CN118987463A

CN118987463A - Therapeutic object conveying device and conveying system based on intervention mode

Info

Publication number: CN118987463A
Application number: CN202411090786.0A
Authority: CN
Inventors: 季培红; 周启蒙; 石龙生; 刘杨; 杨立峰
Original assignee: Hangzhou Juzheng Medical Technology Co ltd
Current assignee: Hangzhou Juzheng Medical Technology Co ltd
Priority date: 2024-08-09
Filing date: 2024-08-09
Publication date: 2024-11-22

Abstract

The present application is based on an interventional treatment delivery device and delivery system, wherein the treatment delivery device comprises: an outer sheath, which is a tubular structure and has a relative distal end and a proximal end, and the inner part of the outer sheath has a treatment delivery channel; a tube assembly, which is movably arranged in the outer sheath; a blocking assembly, which comprises a first balloon and a second balloon for temporarily blocking blood flow, which are arranged in sequence along the axial direction of the outer sheath, and between the first balloon and the second balloon is the expected treatment delivery position; a retaining assembly, which is used to keep the blood vessel at the expected treatment delivery position in an expanded state, and the retaining assembly adopts one of the following structures: a, a support frame; b, a light-emitting component. The treatment delivery device and delivery system based on an interventional method provided by the present application prevent the blood vessel from contracting when delivering drugs to the site of endothelial injury, and perform drug treatment in a state where the blood vessel is stretched, which has a better treatment effect.

Description

Therapeutic object conveying device and conveying system based on intervention mode

Technical Field

The application relates to the technical field of medical instruments, in particular to a therapeutic object conveying device and a conveying system based on an intervention mode.

Background

Cardiovascular diseases such as hypertension and coronary heart disease can bring vascular endothelial injury to patients, and in order to repair vascular endothelial injury, a plurality of modes can be adopted, wherein one mode is to convey medicines to an endothelial injury part through an interventional means, the vascular endothelial injury part is easy to generate stenosis, the vascular endothelial injury part is easy to shrink under the stimulation of the medicines, and vascular repair is carried out under the condition of vascular shrinkage, so that the effect is not ideal.

Disclosure of Invention

Based on this, provide a therapeutic object conveying device and conveying system based on intervention mode, when carrying the medicine to the skin damage position, make the blood vessel avoid taking place to shrink, the therapeutic effect of medicine is better.

A therapeutic delivery device based on an interventional approach, comprising:

an outer sheath of tubular construction having opposed distal and proximal ends, the interior of the outer sheath having a therapeutic delivery channel;

the pipe assembly is movably arranged in the outer sheath;

The plugging assembly comprises a first balloon and a second balloon which are sequentially arranged along the axial direction of the outer sheath and used for temporarily blocking blood flow, and an expected conveying position of a therapeutic object is arranged between the first balloon and the second balloon;

a retention assembly for maintaining a vessel at a desired delivery location of a treatment in an expanded state, the retention assembly adopting one of the following structures:

a. a supporting frame which is a cylindrical structure capable of being deformed in the radial direction as a whole, and has a loading state capable of being accommodated in the outer sheath and an expanding state exposed to the distal end side of the outer sheath;

b. And a light emitting part fixed on the tube assembly, the light emitting part having a working part in an expected delivery position of the therapeutic object, the working part being used for outputting first light rays with a wavelength range of 400-1200 nm.

The following provides several alternatives, but not as additional limitations to the above-described overall scheme, and only further additions or preferences, each of which may be individually combined for the above-described overall scheme, or may be combined among multiple alternatives, without technical or logical contradictions.

Optionally, the wavelength range of the first light is 600-850 nm.

Optionally, the first balloon is at the periphery of the sheath distal end site;

The second balloon is positioned at the periphery of the extension part, and the first balloon and the second balloon are respectively positioned at the upstream and downstream of the expected delivery position of the therapeutic substance along the blood flow direction.

Optionally, a first fluid channel communicated with the first balloon is arranged in the side wall of the outer sheath and used for conveying fluid to the first balloon.

