Three, summary of the invention
The present invention is exactly the problem that exists at above-mentioned sticking patch, a kind of two-in-one disjunctor sticking patch that is used for tension-free hernioplasty is provided, it is single to solve existing sticking patch design function, the displacement of easily crispaturaing, thickness can not be adjusted, molding sticking patch area coverage is little, placement location is shallow excessively, net plug sticking patch fix not good, the sticking patch price is expensive; The spermatic cord traveling is subjected to sticking patch to influence the distortion pressurized; Protection for nerve fiber under cremasteric reservation, utilization and the obliquus externus abdominis m. aponeurosis (aponeuroses) is not enough, patient's postoperative comfort level difference and the high technical problem of relapse rate.
Technical scheme of the present invention: a kind of two-in-one disjunctor sticking patch that is used for tension-free hernioplasty, comprise big sticking patch 1, little sticking patch 2, big sticking patch 1 is provided with little sticking patch 2, big sticking patch 1 be shaped as hilt shape, the top is a large rectangle, the limit, bottom right is a little rectangle, large rectangle is of a size of 15cm-10cm * 8cm-6cm, the radius of chamfering is 1-2cm, and little rectangular dimension is 8cm-5.5cm * 1cm-0.5cm, and the radius of chamfering is 2cm; Little sticking patch 2 be shaped as duckbill shape, length * wide 10cm-6cm * the 5cm-3cm that is of a size of, the right is a semicircle, the left side is a rectangle, the radius R of semicircle is 2-1.5cm, the thickness of big sticking patch 1, little sticking patch 2 is 0.4-0.6mm, and the cambered top end on the little sticking patch 2 is 2cm-1.5cm apart from the rightmargin of big sticking patch 1 from a, and the top distance b of the big sticking patch 1 of the top margin of little sticking patch 2 is 3cm; Big sticking patch 1 and little sticking patch 2 are provided with spermatic cord hole 3, spermatic cord hole 3 be shaped as circle, diameter is 0.5cm-0.8cm, the center of circle in spermatic cord hole 3 to the left side of big sticking patch 1 disconnects, the cambered top end distance of the little sticking patch 2 of the distance of center circle in spermatic cord hole 3 is c, and c equals 6.5cm-4cm, and the long back gauge of the little sticking patch 2 of the distance of center circle in spermatic cord hole 3 is d, d equals 3cm-1.5cm, and a kind of material that is used for the two-in-one disjunctor sticking patch of tension-free hernioplasty is a polypropylene.
The present invention compared with prior art has following beneficial effect: a kind of two-in-one disjunctor sticking patch that is used for tension-free hernioplasty, combine multiple sticking patch design concept, and big or small slice is cut out according to the forward and backward gap of transverse fascia of dissecting and is decided; Wherein the sticking patch that area is big lies on preperitoneal space around spermatic cord, has covered interior collar extension, He Shi triangle, femoral canal internal orifice and homonymy rectus abdominis m. venter posterior, does not omit the hernia hole; Simultaneously the sticking patch overlay region exports as spermatic cord, more accurately control cord bore expansion degree (normal 0.5-0.8cm, scalable value is ± 0.2cm), prevents that hernia from deviating from; The sticking patch that area is little is fixed in He Shi triangle, transverse fascia.Like this, 3 weak links of inguinal hernia (hernia ring, transverse fascia is damaged or pectineus hole, inguinal canal rear wall) are repaired respectively and strengthened, and straight hernia or the tiltedly generation of hernia even femoral hernia have effectively been prevented, because of all adopting flat sticking patch, greatly reduce relapse rate and patient's hospitalization cost.The testis elevator covering of small pieces by spermatic cord and after sewing up simultaneously increases apart from body surface thickness, and according to the adjustable sheet thickness of reorganizing and bringing up to full strength of stomach wall situation, the stomach wall subcutaneous fat is few, the smooth person of stomach wall selects thin sticking patch; The stomach wall subcutaneous fat is many, stomach wall bulge person selects than the Mangnolia officinalis sheet; Established the anatomic basis that alleviates the postoperative discomfort.
