CN111449814B

CN111449814B - Stent-assisted placement device and method of use thereof

Info

Publication number: CN111449814B
Application number: CN202010410724.9A
Authority: CN
Inventors: 苏剑云; 谢洪涛; 何占元
Original assignee: Changzhou Health Microport Medical Device Co ltd
Current assignee: Changzhou Heshi Minimally Invasive Medical Equipment Co.,Ltd.
Priority date: 2020-05-15
Filing date: 2020-05-15
Publication date: 2025-03-28
Anticipated expiration: 2040-05-15
Also published as: CN111449814A

Abstract

The present invention discloses a stent auxiliary placement device and a method of using the same, which is used to place the stent between the outer tube and the core tube of a stent delivery device, and includes a connector, which is suitable for being installed on the stent delivery device, and which has a channel, at least part of which has a closing section that gradually closes from the proximal end to the distal end after the connector is installed on the stent delivery device; wherein, when the connector is installed on the stent delivery device, the stent is suitable for entering the accommodation space between the outer tube and the core tube after passing through the closing section. The present invention can quickly load the stent into the stent delivery device, and avoid the phenomenon that the stent cannot be opened normally due to improper storage conditions when the stent is pre-installed in the stent delivery device, resulting in adhesion of the stent film.

Description

Auxiliary stent placement device and application method thereof

Technical Field

The invention relates to a bracket auxiliary placement device and a use method thereof.

Background

At present, a non-vascular nickel-titanium alloy self-expanding stent is pre-installed in a stent conveying device before delivery, and the stent is in a contracted state for a long time, so that the stent cannot be normally expanded due to adhesion of a film on the surface when the stent is opened and released.

If the stent is not pre-installed in the stent delivery device, it is difficult for a doctor to smoothly install the stent on site during an operation, and firstly, the stent end has more than ten branches, and the bare hand cannot ensure that the stent end completely enters the outer tube of the stent delivery device. Secondly, the length direction of the bracket after contraction is longer, about 20 cm. All shrink to support conveyor outer tube in very difficult, most probably cause support conveyor's core pipe to bend or the outer tube to warp the condition, above all can lead to the inefficacy of whole apparatus bad, and the doctor is the operation of wearing gloves in the operating room in addition, can make the above-mentioned process degree of difficulty greatly increase.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provide a bracket auxiliary placement device, which can quickly mount a bracket into a bracket conveying device and avoid the phenomenon that the bracket cannot be normally opened due to film adhesion of the bracket caused by improper storage conditions when the bracket is preinstalled in the bracket conveying device.

In order to solve the technical problems, the technical scheme of the invention is that the auxiliary stent placement device is used for placing a stent between an outer tube and a core tube of a stent conveying device and comprises the following components:

a connector adapted to be mounted on the stent delivery device, the connector having a passage, at least a portion of the passage having a closing-in section that gradually closes in a distal direction from a proximal end after the connector is mounted on the stent delivery device,

When the connecting piece is arranged on the bracket conveying device, the bracket is suitable for entering the accommodating space between the outer pipe and the core pipe after passing through the closing-in section.

Further, the closing-in section is arranged at the inlet part of the channel.

Further, the channel is further provided with a conveying through hole section, and the closing-in section and the conveying through hole section are arranged from the proximal end to the distal end.

Further, when the connector is mounted on the stent delivery device, the channel communicates with the receiving space between the outer tube and the core tube to allow the stent to enter the receiving space between the outer tube and the core tube.

Further, when the connecting piece is arranged on the bracket conveying device, the cavity of the outer tube is abutted to the outlet part of the channel, and the core tube penetrates through the channel so that the channel is communicated with the accommodating space between the outer tube and the core tube.

Further, in order to enable the connecting piece to be installed on the support conveying device, the connecting piece is further provided with an outer tube limiting hole which is communicated with the channel and is suitable for being clamped with the outer tube and provided with a step surface propped against the outer end surface of the outer tube after the outer tube is clamped in place.

Further, the closing-in section is a taper hole.

Further, the connecting piece comprises two butt-joint pieces connected together, wherein,

One side of the two butt joint pieces is hinged, and the other side is spliced by at least one splicing mechanism after the two butt joint pieces are assembled in place in a turnover way;

or the two sides of the two butt joint pieces are respectively spliced by at least one splicing mechanism.

