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WO2013097261A1 - Nasal sinus stent and special placement device therefor - Google Patents

Nasal sinus stent and special placement device therefor Download PDF

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Publication number
WO2013097261A1
WO2013097261A1 PCT/CN2012/000196 CN2012000196W WO2013097261A1 WO 2013097261 A1 WO2013097261 A1 WO 2013097261A1 CN 2012000196 W CN2012000196 W CN 2012000196W WO 2013097261 A1 WO2013097261 A1 WO 2013097261A1
Authority
WO
WIPO (PCT)
Prior art keywords
flexible
control handle
sinus stent
sinus
inner tube
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/CN2012/000196
Other languages
French (fr)
Chinese (zh)
Inventor
毛建勇
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.)
MAXENMED (GUANGZHOU) CO Ltd
Original Assignee
MAXENMED (GUANGZHOU) CO Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by MAXENMED (GUANGZHOU) CO Ltd filed Critical MAXENMED (GUANGZHOU) CO Ltd
Publication of WO2013097261A1 publication Critical patent/WO2013097261A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0065Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/0078Quadric-shaped hyperboloidal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0037Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in height or in length

Definitions

  • the present invention relates to an auxiliary instrument for sinus expansion, and more particularly to a sinus stent.
  • the invention also relates to a dedicated delivery device for the sinus stent described above.
  • a former object of the present invention is to provide a sinus stent which is simple in structure and effective in use.
  • a further object of the present invention is to provide a special delivery device for a sinus stent which is compact in structure and simple in operation.
  • the former technical solution of the present invention is realized as follows: a sinus stent, the stent is a cylindrical body, and the cylindrical wall of the cylindrical body is a mesh structure made of an elastic material; the outer diameter of the cylindrical body is 4 ⁇ 15mm, the length of the cylindrical body is 6 ⁇
  • the cylindrical body is composed of a support portion and a positioning portion disposed at two ends of the support portion, and the support portion and the positioning portion are integrally formed as a whole; the outer diameter of the support portion is 5 to 10, 5 ⁇ The diameter of the diameter of 0. 05 ⁇ 0. 5ram. The diameter of the wire is 0. 05 ⁇ 0. 5ram.
  • the mesh structure has a mesh size of 1 mm 2 to 9 mm 2 .
  • the sinus stent of the mesh structure can effectively support the sinus ostium after balloon expansion, and prevent the symptoms of re-stenosis of the sinus mouth, thereby rapidly and effectively treating sinusitis and achieving the desired effect. There is no need to repeat the review several times, which not only reduces the suffering of the patient, but also saves the patient's expenses.
  • a special delivery device for a sinus stent comprising a control handle, wherein the control handle has a long hole in a side wall thereof, and a sliding handle is arranged in the long hole, the sliding
  • the free end of the handle is connected with a flexible outer sleeve, the free end of the flexible outer sleeve extends outside the control handle;
  • the flexible outer sleeve is provided with a flexible inner tube, and one end of the flexible inner tube passes through the control handle and is external
  • the other end of the flexible inner tube cooperates with the flexible outer sleeve to form a placement cavity for placing the compressed sinus stent.
  • the flexible end of the flexible inner tube is provided with a flexible guiding head, a flexible guiding head
  • the description is located on the outside of the flexible outer casing and the outer diameter of the flexible guide head is adapted to the outer diameter of the flexible outer casing, and the flexible guide head (7) is provided with an axial through hole communicating with the flexible inner tube (5).
  • the outer wall of the flexible inner tube on the rear side of the flexible guide head is provided with an annular groove in the circumferential direction, and the placement cavity is formed by the annular groove and the flexible outer sleeve.
  • the side wall of the control handle is provided with a wire joint communicating with the outside, and one end of the flexible inner tube contacting the control handle is connected with the wire guide.
  • the present invention uses the guide wire used in the sinus balloon expansion to find the position of the sinus, and through the cooperation of the flexible inner tube and the flexible outer sleeve, the sinus stent is transported to the sinus mouth under the control of the control handle, and passes The sliding handle controls the movement of the flexible outer sleeve to release the sinus stent, so that the sinus stent naturally expands and abuts against the sinus wall, thereby completing the expansion support of the sinus ostium.
