CN117695064A - Implantable saccule device - Google Patents

Implantable saccule device Download PDF

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Publication number
CN117695064A
CN117695064A CN202410166064.2A CN202410166064A CN117695064A CN 117695064 A CN117695064 A CN 117695064A CN 202410166064 A CN202410166064 A CN 202410166064A CN 117695064 A CN117695064 A CN 117695064A
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CN
China
Prior art keywords
balloon
balloon body
bodies
connecting pipe
self
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN202410166064.2A
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Chinese (zh)
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CN117695064B (en
Inventor
张书勇
吴晓
袁飞
李晓萌
李春明
殷敬华
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Shanghai Perli Medical Materials Co ltd
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Shanghai Perli Medical Materials Co ltd
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Priority to CN202410166064.2A priority Critical patent/CN117695064B/en
Publication of CN117695064A publication Critical patent/CN117695064A/en
Application granted granted Critical
Publication of CN117695064B publication Critical patent/CN117695064B/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/40Joints for shoulders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30721Accessories
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/16Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/18Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/20Polysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/22Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/227Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/22Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24Collagen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30721Accessories
    • A61F2002/30754Implants for interposition between two natural articular surfaces
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/40Joints for shoulders
    • A61F2002/4088Acromial components
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/24Materials or treatment for tissue regeneration for joint reconstruction

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biophysics (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention provides an implantable balloon device, which relates to the technical field of medical appliances, wherein at least two balloon bodies are arranged, and each balloon body is mutually independent; the connecting pipe is connected with the balloon body in a sealing way, the conveying conduit is inserted into the connecting pipe from the inserting port, and external fillers pass through the conveying conduit and are discharged from a liquid outlet of the connecting pipe and enter the balloon body to realize filling; because at least a part of the connecting pipe stretches into the balloon body, a self-adsorption film tube is arranged between the liquid outlet and the inserting port, when no support exists in the self-adsorption film tube, the filler in the balloon body applies pressure to the self-adsorption film tube, and the tube wall of at least a part of the self-adsorption film tube is flattened to be in contact with each other to realize sealing, so that all the balloon bodies are sealed, and quick sealing is realized. The invention is composed of at least two balloon bodies, and the possibility of simultaneous rupture of all balloon bodies is low, so that the whole rupture of the balloon can be effectively prevented.

Description

Implantable saccule device
Technical Field
The invention relates to the technical field of medical appliances, in particular to an implantable saccule device for separating or supporting tissues.
Background
Tendon sleeves, also known as rotator sleeves, are a collective term for a group of tendons that surround the humeral head, respectively, are tendons that cover the subscapular muscle in front of the shoulder joint, the supraspinatus above and the subscapular muscle behind and the small circular muscle, and are interconnected to form an approximately annular tendon plate that surrounds the shoulder joint, playing an important role in the stabilization of the shoulder joint.
Rotator cuff tear is a common middle-aged and elderly shoulder joint disease, and the main symptom is pain caused by contact of rotator cuff tear parts with subacromion, and resistance cannot be resisted during active abduction, so that the movement function of the shoulder joint is affected.
The effect of the operation treatment for the giant rotator cuff tear is poor, and the operation is easy to tear again. Implantable rotator cuff balloons are one treatment modality that has emerged in recent years, and rotator cuff balloon products that are currently marketed are biodegradable subacromion spacers that are implanted under the acromion under arthroscopy to reduce friction between the acromion and the humeral head or rotator cuff, restore shoulder function and alleviate pain, biodegrade within one year of implantation.
However, during daily shoulder movements, the surface of the balloon is worn or bone is punctured, and when the shoulder is impacted severely, the balloon may be broken, so that the function of the balloon is disabled, and meanwhile, a large amount of content is released into the body instantaneously, so that adverse effects are caused.
It is a technical problem that needs to be solved at present for a person skilled in the art how to reduce the risk of balloon rupture.
Disclosure of Invention
The invention provides an implantable balloon device, which is characterized in that more than two balloon bodies are arranged, the possibility of simultaneous rupture of all balloon bodies is low, and the balloon rupture is effectively prevented, and the specific scheme is as follows:
An implantable balloon device comprises at least two balloon bodies and a connecting pipe, wherein each balloon body is independent;
the connecting pipes are connected to the balloon body in a sealing way, and the balloon bodies are connected with each other through the connecting pipes and are communicated with the outside through the connecting pipes; at least a part of the connecting pipe extends into the balloon body;
the connecting pipe is provided with an inserting port and a liquid outlet, the inserting port is used for inserting a conveying catheter, each balloon body is correspondingly communicated with at least one liquid outlet, and the filler conveyed by the conveying catheter is injected into each balloon body through the liquid outlet and fills each balloon body; a self-adsorption membrane tube is arranged between the liquid outlet and the plug-in mounting port, and each liquid outlet is correspondingly provided with the self-adsorption membrane tube;
when the filling of the balloon body is finished and no support exists in the self-absorption membrane tube, the filler in the balloon body applies pressure to the self-absorption membrane tube, and at least one part of the tube wall of the self-absorption membrane tube is flattened to be in contact with each other so as to realize sealing, so that all the balloon bodies are sealed.
Optionally, at least two balloon bodies are mutually nested to form a multi-layer balloon, and the connecting pipe sequentially extends into each layer of balloon body.
Optionally, at least two balloon bodies are mutually connected in series to form a balloon string, and the connecting pipe sequentially extends into each layer of balloon body.
Optionally, the degradation rate of the balloon body located further outside is greater than or equal to the degradation rate of the balloon body located further inside;
and/or the bursting difficulty of the balloon body at the outer position is less than or equal to the bursting difficulty of the balloon body at the inner position;
and/or the inflation pressure of the balloon body positioned outside is less than or equal to the inflation pressure of the balloon body positioned inside.
Optionally, the delivery catheter comprises an inner sleeve and an outer sleeve nested within each other and capable of relative sliding;
the side wall of the inner sleeve is provided with at least one group of inner liquid discharge ports, and the side wall of the outer sleeve is provided with at least two groups of outer liquid discharge ports; the number of the groups of the outer liquid discharge ports is greater than or equal to the number of the sacculus bodies;
and/or a lubricant is arranged between the inner sleeve and the outer sleeve to reduce friction;
and/or the end part of the inner sleeve extending into the outer sleeve is closed;
and/or, when the outer sleeve is inserted in the initial position in the connecting pipe, at least one group of the inner liquid drain ports are in butt joint with at least one group of the outer liquid drain ports;
And/or a clamping structure is arranged between the inner sleeve and the outer sleeve, and the outer sleeve can be taken out when the inner sleeve is pulled out;
or the conveying conduit is a single-layer pipe, and the inner end part of the conveying conduit extending into the connecting pipe is closed; the side wall of the conveying catheter is provided with a liquid discharge channel for discharging liquid to the balloon body.
