CN113069243A

CN113069243A - Expandable sheath tube and conveying device

Info

Publication number: CN113069243A
Application number: CN202110289853.1A
Authority: CN
Inventors: 李敬
Original assignee: Sano Xinchang Medical Technology Co ltd
Current assignee: Sano Xinchang Medical Technology Co ltd
Priority date: 2021-03-15
Filing date: 2021-03-15
Publication date: 2021-07-06

Abstract

The invention provides an expandable sheath and a conveying device, belonging to the technical field of medical instruments, wherein the expandable sheath comprises: the pipe body is provided with a first cavity for conduction; the tube body has a contracted state of contracting along the radial direction in the insertion process and also has an expanded state of presenting a circular channel in the cavity in the use process; the puncture piece is suitable for being arranged in the first cavity of the tube body in a penetrating way; the puncture piece is provided with a sharp end which extends out of the tube body and is used for puncture; the hemostatic assembly is arranged at the tail end of the tube body; a silica gel gasket is arranged inside the hemostasis assembly; according to the expandable sheath, when a doctor uses the sheath, the sheath enters the myocardial incision in a contraction state of contracting along the radial direction, so that the incision of the myocardium can be reduced during the surgical intervention of the doctor, the postoperative recovery time and corresponding complications of a patient are reduced, and the pain of the patient is relieved.

Description

Expandable sheath tube and conveying device

Technical Field

The invention relates to the technical field of medical instruments, in particular to an expandable sheath tube and a conveying device.

Background

The heart is a very important organ of the human body and provides power for the blood circulation of the human body, the heart is divided into a left part and a right part, each part comprises a ventricle and an atrium, the ventricle and the atrium are separated by a ventricular septum and an atrial septum, and valves for preventing the blood from flowing backwards are arranged among the atrium, the ventricle and the artery. The valve between the left atrium and the left ventricle is the mitral valve, and when any structure of the mitral valve is in trouble, the valve is diseased.

There are many means and ways to perform heart valve replacement or repair surgery; among them, surgical intervention has been widely performed worldwide, and its outstanding features are minimal invasion and safety. In the surgical intervention, a scalpel is generally used to cut the pericardium and the myocardial tissue, and a channel of the catheter sheath is opened to enter the heart, so that the instruments can smoothly enter the lesion through the sheath in the subsequent operation.

In the prior art, the pericardium and the myocardial tissue are opened according to the diameter of the sheath tube, and after the device implantation or the valve repair is completed, the myocardial and pericardial tissue still needs to be sutured, but if the wound is large, the recovery time of the patient after the operation is long, and other pathological changes are easily induced.

Disclosure of Invention

Therefore, the technical problem to be solved by the present invention is to overcome the defects of the prior art that the wound is large, the recovery time of the patient after the operation is long and other pathological changes are easily induced, thereby providing an expandable sheath.

The invention also provides a conveying device with the sheath tube.

In order to solve the above technical problem, the present invention provides an expandable sheath, including:

the pipe body is provided with a first cavity for conduction; the tube body has a contracted state of contracting along the radial direction in the insertion process and also has an expanded state of presenting a circular channel in the cavity in the use process;

the puncture piece is suitable for being arranged in the first cavity of the tube body in a penetrating way; the puncture piece is provided with a sharp end which extends out of the tube body and is used for puncture;

the hemostasis subassembly, the inside of hemostasis subassembly has the silica gel gasket.

Preferably, the tube body comprises:

the elastic tube is provided with two layers which are sleeved with each other;

the metal bracket is arranged between the two layers of elastic tubes; the metal bracket can drive the elastic tube to expand under the action of external force.

Preferably, the pipe body is a single-layer pipe made of elastic materials; the tube body is folded when in a contracted state and cylindrical when in an expanded state.

Preferably, the method further comprises the following steps: the sheath tube seat is arranged at the tail end of the tube body; the sheath tube seat is provided with a second cavity communicated with the first cavity; the end of the sheath tube seat far away from the tube body is provided with a containing groove for containing the hemostatic assembly.

