CN111759532A - A long-term subacromial balloon independent of wall tightness - Google Patents

Abstract

The invention discloses a subacromial balloon which is independent of the sealing property of a balloon wall and can be used for a long time. The upper surface of the saccule is adhered with the lower surface of the coracoid ligament, in-situ self-forming hydrogel is filled in the saccule, and the hydrogel can exist alone as a solid after being absorbed by the saccule wall. The balloon can restore the distance between the head and the shoulder of the humerus, improve the abduction and uplifting functions of shoulder joints, restore the original shape after extrusion, release the medicine to play the role of treatment such as pain relief and the like, has no problem of non-lasting curative effect caused by air leakage, degradation and the like, does not move in gaps under the shoulder to cause accidental injury, and is simple and convenient to place and operate.

Description

A long-term subacromial balloon independent of wall tightness

technical field

The invention belongs to the field of medical devices, and relates to a subacromial balloon that can be used for a long time, in particular to a long-term useable subacromial balloon that does not depend on the sealing property of the bag wall.

Background technique

The rotator cuff is a general term for the supraspinatus, infraspinatus, teres minor and subscapularis muscles, which originate from the outside of the scapula, pass below the acromion, wrap around the humeral head and insert on the outside of the humeral head, and are closely connected to the shoulder joint capsule. The main function of the rotator cuff is to maintain the position of the humeral head during upper arm abduction, keeping it close to the glenoid of the scapula. Rotator cuff injury will significantly affect the abduction ability of the upper extremity. Rotator cuff injuries are associated with tendon strain, degeneration, and indirect violence. The surgical treatment of rotator cuff injury is now mostly arthroscopic minimally invasive treatment, and the effect is better. The goal of surgical treatment is to restore rotator cuff structural continuity and restore rotator cuff function.

A rotator cuff tear with an anterior-posterior diameter of more than 5 cm is called a giant rotator cuff tear. Huge rotator cuff tears are often accompanied by the upward movement of the humeral head and the reduction of the humeral head-acromial space, which damages the biomechanics of the shoulder joint, which significantly affects the lifting and abduction functions of the shoulder joint, and the patient's quality of life decreases significantly. The treatment of giant rotator cuff tears is difficult and the prognosis is not ideal. Some large rotator cuff tears cannot be repaired, and most repairable tears have unfavorable factors such as poor tissue conditions and high post-repair tension, and the recurrence rate of postoperative tear is high.

At present, there is an inflatable balloon on the market. After being placed between the humerus and the acromion and filled with gas, the distance between the humeral head and the acromion can be maintained and the normal biomechanics of the shoulder joint can be restored. However, the balloon is made of absorbable material, which is completely degraded within one year and becomes invalid. Before degradation, there is also the risk of air leakage after wear and tear. Air leakage will weaken or even completely lose the therapeutic effect of the device, and cannot guarantee the stability and durability of the curative effect. The position of the balloon in the subacromial space is not fixed, and there is a risk of uncontrollable movement and compression of peripheral nerves and blood vessels.

By searching the existing patent documents, several disclosed subacromial balloons based on existing products were found (patent numbers CN111096824A, CN105350266A, CN109091247A, CN209048360U, CN305352622S, etc.). However, affected by the traditional concept, the structure of this type of balloon still follows the "wall + filler" model, using gas, liquid or ordinary gel to inject into the balloon, the filler itself cannot be formed, and the sealing of the balloon wall needs to be ensured to prevent The filler forms a constraint, maintaining the balloon shape. Due to the limitations of the existing technology, once the balloon wall is damaged in a small area or even point-like due to long-term use, the sealing performance will be affected, resulting in leakage of the filler, overall deformation of the balloon, weakened support, and the risk of wear increases with the use of time. After the balloon is deformed as a whole due to the leakage of the filler, the fixation effect achieved by the unique shape of the balloon in some solutions cannot be maintained.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a subacromial balloon that can be used for a long time without relying on the airtightness of the capsule wall in view of the above-mentioned defects in the prior art; it mainly solves the air leakage that may be caused by the subacromial balloon in clinical application, deformation, failure, etc.