Further, the plugging mechanism includes:

a docking pin provided on any one of the docking members;

and the butt joint hole is arranged on the rest butt joint piece and matched with the butt joint pin shaft hole.

Further, in order to prevent the core tube from being bent and damaged when the stent is loaded into the stent auxiliary placement device, the stent auxiliary placement device further comprises a support rod adapted to be inserted into the cavity of the core tube to prevent the core tube from being bent during the process of placing the stent into the stent delivery device.

Further, the connecting piece is of a transparent structure.

Further, in order to be able to fix the outer tube, the stent is conveniently pushed into the accommodation space between the outer tube and the core tube, the stent auxiliary placement device further comprises an auxiliary sleeve adapted to be sleeved over at least part of the outer tube and to be actuated to fix the outer tube during placement of the stent into the stent delivery device.

Further, the auxiliary bushing includes:

the outer supporting pipe is provided with at least one pressing and pinching groove;

a flexible inner tube disposed within the support outer tube, the flexible inner tube adapted to be held in place by a force applied from the pinch groove to at least partially abut the outer tube after the auxiliary sleeve is received within at least a portion of the outer tube.

Further, the flexible inner tube is made of a medical latex material.

The invention also provides a using method of the bracket auxiliary placement device, which comprises the following steps:

s1, pushing out a core tube from a bracket conveying device;

S2, installing a connecting piece on the bracket conveying device to enable the channel to be communicated with the accommodating space between the outer tube and the core tube;

S3, enabling the support to pass through the core tube, enabling the distal end of the support to be plugged into the closing-in section, conveying the support to the distal end of the support conveying device until the portion of the distal end of the support enters the accommodating space between the outer tube and the core tube, and taking down the connecting piece;

and S4, fixing the outer tube, and continuously conveying the support to the distal end part of the support conveying device until the support is completely retracted into the accommodating space between the outer tube and the core tube.

Further, the method is implemented based on a stent-assisted placement device;

The method further comprises the following steps:

The auxiliary sleeve is sleeved into the outer tube between the step S1 and the step S2;

in step S4, the outer tube is fixed by the auxiliary sleeve.

After the technical scheme is adopted, the invention has the following beneficial effects:

1. The auxiliary stent placement device can be used for rapidly loading the stent into the stent conveying device in an operating room on site, so that the phenomenon that the stent cannot be normally opened due to the adhesion of a film of the stent caused by improper preservation conditions in the stent conveying device is avoided, and when a doctor uses the auxiliary stent placement device to place the stent, the difficulty in installation can be greatly reduced, and the stent can be rapidly loaded in 2 minutes after simple training and has no damage to instruments.

2. The closing-in section that sets up in the connecting piece among the auxiliary placement device of support can realize once only making the support tip all get into in the outer tube of support conveyor, and is efficient and not damaged to the support surface.

3. The auxiliary sleeve in the device can realize that the support is completely contracted into the conveying device smoothly, and the phenomenon that the outer tube of the conveying device is bent or deformed is avoided.

4. The support rod in the device can avoid the phenomenon that the core tube of the support conveying device is bent, and can ensure the straightness of the support in the support conveying device.

Drawings

FIG. 1 is an assembled schematic view of a stent placement device of the present invention;

FIG. 2 is a perspective view of a first structural connector of the present invention;

FIG. 3 is a perspective view of a connector of a second construction according to the present invention;

FIG. 4 is a perspective view of a third embodiment of a connector according to the present invention;

FIG. 5 is a cross-sectional view of the structure of the connector of the present invention;

FIG. 6 is a perspective view of an auxiliary sleeve of a first construction of the present invention;

Fig. 7 is a perspective view of an auxiliary bushing of a second construction according to the invention.

Detailed Description

In order that the invention may be more readily understood, a more particular description of the invention will be rendered by reference to specific embodiments that are illustrated in the appended drawings.

In the first embodiment, the stent delivery device is the prior art, and the stent 10 of the stent delivery device needs to be placed between the outer tube 20 and the core tube 30 in order for the stent 10 to be delivered by the stent delivery device.

In this embodiment, the proximal end of the stent delivery device is referred to as the core tube 30 end.