Preferably, the hemostatic assembly further comprises:

the thick rubber cushion is annular and is arranged in the accommodating groove;

the silica gel gasket is arranged in the accommodating groove and positioned on one side of the thick rubber pad; and a notch is arranged on the silica gel gasket.

Preferably, the method further comprises the following steps: the anti-folding tube is arranged between the sheath tube seat and the tube body; the anti-folding pipe is made of hard materials.

Preferably, the puncture piece is a puncture needle with a tip, and the other end of the puncture needle is provided with a handle; the puncture needle is made of a high polymer material or a metal material.

Preferably, the puncture needle is hollow, and the puncture needle is suitable for accommodating a guide wire to enter and pass through.

The present invention also provides a delivery device comprising the expandable sheath of any of the above; also included is a balloon assembly for expanding the shaft.

Preferably, the balloon assembly comprises:

a high pressure balloon having an inflation cavity for containing a gas; the high-pressure balloon is suitable for being arranged in a first cavity of the tube body in a folding mode;

the outer tube is communicated with the inflation cavity of the high-pressure balloon.

The tip is connected with the inflation cavity of the high-pressure balloon and the inner tube cavity and plays a role of a puncture needle head end.

The technical scheme of the invention has the following advantages:

1. the present invention provides an expandable sheath, comprising: the tube body, the puncture piece and the hemostatic assembly; the tube body has a contracted state and an expanded state; the tube body is in a contraction state at the beginning, and an opening which can enable the tube body in the folding state to enter is cut on the myocardium; the puncture needle enters through the tip of the puncture needle and carries the tube body to enter, and when the puncture needle is used, the tube body is expanded from a contraction state to an expansion state, so that the puncture needle is convenient to use;

when the sheath tube is used by a doctor, the sheath tube enters the myocardial incision under the contraction state of contracting along the radial direction, so that the myocardial incision can be reduced by the doctor in the process of performing surgical intervention operation, the postoperative recovery time and corresponding complications of a patient are reduced, and the pain of the patient is relieved.

2. The invention provides an expandable sheath, a catheter body comprises: an elastic tube and a metal bracket; the metal stent can be expanded to provide a higher radial support force for the shaft when expanded to a desired diameter.

3. The expandable sheath provided by the present invention further comprises: the anti-folding tube is arranged between the sheath tube seat and the tube body; the anti-folding pipe is made of hard materials; when the pipe shaft is pushed to the centripetal muscle, the anti-bending pipe can bear the stress generated between the sheath pipe seat and the pipe shaft, and the pipe shaft is prevented from being bent.

4. The delivery device provided by the invention comprises the expandable sheath, so that the delivery device has the advantages of any one of the above; and a high pressure balloon for expanding the tube body from the contracted state to the expanded state.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

Fig. 1 is a perspective view of an expandable sheath according to the present invention.

Fig. 2 is a schematic structural diagram of an elastic tube according to the present invention.

Fig. 3 is a partially enlarged view of a portion a shown in fig. 2.

Fig. 4 is a perspective view of the elastic tube of the present invention in a contracted state.

FIG. 5 is a perspective view of an expanded state of the flexible tube of the present invention.

Fig. 6 is a schematic structural view of the metal stent of the present invention.

Fig. 7 is a schematic structural view of another elastic tube of the present invention.

Fig. 8 is a partially enlarged view of the elastic tube shown in fig. 7.

Fig. 9 is a schematic view of an exploded configuration of the hemostatic assembly of the present invention.

Fig. 10 is a schematic perspective view of the silica gel gasket of the present invention.

Fig. 11 is a perspective view of the puncture needle of the present invention.

Fig. 12 is a schematic structural view of a balloon assembly of the present invention.

