CN102895008B - Medical occluder and induction system thereof - Google Patents

Abstract

The invention relates to the field of medical devices, in particular to a degradable medical occluder. The medical occluder includes an occluder support (1), a membrane arranged on the occluder support (1), and a mandrel (2) fixed to the distal end (5) of the occluder support; the The mandrel (2) passes through the occluder support (1), one end of the mandrel (2) is fixedly connected to the distal end (5) of the occluder support, and the other end is provided with a 4) The matched engaging structure enables the proximal end (4) of the occluder support (4) to engage and lock with the other end of the mandrel (2) when the occluder support (1) is deployed, and the medical occluder The device is made of degradable polymer. The medical occluder can degrade automatically after entering the human body, eliminating the hidden danger of side effects caused by the occluder remaining in the human body.

Description

Medical occluder and its delivery system

technical field

The invention relates to the field of medical devices, in particular to a degradable medical occluder and a delivery system thereof.

Background technique

Interventional treatment of congenital heart disease has become very common, and occluder is the main instrument of interventional treatment. At present, many companies at home and abroad have products on the market, but these products are made of nickel-titanium memory alloy wire, and then heat-set; the superelasticity of nickel-titanium alloy is used to prepare a self-expanding occluder. However, the human body’s demand for devices is not long-term. The intima will be completely covered in about 3 months. At this time, the occluder is a useless foreign body, and it is accompanied by various side effects, such as the dissolution of nickel ions and the destruction of human tissues. wait.

The ideal occluder should meet the occlusion function and at the same time, the occluder can degrade by itself after the lesion is cured. But apart from nickel-titanium alloys, there is currently no suitable superelastic material, let alone a degradable superelastic material.

Contents of the invention

(1) Technical problems to be solved

The purpose of the present invention is to provide a degradable occluder to solve the problem that the occluder cannot degrade automatically after the lesion is cured.

(2) Technical solution

Technical scheme of the present invention is as follows:

A medical occluder, comprising a occluder bracket, a membrane arranged on the occluder bracket, and a mandrel fixed to the distal end of the occluder bracket; it is characterized in that: the mandrel passes through the The occluder bracket, one end of the mandrel is fixedly connected to the distal end of the occluder bracket, and the other end is provided with an engaging structure matched with the proximal end of the occluder bracket, so that when the occluder bracket is deployed, the occluder bracket The proximal end of the device bracket is engaged and locked with the other end of the mandrel, and the medical occluder is made of degradable polymer.

Preferably, the other end of the mandrel is provided with an engaging protrusion, and the proximal end of the occluder bracket is provided with an engaging groove matching the engaging protrusion.

Preferably, an engaging protrusion is provided at the proximal end of the occluder bracket, and an engaging groove matching the engaging protrusion is provided at the other end of the mandrel.

Preferably, the support waist is a stretchable structure.

Preferably, gaps are provided on the upper panel between the distal end of the occluder bracket and the waist of the bracket, and on the lower panel between the proximal end of the bracket of the occluder and the waist of the bracket. When the occluder bracket is unfolded, the upper and lower panels are bent and deformed at the gap.

Preferably, the upper panel between the distal end of the occluder bracket and the waist of the bracket, and the lower panel between the proximal end of the bracket of the occluder and the waist of the bracket are connected in series by at least two sections When the occluder bracket is deployed, the upper and lower panels are bent and deformed at the series connection of the bracket bars.

The delivery system of the medical occluder includes an inner push rod, the inner push rod is covered with an outer push tube that can move axially relative to it, and the outer push tube is covered with an outer tube that can move axially relative to it The sheath, the outer pushing tube is flexibly connected with the proximal end of the occluder support.

Preferably, the inner push rod is matched with the connecting head of the mandrel end to form a connection in the axial direction, and there is no or only partial connection in the transverse direction.

Preferably, an inner push rod sleeve that can move axially relative to the inner push rod and the outer push tube is arranged between the inner push rod and the outer push tube.

Preferably, the delivery system further includes a handle, and the handle is used to control the movement of the inner pushing rod relative to the outer pushing tube and the outer pushing tube relative to the outer tube sheath.

(3) Beneficial effects

The medical occluder provided by the present invention breaks away from the restriction that traditional occluders must use memory alloys or superelastic alloys by providing a matching card and structure between the mandrel and the occluder bracket; Material, the medical occluder provided by the invention can degrade automatically after entering the human body, eliminating the hidden danger of side effects caused by the occluder remaining in the human body.