The purpose of this invention is to realize through the following technical solutions:

The present invention relates to a hydrogel-filled and fixable subacromial balloon, the balloon comprising:

a capsule body, wherein a cavity is set in the capsule body;

Hydrogel, after the hydrogel components are injected into the capsule and mixed, they can be formed by reaction and/or by UV irradiation;

A filling part, the filling part comprises a connected outer filling conduit and a heat sealing part, the heat sealing part is arranged outside the opening of the bag body; the filling part is used for water gel to pass through and enter the hollow of the bag body intracavity.

The inside of the cavity inside the capsule is a filling space, and the filling space is communicated with the outer space of the capsule through a filling component, and the size of the filled cavity can be adjusted by changing the quality of the filling material.

As an embodiment of the present invention, the upper surface of the capsule body is provided with an adhesive part that adheres to the lower surface of the coracoacromial ligament.

As an embodiment of the present invention, the upper surface of the capsule is adhered to the lower surface of the coracoacromial ligament by a medical adhesive; the position is fixed.

As an embodiment of the present invention, in use, the balloon is placed in the space between the lower surface of the acromion and the upper surface of the humeral head.

As an embodiment of the present invention, the balloon is filled with a self-forming hydrogel, and after the hydrogel is formed, the balloon body has a solid structure.

Further, the hydrogel exists alone as a solid body after the capsule wall is absorbed.

As an embodiment of the present invention, the sealing of the capsule is achieved by heating and pressing the heat-sealing portion. Then cut off the filling outer conduit and part of the heat seal along the sealing boundary.

As an embodiment of the present invention, the material of the capsule body is a medical degradable material (with a lower melting point). Preferably, the material of the capsule body is polycaprolactone, polyethylene glycol and the like.

As an embodiment of the present invention, the hydrogel is an injectable and in situ self-forming medical material. It is preferred to include a hydrogel made by mixing organic and inorganic components. The organic components include hyaluronic acid, alginate, amino acids, gelatin, etc.; and the inorganic components include silicate bioceramics such as diopside, flavonite, and yellow feldspar.

As an embodiment of the present invention, the lower surface of the balloon body is a concave arc surface, which is compatible with the humeral head.

As an embodiment of the present invention, the bag body and the filling part are integrally formed.

The subacromial balloon provided by the invention can be used for a long time. After the hydrogel is filled into the cavity of the balloon body through the filling component, it is shaped by the balloon wall; after the hydrogel is shaped, the balloon has a solid structure; The wall is made of absorbable material. After the balloon wall loses its integrity and sealing due to absorption and wear, the internal hydrogel still maintains its original shape and mechanical strength to ensure the continued existence of the balloon function.

Compared with the prior art, the present invention has the following beneficial effects:

1. In the present invention, after the subacromial space is placed and filled, the upper surface of the balloon is fixed with the coracoacromial ligament with an adhesive to avoid uncontrollable displacement of the balloon in the future, and the fixing method is simple and safe;

2. The inside of the balloon is in the form of a solid body after being filled with hydrogel. After the hydrogel is formed, the original shape can be maintained. The balloon wall only plays a role in assisting the forming, and there is no need to maintain the seal for a long time. The hydrogel can make the mechanical effect of the balloon continue to exist, and the abrasion or absorption of the hydrogel only leads to the change of the local but not the overall shape of the solid body, so as to achieve a long-term therapeutic effect.