Description of reference numerals:

1. a tube body; 2. puncturing needle; 3. the pipe is prevented from being folded; 4. a sheath seat; 5. a sheath cap; 6. a limiting plate; 7. an elastic tube; 8. a metal bracket; 9. a thick rubber pad; 10. a silica gel gasket; 11. a handle; 12. a high pressure balloon; 13. an outer tube; 14. a handle.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

Example 1

The expandable sheath provided in this embodiment, as shown in fig. 1, includes a catheter body 1, a puncture needle 2 and a hemostatic assembly; the tube body 1 is provided with a first cavity for conduction, and the tube body 1 has a contraction state and an expansion state; when the tube body 1 is in a radial contraction state, an opening which can enable the tube body 1 in the radial contraction state to enter is cut on the myocardium; the puncture needle 2 enters the catheter body 1 with the tip, and when the puncture needle is used, the catheter body 1 is expanded from a contraction state to an expansion state in a circular channel, so that the puncture needle is convenient to use;

when the sheath tube is used by a doctor, the sheath tube enters the myocardial incision under the state of radial contraction, so that the myocardial incision can be reduced by the doctor in the process of surgical intervention, the postoperative recovery time and corresponding complications of a patient are reduced, and the pain of the patient is relieved.

As shown in fig. 2, the tube body 1 is composed of an elastic tube 7 and a metal bracket 8, wherein the elastic tube 7 has high elasticity and can be expanded; the material of the elastic tube 7 is nylon or Pebax.

As shown in fig. 3, the elastic tube 7 has a double-layer structure; the metal stent 8 is arranged between the two layers of the tube body 1, can be in the shape of a stent or a spring ring, as shown in fig. 4, can be in a contracted state, as shown in fig. 5, and can also be expanded; when the metal stent 8 is expanded to a required diameter, the supporting elastic tube 7 is expanded with a high supporting force; when the shape of the metal stent 8 is a stent, cobalt-chromium alloy or 316L stainless steel is preferably selected.

As shown in fig. 6, the metal stent 8 is in an unexpanded state. In the description of this embodiment, the end that first enters the myocardium is called the leading end, and the other end is the trailing end.

As an alternative embodiment, as shown in fig. 7, the elastic tube 7 is made of a simple polymer material, which may be nylon or Pebax; as shown in fig. 8, the front end of the tube body 1 is folded to reduce the diameter; after the physician has accessed the apical opening with the smaller diameter shaft 1, the physician may open the folded shaft 1 using the high pressure balloon 12 and expand to the desired diameter before implanting the desired device into the heart.

As shown in fig. 9, one end of the anti-folding pipe 3 is connected to the tail end of the pipe body 1, and the anti-folding pipe 3 is made of hard material; the other end of the anti-folding tube 3 is connected with a sheath tube seat 4; the anti-folding tube 3 is arranged between the tube body 1 and the sheath tube seat 4 and is used for bearing stress in the process of inserting the myocardial and preventing the tube body 1 close to the sheath tube seat 4 from being folded;

the sheath tube seat 4 is provided with a second cavity which is communicated with the first cavity of the tube body 1; the sheath tube seat 4 is provided with a limiting plate 6, the length of which is longer than the diameter of the tube body 1 and is used for limiting the tube body 1 from entering the position of the myocardium; one end of the sheath tube seat 4, which is far away from the tube body 1, is provided with an accommodating groove, and a thick rubber gasket 9 and a silica gel gasket 10 are sequentially arranged in the accommodating groove; the thick rubber cushion 9 is in a ring shape; one end cover with a containing groove on the sheath tube seat 4 is provided with a sheath tube cap 5, and the sheath tube cap 5 is provided with a through hole for the puncture piece to pass through.

As shown in fig. 10, the silicone gasket 10 is circular, and has a cross-shaped incision in the middle, when the puncture element or the device passes through the cross-shaped incision, the device or the puncture element is wrapped by the soft silicone gasket, so as to prevent blood in the heart from flowing out of the human body.

As shown in fig. 11, the puncture element is in the form of a puncture needle 2, the puncture needle 2 has a tip at the front end and a handle 11 at the tail end, and the puncture needle 2 is made of a polymer material or a metal material with good biocompatibility; the puncture needle 2 is designed to be a hollow structure, so that the injection of contrast solution and the passing of a guide wire are facilitated;

the front end of the puncture needle 2 is a conical smooth structure and forms smooth transition with the tube body 1, when the front end of the puncture needle 2 punctures into the heart, the tube body 1 completes insertion, and the first cavity of the tube body 1 forms a channel for conveying needed medical instruments.

