CN110974489B - Special-shaped balloon capable of relieving injury of human tissues and other tissues and preparation method thereof - Google Patents

Special-shaped balloon capable of relieving injury of human tissues and other tissues and preparation method thereof Download PDF

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Publication number
CN110974489B
CN110974489B CN201910961622.3A CN201910961622A CN110974489B CN 110974489 B CN110974489 B CN 110974489B CN 201910961622 A CN201910961622 A CN 201910961622A CN 110974489 B CN110974489 B CN 110974489B
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sub
saccule
special
shaped
balloon
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CN110974489A (en
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郝欣欣
李凌晨
蒋冠森
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Hangzhou Rejoin Mastin Medical Device Co ltd
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Hangzhou Rejoin Mastin Medical Device Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/40—Joints for shoulders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4612—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of shoulders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • A61F2002/30586—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid having two or more inflatable pockets or chambers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30673—Lubricating means, e.g. synovial pocket

Abstract

The invention relates to a special-shaped saccule for reducing the injury of human soft tissue and other tissues and a preparation method thereof.A material with biocompatibility is extruded from an extruder to form a special-shaped saccule blank, the special-shaped saccule blank mainly comprises a plurality of sub-saccule blanks with openings, two adjacent sub-saccule blanks are connected through a pressing line, and then a saccule forming machine is adopted to carry out gas injection blow molding on each sub-saccule blank; the prepared special-shaped saccule is an inflatable and biocompatible saccule and mainly comprises a plurality of sub-saccules, and two adjacent sub-saccules are connected through a press line. The special-shaped balloon for reducing the injury of the soft tissue and other tissues of the human body has a simple preparation method; the surface of the special-shaped saccule is uneven, the stability of the transplanted part is better, the special-shaped saccule is not easy to slip, and the special-shaped saccule can be stressed at multiple points in the movement process, so that the stress of the special-shaped saccule to a single point is small on average, the pressure intensity is relatively small, the special-shaped saccule can play a better buffering role, and the wear resistance fastness is improved.

Description

Special-shaped balloon capable of relieving injury of human tissues and other tissues and preparation method thereof
Technical Field
The invention belongs to the technical field of medical instruments, and relates to a special-shaped balloon for relieving the injury of human soft tissues and other tissues and a preparation method thereof.
Background
Through repeated intense movements, delicate soft tissues are often subject to wear and tear damage by rubbing against each other and/or against hard tissues such as bone. Rotator cuff tendon tears and joint capsule ruptures are examples of such injuries. In addition, inflammation, infection, disease, and/or genetic predisposition to cause degeneration of these tissues may adversely affect these tissues.
In order to solve the above problems, patent CN104473704A discloses a prosthesis (balloon) for alleviating injury of human soft tissue and other tissues, which is an expandable, biodegradable, simulated naturally occurring bursa, and can be inflated with a filler, which can be gas, liquid or gel, and this gap filling can indirectly improve the function of smooth movement of joint tissues and alleviate pain caused by joint discomfort. Mainly because: on one hand, the elasticity of the balloon can play a role in stabilizing pain sensory receptors, and on the other hand, the barrier formed by the balloon can effectively prevent the release and the diffusion of inflammatory transmitters, so that the stimulation to the pain sensory receptors is reduced.
However, due to the design of the spherical structure of the balloon, the problems of large single-point stress, strong pressure and insufficient wear resistance fastness exist in the movement process.
Therefore, it is necessary to develop a shaped balloon to solve the above problems.
Disclosure of Invention
The invention aims to solve the problems of large single-point stress, strong pressure and insufficient wear resistance fastness of a balloon designed by a spherical structure in the prior art, and provides a special-shaped balloon for reducing the damage of human soft tissues and other tissues and a preparation method thereof. The surface of the special-shaped saccule is uneven, and can bear force at multiple points in the movement process, so that the special-shaped saccule has small average single-point stress, relatively small pressure intensity and difficult deformation, can play a better buffering role, and improves the wear resistance fastness.
In order to achieve the purpose, the invention adopts the following scheme:
the special-shaped saccule for reducing the injury of the human soft tissue and other tissues is an inflatable and biocompatible saccule which mainly comprises a plurality of sub-saccules, and two adjacent sub-saccules are connected through a press line.