  • the use of sinus rest and stenosis may occur after two years of balloon dilatation. If the sinus stent is used, the time for narrowing the sinus can be more than doubled.
  • Embodiment 1 is a schematic structural view of Embodiment 1 of a sinus stent according to the present invention
  • Figure 2 is a cross-sectional view taken along line AA of Figure 1;
  • Figure 3 is a schematic view showing the structure of the sinus stent of the present invention.
  • Figure 4 is a cross-sectional view of Figure 3 at BB;
  • Figure 5 is a schematic structural view of a conveying device of the present invention.
  • Figure 6 is a schematic view showing the structure of the delivery device of the present invention after placing the sinus stent
  • Figure 7 is a partial enlarged view of the portion C in Figure 5;
  • Figure 8 is a partial enlarged view of the portion D in Figure 6;
  • Figure 9 is a schematic view showing the structure of the delivery device of the present invention when releasing the sinus stent
  • Figure 10 is a schematic view showing the structure of the delivery device of the present invention after releasing the sinus stent.
  • cylindrical body 1 support part la, positioning part lb, control handle 2, sliding handle 3, flexible outer sleeve 4, flexible inner tube 5, placement cavity 6, flexible guide head 7, guide wire joint 8.
  • the stent is a cylindrical body 1, the cylinder wall of which is a mesh structure made of an elastic material; the outer diameter of the cylindrical body 1 is 4 to 15 mm, the length of the cylindrical body 1 is 6 to 20 mm. 5 ⁇ The diameter of the wire is 0. 05 ⁇ Instruction manual
  • the mesh size of the mesh structure is 1 mm 2 to 9 mm 2 .
  • a special delivery device for a sinus stent of the present invention comprises an elongated control handle 2, and a long hole is arranged along the length direction on the side wall of the control handle 2, and is arranged in the long hole.
  • a sliding handle 3 There is a sliding handle 3, and the free end of the sliding handle 3 in the control handle 2 is connected with a flexible outer sleeve 4, the free end of the flexible outer sleeve 4 extends outside the control handle 2; and the flexible inner sleeve 5 is provided with a flexible inner tube 5
  • the flexible inner tube 5 end passes through the control handle 2 and communicates with the outside, and the other end of the flexible inner tube 5 cooperates with the flexible outer sleeve 4 to form a placement cavity 6 for placing the compressed sinus support.
  • an annular groove is circumferentially provided on the outer wall of the flexible inner tube 5 on the rear side of the flexible guide head 7, and the placement chamber 6 is formed by the annular groove and the flexible outer sleeve 4.
  • a flexible flexible guide head 7 is provided at the free end of the flexible inner tube 5, and the flexible guide head 7 is located outside the flexible outer sleeve 4 and outside the flexible guide head 7.
  • the diameter is adapted to the outer diameter of the flexible outer sleeve 4, and the flexible guide head 7 is provided with an axial through hole communicating with the flexible inner tube 5.
  • a guide wire joint 8 communicating with the outside is provided on the side wall of the control handle 2, and one end of the flexible inner tube 5 in contact with the control handle 2 is connected to the wire guide 8.
  • the guide wire connector 8 is provided with a tapered inner hole, and a guide wire joint 8 having a tapered inner hole is used to facilitate the entry of the guide wire into the inner cavity of the flexible inner tube 5.
  • an appropriate size of the sinus stent 1 is selected, and the sinus stent 1 is compressed and placed into the placement chamber 6.
  • the free end of the guide wire is inserted from the flexible guide head 7 and protrudes from the guide wire connector 8 by using the guide wire used in the operation, and the operator controls the flexibility by the control handle 2
  • the outer sleeve 4 and the flexible inner tube 5 are guided by the front flexible guide head 7, find the position of the sinus, and then extend into the sinus cavity.
  • a sinus stent of the present invention has the same structure as that of Embodiment 1, except that the cylindrical body 1 is composed of a support portion 1a and a positioning portion lb disposed at both ends of the support portion 1a.
  • the support portion 1a and the positioning portion 1b are integrally formed; the outer diameter of the support portion 1a is 5 to 10, and the outer diameter of the positioning portion 1b is 6 to 14 nm.
  • This structure can make the sinus stent less prone to displacement in the sinus ostium, and the time for re-stenosis of the sinus ostium can be further prolonged.
  • the method of use and positioning is the same as that of the first embodiment.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)

