CN113995556A - Expandable sheath, introducer using the same, and method of use thereof - Google Patents

Expandable sheath, introducer using the same, and method of use thereof Download PDF

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Publication number
CN113995556A
CN113995556A CN202111464969.0A CN202111464969A CN113995556A CN 113995556 A CN113995556 A CN 113995556A CN 202111464969 A CN202111464969 A CN 202111464969A CN 113995556 A CN113995556 A CN 113995556A
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CN
China
Prior art keywords
expandable sheath
elastic
expandable
lumen
cylinder
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Pending
Application number
CN202111464969.0A
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Chinese (zh)
Inventor
钟伟
王松
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.)
Shanghai Yixin Medical Devices Co ltd
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Shanghai Yixin Medical Devices 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.)
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Publication date
Application filed by Shanghai Yixin Medical Devices Co ltd filed Critical Shanghai Yixin Medical Devices Co ltd
Priority to CN202111464969.0A priority Critical patent/CN113995556A/en
Publication of CN113995556A publication Critical patent/CN113995556A/en
Pending legal-status Critical Current

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    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0045Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008Strength or flexibility characteristics of the catheter tip

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

Abstract

The invention discloses an expandable sheath, which is in a lengthwise shape with a lumen, wherein the lengthwise direction is axial, and the direction vertical to the axial direction is radial; the expandable sheath comprises an elastic layer which can elastically deform in the radial direction and forms an inner cavity, and a reinforcing piece arranged in the inner cavity of the elastic layer; the reinforcing part is a cylinder formed by coiling a longitudinal elastic part, the cylinder is positioned in the inner cavity of the elastic layer, the axial direction of the cylinder and the axial direction of the tube cavity are in the same direction, the longitudinal direction of the elastic part is a second longitudinal direction, and the elastic part can elastically deform in the second longitudinal direction.

