CN112618916A - Extension catheter - Google Patents

Abstract

An extension catheter is disclosed that includes a pusher member having a distal portion with a first thickness and a proximal portion with a second thickness, and a catheter body including a lumen, an intermediate layer, and an outer layer, the intermediate layer being positioned between the lumen and the outer layer, wherein the distal portion is positioned in the outer layer, and the first thickness is less than the second thickness.

Description

Extension catheter

FIELD

The present disclosure relates generally to the field of medical devices, and more particularly to medical devices used in the field of percutaneous coronary intervention.

Background

The coronary artery is the artery supplying blood to the heart, originates in the aortic sinus at the root of the aorta, divides into two branches, and runs on the surface of the heart.

Interventional therapy is a general term for a series of techniques for minimally invasive treatment by introducing specific instruments into a lesion site of a human body through natural pores or tiny wounds of the human body by using a puncture needle, a catheter and other interventional devices under the guidance and monitoring of digital subtraction angiography, CT, ultrasound, magnetic resonance and other imaging devices.

High-efficient wineThe above-mentioned

In one aspect, the present disclosure is directed to an extension catheter including a pusher member including a distal portion having a first thickness and a proximal portion having a second thickness, and a catheter body including a lumen, an intermediate layer, and an outer layer, the intermediate layer being positioned between the lumen and the outer layer, wherein the distal portion is positioned in the outer layer, and the first thickness is less than the second thickness.

In certain embodiments, the catheter body has a shore hardness that increases proximally along the distal end of the catheter body.

In certain embodiments, the catheter body HAs a shore hardness of about 20HA to 70 HA.

In certain embodiments, the distal portion comprises a first end.

In certain embodiments, the distal portion further comprises at least a middle section between the first end and the proximal portion, the middle section having a thickness greater than the first thickness but less than the second thickness.

In certain embodiments, the distal portion further comprises a middle section between the first end and the second end, and the middle section has a thickness greater than the first thickness but less than the second thickness.

In certain embodiments, the first thickness is about 0.02mm to about 0.5mm and the second thickness is about 0.1mm to about 2 mm.

In certain embodiments, the outer layer includes an extension extending along the distal end toward the proximal end of the push member.

In certain embodiments, the extension extending along the distal end toward the proximal end of the pusher member is greater than or equal to about 0.5mm in length.

In certain embodiments, the distal end portion of the push member is bonded to the intermediate layer by welding.

In certain embodiments, the intermediate layer is bonded to the outer layer by heat sealing.

In certain embodiments, the distal portion is in a stepped arrangement with the proximal portion adjacent thereto.

In certain embodiments, the distal portion is in a stepped arrangement with the intermediate section adjacent thereto.

In certain embodiments, the distal portion has a length of about 0.1cm to about 10 cm.

In another aspect, the present disclosure is directed to a medical device comprising an extension catheter including a pusher member and a catheter body, the pusher member including a distal portion having a first thickness and a proximal portion having a second thickness, the catheter body including a lumen, an intermediate layer, and an outer layer, the intermediate layer being positioned between the lumen and the outer layer, wherein the distal portion is positioned in the outer layer and the first thickness is less than the second thickness.

In yet another aspect, the present disclosure is directed to a method of Percutaneous Coronary Intervention (PCI) comprising administering to an individual in need thereof a medical device comprising an extension catheter including a pusher member comprising a distal portion having a first thickness and a proximal portion having a second thickness, and a catheter body comprising a lumen, an intermediate layer, and an outer layer, the intermediate layer being positioned between the lumen and the outer layer, wherein the distal portion is positioned in the outer layer, and the first thickness is less than the second thickness.

Brief description of the drawings

Fig. 1 schematically illustrates an extension catheter in certain embodiments of the present disclosure.

Fig. 2 schematically illustrates a transition structure of an extension duct in certain embodiments of the present disclosure.

Fig. 3 schematically illustrates the structure of a push member of an extension catheter in an embodiment of the present disclosure.

Fig. 4 schematically illustrates the structure of a push member of an extension catheter in an embodiment of the present disclosure.

Fig. 5 schematically illustrates the structure of a push member of an extension catheter in an embodiment of the present disclosure.

Fig. 6 schematically shows a plan view of a guide catheter pushed through the aorta to the coronary ostia.

Fig. 7 schematically illustrates a plan view of an extension catheter of the present disclosure used in conjunction with a guide catheter.

