) of the balloon catheter inserted into the lesion of the patient can be greatly reduced, and the entry into the lesion of the patient becomes easy.
  • the optical fiber is fixed at a specific position during use of the balloon catheter, so the light emitted from the end of the optical fiber The position can be easily fixed to a specific position.
  • the present invention also includes other effects that can be expected from the above-described configuration.
  • FIG. 1 shows a balloon catheter for treatment of the sinus and ear canals according to an embodiment of the present invention.
  • Figure 2 is a cross-sectional view of the balloon catheter of Figure 1.
  • Figure 3 is a cross-sectional view of the body portion of the balloon catheter of Figure 1.
  • Figure 4 shows the balloon catheter assembly of the balloon catheter of Figure 1.
  • Figure 5 is a cross-sectional view of the balloon catheter assembly of Figure 4.
  • Figure 6 shows the guide portion of the balloon catheter of Figure 1.
  • FIG. 7 shows various modifications of the guide part of FIG. 6 .
  • FIG. 8 is a cross-sectional view of the guide part of FIG. 6 .
  • FIG. 9 is an enlarged view of part A of FIG. 8 .
  • FIG. 10 is a cross-sectional view in the direction P-P of FIG. 1 .
  • FIG. 11 is a perspective view of the body of FIG. 1 as viewed from above.
  • Figure 12 shows the main configuration of the optical fiber lighting unit of the balloon catheter of Figure 1.
  • FIG. 13 is a view showing a conventional balloon catheter.
  • FIG. 1 shows a balloon catheter (hereinafter, simply referred to as a 'balloon catheter') for treatment of the sinus and ear canals according to an embodiment of the present invention.
  • a balloon catheter hereinafter, simply referred to as a 'balloon catheter'
  • this balloon catheter is a main configuration, including a body portion (1), a balloon catheter assembly (2), a guide portion (3), and an optical fiber illumination portion (4).
  • the body portion 1 is provided with a guide port mounting portion 11 at its distal end. And the body portion 1 includes an opening 11 that allows the sliding pressing portion 28 of the balloon catheter assembly 2 to be described later to be seated and slide in the front-rear direction of the body portion 1 .
  • the opening 11 is formed to be elongated in the longitudinal direction of the body portion 1 as shown in FIG. 11 .
  • the balloon catheter coupling body (2) is coupled to the body part (1) to be movable relative to the body part (1).
  • the balloon catheter assembly 2 is a balloon 21, an inner tube 22, an outer tube 23, a guide tube 24, a cover tube 27, It has an inner tube holder 25, a Y port 26, and a pressing part 28 for sliding.
  • One end of the inner tube 22 is inserted into the balloon 21 and fused to the distal portion 211 of the balloon 21 , and the other end extends in a direction away from the balloon 21 .
  • the outer tube 23 surrounds the inner tube 22 with a predetermined gap (through this, a fluid for balloon inflation is inserted) with the inner tube 22, and one end is fused to the proximal portion 212 of the balloon 21.
  • the guide tube 24 may surround the outer tube 23 and be fused to the outer tube 23 .
  • the cover tube 27 may surround the guide tube 24 and be fused to the guide tube 24 .
  • the other end of the inner tube 22 is fixed to the inner tube holder 25 .
  • the Y port 26 has a first port 261 for fluid input, a second port 262 to which the inner tube holder 25 is fixed, and a front through hole 263 to which the cover tube 27 is fixed. do.
  • the sliding pressing unit 28 is fixed to the outer wall of the first port 261 .
  • the user may apply a force to the sliding pressing unit 28 to relatively move the balloon catheter assembly 2 to the body unit 1 in the longitudinal direction (horizontal direction based on FIG. 1) of the balloon catheter.
  • the guide part 3 includes a guide port 31 , a first tube 32 , a second tube 33 , and a guide part 3 as shown in FIGS. 6 to 8 . .
  • the guide port 31 is detachably coupled to the guide port mounting part 11 .
  • the second half of the inner diameter of the guide port 31 is gradually enlarged in diameter, and the outer diameter of the guide port mounting portion 11 is gradually enlarged, so that the outer diameter of the guide port mounting portion 11 is equal to the inner diameter of the guide port 31 They can be fitted to each other.
  • annular groove 311 forming a step is formed on the inner wall of the guide port 31 , and one end of the first tube 32 is positioned in the annular groove 311 while being positioned at the step. by the guide port 31 is supported on the inner wall.
  • One end of the second tube 33 may also extend to one end of the first tube 32 .
  • the first tube 32 has one end coupled (eg, bonding) to the first half of the inner diameter of the guide port 31, and the other end is in a direction away from the guide port 31 (the front of the catheter, the left direction of FIG. 1 ) is extended
  • the first tube 32 is made of, for example, stainless steel, and has a higher hardness than the second tube 33 to secure the ductility.
  • the second tube 33 is coupled (eg, bonded) to the inner wall of the first tube 32 and extends to protrude from the other end of the first tube 32 .
  • the second tube 33 is made of, for example, a material having a hardness of 72D or higher to maintain straightness.
  • the second tube 33 may be provided with a plurality of sets, the other ends of which are bent at different predetermined angles.
  • the second tube 33 for maxillary sinus surgery has a predetermined angle of 110° (Fig. 7 (a)), and the second tube 33 for sphenoid sinus treatment has a predetermined angle of 0° (Fig. 7). (f)), the second tube 33 for frontal sinus surgery may have a predetermined angle of 70° ((c) of FIG. 7). Therefore, the user can solve the problem that the patient with severe lesion is difficult to enter with the conventional catheter because the sinus entrance is narrow, and can effectively perform the procedure using the balloon catheter.
  • the soft tip 34 is coupled to the end of the other end of the second tube 33 .
  • the soft tip 34 may be made of a hardness of, for example, 35D so that it is not sharp even when approaching the patient's lesion and thus does not get hurt.
  • the hardness of the soft tip 34 is smaller than the hardness of the second tube 33
  • the hardness of the second tube 33 is formed to be smaller than the hardness of the first tube 32, for example, a balloon catheter in the nasal cavity. It is possible to effectively treat the patient by maintaining straightness without injuring the patient's lesion during insertion.
  • the optical fiber lighting unit 4 is mounted on the body unit 1 .
  • the optical fiber lighting unit 4 includes a power source 41, an optical fiber 42 that emits light by receiving power from the power source 41, and a power blocking plate 43 that is detachably mounted and can cut off power from the power source 41.
  • the optical fiber 42 is inserted into the second port 262 and the inner tube 22 to protrude to the distal part 211 of the balloon 21 by the user to hold the optical fiber 42 . can be pushed or pulled.
  • the balloon catheter assembly 2 has an optical fiber holding part 29 at the rear end of the inner tube holder 25 , and the optical fiber 42 passes through the optical fiber holding part 29 . to be inserted.
  • the optical fiber holding part 29 is made of, for example, silicon, so that the optical fiber 42 can be moved relative to the optical fiber holding part 29 when pulling or pushing with a force greater than or equal to a predetermined force, and less than the predetermined force The force of can prevent this movement from occurring. Therefore, if the user pushes or pulls the optical fiber 42 more than a predetermined force in order to move the optical fiber 42 to a specific position, and then removes the force, the optical fiber 42 is fixed at a specific position during use of the balloon catheter. Therefore, the position of the light emitted from the end of the optical fiber 42 can be fixed to a specific position.
  • the balloon catheter assembly 2 is moved relative to the guide portion 3, that is, the guide portion 3 is mounted.
  • the balloon catheter assembly 2 also works in conjunction and moves in the right direction, and through this, the guide The balloon 21 is inserted into the second tube 33 of the part 3 so that the balloon 21 is not exposed to the outside.
  • the diameter (size) of the balloon catheter inserted into the lesion of the patient can be greatly reduced, and the entry into the lesion of the patient becomes easy.
  • the position of the distal end can be adjusted and fixed by appropriately pulling or pushing the optical fiber 42, thereby making it easier to enter the lesion of the patient.
  • the guide part 3 in which the second tube 33 is bent at 110° is connected to the guide port mounting part 11 of the body part 1, and when entering the sphenoid sinus, the second The tube 33 connects the guide part 3, which is straight at 0°, to the guide port mounting part 11 of the body part 1, and also, when entering the frontal sinus, the second tube 33 is a straight line bent at 70°
  • the present invention can be used in a balloon catheter used for the treatment of the sinus and ear canals.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Vascular Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Dentistry (AREA)
  • Optics & Photonics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Acoustics & Sound (AREA)
  • Psychology (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