Abstract

Disclosed are a nasal sinus stent and a special placement device therefor. The nasal sinus stent has a cylindrical body (1), and the cylinder wall of the cylindrical body (1) is a mesh structure made of an elastic material. The placement device comprises a control handle (2) having provided on the side whereof a slot hole; a slide handle (3) is provided in the slot hole, and the free end of the slide handle (3) located within the control handle (2) is connected with a flexible sleeve (4), while the free end of the flexible sleeve (4) extends to the exterior surface of the control handle (2); a flexible inner pipe (5) is movably fitted in the flexible sleeve (4), with one end of the flexible inner pipe (5) passing through the control handle (2) and thus being in communication with the exterior, and with the other end of the flexible inner pipe (5) being combined with the flexible sleeve (4) to form an accommodation cavity (6) for holding the compressed nasal sinus stent. The nasal sinus stent has a simple structure and good usage results, and the special placement device of the nasal sinus stent is structurally compact and operationally simple and convenient.

Description

说 明 书 鼻窦支架以及其专用输送装置 技术领域  Description Sinus stent and its special delivery device

本发明涉及一种鼻窦扩张用辅助器械, 更具体地说, 尤其涉及一种鼻窦支架。 本发明还 涉及上述鼻窦支架的专用输送装置。  The present invention relates to an auxiliary instrument for sinus expansion, and more particularly to a sinus stent. The invention also relates to a dedicated delivery device for the sinus stent described above.

背景技术 Background technique

使用球囊扩张术治疗鼻窦炎,经过一段时间后,有一部分病人出现窦口再次狭窄的症状, 影响窦腔的引流, 导致病变复发, 影响手术疗效, 从而需要进行二次手术。 同时, 为了避免 出现上述症状, 需要患者反复进行复查, 不仅会增加医源性创作, 而且增加患者的痛苦, 加 重患者的经济负担。  After balloon sinus surgery for sinusitis, after a period of time, some patients have symptoms of sinus stenosis, affecting the drainage of the sinus cavity, leading to recurrence of the disease, affecting the curative effect, thus requiring a second operation. At the same time, in order to avoid the above symptoms, the patient needs to be reviewed repeatedly, which not only increases the iatrogenic creation, but also increases the suffering of the patient and aggravates the economic burden of the patient.

发明内容 Summary of the invention

本发明的前一目的在于提供一种结构简单、 使用效果好的鼻窦支架。  A former object of the present invention is to provide a sinus stent which is simple in structure and effective in use.

本发明的后一目的在于提供一种结构紧凑、 操作简单方便的鼻窦支架专用输送装置。 本发明的前一技术方案是这样实现的: 一种鼻窦支架, 该支架为筒形体, 该筒形体的筒 壁是由弹性材料制成的网状结构; 所述筒形体的外径为 4〜15mm, 所述筒形体的长度为 6〜 A further object of the present invention is to provide a special delivery device for a sinus stent which is compact in structure and simple in operation. The former technical solution of the present invention is realized as follows: a sinus stent, the stent is a cylindrical body, and the cylindrical wall of the cylindrical body is a mesh structure made of an elastic material; the outer diameter of the cylindrical body is 4~ 15mm, the length of the cylindrical body is 6~

20 " 20 "

上述的鼻窦支架中, 所述的筒形体由支撑部和设置在支撑部两端的定位部组成, 支撑部 与定位部为一体成型的整体结构; 所述支撑部的外径为 5〜10 , 所述定位部的外径为 6〜 上述的鼻窦支架中, 所述的网状结构为镍钛记忆合金制成的丝线编织而成, 所述丝线的 直径为 0. 05〜0. 5ram。  In the above sinus stent, the cylindrical body is composed of a support portion and a positioning portion disposed at two ends of the support portion, and the support portion and the positioning portion are integrally formed as a whole; the outer diameter of the support portion is 5 to 10, 5毫米。 The diameter of the diameter of 0. 05~0. 5ram. The diameter of the wire is 0. 05~0. 5ram.