Detailed description of the invention

In the following description, certain specific details are included to provide a thorough understanding of various embodiments of the disclosure. One skilled in the relevant art will recognize, however, that the embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, and so forth.

Throughout this specification and the claims which follow, unless the disclosure requires otherwise, the words "comprise", "comprises", and "comprising" are to be construed in an open, inclusive sense, i.e., "including but not limited to".

Reference throughout the specification to "one embodiment," "an embodiment," "in another embodiment," or "in certain embodiments" means that a particular reference element, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" or "in another embodiment" or "in certain embodiments" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular elements, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

Definition of

In the present disclosure, the term "Coronary Artery (CA)" refers to the Artery supplying the blood to the heart, originating in the aortic root sinus, bifurcating left and right, and running on the surface of the heart.

In the present disclosure, the term "interventional therapy" refers to a general term of a series of techniques for minimally invasive therapy by introducing a specific instrument into a lesion site of a human body through a natural duct or a tiny wound of the human body by using a puncture needle, a catheter and other interventional devices under guidance and monitoring of an imaging device such as a digital subtraction angiography, CT, ultrasound and magnetic resonance.

In the present disclosure, the term "hardness" refers to the ability of a material to locally resist the penetration of hard objects into its surface.

In the present disclosure, the term "shore hardness", also known as "shore hardness", refers to the hardness of non-metallic materials such as plastics, rubber and glass, measured in HA.

In the present disclosure, the term "polymer", also known as "macromolecular compound", generally refers to compounds having a relative molecular mass of up to several thousand to several million.

In this disclosure, the term "heat sealing" refers to manufacturing processes and techniques that join metals or other thermoplastic materials by high temperature, heat application.

In this disclosure, the term "welding" refers to manufacturing processes and techniques that join metals or other thermoplastic materials in a heated, high temperature, or high pressure manner.

In the present disclosure, the term "proximal" refers to the end that is proximal to the user when using the extension catheter of the present disclosure.

In the present disclosure, the term "distal end" refers to the end that is distal to the user when using the extension catheter of the present disclosure.

In the present disclosure, the term "polyamide-polyether block copolymer" refers to a polymer consisting of polyamide and polyether backbone blocks.

In the present disclosure, the term "Thermoplastic Polyurethanes (TPU)" refers to (AB) n-block linear polymers, a being a high molecular weight (1000 to 6000) polyester or polyether, B being a diol containing 2 to 12 linear carbon atoms, and the AB interstrand chemical structure being a diisocyanate.

In the present disclosure, the term "thickness" refers to an average thickness.

In the present disclosure, the term "sheath thickness" refers to the thickness of the outer layer of the catheter body that sheaths the distal end of the pusher member.

Detailed Description

In one aspect, the present disclosure is directed to an extension catheter 10 comprising a pusher member 100 and a catheter body 200, the pusher member 100 comprising a distal portion 101 having a first thickness H1 and a proximal portion 102 having a second thickness H2, the catheter body 200 comprising a lumen 201, an intermediate layer 202, and an outer layer 203, the intermediate layer 202 being positioned between the lumen 201 and the outer layer 203, wherein the distal portion 101 is positioned in the outer layer 203 and the first thickness H1 is less than the second thickness H2.

In certain embodiments, the distal portion 101 is located entirely within the outer layer 203 of the catheter body.

In certain embodiments, the distal portion 101 is partially located in the outer layer 203 of the catheter body.

In certain embodiments, the catheter body has a shore hardness that increases proximally along the distal end of the catheter body.

In certain embodiments, the catheter body HAs a shore hardness of about 20HA to 70 HA.

In certain embodiments, exemplary materials that can be used for the cavity 201 of the present disclosure include, but are not limited to, polytetrafluoroethylene, High Density Polyethylene (HDPE), and tetrafluoroethylene-perfluoroalkoxy vinyl ether copolymer (PFA).

In certain embodiments, exemplary materials that can be used for the intermediate layer 202 of the present disclosure include, but are not limited to, braids, coils, meshes, rings, segments, fibers, interstitial arrays of fibers, and any combination thereof.

In certain embodiments, exemplary materials that can be used for the outer layer 203 of the present disclosure include, but are not limited to, nylon, polypropylene, polyvinyl chloride, polyamide, polyimide, and any combination thereof.

In certain embodiments, the distal portion 101 includes a first end 1011.

