阅读说明：本技术 减轻人体软组织损伤的可撕拉异形球囊及其制备方法 (Tearable special-shaped balloon capable of relieving human soft tissue injury and preparation method thereof ) 是由 郝欣欣 李凌晨 蒋冠森 于 2019-10-11 设计创作，主要内容包括：本发明涉及一种减轻人体软组织损伤的可撕拉异形球囊及其制备方法,制备方法为：先将具有生物相容性的材料从挤出机中挤出形成主要由多个带开口的子球囊囊坯组成的异形球囊囊坯,相邻两个子球囊囊坯通过线条状可撕拉部件连接,再采用球囊成型机对各子球囊囊坯进行注气吹塑；最终制得的可撕拉异形球囊主要由多个子球囊组成,相邻两个子球囊通过线条状可撕拉部件连接。本发明的减轻人体软组织损伤的可撕拉异形球囊的制备方法简单,制得的可撕拉异形球囊表面凹凸不平,在移植部位的稳定性更好,不易滑脱,运动过程中可多点受力,起到更好的缓冲作用,可撕拉异形球囊是可被裁剪的,可针对性缓解不同类型、不同程度的软组织损伤。(The invention relates to a tearable special-shaped saccule for relieving human soft tissue injury and a preparation method thereof, wherein the preparation method comprises the following steps: extruding a biocompatible material from an extruder to form a special-shaped sacculus capsule blank mainly comprising a plurality of sub-sacculus capsule blanks with openings, connecting two adjacent sub-sacculus capsule blanks through linear tearable parts, and performing gas injection and blow molding on each sub-sacculus capsule blank by using a sacculus forming machine; the finally prepared tearable special-shaped saccule mainly comprises a plurality of sub-saccules, and two adjacent sub-saccules are connected through a linear tearable part. The tearable profiled balloon for reducing the soft tissue injury of the human body has the advantages of simple preparation method, uneven surface of the prepared tearable profiled balloon, better stability at the transplanted part, difficult slipping, multi-point stress during the movement process, better buffer effect, capability of being cut and targeted relief of soft tissue injuries of different types and degrees.)

1. The tearable special-shaped sacculus for reducing the injury of the soft tissue of the human body is an expandable sacculus with biocompatibility, and is characterized in that: the utility model mainly comprises a plurality of sub-sacculus, and two adjacent sub-sacculus pass through the connection of line form tearable part.

2. The tearable profiled balloon for alleviating soft tissue injury of human body according to claim 1, wherein the tearable profiled balloon for alleviating soft tissue injury of human body has a tensile strength of 2.8 to 3.2MPa and a strain at break of 30% to 50%.

3. The tearable profiled balloon for alleviating soft tissue injury of human body according to claim 1, wherein the number of the sub-balloons is 2-4; the sub-saccule and the tear-off component 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 tearable profiled balloon for alleviating soft tissue injury of human body according to claim 1, wherein the tearable member is a tear strip, the tear strip is composed of a tear strip body and a tear line located in the tear strip body, the tear line is composed of a plurality of line segments, and the distance between two adjacent line segments is 0.2-0.3 times the length of the tear line.

5. The tearable profiled balloon for alleviating soft tissue injury of a human body according to any one of claims 1 to 4, wherein each sub-balloon is in a column shape after being inflated, all sub-balloons are arranged side by side, and both ends of all sub-balloons and all tearable members are flush;

after the special-shaped saccule is expanded, along the arrangement direction of the sub-saccules, the end a of the outermost sub-saccule is far away from the middle sub-saccule, the end b is close to the middle sub-saccule, the outermost sub-saccule linearly tapers from the middle to the end a thereof and also tapers to the end b thereof, and each middle sub-saccule tapers from the middle to the two ends thereof;

or after the special-shaped saccule is inflated, each sub-saccule gradually shrinks from the middle to the arcs at the two ends of the sub-saccule along the arrangement direction of the sub-saccules.

6. The tearable profiled balloon for alleviating soft tissue injury of a human body according to claim 5, wherein after the profiled balloon is inflated, along the arrangement direction of the sub-balloons, the distance between two adjacent sub-balloons is 0.2 to 0.6cm, and the distance between two adjacent tearable members is 0.4 to 2.5 cm; the length of each sub-saccule is 2-10 cm along the extension direction of each sub-saccule; along the direction mutually perpendicular with the arrangement direction and the extending direction of the sub-saccule, the heights of the sub-saccule and the tear-off part are 0.8-2.2 cm and 0.2-15 mm respectively.