The irregular balloon is expanded to form a concave-convex shape on the surface of the whole balloon, the surface of the balloon can be stressed at multiple points in the movement process, the convex surfaces of two alternate sub-balloons are respectively stressed in the movement process after the balloon is transplanted into a patient, when the movement amplitude is large, the concave surface parts of the sub-balloons can contact with soft tissues of the patient and can be stressed, the integral supporting force is stronger, the multi-point stress is realized, the average single-point stress is small, the pressure intensity is relatively small, the deformation is difficult, the better buffering effect can be realized, the wear resistance fastness of the balloon is improved along with the reduction of the pressure intensity and the dispersion of the force, the service cycle of the balloon is prolonged, and the balloon with the concave-convex structure can be more stably positioned at a damaged part and is not easy to slip and dislocate after being implanted into a human body; and the common saccule in the prior art has single stress in the movement process, relatively large pressure and no abrasion resistance.
The process of implanting the special-shaped saccule into the worn or torn part of the human body comprises the following steps: firstly, examining the damaged condition of the rotator cuff of a patient through an arthroscope, confirming that the rotator cuff is suitable for debridement of the damaged part after an operation, measuring the space under the acromion by using an arthroscope probe, and selecting a proper balloon size for implantation; then, preparing a balloon inflation system in vitro, placing the balloon in a channel tube of the inflation system, establishing an operation channel by using the channel tube, placing the channel tube in a joint of a patient, enabling the inflation system to enter the body and be connected to the balloon, starting to fill filler into the balloon to reach a target height, sealing the balloon after the internal pressure and the external pressure of the balloon are stable, removing the inflation system, and finally checking whether the balloon has dislocation, and finishing the implantation process of the balloon.
As a preferable scheme:
according to the special-shaped saccule for relieving the injury of the human soft tissue and other tissues, the tensile strength of the special-shaped saccule for relieving the injury of the human soft tissue and other tissues is 2.8-3.2 MPa, and the breaking strain is 30-50%, so that compared with a common saccule made of the same material, the tensile strength of the special-shaped saccule is improved by 2-3 times, and the breaking strain is improved by 10-15%.
The number of the sub-balloons of the special-shaped balloon for relieving the injury of the soft tissue and other tissues of the human body is 2-4; the sub-saccule and the press line are made of biodegradable materials; the biodegradable material is selected from more than one of PLA, PLGA, PLCL and PCL; the wall thickness of the sub-saccule is 0.1-0.3 mm.
The deformed saccule for relieving the injury of the soft tissue and other tissues of the human body has the advantages that each sub saccule is in a columnar shape after being expanded, all the sub saccules are arranged side by side, and two ends of all the sub saccules and all the bonding lines are flush; the two ends of all the sub-balloons and all the bonding lines are not strictly flush, and the arrangement mode is the most preferable scheme, so that the arrangement shape is more regular and the processing is easy.
After the special-shaped saccule for relieving the injury of the soft tissue and other tissues of the human body is expanded, along the arrangement direction of the sub-balloons, the end a of the outermost sub-balloon is far away from the middle sub-balloon, the end b is close to the middle sub-balloon, the outermost sub-balloon linearly tapers from the middle to the end a thereof (namely, the cross section of the part between the middle and the end a is a V-shaped broken line) and tapers towards the arc line of the end b thereof (namely, the cross section of the part between the middle and the end b is an arc line, preferably, the arc line is an arc line or an elliptical arc), each middle sub-balloon tapers from the middle to the arc line of the two ends thereof (preferably, the arc line is an arc line or an elliptical arc), the structure of the special-shaped balloon simulates the naturally existing subacromial bursa and is more fit with the structure of a shoulder joint, the human body is not easy to slip and dislocate, and can be used for expanding the gap between the acromion/coracoid process and the deltoid muscle.
After the special-shaped saccule for relieving the injury of the soft tissue and other tissues of the human body is expanded, each sub-saccule gradually shrinks from the middle to the arc lines at the two ends of the sub-saccule along the arrangement direction of the sub-saccule (preferably, the arc lines are circular arcs or elliptical arcs).