A balloon catheter for treating nasal passages and Eustachian tube according to an embodiment of the present invention comprises: a body part having a guide port mounting portion; a balloon catheter coupling structure having a balloon, and coupling to the body part to be movable relative to the body part; a guide part having a guide port, which is detachably coupled to the guide port mounting portion, a first tube, of which one end is coupled to the guide port and the other end extends in a direction away from the guide port, a second tube, which is coupled to the inner wall of the first tube and protrudingly extends from the other end of the first tube, and a soft tip which is coupled to an end of the second tube; and an optical fiber lighting part mounted on the body part and having an optical fiber.

Description

부비관 및 이관 치료용 풍선카테터Balloon catheter for the treatment of sinus and ear canal

본 발명은 풍선카테터에 관한 것으로, 상세하게는 부비관 및 이관 치료에 사용되는 풍선카테터에 관한 것이다.The present invention relates to a balloon catheter, and more particularly, to a balloon catheter used for treatment of the sinuses and otitis.

우리 몸의 얼굴 뼛속에는 몇 개의 공간들이 있으며, 이 빈 공간을 부비동이라 부른다. 그리고 부비동이라 부르는 공간 안에 세균이나 바이러스가 침투하여 염증이 발생한 것을 부비동염이라고 한다. There are several spaces in the facial bones of our body, and these empty spaces are called sinuses. And when bacteria or viruses penetrate into the space called the sinuses and cause inflammation, it is called sinusitis.

이러한 부비동염을 치료하기 위한 방법으로 풍선 카테터를 시술 방법이 사용되고 있으며, 이 방법은 기존의 수술 방법보다 시술 후 회복이 빠른 장점이 있다. As a method for treating such sinusitis, a balloon catheter operation method is used, and this method has the advantage of faster recovery after the operation than the conventional surgical method.

풍선 카테터를 사용하는 부비동염 시술은 우선 카테터를 비강에 삽입하고, 부비동 입구부에서 카테터의 말단에 위치하는 풍선을 확장시켜 부비동 내부의 염증, 분비물 등을 제거하는 방식으로 시행된다.Sinusitis surgery using a balloon catheter is performed by first inserting a catheter into the nasal cavity, and then expanding the balloon located at the end of the catheter at the entrance to the sinus to remove inflammation and secretions from the inside of the sinus.

도 13에는, 한국공개특허 제10-2018-0113660호에 개시된 부비동염 수술에 사용될 수 있는 풍선카테터를 도시하고 있다. 참고로, 도 13은 상기 한국공개특허의 도 1에 해당하는 것으로서, 편의상 도면부호 등은 수정 없이 그대로 표시하였다.13 shows a balloon catheter that can be used for sinusitis surgery disclosed in Korean Patent Application Laid-Open No. 10-2018-0113660. For reference, FIG. 13 corresponds to FIG. 1 of the Korean Patent Application Laid-Open, and for convenience, reference numerals and the like are indicated without modification.

그런데 기존의 풍선카테터는 직진 방향으로 삽입하는 것은 쉬우나 꺾인 방향으로 진입하는 게 어렵다. 특히, 부비동의 상악동은 풍선카테터가 진입하기 위해서는 관주액 주입관(120)이 직진 상태에서 약 110° 이상 꺾인 상태가 되어야 하는데, 풍선카테터의 특성상 직진성이 떨어져 상악동으로 진입하는 것이 어려웠다. 또한, 병변이 심한 환자는 부비강 입구부가 좁아서, 풍선(130) 진입이 어려워 풍선카테터 시술을 하는데 문제가 있었다.However, the conventional balloon catheter is easy to insert in a straight direction, but difficult to enter in a bent direction. In particular, in order for the balloon catheter to enter the maxillary sinus of the sinus, the irrigation fluid injection tube 120 must be bent at least about 110° in a straight state. In addition, patients with severe lesions had a problem in performing balloon catheterization because the entrance to the sinuses was narrow, making it difficult to enter the balloon 130 .