Alternatively, the outer sheath is a double-layered tube structure and has radially opposed inner and outer lumens, wherein the inner lumen serves as a channel for the tube assembly and the outer lumen is isolated to form a first fluid channel for delivering fluid to the first balloon and a therapeutic delivery channel for delivering therapeutic to a desired therapeutic delivery site.

Optionally, the supporting frame is made of a memory material, the cylindrical structure of the supporting frame is in a hollow grid shape, and the supporting frame is switched from a loading state to an expanding state in a self-expanding mode after being exposed to the outer sheath.

Optionally, the tube assembly comprises:

An inner tube, the lumen of the inner tube providing a guidewire channel;

The outer tube is sleeved outside the inner tube, the distal end of the outer tube is communicated with the second balloon, and the radial gap between the outer tube and the inner tube is used as a second fluid channel communicated with the second balloon.

Optionally, the light emitting component is an optical fiber or Micro LED, the light emitting component is located within a radial gap of the inner tube and the outer tube, the light emitting component is fixed to an outer wall of the inner tube and extends proximally along the second fluid channel.

Optionally, the therapeutic delivery device has as a whole:

The working state is that each balloon is inflated by fluid and is exposed to the outer sheath, the supporting frame is exposed to the outer sheath to be in an expanded state or the working part of the light-emitting component is positioned at the expected delivery position of the therapeutic object to emit light;

In the delivery state, each balloon shape is folded and is contained in the outer sheath, the supporting frame is contained in the outer sheath in the loading state or the light-emitting component is contained in the outer sheath and does not emit light.

The application also provides a therapeutic object conveying system based on an interventional mode, which comprises the following steps:

The therapeutic object conveying device;

a first perfusion device for providing therapeutic substances delivered into the blood vessel and in communication with the therapeutic substance delivery channel;

And the second perfusion device is respectively communicated with the first balloon and the second balloon through fluid pipelines.

The therapeutic object conveying device and the conveying system based on the intervention mode, provided by the application, can prevent the blood vessel from contracting when the medicine is conveyed to the damaged part of the inner skin, and can perform medicine treatment in a state of stretching the blood vessel, so that the treatment effect is better.

Drawings

FIG. 1a is a schematic illustration of an interventional procedure-based treatment delivery device of the present application (with a light emitting component for the retention assembly);

FIG. 1b is an enlarged view of portion A of FIG. 1 a;

FIG. 2a is a schematic illustration of an interventional procedure-based treatment delivery device of the present application (with a holding assembly using a support frame);

FIG. 2B is an enlarged view of portion B of FIG. 2 a;

FIG. 3 is a schematic illustration of a first balloon and its associated components of the interventional-based treatment delivery device of the present application;

Fig. 4 is an enlarged view of a portion C in fig. 3;

FIG. 5 is a schematic illustration of a second balloon and its associated components (a holding assembly employing a support frame) in an interventional procedure-based treatment delivery device of the present application;

Fig. 6 is an enlarged view of a portion D in fig. 5;

FIG. 7 is a schematic view of one embodiment of a support frame;

FIG. 8 is a schematic illustration of a second balloon and its associated components (a light emitting component for the retention assembly) in an interventional procedure based treatment delivery device of the present application;

fig. 9 is an enlarged view of the portion E in fig. 8.

In the figure: 100. a therapeutic substance delivery device; 110. an outer sheath; 111. a first fluid passage; 112. a therapeutic substance delivery channel; 113. an inner cavity; 114. an outer cavity; 120. a support frame; 130. a tube assembly; 131. an inner tube; 132. an outer tube; 133. a second fluid passage; 140. a light emitting member; 150. a plugging assembly; 151. a first balloon; 152. a second balloon; 171. a first handle; 1711. a first interface; 1712. a second interface; 1713. a third interface; 172. a second handle; 1721. a fourth interface; 1722. a fifth interface; 180. a guidewire channel; 190. and a developing ring.

Y, distal end; J. a proximal end.