Description

Expandable sheath, introducer using the same, and method of use thereof
Technical Field
The present invention relates to a sheath for use with catheter-based techniques for repairing and/or replacing heart valves, and for delivering implants, such as prosthetic valves to the heart via the patient's vasculature.
Background
Endovascular delivery catheter assemblies are used to implant prosthetic devices, such as prosthetic valves, in a location in the body that is not easily accessible by surgery or in situations where minimally invasive surgery is desired. For example, aortic, mitral, tricuspid, and/or pulmonary prosthetic valves can be delivered to a treatment site using minimally invasive surgical techniques.
The introducer sheath is used to safely introduce the delivery device into the vasculature (e.g., femoral artery) of a patient. The introducer sheath generally has an elongate sleeve that is inserted into the vasculature and a housing containing one or more sealing valves that allow the delivery device to be placed in fluid communication with the vasculature with minimal blood loss. Once the introducer sheath is positioned within the vasculature, the shaft of the delivery apparatus is advanced through the sheath and carries the prosthetic device into the vasculature.
Since the introducer is used to facilitate insertion of a medical device into a blood vessel, trauma to the blood vessel may be reduced by minimizing the size of the introducer. Some medical device manufacturers have also designed radially deformable introducers that have a small outer dimension when inserted into the vasculature and are capable of radial expansion as needed to introduce a medical device.
Chinese patent application No. 201780027828.8, published at 12/21 in 2018, discloses a radially expandable introducer. The introducer has a tearable outer layer that is torn at a weak point and a folded inner layer within the lumen of the outer layer that unfolds expanding the radial dimension of the introducer as the delivery apparatus carries the medical device through the introducer.
Chinese patent application No. 201880040805.5, published on 7/2/2020, discloses a radially expandable sheath comprising an elastic outer layer and a folded inner layer disposed within the inner lumen of the elastic outer layer. When the delivery device carries the medical device through the expandable sheath, the outer layer is radially elastically expanded and the folded inner layer unfolds, thereby expanding the radial dimension of the expandable sheath.
Since expandable sheaths have the advantage of significantly reducing trauma to the vessel compared to non-expandable sheaths, further development of expandable sheaths is still necessary.
Disclosure of Invention
The invention aims to provide an expandable sheath with simple structure.
In order to solve the technical problems, the invention provides the following technical scheme: an expandable sheath, the expandable sheath is a lengthwise shape with a lumen, the lengthwise direction is an axial direction, and the direction perpendicular to the axial direction is a radial direction; the expandable sheath comprises an elastic layer which can elastically deform in the radial direction and forms an inner cavity, and a reinforcing piece arranged in the inner cavity of the elastic layer; the reinforcing part is a cylinder formed by coiling a longitudinal elastic part, the cylinder is positioned in the inner cavity of the elastic layer, the axial direction of the cylinder and the axial direction of the tube cavity are in the same direction, the longitudinal direction of the elastic part is a second longitudinal direction, and the elastic part can elastically deform in the second longitudinal direction.
Compared with the prior art, the invention has the following beneficial effects: the expandable sheath is an elastic layer with an inner cavity and a reinforcing piece positioned in the inner cavity of the elastic layer, wherein the reinforcing piece is a cylinder formed by coiling a longitudinal elastic piece; the expandable sheath of the present invention is not only elastically deformable in the radial direction, but also structurally simple relative to the prior art.
Preferably, in the radially unexpanded state of the expandable sheath, two adjacent turns of the elastic element axially abut each other.
Preferably, the expandable sheath includes a lubricating layer disposed within the cylindrical lumen.
In one embodiment, the material of the lubricating layer is selected from one or more of polyurethane, silicone, rubber, fluoropolymer, TPE, PEBAX.
In one embodiment, the material of the elastic layer is silicone, rubber, TPU, TPE or PEBAX.
Preferably, the elastic member is a spring wound around the second longitudinal direction.
The invention also provides an introducer comprising the expandable sheath.
The invention also provides a using method of the guide, which comprises the following steps: passing a guide through the lumen of the expandable sheath and projecting out of the distal end of the expandable sheath; passing the expandable sheath through a lumen or vessel of the human body to a predetermined location under guidance of the guide; the guide is withdrawn through the expandable sheath, leaving the expandable sleeve in place in the lumen or vessel of the body to provide instrument access.
Drawings
FIG. 1 is a schematic perspective view of an introducer of the present invention;
FIG. 2 is an exploded view of one embodiment of the expandable sheath of the present invention;
FIG. 3 is a schematic view of a strength member of the present invention in an uncoiled state;
FIG. 4 is a partially cut-away schematic view of an expandable sheath of the present invention;
FIG. 5 is a schematic cross-sectional view of an expandable sheath of the present invention in an radially unexpanded state;
FIG. 6 is a schematic cross-sectional view of an expandable sheath of the present invention in a radially expanded state;
FIG. 7 is a schematic view of the introducer with the guide member assembled therein;
fig. 8 is a schematic view of the guide.
Detailed Description
The following detailed description of the embodiments of the present invention is provided in conjunction with the accompanying drawings, and is not intended to limit the scope of the invention. The term "proximal" refers to the end near the hand-held operation, as opposed to "distal" which refers to the end near the treatment site (e.g., heart) after entering the body. The terms "first" and "second" are used merely to simplify the description of words for distinguishing between similar objects and are not to be construed as a precedence or importance of a particular order.
Example one
Referring to fig. 1, fig. 1 is a perspective view of an introducer 100 of the present invention, the introducer 100 including an elongated expandable sheath 1 and a housing assembly 2 at a proximal end of the expandable sheath 1. The proximal end of the housing assembly 2 may be fitted with a haemostatic valve, the distal end of the housing assembly 2 being connected to the proximal end of the expandable sheath 1. The housing assembly 2 and the expandable sheath 1 each have a lumen, and the lumens of the coupled housing assembly 2 and expandable sheath 1 communicate with each other to form a passageway of the delivery system.