In a word, the sticking patch of the application of the invention in Tension-free Hernioplasty, combine Stoppa, Lichtenstien, three kinds of basic surgical characteristics of Plug, and can control sticking patch spermatic cord bore expansion degree, the sticking patch ring week little by area fixedly prevents the sticking patch rotation displacement, keep the testis elevator, the spermatic cord original position is placed, strengthen preperitoneal space sticking patch area, do not cover nerve, the transverse fascia that constitutes internal ring damaged replaced and strengthen, do not interspace, make the tension-free hernioplasty relapse rate be lower than domestic and international standard, the postoperative comfort level is compared other art formula and is obviously improved, and reaches good clinical effectiveness, obtains better social benefit and economic benefit.
Below further specify beneficial effect of the present invention by concrete relative analysis and clinical trial:
1, the operation of two-in-one disjunctor sticking patch operation and domestic and international sticking patch at present commonly used relatively
2, clinical initial stage perspective study
In order to inquire into the clinical application effect of two-in-one disjunctor sticking patch in the inguinal hernia operation.
Project team planned at the bottom of calendar year 2001, from January, 2002 to 2003 year December, will accept II-IV type inguinal hernia patient 240 examples for medical treatment, was divided into three groups at random and compared to use different sticking patch and modus operandi.Be respectively two-in-one disjunctor sticking patch group (A group) 120 examples, net plug filling sticking patch group (B group) 60 examples, three-in-one hernia device group (C group) 60 examples, male 232 examples, women 8 examples; Minimal ages 22 years old, maximum 93 years old age.3 groups of physical data differences do not have significance (P>0.05) and have comparability.With March, in June, 1 year, 2 years, further consultation or communication were that the mode of following up a case by regular visits to, time are 2-3, specifically see Table 1.
Table 1:240 example II-IV type inguinal hernia patient random packet situation
The two-in-one disjunctor sticking patch of material source group adopts Ahmedabad, Bei Lang 15cm * 15cm plane sticking patch to manufacture; Hernia ring filling group is utilized Ahmedabad Bard Perfix Plug product, every cover is divided into two parts, be molding sticking patch and hernia ring filling thing, the former is 8cm * 4cm rectangle mesh sticking patch, and the latter is conical Flos Mume lobe sample net sheet material, high 3cm, the three-in-one hernia device of diameter 3cm group is the Pu Liling of a U.S. Johnson ﹠ Johnson hernia device (PHS), and model is PHSL-1, comprises a top layer sheet, a bottom chip and the middle cylindrical net sheet that links to each other, material is the monofilament polypropylene.
Three groups of postoperative wounds infection of interpretation of result, uncomfortable (pain, foreign body sensation), postoperative recurrence at a specified future date, sticking patch expense situation relative analysis following (table 2)
* discomfort at a specified future date refers to occur in the symptoms such as local chronic pain, numbness or foreign body sensation in postoperative March to 2 year.
* statistical method adopts the t check, and data are with mean+SD (x ± s) expression.
Statistical result showed, hospital stays, two A groups of infection of incisional wound and B, C do not have significant difference (P>0.05), not statistically significant for two groups.The B group has two examples and example recurrence in half a year after surgery respectively with the C group, and does not have significant difference (P>0.05), not statistically significant between the A group.Three of pain, foreign body sensation and sticking patch expenses, the A group is lower than two groups of B, C, and there were significant differences between two groups (P<0.05), has statistical significance.Comparing result, the comprehensive characteristics that demonstrate two-in-one sticking patch are better than other sticking patch art formula.
3, clinical long-term effect contrast
Sum up my center tension-free hernioplasty case 1288 examples over 4 years, clinical recurrence rate, comfort level and the health economics benefit of wherein 4 kinds of sticking patch operations are done one estimate
Four kinds of sticking patch operation methods of table one relapse rate relatively
Calculate through four groups of rates direct probability relatively, P=0.001 presses α=0.05 level, refusal H
o, accept H
1, can think generally has difference between four groups of relapse rates; Press the multiple comparisons principle, two-in-one disjunctor sticking patch method and method of triads, P=0.119, relapse rate still can not be thought between two groups difference; Compare with plane sticking patch method after the merging, P=0.026 can think that two-in-one disjunctor sticking patch method, method of triads relapse rate and plane sticking patch method, net plug completion method (P=0.003) relapse rate difference have statistical significance again.