Detailed Description

The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

For a better description and illustration of embodiments of the application, reference should be made to one or more of the accompanying drawings, but the additional details or examples used to describe the drawings should not be construed as limiting the scope of any of the inventive, presently described embodiments or preferred modes of carrying out the application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

Referring to fig. 1a, 1b, 2a, and 2b, an interventional therapy delivery device 100 includes:

An outer sheath 110 of tubular construction having opposite distal and proximal ends, the interior of the outer sheath having a therapeutic delivery channel;

a tube assembly 130 movably disposed within the outer sheath 110;

The occlusion assembly 150, the occlusion assembly 150 comprises a first balloon 151 and a second balloon 152 which are sequentially arranged along the axial direction of the outer sheath 110 and used for temporarily blocking blood flow, and an expected delivery position of a therapeutic object is arranged between the first balloon 151 and the second balloon 152;

A retention assembly for maintaining a vessel at a desired delivery location of a treatment in an expanded state, the retention assembly being configured in one of the following configurations:

a. A holder 120 having a cylindrical structure which is deformable in the radial direction as a whole, and which has a loading state in which the holder 120 can be accommodated in the outer sheath 110 and an expanded state in which the holder is exposed to the distal end side of the outer sheath 110 (the holder being in the expanded state in fig. 2a and 2 b);

b. And a light emitting part 140 fixed to the tube assembly 130, the light emitting part 140 having a working part in an expected delivery position of the therapeutic substance, the working part being for outputting a first light having a wavelength range of 400 to 1200 nm.

The therapeutic substance delivery device provided by the application is used for delivering a therapeutic substance to an expected position, a blood vessel of the expected position is narrowed in the process of delivering the therapeutic substance or is contracted due to stimulation in the process of delivering a medicine, in order to ensure that the blood vessel of the expected position always maintains a necessary expansion state in the process of delivering the medicine, a holding component is arranged in the therapeutic substance delivery device, the holding component can adopt two structures, namely a supporting frame and a luminous component, which can play a role of keeping the blood vessel in the expansion state, one of the two structures is selected, the supporting frame and the luminous component are all carried out under the premise that the supporting frame and the luminous component are not simultaneously present, only one of the supporting frame and the luminous component is needed, and fig. 1a and fig. 1b are schematic diagrams adopting the luminous component as the holding component, and fig. 2a and fig. 2b are schematic diagrams adopting the supporting frame as the holding component.

When the holding component is a supporting frame, the working process of the therapeutic object conveying device provided by the application is as follows:

In the delivery process, the supporting frame 120, the pipe assembly 130 and the plugging assembly 150 are all contained in the outer sheath 110 (the supporting frame 120 is located in a radial gap between the pipe assembly 130 and the outer sheath 110), after reaching a target site, the pipe assembly 130 extends out of the outer sheath 110, the supporting frame 120 is exposed to the far end side of the outer sheath 110, and is switched to an expanded state to support a blood vessel of the target site, and a therapeutic object is delivered to the target site for treatment, in the treatment process, the expanded state of the supporting frame is always maintained, and after the treatment is finished, the supporting frame 120 is not kept at the target site for a long time, but is withdrawn from the blood vessel of the target site.

Referring to fig. 7, one structural form of the support frame 120 is shown in fig. 7, the support frame 120 has a hollow grid structure, the support frame 120 is compressible in a radial direction, the distal end of the support frame 120 is in an open structure, the proximal end of the support frame 120 is bundled into a linear shape and then extends out of the proximal end of the outer sheath 110, the support frame 120 and the tube assembly 130 are not fixedly connected, in the delivery process, the support frame 120 and the tube assembly 130 can be movably connected (for example, a protrusion is arranged on the outer wall of the tube assembly and can push the support frame 120 to move, the movable connection is understood to have a mutual acting force instead of a substantial connecting relationship), when the tube assembly 130 extends out of the outer sheath 110, the support frame 120 can be driven to be exposed to the distal end side of the outer sheath 110, when the support frame 120 is in an expanded state in a radial direction, after the support frame 120 is released, a drug is delivered to a blood vessel at a desired position, in advance, the first balloon 151 and the second balloon 152 can be evacuated from the vessel at the target position, only the support frame 120 is kept at the target position, so that the first balloon 151 can prevent long-time from blocking, and simultaneously, when the first balloon and the second balloon 152 are evacuated from the support frame 151 and the second balloon 152 can still be prevented from further damaging the inner wall of the target position.

