CN101172063A - Bracket for lung volume reduction - Google Patents

Abstract

The invention relates to a lung volume reduction supporting rack, which belongs to the medical appliance technical field. The invention is characterized in that the supporting rack comprises a meshy framework (1) and an unidirectional flapper (2), the unidirectional flapper (2) is of a cone-shaped body or a spherical body, which has a cavity and presents a horn shape at one end, one end of the meshy framework (1) connecting with the unidirectional flapper (2) also presents a horn shape, the horn end of the unidirectional flapper (2) is connected with the horn end of the meshy framework (1), a supporting metallic filament (3) is arranged on the inner surface of the unidirectional flapper (2), and the supporting metallic filament (3) either is tightly bonded at the outer end of the unidirectional flapper (2) or is tightly bonded at the inner end of the unidirectional flapper (2). The invention is characterized in that the structure is simple, the inserting is convenient, the fixing is reliable, the operation is convenient, the time is saved, the pain of a patient is small, the remedy effect is small, the deuteropathy is less, and the applicable scope is wide. Through the micro-invasive technology, the invention not only reaches the effect of open-chest and lung volume reduction operation, but also avoids the defects that the wound of open-chest operation is big, the position is difficult, the requirement to pulmonary function is high, the postoperation deuteropathy is numerous, and the death rate is high. The invention has good clinical application foreground and market foreground.

Description

Bracket for lung volume reduction

Technical field

The present invention relates to a kind of medical apparatus and instruments, especially a kind of pulmonary Minimally Invasive Surgery support, specifically a kind of bracket for lung volume reduction.

Background technology

Emphysema (pulmonary emphysema) are meant that alveolar bronchiole is the persistency expansion with tip lung tissue far away because of residual volume increases, and destroy with alveolar septum, so that lung tissue elasticity weakens a kind of pathological state that volume increases.As flow limitation occurs and can not completely reversibility the time, then be diagnosed as chronic obstructive pulmonary disease (COPD).

Emphysema are a kind of common chronic obstructive pulmonary diseases.Traditionally, emophysematous treatment comprise oxygen uptake, prevention pulmonary infection, bronchus spasmolysis etc., but curative effect is very limited based on internal medicine.According to statistics, whole latter stage the emphysema patient 5 years survival rate less thaies 50%, similar with postoperative nonsmall-cell lung cancer (a big class of pulmonary carcinoma is different from small cell lung cancer, latter's grade of malignancy height).One of emophysematous way of surgical intervention is lung transplantation, but this technology immaturity still at home really carries out needing time, and expense costliness (operation needs tens thousand of units, and postoperative is taken expensive immunosuppressant all the life).The later stage nineties, carried out the emophysematous new art formula of a kind of treatment---lung volume reducing operation abroad, obtained good effect.Practice confirms that the symptom of Most patients, motor capacity, lung function index can be significantly improved, more than the how sustainable 3-4 of curative effect.

The lung volume reduction surgery (LVRS) through improvement that nineteen ninety-five begins to occur has been opened up the new way that emphysema are treated.Recent large sample random research confirms that the no function lung tissue of LVRS excision excessive expansion can prolong the patient's life span and the quality of making the life better.Though there are some researches show that the operative mortality of LVRS and complication are acceptables, but case for one group of FEV1 and DLCO≤20%, mortality rate is but up to 16% in its postoperative 30 days, and the LVRS post-operative complication only lung continue one of gas leakage just up to 68%, these factors cause a lot of people to be difficult to accept this operation.

Fessler and Permutt have been to increase the absolute volume and the percentage ratio of the lung tissue that function is arranged by discovering mechanism that LVRS can improve pulmonary function.Based on this result of study, there is the scholar to propose the use bronchoscope in recent years and carries out lung volume reducing operation (BLVR), now on zooperal basis, be successfully applied to clinically, short term effect is good and represented good prospect.