Optionally, a fixing piece is arranged between two adjacent balloon bodies, and the fixing piece is used for limiting the relative position between the balloon bodies;
and/or the whole connecting pipe adopts a self-adsorption membrane pipe, and can be adsorbed together after the conveying guide pipe which is internally supported is pulled out; the part which is not connected is reserved at the edge to form the inserting port and the liquid outlet;
or the connecting pipe is formed by splicing a part of hard pipe and a part of self-adsorption film pipe, and the part of the self-adsorption film pipe can be adsorbed to form a seal;
and/or two liquid outlets corresponding to the same balloon body are oppositely arranged.
Optionally, the balloon body and the adapter tube adopt biodegradable medical high polymer materials or biocompatible materials with the same components or different components, wherein the biodegradable medical high polymer materials comprise one or a mixture of more materials of polyethylene glycol, polylactic acid-glycolic acid copolymer, polylactic acid, polycaprolactone, poly L-lactide-caprolactone, polypeptide, collagen and methylcellulose, and the biocompatible materials comprise one or a mixture of more materials of polyester, polyamide, polyvinyl chloride, nylon, polyurethane and silica gel.
Optionally, the connection tube extends into from one side edge of the balloon body and extends to the other opposite side edge of the balloon body, and each balloon body and the connection tube have at least two fixing positions;
and/or a hard pipe section is arranged at the connection position of the balloon body and the connecting pipe, so that the contact area between the balloon body and the connecting pipe is increased.
Optionally, the connecting pipe comprises a branch pipeline, and the liquid outlet is arranged in the branch pipeline;
the branch pipeline can extend into the space between the two mutually nested sacculus bodies; the branch pipeline adopts a self-adsorption membrane pipe, and other parts of the connecting pipe adopt hard pipes or self-adsorption membrane pipes;
and/or the connecting pipe is provided with an elastic shrinkage ring which can generate shrinkage elastic force and is used for pressing the connecting pipe on the surface of the conveying conduit inserted into the connecting pipe.
Optionally, a partition wall is arranged in the balloon body, the partition wall is used for dividing the interior of the balloon body into at least two independent or non-independent chambers, and the connecting pipe supplies filler to each chamber through the liquid outlet;
the number of the liquid discharge channels or the number of the outer liquid discharge ports arranged on the conveying guide pipe is equal to the number of the chambers.
Optionally, graduation marks are arranged on the outer surface of the side wall of the proximal end of the conveying catheter and used for positioning the withdrawal distance; and the positioning mark is used for positioning and marking the positions of the inner liquid discharge ports relative to different outer liquid discharge ports when the inner sleeve is retracted so as to control the conveying guide pipe to convey the filler to each balloon body.
The invention provides an implantable balloon device, at least two balloon bodies are arranged, and each balloon body is mutually independent; the connecting pipe is connected with the balloon body in a sealing way, the conveying conduit is inserted into the connecting pipe from the inserting port, and external fillers are conveyed through the conveying conduit and discharged from a liquid outlet of the connecting pipe to enter the balloon body to realize filling; because at least a part of the connecting pipe stretches into the balloon body, a self-adsorption film pipe is arranged between the liquid outlet and the inserting port, the self-adsorption film pipe can be extruded and deformed, when the filler in the balloon body reaches a certain amount, the conveying catheter is pulled out, when no internal expanding force exists in the connecting pipe, the filler in the balloon body applies pressure to the abutting pipe, and the pipe wall of at least a part of the self-adsorption film pipe is flattened and contacted with each other to realize sealing, so that the effect of pulling out, namely sealing, of the conveying catheter is realized. The invention is composed of at least two balloon bodies, and the possibility of simultaneous rupture of all balloon bodies is low, so that the balloon bodies can be effectively prevented from being ruptured, the balloon function failure is avoided, and meanwhile, the content released by the balloon rupture is reduced, so that the adverse effect of a large amount of content on the body is reduced.
Drawings
In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a front view of a first and second embodiment of an implantable balloon device provided by the present invention;
FIG. 2 is a side view of a first and second embodiment of an implantable balloon device provided by the present invention;
FIG. 3 is a schematic cross-sectional view of the first embodiment corresponding to the direction A-A in FIG. 1;
FIG. 4 is a schematic cross-sectional view of the first embodiment corresponding to the direction B-B in FIG. 2;
FIG. 5 is a schematic cross-sectional view of a second embodiment corresponding to the direction A-A in FIG. 1;
FIG. 6 is a schematic cross-sectional view of a second embodiment corresponding to the direction B-B in FIG. 2;
FIG. 7 is a front view of a third embodiment of an implantable balloon device provided by the present invention;
FIG. 8 is a side view of a third embodiment of an implantable balloon device provided by the present invention;
FIG. 9 is a schematic cross-sectional view of FIG. 7 taken along the direction C-C;
FIG. 10 is a schematic cross-sectional view taken along the direction D-D in FIG. 8;
FIG. 11 is a schematic cross-sectional view of a first embodiment of a delivery catheter;
FIG. 12 is an enlarged view of a portion I of FIG. 11;
FIG. 13 is an enlarged view of a portion II of FIG. 11;
FIG. 14 is a schematic view of the overall structure of a first embodiment of a delivery catheter;
FIG. 15 is a schematic cross-sectional view taken along the direction E-E in FIG. 14;
FIG. 16 is an isometric view of a second embodiment of a delivery catheter;
FIG. 17 is a schematic cross-sectional view of a second embodiment of a delivery catheter;
fig. 18 is a schematic cross-sectional view of a barrier wall disposed inside a balloon body.
The drawings include:
balloon body 1, partition wall 11, adapter tube 2, insertion port 21, liquid outlet 22, branch pipe 23, elastic contraction ring 24, delivery catheter 3, inner sleeve 31, inner liquid outlet 311, outer sleeve 32, outer liquid outlet 321, and fixing member 4.
Detailed Description
The core of the invention is to provide an implantable balloon device, which has low possibility of simultaneously breaking all balloon bodies by arranging more than two balloon bodies, and effectively prevents the whole balloon from breaking.
In order to better understand the technical solutions of the present invention, the following describes the implantable balloon device of the present invention in detail with reference to the accompanying drawings and the specific embodiments.