After the special-shaped saccule is inflated, the distance between two adjacent saccules is 0.2-0.6 cm and the distance between two adjacent bonding lines is 0.4-2.5 cm along the arrangement direction of the saccules; the length of each sub-saccule is 2-10 cm along the extension direction of each sub-saccule; along the direction which is mutually vertical to the arrangement direction and the extension direction of the sub-saccule, the heights of the sub-saccule and the pressure joint line are 0.8-2.2 cm and 0.2-15 mm respectively.
In the deformed balloon for reducing the injury of the soft tissue and other tissues of the human body, one sub-balloon is expanded to be spherical or oblate, the other sub-balloons are expanded to be hollow annular, the hollow annular sub-balloons are mutually sleeved, and the spherical or oblate spherical sub-balloons are positioned in the hollow parts of the hollow annular sub-balloons with the smallest hollow part size.
After the special-shaped saccule is inflated, the width of a press line is 0.2-0.6 cm, the width of a hollow annular sub-saccule is 0.4-2.5 cm, the height of each sub-saccule is 0.8-2.2 cm, the height of the press line is 0.2-15 mm, and the inner diameter of the hollow annular sub-saccule with the smallest hollow part size, namely the diameter of the spherical sub-saccule, is not limited and can be adjusted according to actual use requirements.
The invention also provides a method for preparing the special-shaped saccule for relieving the injury of the human soft tissue and other tissues, which comprises the steps of extruding a biocompatible material from an extruder to form a special-shaped saccule blank, wherein the special-shaped saccule blank mainly comprises a plurality of sub-saccule blanks with openings, two adjacent sub-saccule blanks are connected through a pressing line, and then performing gas injection blow molding on each sub-saccule blank by using a saccule forming machine to form the special-shaped saccule for relieving the injury of the human soft tissue and other tissues, or further welding and assembling the openings of the sub-saccule blanks and a guide pipe, so that the special-shaped saccule can be expanded by filling gas, liquid, anti-inflammatory drugs and the like which have good biocompatibility with the special-shaped saccule into the special-shaped saccule through the guide pipe; the preparation method of the special-shaped balloon for reducing the injury of the soft tissue and other tissues of the human body can also comprise the steps of firstly preparing a plurality of sub-balloon bag blanks respectively, then carrying out pressing and then carrying out gas injection blow molding on the plurality of sub-balloon bag blanks to obtain the special-shaped balloon, or carrying out gas injection blow molding on the plurality of sub-balloon bag blanks and then carrying out pressing to obtain the special-shaped balloon, or can also comprise the steps of firstly preparing a common balloon and then folding or pressing the common balloon to form the special-shaped balloon, and compared with the integral forming, the preparation methods are time-consuming and labor-consuming and have higher cost.
Has the advantages that:
(1) the surface of the special-shaped saccule for reducing the injury of the soft tissue and other tissues of the human body is uneven, and can bear force at multiple points in the movement process, so that the special-shaped saccule has small average single-point stress, relatively small pressure intensity, difficult deformation and good pressure resistance, can play a better buffer role, and improves the wear resistance fastness;
(2) the surface of the special-shaped saccule for reducing the injury of the soft tissue and other tissues of the human body is uneven, so that the special-shaped saccule is not easy to slip and dislocate in the human body, and can play a better stabilizing effect;
(3) the preparation method of the special-shaped saccule for reducing the injury of the soft tissue and other tissues of the human body is simple and easy to popularize.
Drawings
Fig. 1 is a schematic structural diagram of a special-shaped balloon for reducing injury of human soft tissue and other tissues in embodiment 1 of the present invention, wherein an x-axis direction of a three-dimensional coordinate system is an arrangement direction of each sub-balloon, a y-axis direction is an extension direction of the sub-balloon, and a z-axis direction is a direction perpendicular to the arrangement direction and the extension direction of the sub-balloon;
FIG. 2 is a cross-sectional view of the contoured balloon of FIG. 1;
FIG. 3 is a schematic structural view of a shaped balloon for reducing injury to soft tissue and other tissues of a human body according to embodiment 2 of the present invention;
FIG. 4 is a cross-sectional view of the contoured balloon of FIG. 3;
fig. 5 and 6 are schematic structural views of a special-shaped balloon for reducing injury of human soft tissue and other tissues in embodiment 3 of the invention.
