CN222788292U - Guiding and extending catheter - Google Patents

Abstract

The application discloses a guiding extension catheter which comprises a guiding catheter body, a transition connecting section and an elastic wedge sleeve, wherein the guiding catheter body comprises a proximal port and a distal port, the guiding catheter body comprises an inner layer, an intermediate layer and an outer layer, the guiding shaft is arranged on one side of the proximal port and comprises a distal end of the guiding shaft and a proximal end of the guiding shaft, the guiding shaft is used for guiding the guiding catheter body to enter a target position, the transition connecting section is used for connecting the guiding catheter body and the guiding shaft, the transition connecting section is of a tubular structure which is formed by extending from the proximal port along the axial direction and comprises an inclined opening, the inner layer extending section, the elastic wedge sleeve and the outer layer extending section, the elastic wedge sleeve provides rigidity and connection strength for the transition connecting section, the distal end of the guiding shaft is centered with but not connected with the intermediate layer and is separated by a second distance of 0.1mm-10mm, and the outer layer extending section wraps the distal ends of the inner layer, the intermediate layer and the guiding shaft and the outer layer extending section are welded into a whole. The guide extension catheter has good flexibility, trafficability and operation reliability.

Description

Guiding and extending catheter

Technical Field

The application relates to the field of medical products, in particular to a guiding and extending catheter.

Background

The guiding and extending catheter is matched with the guiding catheter or the sheath tube in the vascular intervention operation, enters the coronary artery, and assists in placing the interventional therapy instrument. The transition piece designs of existing guiding and extending catheter technologies fall into two general categories, the first category being plastic skirt transition and the second category being metal skirt transition. The plastic skirt transition structure is characterized in that a metal reinforcing layer of a guide pipe is directly connected with a metal guide shaft to ensure tensile strength, a plastic layer of the guide pipe extends to a plastic bevel opening (or skirt) which is formed by cutting the guide shaft in a transition area to form an arc shape or a step shape, the plastic bevel opening is also an inner cavity inlet of the guide pipe, and the transition is completed through the arc shape or the step shape of the plastic bevel opening; the transition structure of the metal skirt is characterized in that the tail end of the guide shaft is connected (usually welded or riveted) with a metal ring, the metal ring is then connected with the plastic layer of the guide pipe in a coating and embedding way to ensure the tensile strength, the metal ring is usually extended from the tail end of the plastic layer of the guide pipe to the metal skirt which is formed into an arc shape or a step shape by cutting the guide shaft in a transition area, the metal skirt is also an inner cavity inlet of the guide pipe, and the transition is completed through the arc shape or the step shape of the metal skirt. In practical use, the over-bending performance is poor, so that the guiding and extending catheter cannot reach a designated position to play a role, or the vascular of a patient is damaged due to too large resistance in the advancing process.

Disclosure of Invention

The application provides a guiding extension catheter, which comprises a guiding catheter, a transition connecting section and an elastic wedge sleeve, wherein the guiding catheter comprises a proximal port and a distal port, the guiding catheter comprises an inner layer, an intermediate layer and an outer layer, the guiding shaft is arranged on one side of the proximal port and used for guiding the guiding catheter to enter a target position, the transition connecting section is used for connecting the guiding catheter and the guiding shaft, the transition connecting section is a tubular structure which is formed by extending axially from the proximal port and comprises an inclined opening, the inner layer extending section, the elastic wedge sleeve and the outer layer extending section, the elastic wedge sleeve provides rigidity and connection strength for the transition connecting section, the elastic wedge sleeve is arranged at the distal end of the guiding shaft, the distal end of the guiding shaft is centered with but not connected to the intermediate layer and is separated by a second distance of 0.1-10 mm, and the inner layer, the inner layer extending section, the intermediate layer, the elastic wedge sleeve and the distal end of the guiding shaft are wrapped and then welded into a whole through hot melting.

