阅读说明：本技术 一种止鼾植入物 (Snore relieving implant ) 是由 杨海 李建军 于 2021-09-06 设计创作，主要内容包括：本发明涉及一种止鼾植入物,其特征在于,包括由可降解材料制成的本体；未受外力作用时本体处于自然态,本体可在外力作用下被拉伸变长从而由自然态变化至拉伸态,撤除外力后处于拉伸态的本体自动回缩向自然态变化；所述止鼾植入物在植入过程中,本体处于拉伸态；所述止鼾植入物植入后,处于拉伸态的本体自动回缩向自然态变化直至长度保持稳定；本体外表面具有倒刺,处于拉伸态的本体自动回缩过程中可通过倒刺带动组织收缩。植入物植入前被拉伸而变长,植入后其会自动回复从而降低长度,在其恢复原长的过程中,两端的倒刺因和组织紧密抓合而缩短软腭的长度,从而实现口咽通气腔道横截面积的增加,以此减缓或消除睡眠呼吸暂停的风险。(The invention relates to a snore stopping implant which is characterized by comprising a body made of degradable materials; the body is in a natural state when not acted by external force, the body can be stretched and lengthened under the action of the external force so as to change from the natural state to a stretched state, and the body in the stretched state automatically retracts to change to the natural state after the external force is removed; in the implantation process of the snore stopping implant, the body is in a stretching state; after the snore stopping implant is implanted, the body in the stretching state automatically retracts and changes to the natural state until the length is kept stable; the outer surface of the body is provided with barbs, and the tissues can be driven to contract through the barbs in the automatic retraction process of the stretched body. The implant is stretched to be lengthened before being implanted, the implant can automatically recover after being implanted so as to reduce the length, and in the process of recovering the original length, the barbs at the two ends are tightly caught with tissues so as to shorten the length of a soft palate, so that the cross-sectional area of an oropharyngeal airway is increased, and the risk of sleep apnea is reduced or eliminated.)

1. An anti-snoring implant, comprising a body made of a degradable material; the body is in a natural state when not acted by external force, the body can be stretched and lengthened under the action of the external force so as to change from the natural state to a stretched state, and the body in the stretched state automatically retracts to change to the natural state after the external force is removed; in the implantation process of the snore stopping implant, the body is in a stretching state; after the snore stopping implant is implanted, the body in the stretching state automatically retracts and changes to the natural state until the length is kept stable; the outer surface of the body is provided with barbs which are tightly caught with tissues in the process that the body in the stretching state automatically retracts to change to the natural state, and the tissues can be driven to contract through the barbs in the process that the body in the stretching state automatically retracts.

2. The anti-snoring implant of claim 1, wherein the body comprises, in order from the distal end to the proximal end, a distal anchoring claw, a distal connecting rod, an intermediate contracting section, a proximal connecting rod, and a proximal anchoring ring, wherein the intermediate contracting section is stretchable to place the body in the stretched state, and the stretched intermediate contracting section is automatically retractable to change the body in the stretched state to the natural state, defining that the end of the device away from the operator is the distal end and the end of the device close to the operator is the proximal end.

3. The snore stopping implant of claim 2, wherein the outer surfaces of said distal connecting rod and said proximal connecting rod have said barbs in opposite directions.

4. The snore stopping implant as recited in claim 3, wherein the barbs on the distal connecting rod are oriented proximally and the barbs on the proximal connecting rod are oriented distally.

5. The snore stopping implant of claim 4, wherein the number of said barbs on said distal connecting rod is between 2 and 6 pairs, and the angle between said barbs and said distal connecting rod is between 35 and 75 degrees; preferably, the number of the barbs on the far-end connecting rod is 3-5 pairs, and the included angle between the barbs and the far-end connecting rod is 45-65 degrees.

6. The snore-stopping implant of claim 4, wherein the number of said barbs on said proximal connecting rod is 2-6 pairs, and the included angle between said barbs and said proximal connecting rod is 105 degrees and 145 degrees; preferably, the number of the barbs on the proximal connecting rod is 3-5 pairs, and the included angle between the barbs and the proximal connecting rod is 115-135 degrees.

7. The snore-stopping implant of claim 2, wherein the intermediate constriction is a plurality of continuous V-shaped structures connected end-to-end in a V-shape, or a plurality of continuous diamond-shaped structures connected end-to-end in a diamond shape, or a helical structure.

8. The snore-stopping implant of claim 2, wherein said body in said natural state has a length of 8-25mm and a maximum outer diameter of 1.5-3.5 mm; preferably, the length of the body in the natural state is 10-20mm, and the maximum outer diameter is 2.0-3.0 mm.