Detailed Description
The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Further, it should be understood that various changes or modifications of the present invention may be made by those skilled in the art after reading the teaching of the present invention, and such equivalents may fall within the scope of the present invention as defined in the appended claims.
Example 1
A special-shaped balloon for reducing the injury of human soft tissues and other tissues is shown in figures 1-2, and the preparation method comprises the following steps: firstly, extruding biocompatible PLA from an extruder to form a special-shaped sacculus capsule blank, wherein the special-shaped sacculus capsule blank consists of three sub-sacculus capsule blanks with openings, connecting two adjacent sub-sacculus capsule blanks through a pressing line, and then performing gas injection and blow molding on each sub-sacculus capsule blank by adopting a sacculus forming machine; wherein the wall thickness of the sub-saccule is 0.1 mm;
all the sub-balloons are in a columnar shape after being expanded, all the sub-balloons are arranged side by side, and the two ends of all the sub-balloons are flush with the two ends of all the bonding lines; along the arrangement direction of the sub-balloons, each sub-balloon is gradually reduced from the middle to the two ends of the sub-balloon in an arc manner, the distance between every two adjacent sub-balloons is 0.4cm, and the distance between every two adjacent bonding lines is 1 cm; the length of each sub-saccule is 8cm along the extending direction of each sub-saccule; along the direction which is mutually vertical to the arrangement direction and the extension direction of the sub-saccule, the heights of the sub-saccule and the pressure joint line are respectively 2cm and 2 mm;
the special-shaped saccule for relieving the injury of the human soft tissue and other tissues has the tensile strength of 2.8MPa and the breaking strain of 35 percent.
Comparative example 1
A balloon for reducing human tissue damage and other tissue damage, which adopts the raw materials, the wall thickness of the balloon, the size and the height of the balloon which are basically the same as those of the balloon in the embodiment 1, the difference is that the balloon in the comparative example 1 is a flat integral structure and does not contain a suture line, the tensile strength of the balloon is 2.5MPa, and the breaking strain is 29 percent;
comparing comparative example 1 with example 1, it can be seen that the performance of the balloon in comparative example 1 is obviously inferior to that of example 1, mainly because the balloon arranged in comparative example 1 is of a flat integral structure, the balloon is stressed singly, the pressure is relatively large, the buffering effect is relatively weak, and the abrasion resistance fastness is not high enough in the movement process; compared with the balloon in the comparative example 1, the balloon in the example 1 has a concave-convex distribution on the surface due to the existence of the bonding line; after the sacculus was transplanted patient internal, in the motion process, the protruding surface of two alternate sub-sacculus atress respectively, when motion range is big, sub-sacculus concave surface part also probably contacts patient's soft tissue, also can the atress, holistic holding power is stronger, non-deformable can play better cushioning effect, the wear-resisting fastness on sacculus surface also obtains improving along with the reduction of pressure and the dispersion of power, and the life cycle extension of sacculus, buffer capacity and wear-resisting fastness have all obtained the promotion.
Example 2
A special-shaped balloon for reducing the injury of human soft tissues and other tissues is shown in figures 3-4, and the preparation method comprises the following steps: firstly, PLGA with biocompatibility is extruded from an extruder to form a special-shaped sacculus capsule blank, the special-shaped sacculus capsule blank consists of four sub-sacculus capsule blanks with openings, two adjacent sub-sacculus capsule blanks are connected through a pressing line, and then a sacculus forming machine is adopted to perform gas injection blow molding on each sub-sacculus capsule blank to form the special-shaped sacculus capsule blank; wherein the wall thickness of the sub-saccule is 0.3 mm;
all the sub-balloons are in a columnar shape after being expanded, all the sub-balloons are arranged side by side, and the two ends of all the sub-balloons are flush with the two ends of all the bonding lines; along the arrangement direction of the sub-balloons, the end a of the sub-balloon at the outermost side is far away from the sub-balloon at the middle, the end b is close to the sub-balloon at the middle, the sub-balloon at the outermost side linearly tapers from the middle to the end a thereof while tapers to the arc line at the end b thereof, the sub-balloon at each middle linearly tapers from the middle to the arc line at both ends thereof, the distance between two adjacent sub-balloons is 0.2cm, and the distance between two adjacent bonding lines is 0.4 cm; the length of each sub-saccule is 10cm along the extending direction of each sub-saccule; along the direction which is mutually vertical to the arrangement direction and the extension direction of the sub-saccule, the heights of the sub-saccule and the pressure joint line are respectively 0.8cm and 0.2 mm;
the special-shaped saccule for relieving the injury of the human soft tissue and other tissues has the tensile strength of 2.9MPa and the breaking strain of 30 percent.