The invention provides an implantable balloon device, which comprises at least two balloon bodies 1 and a connecting tube 2, wherein the balloon bodies 1 are arranged in at least two, and the balloon bodies 1 are mutually independent, namely, the inside of each balloon body 1 can independently contain filling materials, and the filling materials in the balloon bodies 1 are not mutually communicated. The balloon 1 is made of a flexible deformable material, the volume of which expands when a filler is present inside the balloon 1. The filler can be liquid or semisolid, has certain fluidity, the semisolid can be hydrogel, such as sodium alginate, sodium hyaluronate, gelatin, etc., which is in liquid state before injection, and forms gel by physical or chemical crosslinking after entering human body. Temperature-sensitive hydrogels made of block copolymers of polyethylene glycol and lactic acid, glycolic acid or caprolactone, such as PLGA-PEG-PLGA, PDLLA-PEG-PDLLA, etc., can also be used, and will remain in a liquid state suitable for injection at room temperature, becoming gel-like at physiological temperature of 37 ℃. The hydrogel is a compound formed by combining hydrophilic high molecular compounds into a three-dimensional network structure, and is mainly combined in a physical or chemical mode, and the physical and chemical properties of the hydrogel are very similar to those of human tissues, so that the hydrogel has the advantages of high moisture content, good biocompatibility, good degradability and the like. The filler is preferably physiological saline, and the content flows out after the balloon is ruptured, so that the sterile physiological saline has little influence on the body. It should be noted that, the shape of each balloon body 1 can be set according to the requirement, as shown in fig. 1, the balloon body 1 in this embodiment adopts a rounded rectangle, and the radian of two corners above is smaller, and the radian of two corners below is larger. As shown in fig. 7, the balloon body 1 in this embodiment adopts a runway shape, and has a rectangular middle region and semicircular left and right ends. The above embodiments only provide two specific configurations, but are not limited thereto, and other configurations are also included in the scope of the present invention. In the embodiment shown in fig. 2 and 8, the balloon body 1 has a flat structure, i.e. a thickness smaller than the length and the width, but may be provided in other shapes such as a sphere.
The adapter tube 2 is connected to the balloon body 1 in a sealing manner, the outer side of the closest end of the balloon body 1 can be flush with the adapter tube 2, and the adapter tube 2 can also slightly extend out of the balloon body 1, and in the embodiment shown in the drawings of the invention, a part of the adapter tube 2 extends out of the balloon body 1.
The adapter tube 2 is a pipeline structure, can be used as a passage for inserting the delivery catheter 3, and can play a role of connection to interconnect the respective balloon bodies 1 together. The balloon bodies 1 are connected with each other through the same connecting pipe 2 and are communicated with the outside through the connecting pipe 2. The adapter tube 2 is provided with an inserting port 21 and a liquid outlet 22, and the inserting port 21 is arranged at the tail end below the adapter tube 2 in combination with fig. 4 and 6, the inserting port 21 is used for inserting the conveying conduit 3, the conveying conduit 3 has certain rigidity, and the supporting force for expanding and dilating can be provided for the adapter tube 2. A self-adsorption membrane tube is arranged between the liquid outlet 22 and the inserting port 21, each liquid outlet 22 is correspondingly provided with a section of self-adsorption membrane tube, the self-adsorption membrane tube is made of flexible deformable material, after the balloon body 1 is filled, the inside of the balloon body 1 is filled with filler, and when no support exists in the self-adsorption membrane tube or no flowing filler exists in the self-adsorption membrane tube after the conveying conduit 3 is drawn out, the filler in the balloon body 1 applies pressure to the outside of the self-adsorption membrane tube, and at least part of tube walls of the self-adsorption membrane tube are flattened to be contacted with each other to realize sealing; each balloon body 1 is at least correspondingly provided with a section of self-adsorption film tube, and the self-adsorption film tube corresponding to each balloon body 1 is flattened, so that all balloon bodies 1 are sealed, and at the moment, the filler in the balloon bodies 1 cannot flow out through the connecting pipe 2, so that the balloon bodies 1 realize automatic sealing.
For the connecting pipe 2 which is integrally made of flexible materials, when the conveying conduit 3 is inserted into the connecting pipe 2, the conveying conduit 3 can prop the connecting pipe 2 open, so that support is provided for the connecting pipe 2; the delivery catheter 3 is capable of delivering a filling material which enters the balloon bodies 1 via the liquid outlet 22 of the adapter tube 2, so that each balloon body 1 is filled. In the subsequent embodiment, the adapter tube 2 is made of a part of hard material, and a flexible branch pipe 23 is arranged; for the connecting pipe 2 made of hard materials, the inner diameter of the connecting pipe 2 is larger than the outer diameter of the conveying conduit 3, a branch pipeline 23 made of flexible materials is arranged on the connecting pipe 2, and filler enters the balloon bodies 1 through the branch pipeline 23, so that each balloon body 1 is filled. The branch line 23 is of moderate length, too short to self-close, and too long to open the branch line 23.
The meaning of "self-absorption" of the adapter tube 2 is that, except that the adapter tube 2 itself is integrally made of a film material to achieve the self-absorption effect, the whole of the adapter tube 2 has the self-absorption effect at this time. The branch pipe 23, which is a branching portion of the adapter tube 2, is also provided with a self-absorption effect by using a film material, and only a part of the adapter tube 2 has the self-absorption effect.
Each balloon body 1 is correspondingly communicated with at least one liquid outlet 22, the liquid outlets 22 are used for injecting fillers into each balloon body 1, when the conveying catheter 3 is inserted into the connecting tube 2, the connecting tube 2 is expanded, the fillers can flow through the inside of the conveying catheter 3, and the fillers flow into the balloon bodies 1 through the conveying catheter 3 and fill each balloon body 1 or each partition inside the balloon bodies 1.
At least a part of the connecting pipe 2 stretches into the balloon body 1, a distance exists between the connecting position of the balloon body 1 and the connecting pipe 2 and the liquid outlet 22, namely a section of entity pipeline exists between the connecting position of the balloon body 1 and the connecting pipe 2 and the liquid outlet 22, and the entity pipeline is used for enabling the filled filler in the balloon body 1 to apply pressure to the connecting pipe 2 when no support exists in the connecting pipe 2 and the filler is stopped to be input into the balloon body 1, the pipe wall of the connecting pipe 2 is flattened to be in contact with each other to realize sealing, the liquid outlet 22 is sealed, and the filler in the balloon body 1 cannot reversely flow out through the liquid outlet 22. The distance between the liquid outlet 22 and the fixed connection position of the connecting tube 2 and the balloon body 1 should be greater than 2mm so as to ensure enough extruded parts.
The implantable balloon device provided by the invention is provided with the plurality of balloon bodies 1, and each balloon body 1 is mutually independent, so that the possibility of breakage and damage of all balloon bodies 1 is very low in the daily use process, the whole balloon body can be effectively prevented from breaking and losing efficacy, only fewer fillers are released into the body after a single balloon body 1 breaks, the influence on the tissues in the body is small, and the adverse influence on the fact that a large amount of internal fillers are released to an affected part instantaneously once the traditional balloon breaks can be avoided. In addition, the plurality of balloon bodies 1 are respectively sealed through the same connecting pipe 2, and when the balloon bodies 1 are filled, the sealing can be realized only by extracting the conveying catheter 3 outwards, no additional operation is needed, and the operation process is more convenient.