The method of using bronchoscope to carry out lung volume reducing operation (BLVR) comprises: (1), flap valve device bronchus are implanted into lung volume reducing operation.Successively several companies are arranged in the research and development of carrying out this device, what bibliographical information was more is to adopt flap valve device (emphasys Medical in the Emphasys trachea; Redwood City CA) carries out BLVR.This device main body is made by silicon, and the outside is the support of a Nitinol, and in order to keep its form, its near-end has the sealing ring with 4 fins of a silicon system, and there is the unidirectional flap valve of the duckbill of a silicon system inside.This flap valve is closed when air-breathing, makes gas can't continue to enter the target area lung tissue of excessive expansion, opens during expiration, makes gas and far-end secretions to discharge.Earlier introduce seal wire when placing this flap valve device, implant delivery device, it is positioned in corresponding section of target area lung tissue or the inferior segmental bronchus, and can change its position or it is removed by biopsy forceps by seal wire by branchofiberoscope.Yim etc. have summed up the primary condition that the flap valve device should possess: 1. can be effectively, the lung that continues subtracts appearance; 2. the result is repeatably; 3. preferably can under local anaesthesia, place through branchofiberoscope; 4. should take out through branchofiberoscope easily; 5. be difficult for displacement; 6. the bronchus endocrine should be got rid of easily; 7. should not produce the pulmonary infection that causes by the sputum retention.(2) the bronchus biological fibrin glue stops up the method lung volume reducing operation.Ingenito etc. are based on the principle of LVRS, have proposed BLVR the wither imagination and the step of target area lung tissue: 1. inject oxygen to the target area, because oxygen is easy to tissue absorption, can promote the pulmonary collapse; 2. the flushing liquor with anti-surfactant washes air flue; 3. absorb remaining surfactant and impel lung to wither fast with vacuum suction; 4. stick with the good fibrin biogel of histocompatibility and block up, the target area lung tissue is reached farthest wither.Domestic once reported in 2000 the serious COPD of an example through mechanical ventilation can't off line the patient, use the self-control biogum to carry out the bronchus obstruction, make patient's success off line, though method is perfect inadequately, but the principle that meets BLVR in theory, reached the purpose of improving pulmonary function, relief of symptoms, all the other clinical researches based on the method do not appear in the newspapers as yet yet.(3), between big airways and edema due to disorder of QI lung tissue, artificially set up the indirect path of non-anatomical through branchofiberoscope guiding, make the expiratory gas volume increase reach the purpose that lung subtracts appearance through tracheascope broncho-pulmonary windowing.Trouble lung 12 examples of cut height edema due to disorder of QI have been carried out in vitro tests research in the use transplant of lung such as Lausberg.Through branchofiberoscope, between segmental bronchi and edema due to disorder of QI lung tissue, set up iatrogenic bypass channel by the guiding of radio frequency probe, and used coronary artery bracket to support.Also have based on the bronchoscope lung volume reducing operation of tissue engineering principle in addition etc.

Above-mentioned all BLVR methods all are based on lung and subtract the Wicresoft that holds principle design and hinder means, have shown good prospect through preliminary zoopery and clinical practice.But owing to be in the starting stage, case quantity is few, still lacks the multicenter based on evidence-based medicine EBM, the random research result of large sample, does not also have the lateral comparison result between the several method, and late result is still unknown.Though the report of severe complication is not arranged but still there is the possibility of potential generation severe complication in some method.

For this reason, it is little to be badly in need of a kind of wound, and the intervention therapeutic apparatus that therapeutic effect is good improves therapeutic effect, reduces medical expense.

Summary of the invention

The objective of the invention is to have that wound is big, the location is difficult, pulmonary function is required height, post-operative complication is many, mortality rate is high problem at existing emphysema treatment open chest surgery commonly used, design a kind of inserting conveniently, fixing reliable, facilitating operation, save time, patient's misery is little, and therapeutic effect is good, complication is few, the bracket for lung volume reduction based on less invasive techniques applied widely.

Technical scheme of the present invention is:

A kind of bracket for lung volume reduction, it is characterized in that it mainly is made up of mesh skeleton 1 andunidirectional flap valve 2,unidirectional flap valve 2 is that an end that has cavity is trumpet-shaped bullet or spheroplast, the end that described mesh skeleton 1 links to each other withunidirectional flap valve 2 also is horn-like, the trumpet end ofunidirectional flap valve 2 links to each other with the trumpet end of mesh skeleton 1, the trumpet end of mesh skeleton 1 can be inserted in the trumpet end ofunidirectional flap valve 2 during concrete linking to each other, also the trumpet end ofunidirectional flap valve 2 can be inserted in the trumpet end of netted internal frame 1 and carry out necessary bonding, atunidirectional flap valve 2 support wire 3 is installed, support wire 3 or closely bond in the outside ofunidirectional flap valve 2, or closely bond inboard atunidirectional flap valve 2.

One end of the support wire 3 of theunidirectional flap valve 2 of described support draws in the vertex of a cone ofunidirectional flap valve 2 or position, ball top, and the other end links to each other with mesh skeleton 1.

The inner surface of described mesh skeleton 1 and/or outer surface are provided with the overlay film layer.

The horn-like opening part of the two ends of described mesh skeleton 1 andunidirectional flap valve 2 is provided with the operation development labelling.