In certain embodiments, catheter body 200 comprises a first polymer P1 having a first shore hardness HS 1.

In certain embodiments, illustrative examples of first polymer P1 that can be used in the present disclosure include, but are not limited to, polyamide-polyether block copolymers, Thermoplastic polyurethane elastomers (TPU), and nylon.

In certain embodiments, the catheter body further comprises a second polymer P2 having a second shore hardness HS 2.

In certain embodiments, illustrative examples of second polymers P2 that can be used in the present disclosure include, but are not limited to, polyamide-polyether block copolymers, Thermoplastic polyurethane elastomers (TPU), and nylons.

In certain embodiments, the catheter body further comprises a third polymer P3 having a third shore hardness HS 3.

In certain embodiments, illustrative examples of the third polymer P3 that can be used in the present disclosure include, but are not limited to, polyamide-polyether block copolymers, Thermoplastic polyurethane elastomers (TPU), and nylon.

In certain embodiments, the first shore HS1 hardness is less than or equal to about 40 HA.

In certain embodiments, the first shore HS1 hardness is about 20HA to about 40 HA.

In certain embodiments, the second shore HS2 hardness is between about 40HA and about 60 HA.

In certain embodiments, the third shore HS3 hardness is greater than or equal to about 60 HA.

In certain embodiments, the third shore HS3 hardness is about 60HA to about 70 HA.

In certain embodiments, the first polymer P1 has a cladding thickness that is less than the cladding thickness of the second polymer P2.

In certain embodiments, the cladding thickness of the second polymer P2 is less than the cladding thickness of the third polymer P3.

In certain embodiments, the first polymer P1 has a cladding thickness of about 0.05mm to 0.15 mm.

In certain embodiments, the second polymer P2 has a coating thickness of about 0.05mm to 0.2 mm.

In certain embodiments, the third polymer P3 has a clad thickness of about 0.05mm to 0.2 mm.

In certain embodiments, distal portion 101 further comprises at least an intermediate section 101N between first end 1011 and distal portion 102, said intermediate section 101N having a thickness HN greater than said first thickness H1 but less than said second thickness H2.

In certain embodiments, the first thickness H1 is about 0.02mm to 0.5 mm.

In certain embodiments, the second thickness H2 is about 0.1mm to 2 mm.

In certain embodiments, the outer layer 203 includes an extension 204 that extends along the distal portion 101 toward the proximal portion 102 of the push member.

In certain embodiments, the extension 204 extending along the distal end 101 toward the proximal end 102 of the pusher member 100 has a length of about 0.5mm or greater.

In certain embodiments, illustrative examples of the cross-sectional shape of the distal portion 101 include, but are not limited to, rectangular, elliptical, and hexagonal.

In certain embodiments, illustrative examples of the cross-sectional shape of the proximal portion 102 include, but are not limited to, circular, oval, square, rectangular, and hexagonal.

In certain embodiments, the thickness H1 of distal portion 101 is substantially uniform.

In certain embodiments, the thickness H2 of the proximal portion 102 is substantially uniform.

In certain embodiments, the thickness H2 of the proximal portion 102 increases proximally along the proximal portion 102 of the push member 100.

In certain embodiments, the thickness H2 of the proximal portion 102 increases proximally and then is uniform along the proximal portion 102 of the push member 100.

In certain embodiments, the thickness H2 of the proximal portion 102 increases and then decreases proximally along the proximal portion 102 of the push member 100.

In certain embodiments, the thickness H2 of the proximal portion 102 decreases and then increases proximally along the proximal portion 102 of the push member 100.

In certain embodiments, illustrative examples of the cross-sectional shape of each intermediate section 101N include, but are not limited to, rectangular, elliptical, and hexagonal.

In certain embodiments, the thickness HN of each intermediate section 101N is substantially uniform.

In certain embodiments, the thickness HN of each intermediate section 101N increases along the first end 1011 of the push member 100 toward the proximal end 102.

Referring to fig. 3, in certain embodiments, the push member 100 includes a distal portion 101 having a first thickness H1 and a distal portion 102 having a second thickness H2, wherein the distal portion 101 includes a first end 1011, the first end 1011 is in a stepped arrangement with the proximal portion 102 adjacent thereto, and the first thickness H1 is less than the second thickness H2.

In certain embodiments, the first thickness H1 is about 0.02mm to 0.5 mm.

In certain embodiments, the first thickness H1 is substantially uniform.