The implantable balloon device provided by the invention comprises two main types of arrangement modes:
first category: using a multi-layer nested structure
In this structure, at least two balloon bodies 1 are mutually nested to form a multi-layer balloon, and the connection pipe 2 sequentially extends into each layer of balloon body 1. Referring to fig. 3, 4, 5 and 6, the embodiment shown in the drawings adopts a multi-layer nested structure, more than two balloon bodies 1 are provided, the sizes of the balloon bodies 1 are different, the volume of each balloon body 1 gradually decreases from the outer layer to the inner layer, a cavity exists between two adjacent balloon bodies 1, and the balloon body 1 at the innermost layer is an independent cavity. The filler is arranged between the two adjacent layers of balloon bodies 1, and the two adjacent layers of balloon bodies 1 are not in direct contact. The balloon is designed according to implantation requirements, and is required to be placed in the body to be completely degraded along with the growth of torn tendons for about one year, the interval distance between implantation sites can be changed during the period, a certain distance is reserved between layers by adopting the multi-layer balloon body 1, the overall size of the outer layers after being broken is reduced (even if the outer layers cannot be broken due to abrasion and puncture, the outer layers can be degraded and broken in a preset time period after implantation due to the adoption of degradable materials), and the growth process is adapted.
In this embodiment, when the implantable balloon device is integrally implanted in the body, only the balloon body 1 on the outermost layer is in contact with the tissue in the body in normal use, and the balloon body 1 inside the outermost layer is immersed in the filler, so that the possibility of damage to the balloon body 1 inside the implantable balloon device can be reduced, and the balloon body 1 inside the implantable balloon device still maintains the inflated state after the balloon body 1 on the outermost layer breaks and fails, and still provides support.
The second category: adopting a multistage series structure
In this configuration, at least two balloon bodies 1 are connected in series to form a balloon string, and the connection pipe 2 sequentially extends into each layer of balloon bodies 1, that is, the connection pipe 2 extends from the side wall of the balloon body 1 closer to the proximal end and extends into the next balloon body 1. The embodiments illustrated in the figures employ a multi-stage series configuration as shown in connection with figures 7, 8, 9, and 10. Different balloon bodies 1 may be of the same size or of different sizes, and the embodiments of the figures are shown with each balloon body 1 of the same size. The interior of each balloon body 1 is independent of each other and does not communicate with each other. In series, the adapter tube 2 extends from one side of the balloon body 1 and on the opposite other side.
In this embodiment, when the implantable balloon device is implanted in its entirety, the outer surface of each balloon 1 is capable of contacting the tissue in the body under normal use conditions, and each balloon 1 is immersed in the filler. Since the respective balloon bodies 1 are arranged in a certain order, the respective balloon bodies 1 are subjected to different external conditions such as extrusion during use, and thus, the extreme case of all the balloon bodies 1 being ruptured can be avoided.
It should be noted that, in the embodiments illustrated in fig. 4 and 6, two layers of balloon bodies 1 are nested with each other to form a whole; in the embodiment shown in fig. 10, three balloons 1 are provided in series, each balloon 1 being of a single-layer structure. The invention also comprises the arrangement form that the first type adopts a multi-layer nested structure and the second type adopts a multi-layer serial structure to be combined with each other, namely, more than two layers of balloon bodies 1 are mutually nested to form a balloon whole, and then the whole balloon bodies are mutually connected in series, the number of the balloon bodies 1 arranged on each balloon whole can be equal or unequal, and the embodiments are included in the protection scope of the invention.
On the basis of any one of the above technical solutions and the combination thereof, the implantable balloon device of the present invention may further be configured to have the following characteristics:
(1) the degradation rate of the balloon 1 located further outside is greater than or equal to the degradation rate of the balloon 1 located further inside.
For the first type, the balloon body 1 close to the outer layer has higher degradation rate in the form of a multi-layer nested structure, and is broken firstly with high probability when in use, and is broken sequentially from the outer layer to the inner layer according to a set sequence. The degradation rate of each balloon body 1 is regulated according to the recovery period of the affected part, the whole balloon realizes a slow release function, the balloon is gradually broken according to the recovery condition of the affected part, and the balloon is completely degraded after all tissues of the affected part grow well.
For the second type, the form of a multistage serial structure is adopted, so that the balloon bodies 1 close to the two ends of the connecting pipe 2 are more easily degraded, the balloon bodies 1 close to the middle are more difficult to degrade, and the balloon bodies 1 connected in series are degraded from the positions of the two ends (outside).
Balloon 1 has the same or different degradation rates, such as adding a certain amount of polydioxanone (PPDO), adjusting the proportion or molecular weight of the degradable material components to control the balloon degradation rate.
(2) The blasting difficulty of the balloon body 1 positioned at the outer position is smaller than or equal to that of the balloon body 1 positioned at the inner position.
Similar to the arrangement of property (1), for the first type, which takes the form of a multi-layered nested structure, the inner balloon material should have the characteristic of equal or greater burst pressure relative to the outer balloon material. For the second type, which adopts a multi-stage series structure, the balloon material near the middle should have the characteristic of equal or larger burst pressure relative to the balloon material near the two ends.
(3) The inflation pressure of the balloon body 1 located further outwards is less than or equal to the inflation pressure of the balloon body 1 located further inwards.
Similar to the arrangement of property (1), for the first type, which takes the form of a multi-layered nested structure, the inflation pressure of the inner balloon body should be greater than or equal to the inflation pressure of the outer balloon body. The outer pressure is lower than or equal to the inner pressure, so that the possibility of pressure leakage of the inner balloon is avoided; the balloon is implanted into a human body to be pressed and deformed, and the balloon is a non-compliant balloon, so that the outer balloon pressure is prevented from being too high at a pressed position.
For the second type, the multi-stage serial structure is adopted, the serial balloon bodies 1 have no pressure requirement, and each balloon body 1 is provided with the pressure with the best adaptation degree according to the position of the placement cavity. Since the serial balloon bodies 1 have no requirement on the filling sequence, if a plurality of outlets are arranged on the inner tube of the balloon (the end far away from the operator) at the far end to be filled first, the balloon bodies 1 can be filled simultaneously, and thus the pressure of the balloon bodies 1 is basically the same.
The above-mentioned characteristics (1), (2) and (3) may be set at the same time, alternatively, or two characteristics may be used in any combination. It should be noted that the present invention should also include an arrangement in which each balloon 1 has the same degradation rate, the same burst pressure, and the same filling pressure.
The implantable balloon device of the present invention comprises a delivery catheter 3, the delivery catheter 3 being used to deliver the balloon body 1 to a designated location. As shown in fig. 11, 12, 13, 14 and 15, the delivery catheter 3 is preferably made of medical stainless steel material, and its shape is preferably flat, and as an embodiment of the adapter tube 2, the adapter tube 2 is stuck together by two layers of planes, and the delivery catheter 3 has a certain thickness, so that the adapter tube 2 is closed after the delivery catheter 3 is withdrawn.