Description of drawings

Other features, objects and advantages of the present invention will become more apparent by reading the detailed description of non-limiting embodiments with reference to the following drawings:

1 is a schematic structural diagram of the fixable balloon provided by the present invention when it is used for the treatment of rotator cuff tear;

Fig. 2 is the structural representation when the present invention is not filled;

Fig. 3 is the structural representation after long-term use of the present invention;

In the figure, 1 is the filling outer catheter, 2 is the heat sealing part, 3 is the balloon, 4 is the filling part, 5 is the acromion, 6 is the clavicle, 7 is the coracoclavicular ligament, 8 is the coracoacromial ligament, and 9 is the coracoid process , 10 is the humeral head, 11 is the glenoid, 12 is the worn capsule wall, and 13 is the formed hydrogel.

Detailed ways

The present invention will be described in detail below with reference to the embodiments. The following examples will help those skilled in the art to further understand the present invention, but do not limit the present invention in any form. It should be noted that, for those skilled in the art, several adjustments and improvements can be made without departing from the inventive concept. These all belong to the protection scope of the present invention.

Example 1

This embodiment provides a long-term subacromial balloon that does not depend on the tightness of the balloon wall; as shown in FIGS. 1 and 2 , the fixable balloon provided by the present invention includes a balloon body 3 , and the inside of the balloon body 3 is There is a cavity to form a filling space, and the filling space communicates with the outside of the capsule body through the filling part 4; after the filling is completed, the size of the capsule body is adjusted by the specific amount of the filling material. The filling part 4 includes a filling outer conduit 1 and a heat sealing part 2 , and the filling part 4 and the balloon body 3 are integrally formed.

The filler in this embodiment is a high-strength self-healing hydrogel based on modified hyaluronic acid (see CN111072997A for the preparation method). The preparation method is as follows: mixing 10% by mass of maleic hydrazide hyaluronic acid and 90% of phosphate buffer solution at room temperature to obtain gel component A; 10% by mass of aldehyde-based hyaluronic acid The acid and 90% phosphate buffer solution are mixed uniformly at room temperature to obtain gel component B; gel component A and component B are mixed in equal volumes and extruded through a syringe to obtain a preliminarily cured self-healing hydrogel. The high-strength self-healing hydrogel is obtained by irradiation with ultraviolet light.

In use, a balloon (balloon) is placed in the subacromial space. As shown in Figure 1, the top of the gap is formed by the acromion 5 and the acromion end of the clavicle 6, the front of the gap is the coracoclavicular ligament 7, the coracoacromial ligament 8 and the coracoid process 9, and the bottom of the gap is the humeral head 10 and the scapula The upper part of the glenoid 11. The filling part is filled with two hydrogel components (that is, the above-mentioned gel component A and component B), mixed to form a gel, and then shaped by ultraviolet light irradiation. The heat-sealing portion 2 is sealed by heating with an ultrasonic knife, and then the filling outer conduit 1 and part of the heat-sealing portion 2 are cut off along the sealing boundary. Then, a part of the upper surface area of the capsule wall was cut off with surgical scissors, and the upper surface of the hydrogel formed in the capsule was exposed in the area. Apply adhesive on the lower surface of the coracoacromial ligament, elevate the balloon or passively move the upper limb on the operative side, so that the upper surface of the balloon and the lower surface of the coracoacromial ligament contact and bond under certain pressure. After placement, the balloon compresses the humeral head, restoring joint motion and reducing pain (Figure 1). The formed hydrogel 13 allows the mechanical effect of the balloon to continue after the worn balloon wall 12 loses its sealing effect on the contents (FIG. 3).

Example 2

This embodiment provides a long-term subacromial balloon that does not depend on the tightness of the balloon wall; as shown in FIGS. 1 and 2 , the fixable balloon provided by the present invention includes a balloon body 3 , and the inside of the balloon body 3 is There is a cavity to form a filling space, and the filling space communicates with the outside of the capsule body through the filling part 4; after the filling is completed, the size of the capsule body is adjusted by the specific amount of the filling material. The filling part 4 includes a filling outer conduit 1 and a heat sealing part 2 , and the filling part 4 and the balloon body 3 are integrally formed.