上述的鼻窦支架中, 所述网状结构的网格大小为 lmm2〜9mm2In the above sinus stent, the mesh structure has a mesh size of 1 mm 2 to 9 mm 2 .

本发明采用上述结构后, 通过网状结构的鼻窦支架, 可以在球囊扩张术后, 有效地支撑 鼻窦口, 防止窦口出现再次狭窄的症状,从而可以快速有效地治疗鼻窦炎并且达到预期效果, 不需要反复多次进行复查, 既减轻了病人的痛苦, 又节省了病人的开支。  After adopting the above structure, the sinus stent of the mesh structure can effectively support the sinus ostium after balloon expansion, and prevent the symptoms of re-stenosis of the sinus mouth, thereby rapidly and effectively treating sinusitis and achieving the desired effect. There is no need to repeat the review several times, which not only reduces the suffering of the patient, but also saves the patient's expenses.

本发明的后一技术方案是这样实现的: 一种鼻窦支架专用输送装置, 包括控制手柄, 其 中所述的控制手柄侧壁上设有长孔, 在长孔内设有滑柄, 所述滑柄位于控制手柄内的自由端 连接有柔性外套, 柔性外套的自由端延伸至控制手柄外面; 在柔性外套内活动套设有柔性内 管, 所述的柔性内管一端穿过控制手柄并与外部相通, 所述的柔性内管另一端与柔性外套配 合形成用于放置压缩后的鼻窦支架的放置腔。  The latter technical solution of the present invention is implemented as follows: a special delivery device for a sinus stent, comprising a control handle, wherein the control handle has a long hole in a side wall thereof, and a sliding handle is arranged in the long hole, the sliding The free end of the handle is connected with a flexible outer sleeve, the free end of the flexible outer sleeve extends outside the control handle; the flexible outer sleeve is provided with a flexible inner tube, and one end of the flexible inner tube passes through the control handle and is external In the same manner, the other end of the flexible inner tube cooperates with the flexible outer sleeve to form a placement cavity for placing the compressed sinus stent.

上述的鼻窦支架专用输送装置中, 所述柔性内管的自由端设有柔性导向头, 柔性导向头 说 明 书 位于柔性外套外侧且柔性导向头的外径与柔性外套的外径相适应, 柔性导向头(7)设有与柔 性内管 (5)连通的轴向通孔。 In the above-mentioned special delivery device for sinus stent, the flexible end of the flexible inner tube is provided with a flexible guiding head, a flexible guiding head The description is located on the outside of the flexible outer casing and the outer diameter of the flexible guide head is adapted to the outer diameter of the flexible outer casing, and the flexible guide head (7) is provided with an axial through hole communicating with the flexible inner tube (5).

上述的鼻窦支架专用输送装置中, 所述的柔性导向头后侧的柔性内管外壁上沿周向设有 环形凹槽, 所述的放置腔由环形凹槽与柔性外套配合形成。  In the above-mentioned special delivery device for sinus stents, the outer wall of the flexible inner tube on the rear side of the flexible guide head is provided with an annular groove in the circumferential direction, and the placement cavity is formed by the annular groove and the flexible outer sleeve.

上述的鼻窦支架专用输送装置中, 所述的控制手柄侧壁上设有与外部相通的导丝接头, 所述柔性内管与控制手柄接触的一端与导丝接头连接。  In the above-mentioned special delivery device for sinus stents, the side wall of the control handle is provided with a wire joint communicating with the outside, and one end of the flexible inner tube contacting the control handle is connected with the wire guide.

