CN111759532A

CN111759532A - Do not rely on sacculus under shoulder peak of cyst wall leakproofness for long-term use

Info

Publication number: CN111759532A
Application number: CN202010647667.6A
Authority: CN
Inventors: 陈俊; 陈雨舟; 盛旦丹
Original assignee: Huashan Hospital of Fudan University
Current assignee: Huashan Hospital of Fudan University
Priority date: 2020-07-07
Filing date: 2020-07-07
Publication date: 2020-10-13

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

Do not rely on sacculus under shoulder peak of cyst wall leakproofness for long-term use

Technical Field

The invention belongs to the field of medical instruments, relates to a subacromial balloon capable of being used for a long time, and particularly relates to a subacromial balloon capable of being used for a long time without depending on the tightness of a balloon wall.

Background

The rotator cuff is a general term for supraspinatus, infraspinatus, teres minor and infrascapula, starts from the outer side of the scapula, passes through the lower part of the acromion, wraps around the humeral head and ends at the outer side of the humeral head, and is tightly connected with the shoulder joint capsule. The main function of the rotator cuff is to maintain the position of the humeral head during abduction of the upper arm so that it remains in close proximity to the glenoid of the scapula. Rotator cuff injury will significantly affect the ability of the upper limb to abduct. Rotator cuff injury is related to tendon strain, degeneration and indirect violence. The surgical treatment of rotator cuff injury adopts the minimally invasive treatment under an arthroscope, and the effect is better. The purpose of the surgical treatment is to reestablish the continuity of the rotator cuff structure and restore the rotator cuff function.

The anterior-posterior diameter of the rotator cuff tear exceeds 5cm, which is called giant rotator cuff tear. The huge rotator cuff tear is mostly accompanied with the humeral head moving upwards and the humeral head-acromion gap becoming smaller, the biomechanics of the shoulder joint are destroyed, the rising and abduction functions of the shoulder joint are obviously affected, and the life quality of the patient is obviously reduced. The treatment of giant rotator cuff tear is difficult, and the prognosis is not ideal. Partial huge rotator cuff tears can not be repaired, and the repairable tears also have adverse factors such as poor tissue conditions, high tension after repair and the like, and the recurrence rate of the postoperative tears is high.

At present, an inflatable balloon is available in the market, and after the inflatable balloon is placed between a humerus and a acromion and filled with gas, the distance between the humerus head and the acromion can be maintained, and normal biomechanics of a shoulder joint can be recovered. However, the balloon is made of an absorbable material, and is completely degraded within one year to lose efficacy, and before degradation, the balloon also has the risk of air leakage after abrasion, and the air leakage can weaken or even completely lose the treatment effect of the device, so that the stability and the durability of the treatment effect cannot be ensured; meanwhile, the air bag is not fixed at the gap position under the acromion, and has the risk of uncontrollable movement so as to press peripheral nerves, blood vessels and the like.

Through a search of the existing patent literature, several disclosed subacromial balloons improved based on the existing products were found (patent nos. CN111096824A, CN105350266A, CN109091247A, CN209048360U, CN305352622S, etc.). However, under the influence of the conventional concept, the construction of such balloons still continues to use a "balloon wall + filler" mode, and the filler itself cannot be molded by injecting gas, liquid or ordinary gel into the balloon, and the balloon wall sealing property needs to be ensured to form a constraint on the filler and maintain the shape of the balloon. Due to the limitation of the existing process, once the capsule wall is damaged in a small area or even in a point shape due to long-term use, the sealing performance is affected, so that the filler leaks out, the whole balloon deforms, the supporting function is weakened, and the abrasion risk is increased along with the prolonging of the use time. After the balloon is deformed integrally due to leakage of the filler, the fixing effect achieved by the specific shape of the balloon cannot be maintained in some schemes.

Disclosure of Invention

The invention aims to provide a subacromial balloon which can be used for a long time without depending on the sealing property of the balloon wall, aiming at the defects of the prior art; mainly solves the problems of air leakage, deformation, failure and the like possibly caused by the subacromial saccule in clinical application.

The purpose of the invention is realized by the following technical scheme:

the invention relates to a hydrogel-filled balloon that can be anchored under the shoulder, comprising:

the bag body is internally provided with a cavity;

the hydrogel components are injected into the capsule body and mixed, and then can be formed by reaction and/or ultraviolet irradiation;

the filling component comprises a filling outer catheter and a heat sealing part which are connected, and the heat sealing part is arranged on the outer side of the opening of the bag body; the filling member is used for the water gel to pass through and enter the cavity of the capsule body.