In certain embodiments, the second thickness H2 is about 0.1mm to 2 mm.

In certain embodiments, the second thickness H2 increases proximally along the proximal portion 102.

In certain embodiments, the second thickness H2 increases proximally along the proximal portion 102 and then is uniform.

In certain embodiments, the second thickness H2 increases and then decreases proximally along the proximal portion 102.

In certain embodiments, the second thickness H2 decreases and increases proximally along the proximal portion 102.

In certain embodiments, the first length L1 of distal portion 101 is about 0.1cm to about 10 cm.

In certain embodiments, the second length L2 of the proximal portion 102 is about 60cm to about 150 cm.

In certain embodiments, the catheter body has a shore hardness that increases proximally along the distal end of the catheter body.

In certain embodiments, the catheter body comprises a first polymer P1 having a first shore hardness HS 1.

In certain embodiments, the first polymer P1 HAs a first shore HS1 hardness of about 20HA to about 70 HA.

In certain embodiments, the outer layer thickness of the catheter body increases proximally along the distal end of the catheter body.

In certain embodiments, the outer layer of the catheter body has a thickness of about 0.05mm to 0.2 mm.

In certain embodiments, the catheter body comprises a first polymer P1 having a first shore hardness HS1 and the outer layer thickness of the catheter body increases proximally along the distal end of said catheter body.

In certain embodiments, the outer layer 203 includes an extension 204 that extends along the distal end 101 toward the proximal end 102 of the push member 100.

In certain embodiments, the extension 204 extending along the distal end 101 toward the proximal end 102 of the pusher member 100 has a length of about 0.5mm or greater.

In certain embodiments, the extension 204 extending along the distal end 101 toward the proximal end 102 of the push member 100 is about 0.1cm to about 10cm in length.

In certain embodiments, the extension 204 extending along the distal end 101 toward the proximal end 102 of the push member 100 can allow the middle layer 202 to be better wrapped to avoid tip unraveling.

In certain embodiments, the extension 204 extending along the distal end 101 toward the proximal end 102 of the pusher member 100 is better compatible with the lumen 201 and avoids direct contact with the intermediate layer 202 as other instruments enter the extension catheter, thereby avoiding scratching.

In certain embodiments, the distal end 101 of the push member 100 is bonded to the intermediate layer 202 by welding.

In certain embodiments, illustrative examples of welding modalities that can be used with the present disclosure include, but are not limited to, laser welding, resistance welding, argon arc welding, and plasma arc welding.

In certain embodiments, the energy that can be used for the laser welding of the present disclosure is about 10W to 40W.

In certain embodiments, examples of shielding gases that can be used for laser welding of the present disclosure include, but are not limited to, argon, nitrogen, and helium.

In certain embodiments, the distal portion 101 of the push member 100 is integrally welded to the intermediate layer 202, thereby reducing the outer diameter of the catheter body while maintaining tensile strength.

In some embodiments, the abutment of the distal end 101 of the pushing member 100 with the intermediate layer 202 provides a smooth transition of the lumen 201 of the catheter body 200, thereby effectively avoiding scratching of other instruments as they enter the extension catheter.

In certain embodiments, the abutment of the distal portion 101 of the push member 100 with the intermediate layer 202 can minimize the outer diameter of the extension catheter.

In certain embodiments, the middle layer 202 is bonded to the outer layer 203 by heat sealing.

In certain embodiments, the distal portion 101 is about 0.1cm to 10cm in length.

In certain embodiments, compliance is enhanced due to the gradual transition of the catheter body 200 and the pusher member 100, thereby avoiding significant catheter body kinking.

Referring to fig. 4, in certain embodiments, the pushing member 100 includes a distal portion 101 having a first thickness H1 and a proximal portion 102 having a second thickness H2, the distal portion including a first end 1011 and an intermediate portion 1012, wherein the intermediate portion 1012 is located between the first end 1011 and the distal portion 102, and the intermediate portion 1012 has a thickness H3 that is greater than the first thickness H1 but less than the second thickness H2.

In certain embodiments, the distal portion 101 is located entirely within the outer layer 203 of the catheter body.

In certain embodiments, the distal portion 101 is partially located in the outer layer 203 of the catheter body.

In certain embodiments, first end 1011 is in a stepped arrangement with intermediate section 1012 adjacent thereto.

In certain embodiments, the intermediate section 1012 is in a stepped arrangement with the proximal section 102 adjacent thereto.