9. The snore-stopping implant of claim 8, wherein said intermediate constriction is 2-9mm in length when said body is in said natural state; preferably, when the body is in the natural state, the length of the intermediate contraction section is 4-7 mm.

10. The snore-stopping implant of claim 1, wherein said body has a degradation period of 4-9 months; preferably, the degradation period of the body is 5-6 months.

Technical Field

The invention relates to a stent type implant which is used for preventing snoring and reducing the sleep apnea risk, and belongs to the technical field of medical appliances.

Background

Obstructive sleep apnea is a sleep respiratory disease with snoring accompanied by apnea and daytime sleepiness as main clinical manifestations, and generally refers to the condition that oral and nasal airflow reaches the medically defined stop flow for 10 seconds or more with blood oxygen saturation reduction and the like at each attack. The number of attacks is more than 30 times in 7-hour per night sleep period of adults. The disease can cause intermittent hypoxia, hypercapnia and sleep disorder, and can cause multiple organ and multiple system damage such as hypertension, coronary heart disease, arrhythmia, cerebrovascular disease, cognitive dysfunction, type II diabetes, etc. The etiology and risk factors include: age, sex, obesity, family history, upper airway anatomy abnormalities, alcohol consumption, sedative hypnotic drugs, and the like. With the increase of age and obesity, the upper airway stenosis is aggravated, and the risk of obstructive sleep apnea is obviously increased. The clinical manifestations are snoring accompanied by snoring sound intermission and apnea, sleep quality reduction, daytime sleepiness or sleepiness, increase of nocturia, etc. Neuropsychiatric symptoms including attention deficit, memory decline, irritability, anxiety or depression, etc. can occur, cardiovascular system and endocrine system abnormalities can occur, respiratory failure can occur in serious patients, and acute respiratory failure or acute exacerbation of chronic respiratory failure can also occur under the action of some induction factors. Therefore, snoring cannot be simply regarded as noise affecting rest of other people in social life, and the noise has more influence on patients with snoring, and is a clinical disease requiring careful examination of patients with snoring, namely obstructive sleep apnea, and many serious complications can be caused by the release of spontaneous flow for snoring.

It is known from anatomy that the clear upper respiratory tract is the key to normal breathing, and the upper respiratory tract is susceptible to stenosis and obstruction in three parts, namely, the nose and nasopharynx, the oropharynx and soft palate, and the tongue root. First, obstructive sleep apnea attacks are often caused by nasal and nasopharyngeal obstructions such as deviated nasal septum, nasal polyps, enlarged turbinates, nasal tumors, adenoids, and nasopharyngeal tumors. Secondly, hypertrophy of the tongue, deformity of jaw bone, tumor after epiglottis, and deformity of throat or cervical vertebra also cause obstructive sleep apnea symptoms. Finally, the oropharynx and the soft palate are the most common parts with blockage during sleep, when airflow passes through the narrow oropharynx, the violent vibration of the uvula generates snore, the larger the degree of the stenosis is, the larger the snore sound is, and the lkamatsu (1964) measures the oropharynx area of a patient suffering from snore, and finds that the oropharynx is narrower, and the soft palate and the uvula are 91% longer.

The treatment of obstructive sleep apnea is generally divided into non-surgical treatment and surgical treatment. The non-operative treatment as the conservative treatment mainly aims at some light and medium patients, and the treatment modes comprise non-invasive positive airway pressure, weight loss, various oral appliances and the like. The patient population that the operation treatment was adapted is wide, including nasal cavity operation, like: nasal septum deflection correction, nasal polyp resection, nasal cavity dilatation, tonsillectomy and adenoidectomy, uvula palatopharynoplasty, soft palate implantation, tongue root and hyoid surgery, tracheotomy and the like. The soft palate implant is simple in operation, small in wound and fast in recovery, has the functions of prevention and treatment, is paid more and more attention to and is particularly suitable for patients with light and medium obstructive sleep apnea without other anatomical part stenosis.

An innovative treatment for simple snoring and mild-to-moderate obstructive sleep apnea is described in US7,047,979 by implanting 2-3 implants of cylindrical configuration into the patient's soft palate. The principle of the method is that an implant made of biomedical materials is implanted into the soft palate through a minimally invasive surgery, and the tension of the soft palate is increased by utilizing a fibrosis effect generated after the implant is implanted, so that the soft palate is not easy to relax and collapse, and the phenomenon that the soft palate covers the respiratory tract to cause sleep apnea is avoided. However, such permanent implants can only stiffen the soft palate and cannot shorten its length, nor of course can the airflow path increase in area to significantly improve symptoms. In addition, during long-term implantation, the soft palate and the implant are easy to rub against each other to cause rupture of the soft palate and the implant, and the implant is exposed to cause discomfort to patients and needs outpatient intervention.