When the scaffold 120 needs to be withdrawn after treatment is completed, the sheath can be pushed up the scaffold 120, and under the action of the sheath, the scaffold 210 radially contracts into the sheath, and the sheath drives the scaffold 120 away from the target site.

When the holding component is a light-emitting component, the working process of the therapeutic object conveying device provided by the application is as follows:

In the delivery process, the light emitting component 140, the tube assembly 130 and the blocking assembly 150 are all contained in the outer sheath 110 (the supporting frame 120 is located in a radial gap between the tube assembly 130 and the outer sheath 110), after reaching a target site, the tube assembly 130 extends out of the outer sheath 110, the light emitting component 140 extends out of the outer sheath 110 along with the tube assembly 130, and applies a first light with a wavelength range of 400-1200 nm to the vessel wall of the target site, the first light has the effects of repairing the vessel endothelium and relieving smooth muscle, after the first light is applied for a certain action time, the vessel wall can be kept in an expanded state within a sufficient time, the condition that rebound does not occur on the vessel wall in the process of delivering a therapeutic substance can be satisfied, the first light also has the effect of repairing the vessel endothelium and can inhibit the occurrence of late vascular restenosis.

The occlusion assembly 150 comprises a first balloon 151 and a second balloon 152, wherein in an operating state, the first balloon 151 and the second balloon 152 are respectively positioned at the upstream and downstream of the blood flow direction so as to temporarily block the blood flow, and as shown in fig. 1b, 2b, 3 and 4, the interior of the outer sheath 110 is provided with a therapeutic substance delivery channel 112; the occlusion assembly 150 includes:

a first balloon 151 disposed at the outer periphery of the distal end portion of the outer sheath 110;

The distal end of the tube assembly has an extension out of the sheath 110, the second balloon 152 being located at the outer periphery of the extension, the first balloon 151 and the second balloon 152 being located upstream and downstream, respectively, of the intended delivery site of the treatment in the direction of blood flow.

The first balloon 151 and the second balloon 152 are filled with fluid, and when in an inflated state, temporary blocking is caused to blood flow, that is, a space without blood flow is created between the first balloon 151 and the second balloon 152 corresponding to the expected delivery position of the therapeutic substance. The inflation sequence of the first balloon 151 and the second balloon 152 is dependent on the trend of the blood flow, and the balloon closer to the upstream position of the blood flow is inflated preferentially to block the blood flow.

As shown in fig. 3 and 4, a first fluid channel 111 communicating with the first balloon 151 is provided in a side wall of the outer sheath 110 for delivering fluid to the first balloon 151. The primary fluid channel 111 extends in the axial direction of the outer sheath 110 to the proximal end of the outer sheath 110.

Referring to fig. 3 and 4, a therapeutic substance delivery channel 112 is provided on a side wall of the outer sheath 110, the therapeutic substance delivery channel 112 extends to a proximal end of the outer sheath 110 along an axial direction of the outer sheath 110, and a distal end of the therapeutic substance delivery channel 112 is opened to deliver a drug to a desired therapeutic substance delivery site.

Referring to fig. 1a, 2a and 3, a first handle 171 is connected to the proximal end of the sheath 110, and the first handle 171 is provided with: a first port 1711 in communication with the first fluid channel 111, a second port 1712 for passing through the tube assembly 130, and a third port 1713 in communication with the therapeutic substance delivery channel 112.

Referring to fig. 1b, 2b, and 4, the outer sheath 110 is a double-layered tube structure and has radially opposite inner and outer lumens 113 and 114, wherein the inner lumen 113 serves as a channel for the tube assembly 130 and the outer lumen 114 is isolated to form a first fluid channel 111 for delivering fluid to the first balloon 151 and a therapeutic substance delivery channel 112 for delivering therapeutic substance to a desired therapeutic substance delivery site.