In certain embodiments, the first thickness H1 is about 0.02mm to 0.5 mm.

In certain embodiments, the first thickness H1 is substantially uniform.

In certain embodiments, the second thickness H2 is about 0.1mm to 2 mm.

In certain embodiments, the second thickness H2 is substantially uniform.

In certain embodiments, the second thickness H2 increases proximally along the proximal portion 102.

In certain embodiments, the second thickness H2 increases proximally along the proximal portion 102 and then is uniform.

In certain embodiments, the second thickness H2 increases and then decreases proximally along the proximal portion 102.

In certain embodiments, the second thickness H2 decreases and increases proximally along the proximal portion 102.

In certain embodiments, intermediate section 1012 has a thickness H3 of about 0.05mm to about 1 mm.

In certain embodiments, thickness H3 of intermediate section 1012 is substantially uniform.

In certain embodiments, the first length L1 of the first end 1011 is about 0.1cm to about 10 cm.

In certain embodiments, the second length L2 of the proximal portion 102 is about 60cm to about 150 cm.

In certain embodiments, the length L3 of intermediate section 1012 is about 0.1cm to about 30 cm.

In certain embodiments, the catheter body has a shore hardness that increases proximally along the distal end of the catheter body.

In certain embodiments, the catheter body comprises a first polymer P1 having a first shore hardness HS 1.

In certain embodiments, the first polymer P1 HAs a first shore HS1 hardness of about 20HA to about 70 HA.

In certain embodiments, the outer layer thickness of the catheter body increases proximally along the distal end of the catheter body.

In certain embodiments, the outer layer of the catheter body has a thickness of about 0.05mm to 0.2 mm.

In certain embodiments, the catheter body comprises a first polymer P1 having a first shore hardness HS1 and the outer layer thickness of the catheter body increases proximally along the distal end of said catheter body.

In certain embodiments, the catheter body comprises a first polymer P1 having a first shore hardness HS1 and a second polymer P2 having a second shore hardness HS 2.

In certain embodiments, the first polymer P1 HAs a first shore HS1 hardness of less than about 40 HA.

In certain embodiments, the first polymer P1 HAs a first shore HS1 hardness of about 20HA to 40 HA.

In some embodiments, the second polymer P2 HAs a second shore HS2 hardness of about 40HA to about 70 HA.

In certain embodiments, the first polymer P1 has a cladding thickness of about 0.05mm to 0.15 mm.

In certain embodiments, the second polymer P2 has a coating thickness of about 0.05mm to 0.2 mm.

In certain embodiments, the outer layer 203 includes an extension 204 that extends along the distal end 101 toward the proximal end 102 of the push member 100.

In certain embodiments, the extension 204 extending along the distal end 101 toward the proximal end 102 of the pusher member 100 has a length of about 0.5mm or greater.

In certain embodiments, the extension 204 extending along the distal end 101 toward the proximal end 102 of the push member 100 is about 0.1cm to about 10cm in length.

In certain embodiments, the extension 204 extending along the distal end 101 toward the proximal end 102 of the push member 100 can allow the middle layer 202 to be better wrapped to avoid tip unraveling.

In certain embodiments, the extension 204 extending along the distal end 101 toward the proximal end 102 of the pusher member 100 is better compatible with the lumen 201 and avoids direct contact with the intermediate layer 202 as other instruments enter the extension catheter, thereby avoiding scratching.

In certain embodiments, the distal end 101 of the push member 100 is bonded to the intermediate layer 202 by welding.

In certain embodiments, illustrative examples of welding modalities that can be used with the present disclosure include, but are not limited to, laser welding, resistance welding, argon arc welding, and plasma arc welding.

In certain embodiments, the energy that can be used for the laser welding of the present disclosure is about 10W to 40W.

In certain embodiments, examples of shielding gases that can be used for laser welding of the present disclosure include, but are not limited to, argon, nitrogen, and helium.

In certain embodiments, the distal portion 101 of the push member 100 is integrally welded to the intermediate layer 202, thereby reducing the outer diameter of the catheter body while maintaining tensile strength.

In some embodiments, the abutment of the distal end 101 of the pushing member 100 with the intermediate layer 202 provides a smooth transition of the lumen 201 of the catheter body 200, thereby effectively avoiding scratching of other instruments as they enter the extension catheter.

In certain embodiments, the abutment of the distal portion 101 of the push member 100 with the intermediate layer 202 can minimize the outer diameter of the extension catheter.