The filler in this embodiment is a composite hydrogel pre-added with drugs, which is formed by mixing sodium alginate, amino acid, and silicate bioceramic containing two or more kinds of multivalent cations in situ (refer to the preparation method). CN106806943B), the preparation method is: a. First, the sodium alginate powder is sterilized by ultraviolet light for 30min, and then the sodium alginate powder is stirred and dissolved at room temperature, the mass volume concentration is 1.5%, and it is 4 ℃ overnight to make it dissolve uniformly; b. Weigh a certain amount of magnesite feldspar bioceramic powder, add it to the sodium alginate solution after ultraviolet sterilization, make its mass volume concentration 2%, and stir evenly; c. Put the mixed solution formed by b into sterile In the syringe on one side of the three-way tube, a certain amount of UV-sterilized glutamic acid powder can be added to the syringe on the other side according to the required gel time, and the mass volume concentration of glutamic acid is 0.5 %, the two are mixed evenly in the three-way pipe; d. During the mixing process, the hydrolysis of glutamic acid will promote the slow release of Ca and Mg ions in the sodium alginate bioceramic powder, and the alginic acid will be released within 5 minutes. Sodium cross-linked into a gel. The added drugs can be local anesthetics (lidocaine, ropivacaine), hyaluronic acid, long-acting glucocorticoids (betamethasone), non-steroidal anti-inflammatory drugs (loxoprofen sodium) , indomethacin) or a mixture of the above classes of drugs.

When in use, the balloon (balloon) is placed in the subacromial space, as shown in Figure 1, the top of the space is formed by the acromion 5 and the acromion end of the clavicle 6, and the front of the space is the coracoclavicular ligament 7, the beak. The shoulder ligament 8 and the coracoid process 9, the bottom of the gap is the upper part of the humeral head 10 and the glenoid 11. The two components of the above-mentioned hydrogel are filled with a double-ended syringe through the filling part, and after mixing, the hydrogel is formed and the capsule body is expanded. After the filling is completed, the heat-sealing portion 2 is sealed by heating with a surgical radiofrequency knife or an ultrasonic knife, and then the filling outer conduit 1 and a part of the heat-sealing portion 2 are cut off along the sealing boundary. Then, a part of the upper surface area of the capsule wall was cut off with surgical scissors, and the upper surface of the hydrogel formed in the capsule was exposed in the area. Apply adhesive on the lower surface of the coracoacromial ligament, elevate the balloon or passively move the upper limb on the operative side, so that the upper surface of the balloon and the lower surface of the coracoacromial ligament contact and bond under certain pressure. After placement, the balloon compresses the humeral head, restoring joint motion and reducing pain (Figure 1). With the absorption of the cyst wall, the drug contained in the hydrogel is gradually released into the subacromial space. The formed hydrogel 13 allows the mechanical effect of the balloon to continue after the worn balloon wall 12 loses its sealing effect on the contents (FIG. 3).

Example 3

This embodiment provides a long-term subacromial balloon that does not depend on the tightness of the balloon wall; as shown in FIGS. 1 and 2 , the fixable balloon provided by the present invention includes a balloon body 3 , and the inside of the balloon body 3 is There is a cavity to form a filling space, and the filling space communicates with the outside of the capsule body through the filling part 4; after the filling is completed, the size of the capsule body is adjusted by the specific amount of the filling material. The filling part 4 includes a filling outer conduit 1 and a heat sealing part 2 , and the filling part 4 and the balloon body 3 are integrally formed.

The filler in this embodiment is a gelatin nanoparticle-iPRF (injectable platelet-rich fibrin) double network structure composite hydrogel (refer to CN110743038A for the preparation method). ~1000g, the top yellow transparent liquid after centrifugation and stratification is the blood extract iPRF, and the hydrogel is obtained after the top yellow transparent liquid and the gelatin nanocolloid particles are fully mixed and solidified; or the gelatin nanocolloid particles are added to fresh The blood sample is put into a centrifuge for 1-10 minutes at a speed of 50-1000 g, and the top layer of brown-yellow colloid after centrifugation and layering is the hydrogel. Among them, the particle size of the gelatin nano-colloid particles is 10nm-2μm, and the surface charge is -40-40mV.