本发明采用上述结构后, 利用鼻窦球囊扩张术中使用的导丝找到窦口位置, 通过柔性内 管与柔性外套的配合, 在控制手柄的控制下将鼻窦支架输送至窦口处, 并通过滑柄控制柔性 外套移动从而释放鼻窦支架,使鼻窦支架自然膨胀贴紧窦口壁,从而完成对窦口的扩张支撑。 使用通常球囊扩张术后两年就可能出现窦口再狭窄的现象, 如果使用鼻窦支架, 可使再次狭 窄的时间延长一倍以上。  After adopting the above structure, the present invention uses the guide wire used in the sinus balloon expansion to find the position of the sinus, and through the cooperation of the flexible inner tube and the flexible outer sleeve, the sinus stent is transported to the sinus mouth under the control of the control handle, and passes The sliding handle controls the movement of the flexible outer sleeve to release the sinus stent, so that the sinus stent naturally expands and abuts against the sinus wall, thereby completing the expansion support of the sinus ostium. The use of sinus rest and stenosis may occur after two years of balloon dilatation. If the sinus stent is used, the time for narrowing the sinus can be more than doubled.

附图说明 DRAWINGS

下面结合附图中的实施例对本实用新型作进一步的详细说明, 但并不构成对本实用新型 的任何限制。  The present invention will be further described in detail below with reference to the embodiments of the accompanying drawings, but no limitation of the invention.

图 1是本发明鼻窦支架实施例 1的结构示意图;  1 is a schematic structural view of Embodiment 1 of a sinus stent according to the present invention;

图 2是图 1中 AA处的剖视图;  Figure 2 is a cross-sectional view taken along line AA of Figure 1;

图 3是本发明鼻窦支架实施例 2的结构示意图;  Figure 3 is a schematic view showing the structure of the sinus stent of the present invention;

图 4是图 3是 BB处的剖视图;  Figure 4 is a cross-sectional view of Figure 3 at BB;

图 5是本发明输送装置的结构示意图;  Figure 5 is a schematic structural view of a conveying device of the present invention;

图 6是本发明输送装置放置鼻窦支架后的结构示意图;  Figure 6 is a schematic view showing the structure of the delivery device of the present invention after placing the sinus stent;

图 7是图 5中 C处的局部放大示意图;  Figure 7 is a partial enlarged view of the portion C in Figure 5;

图 8是图 6中 D处的局部放大示意图;  Figure 8 is a partial enlarged view of the portion D in Figure 6;

图 9是本发明输送装置释放鼻窦支架时的结构示意图;  Figure 9 is a schematic view showing the structure of the delivery device of the present invention when releasing the sinus stent;

图 10是本发明输送装置释放鼻窦支架后的结构示意图。  Figure 10 is a schematic view showing the structure of the delivery device of the present invention after releasing the sinus stent.

图中: 筒形体 1、支撑部 la、 定位部 lb、控制手柄 2、滑柄 3、柔性外套 4、柔性内管 5、 放置腔 6、 柔性导向头 7、 导丝接头 8。  In the figure: cylindrical body 1, support part la, positioning part lb, control handle 2, sliding handle 3, flexible outer sleeve 4, flexible inner tube 5, placement cavity 6, flexible guide head 7, guide wire joint 8.

具体实施方式 detailed description

实施例 1  Example 1

参阅图 1和图 2所示, 本发明的一种鼻窦支架, 支架为筒形体 1 , 该筒形体 1的筒壁是 由弹性材料制成的网状结构; 所述筒形体 1的外径为 4〜15mm, 所述筒形体 1的长度为 6〜 20mm。本实施例中的网状结构为镍钛记忆合金制成的丝线编织而成,所述丝线的直径为 0. 05〜 说 明 书 Referring to Figures 1 and 2, a sinus stent of the present invention, the stent is a cylindrical body 1, the cylinder wall of which is a mesh structure made of an elastic material; the outer diameter of the cylindrical body 1 is 4 to 15 mm, the length of the cylindrical body 1 is 6 to 20 mm. 5〜 The diameter of the wire is 0. 05~ Instruction manual

0. 5mm。 优选为 0. 1画和 0. 2mm两种。 同时, 所述网状结构的网格大小为 lmm2〜9mm20. 5mm. 2毫米两个。 Two paintings and 0. 2mm two. Meanwhile, the mesh size of the mesh structure is 1 mm 2 to 9 mm 2 .