A situation arises relatively (within the postoperative 3 months) for four kinds of sticking patch operation methods of table two pain
Calculate through four groups of rates direct probability relatively, P=0.001 presses α=0.05 level, refusal H
o, accept H
1, can think generally has difference between four groups of pain incidence rates; Press the multiple comparisons principle, two-in-one disjunctor sticking patch method and method of triads, plane sticking patch method, net plug completion method compare, and difference all has statistical significance.
The local lump emotion of four kinds of sticking patch operation methods of table three condition relatively
Calculate through four groups of rates direct probability relatively, P=0.001 presses α=0.05 level, and refusal HO accepts H1, and can think generally has difference between four groups of local lump senses; Press the multiple comparisons principle, two-in-one disjunctor sticking patch method and method of triads, plane sticking patch method (P=0.008), net plug completion method compare, and difference all has statistical significance.
Four kinds of sticking patch operation methods of table four health economics benefit relatively
Through four kinds of operation hospitalization costs relatively, zero difference between individualities such as lab testing expense, antibiotic expense, berth, nursing, diagnosis and treatment expense wherein, the hospitalization cost of two-in-one disjunctor sticking patch operation is starkly lower than other three kinds.
Clinical practice
From year October in February, 2002 to 2006, cook sticking patch of the present invention 813 examples of performing the operation altogether, male 786 examples, women 27 examples; Minimal ages 17 years old, maximum 101 years old age.
This art formula adapts to except that I type hernia, above various indirect inguinal hernia of 18 one full year of life, straight hernia, and wherein I type hernia 0 example, II type hernia 228 examples, III type hernia 447 examples, IV type hernia 138 examples, postoperative was followed up a case by regular visits to 3 months-4 years.
This group hernia merges other disease, must treat through conservative treatment before the art, performs the operation after the stable disease.This group of surgical effect is observed 813 cases, and all in feed in postoperative 12-24 hour and activity down, postoperative 3 days body temperature, total white blood cells and Classification Change are all in normal range.Antibiotic used 3-5 days, and otch does not have redness and sepage, pain 0.86% (7 examples/813 examples) in the postoperative 3 months-4 years, and local lump sense 1.1% (9 examples/813 examples) does not have and infects, and follows up a case by regular visits to the Shang Weijian recurrence 3 months-4 years.
Five, the specific embodiment:
Embodiment 1
A kind of two-in-one disjunctor sticking patch that is used for tension-free hernioplasty, comprise big sticking patch 1, little sticking patch 2, overlap to the center of circle line in the spermatic cord hole 3 that prolongs and be bonded with big sticking patch 1 in the left side of little sticking patch 2, big sticking patch 1 be shaped as hilt shape, the top is a large rectangle, the limit, bottom right is a little rectangle, large rectangle is of a size of 15cm * 8cm, the radius of chamfering is 2cm, and little rectangular dimension is 8cm * 1cm, and the radius of chamfering is 2cm; Little sticking patch 2 be shaped as duckbill shape, length * wide 10cm * the 5cm that is of a size of, the right is a semicircle, the left side is a rectangle, the radius R of semicircle is 2cm, the thickness of big sticking patch 1, little sticking patch 2 is 0.6mm, and the cambered top end on the little sticking patch 2 is 2cm apart from the rightmargin of big sticking patch 1 from a, and the top distance b of the big sticking patch 1 of the top margin of little sticking patch 2 is 3cm; Big sticking patch 1 and little sticking patch 2 are provided with spermatic cord hole 3, spermatic cord hole 3 be shaped as circle, diameter is 0.8cm, the center of circle in spermatic cord hole 3 to the left side of big sticking patch 1 disconnects, the cambered top end distance of the little sticking patch 2 of the distance of center circle in spermatic cord hole 3 is c, c equals 6.5cm, and the long back gauge of the little sticking patch 2 of the distance of center circle in spermatic cord hole 3 is d, and d equals 3cm.15cm * 15cm polypropylene plane sticking patch that a kind of material selection The Budd Co. that is used for the two-in-one disjunctor sticking patch of tension-free hernioplasty produces.
Operation method
Oblique hernia art formula: get the conventional otch 4cm of hernia, the obliquus externus abdominis m. aponeurosis (aponeuroses) is cut in layering, manifests obliquus internus abdominis m. under the aponeurosis (aponeuroses), transversus abdominis m., testis elevator and neural traveling.
