CN117679614A

CN117679614A - Pressure-controlled balloon for supporting, compressing and drug delivery

Info

Publication number: CN117679614A
Application number: CN202311620895.4A
Authority: CN
Inventors: 曾明; 周敏; 官小莉; 向雯
Original assignee: Tongji Hospital Affiliated To Tongji Medical College Of Huazhong University Of Science & Technology
Current assignee: Tongji Hospital Affiliated To Tongji Medical College Of Huazhong University Of Science & Technology
Priority date: 2023-11-30
Filing date: 2023-11-30
Publication date: 2024-03-12

Abstract

The embodiment of the application provides a pressure-controlled balloon for supporting, compressing and drug delivery, which comprises a balloon body and a fixed shaft. The bag body is provided with an inlet and a containing cavity for containing medicines, and the wall part of the bag body is provided with a release hole communicated with the containing cavity. The fixed shaft is fixedly connected to the bottom of the accommodating cavity and extends to the inlet and outlet from the bottom of the accommodating cavity, wherein the balloon is in an extending state and a contracting state, and the balloon body can be switched between the extending state and the contracting state along the axial direction of the fixed shaft so as to adjust the opening area of the release hole. The sacculus that this application provided, whether be in the extension state or be in the shrink state, can both adjust the open area of release hole easily, and the medicine that flows into the holding chamber can flow into treatment position through the open area of release hole to the medicine dosage can realize managing and controlling through adjusting the open area of release hole, and then makes the medicine dosage that flows into treatment position can satisfy different stages and treat required, thereby reaches ideal treatment.

Description

Pressure-controlled balloon for supporting, compressing and drug delivery

Technical Field

The application relates to the technical field of medical instruments, in particular to a pressure-controlled balloon for supporting, compressing and drug delivery.

Background

In the treatment of some diseases, it may be desirable to administer the drug to a treatment site, such as a nasal, abdominal, thoracic, pelvic, vascular, etc., using a balloon. In the route of administration, the delivered dose of the drug may need to be adjusted at different time periods to achieve a better therapeutic effect. However, in the related art, the drug delivery dose is difficult to control, and thus the desired therapeutic effect cannot be achieved. In addition, to the position such as postoperative wound, still easily bleed, on the one hand easily causes postoperative infection, on the other hand still easily influences the absorption of dosing, and then influences the treatment. For special parts such as narrow auditory meatus and posterior naris locking operation, the support is usually needed to form proper space and shape, and thus the clinical requirement brings a lot of inconvenience to the whole treatment period of patients.

Disclosure of Invention

The application provides a pressure-controlled balloon for supporting, compressing and drug delivery, which can reduce the difficulty in adjusting the dosage delivered by the drug, thereby helping to promote the therapeutic effect.

The embodiment of the application provides a pressure-controlled balloon for supporting, compressing and drug delivery, which comprises a balloon body and a fixed shaft. The bag body is provided with an inlet and a containing cavity for containing medicines, and the wall part of the bag body is provided with a release hole communicated with the containing cavity. The fixed shaft is fixedly connected to the bottom of the accommodating cavity and extends to the inlet and outlet from the bottom of the accommodating cavity, wherein the balloon is in an extending state and a contracting state, and the balloon body can be switched between the extending state and the contracting state along the axial direction of the fixed shaft so as to adjust the opening area of the release hole.

According to the balloon provided by the embodiment of the application, the medicine can flow into the accommodating cavity through the inlet, so that the pressure in the accommodating cavity is increased, the balloon is in an extending state, the balloon body extends along the axial direction of the fixed shaft to open the release hole, and the opening area of the release hole is regulated along with the extending degree of the balloon body; when the pressure in the accommodating cavity is reduced, the balloon is in a contracted state, the release hole is not closed immediately, and the opening area of the release hole can be gradually adjusted. Therefore, no matter the balloon is in an extending state or a contracting state, the opening area of the release hole can be easily adjusted, the medicine flowing into the accommodating cavity can flow into the treatment part through the opening area of the release hole, and the medicine dosage can be controlled by adjusting the opening area of the release hole, so that the medicine dosage flowing into the treatment part can meet the treatment requirements of different stages, and the ideal treatment effect can be achieved.

In some possible embodiments, the capsule comprises a plurality of first segments and a plurality of second segments, the first segments are provided with first accommodation cavities, the second segments are connected between two adjacent first segments, the second segments are provided with second accommodation cavities, wherein the first accommodation cavities and the second accommodation cavities are communicated to form accommodation cavities, the release holes are positioned at the joints of the first segments and the second segments, and an included angle theta 1 of the first segments and the second segments in an extending state is larger than an included angle theta 2 of the first segments and the second segments in a contracting state.