7. The tearable irregularly shaped balloon for alleviating soft tissue injury in human bodies according to any of claims 1 to 4, wherein one of the sub-balloons is spherical or oblate after inflation, the other sub-balloons are hollow annular after inflation, the hollow annular sub-balloons are sleeved with each other, and the spherical or oblate sub-balloons are located in the hollow portion of the hollow annular sub-balloon with the smallest hollow portion size.

8. The tearable profiled balloon for alleviating soft tissue injury of human body according to claim 7, wherein after the profiled balloon is inflated, the tearable member has a width of 0.2 to 0.6cm, the hollow ring-shaped sub-balloons have a width of 0.4 to 2.5cm, each sub-balloon has a height of 0.8 to 2.2cm, and the tearable member has a height of 0.2 to 15 mm.

9. The method for preparing the tearable profiled balloon for alleviating soft tissue injury in human body according to any one of claims 1 to 8, wherein: firstly, 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, two adjacent sub-sacculus bag blanks are connected through a linear tearable part, and then, carrying out gas injection and blow molding on each sub-sacculus bag blank by adopting a sacculus forming machine to form the tearable special-shaped sacculus for reducing the injury of human soft tissues.

Technical Field

The invention belongs to the technical field of medical instruments, and relates to a tearable special-shaped balloon capable of relieving human soft tissue injury 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.

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, and in addition, due to the specificity of human bones and the diversity of human tissue damage types, the balloon structure with a single size may bring great discomfort to patients.

Therefore, there is a need to develop a tear-off shaped balloon to solve the above problems.

Disclosure of Invention

The invention aims to solve the problems that a balloon designed by a spherical structure in the prior art has large single-point stress, strong pressure, insufficient wear-resistant fastness and poor adaptability to human tissues, and provides a tearable special-shaped balloon capable of relieving human soft tissue injury and a preparation method thereof.

In order to achieve the purpose, the invention adopts the following scheme:

the tearable special-shaped saccule for relieving the injury of the soft tissue of the human body is an inflatable saccule with biocompatibility and mainly comprises a plurality of sub-saccules, and two adjacent sub-saccules are connected through a linear tearable part.

The tearable special-shaped balloon consists of a plurality of sub-balloons, a tearable part is arranged between every two adjacent sub-balloons, and the surface of the whole balloon forms a concave-convex shape after the tearable special-shaped balloon is expanded. This sacculus can whole implantation use, use as little sacculus after tearing also, when the whole implantation of sacculus uses, in the motion process, the sacculus surface can the multiple spot atress, because the sacculus surface is concavo-convex shape and distributes, lead to the sacculus to transplant to patient after internal, in the motion process, two alternate sub-sacculus convex surfaces atress respectively, when motion range is big, sub-sacculus concave surface part also probably contacts patient's soft tissue, also can the atress, the holistic holding power of sacculus is stronger, non-deformable, difficult emergence dislocation slides, can play better buffering and fixed action, the wear-resisting fastness on sacculus surface also obtains improving along with the reduction of pressure and the dispersion of power, the life cycle of sacculus has been prolonged, whether the user can tear according to the demand decision when using the sacculus and pull the part that can tear simultaneously. The balloon has the advantages that the balloon can be cut according to different rotator cuff injury conditions of different patients, the discomfort caused by the overlarge or undersize balloon is avoided, and the function of smooth movement of joint tissues is effectively improved; the common saccule in the prior art has the advantages of single stress, relatively large pressure, no abrasion resistance, short service cycle and no possibility of adjusting the size according to requirements due to the single stress in the movement process.

The process of implanting the special-shaped saccule into the worn or torn part of the human body comprises the following steps: firstly, arthroscopy inspects the damaged condition of the rotator cuff of a patient, confirms that the rotator cuff is suitable for debridement of the damaged part after an operation, measures the space under the acromion by using an arthroscopy probe, selects a proper balloon size to prepare for implantation, then prepares a balloon inflation system in vitro, places the balloon in a channel tube of the inflation system, establishes an operation channel by using the channel tube, places the channel tube in the joint of the patient, puts the inflation system into the body, connects the inflation system to the balloon, starts to fill filler into the balloon to reach a target height, seals the balloon after the internal and external pressure of the balloon is stable, removes the inflation system, finally inspects whether the balloon has dislocation condition, and completes the implantation process of the balloon.

As a preferable scheme:

according to the tearable profiled balloon for alleviating the human soft tissue injury, the tensile strength of the tearable profiled balloon for alleviating the human soft tissue injury is 2.8-3.2 MPa, and the breaking strain is 30-50%, compared with a common balloon made of the same material, the tensile strength of the tearable profiled balloon is improved by 2-3 times, and the breaking strain is improved by 10-15%.