The inside space that is filled of utricule cavity, the space that fills is through filling part and utricule exterior space intercommunication, and the size accessible after the cavity is filled is adjusted through changing the filler quality.

As an embodiment of the invention, the upper surface of the capsule body is provided with an adhesive part adhered with the lower surface of the coracoid ligament.

As an embodiment of the invention, the upper surface of the balloon is bonded with the lower surface of the coracoid ligament by medical adhesive; the position is fixed.

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

Further, the hydrogel exists alone as a solid after the absorption of the capsule wall.

As an embodiment of the present invention, the sealing of the capsule is achieved by heat-pressing the heat-sealed portion. The filling outer tube and part of the heat-seal portion are cut along the seal boundary.

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

As an embodiment of the present invention, the hydrogel is a medical material that is injectable and self-formable in situ. Preferably, the hydrogel is prepared by mixing an organic component and an inorganic component. The organic components comprise hyaluronic acid, alginate, amino acid, gelatin and the like; the inorganic component comprises silicate bioceramics such as diopside, akermanite, etc.

As an embodiment of the present invention, the lower surface of the balloon is a concave curved surface adapted to the humeral head.

As an embodiment of the invention, the bladder is integrally formed with the filling member.

The subacromial balloon capable of being used for a long time is formed by constraining the balloon wall after hydrogel is filled into the cavity of the balloon body through the filling part; after the hydrogel is formed, the balloon is of a solid structure; the balloon wall is made of an absorbable material, and after the balloon wall loses integrity and tightness due to absorption and abrasion, the internal hydrogel still maintains the original shape and mechanical strength, so that the balloon function is ensured to continue to exist.

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

1. after the balloon is placed in the gap under the acromion and filled, the upper surface of the balloon is fixed with the coracoid ligament by using the adhesive, thereby avoiding the uncontrollable displacement of the balloon in the future and having simple and safe fixing mode;

2. the solid hydrogel is filled in the capsule body and can maintain the original shape after the hydrogel is formed, the balloon wall only plays a role in assisting the forming without maintaining the sealing for a long time, the hydrogel in the solid shape enables the mechanical action of the balloon to continue to exist after the balloon wall is worn, and the hydrogel is worn or absorbed to only cause the change of the local shape of the solid body but not the integral shape, so that the long-term treatment effect is achieved.

Drawings

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

FIG. 1 is a schematic structural view of a fixable balloon used for rotator cuff tear treatment according to the invention;

FIG. 2 is a schematic view of the unfilled structure of the present invention;

FIG. 3 is a schematic view of the structure of the present invention after long-term use;

in the figure, 1 is a filling outer catheter, 2 is a heat-seal part, 3 is a balloon body, 4 is a filling part, 5 is a acromion, 6 is a clavicle, 7 is a coracoid clavicle, 8 is a coracoid ligament, 9 is a coracoid process, 10 is a humeral head, 11 is a scapula, 12 is a worn capsular wall, and 13 is formed hydrogel.

Detailed Description

The present invention will be described in detail with reference to examples. The following examples will assist those skilled in the art in further understanding the invention, but are not intended to limit the invention in any way. It should be noted that it would be apparent to those skilled in the art that several modifications and improvements can be made without departing from the inventive concept. All falling within the scope of the present invention.

Example 1

The embodiment provides a subacromial balloon which can be used for a long time and does not depend on the tightness of the balloon wall; as shown in fig. 1 and 2, the fixable balloon provided by the invention comprises a balloon body 3, wherein a cavity is formed in the balloon body 3 to form a filling space, and the filling space is communicated with the outside of the balloon body through a filling part 4; after filling, the size of the capsule body is adjusted by the specific amount of the filling material. The filling part 4 comprises a filling outer catheter 1 and a heat sealing part 2, and the filling part 4 and the capsule body 3 are integrally formed.

The filler of this example is a high strength self-healing hydrogel based on modified hyaluronic acid (see CN111072997A for preparation method). The preparation method comprises the following steps: uniformly mixing 10% by mass of maleic hydrazide hyaluronic acid with 90% by mass of phosphoric acid buffer solution at room temperature to obtain a gel component A; mixing aldehyde hyaluronic acid 10% by mass and phosphoric acid buffer solution 90% by mass uniformly at room temperature to obtain a gel component B; and mixing the gel component A and the gel component B in equal volume, extruding the mixture by using an injector to obtain the initially cured self-healing hydrogel, and irradiating the mixture by using ultraviolet rays to obtain the high-strength self-healing hydrogel.