Description of drawings

Fig. 1 is a schematic diagram of the occluder bracket before deformation in Example 1 of the present invention;

Fig. 2 is a schematic diagram of the occluder in Embodiment 1 of the present invention;

Fig. 3 is the schematic diagram of the occluder designed for PDA in the embodiment of the present invention 2;

4 is a schematic diagram of an occluder designed for ASD in Embodiment 2 of the present invention;

Fig. 5 is a schematic diagram of the delivery system in Embodiment 3 of the present invention.

In the figure: 1: occluder support; 2: mandrel; 3: support waist; 4: proximal end of occluder support; 5: distal end of occluder support; 6: upper plate; 7: lower plate; 8: Gap; 9: mandrel end connector; 10: inner push rod; 11: inner push rod end connector; 12: inner push rod sleeve; 13: outer push tube.

Detailed ways

The specific implementation manner of the present invention will be further described below in conjunction with the drawings and embodiments.

Example 1

A medical occluder designed for VSD (Ventricular septal defect) as shown in Figure 2: including an occluder bracket 1, a membrane set on the occluder bracket 1, and one end fixed to the occluder bracket The mandrel 2 of the occluder bracket is called the distal end 5 of the occluder bracket, and the other end is called the proximal end 4 of the occluder bracket; the mandrel 2 passes through the occluder bracket 1, and the mandrel 2 One end is fixedly connected with the distal end 5 of the occluder bracket, and the other end is provided with a snap-fit structure matched with the proximal end 4 of the occluder bracket, so that when the occluder bracket 1 is deployed, the proximal end 4 of the occluder bracket is in contact with the mandrel. 2 The other end snaps and locks, and the medical occluder is made of degradable polymer. The degradable polymer can be silk fibroin, PLA (polylactic acid), PGA (polyglycolic acid), PGLA (polyglycolide) or composite materials.

Such a structural design breaks away from the restriction that traditional occluders must use memory alloys or superelastic alloys; as the material used is degradable polymer, the medical occluder provided by the invention can degrade itself after entering the human body, eliminating the need for The hidden danger of side effects caused by the occluder remaining in the human body.

Further, the other end of the mandrel 2 is provided with an engaging protrusion, and the proximal end 4 of the occluder support is provided with an engaging groove matching the engaging protrusion. Alternatively, the proximal end 4 of the occluder bracket is provided with an engaging protrusion, and the other end of the mandrel 2 is provided with an engaging groove matching the engaging protrusion. The purpose is to ensure that the proximal end 4 of the occluder stent can be strongly restrained when it reaches the corresponding position on the mandrel 2 , and ensure that the occluder stent 1 cannot rebound freely after deployment and maintain the occluded state.

Further, the stent waist 3 is a stretchable structure, and its length and diameter can be determined according to the needs. The purpose is to ensure that the occluder can be expanded to the length and diameter required for treatment. In this embodiment, a rhombus structure is adopted.

Further, gaps 8 are provided on the upper panel 6 between the distal end 5 of the occluder bracket and the waist 3 of the bracket, and on the lower panel 7 between the proximal end 4 of the bracket of the occluder bracket and the waist 3 of the bracket. It is used for shaping conveniently, and the inflection points of the upper disk surface 6 and the lower disk surface 7 are formed after deformation. Alternatively, the upper panel 6 located between the distal end 5 of the occluder bracket and the waist 3 of the bracket, and the lower panel 7 located between the proximal end 4 of the bracket of the occluder bracket and the waist 3 of the bracket are composed of at least two sections of bracket strips that are movable in series , when the occluder bracket 1 is unfolded, the upper panel 6 and the lower panel 7 are bent and deformed at the series connection of the bracket bars, which is convenient for shaping.

Example 2

An occluder designed for PDA (Patentductus arteriosus, patent ductus arteriosus), as shown in Figure 3; an occluder designed for ASD (Atrial septal defect, atrial septal defect), as shown in Figure 4. They differ from Embodiment 1 only in appearance: the lower disc surface of the occluder designed for PDA and ASD is flatter than the upper disc surface.

Example 3

The delivery system of the medical occluder as shown in Figure 5 includes an inner push rod 10, the inner push rod 10 is covered with an outer push tube 13 that can move axially relative to it, and the outer push tube 13 is covered with a push tube that can move axially relative to it. The outer sheath, the outer pusher tube 13 is connected to the proximal end 4 of the occluder support through a rope, and can also be connected through a connecting groove, mainly to realize deployment and recovery of the occluder; the outer sheath is mainly used to protect the occluder.