In some possible embodiments, the material of the first section and the material of the second section each comprise a shape memory material configured to switch the bladder between the expanded state and the contracted state in response to a change in fluid pressure within the receiving chamber.

In some possible embodiments, the shape memory material comprises at least one of a shape memory polyolefin polymer, a shape memory biodegradable material, a shape memory polyurethane polymer, a thermoplastic shape memory epoxy polymer, and a thermoplastic shape memory polyurethane polymer.

In some possible embodiments, the surface of the first and/or second segment remote from the fixed shaft is at least partially coated with a hemostatic agent.

In some possible embodiments, the release holes have a pore size of less than or equal to 5 μm.

In some possible embodiments, the balloon further comprises a sealing film disposed in the release hole for sealing the release hole, the sealing film having a concentration of 10L/(m) under a pressure of 0.1MPa ² H) the following permeation fluxes.

In some possible embodiments, the pore sealing membrane allows solute molecules having a molecular weight of less than or equal to 10000Da to pass through.

In some possible embodiments, the stationary shaft has an infusion lumen, and the stationary shaft is provided with a liquid outlet communicating the receiving lumen with the infusion set.

In some possible embodiments, the balloon further comprises a seal sealingly connected between the mouth of the inlet and the fixed shaft.

The foregoing description is only an overview of the technical solutions of the present specification, and may be implemented according to the content of the specification in order to make the technical means of the present specification more clearly understood, and in order to make the above-mentioned and other objects, features and advantages of the present specification more clearly understood, the following detailed description of the present specification is given.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and that other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 illustrates a schematic view of a balloon provided in some embodiments of the present application in an extended state;

FIG. 2 illustrates a schematic view of the balloon provided in some embodiments of the present application when fully extended;

fig. 3 illustrates a schematic structural view of a balloon provided in some embodiments of the present application in a contracted state.

Reference numerals in the specific embodiments are as follows:

10-balloon;

100-capsule body;

110-inlet;

120-accommodating chambers;

130-a release hole;

140-first section;

141-a first accommodation chamber;

150-a second stage;

151-a second accommodation chamber;

200-fixed shaft.

Detailed Description

For the purposes of making the objects, technical solutions and advantages of the embodiments of the present application more apparent, the technical solutions in the embodiments of the present application will be clearly described below with reference to the drawings in the embodiments of the present application, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by one of ordinary skill in the art based on the embodiments herein without making any inventive effort, are intended to be within the scope of the present application.

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 in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application; the terms "comprising" and "having" and any variations thereof in the description and claims of the present application and in the description of the figures above are intended to cover non-exclusive inclusions. The terms first, second and the like in the description and in the claims or in the above-described figures, are used for distinguishing between different objects and not necessarily for describing a particular sequential or chronological order.

Reference in the specification to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment of the application. The appearances of such phrases in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments.

In the description of the present application, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "attached" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the terms in this application will be understood by those of ordinary skill in the art as the case may be.

The term "and/or" in this application is merely an association relation describing an associated object, and indicates that three relations may exist, for example, a and/or B may indicate: a exists alone, A and B exist together, and B exists alone. In this application, the character "/" generally indicates that the associated object is an or relationship.

In the embodiments of the present application, the same reference numerals denote the same components, and in the interest of brevity, detailed descriptions of the same components are omitted in different embodiments. It should be understood that the thickness, length, width, etc. dimensions of the various components in the embodiments of the present application illustrated in the figures are merely exemplary and should not be construed as limiting the present application in any way.

Referring to fig. 1-3, an embodiment of the present application provides a pressure-controlled balloon 10 for supporting, compressing and delivering drugs, comprising a balloon body 100 and a fixed shaft 200. The capsule 100 has an inlet 110 and a receiving chamber 120 for receiving a medicine, and a wall portion of the capsule 100 is provided with a release hole 130 communicating with the receiving chamber 120. The fixed shaft 200 is fixedly coupled to the bottom of the accommodating chamber 120 and extends the inlet and outlet 110 from the bottom of the accommodating chamber 120, wherein the balloon 10 has an extended state and a contracted state, and the balloon body 100 is convertible between the extended state and the contracted state along the axial direction of the fixed shaft 200 to adjust the opening area of the release hole 130.

In the balloon 10 provided by the embodiment of the application, the medicine can flow into the accommodating cavity 120 through the inlet 110, so that the pressure in the accommodating cavity 120 is increased, the balloon 10 is in an extending state, the balloon body 100 extends along the axial direction of the fixed shaft 200 to open the release hole 130, and the opening area of the release hole 130 is adjusted along with the extending degree of the balloon body 100; when the pressure in the accommodating chamber 120 is reduced, the balloon 10 is in a contracted state, the release hole 130 is not immediately closed, and the opening area of the release hole 130 can be gradually adjusted. Therefore, the opening area of the release hole 130 can be easily adjusted regardless of whether the balloon 10 is in the extended state or the contracted state, and the medicine flowing into the accommodating chamber 120 can flow into the treatment site through the opening area of the release hole 130, and the medicine dosage can be controlled by adjusting the opening area of the release hole 130, so that the medicine dosage flowing into the treatment site can meet the treatment requirements of different stages, thereby achieving the desired treatment effect.

