CN100425207C - Connected two-in-one patch for strainless hernia repair - Google Patents

Connected two-in-one patch for strainless hernia repair Download PDF

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CN100425207C
CN100425207C CNB2006100707107A CN200610070710A CN100425207C CN 100425207 C CN100425207 C CN 100425207C CN B2006100707107 A CNB2006100707107 A CN B2006100707107A CN 200610070710 A CN200610070710 A CN 200610070710A CN 100425207 C CN100425207 C CN 100425207C
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sticking patch
little
patch
big
spermatic cord
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CN1985767A (en
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刘克忠
张志敏
刘亚奇
刘玉荣
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TransEasy Medical Tech. Co.,Ltd.
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刘克忠
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Abstract

The present invention discloses a kind of connected two-in-one patch for strainless hernia repair. The patch of polypropylene includes large patch in hilt form and small patch in duck bill form, is in 0.4-0.6 mm thick, and has opened circular spermatic cord hole. The patch of the present invention has the synthesized features of Stoppa operation, Lichtenstien operation and Plug operation, including less shift, adjustable thickness, great area, deep setting position, etc.

Description

A kind of two-in-one disjunctor sticking patch that is used for tension-free hernioplasty
One, technical field:
The invention belongs to a kind of clinical surgery operation implant into body material, be specifically related to a kind of two-in-one disjunctor sticking patch that is used for tension-free hernioplasty.
Two, background technology
Hernia is the commonly encountered diseases and the frequently-occurring disease of general surgery, and it is the unique method of radical cure hernia that clinical practice has confirmed to perform the operation.And hernia operation art formula is more, and classification is outer two kinds: tension force herniorrhaphy and tension-free hernioplasty are arranged.
Since Bassini initiative has the tension force herniorrhaphy, year historical surplus in the of existing 100 so far, satisfied although its general curative effect still claims, the argument of relevant each art formula according to and indication arguement is arranged always, the postoperative recurrence and the complication of hernia repairing still have problems.It is reported that the postoperative recurrence rate of just sending out inguinal hernia is about 10%, and the recurrent hernia can be up to 20%, total complication rate is also between 7%-12%.As the tension force herniorrhaphy is arranged, its weak point is mainly reflected in the following aspects: 1, all be to repair with patient's's defectiveness adjacent tissue.2, will not draw over to one's side by force, sew up at the tissue at normal anatomy position, tension force be very big, does not meet operating principle.3, " stitching of associating tendon and inguinal ligament " is two kinds of stitchings between different tissues, is difficult for producing real healing.4, a large amount of toe-ins of leaving of prothesis have increased the chance of postoperative generation complication.
The art of tension-free hernia typing both at home and abroad formula has simple fascia to sew up prothesis, Lichtenstein (monolayer plain film repairing operation), Rutkow operation (hernia ring fill-type does not have the tension force kposthesis), Gilbert operation (three-in-one no tension force kposthesis), peritoneoscope inguinal hernia kposthesis (LiHR) etc.Tension-free hernioplasty is low with its relapse rate at present, recovery is fast, makes the hernia surgical technic that very quantum leap arranged, and as the main operation of radical cure hernia, progressively having replaced tradition has the tension force herniorrhaphy.Yet tension-free hernioplasty is promoted in China in recent years, has also occurred post-operative complication and operation defective simultaneously.Relapse rate is 1-5% behind China's tension-free hernioplasty, decreases than traditional operation, but still has gap with comparing abroad.The reason of postoperative recurrence except taking out the sticking patch because of the sticking patch deep infection, mainly is the operation blurred anatomy, sticking patch crispatura displacement, the sticking patch area is little, placement location is improper, net plug or sticking patch are fixed not good.Again from various operation totally, no matter external or domestic operation is noted inadequately for the protection of nerve fiber under cremasteric reservation, utilization and the obliquus externus abdominis m. aponeurosis (aponeuroses); Sticking patch enters human body can produce foreign body sensation, has influenced the comfort level of patient's postoperative to a certain extent.In view of domestic above-mentioned present situation, all kinds of hernias for the treatment of each age group with in type import repair materials have seemed very unreasonable, and what have gives a strained interpretation, and increase patient's misery; The little hernia that has is done waste material greatly; The operation technique that has is not in place, causes patient to recur.
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
Figure C20061007071000051
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
Figure C20061007071000061
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
Figure C20061007071000071
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
Figure C20061007071000081
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
Figure C20061007071000082
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
Figure C20061007071000083
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.
Four, description of drawings:
Fig. 1 is a structural representation of the present invention.
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.

Claims (1)

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), it is characterized in that: 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 of top margin (1) 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 of distance of center circle (2) in spermatic cord hole (3) is c, and c equals 6.5cm-4cm, and the long back gauge of the little sticking patch of distance of center circle (2) of 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.
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CN101889881A (en) * 2010-07-21 2010-11-24 薛运章 Two-arm lap joint type patch for laparoscopic herniorrhaphy
CN110090089A (en) * 2019-04-28 2019-08-06 宋大鹏 Indirect inguinal hernia inner ring seals sticking patch and its application method

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CN2590576Y (en) * 2002-12-30 2003-12-10 周建平 Netted mantle sheet for repairing abdominal external hernia
US20050192600A1 (en) * 2004-02-24 2005-09-01 Enrico Nicolo Inguinal hernia repair prosthetic
CN201005729Y (en) * 2006-12-06 2008-01-16 刘克忠 Two-in-one conjoined sticking patch for non-tension herniorrhaphy

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