Beneficial effect of the present invention:

Will support of the present invention implant section or section following bronchus under patient's emphysema by using branchofiberoscope.Unidirectional flap valve is open tube chamber when exhaling, when air-breathing, close tube chamber, the lung tissue gas at blocking-up position, emphysema place enters, the secretions of the sick lung tissue of drain is simultaneously protected from infection, and makes that the disease lung tissue withers, fibrosis, thereby healthy lung tissue expansion space is strengthened, ratio of ventilation and blood flow improves, and recovers the partial function of lung, thereby improves patient's symptom.

Characteristics such as support of the present invention has simple in structure, inserts conveniently, and is fixing reliable, and facilitating operation saves time, and patient's misery is little, and therapeutic effect is good, and complication is few, and is applied widely.By less invasive techniques, both reached the effect of opening the breast lung volume reducing operation, avoided the wound of open chest surgery big again, the location is difficult, pulmonary function is required shortcomings such as height, post-operative complication are many, mortality rate height, has good potential applicability in clinical practice and market prospect.

Description of drawings

Fig. 1 is a perspective view of the present invention.

Fig. 2 is an orthographic projection sketch map of the present invention.

Fig. 3 is one of structural representation of unidirectional flap valve of the present invention.

Fig. 4 be unidirectional flap valve of the present invention structural representation two.

The specific embodiment

The present invention is further illustrated below in conjunction with drawings and Examples.

Shown in Fig. 1,2,3,4.

A kind of bracket for lung volume reduction, it mainly is made up of mesh skeleton 1 andunidirectional flap valve 2 and (sees Fig. 1, shown in 2),unidirectional flap valve 2 is that an end that has cavity is trumpet-shaped bullet (as Fig. 3) or spheroplast's (hemisphere) (as Fig. 4), the end that described mesh skeleton 1 links to each other withunidirectional flap valve 2 also is horn-like, concrete enforcement both can adopt the trumpet end ofunidirectional flap valve 2 to insert in the trumpet end of mesh skeleton 1 and the version that links to each other with it, also can adopt trumpet end with mesh skeleton 1 to insert in the trumpet end ofunidirectional flap valve 2 and the version that is attached thereto,unidirectional flap valve 2 is equipped with support wire 3, support wire 3 can closely bond in the outside ofunidirectional flap valve 2, also can closely bond the inboard at unidirectional flap valve 2.One end of support wire 3 draws in the vertex of a cone ofunidirectional flap valve 2 or position, ball top, and the other end links to each other with mesh skeleton 1 (junction point is generally the horn mouth position, also can be other position), and support wire 3 can be single structure, also can be many root architectures.One end of many root architectures draws in ball top or vertex of a cone place, and the tinsel of (or other position) links to each other on the horn mouth of the other end and mesh skeleton 1.

During concrete enforcement, the inner surface on the surface of mesh skeleton 1 or outer surface can be covered with the overlay film layer individually or simultaneously, and the film material can adopt the good materials of biocompatibility such as medical grade silicon rubber, medical polyurethane.In addition, for the ease of location of operation, can be provided with the operation development labelling at the two ends of mesh skeleton 1 and the horn-like opening part ofunidirectional flap valve 2.

The tinsel of support wire, woven mesh skeleton 1 can adopt Nitinol or stainless steel silk, and the manufacture method of mesh skeleton 1 can adopt prior art to be realized.

Below be the manufacture method of the bracket for lung volume reduction of several different structures:

1, is woven into mesh skeleton 1 with single Nickel-titanium alloy for medical purpose silk, then the support surfaces externally and internally covered silicone rubber membrane.The mesh skeleton head end is a toroidal.Unidirectional flap valve 2 adopts the medical grade silicon rubber film, and by Mold Making, head end also is trumpet type,unidirectional flap valve 2 one sides and mesh skeleton 1 tight bond, and opposite side can unidirectionally be ventilated.Unidirectional flap valve 2 adopts four one metal wires as support.The diameter of whole bracket for lung volume reduction is 4mm-10mm, and length is 10-20mm.

2, be woven into mesh skeleton 1 with single stainless steel silk, then mesh skeleton 1 surfaces externally and internally covered silicone rubber membrane.Mesh skeleton 1 head end is a toroidal.Unidirectional flap valve 2 adopts the medical grade silicon rubber film, and by Mold Making, head end is trumpet type,unidirectional flap valve 2 one sides and mesh skeleton 1 tight bond, and opposite side can unidirectionally be ventilated.Unidirectional flap valve can adopt four one metal wires as support.The diameter of whole bracket for lung volume reduction is 4mm-10mm, and length is 10-20mm.