Example 2

The present embodiment provides a delivery device comprising the expandable sheath of embodiment 1. Meanwhile, the conveying device also comprises a balloon component used for expanding the sheath tube; as shown in fig. 12, the balloon assembly includes a high pressure balloon 12, the high pressure balloon 12 has an inflation cavity for containing gas, one end of the inflation cavity is connected with an outer tube 13, the other end of the outer tube 13 is connected with a handle 14, and also has a tip which is connected with the inflation cavity and the inner tube cavity of the high pressure balloon and functions as a puncture needle tip.

The high-pressure balloon 12 is designed to be used for withdrawing the puncture needle 2 after the sheath tube in the embodiment 1 is assisted to enter the puncture position by the puncture needle 2, and the high-pressure balloon 12 penetrates into the first cavity of the folded tube body 1 to be inflated, so that the tube body 1 is expanded.

As an alternative embodiment, the high pressure balloon 12 is folded and retained in the first cavity of the folded tube body 1 in a pre-installed manner, meanwhile, the front end of the high pressure balloon 12 is a tapered smooth structure and is made of a hard material, and forms a smooth transition with the tube body 1, when the high pressure balloon is punctured into the body, the tube body 1 is inserted, and then the high pressure balloon 12 is directly expanded to expand the tube body 1, so as to form a stable passage.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims

1. An expandable sheath, comprising:

the pipe body (1) is provided with a first cavity for conduction; the tube body (1) has a contracted state of contracting in the radial direction in the insertion process and also has an expanded state of presenting a circular channel in the cavity in the use process;

the puncture piece is suitable for being arranged in the first cavity of the tube body (1) in a penetrating way; the puncture piece is provided with a tip extending out of the tube body (1) for puncture;

the hemostasis assembly is arranged at the tail end of the tube body (1); a silica gel gasket is arranged inside the hemostasis assembly;

the tube body (1) is provided with a silica gel gasket (10) which covers the cavity of the tube body (1).

2. The expandable sheath according to claim 1, wherein the shaft (1) comprises:

an elastic tube (7) having two layers nested with each other;

the metal bracket (8) is arranged between the two layers of the elastic tubes (7); the metal support (8) can drive the elastic tube (7) to expand under the action of external force.

3. The expandable sheath according to claim 1, wherein the shaft (1) is a single-layer tube made of an elastic material; the tube body (1) is folded when in a contracted state and cylindrical when in an expanded state.

4. The expandable sheath of any one of claims 1-3, further comprising: a sheath tube seat (4) arranged at the tail end of the tube body (1); the sheath tube seat (4) is provided with a second cavity communicated with the first cavity; one end of the sheath tube seat (4) far away from the tube body (1) is provided with a containing groove for containing the hemostatic assembly.

5. The expandable sheath of claim 4, wherein the hemostasis assembly further comprises:

the thick rubber cushion (9) is annular and is arranged in the accommodating groove;

the silica gel gasket (10) is arranged in the accommodating groove and is positioned on one side of the thick rubber pad (9); the silica gel gasket (10) is provided with a notch.

6. The expandable sheath of claim 4, further comprising: the anti-folding pipe (3) is arranged between the sheath pipe seat (4) and the pipe body (1); the anti-folding pipe (3) is made of hard materials.

7. The expandable sheath according to claim 5 or 6, wherein the puncture member is a puncture needle (2) having a tip, and the other end of the puncture needle (2) has a handle (11); the puncture needle (2) is made of a high polymer material or a metal material.

8. The expandable sheath of claim 7, wherein the puncture needle (2) has a hollow interior, the interior of the puncture needle (2) being adapted to receive a guidewire therethrough.

9. A delivery device comprising the expandable sheath of any one of claims 1-8; also comprises a balloon component used for expanding the tube body (1).

10. The delivery device of claim 9, wherein the balloon assembly comprises:

a high pressure balloon (12) having an inflation lumen for containing a gas; the high-pressure balloon (12) is suitable for being arranged in a first cavity of the tube body (1) in a folding mode;

and the outer tube (13) is communicated with the inflation cavity of the high-pressure balloon (12).