In certain embodiments, the middle layer 202 is bonded to the outer layer 203 by heat sealing.

In certain embodiments, the distal portion 101 is about 0.1cm to 10cm in length.

In certain embodiments, compliance is enhanced due to the gradual transition of the catheter body 200 and the pusher member 100, thereby avoiding significant catheter body kinking.

Referring to fig. 5, in certain embodiments, the pushing member 100 includes a distal portion 101 having a first thickness H1 and a proximal portion 102 having a second thickness H2, the distal portion 101 having a first end 1011 and intermediate segments 1012 and 1013, wherein the intermediate segments 1012 and 1013 are positioned between the first end 1011 and the proximal portion 102, and the intermediate segments 1012 and 1013 have thicknesses H3 and H4 that are both greater than the first thickness H1 and less than the second thickness H2.

In certain embodiments, the distal portion 101 is located entirely within the outer layer 203 of the catheter body.

In certain embodiments, the distal portion 101 is partially located in the outer layer 203 of the catheter body.

In certain embodiments, the thickness H3 of the intermediate section 1012 adjacent the first end 1011 is less than the thickness H4 of the intermediate section 1013 adjacent the proximal end 102.

In certain embodiments, first end 1011 is in a stepped arrangement with intermediate section 1012 adjacent thereto.

In certain embodiments, the intermediate section 1013 is in a stepped arrangement with the distal end 102 adjacent thereto.

In certain embodiments, intermediate section 1012 is in a stepped arrangement with intermediate section 1013 adjacent thereto.

In certain embodiments, the first thickness H1 is about 0.02mm to 0.5 mm.

In certain embodiments, the first thickness H1 is substantially uniform.

In certain embodiments, the second thickness H2 is about 0.1mm to 2 mm.

In certain embodiments, the second thickness H2 is substantially uniform.

In certain embodiments, the second thickness H2 increases proximally along the proximal portion 102.

In certain embodiments, the second thickness H2 increases proximally along the proximal portion 102 and then is uniform.

In certain embodiments, the second thickness H2 increases and then decreases proximally along the proximal portion 102.

In certain embodiments, the second thickness H2 decreases and increases proximally along the proximal portion 102.

In certain embodiments, intermediate section 1012 has a thickness H3 of about 0.05mm to about 1 mm.

In certain embodiments, thickness H3 of intermediate section 1012 is substantially uniform.

In certain embodiments, the thickness H4 of middle section 1013 is about 0.05mm to about 1 mm.

In certain embodiments, thickness H4 of middle section 1013 is substantially uniform.

In certain embodiments, the first length L1 of the first end 1011 is about 0.1cm to about 10 cm.

In certain embodiments, the second length L2 of the proximal portion 102 is about 60cm to about 150 cm.

In certain embodiments, length L3 of intermediate section 1012 is about 0.1mm to 30 mm.

In certain embodiments, length L4 of intermediate section 1013 is about 0.1mm to 30 mm.

In certain embodiments, the catheter body has a shore hardness that increases proximally along the distal end of the catheter body.

In certain embodiments, the catheter body comprises a first polymer P1 having a first shore hardness HS 1.

In certain embodiments, the first polymer P1 HAs a first shore HS1 hardness of about 20HA to about 70 HA.

In certain embodiments, the outer layer thickness of the catheter body increases proximally along the distal end of the catheter body.

In certain embodiments, the outer layer of the catheter body has a thickness of about 0.05mm to 0.2 mm.

In certain embodiments, the catheter body comprises a first polymer P1 having a first shore hardness HS1 and the outer layer thickness of the catheter body increases proximally along the distal end of said catheter body.

In certain embodiments, the catheter body comprises a first polymer P1 having a first shore hardness HS1 and a second polymer P2 having a second shore hardness HS 2.

In certain embodiments, the first polymer P1 HAs a first shore HS1 hardness of less than about 40 HA.

In certain embodiments, the second polymer P2 HAs a second shore HS2 hardness of greater than about 40 HA.

In certain embodiments, the catheter body comprises a first polymer P1 having a first shore hardness HS1, a second polymer P2 having a second shore hardness HS2, and a third polymer P3 having a third shore hardness HS 3.

In certain embodiments, the first polymer P1 HAs a first shore HS1 hardness of less than about 40 HA.