In embodiments of the present application, the shape of the balloon 10 may include any balloon 10 shape known in the art, such as conical, square, spherical, conical/spherical, oblong, tapered, dog-bone, stepped, offset, conical, offset, and the like. Furthermore, the neck of the balloon 10 may be one or more, i.e. the inlet 110 or the outlet of the balloon 10 is located at the neck, and the specific design may be selected according to the practical application requirements. 1-3, the balloon 10 disclosed in embodiments of the present application has a neck with the inlet 110 located therein. In addition, the size of the balloon 10 may be designed according to practical application requirements, and the present application is not particularly limited herein.

In some alternative embodiments of the present application, the release holes 130 may be bar-shaped through holes, circular through holes, square through holes, or other shaped through holes. The medicine in the accommodating chamber 120 can be introduced into the treatment site through the above-mentioned through holes via nasal cavities, blood vessels, etc.

In the above embodiments, the aperture of the release hole 130 is within a proper range to allow most of the polymer drug to pass through.

In some alternative embodiments of the present application, the aperture of the release aperture 130 is less than or equal to 5 μm.

By way of example only, and not by way of limitation, the aperture of the release aperture 130 may be, but is not limited to, 0.1 μm, 0.2 μm, 0.3 μm, 0.4 μm, 0.5 μm, 0.6 μm, 0.7 μm, 0.8 μm, 0.9 μm, 1 μm, 1.1 μm, 1.2 μm, 1.3 μm, 1.4 μm, 1.5 μm, 1.6 μm, 1.7 μm, 1.8 μm, 1.9 μm, 2 μm, 2.1 μm, 2.2 μm, 2.3 μm, 2.4 μm, 2.5 μm 2.6 μm, 7 μm, 2.8 μm, 2.9 μm, 3 μm, 3.1 μm, 2 μm, 3.3 μm, 3.4 μm, 3.5 μm, 3.6 μm, 3.7 μm, 3.8 μm, 3.9 μm, 4 μm, 4.1 μm, 4.2 μm, 4.3 μm, 4.4 μm, 4.5 μm, 6 μm, 4.7 μm, 4.8 μm, 4.9 μm, 5 μm or a range of values consisting of any two of the foregoing.

In the embodiment of the present application, in addition to adjusting the opening area of the release hole 130 by moving the balloon 100 in the axial direction to achieve the drug dose flowing into the treatment site, the drug dose flowing into the treatment site may be further controlled by other means.

In some alternative embodiments of the present application, the balloon 10 further comprises a sealing film disposed in the release hole 130 for sealing the release hole 130, the sealing film having a thickness of 10L/(m) under a pressure of 0.1MPa ² H) the following permeation fluxes.

In some alternative embodiments of the present application, the pore sealing membrane allows solute molecules having a molecular weight of less than or equal to 10000Da to pass through.

With continued reference to fig. 1-3, in some alternative embodiments of the present application, the bladder 100 includes a plurality of first segments 140 and a plurality of second segments 150, the first segments 140 have a first receiving cavity 141, the second segments 150 are connected between two adjacent first segments 140, the second segments 150 have a second receiving cavity 151, wherein the first receiving cavity 141 and the second receiving cavity 151 are in communication to form the receiving cavity 120, wherein the release hole 130 is located at a connection between the first segments 140 and the second segments 150, and an included angle θ1 between the first segments 140 and the second segments 150 in an extended state is greater than an included angle θ2 between the first segments 140 and the second segments 150 in a contracted state.

It will be appreciated that when adjacent first and second segments 140, 150 are brought closer together, i.e., balloon 10 is in a contracted state, the opening area of release aperture 130 gradually decreases; when the adjacent first and second sections 140, 150 are spaced apart from each other, i.e., the balloon 10 is in an extended state, the opening area of the release aperture 130 gradually increases.

In some alternative embodiments of the present application, the material of first section 140 and the material of second section 150 each comprise a shape memory material configured to switch bladder 100 between the expanded state and the contracted state in response to a change in fluid pressure within receiving chamber 120.

In this application, a shape memory material is a material that has an initial shape, and is capable of sensing a change in an external condition (e.g., an external stimulus such as temperature, pressure, light, etc.) after being deformed and fixed in another shape. And in response to such changes, the mechanical properties (e.g., shape, position, strain, etc.) are adjusted to return to the original shape. That is, when the first and second sections 140 and 150 are deformed and fixed in another shape after the initial shape, they can be restored to the initial shape when stimulated by external conditions.