参阅图图 5和图 7所示, 本发明的一种鼻窦支架专用输送装置, 包括长条形的控制手柄 2, 在控制手柄 2侧壁上沿长度方向设有长孔, 在长孔内设有滑柄 3, 所述滑柄 3位于控制手 柄 2内的自由端连接有柔性外套 4, 柔性外套 4的自由端延伸至控制手柄 2外面; 在柔性外 套 4内活动套设有柔性内管 5, 所述的柔性内管 5—端穿过控制手柄 2并与外部相通, 所述 的柔性内管 5另一端与柔性外套 4配合形成用于放置压缩后的鼻窦支架的放置腔 6。 本实施 例中, 在柔性导向头 7后侧的柔性内管 5外壁上沿周向设有环形凹槽, 所述的放置腔 6由环 形凹槽与柔性外套 4配合形成。 同时, 为了更加方便柔性外套 4和柔性内管 5的移动, 在柔 性内管 5的自由端设有锥形的柔性导向头 7, 柔性导向头 7位于柔性外套 4外侧且柔性导向 头 7的外径与柔性外套 4的外径相适应, 柔性导向头 7设有与柔性内管 5连通的轴向通孔。 进一步地,在控制手柄 2侧壁上设有与外部相通的导丝接头 8,所述柔性内管 5与控制手柄 2 接触的一端与导丝接头 8连接。 所述的导丝接头 8设有锥形内孔, 带锥形内孔的导丝接头 8, 其作用是方便导丝进入柔性内管 5内孔腔。  Referring to FIG. 5 and FIG. 7 , a special delivery device for a sinus stent of the present invention comprises an elongated control handle 2, and a long hole is arranged along the length direction on the side wall of the control handle 2, and is arranged in the long hole. There is a sliding handle 3, and the free end of the sliding handle 3 in the control handle 2 is connected with a flexible outer sleeve 4, the free end of the flexible outer sleeve 4 extends outside the control handle 2; and the flexible inner sleeve 5 is provided with a flexible inner tube 5 The flexible inner tube 5 end passes through the control handle 2 and communicates with the outside, and the other end of the flexible inner tube 5 cooperates with the flexible outer sleeve 4 to form a placement cavity 6 for placing the compressed sinus support. In the present embodiment, an annular groove is circumferentially provided on the outer wall of the flexible inner tube 5 on the rear side of the flexible guide head 7, and the placement chamber 6 is formed by the annular groove and the flexible outer sleeve 4. Meanwhile, in order to facilitate the movement of the flexible outer sleeve 4 and the flexible inner tube 5, a flexible flexible guide head 7 is provided at the free end of the flexible inner tube 5, and the flexible guide head 7 is located outside the flexible outer sleeve 4 and outside the flexible guide head 7. The diameter is adapted to the outer diameter of the flexible outer sleeve 4, and the flexible guide head 7 is provided with an axial through hole communicating with the flexible inner tube 5. Further, a guide wire joint 8 communicating with the outside is provided on the side wall of the control handle 2, and one end of the flexible inner tube 5 in contact with the control handle 2 is connected to the wire guide 8. The guide wire connector 8 is provided with a tapered inner hole, and a guide wire joint 8 having a tapered inner hole is used to facilitate the entry of the guide wire into the inner cavity of the flexible inner tube 5.