본 발명은 상술한 바와 같은 종래기술의 문제점을 해결하기 위한 것으로서, 본 발명의 목적은 부비동에 효율적으로 직진성을 확보하면서 진입할 수 있고, 진입 시 크기를 최소화할 수 있는 부비관 및 이관 치료용 풍선카테터를 제공하는 것이다.The present invention is to solve the problems of the prior art as described above, and an object of the present invention is to enter the sinuses while efficiently securing straightness, and to minimize the size at the time of entry. to provide a catheter.

상기의 목적을 달성하기 위하여, 본 발명의 한 실시예에 따른 부비관 및 이관 치료용 풍선카테터는, 가이드포트장착부를 구비하는 보디부, 풍선을 구비하고, 상기 보디부에 상대적으로 이동 가능하게 상기 보디부에 결합하는 풍선카테터 결합체, 상기 가이드포트장착부에 탈착 가능하게 결합하는 가이드포트와, 상기 가이드포트에 일단이 결합하고 타단은 상기 가이드포트로부터 멀어지는 방향으로 연장되는 제1 튜브와, 상기 제1 튜브의 내벽에 결합하고 상기 제1 튜브의 타단으로부터 돌출되게 연장되는 제2 튜브와, 상기 제2 튜브의 말단에 결합하는 소프트팁을 구비하는 가이드부, 그리고 상기 보디부에 장착되고, 광파이버를 구비하는 광파이버조명부를 포함하는 것을 특징으로 한다.In order to achieve the above object, the balloon catheter for sinus and ear canal treatment according to an embodiment of the present invention is provided with a body portion having a guide port mounting portion, a balloon, and relatively movable to the body portion. A balloon catheter assembly coupled to the body portion, a guide port detachably coupled to the guide port mounting portion, and a first tube having one end coupled to the guide port and the other end extending in a direction away from the guide port, the first A second tube coupled to the inner wall of the tube and extending to protrude from the other end of the first tube, a guide portion having a soft tip coupled to the end of the second tube, and mounted on the body portion, comprising an optical fiber It is characterized in that it comprises an optical fiber lighting unit.

또한, 상기 소프트팁의 경도는 상기 제2 튜브의 경도보다 작고, 상기 제2 튜브의 경도는 상기 제1 튜브의 경도보다 작은 것을 특징으로 한다.In addition, the hardness of the soft tip is smaller than that of the second tube, and the hardness of the second tube is smaller than that of the first tube.

또한, 상기 가이드포트의 내벽에는 단차를 형성하는 환형홈이 형성되고, 상기 환형홈에는 상기 제1 튜브의 일단이 위치하는 것을 특징으로 한다.In addition, an annular groove forming a step is formed on the inner wall of the guide port, and one end of the first tube is positioned in the annular groove.

또한, 상기 제2 튜브는, 그 타단이, 서로 다른 미리 정해진 각도로 꺾여 있는 복수 개가 구비되는 것을 특징으로 한다. In addition, the second tube is characterized in that the other end is provided with a plurality of bent at different predetermined angles.

또한, 상악동 시술용 상기 제2 튜브는 상기 미리 정해진 각도가 110°이고, 접형동 시술용 상기 제2 튜브는 상기 미리 정해진 각도가 0°이고, 전두동 시술용 상기 제2 튜브는 상기 미리 정해진 각도가 70°인 것을 특징으로 한다.In addition, the second tube for maxillary sinus surgery has the predetermined angle of 110°, the second tube for sphenoid sinus surgery has the predetermined angle of 0°, and the second tube for frontal sinus surgery has the predetermined angle of 70 It is characterized as °.

또한, 상기 풍선카테터 결합체는 일단은 상기 풍선에 삽입되어 상기 풍선의 원위부에 융착되고, 타단은 상기 풍선으로부터 멀어지는 방향으로 연장되는 내부튜브, 상기 내부튜브와 미리 정해진 간극을 두고 상기 내부튜브를 감싸고, 일단이 상기 풍선의 근위부에 융착되는 외부튜브, 상기 외부튜브를 감싸고 상기 외부튜브에 융착되는 가이드튜브, 상기 가이드튜브를 감싸고 상기 가이드튜브에 융착되는 커버튜브, 상기 내부튜브의 타단이 고정되는 내부튜브홀더, 유체투입용 제1 포트와, 상기 내부튜브홀더가 고정되는 제2 포트와, 상기 커버튜브가 고정되는 전방관통홀을 구비하는 Y포트, 그리고 상기 제1 포트의 외벽에 고정되는 슬라이딩용 가압부를 더 포함하는 것을 특징으로 한다. In addition, one end of the balloon catheter assembly is inserted into the balloon and fused to the distal portion of the balloon, and the other end is an inner tube extending in a direction away from the balloon, the inner tube and the inner tube with a predetermined gap and wraps around the inner tube, An outer tube whose one end is fused to the proximal portion of the balloon, a guide tube that surrounds the outer tube and is fused to the outer tube, a cover tube that surrounds the guide tube and is fused to the guide tube, and an inner tube to which the other end of the inner tube is fixed A holder, a first port for fluid input, a second port to which the inner tube holder is fixed, a Y port having a front through hole to which the cover tube is fixed, and a sliding pressurization fixed to the outer wall of the first port It is characterized in that it further includes wealth.

또한, 상기 보디부는 상기 슬라이딩용 가압부가 안착 되어 상기 보디부의 전후 방향으로 슬라이드 될 수 있도록 하는 개구를 포함하는 것을 특징으로 한다.In addition, the body portion is characterized in that it includes an opening through which the sliding pressing portion is seated so as to slide in the front and rear directions of the body portion.

또한, 상기 풍선카테터 결합체는 상기 내부튜브홀더의 후단에 광파이버홀딩부를 구비하고, 상기 광파이버가 광파이버홀딩부를 관통하여 삽입되고, 상기 광파이버홀딩부는 실리콘제로 제작되어, 미리 정해진 힘 이상의 힘으로 잡아당기거나 밀 때 상기 광파이버가 상기 광파이버홀딩부에 상대적으로 이동될 수 있도록 하는 것을 특징으로 한다.In addition, the balloon catheter assembly is provided with an optical fiber holding part at the rear end of the inner tube holder, the optical fiber is inserted through the optical fiber holding part, the optical fiber holding part is made of silicone, pulling or pushing with a force greater than a predetermined force When the optical fiber is characterized in that it can be moved relative to the optical fiber holding part.