In the above embodiment, the shape memory material may be a shape memory polymer material composed of a stationary phase or hard phase and a softening-hardening reversible phase or soft phase, having a shape memory effect by reversible change of the reversible phase.

In some alternative embodiments of the present application, the shape memory material comprises at least one of a shape memory polyolefin polymer, a shape memory biodegradable material, a shape memory polyurethane polymer, a thermoplastic shape memory epoxy polymer, and a thermoplastic shape memory polyurethane polymer.

In embodiments of the present application, when balloon 10 is fully extended, balloon 100 is able to contact and squeeze the wound surface to stop bleeding from the wound surface; alternatively, when the sinus is blocked, the balloon 10 stretches into the nasal cavity and spreads out, so that edema and adhesion can be reduced, the sinus ostia can be dredged, and the medicine can be continuously delivered.

In some alternative embodiments of the present application, the surface of the first and/or second sections 140, 150 distal from the stationary shaft 200 is at least partially coated with a hemostatic agent. The hemostatic agent can effectively stop bleeding at the part to be treated, and is beneficial to improving the treatment effect.

In some alternative embodiments of the present application, the stationary shaft 200 has an infusion lumen, and the stationary shaft 200 is provided with a liquid outlet communicating with the receiving lumen 120 and the infusion set.

In some alternative embodiments of the present application, balloon 10 further includes a seal member sealingly coupled between the mouth of inlet 110 and stationary shaft 200.

In the above embodiments, the sealing member may be any medical gel known in the art, and the present application is not particularly limited herein.

The balloon provided by the application can be used for supporting forming or opening and re-passage besides being used for delivering nasal medicines, such as external auditory meatus stenosis, posterior naris occlusion operation and the like.

Finally, it should be noted that: the above experimental examples are only for illustrating the technical scheme of the present application, and are not limiting; although the present application has been described in detail with reference to the foregoing experimental examples, it should be understood by those of ordinary skill in the art that: the technical scheme recorded in each experimental example can be modified or part or all of the technical characteristics can be replaced equivalently; these modifications or substitutions do not depart from the essence of the corresponding technical solutions from the scope of the technical solutions of experimental examples of the present application.

Claims

1. A pressure-controlled balloon for supporting, compressing and drug delivery, comprising:

the capsule body is provided with an inlet and a containing cavity for containing medicines, and a wall part of the capsule body is provided with a release hole communicated with the containing cavity;

the fixed shaft is fixedly connected to the bottom of the accommodating cavity and extends out of the inlet from the bottom of the accommodating cavity;

wherein the balloon has an extended state and a contracted state, and the balloon is convertible between the extended state and the contracted state in an axial direction of the fixed shaft to adjust an opening area of the release hole.

2. The balloon of claim 1, wherein the balloon body comprises:

a plurality of first segments having a first receiving cavity, an

A plurality of second segments connected between two adjacent first segments, the second segments having a second receiving cavity;

the first accommodating cavity is communicated with the second accommodating cavity to form the accommodating cavity, the release hole is positioned at the joint of the first section and the second section, and the included angle theta 1 of the first section and the second section in the extending state is larger than the included angle theta 2 of the first section and the second section in the contracting state.

3. The balloon of claim 2, wherein the material of the first section and the material of the second section each comprise a shape memory material configured to switch the balloon between the extended state and the contracted state in response to a change in fluid pressure within the receiving chamber.

4. The balloon of claim 3, wherein the shape memory material comprises at least one of a shape memory polyolefin polymer, a shape memory biodegradable material, a shape memory polyurethane polymer, a thermoplastic shape memory epoxy polymer, and a thermoplastic shape memory polyurethane polymer.

5. The balloon of any one of claims 1-4, wherein a surface of the first segment and/or the second segment remote from the fixed shaft is at least partially coated with a hemostatic agent.

6. The balloon of claim 1 or 2, wherein the release holes have a pore size of less than or equal to 5 μιη.

7. The balloon of claim 1, wherein the balloon further comprises:

and the hole sealing film is arranged in the release hole and used for sealing the release hole, and the hole sealing film has a permeation flux below 10L/(m < 2 >. H) under the condition of 0.1 MPa.

8. The balloon of claim 7, wherein the sealing membrane allows solute molecules having a molecular weight of less than or equal to 10000Da to pass through.

9. The balloon of claim 1, wherein the stationary shaft has an infusion lumen and the stationary shaft defines a fluid outlet communicating the receiving lumen with the infusion set.

10. The balloon of claim 9, wherein the balloon further comprises: and a sealing member sealingly connected between the mouth of the inlet and the fixed shaft.