The application further provides a guiding extension catheter which comprises a guiding catheter body, wherein the guiding catheter body comprises a proximal port and a distal port, the guiding catheter body comprises an inner layer, an intermediate layer and an outer layer, the guiding shaft is arranged on one side of the proximal port and used for guiding the guiding catheter body to enter a target position, the distal end of the guiding shaft is a round metal rod, the proximal end of the guiding shaft is a flat metal rod, a transitional connecting section is used for connecting the guiding catheter body and the guiding shaft, the transitional connecting section is of a tubular structure which is formed by extending from the proximal port axially and comprises an inclined opening, the inner layer extending section, an elastomer wedge sleeve and the outer layer extending section, the elastomer wedge sleeve is arranged at the distal end of the guiding shaft, the elastomer wedge sleeve provides rigidity and connection strength for the transitional connecting section, the distal end of the guiding shaft is centered with the intermediate layer but not connected and is separated by a second distance of 0.1mm-10mm, and the outer layer extending section and the inner layer extending section, the intermediate layer and the elastomer wedge sleeve and the distal end of the guiding shaft are wrapped and then welded into a whole.

At least some embodiments have the advantage that the transition section of the guide extension catheter comprises an elastomeric wedge sleeve that is not connected to the intermediate layer, which combines super-flexibility, good mechanical transfer and transition properties, and reliable connection strength, so that such guide extension catheter is significantly improved over the prior art in key properties including passability and operational reliability.

Drawings

A further understanding of the nature and advantages of the present application may be realized by reference to the remaining portions of the specification and the drawings wherein like reference numerals are used throughout the several drawings. In some cases, a sub-label is placed after a reference number and hyphen to represent one of many similar components. When reference is made to a reference numeral without specification to an existing sub-label, it is intended to refer to all such similar components.

Fig. 1 is a schematic view of the use scenario of a guiding elongate catheter of one embodiment of the present application.

Fig. 2 is a schematic structural view of a guide extension catheter according to an embodiment of the present application.

Fig. 3 is a cross-sectional view of the guide extension catheter of the embodiment depicted in fig. 2 in the 3-3 direction.

Fig. 4A is a partial forward schematic view of the structure shown in fig. 3.

Fig. 4B is a partial top view schematic of the structure shown in fig. 3.

Detailed Description

The embodiments are described in more detail below with reference to the following examples, which are provided herein by way of illustration only and are not intended to be limiting.

The present application has various modifications which can be expected by those skilled in the art, and can achieve the effect of the present application.

The application is limited by the definition of space or position, such as inner, outer, upper, lower, left, right, top, bottom, front and back, taking the placement position of the guiding extension catheter in the use state as a reference.

In the present application, the term "comprising" means including but not limited to the following elements, i.e. not excluding other elements.

In the application, one end of the guiding and extending catheter, which is relatively close to the hand of an operator, is a 'near end', and the corresponding end, which is relatively far away from the hand of the operator, is a 'far end', in the use state of the guiding and extending catheter, or both ends of any part of the guiding and extending catheter.

In the present application, the term "axial direction" means a direction in which a central axis of the extension tube or an extension line of the central axis is directed.

In the present application, the term "circumferential" refers to the direction in which the circumferential wall of the guide extension tube is located.

In the present application, the term "oblique" refers to a direction forming an acute angle intersecting line with the central axis of the guide tube.

In the present application, the term "joined" refers to a particular two-part physical rigid connection, including but not limited to, welding, brazing, riveting, and the like. "unconnected" means that the particular two parts are not directly physically rigidly connected.

In the present application, the terms "about" and "approximately" denote ranges of accuracy that one of ordinary skill in the art would understand to still ensure the technical effect of the feature in question. The term generally means a deviation of 10%, preferably 5%, from the indicated values.