The tearable special-shaped saccule for relieving the human soft tissue injury has 2-4 sub-saccules; the balloon simulation in vivo is mainly that the acromion sliding bag is simulated in vivo, the volume of the acromion sliding bag in vivo is small, too many tearing balloons are arranged, the single balloon is too small, and dislocation is easy to occur in vivo, so that only 2-4 tearing balloons are designed, the requirement of cutting is met on one hand, and the size of the basic balloon is met on the other hand; the sub-saccule and the tear-off component 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.

As the tearable abnormal-shaped saccule for relieving the injury of the soft tissues of the human body, the tearable part is the tearable strip, the tearable strip consists of the tearable strip body and the tearable wire positioned in the tearable strip body, the tearable wire consists of a plurality of line segments, and the distance between two adjacent line segments is 0.2-0.3 times of the length of the tearable wire.

The tearable abnormal-shaped saccule for alleviating the soft tissue injury of the human body as described in any one of the above, after being inflated, each sub-saccule is in a column shape, all the sub-saccules are arranged side by side, and both ends of all the sub-saccules and all the tearable parts are flush;

after the special-shaped saccule is inflated, along the arrangement direction of the sub-saccules, the end a of the outermost sub-saccule is far away from the middle sub-saccule, the end b is close to the middle sub-saccule, the outermost sub-saccule 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 also tapers to 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 line), each middle sub-saccule 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 line), and the structure of the special-shaped saccule simulates a naturally existing subacromial bursa and is more fit with the structure of a shoulder joint, slippage and dislocation is not easy to occur;

or after the special-shaped saccule is inflated, each sub-saccule is gradually reduced from the middle to the arcs at the two ends of the sub-saccule along the arrangement direction of the sub-saccule (preferably, the arcs 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 tearable parts 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 mutually perpendicular with the arrangement direction and the extending direction of the sub-saccule, the heights of the sub-saccule and the tear-off part are 0.8-2.2 cm and 0.2-15 mm respectively.

In the tearable abnormal-shaped saccule for alleviating the soft tissue injury of the human body, one sub-saccule is spherical or oblate after being expanded, the other sub-saccule is hollow and annular after being expanded, the hollow annular sub-saccules are mutually sleeved, and the spherical or oblate spherical sub-saccule is positioned in the hollow part of the hollow annular sub-saccule with the smallest hollow part size.

After the special-shaped saccule is inflated, the width of the tearable component is 0.2-0.6 cm, the width of the 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 tearable component 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 tearable special-shaped saccule for relieving the human soft tissue injury, 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, connecting two adjacent sub-saccule blanks through a linear tearable part, and then performing gas injection and blow molding on each sub-saccule blank by using a saccule forming machine to form the tearable special-shaped saccule for relieving the human soft tissue injury, or further welding and assembling the open end of each sub-saccule blank and a guide pipe, so that gas, liquid, anti-inflammatory drugs and the like with good biocompatibility with the special-shaped saccule can be filled into the special-shaped saccule through the guide pipe to realize the expansion of the special-shaped saccule; the preparation method of the tearable special-shaped balloon for alleviating the soft tissue injury of the human body can also comprise the steps of firstly preparing a plurality of sub-balloon bag blanks respectively, then carrying out pressing (forming a dotted line by control in the pressing process) on the plurality of sub-balloon bag blanks and then carrying out gas injection blow molding 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 (forming a dotted line by control in the pressing process) to obtain the special-shaped balloon, or can also comprise the steps of preparing a common balloon firstly 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-; the tear-off component in the form of a strip may be formed directly in the balloon-forming machine or may be formed by post-processing, for example by extruding from an extruder a score line, a portion of which is removed so that the score line changes from a solid line to a broken line.

Has the advantages that:

(1) the tearable special-shaped saccule for relieving the soft tissue injury of the human body has uneven surface and can bear force at multiple points in the movement process, so that the tearable special-shaped saccule has small force on average to a single point, relatively small pressure intensity, difficult deformation and good pressure resistance, can play a better buffer role and improve the wear resistance fastness;

(2) the tearable special-shaped saccule for relieving the human soft tissue injury can be cut, and can pertinently relieve different types and different degrees of tissue injuries;

(3) the preparation method of the tearable special-shaped saccule for relieving the soft tissue injury of the human body is simple and easy to popularize.

Drawings

Fig. 1 is a schematic structural diagram of a tearable irregularly-shaped balloon for alleviating soft tissue injury of a human body 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 tearable shaped balloon for alleviating soft tissue injury in 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 tearable profiled balloon for alleviating soft tissue injury in human body according to embodiment 3 of the present invention;

FIG. 7 is a schematic view of the connection of the tear strip to the sub-balloon;

wherein, 1-sub saccule, 2-tearing line and 3-tearing line body.

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.