In certain embodiments, the second polymer P2 HAs a second shore HS2 hardness of about 40HA to 60 HA.

In some embodiments, the second polymer P3 HAs a third shore HS3 hardness of greater than about 60 HA.

In certain embodiments, the intermediate stage polymer P3 has a cladding thickness that is greater than the cladding thickness of the first polymer P1 but less than the cladding thickness of the second polymer P2.

In certain embodiments, the intermediate stage polymer P4 has a cladding thickness greater than the cladding thickness of the first polymer P1 but less than the cladding thickness of the second polymer P2, and the intermediate stage polymer P4 has a cladding thickness greater than the cladding thickness of the intermediate stage polymer P3.

In certain embodiments, the first polymer P1 has a coating thickness of about 0.05mm to about 0.15mm

In certain embodiments, the second polymer P2 has a coating thickness of about 0.05mm to 0.2 mm.

In certain embodiments, the intermediate stage polymer P3 has a coating thickness of about 0.05mm to 0.2 mm.

In certain embodiments, the outer layer 203 includes an extension 204 that extends along the distal end 101 toward the proximal end 102 of the push member 100.

In certain embodiments, the extension 204 extending along the distal end 101 toward the proximal end 102 of the pusher member 100 has a length of about 0.5mm or greater.

In certain embodiments, the extension 204 extending along the distal end 101 toward the proximal end 102 of the push member 100 is about 0.05mm to about 0.2mm in length.

In certain embodiments, the extension 204 extending along the distal end 101 toward the proximal end 102 of the push member 100 can allow the middle layer 202 to be better wrapped to avoid tip unraveling.

In certain embodiments, the extension 204 extending along the distal end 101 toward the proximal end 102 of the pusher member 100 is better compatible with the lumen 201 and avoids direct contact with the intermediate layer 202 as other instruments enter the extension catheter, thereby avoiding scratching.

In certain embodiments, the distal end 101 of the push member 100 is bonded to the intermediate layer 202 by welding.

In certain embodiments, illustrative examples of welding modalities that can be used with the present disclosure include, but are not limited to, laser welding, resistance welding, argon arc welding, and plasma arc welding.

In certain embodiments, the energy that can be used for the laser welding of the present disclosure is about 10W to 40W.

In certain embodiments, examples of shielding gases that can be used for laser welding of the present disclosure include, but are not limited to, argon, nitrogen, and helium.

In certain embodiments, the distal portion 101 of the push member 100 is integrally welded to the intermediate layer 202, thereby reducing the outer diameter of the catheter body while maintaining tensile strength.

In some embodiments, the abutment of the distal end 101 of the pushing member 100 with the intermediate layer 202 provides a smooth transition of the lumen 201 of the catheter body 200, thereby effectively avoiding scratching of other instruments as they enter the extension catheter.

In certain embodiments, the abutment of the distal portion 101 of the push member 100 with the intermediate layer 202 can minimize the outer diameter of the extension catheter.

In certain embodiments, the middle layer 202 is bonded to the outer layer 203 by heat sealing.

In certain embodiments, the distal portion 101 is about 0.1cm to 10cm in length.

In certain embodiments, compliance is enhanced due to the gradual transition of the catheter body 200 and the pusher member 100, thereby avoiding significant catheter body kinking.

In certain embodiments, the push member 100 comprises a distal portion 101 having a first thickness H1 and a proximal portion 102 having a second thickness H2, the distal portion 101 having a first end 1011 and a plurality of intermediate segments 101N, wherein the plurality of intermediate segments 101N are located between the first end 1011 and the proximal portion 102, and each of the plurality of intermediate segments 101N has a thickness greater than the first thickness H1 but less than the second thickness H2.

In certain embodiments, the distal portion 101 is located entirely within the outer layer 203 of the catheter body.

In certain embodiments, the distal portion 101 is partially located in the outer layer 203 of the catheter body.

In certain embodiments, the catheter body has a shore hardness that increases proximally along the distal end of the catheter body.

In certain embodiments, the catheter body HAs a shore hardness of about 20HA to 70 HA.

In certain embodiments, the push member 100 comprises a distal portion 101 having a first thickness H1 and a proximal portion 102 having a second thickness H2, the distal portion 101 having a first end 1011 and a plurality of intermediate segments 101N, wherein the plurality of intermediate segments 101N are located between the first end 1011 and the proximal portion 102, each of the plurality of intermediate segments 101N has a thickness greater than the first thickness H1 but less than the second thickness H2, and each of the plurality of intermediate segments 101N increases in thickness from the first end 1011 to the proximal portion 102.