The outer cavity 114 separates and forms the first fluid channel 111 and the therapeutic substance delivery channel 112, that is, the first fluid channel 111 and the therapeutic substance delivery channel 112 are independent from each other, and one part of the space of the outer cavity 114 serves as the first fluid channel 111 and the other part of the space serves as the therapeutic substance delivery channel 112.

Referring to fig. 4, a developing ring 192 is fixedly sleeved on the outer sheath 110, and the developing ring 192 is made of metal and can indicate the position of the first balloon 151 under the action of a developer.

The stent 120 is made of a memory material, and is switched from a loading state to an expanded state by self-expanding after being exposed to the sheath 110. The structure of the support 120 may take various forms, for example, in the embodiment shown in fig. 7, and the cylindrical structure of the support 120 is a hollow grid.

Referring to fig. 5, the tube assembly 130 includes:

an inner tube 131, the lumen of the inner tube 131 providing a guidewire channel 180;

The outer tube 132 is sleeved outside the inner tube 131, the distal end of the outer tube 132 is communicated with the second balloon 152, a radial gap between the outer tube 132 and the inner tube 131 serves as a second fluid channel 133 communicated with the second balloon 152, the supporting frame 120 is positioned in the radial gap between the outer tube 132 and the outer sheath 110, and the proximal end of the supporting frame 120 extends out of the proximal end of the outer sheath 110 after being converged.

When the scaffold 120 is in the loading state (the scaffold 120 is shown in the loading state in fig. 5 and 6), the scaffold 120 and the outer tube 132 are simultaneously received in the outer sheath 110, and when the outer tube 132 extends out of the outer sheath 110, the scaffold 120 moves out of the outer sheath 110 along with the outer tube 132, and the scaffold 120 self-expands and switches to the expanding state.

Referring to fig. 5 and 6, a second handle 172 is connected to the proximal side of the tube assembly 130, the second handle 172 having a fourth port 1721 in communication with the guidewire channel 180 and a fifth port 1722 in communication with the second fluid channel 133.

Referring to fig. 5 and 6, a developing ring 192 is fixed on the inner tube 131, and the developing ring 192 is made of metal material, so that the position of the second balloon 152 can be indicated under the action of the developer.

The distal end of the support frame 120 is slidable relative to the outer tube 132, and in order to avoid damage to the wall of the outer tube 132 when the distal end of the support frame 120 slides, a support sleeve is slidably mounted on the outer periphery of the outer tube 132, and the distal end of the support frame 120 is connected to the support sleeve. Relative sliding movement between the distal end of the support bracket 120 and the outer tube 132 is achieved by the support sleeve.

Referring to fig. 8 and 9, the light emitting member 140 is an optical fiber or Micro LED, and the light emitting member 140 is positioned in a radial gap between the inner tube 131 and the outer tube 132. The light emitting member 140 is fixed to the outer wall of the inner tube 131 and extends proximally along the second fluid channel 133.

When the Micro LED is adopted, a power supply is required to be configured, and the power supply can adopt miniaturized components such as button cells and the like, so that the whole balloon catheter device is light.

The wavelength range of the first light is 600-850 nm. The wavelength of the first light has an effect on the therapeutic effect, and preferably the wavelengths used include 635nm, 650nm, or 808nm. The wavelength of the first light is not constant in the treatment process, and can be adjusted according to the treatment process, for example, when the treatment is just started, a wave band with a shorter wavelength can be selected, and a wave band with a longer wavelength can be selected in the middle of the treatment.

The therapeutic substance delivery device 100 has as a whole:

An operating state in which each balloon (including the first balloon 151 and the second balloon 152) is inflated by the fluid and is exposed to the outer sheath 110, the support frame 120 is exposed to the outer sheath 110 in an expanded state or the operating part of the light emitting part 140 is in an expected delivery position of the therapeutic substance to emit light;

In the delivery state, each balloon (including the first balloon 151 and the second balloon 152) is folded in shape and is housed in the outer sheath 110, the holder 120 is housed in the outer sheath in the loading state, or the light emitting member 140 is housed in the outer sheath 110 and does not emit light.