In a specific embodiment, the delivery catheter 3 comprises an inner sleeve 31 and an outer sleeve 32 nested inside each other, the inner sleeve 31 and the outer sleeve 32 can move relatively along the axial direction (up and down direction in fig. 11), and a lubricant is arranged between the inner sleeve 31 and the outer sleeve 32 to reduce friction, and the sleeve gap can be lubricated by medical sterile paraffin oil. Typically, the length of the inner sleeve 31 is greater than the length of the outer sleeve 32, the proximal end of the inner sleeve 31 (the end used by the operator) protrudes to the outside, and the outer sleeve 32 need only be equal to or slightly greater than the length of the adapter tube 2.
Referring to fig. 11, 12 and 13, at least one group of inner liquid discharge ports 311 are formed in the side wall of the inner sleeve 31, at least two groups of outer liquid discharge ports 321 are formed in the side wall of the outer sleeve 32, the number of the groups of outer liquid discharge ports 321 is greater than or equal to that of the balloon bodies 1, at least one group of outer liquid discharge ports 321 are correspondingly formed in each balloon body 1, the end portion, extending into the outer sleeve 32, of the inner sleeve 31 is arranged in a closed mode, acting force of the filler on the balloon bodies 1 can be offset, and the acting force can be offset by fixing the position of the conveying catheter at the proximal end; when the inner liquid outlet 311 and the outer liquid outlet 321 are opposite, communication is formed for circulating the filler, and when the inner liquid outlet 311 and the outer liquid outlet 321 are opposite as shown in fig. 13, the filler in the conveying conduit 3 is discharged through the inner liquid outlet 311 and the outer liquid outlet 321; when the inner drain 311 is facing the solid portion of the outer sleeve 32, the filler in the delivery conduit 3 stops draining. One, two or more openings may be provided for one set of inner drain ports 311 or one set of outer drain ports 321.
The positions of the outer liquid discharge ports 321 are set, the outer sleeve 32 is inserted into the innermost end of the adapter tube 2 (i.e. the outer sleeve 32 is inserted into the initial position of the adapter tube 2), and at this time, each set of outer liquid discharge ports 321 arranged on the outer sleeve 32 is respectively abutted with each liquid discharge port 22 arranged on the adapter tube 2. At least one group of inner liquid discharge ports 311 is butted with at least one group of outer liquid discharge ports 321, and at this time, the filler can be injected into the corresponding balloon body 1 through the butted outer liquid discharge ports 321. When the inner sleeve 31 is inserted into the innermost end of the outer sleeve 32, the inner liquid drain 311 just faces the first balloon body 1 to be filled. When a plurality of chambers are arranged in the balloon body 1, at least one opening is arranged on the connecting pipe 2 connected with each independent chamber, and the outer liquid drain 321 can fill the connecting pipe 2 through the opening on the connecting pipe 2.
When the conveying catheter 3 works, the outer sleeve 32 is kept relatively fixed, the inner liquid outlet 311 is opposite to one group of outer liquid outlet 321, filler is input through the end inlet of the inner sleeve 31, and finally the filler enters one of the balloon bodies 1 through the outer liquid outlet 321 (as shown by an arrow in fig. 15), and fills the balloon body 1 to reach the set pressure. After one balloon body 1 is filled, the inner sleeve 31 is slid, the inner sleeve 31 is pulled out, the outer liquid outlet 321 after use is blocked and sealed by the side wall of the inner sleeve 31, the inner liquid outlet 311 is moved to the outer liquid outlet 321 corresponding to the balloon body 1 to be filled next, the tail end of the inner sleeve 31 is kept sealed, at this time, the outer liquid outlet 321 corresponding to the balloon body 1 at the upper stage is always kept in a sealed state, and the connecting pipe 2 in the filled balloon body 1 is extruded by the filler to be automatically kept sealed. The above operation is repeated to fill each balloon body 1 with a filler with proper pressure, so that the implantable balloon device of the invention is positioned at the implantation position, and finally the delivery catheter 3 is entirely retracted to complete filling placement.
With reference to fig. 16 and 17, the delivery conduit 3 may be provided as a single layer tube, with the inner end of the delivery conduit 3 extending into the adapter tube 2 being closed; the side wall of the conveying conduit 3 is provided with a liquid discharge channel A for discharging liquid to the balloon bodies 1, each balloon body 1 is at least provided with one liquid discharge channel A correspondingly, and when the conveying conduit 3 is inserted in place, each liquid discharge channel A corresponds to the balloon body 1 respectively; the respective drainage channels a simultaneously drain the filler outwardly, as indicated by arrows in fig. 17, and the filler is simultaneously delivered to the respective balloon bodies 1 using the delivery catheter 3 of the single-layer tube.
In an alternative embodiment, the end of the delivery catheter 3 is open as an outflow channel for the filling material, and when filling the filling material, the filling material can flow out of the outflow channel at the end of the delivery catheter 3 and be delivered to the balloon body 1 via the adapter tube 2.
The single-layer tube adopted by the conveying catheter 3 can be used under the condition that the balloon can be clamped after being pressurized and the whole balloon cannot be displaced too much due to the single-layer tube pumping. The sleeve structure of the delivery catheter 3 can solve the problem that the balloon is displaced when the delivery catheter 3 is drawn (for example, when the filling material is completely filled and the delivery catheter 3 is drawn).
Still further, the present invention may provide a locking structure (not shown in the drawings) between the inner sleeve 31 and the outer sleeve 32, and the locking structure may be a locking block provided on the inner sleeve 31 and the outer sleeve 32, respectively, or a locking block and a locking groove. When the inner sleeve 31 is pulled out to make the clamping structures contact each other, the clamping structures transmit the pulling-out acting force, so that the outer sleeve 32 is taken out when the inner sleeve 31 is pulled out. That is, before the detent structure contacts, the inner sleeve 31 moves axially relative to the outer sleeve 32, the outer sleeve 32 remains in place, and after the detent structure contacts, the inner sleeve 31 applies a pulling force relative to the outer sleeve 32, so that the outer sleeve 32 can be pulled out of the adapter tube 2, and the whole process of taking out the delivery catheter 3 is completed. The inner sleeve 31 and the outer sleeve 32 may not be provided with a locking structure, the inner sleeve 31 and the outer sleeve 32 may be pulled out respectively, and if the locking structure is not provided, the outer sleeve 32 may extend out of the body a little, and may be pulled out directly after filling is completed.
In one embodiment, a fixing member 4 is disposed between two adjacent balloon bodies 1, and the fixing member 4 is used to define the relative position between the balloon bodies 1; the circumferential distance between the balloon bodies 1 can be set according to the pressure generated by the actual movement of an implantation position, the balloon provided by the invention is a non-compliant balloon, the size deformation is small, the distance between the balloon bodies 1 in a serial connection mode is not required, and the balloon bodies 1 can not be squeezed together; the whole shape of the balloon is changed according to the using position, the balloon can be narrow at the upper part and wide at the lower part, and the middle of the thickness of the balloon is slightly bulging.
