CN1098903C - 生物相容性胶 - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
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- C09J105/00—Adhesives based on polysaccharides or on their derivatives, not provided for in groups C09J101/00 or C09J103/00
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- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
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Abstract
一种或多种糖,例如一种或多种无毒单糖、二糖、三糖、低聚糖或多聚糖在制造生物相容性胶方面的应用,所述胶用于将第一组织粘附于第二组织表面上。该生物相容性胶适于作暂时粘合用胶,该胶可以用在要使医用组织从医疗器械上转移到人或动物体组织表面的情况下。例如,在用肺体积减小手术治疗肺气肿时,一排或多排U型钉通过缓冲材料射到肺部之后,所述缓冲材料便从外科手术射钉器的叉形头上转移到病肺上。所述生物相容性胶对于将医用组织直接粘合或固定于人或动物体组织上也是很有用的,比如将补片敷于哺乳动物皮肤上。
Description
发明技术领域
本发明涉及一种已知物质的新应用,即用于制造将一种组织粘附于另一种组织的生物相容性胶,本发明具体应用于(当然并不是专用)外科手术或其它医疗技术中,例如治疗肺气肿减小肺体积术,或治疗身体器官或组织。本发明还涉及以此种胶涂料提供高聚物材料进行修补的医疗器械。
发明背景
肺气肿是以趋向于降低肺气量为特征的肺部症状。患该病的病人一般只能保留正常人肺气量的15-20%。为改善肺气量,借助称之为“肺体积减小手术”的技术修剪掉部分肺,使30%左右肺体积切除,而有助于健康组织扩充,从而改善肺气量。该手术通常是用直线型外科手术射钉器,沿着切除线放置两排靠近的U形钉,然后沿U形钉线切下组织而完成的。虽然切割可在其中一排靠近病肺一侧进行,但一般是在两排之间进行的。照此法可进行数次,直至病肺部分完全切除为止。
当进行减小肺体积手术或其它肺部手术时,一个共同的并发症是持续性漏气,使得空气长时间大量从肺部漏出。据记载这主要是由于肺再膨胀时U形钉留下的孔洞会扩大或撕开造成的。
通过使用一种带状材料于于术射钉器上,并使U形钉通过该材料插入,则可抑制漏气现象。例如EP-A-0667119(Bio-Vascular公司),已知制得一种含牛心包的动物组织材料带,由粗线暂时捆缚在一个支架元件上,限定为管状构形,使之能够在外科U形钉枪的一个颌部或叉形头上滑动。该动物组织材料带在叉形头上的放置方式要使U形钉可通过该带插入,然后切除有病组织。这样,在这一阶段,有病组织仍然暂时与健康组织相连,因该材料带仍然系在支架元件上。将捆线解开,使该材料带脱离支架,这样有病组织与健康组织也就分离了。
该EP-A-0667119提出的放置动物材料带在U形钉枪的叉形头上,使U形钉可以从其中穿过射入病肺中的方法有几个缺点。
第一,切除病变组织后要直至支架元件从带上卸下后才能使其移出。第二,支架元件使得组织切割很困难,尤其是使用内窥镜技术的情况下,该支架显得很碍事。第三,所述动物组织带只是由支架元件松松地固定在外科手术射钉器上,很容易滑下。这些缺点仍然造成难题,尤其是使用内窥镜技术更是如此。
发明内容
本发明提供将医疗领域使用的第一种组织粘接或牢固固定在第二种组织之表面的方法。因此,根据本发明,提供一种或多种糖在制造生物相容性胶方面的应用,该胶适宜以可揭下方式将第一种组织粘合于第二种组织的表面。例如,采用一种或多种无毒单糖、二糖、三糖、低聚糖或高聚糖来制造所述生物相容性胶。
该胶具体用于第一组织是处置人体或动物体组织表面的医用组织,而第二组织属于医疗器械的情况。该胶能使医用组织从医疗器械转移到身体组织表面。例如,身体组织可以是人或动物体内组织,而医疗器械是侵入性外科手术中使用的外科侵入器械,其中医用组织可从外科手术器械中转移到体内组织表面上。肺部体积减小手术涉及此种外科技术。这种情况下,医用组织可以起缓冲物质的作用,修补射向病肺中的U形钉的一条或多条线缝,从而防止手术后的漏气现象。一旦该物质从手术器械上移出,便并不需要由该胶来将缓冲物质粘合于体内器官上,即手术期间,该胶只简单地起暂时胶合作用。