The transitional connection section of the guiding and extending catheter between the guiding catheter and the guiding shaft is the key point of the whole guiding and extending catheter, and the connection performance and the transitional performance determine whether the guiding and extending catheter can play a role in practical use. In the process of pushing the guiding and extending catheter in the human body, the guiding and extending catheter usually encounters channel tortuosity or vascular stenosis, at this time, the section of the guiding tube is larger, the guiding tube is easily blocked at first, the section of the guiding shaft is smaller, the section ratio of the guiding tube and the guiding tube is usually larger (for example 80:1), meanwhile, the difference of the hardness of the guiding tube and the guiding tube is larger in structure, so that the guiding and extending catheter usually generates larger stress concentration at a transitional connecting section in the actual pushing process, and is easy to deform and bend at an excessive part, and the mechanical transmission coaxiality of the guiding and extending catheter is damaged, so that pushing force applied from the operating end of the guiding shaft outside the human body cannot be effectively transmitted to the guiding tube body through the transitional connecting section, and the guiding and extending catheter cannot continue to move forward and cannot reach a designated position to play a role. When the transition connecting section deforms in operation, deformation of the inner cavity entrance of the guide tube is directly caused, the deformation of the inner cavity entrance is extremely easy to cause loss of the effective inner cavity of the guide extension catheter, and thus the originally matched interventional therapy instrument is blocked at the guide tube entrance and cannot enter the inner cavity, so that the guide extension catheter fails. When the guiding and extending catheter is retracted, the guiding catheter may be blocked due to deformation or channel collapse, so that the retraction resistance of the guiding catheter is higher than that of a normal guiding catheter, the whole tensile strength of the guiding and extending catheter is tested at the moment, and the transition connecting section is usually damaged firstly when the weak part is pulled due to the structural reasons, so that the product is broken, and the life of a patient is endangered.

The transition connecting section of the guiding extension catheter comprises an elastomer wedge sleeve which is not connected with the middle layer, so that the transition connecting section has super-flexibility, good mechanical transmissibility, transitivity and reliable connection strength, and the key performance of the guiding extension catheter is obviously improved in aspects including trafficability and mechanical transmission reliability compared with the prior art. Further, the guiding extension catheter can fully and reliably play a role in the operation, thereby helping to shorten the operation time and improve the success rate of the operation. The specific technical scheme is as follows:

One aspect of the application provides a guiding extension catheter, which comprises a guiding catheter, a transition connecting section and an elastic wedge sleeve, wherein the guiding catheter comprises a proximal port and a distal port, the guiding catheter comprises an inner layer, an intermediate layer and an outer layer, the guiding shaft is arranged on one side of the proximal port and used for guiding the guiding catheter to enter a target position, the transition connecting section is used for connecting the guiding catheter and the guiding shaft, the transition connecting section is a tubular structure which is formed by extending axially from the proximal port and comprises an inclined opening, the inner layer extending section, the elastic wedge sleeve and the outer layer extending section, the elastic wedge sleeve provides rigidity and connection strength for the transition connecting section, the elastic wedge sleeve is arranged at the distal end of the guiding shaft, the distal end of the guiding shaft is centered with but not connected with the intermediate layer and is separated by a second distance of 0.1-10 mm, and the outer layer extending section wraps the inner layer, the inner layer extending section, the intermediate layer, the elastic wedge sleeve and the distal end of the guiding shaft into a whole through hot melt welding.

In at least one embodiment, the distal end of the guide shaft is a round metal rod and the proximal end of the guide shaft is a flat metal rod.

In at least one embodiment, the outer layer and the outer layer extension are nylon, polyurethane or thermoplastic elastomer, the inner layer and the inner layer extension are high molecular polymers, the middle layer is a metal mesh layer, and the elastomer wedge sleeve is nylon, polyurethane or thermoplastic elastomer.

The application provides a guiding extension catheter which comprises a guiding catheter body, wherein the guiding catheter body comprises a proximal port and a distal port, the guiding catheter body comprises an inner layer, an intermediate layer and an outer layer, the guiding shaft is arranged on one side of the proximal port and used for guiding the guiding catheter body to enter a target position, the distal end of the guiding shaft is a round metal rod, the proximal end of the guiding shaft is a flat metal rod, a transition connection section is used for connecting the guiding catheter body and the guiding shaft, the transition connection section is of a tubular structure which is formed by extending from the proximal port axially and comprises an inclined opening, and comprises an inner layer extension section, an elastomer wedge sleeve and an outer layer extension section, wherein the elastomer wedge sleeve is arranged at the distal end of the guiding shaft, the elastomer wedge sleeve provides rigidity and connection strength for the transition connection section, the distal end of the guiding shaft is centered with the intermediate layer but not connected and is separated by a second distance of 0.1mm-10mm, and the inner layer extension section, the intermediate layer and the middle layer and the outer layer are wrapped and the outer layer are welded into a whole.