Referring to fig. 3 and 4, a structure in which fixing members 4 are provided is shown, the fixing members 4 are fixed to each balloon body 1, all balloon bodies 1 may be connected by one fixing member 4, and if there are a plurality of balloon bodies 1, they may be connected by different fixing members 4; the number of the fixing members 4 provided between two adjacent balloon bodies 1 is at least one, and two or more fixing members may be provided. When the diameters of the balloon bodies 1 of the layers differ greatly, the connecting pipe 2 can be connected with the balloon bodies 1 of the layers through the fixing piece 4, so that the arrangement of the balloon bodies 1 of the inner layer is ensured, the delivery catheter 3 is convenient to retract, the relative positions between the balloon bodies 1 are limited through the fixing piece 4, and the position deviation is avoided.
In the embodiment shown in fig. 3 and 4, the fixing piece 4 extends along the same direction as the connecting tube 2, the fixing piece 4 is fixed at the end part of the connecting tube 2, and the fixing piece 4 is of an internal solid structure; the fastening element 4 can also be provided independently of the adapter tube 2. The fixing member 4 and the adapter tube 2 may extend in different directions, may be disposed at any position between the inner and outer balloon bodies 1, and is not particularly limited. The fixing member 4 may be provided in one or two or more, and the specific number is not limited.
In one embodiment, the whole of the connecting tube 2 adopts a self-adsorption film tube, the connecting tube 2 is formed by fixing two films, the connecting tube 2 is formed by an upper film layer and a lower film layer, and the connecting tube 2 is connected through hot-melt welding, so that the connecting tube 2 forms a flat structure, the cross section of the connecting tube 2 is approximately elliptical when the conveying conduit 3 is inserted into the connecting tube, and the connecting tube 2 is mutually attached when the conveying conduit 3 is not inserted into the connecting tube. The non-connection part is reserved at the edge of the connecting pipe 2 to form an inserting port 21 and a liquid outlet 22 for the filler to flow in and out.
In one embodiment, the connection tube 2 is formed by splicing a part of hard tube and a part of self-adsorption film tube, the part of the self-adsorption film tube can be adsorbed to form a seal, the hard tube part cannot be extruded and deformed by the filler, and the sealing of the balloon body 1 can be realized by virtue of the self-adsorption film tube which is locally arranged. For example, the connecting pipe 2 is in a linear structure and is formed by alternately connecting a hard pipe and a self-absorption film pipe, and each balloon body 1 is at least provided with a section of self-absorption film pipe correspondingly, and the sealing of the balloon body 1 can be realized through the self-absorption film pipe.
In an embodiment, referring to fig. 4 and fig. 6, the arrows indicate the inflow direction of the filler in the two balloon bodies 1, and two liquid outlets 22 corresponding to the same balloon body 1 are oppositely arranged, that is, the filler can enter the balloon body 1 through the two liquid outlets 22 at the same time, and is filled and injected into the balloon body 1 symmetrically, so that the pushing force of the filler on the balloon body 1 can be counteracted, and the balloon body 1 can be ensured to be filled quickly and uniformly. The arrangement form of the liquid outlets 22 corresponds to the outer liquid outlet 321 and the inner liquid outlet 311 of the conveying conduit 3, and each liquid outlet 22 corresponds to one outer liquid outlet 321.
Since each balloon 1 is realized by the movement of the inner sleeve 31 relative to the outer sleeve 32, and can be conveyed only when the inner liquid discharge port 311 and the outer liquid discharge port 321 are opposite to each other, it is necessary to ensure that the arrangement form of the liquid discharge ports 22 is uniform for each balloon 1.
Specifically, graduation marks (as shown by L in fig. 14) may be provided on the outer surface of the proximal side wall of the delivery catheter 3 for positioning the withdrawal distance, so that the liquid outlet of the delivery catheter 3 can be withdrawn from the liquid outlet 22 corresponding to one balloon body 1 to the liquid outlet 22 corresponding to the next balloon body 1, and the graduation marks are provided on the outer surface of the inner sleeve 31 by pulling out and sliding the inner sleeve 31 during filling. The scale marks are used for positioning and marking the positions of the inner liquid discharge ports 311 relative to different outer liquid discharge ports 321 when the inner sleeve 31 is retracted (the inner sleeve 31 moves relative to the outer sleeve 32), and the outer liquid discharge ports 321 which are in butt joint with the inner liquid discharge ports 311 can convey the filler so as to control the conveying guide pipe 3 to convey the filler to different balloon bodies 1; if a plurality of chambers are longitudinally arranged in one balloon body 1, a structure that the inner sleeve and the outer sleeve are mutually matched can also be adopted, and the inner sleeve is drawn to move the position of the inner liquid outlet. When the delivery catheter 3 and the adapter tube 2 are in the initial position (the initial position is that when the delivery catheter 3 is inserted into the adapter tube 2 to the limit structure, the end blocking position of the adapter tube 2 is preferred) and the inner sleeve 31 is inserted into the innermost end of the outer sleeve 32, when only one group of inner liquid discharge ports 311 are arranged on the inner sleeve 31, the inner liquid discharge ports 311 correspond to the outer liquid discharge ports 321 at the farthest end of the outer sleeve 32, liquid is discharged to one balloon body 1, the balloon body 1 is positioned to the other balloon body 1 through the scale marks after liquid discharge is completed, and the process is repeated until the whole balloon body 1 is filled.
The balloon body 1 and the connecting tube 2 are made of high polymer materials with the same components or different components. The multi-layered balloon body 1 and the adapter tube 2 may comprise biodegradable medical polymer materials or biocompatible materials having the same or different components, wherein the biodegradable medical polymer materials comprise polyethylene glycol, polylactic acid-glycolic acid copolymer, polylactic acid, polycaprolactone, poly L-lactide-caprolactone, polypeptide, collagen, methylcellulose, or a mixture of one or more materials, and the biocompatible materials comprise polyesters, polyamides, polyvinylchloride, nylon, polyurethanes, or a mixture of one or more materials. If the implantable balloon is required to replace tissues and organs in the human body, a biocompatible material is preferred; biodegradable materials are preferred if the implantable balloon provides temporary auxiliary support.
In one embodiment, the adapter tube 2 extends into from one side edge of the balloon body 1 and extends to the other side edge opposite to the balloon body 1, at least two fixing positions exist between each balloon body 1 and the adapter tube 2, as shown in fig. 5 and 6, the adapter tube 2 extends from the lower side edge of the balloon body 1 to extend upwards to the upper side edge of the balloon body 1, two fixing positions exist between each balloon body 1 and the adapter tube 2, and the upper end of the adapter tube 2 is kept closed. A certain positioning effect is formed on the balloon body 1 through the connecting pipe 2. The connecting tube 2 and the balloon body 1 are fixed by hot melt bonding or are connected by using an adhesive.
The preferable scheme is that a hard pipe section is arranged at the connection position of the balloon body 1 and the connecting pipe 2, and the contact area between the balloon body 1 and the connecting pipe 2 is increased through the hard pipe section, so that the balloon body 1 can be firmly fixedly connected with the connecting pipe 2.