또한, 상기 풍선카테터 결합체는 상기 가이드부에 대해 상대적으로 이동하여, 상기 제2 튜브의 내부로 상기 풍선이 삽입되어 외부로 드러나지 않을 수 있는 것을 특징으로 한다. In addition, the balloon catheter assembly is moved relative to the guide portion, characterized in that the balloon is inserted into the interior of the second tube may not be exposed to the outside.

상술한 구성을 가진 본 발명의 실시예에 따른 풍선카테터는 다음과 같은 효과를 가진다.The balloon catheter according to an embodiment of the present invention having the above configuration has the following effects.

환자의 병변에 따라 시술 현장에서, 적절한 가이드부(3)를 선택하여 풍선카테터의 직진성을 확보할 수 있다. Depending on the lesion of the patient, the straightness of the balloon catheter can be secured by selecting an appropriate guide part 3 at the operation site.

또한, 가이드부가 장착된 보디부를 사용자가 잡은 상태에서 슬라이딩용 가입부를 우측 방향(도 1 기준)으로 이동시킬 경우 풍선카테터 결합체도 연동하여 우측 방향으로 이동하고, 이를 통하여, 가이드부의 제2 튜브 내부로 풍선이 삽입되어 풍선이 외부로 드러나지 않게 된다. 이 경우, 환자의 병변에 삽입되는 풍선카테터의 직경(크기)를 대폭 줄일 수 있어, 환자의 병변으로서의 진입이 용이하게 된다. In addition, when the user holds the body part equipped with the guide part and moves the sliding subscription part in the right direction (based on FIG. 1), the balloon catheter assembly also moves in the right direction in conjunction with it, and through this, the guide part into the second tube inside The balloon is inserted so that the balloon is not exposed to the outside. In this case, the diameter (size) of the balloon catheter inserted into the lesion of the patient can be greatly reduced, and the entry into the lesion of the patient becomes easy.

또한, 사용자가 특정 위치로 광파이버를 이동시키기 위해서 광파이버를 미리 정해진 힘 이상으로 밀거나 당긴 후, 힘을 제거하면, 본 풍선카테터의 사용 중에 광파이버가 특정 위치에 고정되므로, 광파이버의 말단에서 나오는 빛의 위치를 특정 위치로 손쉽게 고정할 수 있다. In addition, if the user pushes or pulls the optical fiber more than a predetermined force in order to move the optical fiber to a specific position and then removes the force, the optical fiber is fixed at a specific position during use of the balloon catheter, so the light emitted from the end of the optical fiber The position can be easily fixed to a specific position.

한편, 본 발명은 명시적으로 기재되지는 않았지만 상술한 구성으로부터 기대할 수 있는 다른 효과도 물론 포함한다.On the other hand, although not explicitly described, the present invention also includes other effects that can be expected from the above-described configuration.

도 1은 본 발명의 한 실시예에 따른 부비관 및 이관 치료용 풍선카테터를 나타낸다.1 shows a balloon catheter for treatment of the sinus and ear canals according to an embodiment of the present invention.

도 2는 도 1의 풍선카테터의 단면도이다.Figure 2 is a cross-sectional view of the balloon catheter of Figure 1.

도 3은 도 1의 풍선카테터의 보디부의 단면도이다.Figure 3 is a cross-sectional view of the body portion of the balloon catheter of Figure 1.

도 4는 도 1의 풍선카테터의 풍선카테터 결합체를 나타낸다.Figure 4 shows the balloon catheter assembly of the balloon catheter of Figure 1.

도 5는 도 4의 풍선카테터 결합체의 단면도이다.Figure 5 is a cross-sectional view of the balloon catheter assembly of Figure 4.

도 6은 도 1의 풍선카테터의 가이드부를 나타낸다.Figure 6 shows the guide portion of the balloon catheter of Figure 1.

도 7은 도 6의 가이드부의 다양한 변형예를 나타낸다.7 shows various modifications of the guide part of FIG. 6 .

도 8은 도 6의 가이드부의 단면도를 나타낸다.FIG. 8 is a cross-sectional view of the guide part of FIG. 6 .

도 9는 도 8의 A 부분의 확대도이다.9 is an enlarged view of part A of FIG. 8 .

도 10은 도 1의 P-P 방향으로의 단면도이다.FIG. 10 is a cross-sectional view in the direction P-P of FIG. 1 .

도 11은 도 1의 보디부를 위에서 내려다본 사시도이다. 11 is a perspective view of the body of FIG. 1 as viewed from above.

도 12는 도 1의 풍선카테터의 광파이버조명부의 주요 구성을 나타낸다.Figure 12 shows the main configuration of the optical fiber lighting unit of the balloon catheter of Figure 1.

도 13은 종래의 풍선카테터를 나타내는 도면이다.13 is a view showing a conventional balloon catheter.

이하, 첨부한 도면을 참고로 하여 본 발명의 실시예에 대하여 본 발명이 속하는 기술 분야에서 통상의 지식을 가진 자가 실시할 수 있도록 상세히 설명한다. 그러나 본 발명은 여러 가지 상이한 형태로 구현될 수 있으며 여기에서 설명하는 실시예에 한정되지 않는다.Hereinafter, with reference to the accompanying drawings, embodiments of the present invention will be described in detail so that those of ordinary skill in the art to which the present invention pertains can practice. However, the present invention may be embodied in several different forms and is not limited to the embodiments described herein.

도 1에는 본 발명의 한 실시예에 따른 부비관 및 이관 치료용 풍선카테터(이하, 간단히 '풍선카테터'라 한다)를 나타낸다.1 shows a balloon catheter (hereinafter, simply referred to as a 'balloon catheter') for treatment of the sinus and ear canals according to an embodiment of the present invention.

도 1 및 도 2에 도시된 바와 같이, 본 풍선카테터는 주요 구성으로서, 보디부(1), 풍선카테터 결합체(2), 가이드부(3), 그리고 광파이버조명부(4)를 포함한다.As shown in Figures 1 and 2, this balloon catheter is a main configuration, including a body portion (1), a balloon catheter assembly (2), a guide portion (3), and an optical fiber illumination portion (4).