As shown in fig. 1 to 6, a stent auxiliary placement device for placing a stent 10 between an outer tube 20 and a core tube 30 of a stent delivery device, comprises:

a connector 1, said connector 1 being adapted to be mounted on a stent delivery device, said connector 1 having a channel, at least part of said channel having a closing-in section 11 which gradually closes in from a proximal end to a distal end after the connector 1 is mounted on the stent delivery device,

When the connector 1 is mounted on the stent delivery device, the stent 10 is adapted to pass through the necked-in section 11 and then enter the receiving space between the outer tube 20 and the core tube 30.

In this embodiment, the connector 1 may be a transparent structure, so that an operator can observe the installation process in time.

As shown in fig. 2 to 5, the closing-in section 11 is disposed at an inlet portion of the channel.

As shown in fig. 5, the channel further has a delivery through-hole section 12, and the constriction section 11 and the delivery through-hole section 12 are arranged in a proximal-to-distal direction.

As shown in fig. 1 and5, when the connector 1 is mounted on the stent delivery device, the passage communicates with the receiving space between the outer tube 20 and the core tube 30 to allow the stent 10 to enter the receiving space between the outer tube 20 and the core tube 30.

As shown in fig. 1 and 5, when the connector 1 is mounted on the stent delivery device, the channel of the outer tube 20 is abutted against the outlet portion of the channel, and the core tube 30 is inserted into the channel so that the channel is communicated with the accommodating space between the outer tube 20 and the core tube 30.

As shown in fig. 5, the connector 1 is further provided with an outer tube limiting hole 13 which is communicated with the channel and is suitable for clamping the outer tube 20, and has a step surface propped against the outer end surface of the outer tube 20 after the outer tube 20 is clamped in place.

As shown in fig. 5, the closing-in section 11 includes, but is not limited to, a tapered hole structure.

The structure of the connector 1 is very large, and specifically includes but is not limited to the following three types:

The first structure is as follows:

As shown in fig. 2, the connector 1 comprises two butt-joint members 100 connected together, wherein,

One side of the two butt joint pieces 100 is hinged, and the other side is spliced by a splicing mechanism after the two butt joint pieces 100 are assembled in place in a turnover mode.

The second structure is as follows:

one side of the two butt joint pieces 100 is hinged, and the other side is spliced by the two splicing mechanisms after the two butt joint pieces 100 are assembled in place in a turnover mode.

The third structure is as follows:

In the embodiment, two sides of the two butt-joint pieces 100 are respectively spliced by at least one splicing mechanism, and in the embodiment, the two sides of the two butt-joint pieces 100 are respectively spliced by one splicing mechanism, and the splicing mechanisms on the two sides are arranged in a staggered manner.

The plugging mechanism in the connecting piece 1 in the above three structures can be as follows:

Comprising the following steps:

a docking pin 100a provided on any one of the docking members 100;

And a docking hole 100b provided on the remaining one docking member 100 and fitted with the shaft hole of the docking pin 100 a.

Specifically, in order to facilitate the butt joint of the butt joint pin 100a and the butt joint hole 100b, a tapered fitting structure may be provided at a portion where both are fitted to each other to facilitate the insertion.

In addition, in order to facilitate the detachment of the connector 1, a groove may be provided at the side of the connector 1, through which the two butt members 100 are detached, respectively.

As shown in fig. 1, the stent delivery device further comprises a support rod 2 adapted to be inserted into the lumen of the core tube 30 to avoid bending of said core tube 30 during placement of the stent 10 into the stent delivery device.

In this embodiment, the support rod 2 may be a metal member, which is made of stainless steel. One end is provided with a step.

When in use, the support rod 2 can be plugged into the core tube 30 of the bracket conveying device, so as to support the core tube 30 and avoid the phenomenon that the core tube 30 is put into and bent when the bracket 10 is pushed.

As shown in fig. 1, the stent delivery device further comprises an auxiliary sleeve 3 adapted to nest over at least a portion of the outer tube 20 and to act to secure the outer tube 20 during placement of the stent 10 into the stent delivery device.

As shown in fig. 6 and 7, the auxiliary sleeve 3 includes:

a supporting outer tube 31, wherein at least one pinching groove 31a is formed on the supporting outer tube 31;

A flexible inner tube 32 provided in the support outer tube 31, the flexible inner tube 32 being adapted to fix the outer tube 20 by applying a force from a pinching groove 31a to at least partially abut the flexible inner tube 32 against the outer tube 20 after the auxiliary tube 3 is fitted into at least a portion of the outer tube 20.