另一外科技术中,可将本发明胶用于肠吻合术和血管手术。血管手术中,所述缓冲物质起防止失血的作用,而非肺体积减小手术中的漏气。
所述缓冲物质可以是EP-A-0667119(Bio-Vascular公司)公开的含牛心包的动物组织材料带。但该材料的缺点是组成牛心包的高聚物在整个放入期间不会在患者体内再吸收或再降解,尤其是因为它倾向于钙化。其它可使用的非降解材料包括TEFLON,即聚四氟乙烯,和DACRON,即聚对苯二甲酸乙二醇酯聚酯材料。而理想材料是生物再吸收性材料。适宜的生物再吸收性材料是聚羟乙酸(PGA)、聚乳酸(PLA)、聚(ε-己内酯)(PCL)、聚(β-苹果酸)(PMLA)和聚(p-二噁烷酮)(PDS)之类的高聚物。就其降解性、生物相容性和再吸收性而言,聚(β-羟基丁酸),一般称之为聚(3-羟基丁酸)(PHB)是特别适宜的,它可以进一步形成一种无纺补片。
本发明另一实施方案中,第一组织是医疗器械,而第二组织是哺乳动物皮肤或毛发之类的有机体组织。这种生物相容性胶可用于需要将医疗器械粘附于哺乳动物皮肤或毛发的地方。例如,可用此胶将电极或压缩器粘附于皮肤及毛发上。
本发明另一实施方案中,第二组织是人或动物体组织,而第一组织是医用组织,所述医用组织是可敷于身体组织,例如敷于哺乳动物皮肤的补片。此情况下,无需使用医疗器械来贴敷。
根据具体的应用情况,本发明的生物相容性胶的组成可以改变。根据所需胶粘度,糖在溶液中至多可占90%重量。但优选含60-90%重量的糖。含80-85%重量糖,尤其是接近85%糖的胶特别优选。
该胶可使用任何溶剂,但水是保证生物相容性的理想溶剂。
胶的粘度取决于所用糖的类型。而且高聚糖不易被人体再吸收且有些还有毒性,为此单糖、二糖之类由于其无毒及很快再吸收性而成为理想之糖。一般常见的果糖、葡萄糖和蔗糖之类的单糖和二糖均可用。
该胶可以溶液形式施用然后使之干燥。该材料可在临使用时润湿。但使用聚(3-羟基丁酸)之类的生物降解性材料时,在制造和贮存时均有水解的危险。该胶可以以分开包装的干粉状使用,临施用前再将之润湿。如果以粘稠状态立即使用,那么为保证最理想粘性,对胶组成有更多控制条件,这也避免使用时必需加水这一条件。
该胶可以含单一糖类,即溶液只由一种糖组成。当该胶以溶液形式涂用并随后干燥,这是完全可接受的。但优选二种或多种不同糖类的混合物,以避免可能出现的结晶问题。
加入吸湿性物质,可使该胶于贮存期间的水分丧失减至最小。所述吸湿性物质可以包括0.5-30%重量的甘油,优选1-10%,10%左右最优选。此外所述吸湿性物质可包括1-30%重量聚乙二醇(PEG),其分子量低于50000。它有可作为润滑剂的另一优点。
根据本发明,还提供含一种或多种糖,适宜以可揭下方式将第一组织粘附于第二组织表面的生物相容性胶。
根据本发明,还进一步提供以可揭下方式将第一组织粘附于第二组织表面的方法,包括将含一种或多种糖的生物相容性胶涂料敷于第一组织或第二组织二者任一之上的步骤。
根据本发明,这里还提供采用外科手术治疗人或动物的方法,该方法包括将医用组织以可揭下方式固定到手术器械上,然后从手术器械上将医用组织转移到人或动物体表面之步骤,其特征在于采用含一种或多种糖的生物相容性胶,将医用组织以可揭下方式固定到手术器械上。
根据本发明另外还提供一种医疗器械,该器械包括高聚物材料补片,和含一种或多种糖的生物相容性胶涂料,所述涂料适宜以可揭下方式将补片粘合到人或动物体组织表面。适宜的高聚物材料包括非降解性材料,例如牛心包、TEFLON,(即聚四氟乙烯),和DACRON(聚对苯二甲酸乙二醇酯聚酯材料)。但理想的材料是生物再吸收性材料。适宜的生物再吸收性材料包括聚羟乙酸(PGA)、聚乳酸(PLA)、聚(ε-己内酯)(PCL)、聚(β-苹果酸)(PMLA),和聚(p-二噁烷酮)(PDS)之类的高聚物。我们发现聚(β-羟基丁酸),一般称作聚(3-羟基丁酸)(PHB),就其降解性、生物相容性和再吸收性而言特别适宜。它还可用作无纺补片。
本发明实施方案的详细介绍
本发明的实施方案现以实施例的方式加以说明,这些实施例详述一种或多种糖在制造将医疗器械,或身体组织或器官,粘附到另一材料上所用生物相容性胶方面的应用。该胶由下述方法之一制备:
(1)一种湿胶,涂敷于:
(a)直线型外科手术射钉器,
(b)人皮肤,
(2)一种干胶,临使用前再润湿。(1)湿胶
在盖有塑料薄膜的烧杯中将水30g加热到70℃,将40g蔗糖、30g果糖和30g葡萄糖加入到该水中,于70℃搅拌约30分钟使之溶解。移去塑料薄膜,将水蒸发约2小时,直至形成含糖85%左右的溶液为止。将该溶液放入玻璃注射器中(1ml),冷至室温备用。
(a)直线型外科手术射钉器
将少量(不足1ml,优选0.05-0.1ml)溶液敷于两条聚(3-羟基丁酸)(PHB)制无纺补片带(1cm×10cm)各条上,将该带放在直线型外科手术射钉器的叉形头上,该器械由美国Ethicon公司(Somerville,N.J.)提供,型号为PROXIMATETM型TLC-75。该带很容易粘到该叉形头上,该器械射出U型钉后,该带很容易从叉形头上揭下。
(b)皮肤
将少量(不足1ml)该溶液敷到用PHB制得的无纺补片(5cm×5cm)上,然后将该补片放到皮肤上,很容易粘到皮肤上。即使10小时后该片仍粘在皮肤上,而且也容易取下。(2)干胶
在盖有塑料薄膜的烧杯中将10g水加热至70℃,然后加入30g蔗糖,70℃下搅拌半小时使蔗糖溶解。揭去塑料薄膜,将1ml该溶液敷于聚(3-羟基丁酸)(PHB)制得的无纺补片带(1cm×10cm)上。然后将该带放入50℃真空炉中5小时使水蒸发。用海绵沾水将该带湿润,并放于直线型外科手术射钉器的叉形头上,其既易粘上又易取下。
Claims (37)
1.一种或多种糖,在制造适宜以可揭下方式粘合第一组织到第二组织表面上所用生物相容性胶方面的应用。
2.权利要求1的应用,其特征在于将一种或多种无毒糖用于制造生物相容性胶。
3.权利要求1或2的应用,其特征在于将一种或多种单糖、二糖、三糖、低聚糖或高聚糖用于制造生物相容性胶。
4.权利要求1-3任一项的应用,其特征在于所述第二组织是人体或动物体组织。
5.权利要求4的应用,其特征在于所述第一组织是医用组织。
6.权利要求1-4任一项的应用,其特征在于所述第一组织是处置人体或动物体组织表面的医用组织,而所述第二组织是医疗器械,由此生物相容性胶能使医用组织从医疗器械上转移到身体组织表面上。
7.权利要求4、5或6的应用,其特征在于所述身体组织是人体或动物体的内部组织。
8.如附属于权利要求6的权利要求7之应用,其特征在于所述医疗器械是侵入手术法所用侵入手术器械,该手术法中,医用组织从手术器械上转移到体内组织的表面。
9.权利要求4、5或6的应用,其特征在于身体组织是人或动物体的皮肤。
10.权利要求5的应用,其特征在于医用组织是补片,而身体组织是人或动物体的皮肤。
11.权利要求8的应用,其特征在于侵入手术器械是治疗人或动物肺气肿所作肺体积减小手术用的手术射钉器,而医用组织是一种缓冲材料,这种情况下,一排或多排U型钉通过该缓冲材料从所述射钉器中射进肺里。
12.前述权利要求任一项的应用,其特征在于第一组织包含生物再吸收材料。
13.权利要求12的应用,其特征在于生物再吸收材料包括聚(3-羟基丁酸)。
14.前述权利要求任一项的应用,其特征在于所述生物相容性胶是含糖60-90%重量的溶液。
15.权利要求14的应用,其特征在于所述生物相容性胶是含糖约85%重量的溶液。
16.权利要求14或15的应用,其特征在于用水作为糖溶剂配成溶液。
17.前述权利要求任一项的应用,其特征在于所述糖包括蔗糖(sugars)。
18.前述权利要求任一项的应用,其特征在于将生物相容性胶配成粘稠状,立即用于粘附第一组织于第二组织表面上。
19.前述权利要求任一项的应用,其特征在于生物相容性胶含有二种或多种不同糖的混合物。
20.权利要求14、15或16的应用,其特征在于所述溶液包含0.5-30%重量的甘油。
21.权利要求14、15或16的应用,其特征在于所述溶液包含1-30%重量分子量低于50000的聚乙二醇。
22.含有一种或多种糖,适宜以可揭下方式将第一组织粘附于第二组织表面的生物相容性胶。
23.权利要求22的生物相容性胶,其特征在于所述生物相容性胶含有一种或多种无毒糖。
24.权利要求22或23的生物相容性胶,其特征在于所述生物相容性胶含有一种或多种单糖、二糖、三糖、低聚糖或高聚糖。
25.权利要求22-24任一项的生物相容性胶,其特征在于所述生物相容性胶是含糖60-90%重量的溶液。