Referring now to FIG. 2, FIG. 2 is an exploded view of the expandable sheath of the present invention. The expandable sheath 1 is elongate with a lumen 10, the longitudinal direction of which is axial x, and the direction perpendicular to the axial x is radial y. The expandable sheath 1 includes an elastic layer 11, and a reinforcing member 12 assembled in the elastic layer 11. The elastic layer 11 may be made of silicone, rubber, TPU (Thermoplastic polyurethanes), TPE (Thermoplastic Elastomer), or PEBAX (polyether block polyamide). The elastic layer 11 is of a hollow structure, forming an inner cavity for assembling the reinforcement 12. Since the elastic layer 11 has elasticity, it can be elastically deformed in the radial direction.
Referring to fig. 3 in conjunction with fig. 2 and 3, fig. 3 is a schematic view of the strength member of the present invention in an uncoiled state, and it is noted that fig. 3 only schematically shows a section of the strength member, not the entire length of the strength member, which is uncoiled. The reinforcing member 12 is a cylindrical body formed by winding an elongated elastic member. The longitudinal direction z of the elastic member is a second longitudinal direction, and the elastic member is elastically deformable in the second longitudinal direction. In the present embodiment, the elastic member is a spring having a longitudinal length, but the elastic member of the present invention is not limited to the spring, and may be any element that is elastically deformable in the second longitudinal direction. The state in which the elastic member is wound as the reinforcing member is shown in fig. 2. An elongated elastic member shown in fig. 3 is taken and wound around an axis x '-x' shown in fig. 2 so as to form a cylindrical body, and the x '-x' direction is the axial direction of the cylindrical body. Since the cylinder is formed by winding the elastic member, each circle forming the circumferential loop of the cylinder can be elastically deformed in the radial direction of the cylinder as a result of the elastic member being elastically deformable in the second longitudinal direction. Since each circle forming the circumferential surround of the cylinder is elastically deformable in the radial direction of the cylinder, the entire cylinder is elastically deformable in the radial direction. Preferably, two adjacent circles formed by winding the elastic member abut against each other, in other words, two adjacent circles forming the cylindrical body abut against each other. With this arrangement, the rigidity of the cylindrical body in the axial direction of the cylindrical body can be improved, that is, the cylindrical body is not easily compressed in the axial direction.
There are two main ways of forming the expandable sheath 1 with the reinforcement 12 and the elastic layer 11. The first is that the elastic member is wound to form a cylindrical reinforcing member 12, the elastic layer 11 is separately molded, and then the reinforcing member 12 is assembled into the inner cavity of the elastic layer 11. The axial direction of the cylinder body coincides with the axial direction of the inner cavity of the elastic layer 11. The second method is that after the elastic member is coiled to form the cylindrical reinforcing member 12, the outer surface of the reinforcing member 12 is coated or poured or brushed with the elastic material to form the elastic layer 11. FIG. 4 is a partially cut-away schematic view of the expandable sheath showing the strength members 12 positioned within the lumen of the elastic layer 11.
Referring to FIGS. 5 and 6, FIG. 5 is a cross-sectional view of the expandable sheath in an unexpanded state, and FIG. 6 is a cross-sectional view of the expandable sheath in a radially expanded state. When a delivery system of larger radial dimensions or a replacement prosthesis of larger radial dimensions is introduced into the expandable sheath, the reinforcing element 12 is subjected to a radial force, which elastically expands the reinforcing element 12 in the radial direction, and the elastic layer 11 is also elastically expanded, so that the inner lumen of the expandable sheath 1 radially enlarges, allowing the delivery system or the replacement prosthesis to pass. When the delivery system is complete, the expandable sheath 1 is radially elastically reduced to restore its original dimensions.
Example two
The second embodiment differs from the first embodiment in that the expandable sheath 1 further comprises a lubricating layer disposed within the cavity of the reinforcing element 12. The lubricant layer may be formed by coating a lubricant in the inner cavity of the reinforcement 12, or may be formed by forming a coating layer in the inner cavity of the reinforcement 12 and spraying a lubricant on the inner wall of the coating layer. The material of the lubricant may be one or a combination of more of polyurethane, silicone, rubber, fluoropolymer, TPE (Thermoplastic Elastomer), PEBAX (polyether block polyamide).
The present invention also provides a guide 100, please refer to fig. 1, 7 and 8, wherein fig. 7 is a schematic view of the guide 100 with a guide member 3 assembled therein; fig. 8 is a schematic view of the guide 3. The guide member 3 includes an elongated body portion 31 and a tip portion 32 located at a distal end of the body portion 31. When using the introducer 100, the tip 32 of the guide 3 is first inserted from the proximal end of the introducer housing assembly 2 until the tip 32 protrudes out of the distal end of the expandable sheath 1. The introducer 100 assembled with the guide member 3 is then inserted from the vascular incision of the human body, and the introducer 100 enters the blood vessel under the guidance of the guide member 3 and gradually goes deep until a predetermined position is reached. After reaching the predetermined position, the introducer 3 is withdrawn, the expandable sheath 1 is left in the blood vessel, and the housing assembly 2 is left outside the body, so that the housing assembly 2 and the expandable sheath 1 together establish a passage through which not only the delivery system can pass, but also the passage can be radially elastically deformed to pass the delivery system or the replacement prosthesis with a larger radial size, and the trauma to the blood vessel is reduced.
The present invention also provides a method of using the introducer 100, the method comprising the steps of: using a guide 3 to pass through the lumen of said expandable sheath 1 and protrude out of the distal end of the expandable sheath 1; passing the expandable sheath 1 through a lumen or vessel of the human body to a predetermined position under guidance of the guide 3; the guide 3 is withdrawn through the expandable sheath 1 and the expandable sleeve 1 is left in the lumen or vessel of the body to provide an instrument channel.
Finally, it should be noted that: the above embodiments are only used to illustrate the present invention and do not limit the technical solutions described in the present invention. Thus, although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted; all such modifications and variations are intended to be included herein within the scope of this disclosure and the present invention and protected by the following claims.