Example 3
A special-shaped balloon for reducing the injury of human soft tissues and other tissues is shown in figures 5-6, and the preparation method comprises the following steps: firstly, PCL with biocompatibility is extruded from an extruder to form a special-shaped sacculus capsule blank, the special-shaped sacculus capsule blank consists of two sub-sacculus capsule blanks with openings, the two adjacent sub-sacculus capsule blanks are connected through a pressing line, and then a sacculus forming machine is adopted to perform gas injection and blow molding on each sub-sacculus capsule blank to form the special-shaped sacculus capsule blank; wherein the wall thickness of the sub-saccule is 0.3 mm;
one sub-balloon is spherical after being expanded, the other sub-balloon is hollow and annular after being expanded, the spherical sub-balloon is positioned in the hollow part of the hollow annular sub-balloon, the width of the press line is 0.2cm, the width of the hollow annular sub-balloon is 0.4cm, the height of each sub-balloon is 0.8cm, and the height of the press line is 0.2 mm;
the special-shaped saccule for relieving the injury of the human soft tissue and other tissues has the tensile strength of 3.2MPa and the breaking strain of 50 percent.
Example 4
The special-shaped saccule for reducing the injury of the soft tissue and other tissues of the human body is prepared by the following steps: firstly, extruding a biocompatible PLA and PCL mixture (the mass ratio is 1:1) from an extruder to form a special-shaped sacculus capsule blank, wherein the special-shaped sacculus capsule blank consists of four sub-sacculus capsule blanks with openings, two adjacent sub-sacculus capsule blanks are connected through a pressing line, and then, a sacculus forming machine is adopted to perform gas injection and blow molding on each sub-sacculus capsule blank; wherein the wall thickness of the sub-saccule is 0.1 mm;
one sub-balloon is spherical after being expanded, the other three sub-balloons are hollow and annular after being expanded, the hollow annular sub-balloons are mutually sleeved, the spherical sub-balloons are positioned in the hollow parts of the hollow annular sub-balloons with the smallest size of the hollow parts, the width of the press line is 0.6cm, the width of the hollow annular sub-balloons is 2.5cm, the height of each sub-balloon is 2.2cm, and the height of the press line is 15 mm;
the special-shaped saccule for relieving the injury of the human soft tissue and other tissues has the tensile strength of 3MPa and the breaking strain of 41 percent.
Comparative example 2
A balloon for reducing human tissue damage, which adopts the raw materials, the wall thickness of the balloon and the size of the balloon are basically the same as those of the balloon in the embodiment 4, except that the balloon in the comparative example 2 is a spherical integral structure and does not contain a suture line, the tensile strength of the balloon is 2.7MPa, and the breaking strain of the balloon is 34 percent;
comparing comparative example 2 with example 4, it can be seen that the performance of the balloon in comparative example 2 is obviously inferior to that of example 4, because the balloon in comparative example 2 has the problems of large single point stress and large pressure during the movement process, and cannot play a role of buffering and bear high pressure; the balloon provided in example 4 had a concave-convex shape distribution on the surface thereof due to the presence of the suture line. After the sacculus was transplanted patient internal, in the motion process, the protruding surface of two alternate sub-sacculus atress respectively, when motion range is big, sub-sacculus concave surface part also probably contacts patient's soft tissue, also can the atress, holistic holding power is stronger, non-deformable can play better cushioning effect, the wear-resisting fastness on sacculus surface also obtains improving along with the reduction of pressure and the dispersion of power, and the life cycle extension of sacculus, buffer capacity and wear-resisting fastness have all obtained the promotion.