Further, the other end of the mandrel 2 has a mandrel end connector 9; the inner push rod 10 is matched with the mandrel end connector 9 to form a connection in the axial direction, and there is no or only part of the connection in the transverse direction, the purpose is to facilitate the occluder freed.

Further, an inner push rod sleeve 12 that can move axially relative to the inner push rod 10 and the outer push tube 13 is provided between the inner push rod 10 and the outer push tube 13, and the mandrel end connector 9 is connected to the inner push rod end. After the connection head 11 is connected, it can shrink back into the inner push rod sleeve 12 to form a lateral restraint. At this time, the inner push rod 10 and the occluder are firmly connected. When releasing, connect the mandrel end connector 9 to the inner push rod end The head 11 pushes out the inner push rod sleeve 12, releases the lateral restraint, controls the inner push rod 10, and the mandrel end connector 9 can break away from the inner push rod end connector 11.

Further, the delivery system further includes a handle, which is used to control the movement of the inner pushing rod 10, the relative outer pushing tube 13, and the outer pushing tube 13 relative to the outer tube sheath. .

In actual operation, it is used in conjunction with the expansion tube. After reaching the lesion, the expansion tube is removed. First, the inner push rod 10 is controlled by the handle to control the occluder. Disconnect from the occluder, control the inner push rod sleeve 12 through the handle, release the lateral restraint, separate the inner push rod 10 from the occluder, and completely release the occluder.

The above embodiments are only used to illustrate the present invention, but not to limit the present invention. Those of ordinary skill in the relevant technical field can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, all Equivalent technical solutions also belong to the protection category of the present invention.

Claims (7)

1. A medical occluder, comprising a occluder support (1), a film disposed on the occluder support (1) and a mandrel (2) fixed to the occluder support distal end (5) ; It is characterized in that: the mandrel (2) passes through the occluder support (1), one end of the mandrel (2) is fixedly connected with the distal end (5) of the occluder support, and the other end is provided with a The engaging structure matched with the proximal end (4) of the occluder support enables the proximal end (4) of the occluder support (4) to engage with the other end of the mandrel (2) when the occluder support (1) is deployed locking, the medical occluder is made of a degradable polymer; Wherein, the upper plate surface (6) between the distal end (5) of the stent of the occluder and the waist of the stent (3), and the proximal end (4) of the stent of the occluder and the waist of the stent ( 3) There are notches (8) on the lower panel (7) between them, and when the occluder support (1) is deployed, the upper panel (6) and the lower panel (7) are placed between the notches (8). bending deformation; the bracket waist (3) is a stretchable rhombus structure; Wherein, the upper plate surface (6) between the distal end (5) of the stent of the occluder and the waist of the stent (3), and the proximal end (4) of the stent of the occluder and the waist of the stent ( 3) The lower panel (7) between them is composed of at least two sections of support strips connected in series. When the occluder bracket (1) is deployed, the upper panel (6) and the lower panel (7) are placed between the brackets. The series connection of the strips is bent and deformed. 2. The medical occluder according to claim 1, characterized in that: the other end of the mandrel (2) is provided with an engaging protrusion, and the proximal end (4) of the occluder bracket is provided with a slots that match the protrusions. 3. The medical occluder according to claim 1, characterized in that: the proximal end (4) of the occluder bracket is provided with an engaging protrusion, and the other end of the mandrel (2) is provided with a slots that match the protrusions. 4. A delivery system for a medical occluder according to claim 1, comprising an inner push rod (10), which is covered with an outer push tube (13) that can move axially relative thereto , the outer push tube (13) is covered with an outer sheath that can move axially relative thereto, and the outer push tube (13) is flexibly connected to the proximal end (4) of the occluder support. 5. The conveying system according to claim 4, characterized in that: the other end of the mandrel (2) has a mandrel end connector (9); the inner push rod (10) is connected to the mandrel end connector ( 9) Matching to form a connection in the axial direction. 6. The conveying system according to claim 5, characterized in that: between the inner push rod (10) and the outer push pipe (13), there is an inner push rod (10) and the outer push pipe (13). ) the inner push rod sleeve (12) for axial movement. 7. The conveying system according to any one of claims 4 to 6, characterized in that: the conveying system also includes a handle connected with the inner push rod (10) and the outer push pipe (13), and the handle is used for It controls the movement of the inner push rod (10) relative to the outer push tube (13) and the outer push tube (13) relative to the outer tube sheath.