As shown in fig. 4 and 6, the connection pipe 2 includes a branch pipe 23, the branch pipe 23 is a part of the connection pipe 2 and forms a structure, the branch pipe 23 and other parts of the connection pipe 2 can be arranged in the same or different manners, the liquid outlet 22 is arranged at the tail end of the branch pipe 23, the branch pipe 23 is perpendicular to the extending direction of the main body of the connection pipe 2, and the branch pipe 23 can extend into the space between the two mutually nested balloon bodies 1; since the space between the two layers of balloon bodies 1 is smaller, if the part is pressed by the filler only, sufficient tightness is difficult to ensure, and therefore, the extension size of the connecting pipe 2 is increased by arranging the branch pipeline 23, so that the sealing effect formed by the filler pressed to the connecting pipe 2 is ensured. The connecting pipe 2 extending into the innermost balloon body 1 can be provided with a branch pipeline, and the connecting pipe 2 in each balloon body 1 in a serial connection mode can be provided with a branch pipeline.
The branch pipeline 23 adopts a self-adsorption membrane pipe, self-sealing can be realized, other parts of the connecting pipe 2 adopt a hard pipe or a self-adsorption membrane pipe, namely, the self-adsorption of the branch pipeline 23 can meet the sealing of the balloon body 1 no matter the main body part of the connecting pipe 2 adopts the hard pipe or the self-adsorption membrane pipe. If the main body of the adapter tube 2 is provided as a self-absorbent membrane tube, the length of the extruded seal is longer.
The connecting pipe 2 can be of a hollow cylindrical structure, a partition can be arranged on the outer wall along the longitudinal direction, the extending direction of the partition is along the flowing direction of the filler, and the connecting pipe 2 cannot be automatically adsorbed and closed due to the connection effect of the partition and the longitudinal partition, so that a branch pipeline 23 is arranged at the opening of the connecting pipe 2. In addition, the main body of the adapter tube 2 can be made of a hard tube, and the adapter tube is arranged only at the branch pipe 23, otherwise, the partition is not well fixedly connected with the adapter tube 2.
Still further, in an embodiment, the elastic contraction ring 24 may be disposed on the adapter tube 2, and as shown in fig. 1 and 2, the elastic contraction ring 24 may be disposed at a position where the balloon body 1 and the adapter tube 2 intersect, or may be disposed at other positions, and the elastic contraction ring 24 may be disposed in one or more ways, and may be disposed only at the outermost side or the elastic contraction ring 24 may be disposed inside the balloon body 1. The elastic constriction ring 24 can generate a constriction elastic force for pressing the adapter tube 2 against the surface of the delivery conduit 3 inserted into the adapter tube 2, preventing the filler from flowing out of the gap.
The implantable balloon device provided by the invention has excellent puncture resistance and buffering performance, and can effectively prevent the balloon device from failing after being punctured by bones after being implanted into a human body. The inner layer or other balloon bodies 1 connected in series can have larger buffer space after a certain balloon body is punctured. And the balloon bodies 1 with the nested structure are mutually independent, and compared with a single-layer balloon, the balloon body has higher pressure resistance, so that the adverse effect caused by complete rupture of the balloon due to external impact and instantaneous release of a large amount of internal fillers to an affected part is greatly reduced. In addition, the degradation rate of each layer of balloon can be regulated according to the recovery period of the affected part, the balloon realizes the slow release function, and the balloon is completely degraded after all tissues of the affected part grow well.
For the multilayer nested structure shown in fig. 4 and 6, the multilayer saccule body 1 is in a contracted state in a non-working state, is curled and wound outside the conveying conduit 3, the conveying conduit 3 is preset in the connecting pipe 2, the size of the conveying conduit is matched with the channel of the connecting pipe 2, the proximal end of the conveying conduit 3 is connected with a pressure pump to control the conveying of the filling, and the distal end of the conveying conduit is provided with an inner liquid outlet 311 and an outer liquid outlet 321 matched with the connecting pipe 2. The inner sleeve 31 is moved during operation to fill the layers of balloon 1. During implantation, a small incision is created by using a surgical knife, a puncture needle is matched with a puncture sheath group to create a working channel, a balloon device is delivered to a target position along the working channel, physiological saline is firstly injected into an inner balloon body 1 through an inner liquid outlet 311 and an outer liquid outlet 321 on a conveying catheter 3, after the inner balloon body 1 is inflated to a preset pressure and is attached and fixed with surrounding bones or tissues, the inner liquid outlet 311 of an inner sleeve 31 is moved to an outer liquid outlet 321 corresponding to a next balloon body 1 according to the proximal scale of the conveying catheter 3, the outer balloon body 1 is inflated again, the whole conveying catheter 3 is withdrawn after the balloon body 1 is inflated sequentially by repeating the action, a connecting tube 2 loses support, and the inner balloon body 1 is automatically attached and sealed under the action of the physiological saline pressure.
For the multi-stage series structure shown in fig. 7 and 8, each balloon body 1 needs to be sequentially filled according to the axial direction of the connecting tube 2 during filling, and the balloon body is sequentially filled from the distal end to the proximal end. If each stage of the multi-stage tandem structure adopts a multi-layer nested structure, the multi-layer nested structure filling process needs to be repeated for each stage.
In one embodiment, at least one partition wall 11 (shown in fig. 18) is disposed inside the balloon body 1, the partition wall 11 is connected to the wall of the balloon body 1, and the partition wall 11 is used for dividing the inside of the balloon body 1 into at least two independent or non-independent chambers, each of which is a partition, and each of the chambers can contain a filler. When the chambers are independent of each other, the fillers in the chambers are isolated from each other; when the chambers are not independent, the fillings therein may communicate with each other, but their flow is reduced by the partition wall 11. In the structure shown in fig. 18, the partition wall 11 is disposed at the connection tube 2, so that the branching pipeline 23 is preferably added, so that the liquid outlet 22 is far away from the partition wall 11, thereby ensuring the self-absorption effect.