Claims (8)

1. An expandable sheath, comprising: the expandable sheath is in a longitudinal shape with a lumen, the longitudinal direction of the expandable sheath is axial, and the direction perpendicular to the axial direction is radial;
the expandable sheath comprises an elastic layer which can elastically deform in the radial direction and forms an inner cavity, and a reinforcing piece arranged in the inner cavity of the elastic layer;
the reinforcing part is a cylinder formed by coiling a longitudinal elastic part, the cylinder is positioned in the inner cavity of the elastic layer, the axial direction of the cylinder and the axial direction of the tube cavity are in the same direction, the longitudinal direction of the elastic part is a second longitudinal direction, and the elastic part can elastically deform in the second longitudinal direction.
2. The expandable sheath of claim 1, wherein: in the radially unexpanded state of the expandable sheath, two adjacent turns of the elastic element are in axial abutment with each other.
3. The expandable sheath of claim 1 or 2, wherein: the expandable sheath includes a lubricating layer disposed in the cylinder lumen.
4. The expandable sheath of claim 3, wherein: the material of the lubricating layer is selected from one or more of polyurethane, silicone, rubber, fluoropolymer, TPE and PEBAX.
5. The expandable sheath of claim 1 or 2, wherein: the elastic layer is made of silicone, rubber, TPU, TPE or PEBAX.
6. The expandable sheath of claim 1 or 2, wherein: the elastic member is a spring wound around the second longitudinal direction.
7. An introducer, characterized by: comprising an expandable sheath according to any one of claims 1 to 6.
8. A method of using the introducer of claim 7, comprising the steps of:
passing a guide through the lumen of the expandable sheath and projecting out of the distal end of the expandable sheath;
passing the expandable sheath through a lumen or vessel of the human body to a predetermined location under guidance of the guide;
the guide is withdrawn through the expandable sheath, leaving the expandable sleeve in place in the lumen or vessel of the body to provide instrument access.
CN202111464969.0A 2021-12-03 2021-12-03 Expandable sheath, introducer using the same, and method of use thereof Pending CN113995556A (en)

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CN202111464969.0A CN113995556A (en) 2021-12-03 2021-12-03 Expandable sheath, introducer using the same, and method of use thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202111464969.0A CN113995556A (en) 2021-12-03 2021-12-03 Expandable sheath, introducer using the same, and method of use thereof

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Publication Number Publication Date
CN113995556A true CN113995556A (en) 2022-02-01

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170281344A1 (en) * 2016-03-31 2017-10-05 Medtronic Vascular, Inc. Expandable introducer sheath having a steering mechanism
US20180303610A1 (en) * 2017-04-24 2018-10-25 Medtronic Vascular, Inc. Elastic introducer sheath
US20190060062A1 (en) * 2017-08-24 2019-02-28 Medtronic Vascular, Inc. Transcatheter prosthesis with sealing component, and systems and methods for delivering and deployment thereof
CN110494182A (en) * 2017-02-09 2019-11-22 波士顿科学国际有限公司 Guide with expansible ability
CN112236186A (en) * 2018-04-30 2021-01-15 爱德华兹生命科学公司 Push-on sheath pattern
CN113727675A (en) * 2019-04-22 2021-11-30 W.L.戈尔及同仁股份有限公司 Expandable sheath

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170281344A1 (en) * 2016-03-31 2017-10-05 Medtronic Vascular, Inc. Expandable introducer sheath having a steering mechanism
CN108883254A (en) * 2016-03-31 2018-11-23 美敦力瓦斯科尔勒公司 Expansible guide sheath with steering mechanism
CN110494182A (en) * 2017-02-09 2019-11-22 波士顿科学国际有限公司 Guide with expansible ability
US20180303610A1 (en) * 2017-04-24 2018-10-25 Medtronic Vascular, Inc. Elastic introducer sheath
CN110536715A (en) * 2017-04-24 2019-12-03 美敦力瓦斯科尔勒公司 Elastic lead-through casing
US20190060062A1 (en) * 2017-08-24 2019-02-28 Medtronic Vascular, Inc. Transcatheter prosthesis with sealing component, and systems and methods for delivering and deployment thereof
CN112236186A (en) * 2018-04-30 2021-01-15 爱德华兹生命科学公司 Push-on sheath pattern
CN113727675A (en) * 2019-04-22 2021-11-30 W.L.戈尔及同仁股份有限公司 Expandable sheath

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