The support outer tube 31 plays a supporting role, and can ensure that the outer tube 20 of the stent delivery device does not suffer from bending or deformation.

In this embodiment, two opposite sides of the outer supporting tube 31 are respectively provided with a pinching groove 31a, and the two pinching grooves 31a are arranged in a staggered manner, preferably in a staggered manner of 5mm in the axial direction, and in addition, as shown in fig. 6, the right angle structure of the pinching grooves 31a is shown, and of course, the groove angle of the pinching grooves 31a can also be in an arc transition structure, so that the strength of the outer supporting tube 31 is better.

The pinching grooves 31a are provided so as to be convenient for the operator to pinch the flexible inner tube 32. The flexible inner tube 32 is in contact with the outer tube 20 of the stent delivery device and the crimping process creates friction to effect delivery of the stent 10. The support outer tube 31 may be made of stainless steel material, and the flexible inner tube 32 may be a special medical latex hose. The support outer tube 31 and the flexible inner tube 32 may be bonded together by means of a special glue.

In use, the auxiliary sleeve 3 is inserted into the outer tube 20 of the stent delivery device, and the stent 10 is pushed to advance inwards by pressing the flexible inner tube 32 with fingers at a certain position.

In this embodiment, when in use, the outer tube 20 of the stent delivery device is clamped in the outer tube limiting hole 13, the connecting piece 1 is closed, the stent 10 is pushed in by the tapered closing section 11, and enters the outer tube 20 of the stent delivery device after passing through the delivery through hole section 12.

An embodiment II is a method for using the stent auxiliary placement device in the embodiment I, wherein the method comprises the following specific steps:

s0, taking out the connecting piece 1, the auxiliary sleeve 3, the supporting rod 2 and the bracket 10 and placing the connecting piece on a clean table top;

s1, taking out the bracket conveying device, loosening a screw cap on a three-way valve of the bracket conveying device, pushing out the core tube 30 from the bracket conveying device, and inserting the support rod 2 into the soft head end part of the core tube 30;

S11, sleeving the auxiliary sleeve 3 into the outer tube 20 from the core tube 30 and advancing to be about 50 mm away from the end face of the outer tube 20;

s2, picking up the opened connecting piece 1, flushing the end face of the outer tube 20 with the step face on the connecting piece 1, and covering the connecting piece 1 to enable the channel to be communicated with the accommodating space between the outer tube 20 and the core tube 30;

S3, penetrating the support 10 through the core tube 30, plugging the distal end part of the support 10 into the closing-in section 11, conveying the support 10 to the distal end part of the support conveying device until the part of the distal end part of the support 10 enters the accommodating space between the outer tube 20 and the core tube 30, and removing the connecting piece 1;

S4, moving the auxiliary sleeve to the outer tube developing ring, fixing the outer tube 20, continuing to convey the support 10 to the distal end of the support conveying device until the support 10 is completely retracted into the accommodating space between the outer tube 20 and the core tube 30, taking out the auxiliary sleeve 3, and drawing out the support rod 2 to finish the installation.

The technical problems, technical solutions and advantageous effects solved by the present invention have been further described in detail in the above-described embodiments, and it should be understood that the above-described embodiments are only illustrative of the present invention and are not intended to limit the present invention, and any modifications, equivalent substitutions, improvements, etc. within the spirit and principle of the present invention should be included in the scope of protection of the present invention.

In the description of the present invention, it should be understood that the terms "orientation" or "positional relationship" are based on the orientation or positional relationship shown in the drawings, and are merely for convenience of description and to simplify the description, rather than to indicate or imply that the apparatus or elements referred to must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as limiting the invention.

In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed, mechanically connected, electrically connected, directly connected, indirectly connected via an intervening medium, or in communication between two elements or in an interaction relationship between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

In the description of the present invention, it should be noted that, directions or positional relationships indicated by terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., are directions or positional relationships based on those shown in the drawings, or are directions or positional relationships conventionally put in use of the inventive product, are merely for convenience of describing the present invention and simplifying the description, and are not indicative or implying that the apparatus or element to be referred to must have a specific direction, be constructed and operated in a specific direction, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used merely to distinguish between descriptions and should not be construed as indicating or implying relative importance.