Example 5
The special-shaped saccule for reducing the injury of the soft tissue and other tissues of the human body is prepared by the following steps: firstly, extruding a biocompatible PLA and PLGA mixture (mass ratio is 1:1) from an extruder to form a special-shaped balloon blank, wherein the special-shaped balloon blank consists of three sub-balloon blanks with openings, two adjacent sub-balloon blanks are connected through a pressing line, and then, a balloon forming machine is adopted to perform gas injection blow molding on each sub-balloon blank to form the special-shaped balloon blank; wherein the wall thickness of the sub-saccule is 0.2 mm;
one sub-balloon is in an oblate spheroid shape after being expanded, the other sub-balloons are in a hollow ring shape after being expanded, the hollow ring-shaped sub-balloons are mutually sleeved, the oblate spheroid sub-balloon is positioned in the hollow part of the hollow ring-shaped sub-balloon with the smallest size of the hollow part, the width of a press line is 0.5cm, the width of the hollow ring-shaped sub-balloon is 2cm, the height of each sub-balloon is 1.8cm, and the height of the press line is 12 mm;
the special-shaped saccule for relieving the injury of the human soft tissue and other tissues has the tensile strength of 3.1MPa and the breaking strain of 46 percent.
Example 6
The special-shaped saccule for reducing the injury of the soft tissue and other tissues of the human body is prepared by the following steps: firstly, extruding a mixture (mass ratio is 2:1:2) of PLA, PLGA and PCL with biocompatibility from an extruder to form a special-shaped sacculus blank, wherein the special-shaped sacculus blank consists of four sub-sacculus blanks with openings, two adjacent sub-sacculus blanks are connected through a pressing line, and then, a sacculus forming machine is adopted to perform gas injection and blow molding on each sub-sacculus blank to form the special-shaped sacculus blank; wherein the wall thickness of the sub-saccule is 0.3 mm;
all the sub-balloons are in a columnar shape after being expanded, all the sub-balloons are arranged side by side, and the two ends of all the sub-balloons are flush with the two ends of all the bonding lines; along the arrangement direction of the sub-balloons, the end a of the sub-balloon at the outermost side is far away from the sub-balloon at the middle, the end b is close to the sub-balloon at the middle, the sub-balloon at the outermost side linearly tapers from the middle to the end a thereof while tapers to the arc line at the end b thereof, the sub-balloon at each middle linearly tapers from the middle to the arc line at both ends thereof, the distance between two adjacent sub-balloons is 0.6cm, and the distance between two adjacent bonding lines is 2.5 cm; the length of each sub-balloon is 7.5cm along the extension direction of each sub-balloon; along the direction which is mutually vertical to the arrangement direction and the extension direction of the sub-saccule, the heights of the sub-saccule and the pressure joint line are respectively 1.7cm and 15 mm;
the special-shaped saccule for relieving the injury of the human soft tissue and other tissues has the tensile strength of 3MPa and the breaking strain of 42 percent.
Example 7
The special-shaped saccule for reducing the injury of the soft tissue and other tissues of the human body is prepared by the following steps: firstly, PLGA with biocompatibility is extruded from an extruder to form a special-shaped sacculus capsule blank, the special-shaped sacculus capsule blank consists of three sub-sacculus capsule blanks with openings, two adjacent sub-sacculus capsule blanks are connected through a pressing line, and then a sacculus forming machine is adopted to perform gas injection blow molding on each sub-sacculus capsule blank to form the special-shaped sacculus capsule blank; wherein the wall thickness of the sub-saccule is 0.1 mm;
all the sub-balloons are in a columnar shape after being expanded, all the sub-balloons are arranged side by side, and the two ends of all the sub-balloons are flush with the two ends of all the bonding lines; along the arrangement direction of the sub-balloons, each sub-balloon is gradually reduced from the middle to the two ends of the sub-balloon in an arc manner, the distance between every two adjacent sub-balloons is 0.5cm, and the distance between every two adjacent bonding lines is 1.2 cm; the length of each sub-saccule is 2cm along the extending direction of each sub-saccule; along the direction which is mutually vertical to the arrangement direction and the extension direction of the sub-saccule, the heights of the sub-saccule and the pressure joint line are respectively 1.3cm and 4 mm;
the special-shaped saccule for relieving the injury of the human soft tissue and other tissues has the tensile strength of 2.8MPa and the breaking strain of 38 percent.