도 3에 도시된 바와 같이, 보디부(1)는 그 선단부에 가이드포트장착부(11)를 구비한다. 그리고 보디부(1)는 후술하는 풍선카테터 결합체(2)의 슬라이딩용 가압부(28)가 안착 되어 보디부(1)의 전후 방향으로 슬라이드 될 수 있도록 하는 개구(11)를 포함한다. 개구(11)는 도 11에 도시된 바와 같이, 보디부(1)의 길이방향으로 길게 형성된다.As shown in Fig. 3, the body portion 1 is provided with a guide port mounting portion 11 at its distal end. And the body portion 1 includes an opening 11 that allows the sliding pressing portion 28 of the balloon catheter assembly 2 to be described later to be seated and slide in the front-rear direction of the body portion 1 . The opening 11 is formed to be elongated in the longitudinal direction of the body portion 1 as shown in FIG. 11 .

풍선카테터 결합체(2)는 보디부(1)에 상대적으로 이동 가능하게 보디부(1)에 결합한다.The balloon catheter coupling body (2) is coupled to the body part (1) to be movable relative to the body part (1).

구체적으로, 도 4 및 도 5에 도시된 바와 같이, 풍선카테터 결합체(2)는 풍선(21), 내부튜브(22), 외부튜브(23), 가이드튜브(24), 커버튜브(27), 내부튜브홀더(25), Y포트(26), 그리고 슬라이딩용 가압부(28)를 구비한다.Specifically, as shown in FIGS. 4 and 5, the balloon catheter assembly 2 is a balloon 21, an inner tube 22, an outer tube 23, a guide tube 24, a cover tube 27, It has an inner tube holder 25, a Y port 26, and a pressing part 28 for sliding.

내부튜브(22)는 일단이 풍선(21)에 삽입되어 풍선(21)의 원위부(211)에 융착되고, 타단은 풍선(21)으로부터 멀어지는 방향으로 연장된다.One end of the inner tube 22 is inserted into the balloon 21 and fused to the distal portion 211 of the balloon 21 , and the other end extends in a direction away from the balloon 21 .

외부튜브(23)는 내부튜브(22)와 미리 정해진 간극(이를 통하여, 풍선 팽창용 유체가 삽입됨)을 두고 내부튜브(22)를 감싸고, 일단이 풍선(21)의 근위부(212)에 융착될 수 있다.The outer tube 23 surrounds the inner tube 22 with a predetermined gap (through this, a fluid for balloon inflation is inserted) with the inner tube 22, and one end is fused to the proximal portion 212 of the balloon 21. can be

가이드튜브(24)는 외부튜브(23)를 감싸고 외부튜브(23)에 융착될 수 있다. The guide tube 24 may surround the outer tube 23 and be fused to the outer tube 23 .

커버튜브(27)는 가이드튜브(24)를 감싸고 가이드튜브(24)에 융착될 수 있다. The cover tube 27 may surround the guide tube 24 and be fused to the guide tube 24 .

내부튜브홀더(25)에는 내부튜브(22)의 타단이 고정된다.The other end of the inner tube 22 is fixed to the inner tube holder 25 .

Y포트(26)는 유체투입용 제1 포트(261)와, 내부튜브홀더(25)가 고정되는 제2 포트(262)와, 커버튜브(27)가 고정되는 전방관통홀(263)를 구비한다. The Y port 26 has a first port 261 for fluid input, a second port 262 to which the inner tube holder 25 is fixed, and a front through hole 263 to which the cover tube 27 is fixed. do.

슬라이딩용 가압부(28)는 제1 포트(261)의 외벽에 고정된다. 슬라이딩용 가압부(28)에 사용자가 힘을 가하여 풍선카테터의 길이 방향(도 1 기준 수평방향)으로 풍선카테터 결합체(2)를 보디부(1)에 상대적으로 이동시킬 수 있다. The sliding pressing unit 28 is fixed to the outer wall of the first port 261 . The user may apply a force to the sliding pressing unit 28 to relatively move the balloon catheter assembly 2 to the body unit 1 in the longitudinal direction (horizontal direction based on FIG. 1) of the balloon catheter.

한편, 가이드부(3)는 도 6 내지 도 8에 도시된 바와 같이, 가이드포트(31)와, 제1 튜브(32)와, 제2 튜브(33)와, 가이드부(3)를 구비한다.Meanwhile, the guide part 3 includes a guide port 31 , a first tube 32 , a second tube 33 , and a guide part 3 as shown in FIGS. 6 to 8 . .

가이드포트(31)는 가이드포트장착부(11)에 탈착 가능하게 결합한다. 이를 위하여, 가이드포트(31)의 내경의 후반부는 직경이 점점 확대되고, 가이드포트장착부(11)은 외경이 점점 확대되도록 하여, 가이드포트(31)의 내경에 가이드포트장착부(11)의 외경이 서로 끼움 결합되도록 할 수 있다. The guide port 31 is detachably coupled to the guide port mounting part 11 . To this end, the second half of the inner diameter of the guide port 31 is gradually enlarged in diameter, and the outer diameter of the guide port mounting portion 11 is gradually enlarged, so that the outer diameter of the guide port mounting portion 11 is equal to the inner diameter of the guide port 31 They can be fitted to each other.

또한, 도 9에 도시된 바와 같이, 가이드포트(31)의 내벽에는 단차를 형성하는 환형홈(311)이 형성되고, 환형홈(311)에는 제1 튜브(32)의 일단이 위치하면서 단차에 의해 가이드포트(31)의 내벽에 지지된다. 제2 튜브(33)의 일단도 제1 튜브(32)의 일단까지 연장될 수 있다.In addition, as shown in FIG. 9 , an annular groove 311 forming a step is formed on the inner wall of the guide port 31 , and one end of the first tube 32 is positioned in the annular groove 311 while being positioned at the step. by the guide port 31 is supported on the inner wall. One end of the second tube 33 may also extend to one end of the first tube 32 .