The implant described in us patent 10835412B2 has barbs at opposite directions at its proximal and distal ends, and after the implant is implanted in the soft palate via a delivery system, the control wire at the tail end of the implant is used to pull the control wire in the direction opposite to that of the implant, and the distal barbs can drive the surrounding tissue to move, so that when the position of clinical requirement is reached, the control wire is removed, and the barbs at the proximal end can anchor the tissue to prevent the stretched tissue from recovering its initial position, thereby realizing the stretching, suspending and hardening effects to achieve the therapeutic purpose. However, it has the following problems: the length of tissue contraction is determined by the experience and actual operation of doctors, and cannot be accurately controlled, so that the individual difference of treatment effect is large.

Disclosure of Invention

It is an object of the present invention to provide a soft palate implant.

In order to achieve the aim, the technical scheme of the invention provides an anti-snoring implant which is characterized by comprising a body made of degradable materials; the body is in a natural state when not acted by external force, the body can be stretched and lengthened under the action of the external force so as to change from the natural state to a stretched state, and the body in the stretched state automatically retracts to change to the natural state after the external force is removed; in the implantation process of the snore stopping implant, the body is in a stretching state; after the snore stopping implant is implanted, the body in the stretching state automatically retracts and changes to the natural state until the length is kept stable; the outer surface of the body is provided with barbs which are tightly caught with tissues in the process that the body in the stretching state automatically retracts to change to the natural state, and the tissues can be driven to contract through the barbs in the process that the body in the stretching state automatically retracts.

Preferably, when the defining apparatus is used, the end far away from the operator is a distal end, the end close to the operator is a proximal section, and then from the distal end to the proximal end, the body is sequentially provided with a distal anchoring claw, a distal connecting rod, an intermediate contracting section, a proximal connecting rod and a proximal anchoring ring, wherein the intermediate contracting section can be stretched so as to enable the body to be in the stretched state, and the stretched intermediate contracting section can automatically retract so as to enable the body in the stretched state to automatically retract to change to the natural state.

Preferably, the outer surfaces of the distal and proximal connecting rods have the barbs in opposite directions.

Preferably, the direction of the barbs on the distal connector bar are directed towards the proximal end and the direction of the barbs on the proximal connector bar are directed towards the distal end.

Preferably, the number of the barbs on the far-end connecting rod is 2-6 pairs, and the included angle between the barbs and the far-end connecting rod is 35-75 degrees; preferably, the number of the barbs on the far-end connecting rod is 3-5 pairs, and the included angle between the barbs and the far-end connecting rod is 45-65 degrees.

Preferably, the number of the barbs on the near end connecting rod is 2-6 pairs, and the included angle between the barbs and the near end connecting rod is 105-145 degrees; preferably, the number of the barbs on the proximal connecting rod is 3-5 pairs, and the included angle between the barbs and the proximal connecting rod is 115-135 degrees.

Preferably, the intermediate contraction section is a plurality of continuous V-shaped structures connected end to end in a V shape, or a plurality of continuous diamond-shaped structures connected end to end in a diamond shape, or a spiral structure.

Preferably, the length of the body in the natural state is 8-25mm, and the maximum outer diameter is 1.5-3.5 mm; preferably, the length of the body in the natural state is 10-20mm, and the maximum outer diameter is 2.0-3.0mm

Preferably, when the body is in the natural state, the length of the intermediate contraction section is 2-9 mm; preferably, when the body is in the natural state, the length of the intermediate contraction section is 4-7 mm.

Preferably, the degradation period of the body is 4-9 months; preferably, the degradation period of the body is 5-6 months.

The invention has the automatic contraction capacity, and the two end surfaces have barbs with opposite directions and have the degradable capacity. In operation, according to the actual anatomical structure of a patient, 1-3 implants provided by the invention are implanted, the implants are stretched and lengthened before being implanted, the implants can automatically recover after being implanted so as to reduce the length, and in the process of recovering the original length, the barbs at two ends are tightly caught with tissues so as to shorten the length of a soft palate, so that the increase of the cross section area of an oropharyngeal airway is realized, and the risk of sleep apnea is reduced or eliminated. Compared with the prior art, the invention has the automatic contraction capability, so the operation effect is less influenced by the experience of doctors and the operation process, the tissue contraction length is accurate and controllable and is basically determined by the structure of the bracket, and therefore, the operation effect deviation of different individuals is small, the result is stable and the consistency is good. After about 6 months of implantation of the present invention, the fibrosis and hardening of the soft palate tissue have been completed, and during this process the implant provided by the present invention gradually degrades to completely disappear. The greatest advantages of the minimally invasive snore-stopping treatment by adopting the implant provided by the invention are that only local anesthesia is needed, the outpatient treatment and operation time is short, the wound is small, the pain is small, the recovery is fast, and the risk that the implant is permanently retained in the body is avoided.