Example 8
The special-shaped saccule for reducing the injury of the soft tissue and other tissues of the human body is prepared by the following steps: firstly, extruding the PLCL with biocompatibility from an extruder to form a special-shaped sacculus capsule blank, wherein the special-shaped sacculus capsule blank consists of three sub-sacculus capsule blanks with openings, two adjacent sub-sacculus capsule blanks are connected through a pressing line, and then, a sacculus forming machine is adopted to perform gas injection and blow molding on each sub-sacculus capsule blank to form the special-shaped sacculus capsule blank; wherein the wall thickness of the sub-saccule is 0.2 mm;
all the sub-balloons are in a columnar shape after being expanded, all the sub-balloons are arranged side by side, and the two ends of all the sub-balloons are flush with the two ends of all the bonding lines; along the arrangement direction of the sub-balloons, the end a of the sub-balloon at the outermost side is far away from the sub-balloon at the middle, the end b is close to the sub-balloon at the middle, the sub-balloon at the outermost side linearly tapers from the middle to the end a thereof while tapers to the arc line at the end b thereof, the sub-balloon at each middle linearly tapers from the middle to the arc line at both ends thereof, the distance between two adjacent sub-balloons is 0.4cm, and the distance between two adjacent bonding lines is 2.2 cm; the length of each sub-saccule is 6cm along the extending direction of each sub-saccule; along the direction which is mutually vertical to the arrangement direction and the extension direction of the sub-saccule, the heights of the sub-saccule and the pressure joint line are respectively 2.2cm and 0.2 mm;
the special-shaped saccule for relieving the injury of the human soft tissue and other tissues has the tensile strength of 2.9MPa and the breaking strain of 36 percent.

Claims (5)

1. The special-shaped saccule for reducing the injury of the human soft tissue and other tissues is an expandable saccule with biocompatibility, and is characterized in that: the balloon mainly comprises a plurality of sub-balloons, and two adjacent sub-balloons are connected through a pressing line; all the sub-balloons are in a columnar shape after being expanded, all the sub-balloons are arranged side by side, and the two ends of all the sub-balloons are flush with the two ends of all the bonding lines; after the special-shaped saccule is expanded, along the arrangement direction of the sub-saccules, the end a of the sub-saccule at the outermost side is far away from the sub-saccule at the middle, the end b is close to the sub-saccule at the middle, the sub-saccule at the outermost side is linearly tapered from the middle to the end a thereof and is simultaneously tapered to the arc line at the end b thereof, and the arc line of each sub-saccule at the middle is tapered from the middle to the arc lines at the two ends thereof.
2. The special-shaped balloon for relieving the injury of the human soft tissue and other tissues as claimed in claim 1, wherein the tensile strength of the special-shaped balloon for relieving the injury of the human soft tissue and other tissues is 2.8-3.2 MPa, and the breaking strain is 30% -50%.
3. A shaped balloon to mitigate soft tissue and other tissue damage in a human body as in claim 1, wherein the number of sub-balloons is 4; the sub-saccule and the press line are made of biodegradable materials; the biodegradable material is selected from more than one of PLA, PLGA, PLCL and PCL; the wall thickness of the sub-saccule is 0.1-0.3 mm.
4. The special-shaped saccule for relieving the injury of the human soft tissue and other tissues according to claim 1, wherein after the special-shaped saccule is inflated, along the arrangement direction of the sub-saccules, the distance between two adjacent sub-saccules is 0.2-0.6 cm, and the distance between two adjacent bonding lines is 0.4-2.5 cm; the length of each sub-saccule is 2-10 cm along the extension direction of each sub-saccule; along the direction which is mutually vertical to the arrangement direction and the extension direction of the sub-saccule, the heights of the sub-saccule and the pressure joint line are 0.8-2.2 cm and 0.2-15 mm respectively.
5. A method of making a contoured balloon according to any one of claims 1 to 4 for reducing injury to soft and other tissues of the human body, comprising: the method comprises the steps of extruding a material with biocompatibility from an extruder to form a special-shaped sacculus bag blank, wherein the special-shaped sacculus bag blank mainly comprises a plurality of sub-sacculus bag blanks with openings, connecting two adjacent sub-sacculus bag blanks through a pressing line, and then performing gas injection and blow molding on each sub-sacculus bag blank by using a sacculus forming machine to form the special-shaped sacculus for reducing the damage of human soft tissues and other tissues.
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