제1 튜브(32)는 일단이 가이드포트(31)의 내경의 전반부에 결합(예컨대, 본드접합)하고, 타단은 가이드포트(31)로부터 멀어지는 방향(카테터의 전방, 도 1 기준 좌측방향)으로 연장된다. 제1 튜브(32)는 예컨대, 스테인리스 스틸로 제작되어 제2 튜브(33)보다 더 높은 경도를 가져 직전성을 확보해 준다.The first tube 32 has one end coupled (eg, bonding) to the first half of the inner diameter of the guide port 31, and the other end is in a direction away from the guide port 31 (the front of the catheter, the left direction of FIG. 1 ) is extended The first tube 32 is made of, for example, stainless steel, and has a higher hardness than the second tube 33 to secure the ductility.

제2 튜브(33)는 제1 튜브(32)의 내벽에 결합(예컨대, 본드접합)하고 제1 튜브(32)의 타단으로부터 돌출되게 연장된다. 제2 튜브(33)는 예컨대, 경도 72D 이상의 소재로 제작되어 진직성이 유지되도록 한다.The second tube 33 is coupled (eg, bonded) to the inner wall of the first tube 32 and extends to protrude from the other end of the first tube 32 . The second tube 33 is made of, for example, a material having a hardness of 72D or higher to maintain straightness.

한편, 제2 튜브(33)는, 도 7에 도시된 바와 같이, 그 타단이, 서로 다른 미리 정해진 각도로 꺾여 있는 복수 개가 세트로 구비될 수 있다. On the other hand, as shown in FIG. 7 , the second tube 33 may be provided with a plurality of sets, the other ends of which are bent at different predetermined angles.

이를 통해, 상악동 시술용 제2 튜브(33)는 미리 정해진 각도가 110°이고(도 7의 (a)), 접형동 시술용 제2 튜브(33)는 미리 정해진 각도가 0°이고(도 7의 (f)), 전두동 시술용 제2 튜브(33)는 미리 정해진 각도가 70°일 수 있다(도 7의 (c)). 따라서, 사용자는 병변이 심한 환자는 부비강 입구부가 좁아서 종래의 카테터로는 진입이 어려운 문제를 해결할 수 있고, 풍선카테터를 사용한 시술을 효과적으로 시행할 수 있다. Through this, the second tube 33 for maxillary sinus surgery has a predetermined angle of 110° (Fig. 7 (a)), and the second tube 33 for sphenoid sinus treatment has a predetermined angle of 0° (Fig. 7). (f)), the second tube 33 for frontal sinus surgery may have a predetermined angle of 70° ((c) of FIG. 7). Therefore, the user can solve the problem that the patient with severe lesion is difficult to enter with the conventional catheter because the sinus entrance is narrow, and can effectively perform the procedure using the balloon catheter.

소프트팁(34)은 제2 튜브(33)의 타단의 말단에 결합한다. 소프트팁(34)은 환자의 병변에 접근하여도 날카롭지 않아 상처입지 않도록 경도를 예컨대, 35D로 제작될 수 있다. 이와 같이, 소프트팁(34)의 경도는 제2 튜브(33)의 경도보다 작게, 제2 튜브(33)의 경도는 제1 튜브(32)의 경도보다 작게 형성하여, 예컨대 풍선카테터를 비강에 삽입시 환자의 병변에 상처를 입히지 않으면서도 직진성을 유지하여 효과적으로 환자를 치료할 수 있다.The soft tip 34 is coupled to the end of the other end of the second tube 33 . The soft tip 34 may be made of a hardness of, for example, 35D so that it is not sharp even when approaching the patient's lesion and thus does not get hurt. In this way, the hardness of the soft tip 34 is smaller than the hardness of the second tube 33, the hardness of the second tube 33 is formed to be smaller than the hardness of the first tube 32, for example, a balloon catheter in the nasal cavity. It is possible to effectively treat the patient by maintaining straightness without injuring the patient's lesion during insertion.

도 12에 도시된 바와 같이, 광파이버조명부(4)가 보디부(1)에 장착된다. 광파이버조명부(4)는 전원(41)과, 전원(41)으로부터 전력을 받아 발광하는 광파이버(42)와, 탈착 가능하게 장착되어 전원(41)으로부터 전력을 차단할 수 있는 전력차단판(43)을 구비한다.As shown in FIG. 12 , the optical fiber lighting unit 4 is mounted on the body unit 1 . The optical fiber lighting unit 4 includes a power source 41, an optical fiber 42 that emits light by receiving power from the power source 41, and a power blocking plate 43 that is detachably mounted and can cut off power from the power source 41. be prepared

또한, 광파이버(42)는 도 2에 도시된 바와 같이, 제2 포트(262) 및 내부튜브(22) 속으로 삽입되어 풍선(21)의 원위부(211)로 돌출되도록 사용자가 광파이버(42)를 밀거나 잡아당길 수 있다. In addition, as shown in FIG. 2 , the optical fiber 42 is inserted into the second port 262 and the inner tube 22 to protrude to the distal part 211 of the balloon 21 by the user to hold the optical fiber 42 . can be pushed or pulled.

이때, 도 5에 도시된 바와 같이, 풍선카테터 결합체(2)는 내부튜브홀더(25)의 후단에 광파이버홀딩부(29)를 구비하고, 광파이버(42)가 광파이버홀딩부(29)를 관통하여 삽입되도록 한다. 이때, 광파이버홀딩부(29)를 예컨대 실리콘제로 제작하여, 미리 정해진 힘 이상의 힘으로 잡아당기거나 밀 때 광파이버(42)가 광파이버홀딩부(29)에 상대적으로 이동될 수 있도록 하고, 미리 정해진 힘 미만의 힘으로는 이러한 이동이 발생하지 않도록 할 수 있다. 따라서, 사용자가 특정 위치로 광파이버(42)를 이동시키기 위해서 광파이버(42)를 미리 정해진 힘 이상으로 밀거나 당긴 후, 힘을 제거하면, 본 풍선카테터의 사용 중에 광파이버(42)가 특정 위치에 고정되므로, 광파이버(42)의 말단에서 나오는 빛의 위치를 특정 위치로 고정할 수 있게 된다. At this time, as shown in FIG. 5 , the balloon catheter assembly 2 has an optical fiber holding part 29 at the rear end of the inner tube holder 25 , and the optical fiber 42 passes through the optical fiber holding part 29 . to be inserted. At this time, the optical fiber holding part 29 is made of, for example, silicon, so that the optical fiber 42 can be moved relative to the optical fiber holding part 29 when pulling or pushing with a force greater than or equal to a predetermined force, and less than the predetermined force The force of can prevent this movement from occurring. Therefore, if the user pushes or pulls the optical fiber 42 more than a predetermined force in order to move the optical fiber 42 to a specific position, and then removes the force, the optical fiber 42 is fixed at a specific position during use of the balloon catheter. Therefore, the position of the light emitted from the end of the optical fiber 42 can be fixed to a specific position.

