CN102438547B - Infra-obturator tension transfer device - Google Patents

Infra-obturator tension transfer device Download PDF

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Publication number
CN102438547B
CN102438547B CN201180000441.6A CN201180000441A CN102438547B CN 102438547 B CN102438547 B CN 102438547B CN 201180000441 A CN201180000441 A CN 201180000441A CN 102438547 B CN102438547 B CN 102438547B
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CN
China
Prior art keywords
retzius
space
infra
urethral support
support structural
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Expired - Fee Related
Application number
CN201180000441.6A
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Chinese (zh)
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CN102438547A (en
Inventor
李政润
李花贞
李守镐
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IOT SOUTH KOREA CO Ltd
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IOT SOUTH KOREA CO Ltd
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Priority claimed from PCT/KR2011/001568 external-priority patent/WO2011108911A2/en
Publication of CN102438547A publication Critical patent/CN102438547A/en
Application granted granted Critical
Publication of CN102438547B publication Critical patent/CN102438547B/en
Expired - Fee Related legal-status Critical Current
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42Gynaecological or obstetrical instruments or methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/047Urethrae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0054V-shaped

Abstract

Disclosed is a tension delivery device for preventing urinary incontinence, which includes: Retzius space-insertion portions which are respectively to be inserted into the Retzius spaces positioned on the left side and right side of the urethra and move in response to the pressure or the Retzius spaces; and a urethral support portion which extends convergently from the Retzius space-insertion portions and serves to support the urethra upward, wherein the lateral cross section of the urethral support portion becomes thinner from Retzius space-insertion portions toward the distal end, and a mesh structure may be provided along the outer surface of the tension transfer device. When the tension transfer device is inserted into the human body, the urethral support portion presses the urethra upward due to an increase in pressure of the Retzius spaces, while the mesh structure provided along the outer surface of the device usually induces the tension of the muscles around the urethra, thereby inhibiting involuntary urinary incontinence caused by muscular relaxation. Even when a urinary incontinence patient exercises, sneezes or coughs to increase the abdominal pressure instantaneously, the device can sufficiently inhibit urinary incontinence. Furthermore, the device does not require a guide needle holder that causes damage, and is minimally invasive so that damage associated with an invasive method can be reduced. Also, the device eliminates the need for spinal anesthesia or sedative anesthesia and does not cause discomfort that can occur when excessive local anesthesia is performed. In addition, it can be easily corrected in a non-invasive manner when the therapeutic effect thereof is insufficient. Furthermore, it is easily removed so that it makes it possible to perform surgery again using other methods when the therapeutic effect thereof is insufficient.