Various aspects of embodiments of the application will be described in detail below with reference to the accompanying drawings.

As shown in fig. 1, a simplified schematic illustration of a guide extension catheter 10 in use with a companion instrument 200. The auxiliary device 200 comprises a primary interventional channel formed by the guide catheter 11 and the guide sheath tube 14, wherein the distal end 12 of the guide catheter enters into a blood vessel, the proximal end 13 of the guide catheter is connected with the Y-shaped hemostatic valve 15, the guide extension catheter 10 enters into the primary interventional channel from the Y-shaped hemostatic valve 15, advances along the inner cavity of the guide catheter 11 and finally exceeds the distal end 12 of the guide catheter to be placed into a blood vessel (such as a coronary artery) which is farther.

Fig. 2 is a schematic view of the exterior of the guide extension catheter 10 according to one embodiment of the present application. As shown in fig. 2, the guide extension catheter 10 includes three major parts of a guide catheter 20, a transition piece 30, and a guide shaft 40. The guide tube is also referred to as distal tube, the guide shaft is also referred to as proximal shaft, and the transition piece may also be referred to as transition portion. Wherein the guide tube 20 is located at the distal end of the guide extension catheter 10, the guide shaft 40 is located at the proximal end of the guide extension catheter 10, and the transition piece 30 is used to achieve connection of the guide tube 20 and the guide shaft 40.

Fig. 3 is a cross-sectional view of the embodiment of fig. 2 of the present application taken in the direction 3-3. As shown in fig. 3, the guide tube 20 is a tubular structure, and is used as a channel of an interventional medical device, the guide tube 20 is structurally provided with an inner layer 21, an intermediate layer 22 and an outer layer 23 from inside to outside in sequence, wherein the inner layer 21, the intermediate layer 22 and the outer layer 23 form the tubular structure comprising an inner cavity 24, the material of the inner layer 21 can be PTFE or other plastics, the material of the intermediate layer 22 can be a stainless steel woven mesh or other metal woven mesh, and the material of the outer layer 23 can be a thermoplastic elastomer, a polyurethane elastomer or other plastics. The guide shaft 40 is an elongated solid rod comprising a body portion 41 and a distal end portion 42, the body portion 41 may be a cylindrical section of stainless steel or other metal rod, the distal end portion 42 is an extension of the body portion 41, the extension may be a punch flattening, a laser cutting flattening, a grinding refining or other treatment, and the length of the distal end portion 42 may be 1mm-50mm. As can be seen in fig. 3, the transition piece 30, which is part of the axial extension from the proximal port 26 of the guide tube 20, connects the guide tube 20 and the guide shaft 40 together, has a beveled opening 25, the beveled opening 25 being in communication with the lumen 24 of the guide tube 20. The transition connection section 30 includes an inner extension section 211, an outer extension section 231, and an elastomer wedge sleeve 35, where the middle layer 22 is not connected to the distal end of the guide shaft 40, but is spaced apart from the distal end by a distance of 0.1mm-10mm, the periphery of the distal end portion 42 of the guide shaft 40 is covered with a section of elastomer wedge sleeve 35, and the covering manner may be hot melt covering or stamping, welding, brazing, riveting, etc., and the material of the elastomer wedge sleeve 35 may be plastic or metal such as nylon. The elastomer wedge sleeve 35 is coated between the outer layer 23 and the guide shaft 40 and is inlaid with the outer layer 23 and the guide shaft 40 into a whole to form a bridge mortise-tenon structure, the structural firmness and tensile strength are greatly enhanced while the structural flexibility is maintained, and after the proximal end of the guide tube 20 is cut off from the redundant tube body part without the middle layer 22 and the elastomer wedge sleeve 35, an arc-shaped bevel opening, namely a bevel opening 25, is finally formed, and the bevel opening 25 is also the inlet for other interventional instruments to enter the guide extension catheter 10. To this end, the above components may be hot melt coated as a unit by the outer layer 23 of the guide tube 20 after the assembly is completed, forming the main structure of the guide extension catheter 10.