또한, 병변이 심한 환자는, 풍선 카테터의 직경을 가급적 최소화 필요가 있는데, 본 실시예에서는 풍선카테터 결합체(2)를 가이드부(3)에 대해 상대적으로 이동, 즉, 가이드부(3)가 장착된 보디부(1)를 사용자가 잡은 상태에서 슬라이딩용 가입부(28)를 우측 방향(도 1 기준)으로 이동시킬 경우 풍선카테터 결합체(2)도 연동하여 우측 방향으로 이동하고, 이를 통하여, 가이드부(3)의 제2 튜브(33) 내부로 풍선(21)이 삽입되어 풍선(21)이 외부로 드러나지 않게 된다. 이 경우, 환자의 병변에 삽입되는 풍선카테터의 직경(크기)을 대폭 줄일 수 있어, 환자의 병변으로서의 진입이 용이하게 된다. 필요시, 광파이버(42)를 적절하게 잡아당기거나 밀어서 그 말단부 위치를 조정 및 고정할 수 있어, 환자의 병변으로 진입을 더 용이하게 한다. In addition, patients with severe lesions need to minimize the diameter of the balloon catheter as much as possible. In this embodiment, the balloon catheter assembly 2 is moved relative to the guide portion 3, that is, the guide portion 3 is mounted. When the user holds the body part 1 and moves the subscription part 28 for sliding in the right direction (based on FIG. 1), the balloon catheter assembly 2 also works in conjunction and moves in the right direction, and through this, the guide The balloon 21 is inserted into the second tube 33 of the part 3 so that the balloon 21 is not exposed to the outside. In this case, the diameter (size) of the balloon catheter inserted into the lesion of the patient can be greatly reduced, and the entry into the lesion of the patient becomes easy. If necessary, the position of the distal end can be adjusted and fixed by appropriately pulling or pushing the optical fiber 42, thereby making it easier to enter the lesion of the patient.

또한, 환자의 병변 즉, 부비강의 상악동 진입시에는 제2 튜브(33)가 110°로 꺾인 가이드부(3)를 보디부(1)의 가이드포트장착부(11)에 연결하고, 접형동 진입시에는 제2 튜브(33)가 0°로 직선인 가이드부(3)를 보디부(1)의 가이드포트장착부(11)에 교체 연결하고, 또한, 전두동 진입시에는 제2 튜브(33)가 70°로 꺾인 직선인 가이드부(3)를 가이드포트장착부(11)에 연결해서 사용함으로써, 환자의 병변에 맞게 적절한 풍선카테터를 시술 현장에서 손쉽게 적용할 수 있다. In addition, when entering the maxillary sinus of the patient's lesion, that is, the sinus, the guide part 3 in which the second tube 33 is bent at 110° is connected to the guide port mounting part 11 of the body part 1, and when entering the sphenoid sinus, the second The tube 33 connects the guide part 3, which is straight at 0°, to the guide port mounting part 11 of the body part 1, and also, when entering the frontal sinus, the second tube 33 is a straight line bent at 70° By connecting the in-guide part 3 to the guide port mounting part 11 and using it, it is possible to easily apply an appropriate balloon catheter to the patient's lesion at the operation site.

이상에서 본 발명의 바람직한 실시예에 대하여 상세하게 설명하였지만 본 발명의 권리범위는 이에 한정되는 것은 아니고 다음의 청구범위에서 정의하고 있는 본 발명의 기본 개념을 이용한 당업자의 여러 변형 및 개량 형태 또한 본 발명의 권리범위에 속하는 것이다.Although preferred embodiments of the present invention have been described in detail above, the scope of the present invention is not limited thereto, and various modifications and improvements by those skilled in the art using the basic concept of the present invention as defined in the following claims are also provided. is within the scope of the

본 발명은 부비관 및 이관 치료에 사용되는 풍선카테터에 이용될 수 있다.The present invention can be used in a balloon catheter used for the treatment of the sinus and ear canals.

Claims (9)