The adapter tube 2 supplies the filling material to each chamber through the liquid outlet 22, so that each chamber of the whole balloon body 1 is filled with the filling material. When a partition wall 11 is provided, the lumen of the balloon body 1 may be divided into two chambers; when two intersecting partition walls 11 are provided, the partition walls 11 form four radial lines around the intersection point, and the lumen of the balloon body 1 can be divided into four chambers. The number of the liquid discharge channels or the number of the outer liquid discharge ports 321 arranged on the conveying conduit 3 is equal to the number of the chambers; that is, when the delivery catheter 3 is a single layer, the number of the liquid discharge channels provided is equal to the total number of the chambers provided by all the balloon bodies 1, and when the delivery catheter 3 is a double layer, the number of the outer liquid discharge ports 321 provided on the outer sleeve 32 is equal to the total number of the chambers provided by all the balloon bodies 1. To ensure that each chamber can be filled independently. One outer drain port 321 may correspond to two liquid outlets 22, or one liquid outlet 22 may be connected to different branch pipes 23, and one outer drain port 321 may correspond to a plurality of branch pipes 23. For manufacturing cost, it is preferable that one chamber corresponds to one outer drain 321 and one drain 22.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (11)

1. An implantable balloon device is characterized by comprising balloon bodies (1) and connecting pipes (2), wherein at least two balloon bodies (1) are arranged, and the balloon bodies (1) are mutually independent;
the connecting pipes (2) are connected to the balloon body (1) in a sealing way, and the balloon bodies (1) are connected with each other through the connecting pipes (2) and are communicated with the outside through the connecting pipes (2); at least a part of the connecting pipe (2) extends into the balloon body (1);
the connecting pipe (2) is provided with an inserting port (21) and a liquid outlet (22), the inserting port (21) is used for inserting a conveying catheter (3), each balloon body (1) is correspondingly communicated with at least one liquid outlet (22), and the filler conveyed by the conveying catheter (3) is injected into each balloon body (1) through the liquid outlet (22) and fills each balloon body (1); a self-adsorption membrane tube is arranged between the liquid outlet (22) and the inserting port (21), and each liquid outlet (22) is correspondingly provided with the self-adsorption membrane tube;
When the filling of the balloon body (1) is finished and no support exists in the self-absorption membrane tube, the filler in the balloon body (1) applies pressure to the self-absorption membrane tube, and at least one part of the tube wall of the self-absorption membrane tube is flattened to be in contact with each other so as to realize sealing, so that all the balloon bodies (1) are sealed.
2. Implantable balloon device according to claim 1, characterized in that at least two of the balloon bodies (1) are nested in each other forming a multi-layered balloon, the adapter tube (2) extending into each layer of the balloon bodies (1) in turn.
3. Implantable balloon device according to claim 1, characterized in that at least two of the balloon bodies (1) are connected in series to form a balloon string, the connection tube (2) extending into each layer of the balloon bodies (1) in turn.
4. An implantable balloon device according to any of claims 1-3, characterized in that the degradation rate of the balloon body (1) located further outwards is greater than or equal to the degradation rate of the balloon body (1) located further inwards;
and/or the blasting difficulty of the balloon body (1) positioned at the outer position is less than or equal to the blasting difficulty of the balloon body (1) positioned at the inner position;
And/or the filling pressure of the balloon body (1) positioned at the outer position is less than or equal to the filling pressure of the balloon body (1) positioned at the inner position.
5. An implantable balloon device according to any one of claims 1 to 3, characterized in that the delivery catheter (3) comprises an inner sleeve (31) and an outer sleeve (32) nested and relatively slidable with respect to each other;
the side wall of the inner sleeve (31) is provided with at least one group of inner liquid drain holes (311), and the side wall of the outer sleeve (32) is provided with at least two groups of outer liquid drain holes (321); the number of the groups of the outer liquid drain ports (321) is more than or equal to the number of the balloon bodies (1);
and/or a lubricant is provided between the inner sleeve (31) and the outer sleeve (32) to reduce friction;
and/or the end part of the inner sleeve (31) extending into the outer sleeve (32) is closed;
and/or, when the outer sleeve (32) is inserted in the initial position of the connecting pipe (2), at least one group of the inner liquid drain ports (311) is in butt joint with at least one group of the outer liquid drain ports (321);
and/or a clamping structure is arranged between the inner sleeve (31) and the outer sleeve (32), and the outer sleeve (32) can be taken out when the inner sleeve (31) is pulled out;
Or the conveying conduit (3) is a single-layer pipe, and the inner end part of the conveying conduit (3) extending into the connecting pipe (2) is closed; the side wall of the conveying conduit (3) is provided with a liquid discharge channel for discharging liquid to the balloon body (1).
6. Implantable balloon device according to claim 4, characterized in that a fixation element (4) is arranged between two adjacent balloon bodies (1), the fixation element (4) being used to define the relative position between the balloon bodies (1);
and/or the whole connecting pipe (2) adopts a self-adsorption membrane pipe, and after the conveying conduit (3) supported inside is drawn out, the whole connecting pipe (2) is adsorbed together; the part which is not connected is reserved at the edge to form the inserting port (21) and the liquid outlet (22);
or the connecting pipe (2) is formed by splicing a part of hard pipe and a part of self-adsorption film pipe, and the part of the self-adsorption film pipe can be adsorbed to form a seal;
and/or two liquid outlets (22) corresponding to the same balloon body (1) are oppositely arranged.
7. The implantable balloon device according to claim 4, wherein the balloon body (1) and the adapter tube (2) are made of biodegradable medical polymer materials or biocompatible materials of the same or different components, wherein the biodegradable medical polymer materials comprise one or more of polyethylene glycol, polylactic acid-glycolic acid copolymer, polylactic acid, polycaprolactone, poly L-lactide-caprolactone, polypeptide, collagen, methylcellulose, and the biocompatible materials comprise one or more of polyesters, polyamides, polyvinylchloride, nylon, polyurethanes, and silica gel.
8. An implantable balloon device according to claim 4, wherein the connection tubes (2) extend in from one side of the balloon body (1) and to the opposite side of the balloon body (1), each balloon body (1) and connection tube (2) having at least two fixed positions;
and/or a hard pipe section is arranged at the connection position of the balloon body (1) and the connecting pipe (2), so that the contact area between the balloon body (1) and the connecting pipe (2) is increased.
9. The implantable balloon device according to claim 4, wherein the connection tube (2) comprises a branch line (23), the liquid outlet (22) being arranged at the branch line (23);
the branch pipeline (23) can extend into the space between the two mutually nested balloon bodies (1); the branch pipeline (23) adopts a self-adsorption membrane pipe, and other parts of the connecting pipe (2) adopt hard pipes or self-adsorption membrane pipes;
and/or an elastic contraction ring (24) is arranged on the connecting pipe (2), and the elastic contraction ring (24) can generate contraction elastic force for pressing the connecting pipe (2) on the surface of the conveying conduit (3) inserted into the connecting pipe (2).
10. Implantable balloon device according to claim 4, characterized in that a partition wall (11) is provided inside the balloon body (1), which partition wall (11) is used to divide the interior of the balloon body (1) into at least two mutually independent or non-independent chambers, the connection tube (2) providing a filling to each of the chambers through the outlet (22);
the number of the liquid discharge channels or the number of the outer liquid discharge ports arranged on the conveying guide pipe (3) is equal to the number of the chambers.
11. The implantable balloon device according to claim 5, wherein the proximal sidewall outer surface of the delivery catheter (3) is provided with graduations for positioning the withdrawal distance; and the positioning device is used for positioning and marking the positions of the inner liquid discharge ports (311) relative to the different outer liquid discharge ports (321) when the inner sleeve (31) is retracted so as to control the conveying guide pipe (3) to convey the filler to each balloon body (1).
CN202410166064.2A 2024-02-06 2024-02-06 Implantable saccule device Active CN117695064B (en)

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