In another aspect, the present disclosure relates to a medical device comprising an extension catheter 10, the extension catheter 10 comprising a pusher member 100 and a catheter body 200, the pusher member 100 comprising a distal portion 101 having a first thickness H1 and a proximal portion 102 having a second thickness H2, the catheter body 200 comprising a lumen 201, an intermediate layer 202 and an outer layer 203, the intermediate layer 202 being located between the lumen 201 and the outer layer 203, wherein the distal portion 101 is located in the outer layer 203 and the first thickness H1 is less than the second thickness H2.

In certain embodiments, the distal portion 101 is located entirely within the outer layer 203 of the catheter body.

In certain embodiments, the distal portion 101 is partially located in the outer layer 203 of the catheter body.

In certain embodiments, the catheter body has a shore hardness that increases proximally along the distal end of the catheter body.

In certain embodiments, the catheter body HAs a shore hardness of about 20HA to 70 HA.

In certain embodiments, the medical device further comprises a guide catheter.

In yet another aspect, the present disclosure relates to a method of Percutaneous Coronary Intervention (PCI) comprising administering to an individual in need thereof a medical device comprising an extension catheter 10, the extension catheter 10 comprising a pusher member 100 and a catheter body 200, the pusher member 100 comprising a distal portion 101 having a first thickness H1 and a proximal portion 102 having a second thickness H2, the catheter body 200 comprising a lumen 201, an intermediate layer 202, and an outer layer 203, the intermediate layer 202 being positioned between the lumen 201 and the outer layer 203, wherein the distal portion 101 is positioned in the outer layer 203 and the first thickness H1 is less than the second thickness H2.

In certain embodiments, the method comprises guiding an extension catheter of the present disclosure to the ostium of the coronary artery.

Referring to fig. 6 and 7, in certain embodiments, the guide catheter 20 may be moved through the aorta a (artey) to a position adjacent to the ostium O of the coronary artery ca (coronary artey).

In certain embodiments, the guide catheter 20 may include a distal end 22.

In certain embodiments, the method comprises guiding the extension catheter 10 of the present disclosure to the coronary ostium O and into a portion of the coronary artery CA.

In the present disclosure, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions.

From the foregoing it will be appreciated that, although specific embodiments of the disclosure have been described herein for purposes of illustration, various modifications or improvements may be made by those skilled in the art without departing from the spirit and scope of the disclosure. Such variations and modifications are intended to fall within the scope of the appended claims of this disclosure.

Claims (10)

1. An extension catheter comprising a pusher member and a catheter body, the pusher member comprising a distal portion having a first thickness and a proximal portion having a second thickness, the catheter body comprising a lumen, an intermediate layer, and an outer layer, the intermediate layer being located between the lumen and the outer layer, wherein the distal portion is located in the outer layer and the first thickness is less than the second thickness.

2. An extension catheter as in claim 1, wherein the catheter body HAs a shore hardness that increases proximally along the distal end of the catheter body, preferably the shore hardness is 20HA to 70 HA.

3. The extension catheter of claim 1 or 2, wherein the distal portion comprises a first end, preferably the distal portion further comprises at least a middle section between the first end and the proximal portion, the middle section having a thickness greater than the first thickness but less than the second thickness, more preferably the first end further comprises a middle section, and the middle section has a thickness greater than the first thickness but less than the second thickness.

4. The extension catheter of any one of claims 1 to 3, wherein the first thickness is 0.02mm to 0.5mm and the second thickness is 0.1mm to 2 mm.

5. An extension catheter as in any of claims 1-4, wherein the outer layer comprises an extension extending along the distal end toward the proximal end of the push member, preferably the extension having a length of 0.5mm or greater.

6. An extension catheter as in any of claims 1-5, wherein the distal end portion of the push member is bonded to the intermediate layer by welding.

7. An extended catheter according to any one of claims 1 to 6, wherein said intermediate layer is bonded to said outer layer by heat sealing.

8. An extension catheter as in any of claims 1-7, wherein the distal portion is in a stepped arrangement with a proximal portion or intermediate portion adjacent thereto.

9. An extension catheter as in any of claims 1-8, wherein the distal portion has a length of 0.1cm to 10 cm.

10. A medical device comprising the extension catheter of any one of claims 1-9.

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