Furthermore, the terms "horizontal," "vertical," "overhang," and the like do not denote a requirement that the component be absolutely horizontal or overhang, but rather may be slightly inclined. As "horizontal" merely means that its direction is more horizontal than "vertical", and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.

In the present invention, unless expressly stated or limited otherwise, a first feature may include first and second features directly contacting each other, either above or below a second feature, or through additional features contacting each other, rather than directly contacting each other. Moreover, the first feature being above, over, and on the second feature includes the first feature being directly above and obliquely above the second feature, or simply indicating that the first feature is higher in level than the second feature. The first feature being below, beneath, and beneath the second feature includes the first feature being directly below and obliquely below the second feature, or simply indicates that the first feature is less level than the second feature.

Claims

1. A stent placement aid for placing a stent (10) between an outer tube (20) and a core tube (30) of a stent delivery device, comprising:

A connecting piece (1), wherein the connecting piece (1) is suitable for being arranged on a stent conveying device, the connecting piece (1) is provided with a channel, at least part of the channel is provided with a closing-in section (11) which gradually closes in from the proximal end to the distal end after the connecting piece (1) is arranged on the stent conveying device,

When the connecting piece (1) is arranged on the bracket conveying device, the bracket (10) is suitable for entering the accommodating space between the outer tube (20) and the core tube (30) after passing through the closing-in section (11);

further comprising an auxiliary sleeve (3) adapted to nest over at least part of said outer tube (20) and to act to secure said outer tube (20) during the placement of the stent (10) into the stent delivery device;

The auxiliary sleeve (3) comprises:

The outer support tube (31) is provided with at least one pinching groove (31 a) on the outer support tube (31);

A flexible inner tube (32) provided in the support outer tube (31), the flexible inner tube (32) being adapted to fix the outer tube (20) by a force applied from a pinching groove (31 a) to at least partially abut the flexible inner tube (32) against the outer tube (20) after the auxiliary sleeve (3) is fitted into at least a portion of the outer tube (20);

When the connecting piece (1) is arranged on the bracket conveying device, the channel is communicated with the accommodating space between the outer tube (20) and the core tube (30) so that the bracket (10) enters the accommodating space between the outer tube (20) and the core tube (30).

2. The stent placement aid of claim 1, wherein,

The closing-in section (11) is arranged at the inlet part of the channel;

And/or the closing-in section (11) is a taper hole;

and/or the connecting piece (1) is a transparent structure.

3. The stent placement aid of claim 1, wherein,

The channel also has a delivery through-hole section (12), and the closing-in section (11) and the delivery through-hole section (12) are arranged from the proximal end to the distal end.

4. The stent placement aid of claim 1, wherein,

When the connecting piece (1) is arranged on the bracket conveying device, the cavity channel of the outer tube (20) is in butt joint with the outlet part of the channel, and the core tube (30) penetrates through the channel so that the channel is communicated with the accommodating space between the outer tube (20) and the core tube (30).

5. The stent placement aid of claim 4, wherein,

The connecting piece (1) is also provided with an outer tube limiting hole (13) which is communicated with the channel and is suitable for being clamped with the outer tube (20) and provided with a step surface propped against the outer end surface of the outer tube (20) after the outer tube (20) is clamped in place.

6. The stent placement aid of claim 1, wherein,

The connecting piece (1) comprises two butt-joint pieces (100) which are connected together, wherein,

One side of the two butt joint pieces (100) is hinged, and the other side is spliced through at least one splicing mechanism after the two butt joint pieces (100) are assembled in place in a turnover way;

or the two sides of the two butt joint parts (100) are respectively spliced by at least one splicing mechanism.

7. The stent placement aid of claim 6, wherein,

The plug-in mechanism comprises:

a docking pin (100 a) provided on any one of the docking members (100);

and a butt joint hole (100 b) arranged on the rest butt joint piece (100) and matched with the shaft hole of the butt joint pin (100 a).

8. The stent placement aid of claim 1, wherein,

And a support rod (2) which is suitable for being inserted into the cavity of the core tube (30) to prevent the core tube (30) from bending during the process of putting the support (10) into the support conveying device.

9. The stent placement aid of claim 1, wherein,

The flexible inner tube (32) is made of a medical latex material.