Drawings

Fig. 1 is a schematic structural view of an anti-snoring implant as disclosed in example 1;

FIG. 2 is a cross-sectional view of the snore-stopping implant delivery process of FIG. 1;

FIG. 3 is a schematic view of the snore stopping implant disclosed in example 2;

FIG. 4 is a schematic structural diagram of an anti-snoring implant as disclosed in example 3;

FIG. 5 is a cross-sectional view of the snore-stopping implant delivery process of FIG. 4, wherein the snore-stopping implant is in tension.

Detailed Description

The invention will be further illustrated with reference to the following specific examples. 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

As shown in fig. 1, the present embodiment discloses a snore stopping implant, which includes a body made of degradable material through an injection molding process. The degradable material comprises polyglycolide, polylactide, polycaprolactone or polydioxanone, or copolymer or blend of the materials. A preferred embodiment is: the degradable material adopts poly (glycolide-caprolactone) copolymer and polydioxanone. In this example, the body was processed by injection molding using poly (glycolide-caprolactone) copolymer, with a degradation period of 6 months.

When the definition instrument is used, the end far away from the operator is the distal end, and the end close to the operator is the proximal section. In this embodiment, from the distal end to the proximal end, the body has a distal anchoring claw 1, a distal connecting rod 2, an intermediate contracting section 3, a proximal connecting rod 4 and a proximal anchoring ring 5 in sequence.

Barbs pointing to the near end and the far end are arranged on the far end connecting rod 2 and the near end connecting rod 4 respectively, and the barbs on the far end connecting rod 2 and the near end connecting rod 4 are 5 pairs. The included angle between the barb on the far-end connecting rod 2 and the far-end connecting rod 2 is 55 degrees, and the included angle between the barb on the near-end connecting rod 4 and the near-end connecting rod 4 is 120 degrees.

In this embodiment, the middle contracting section 3 is a continuous rhombic structure with a plurality of rhombuses connected end to end, so that the middle contracting section 3 can be stretched to enable the body to be in a stretched state, and meanwhile, the stretched middle contracting section 3 can automatically retract to enable the body in the stretched state to automatically retract to change to a natural state. In this embodiment, when the body is in the natural state, the length of the body is 18.5mm, and the length of the middle contraction section 3 is 5 mm. The maximum outer diameter of the body is 2.9 mm. After loading into the delivery system, the body was stretched to 26mm with a maximum outer diameter of 2.1 mm.

In order to implant the snore stopping implant shown in figure 1 into a human body, the snore stopping implant can be implanted through a tubular delivery system. In this embodiment, as shown in fig. 2, the snore stopping implant is implanted in the body by a tubular delivery device. Prior to implantation, the implant is stretch-tied within the tube. Upon reaching the lesion, the implant is released into the body and the tissue is stretched and shortened by the close engagement of the barbs during the recovery of the intermediate contracting section 3.

Example 2

As shown in fig. 3, the difference between the snore stopping implant disclosed in this embodiment and embodiment 1 is that:

1) the body is processed by adopting poly (glycolide-L-lactide) copolymer through an injection molding process, and the degradation period is 5 months.

2) The middle contraction section 3 is a continuous V-shaped structure with a plurality of V-shaped end-to-end connection.

3) When the body is in a natural state, the length of the body is 16mm, and the length of the middle contraction section 3 is 5 mm. The maximum outer diameter of the body is 2.6 mm. After loading into the delivery system, the body was stretched to 26mm with a maximum outer diameter of 2.0 mm.

The other structures and operation principles of this embodiment are the same as those of embodiment 1.

Example 3

As shown in fig. 4, the difference between the snore stopping implant disclosed in this embodiment and embodiment 1 is that:

1) the body is woven and processed by polydioxanone silk, and the degradation period is 6 months.

2) The intermediate convergent section 3 is of a helical configuration.

3) When the body is in a natural state, the length of the body is 15mm, and the length of the middle contraction section 3 is 5.5 mm. The maximum outer diameter of the body is 2.1 mm. After loading into the delivery system, the body is stretched to 27mm with a maximum outer diameter of 1.85 mm.

4) The snore stopping implant is implanted into the body by a needle type conveyor. Before implantation, the distal end of the implant is fixed to the needle and the proximal end is pulled by the wire. Upon reaching the lesion, the implant is released into the body and the tissue is stretched and shortened by the close engagement of the barbs during the recovery of the intermediate contracting section 3.

The other structures and operation principles of this embodiment are the same as those of embodiment 1.