26.权利要求25的生物相容性胶,其特征在于所述生物相容性胶是含糖约85%重量的溶液。
27.权利要求25或26的生物相容性胶,其特征在于以水作为糖的溶剂,配成溶液。
28.权利要求22-27任一项的生物相容性胶,其特征在于所述糖包括蔗糖(sugars)。
29.权利要求22-28任一项的生物相容性胶,其特征在于所述生物相容性胶配成粘稠状,立即用于粘附第一组织到第二组织表面上。
30.权利要求22-29任一项的生物相容性胶,其特征在于所述生物相容性胶含二种或多种不同糖的混合物。
31.权利要求25、26或27的生物相容性胶,其特征在于所述溶液含有0.5-30%重量的甘油。
32.权利要求25、26或27的生物相容性胶,其特征在于所述溶液含有1-30%重量分子量低于50000的聚乙二醇。
33.将第一组织粘附于第二组织表面的方法,包括将含一种或多种糖的生物相容性胶涂料涂敷于第一组织或第二组织二者任一之上这一步骤。
34.一种医疗器械,包括高聚物材料补片和含一种或多种糖的生物相容性胶涂料,所述胶适宜以可揭下方式将所述补片粘附于人或动物体组织表面上。
35.权利要求34的医疗器械,其特征在于所述生物相容性胶含一种或多种无毒糖。
36.权利要求34或35的医疗器械,其特征在于所述生物相容性胶含一种或多种单糖、二糖、三糖、低聚糖或高聚糖。
37.权利要求34-36任一项的医疗器械,其特征在于所述补片包括聚(3-羟基丁酸)无纺补片。
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SE9602226A SE9602226D0 (sv) | 1996-06-05 | 1996-06-05 | Biocompatible glue |
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SE9602226D0 (sv) | 1996-06-05 |
CZ396498A3 (cs) | 1999-04-14 |
JP2000511580A (ja) | 2000-09-05 |
IS4911A (is) | 1998-11-30 |
NO985701D0 (no) | 1998-12-04 |
IL127106A0 (en) | 1999-09-22 |
ID17315A (id) | 1997-12-18 |
EP0904331A1 (en) | 1999-03-31 |
PL330349A1 (en) | 1999-05-10 |
NZ332963A (en) | 2000-07-28 |
US20020045919A1 (en) | 2002-04-18 |
BR9709640A (pt) | 1999-08-10 |
SE9804183D0 (sv) | 1998-12-03 |
HUP0002497A2 (hu) | 2000-11-28 |
AU723445B2 (en) | 2000-08-24 |
AR007507A1 (es) | 1999-11-10 |
KR20000016341A (ko) | 2000-03-25 |
TW350769B (en) | 1999-01-21 |
HUP0002497A3 (en) | 2003-10-28 |
WO1997046632A1 (en) | 1997-12-11 |
ZA974887B (en) | 1998-12-03 |
TR199802510T2 (xx) | 1999-02-22 |
CA2256322A1 (en) | 1997-12-11 |
SE9804183L (sv) | 1999-01-28 |
NO985701L (no) | 1999-02-05 |
SE518343C2 (sv) | 2002-09-24 |
US20020138092A1 (en) | 2002-09-26 |
US6428561B1 (en) | 2002-08-06 |
AU3198297A (en) | 1998-01-05 |
CN1221443A (zh) | 1999-06-30 |
RU2203095C2 (ru) | 2003-04-27 |
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