3, be woven into mesh skeleton 1 with single Nickel-titanium alloy for medical purpose silk, then mesh skeleton 1 surfaces externally and internally covered silicone rubber membrane.Mesh skeleton 1 head end is a toroidal.Unidirectional flap valve 2 adopts polyurethane film, and by Mold Making, head end is trumpet type,unidirectional flap valve 2 one sides and mesh skeleton 1 tight bond, and opposite side can unidirectionally be ventilated.Unidirectional flap valve 2 can adopt three one metal wires as support.Whole bracket for lung volume reduction diameter is 4mm-10mm, and length is 10-20mm.

4, be woven into mesh skeleton 1 with single stainless steel silk, then mesh skeleton 1 surfaces externally and internally covered silicone rubber membrane.Mesh skeleton 1 head end is a toroidal.Unidirectional flap valve 2 adopts polyurethane film, and by Mold Making, head end is trumpet type, a side ofunidirectional flap valve 2 and mesh skeleton 1 tight bond, and opposite side can unidirectionally be ventilated.Unidirectional flap valve 2 can adopt three one metal wires as support.Whole bracket for lung volume reduction diameter is 4mm-10mm, and length is 10-20mm.

5, be woven into mesh skeleton 1 with single stainless steel silk, then mesh skeleton 1 surfaces externally and internally covered polyurethane film.Mesh skeleton 1 head end is a toroidal.Unidirectional flap valve 2 adopts polyurethane film, and by Mold Making, head end is trumpet type, a side ofunidirectional flap valve 2 and mesh skeleton 1 tight bond, and opposite side can unidirectionally be ventilated.Unidirectional flap valve 2 can adopt four one metal wires as support.Whole bracket for lung volume reduction diameter is 4mm-10mm, and length is 10-20mm.

6. be woven into mesh skeleton 1 with single Nickel-titanium alloy for medical purpose silk, then mesh skeleton 1 surfaces externally and internally covered silicone rubber membrane.Mesh skeleton 1 head end is a toroidal.Unidirectional flap valve 2 adopts the medical grade silicon rubber film, and by Mold Making, head end is trumpet type, a side ofunidirectional flap valve 2 and mesh skeleton 1 tight bond, and opposite side can unidirectionally be ventilated.Unidirectional flap valve 2 can adopt three one metal wires as support.The diameter of whole bracket for lung volume reduction is 4mm-10mm, and length is 10-20mm.

Operation principle of the present invention is:

During clinical use, earlier the support compression is entered carrier, guide by bronchoscope, under * light or other image monitoring equipment monitors, by carrier this support is delivered to the target segmenta bronchopulmonalia, then support is discharged, support returns to original shape, and is fixed on the target trachea section that needs shutoff by its support force, and one-way valve 2 is when air-breathing, thereby gas enters one-way valve 2 spreadings from its flared horn, reach the purpose of stopping up trachea, make the air bronchus end that can't put in place, when exhaling, a small amount of gas in the lung tissue at blocking-up position, emphysema place can enter in the main trachea by the outside of one-way valve 2, the secretions of the sick lung tissue of drain is simultaneously protected from infection, because bronchus can not obtain enough oxygen, therefore the disease lung tissue is withered, fibrosis, thereby healthy lung tissue expansion space is strengthened, and ratio of ventilation and blood flow improves, and has recovered the partial function of lung, thereby improved patient's symptom, reached the purpose of treatment.

Claims (4)

1. bracket for lung volume reduction, it is characterized in that it mainly is made up of mesh skeleton (1) and unidirectional flap valve (2), unidirectional flap valve (2) is that an end that has cavity is trumpet-shaped bullet or spheroplast, the end that described mesh skeleton (1) links to each other with unidirectional flap valve (2) also is horn-like, the trumpet end of unidirectional flap valve (2) links to each other with the trumpet end of mesh skeleton (1), at unidirectional flap valve (2) support wire (3) is installed, support wire (3) or closely bond in the outside of unidirectional flap valve (2), or closely bond inboard in unidirectional flap valve (2).

2. bracket for lung volume reduction according to claim 1, an end that it is characterized in that the support wire (3) of the unidirectional flap valve of described support (2) draw in the vertex of a cone of unidirectional flap valve (2) or position, ball top, and the other end links to each other with mesh skeleton (1).

3. bracket for lung volume reduction according to claim 1 is characterized in that the inner surface of described mesh skeleton (1) and/or outer surface are provided with the overlay film layer.

4. bracket for lung volume reduction according to claim 1 is characterized in that the two ends of described mesh skeleton (1) and the horn-like opening part of unidirectional flap valve (2) are provided with the operation development labelling.

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