When in use, the saccule (sac body) is placed in the gap under the acromion. As shown in fig. 1, the top of the gap is constituted by the acromion 5 and the acromion end of the clavicle 6, the coracoid ligament 7, the coracoid ligament 8, and the coracoid process 9 are located in front of the gap, and the base of the gap is the upper part of the humeral head 10 and the scapula 11. Filling two hydrogel components (namely the gel component A and the gel component B) into the filling component, mixing the two hydrogel components to form gel, irradiating the gel by using an ultraviolet lamp to form the gel, heating the heat-sealing part 2 by using a radio frequency knife or an ultrasonic knife for operation after the shaping is finished, and cutting off the filling outer catheter 1 and part of the heat-sealing part 2 along the sealing boundary line. Thereafter, a surgical scissors is used to cut away a portion of the upper surface of the wall, which exposes the upper surface of the intracapsular shaping hydrogel. Coating adhesive on the lower surface of the coracoid ligament, lifting the balloon or the upper limb of the passive movable operation side, and enabling the upper surface of the balloon to be contacted and adhered with the lower surface of the coracoid ligament under certain pressure. After placement, the balloon can press the humeral head, recover joint movement and reduce pain (fig. 1). After the worn wall 12 loses its sealing effect on the contents, the formed hydrogel 13 allows the mechanical action of the balloon to continue (fig. 3).

Example 2

The filler in this embodiment is a composite hydrogel into which a drug is previously added, and is formed by mixing sodium alginate, amino acid and silicate bioceramic containing two or more multivalent cations and then forming in situ (see CN106806943B for a preparation method), and the preparation method is as follows: a. firstly, carrying out ultraviolet sterilization on sodium alginate powder for 30min, then stirring and dissolving the sodium alginate powder at room temperature, wherein the mass volume concentration is 1.5%, and standing overnight at 4 ℃ to ensure that the sodium alginate powder is uniformly dissolved; b. weighing certain akermanite biological ceramic powder, adding the powder into a sodium alginate solution after ultraviolet sterilization to ensure that the mass volume concentration of the powder is 2%, and uniformly stirring; c. b, filling the mixed solution formed in the step b into an injector at one side of a sterile three-way pipe, adding a certain amount of ultraviolet sterilized glutamic acid powder into the injector at the other side according to the required gel time, and enabling the mass volume concentration of the glutamic acid to be 0.5%, and uniformly mixing the glutamic acid powder and the glutamic acid in the three-way pipe; d. in the mixing process, the hydrolysis of the glutamic acid can promote the akermanite biological ceramic powder to slowly release two ions of Ca and Mg in the sodium alginate, and the sodium alginate is crosslinked into gel within 5 min. The added medicine can be local anesthetic medicine (lidocaine, ropivacaine), hyaluronic acid, long-acting glucocorticoid (betamethasone), nonsteroidal anti-inflammatory medicine (loxoprofen sodium, indomethacin) or mixture of the medicines.

When in use, the saccule (balloon) is placed in the subacromial gap, as shown in fig. 1, the top of the gap is composed of the acromion 5 and the acromion end of the clavicle 6, the coracoid ligament 7, the coracoid ligament 8 and the coracoid process 9 are arranged in front of the gap, and the bottom of the gap is the upper part of the humeral head 10 and the scapula pelvis 11. Filling the two components of the hydrogel into the filling part by using a double-head injector, mixing, forming the hydrogel, and expanding the capsule body. After the filling, the heat-sealed portion 2 is sealed by heating with a radio frequency knife or an ultrasonic knife for operation, and the filling outer tube 1 and a part of the heat-sealed portion 2 are cut along the sealing boundary. Thereafter, a surgical scissors is used to cut away a portion of the upper surface of the wall, which exposes the upper surface of the intracapsular shaping hydrogel. Coating adhesive on the lower surface of the coracoid ligament, lifting the balloon or the upper limb of the passive movable operation side, and enabling the upper surface of the balloon to be contacted and adhered with the lower surface of the coracoid ligament under certain pressure. After placement, the balloon can press the humeral head, recover joint movement and reduce pain (fig. 1). As the capsule wall absorbs, the drug carried by the hydrogel is gradually released to the space under the acromion. After the worn wall 12 loses its sealing effect on the contents, the formed hydrogel 13 allows the mechanical action of the balloon to continue (fig. 3).