The proximal end of the guide tube 20, the elastomer wedge 35 and the distal end of the guide shaft 40 together form the transition connecting section 30 of the guide extension tube, and the existence of the elastomer wedge 35 relieves the larger stress concentration at the two ends of the transition connecting section 30 due to larger section area difference (such as 80:1) and structural hardness difference, and improves the mechanical transmissibility and transitivity of the transition connecting section 30. This design greatly reduces the segment metal coverage of the transition joint, thereby significantly improving the flexibility and overbending capability of the transition joint segment 30, and at the same time, improving the joint strength and structural rigidity of the transition joint segment, thereby significantly improving the critical performance of the overall guide extension catheter 10, including passability and steering reliability.

Fig. 4A-4B are partial simplified schematic illustrations of the structure shown in fig. 3. The relative positions of the major components of the guide extension tube skeleton structure are shown, including, primarily, the intermediate layer 22 and the guide shaft 40. The intermediate layer 22 has a second spacing 312 centered on the distal end of the guide shaft 40 and spaced from the distal end by a distance of 0.1mm-10mm, which enhances the softness of the structure and avoids increased thickness due to stacking to reduce the overall structure thickness and significantly enhance the mechanical and transitional properties of the transitional coupling segment 30.

The method provided by the example embodiments in this specification are merely examples, and examples of one method do not limit examples of another method. The apparatus/methods discussed in one figure may be added to or exchanged with the apparatus/methods in other figures. Furthermore, specific digital data values (e.g., specific numbers, amounts, categories, etc.) or other specific information are used only to discuss example embodiments, and such specific information is not intended to limit example embodiments.

Claims (4)

1. A guide extension catheter, comprising:

The guide tube comprises a proximal port and a distal port, and comprises an inner layer, an intermediate layer and an outer layer;

A guide shaft provided on the proximal port side, the guide shaft being for guiding the guide tube into a target position;

the transition connecting section is a tubular structure which is formed by extending along the axial direction of the proximal port and comprises an inclined opening, and comprises an inner-layer extending section, an elastomer wedge sleeve and an outer-layer extending section;

wherein the elastomeric wedge sleeve is disposed at a distal end of the guide shaft;

The distal end of the guide shaft is centered but unattached to the intermediate layer and spaced a second distance of 0.1mm-10mm apart;

The outer layer and the outer layer extension section are formed by wrapping the distal ends of the inner layer, the inner layer extension section, the middle layer, the elastomer wedge sleeve and the guide shaft and then welding the distal ends into a whole through hot melting.

2. The guide extension catheter of claim 1, wherein the distal end of the guide shaft is a round metal rod and the proximal end of the guide shaft is a flat metal rod.

3. The guide and extension catheter of claim 1, wherein the outer layer and outer layer extension are nylon, polyurethane or thermoplastic elastomer, the inner layer and inner layer extension are high molecular polymer, the middle layer is a metal mesh layer, and the elastomeric wedge sleeve is nylon, polyurethane or thermoplastic elastomer.

4. A guide extension catheter, comprising:

The guide tube comprises a proximal port and a distal port, and comprises an inner layer, an intermediate layer and an outer layer;

The guide shaft is arranged at one side of the proximal port and used for guiding the guide tube to enter a target position, the distal end of the guide shaft is a round metal rod, and the proximal end of the guide shaft is a flat metal rod;

The transition connecting section is a tubular structure which is formed by extending along the axial direction of the proximal port and comprises an inclined opening, and comprises an inner-layer extending section, an elastomer wedge sleeve and an outer-layer extending section, wherein the elastomer wedge sleeve is arranged at the distal end of the guide shaft;

The distal end of the guide shaft is centered but unattached to the intermediate layer and spaced a second distance of 0.1mm-10mm apart;

The outer layer and the outer layer extension section are formed by wrapping the distal ends of the inner layer, the inner layer extension section, the middle layer, the elastomer wedge sleeve and the guide shaft and then welding the distal ends into a whole through hot melting.