When in use, the balloon (balloon) is placed in the subacromial space, as shown in Figure 1, the top of the space is formed by the acromion 5 and the acromion end of the clavicle 6, and the front of the space is the coracoclavicular ligament 7, the beak. The shoulder ligament 8 and the coracoid process 9, the bottom of the gap is the upper part of the humeral head 10 and the glenoid 11. The filling part is filled with the two components of the hydrogel according to the volume ratio with a double-headed syringe and mixed to make the capsule body swell. After sealing, the filling outer conduit 1 and part of the heat-sealing part 2 are cut off along the sealing boundary. Then, a part of the upper surface area of the capsule wall was cut off with surgical scissors, and the upper surface of the hydrogel formed in the capsule was exposed in the area. Two components of hydrogel were coated on the lower surface of the coracoacromial ligament, the balloon was elevated or the upper limb on the surgical side was passively moved, so that the upper surface of the balloon and the lower surface of the coracoacromial ligament contacted and bonded under certain pressure. After placement, the balloon compresses the humeral head, restoring joint motion and reducing pain (Figure 1). The formed hydrogel 13 allows the mechanical effect of the balloon to continue after the worn balloon wall 12 loses its sealing effect on the contents (FIG. 3).

Specific embodiments of the present invention have been described above. It should be understood that the present invention is not limited to the above-mentioned specific embodiments, and those skilled in the art can make various variations or modifications within the scope of the claims, which do not affect the essential content of the present invention. The embodiments of the present application and features in the embodiments may be combined with each other arbitrarily, provided that there is no conflict.

Claims (10)

1. a fixable subacromial balloon filled with hydrogel, is characterized in that, described balloon comprises: a capsule body, wherein a cavity is set in the capsule body; A hydrogel, which is an injectable and in-situ self-forming hydrogel; A filling part, the filling part comprises a connected outer filling conduit and a heat sealing part, the heat sealing part is arranged outside the opening of the bag body; the filling part is used for water gel to pass through and enter the hollow of the bag body intracavity. 2 . The hydrogel-filled and fixable subacromial balloon according to claim 1 , wherein the upper surface of the balloon body is provided with an adhesive portion that adheres to the lower surface of the coracoacromial ligament. 3 . 3 . The hydrogel-filled fixable subacromial balloon according to claim 1 , wherein the upper surface of the balloon body is bonded to the lower surface of the coracoacromial ligament by a medical adhesive. 4 . 4. The balloon that can be fixed under the acromion of filling hydrogel according to claim 2 or 3 is characterized in that, during use, the balloon is placed between the lower surface of the acromion and the upper surface of the humeral head. gap between. 5 . The hydrogel-filled balloon under the acromion can be fixed according to claim 1 , wherein the balloon is filled with hydrogel, and after the hydrogel is formed, the balloon body is in a solid structure. 6 . 6 . The hydrogel-filled and fixable subacromial balloon according to claim 5 , wherein the hydrogel exists alone as a solid body after the balloon wall is absorbed. 7 . 7 . The hydrogel-filled and fixable subacromial balloon according to claim 1 , wherein the sealing of the balloon body is achieved by hot pressing the heat sealing portion. 8 . 8 . The hydrogel-filled and fixable subacromial balloon according to claim 1 , wherein the material of the balloon body is a medical degradable material. 9 . 9 . The hydrogel-filled and fixable subacromial balloon according to claim 1 , wherein the lower surface of the balloon body is a concave arc surface, which is compatible with the humeral head. 10 . 10 . The hydrogel-filled fixable subacromial balloon of claim 1 , wherein the balloon body and the filling component are integrally formed. 11 .

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