In the working state, referring to fig. 1a, 1b, 2a and 2b, the first balloon 151 and the second balloon 152 in fig. 1a, 1b, 2a and 2b are inflated by fluid, and the support frame 120 is in an expanded state and is exposed to the outer sheath 110.

The present application also provides a delivery system for delivering a therapeutic agent into a blood vessel, comprising:

the therapeutic substance delivery device 100 of the present application;

A first perfusion device for providing therapeutic substances delivered intravascularly and in communication with a therapeutic substance delivery channel 112;

the second perfusion apparatus is in communication with the first balloon 151 and the second balloon 152, respectively, via fluid lines.

The first balloon 151 and the second balloon 152 may be in communication with the same second perfusion apparatus through fluid lines, and the perfusion of the first balloon 151 and the second balloon 152 may be controlled independently, or the first balloon 151 and the second balloon 152 may be provided with respective perfusion apparatuses.

The therapeutic substance delivered into the blood vessel comprises pentagalloylglucose, which is a phenolic compound having a plurality of phenolic groups, which can crosslink elastin in the blood vessel in vivo to stabilize the blood vessel.

The application also provides a deployment method of the vascular therapeutic substance, which comprises the following steps:

Temporarily blocking blood flow upstream and downstream of the designated site in the blood flow direction;

Expanding at a designated site where delivery of the vascular treatment is desired to maintain the spatial shape of the designated site;

the treatment is released to the designated site and maintained for a predetermined treatment time.

Firstly, the blood flow is temporarily blocked at the designated site where the vascular treatment is expected to be delivered by the blocking assembly at the upstream and downstream of the designated site, secondly, the vascular dilation is performed by the stent or the light emitting member, and finally, the treatment is delivered to the designated site.

The stent or the luminous component is adopted to dilate the blood vessel, so that the blood vessel maintains the necessary dilating form, and then the therapeutic substance is delivered into the blood vessel, wherein the therapeutic substance is pentagalloylglucose, and elastin in the blood vessel can be crosslinked.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the application. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application. Accordingly, the scope of protection of the present application is to be determined by the appended claims.

Claims

1. Therapeutic object conveying device based on intervention mode, characterized by comprising:

the pipe assembly is movably arranged in the outer sheath;

2. The interventional procedure based treatment delivery device of claim 1, wherein the first light has a wavelength in the range of 600-850 nm.

3. The interventional procedure-based treatment delivery device of claim 1, wherein,

The first balloon is arranged at the periphery of the distal end part of the outer sheath;

4. The interventional procedure based treatment delivery device of claim 3, wherein a first fluid channel is provided in a sidewall of the outer sheath in communication with the first balloon for delivering fluid to the first balloon.

5. The interventional procedure based treatment delivery device of claim 3, wherein the outer sheath is a double-layered tube structure and has radially opposed inner and outer lumens, wherein the inner lumen serves as a channel for the tube assembly and the outer lumen isolates a first fluid channel for delivering fluid to the first balloon and a treatment delivery channel for delivering treatment to a desired treatment delivery site.

6. The interventional therapy delivery device according to claim 1, wherein the scaffold is made of a memory material, and the tubular structure of the scaffold is in a hollow grid shape, and is switched from a loading state to an expanded state by a self-expanding manner after being exposed to the sheath.

7. The interventional-based treatment delivery device of claim 3, wherein the tube assembly comprises:

An inner tube, the lumen of the inner tube providing a guidewire channel;

8. The interventional therapy delivery device of claim 1, wherein the light emitting component is an optical fiber or Micro LED, the light emitting component being located within a radial gap of the inner tube and the outer tube, the light emitting component being secured to an outer wall of the inner tube and extending proximally along the second fluid channel.

9. The interventional procedure-based treatment delivery device of claim 1, wherein the treatment delivery device has, in its entirety:

10. A therapeutic delivery system based on an interventional procedure, comprising:

the therapeutic delivery device of any one of claims 1-9;