부비관 및 이관 치료용 풍선카테터로서, As a balloon catheter for the treatment of sinus and ear canal, 가이드포트장착부를 구비하는 보디부, A body portion having a guide port mounting portion, 풍선을 구비하고, 상기 보디부에 상대적으로 이동 가능하게 상기 보디부에 결합하는 풍선카테터 결합체, A balloon catheter assembly having a balloon and coupled to the body portion to be movable relative to the body portion, 상기 가이드포트장착부에 탈착 가능하게 결합하는 가이드포트와, 상기 가이드포트에 일단이 결합하고 타단은 상기 가이드포트로부터 멀어지는 방향으로 연장되는 제1 튜브와, 상기 제1 튜브의 내벽에 결합하고 상기 제1 튜브의 타단으로부터 돌출되게 연장되는 제2 튜브와, 상기 제2 튜브의 말단에 결합하는 소프트팁을 구비하는 가이드부, 그리고A guide port detachably coupled to the guide port mounting portion, a first tube having one end coupled to the guide port and the other end extending in a direction away from the guide port, and coupled to the inner wall of the first tube and the first tube A second tube extending to protrude from the other end of the tube, and a guide portion having a soft tip coupled to the end of the second tube, and 상기 보디부에 장착되고, 광파이버를 구비하는 광파이버조명부An optical fiber lighting unit mounted on the body and having an optical fiber 를 포함하는 풍선카테터.A balloon catheter comprising a. 제1항에서,In claim 1, 상기 소프트팁의 경도는 상기 제2 튜브의 경도보다 작고, 상기 제2 튜브의 경도는 상기 제1 튜브의 경도보다 작은The hardness of the soft tip is less than the hardness of the second tube, the hardness of the second tube is less than the hardness of the first tube 풍선카테터.balloon catheter. 제2항에서,In claim 2, 상기 가이드포트의 내벽에는 단차를 형성하는 환형홈이 형성되고, 상기 환형홈에는 상기 제1 튜브의 일단이 위치하는An annular groove forming a step is formed on the inner wall of the guide port, and one end of the first tube is located in the annular groove. 풍선카테터.balloon catheter. 제3항에서, In claim 3, 상기 제2 튜브는,The second tube, 그 타단이, 서로 다른 미리 정해진 각도로 꺾여 있는 The other end is bent at different predetermined angles 복수 개가 구비되는 provided with multiple 풍선카테터.balloon catheter. 제4항에서,In claim 4, 상악동 시술용 상기 제2 튜브는 상기 미리 정해진 각도가 110°이고, 접형동 시술용 상기 제2 튜브는 상기 미리 정해진 각도가 0°이고, 전두동 시술용 상기 제2 튜브는 상기 미리 정해진 각도가 70°인The second tube for maxillary sinus surgery has a predetermined angle of 110°, the second tube for sphenoid sinus surgery has a predetermined angle of 0°, and the second tube for frontal sinus surgery has a predetermined angle of 70° 풍선카테터.balloon catheter. 제1항에서,In claim 1, 상기 풍선카테터 결합체는The balloon catheter assembly is 일단은 상기 풍선에 삽입되어 상기 풍선의 원위부에 융착되고, 타단은 상기 풍선으로부터 멀어지는 방향으로 연장되는 내부튜브,One end is inserted into the balloon and fused to the distal portion of the balloon, the other end is an inner tube extending in a direction away from the balloon, 상기 내부튜브와 미리 정해진 간극을 두고 상기 내부튜브를 감싸고, 일단이 상기 풍선의 근위부에 융착되는 외부튜브,An outer tube that surrounds the inner tube with a predetermined gap with the inner tube, one end of which is fused to the proximal portion of the balloon; 상기 외부튜브를 감싸고 상기 외부튜브에 융착되는 가이드튜브,A guide tube that surrounds the outer tube and is fused to the outer tube; 상기 가이드튜브를 감싸고 상기 가이드튜브에 융착되는 커버튜브,A cover tube that surrounds the guide tube and is fused to the guide tube; 상기 내부튜브의 타단이 고정되는 내부튜브홀더,an inner tube holder to which the other end of the inner tube is fixed; 유체투입용 제1 포트와, 상기 내부튜브홀더가 고정되는 제2 포트와, 상기 커버튜브가 고정되는 전방관통홀을 구비하는 Y포트, 그리고A Y port having a first port for introducing a fluid, a second port to which the inner tube holder is fixed, and a front through hole to which the cover tube is fixed, and 상기 제1 포트의 외벽에 고정되는 슬라이딩용 가압부A sliding pressing part fixed to the outer wall of the first port 를 더 포함하는 further comprising 풍선카테터.balloon catheter. 제6항에서, In claim 6, 상기 보디부는 상기 슬라이딩용 가압부가 안착 되어 상기 보디부의 전후 방향으로 슬라이드 될 수 있도록 하는 개구를 포함하는 풍선카테터.The body portion is a balloon catheter comprising an opening that allows the sliding pressing portion to be seated to slide in the front-rear direction of the body portion. 제6항에서, In claim 6, 상기 풍선카테터 결합체는 상기 내부튜브홀더의 후단에 광파이버홀딩부를 구비하고, 상기 광파이버가 광파이버홀딩부를 관통하여 삽입되고, 상기 광파이버홀딩부는 실리콘제로 제작되어, 미리 정해진 힘 이상의 힘으로 잡아당기거나 밀 때 상기 광파이버가 상기 광파이버홀딩부에 상대적으로 이동될 수 있도록 하는The balloon catheter assembly is provided with an optical fiber holding part at the rear end of the inner tube holder, the optical fiber is inserted through the optical fiber holding part, and the optical fiber holding part is made of silicone, and when pulling or pushing with a force greater than a predetermined force, the so that the optical fiber can be moved relative to the optical fiber holding part 풍선카테터.balloon catheter. 제1항에서, In claim 1, 상기 풍선카테터 결합체는 상기 가이드부에 대해 상대적으로 이동하여, 상기 제2 튜브의 내부로 상기 풍선이 삽입되어 외부로 드러나지 않을 수 있는 The balloon catheter assembly is moved relative to the guide portion, the balloon is inserted into the interior of the second tube that may not be exposed to the outside 풍선카테터balloon catheter
PCT/KR2021/014027 2020-11-19 2021-10-12 Balloon catheter for treating nasal passages and eustachian tube Ceased WO2022108115A1 (en)

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KR1020200155761A KR20220069172A (en) 2020-11-19 2020-11-19 Balloon Catheter for treating sinus orifice and eustachian tube

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20120012796A (en) * 2009-03-20 2012-02-10 아클라런트, 인코포레이션 Guide system with suction force
KR20150144392A (en) * 2014-06-16 2015-12-28 (주)태연메디칼 Catheter having direction control function of balloon
KR101802317B1 (en) * 2016-11-25 2017-11-29 (의료)길의료재단 Sinus balloon catheter with adjustable bending angle and balloon position
KR20170139589A (en) * 2015-04-22 2017-12-19 아클라런트, 인코포레이션 Balloon expansion system with malleable inner guide
KR20200041845A (en) * 2020-04-02 2020-04-22 (주)메가메디칼 balloon catheter

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20180113660A (en) 2017-04-06 2018-10-17 (주)메가메디칼 balloon catheter and medical navigation system using the same

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20120012796A (en) * 2009-03-20 2012-02-10 아클라런트, 인코포레이션 Guide system with suction force
KR20150144392A (en) * 2014-06-16 2015-12-28 (주)태연메디칼 Catheter having direction control function of balloon
KR20170139589A (en) * 2015-04-22 2017-12-19 아클라런트, 인코포레이션 Balloon expansion system with malleable inner guide
KR101802317B1 (en) * 2016-11-25 2017-11-29 (의료)길의료재단 Sinus balloon catheter with adjustable bending angle and balloon position
KR20200041845A (en) * 2020-04-02 2020-04-22 (주)메가메디칼 balloon catheter

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