The first step is set up transverse fascia anterior diastema (first gap): cut 2-3cm along smart film in testis elevator and the spermatic cord, the upper and lower testis elevator lobe that retracts strips out spermatic cord, and high-order closed hernical sac can expose inguinal canal rear wall transverse fascia, to place little sticking patch.
Second step was set up preperitoneal space (second gap): with the hernical sac stump is the center, ring week is cut transverse fascia, inwardly (extension reaches right rectus abdominis m. venter posterior), last (behind the conjoined tendon), outer (behind the arciform edge belly of muscle) passivity are separated preperitoneal space 4-6cm, simultaneously, peritoneum or recessive femoral hernia capsule that the femoral canal internal orifice attaches are peeled off out fully, about 15 * the 9cm of interval area is to place big sticking patch.
The 3rd step was inserted first and second gap with a kind of two-in-one disjunctor sticking patch that is used for tension-free hernioplasty: a kind of two-in-one disjunctor sticking patch that is used for tension-free hernioplasty is inserted in spermatic cord, sews up the rope hole, diameter is controlled at 0.6-0.8cm.The sticking patch that area is big lies on and expands the extraperitoneal space of opening, and adjusts the net sheet and confirms to surpass hernia ring periphery 4-6cm, and the pectineus hole covers fully; Before again that area is little sticking patch lies on transverse fascia, successively with inguinal ligament in 1/2, after the sheath of rectus abdominis outer rim, conjoined tendon, arciform edge 1cm belly of muscle ring week the fixing 10-12 pin of sewing up, seek and visit no leak, smart film, obliquus externus abdominis m. aponeurosis (aponeuroses), skin in elevator of suture in situ testis and the spermatic cord.
Embodiment 2
A kind of two-in-one disjunctor sticking patch that is used for tension-free hernioplasty, comprise big sticking patch 1, little sticking patch 2, overlap to the center of circle line in the spermatic cord hole 3 that prolongs and be bonded with big sticking patch 1 in the left side of little sticking patch 2, big sticking patch 1 be shaped as hilt shape, the top is a large rectangle, the limit, bottom right is a little rectangle, large rectangle is of a size of 10cm * 6cm, the radius of chamfering is 1cm, and little rectangular dimension is 5.5cm * 0.5cm, and the radius of chamfering is 2cm; Little sticking patch 2 be shaped as duckbill shape, length * wide 6cm * the 3cm that is of a size of, the right is a semicircle, the left side is a rectangle, the radius R of semicircle is 2cm, the thickness of big sticking patch 1, little sticking patch 2 is 0.4mm, and the cambered top end on the little sticking patch 2 is 1.5cm apart from the rightmargin of big sticking patch 1 from a, and the top distance b of the big sticking patch 1 of the top margin of little sticking patch 2 is 3cm; Big sticking patch 1 and little sticking patch 2 are provided with spermatic cord hole 3, spermatic cord hole 3 be shaped as circle, diameter is 0.5cm, the center of circle in spermatic cord hole 3 to the left side of big sticking patch 1 disconnects, the cambered top end distance of the little sticking patch 2 of the distance of center circle in spermatic cord hole 3 is c, c equals 4cm, and the long back gauge of the little sticking patch 2 of the distance of center circle in spermatic cord hole 3 is d, and d equals 1.5cm.15cm * 15cm polypropylene plane sticking patch that a kind of material selection Bei Lang company that is used for the two-in-one disjunctor sticking patch of tension-free hernioplasty produces.
Operation method
Straight hernia art formula: cut with the operation method layering among the embodiment 1, isolate spermatic cord and straight hernical sac, after handling hernical sac, cut transverse fascia along the arciform lower edge of conjoined tendon, fan-shaped preperitoneal space 4-5cm after isolating sheath of rectus abdominis successively, behind the arciform lower edge of conjoined tendon, so far the forward and backward gap of transverse fascia is communicated with, a kind of two-in-one disjunctor sticking patch that is used for tension-free hernioplasty of cutting, be inserted in spermatic cord, the sticking patch that area is big lies on extraperitoneal space, and with sheath of rectus abdominis after, 1.5cm sutured 8 pins behind the arciform lower edge of conjoined tendon; The sticking patch little with area substitutes transverse fascia, sews up the 4-6 pin with the arciform lower edge of incision, puts back to spermatic cord, sews up testis elevator, obliquus externus abdominis m. aponeurosis (aponeuroses), skin.