参阅图 6、 图 8至图 10所示, 具体使用时, 根据患者的具体情况, 选择合适大小的鼻窦 支架 1, 并 鼻窦支架 1压缩后置入放置腔 6内。 在鼻窦球囊扩张术后, 利用术中使用的导 丝, 将导丝的自由端从柔性导向头 7穿入并并从导丝接头 8处伸出,, 操作者手拿控制手柄 2 控制柔性外套 4和柔性内管 5在前端柔性导向头 7的导向下,找到窦口位置,然后伸入窦腔, 在内窥镜下确认鼻窦支架位于窦口处后, 用手拨动控制手柄 2上的滑柄 3, 使柔性外套 4往 近端移动, 使放置腔 6露出, 从而将鼻窦支架释放出来, 释放后的鼻窦支架自然膨胀贴紧窦 口壁; 然后再沿着导丝拖动控制手柄 2从而将柔性外套 4和柔性内管 5取出, 完成手术。 使 用通常的球囊扩张术两年后, 即可能出现窦口再狭窄的情况, 如果使用本发明的鼻窦支架, 可使再次狭窄的时间延长一倍以上。  Referring to Fig. 6 and Fig. 8 to Fig. 10, in specific use, according to the specific condition of the patient, an appropriate size of the sinus stent 1 is selected, and the sinus stent 1 is compressed and placed into the placement chamber 6. After the sinus balloon dilatation, the free end of the guide wire is inserted from the flexible guide head 7 and protrudes from the guide wire connector 8 by using the guide wire used in the operation, and the operator controls the flexibility by the control handle 2 The outer sleeve 4 and the flexible inner tube 5 are guided by the front flexible guide head 7, find the position of the sinus, and then extend into the sinus cavity. After confirming that the sinus stent is located at the sinus ostium under the endoscope, manually push the control handle 2 The sliding handle 3 moves the flexible outer sleeve 4 to the proximal end to expose the placement cavity 6, thereby releasing the sinus stent, and the released sinus stent naturally expands to abut the sinus wall; then dragging the control handle along the guide wire 2 Thereby the flexible outer sleeve 4 and the flexible inner tube 5 are taken out to complete the operation. Two years after the usual balloon dilatation, sinus restenosis may occur, and if the sinus stent of the present invention is used, the time for re-stenosis may be more than doubled.

实施例 2  Example 2

参阅图 3和图 4所示, 本发明的一种鼻窦支架, 其结构与实施例 1基本相同, 不同之处 在于, 筒形体 1由支撑部 la和设置在支撑部 la两端的定位部 lb组成, 支撑部 la与定位部 lb为一体成型的整体结构; 所述支撑部 la的外径为 5〜10隱, 所述定位部 lb的外径为 6〜 14rnm。 这种结构可以使鼻窦支架在窦口内不易出现位移情况, 可以使窦口再次狭窄的时间进 一步延长。 其使用及定位方法与实施例 1相同。  Referring to FIG. 3 and FIG. 4, a sinus stent of the present invention has the same structure as that of Embodiment 1, except that the cylindrical body 1 is composed of a support portion 1a and a positioning portion lb disposed at both ends of the support portion 1a. The support portion 1a and the positioning portion 1b are integrally formed; the outer diameter of the support portion 1a is 5 to 10, and the outer diameter of the positioning portion 1b is 6 to 14 nm. This structure can make the sinus stent less prone to displacement in the sinus ostium, and the time for re-stenosis of the sinus ostium can be further prolonged. The method of use and positioning is the same as that of the first embodiment.