Example 3

The filler in this example is gelatin nanoparticle-iPRF (injectable platelet-rich fibrin) double-network structure composite hydrogel (see CN110743038A for preparation method), and the preparation method is as follows: centrifuging a fresh blood sample for 1-10 min at a rotating speed of 50-1000 g, wherein the centrifuged and layered top-layer yellow transparent liquid is blood extract iPRF, and rapidly mixing the top-layer yellow transparent liquid with gelatin nano colloidal particles uniformly and curing to obtain the hydrogel; or adding the gelatin nano colloidal particles into a fresh blood sample, placing the mixture into a centrifuge for centrifugation for 1-10 min at the rotation speed of 50-1000 g, and obtaining the top brown yellow colloid after centrifugation and layering, namely the hydrogel. Wherein the particle size of the gelatin nano colloidal particles is 10nm-2 μm, and the surface charge is-40 mV.

When in use, the saccule (balloon) is placed in the subacromial gap, as shown in fig. 1, the top of the gap is composed of the acromion 5 and the acromion end of the clavicle 6, the coracoid ligament 7, the coracoid ligament 8 and the coracoid process 9 are arranged in front of the gap, and the bottom of the gap is the upper part of the humeral head 10 and the scapula pelvis 11. Filling the two components of the hydrogel into the filling component by a double-head injector according to the volume ratio, uniformly mixing to expand the capsule body, heating the heat-sealing part 2 by a radio frequency knife or an ultrasonic knife for operation after the hydrogel is formed, and cutting off the filling outer catheter 1 and part of the heat-sealing part 2 along the sealing boundary line. Thereafter, a surgical scissors is used to cut away a portion of the upper surface of the wall, which exposes the upper surface of the intracapsular shaping hydrogel. Coating two components of hydrogel on the lower surface of the coracoid ligament, lifting the balloon or passively moving the upper limb on the operation side, and enabling the upper surface of the balloon to be contacted and bonded with the lower surface of the coracoid ligament under certain pressure. After placement, the balloon can press the humeral head, recover joint movement and reduce pain (fig. 1). After the worn wall 12 loses its sealing effect on the contents, the formed hydrogel 13 allows the mechanical action of the balloon to continue (fig. 3).

The foregoing description of specific embodiments of the present invention has been presented. It is to be understood that the present invention is not limited to the specific embodiments described above, and that various changes and modifications may be made by one skilled in the art within the scope of the appended claims without departing from the spirit of the invention. The embodiments and features of the embodiments of the present application may be combined with each other arbitrarily without conflict.

Claims

1. A hydrogel-filled fixable sub-acromion balloon, the balloon comprising:

the bag body is internally provided with a cavity;

a hydrogel which is an injectable and in-situ self-forming hydrogel;

2. The hydrogel-filled fixable subacromial balloon of claim 1 wherein said balloon upper surface is provided with an adhesive portion for adhering to a coracoid ligament lower surface.

3. The hydrogel-filled fixable subacromial balloon of claim 1 wherein said balloon upper surface is bonded to the coracoid ligament lower surface by a medical adhesive.

4. The hydrogel-filled fixable subacromial balloon according to claim 2 or 3, wherein, in use, said balloon is placed in the interspace between the inferior surface of the acromion and the superior surface of the humeral head.

5. The hydrogel-filled fixable subacromial balloon as claimed in claim 1, wherein the balloon body is filled with hydrogel, and after the hydrogel is formed, the balloon body is of a solid structure.

6. The hydrogel-filled fixable subacromial balloon of claim 5, wherein the hydrogel is present alone as a solid after absorption by the balloon wall.

7. The hydrogel-filled securable subacromial balloon of claim 1, wherein the sealing of the balloon is achieved by heat-pressing the heat seal.

8. The hydrogel-filled fixable subacromial balloon of claim 1, wherein the material of said balloon is a medical grade degradable material.

9. The hydrogel-filled fixable subacromial balloon of claim 1, wherein the balloon lower surface is concavely curved to conform to a humeral head.

10. The hydrogel-filled fixable subacromial balloon of claim 1, wherein said balloon is integrally formed with a filling member.