Claims

权 利 要 求 书 Claim 1. 一种鼻窦支架, 其特征在于, 该支架为筒形体 (1 ), 该筒形体(1 ) 的筒壁是由弹性 材料制成的网状结构;所述筒形体(1 )的外径为 4〜15nim,所述筒形体(1 )的长度为 6~20皿。 A sinus stent, characterized in that the stent is a cylindrical body (1), the cylindrical wall of the cylindrical body (1) is a mesh structure made of an elastic material; the outer diameter of the cylindrical body (1) The length of the cylindrical body (1) is 4 to 15 nim, which is 4 to 15 nm. 2. 根据权利要求 1所述的鼻窦支架, 其特征在于, 所述的筒形体 (1 ) 由支撑部 (la) 和设置在支撑部 (la)两端的定位部(lb)组成, 支撑部 (la) 与定位部(lb)为一体成型 的整体结构; ·所述支撑部 (la) 的外径为 5〜10mni, 所述定位部 (lb) 的外径为 6〜14mra。  2. The sinus stent according to claim 1, wherein the cylindrical body (1) is composed of a support portion (1a) and a positioning portion (lb) disposed at both ends of the support portion (1a), the support portion ( La) an integral structure integrally formed with the positioning portion (lb); the outer diameter of the support portion (1a) is 5 to 10 mni, and the outer diameter of the positioning portion (lb) is 6 to 14 mra. 3. 根据权利要求 1所述的鼻窦支架, 其特征在于,所述的网状结构为镍钛记忆合金制成 的丝线编织而成, 所述丝线的直径为 0. 05〜0. 5画。  5 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。. 4. 根据权利要求 1所述的鼻窦支架, 其特征在于, 所述网状结构的网格大小为 1 mm2〜 9醒 24. The sinus stent according to claim 1, wherein the mesh structure has a mesh size of 1 mm 2 to 9 awake 2 . 5. 一种鼻窦支架专用输送装置, 包括控制手柄(2), 其特征在于, 所述的控制手柄(2) 侧壁上设有长孔, 在长孔内设有滑柄(3), 所述滑柄 (3)位于控制手柄 (2) 内的自由端连 接有柔性外套(4), 柔性外套(4)的自由端延伸至控制手柄(2)外面; 在柔性外套(4) 内 活动套设有柔性内管 (5), 所述的柔性内管 (5) —端穿过控制手柄 (2) 并与外部相通, 所 述的柔性内 (5)另一端与柔性外套(4)配合形成用于放置压缩后的鼻窦支架的放置腔(6)。  A special delivery device for a sinus stent, comprising a control handle (2), wherein the control handle (2) has a long hole in a side wall thereof, and a sliding handle (3) is arranged in the long hole. The free end of the slider (3) in the control handle (2) is connected with a flexible outer sleeve (4), the free end of the flexible outer sleeve (4) extends outside the control handle (2); the movable sleeve in the flexible outer sleeve (4) A flexible inner tube (5) is provided, the end of the flexible inner tube (5) passing through the control handle (2) and communicating with the outside, and the other end of the flexible inner portion (5) is formed with the flexible outer sleeve (4) A placement chamber (6) for placing the compressed sinus stent. 6. 根据权利要求 5所述的鼻窦支架专用输送装置, 其特征在于, 所述柔性内管(5) 的 自由端设有柔性导向头(7), 柔性导向头(7)位于柔性外套(4)外侧且柔性导向头(7) 的 外径与柔性外套(4)的外径相适应; 柔性导向头(7)设有与柔性内管(5)连通的轴向通孔。  6. The special delivery device for sinus stent according to claim 5, characterized in that: the flexible end of the flexible inner tube (5) is provided with a flexible guiding head (7), and the flexible guiding head (7) is located in a flexible outer casing (4) The outer diameter of the outer flexible guide head (7) is adapted to the outer diameter of the flexible outer casing (4); the flexible guide head (7) is provided with an axial through hole communicating with the flexible inner tube (5). 7. 根据权利要求 6所述的鼻窦支架专用输送装置, 其特征在于, 所述的柔性导向头(7) 后侧的柔性内管 (5) 外壁上沿周向设有环形凹槽, 所述的放置腔(6) 由环形凹槽与柔性外 套(4)配合形成。  The special delivery device for sinus stent according to claim 6, wherein an outer annular wall of the flexible inner tube (5) on the rear side of the flexible guiding head (7) is provided with an annular groove in a circumferential direction, the placing The cavity (6) is formed by a combination of an annular groove and a flexible outer casing (4). 8. 根据权利要求 7所述的鼻窦支架专用输送装置, 其特征在于, 所述的控制手柄 (2 ) 侧壁上设有与外部相通的导丝接头 (8), 所述柔性内管(4)与控制手柄(2)接触的一端与 导丝接头(8)连接。  The special delivery device for a sinus stent according to claim 7, wherein a side of the control handle (2) is provided with a wire guide (8) communicating with the outside, and the flexible inner tube (4) The end that is in contact with the control handle (2) is connected to the wire guide (8). 9. 根据 利要求 8所述的鼻窦支架专用输送装置, 其特征在于, 所述的导丝接头 (8) 设有锥形内孔。  9. The sinus stent-specific delivery device according to claim 8, wherein the guide wire connector (8) is provided with a tapered inner hole.
PCT/CN2012/000196 2011-12-31 2012-02-20 Nasal sinus stent and special placement device therefor Ceased WO2013097261A1 (en)

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