Description

Infra-obturator tension transfer device
Technical field
The present invention relates to a kind of nervous conversion equipment (Infra-Obturator tension transfer device:IOT) suppressing or prevent urinary incontinence phenomenon, this nervous conversion equipment puts into body after such as only minimally cutting urethra lower portion, Retzius' space (Retzius Space) and urethra bottom is utilized to increase abdominal pressure, due to the muscular tone phenomenon of Retzius' space etc., thus suppress urinary incontinence; Or based on the structure be combined with other mesh sheet, prevent muscle at ordinary times from losing the nervous urinary incontinence phenomenon caused in advance.
Background technology
The symptom of independently not urinating is urinary incontinence.Motion or mobile, abdominal pressure increase when laughing at or cough, likely cause urinary incontinence.Its reason has old, pregnant, childbirth, chronic cough, asthma, vigorous exercise etc., sometimes attends by obesity or amenorrhea symptom is deepened.This urinary incontinence is initiated because the sphincter of urethra of bladder and support urethra is nervous usually.
About treatment urinary incontinence, be necessary to mention No. US6808485, US granted patent, No. JP1998-155897, Japanese Laid-Open Patent, No. 10-2003-34218, Korean Patent Laid etc.Technology disclosed in above-mentioned patent documentation inserts elastic plugin to vagina inside or in urethra or periureteric tissue, inject hydrogel (hydrogel) particle (polymer: polymer).
Recently, by TOT (through closed pore bladder neck suspension, Trans-Obturator Tape), the passage below from inguinal region to urethra is generated with needle-like saddle (guide needle holder), polypropylene mesh (prolene mash) is hung on saddle (holder) (or reversal of the natural order of things), support, below urethra, to treat urinary incontinence with this.
But although this nearest mode adopts existing microinvasion method, usually need to carry out spinal anesthesia or sleep anesthesia, and damage is brought to inguinal region → closed pore → suburethral muscle and ligament and blood vessel.Therefore the structural damage on its homologic anatomy, the probability of inflammation are higher.In addition, there is set in postoperative mesh sheet (mash), is difficult to carry out second operation, and cannot removes mesh sheet.In addition, the equipments such as the needle-like saddle of easily initiation damage are needed to use.
Summary of the invention
Technical task
The present invention proposes to solve the problem, its object is to: a kind of nervous conversion equipment (Infra-Obturator tension transfer device:IOT) suppressing or prevent urinary incontinence phenomenon is provided, this nervous conversion equipment puts into body after such as only minimally cutting urethra lower portion, Retzius' space (Retzius Space) and urethra bottom is utilized to increase abdominal pressure, due to the muscular tone phenomenon of Retzius' space etc., thus suppress urinary incontinence; Or based on the structure be combined with other mesh sheet, prevent muscle at ordinary times from losing the nervous urinary incontinence phenomenon caused in advance.
Another object of the present invention is to: provide a kind of and prevent at ordinary times because muscle loses the nervous nervous conversion equipment that urinary incontinence phenomenon occurs, along the peripheral position joined web sheet of this nervous conversion equipment, induction mesh sheet makes it be fitted in inside of human body tissue, allows the muscle near urethra continue in tension.
Problem solution
In order to achieve the above object, the nervous conversion equipment of the present invention the 1st embodiment, is characterized in that, is made up of: urethral support structural portion such as lower part, the direction in its side section distally portion is thinning gradually, thus upwards supports urethra from below; Neck cervical region, extends to Retzius' space from the both sides of above-mentioned urethral support structural portion; Mounting structure portion, Retzius' space, the Retzius' space (Retzius Space) inserted respectively about being positioned at above-mentioned urethra is inner, corresponding to the pressure of above-mentioned Retzius' space, pass on revolving force to above-mentioned neck portion, above-mentioned urethral support structural portion is moved up; Wherein, mounting structure portion, described Retzius' space has elastic force decay hole, in order to the up-down vibration portion, above-mentioned Retzius' space that decays.
Mounting structure portion, described Retzius' space has to the outstanding structure in front, Retzius' space.
Described nervous conversion equipment is biocompatibility (biocompatible) solids, particularly silica gel material solids.The industry is well-known, as long as to have no side effect to human body, characteristic conforms technical requirement of the present invention, just can form above-mentioned solids with any material.In addition, inner at above-mentioned nervous conversion equipment, can fill fluid.Described fluid can be any one in air, saline solution, hydrogel.
Infra-obturator tension transfer device of the present invention, is characterized in that, is made up of: urethral support structural portion such as lower part, and the direction in side section distally portion is thinning gradually, thus from the above-mentioned urethra of urethra lower support; Neck cervical region, from the both sides of above-mentioned urethral support structural portion, extends to Retzius' space; Elastic extenuation portion, be inserted into the Retzius' space be positioned at about urethra respectively inner, corresponding to above-mentioned Retzius' space pressure, pass on revolving force to above-mentioned neck portion, above-mentioned urethral support structural portion is moved up, there is dull and stereotyped hook formation with the above-mentioned Retzius' space up-down vibration that decays.
Infra-obturator tension transfer device of the present invention, is characterized in that, is made up of: urethral support structural portion such as lower part, and the direction in side section distally portion is thinning gradually, thus from the above-mentioned urethra of urethra lower support; Neck cervical region, extends to Retzius' space from the both sides of above-mentioned urethral support structural portion; Mounting structure portion, Retzius' space, is inserted into the Retzius' space be positioned at about urethra inner respectively, corresponding to above-mentioned Retzius' space pressure, passes on revolving force to above-mentioned neck portion, above-mentioned urethral support structural portion is moved up; And mesh sheet, encircle each neck cervical region from the above-mentioned urethral support structural portion back side with U-shape, overlapping part is thermally bonded; Wherein, mounting structure portion, described Retzius' space has elastic force decay hole, with the above-mentioned Retzius' space up-down vibration that decays.The side section in above-mentioned urethral support portion is in the shape distally thinning gradually from mounting structure portion, above-mentioned Retzius' space.
Beneficial effect
Nervous conversion equipment of the present invention, in urine incontinence motion, sneeze, cough, when abdominal pressure increases suddenly, utilizes the pressure of Retzius' space to increase, allows urethral support structural portion pressurize to urethra area, can fully suppress urinary incontinence phenomenon.In addition, the present invention, owing to being wound with mesh sheet at the peripheral position of nervous conversion equipment, makes the muscle of urethra area also in tension at ordinary times, can suppress because losing the nervous unexpected urinary incontinence phenomenon caused.
Nervous conversion equipment of the present invention does not need to use the needle-like saddle causing damage, owing to adopting microinvasion method, associated injury can be reduced to greatest extent, and spinal anesthesia, sleep anesthesia etc. need not be carried out, the malaise symptoms because excessive local anesthesia causes can be avoided.
In addition, easily follow-up correction can be carried out by non-invasion and attack method when curative effect is bad.And owing to being easy to remove, as poor effect can easy additive method etc. be performed the operation again.And operating time, minimizing postoperative complication and side effect can be shortened, reduce surgery cost, due to high price imported material can be replaced, can reduce costs.
Accompanying drawing explanation
Fig. 1 is the nervous conversion equipment schematic diagram of the present invention the 1st embodiment;
Fig. 2 is the nervous conversion equipment side schematic view of Fig. 1;
Fig. 3 is the nervous conversion equipment front schematic view of Fig. 1, is the placement state generalized schematic relevant to urethra position;
Fig. 4 is the nervous conversion equipment of the present invention the 1st embodiment when being made up of solid matter, the view that the increase along with abdominal pressure links with it;
Fig. 5 is the nervous conversion equipment front schematic view of Fig. 4, which show the state along with the increase of abdominal pressure, upwards support urethra bottom;
Fig. 6 a, 6b are the nervous conversion equipment main operational principle schematic diagrams of the present invention the 1st embodiment;
Fig. 7 be the nervous conversion equipment of hypothesis the present invention the 1st embodiment be made up of solids or especially time inside when being filled with fluid, the view linked is carried out in the increase along with abdominal pressure;
Fig. 8 is the nervous conversion equipment front schematic view of Fig. 7, is the view along with the increase of abdominal pressure, upwards support urethra bottom;
Fig. 9 is the nervous conversion equipment schematic diagram of the present invention the 2nd embodiment;
Figure 10 a, 10b are the present invention the 2nd embodiment nervous conversion equipment main operational principle schematic diagrams;
Figure 11 is the present invention the 3rd embodiment schematic diagram;
Figure 12 illustrates the schematic diagram that the present invention arranges structure;
Figure 13 is that the present invention arranges view.
Detailed description of the invention
Closed pore (obturator foramen) in the application's book refers to locking space as shown in figure 12, is be engaged by skeleton the space formed with locking states continuously by circle.This closed pore is formed by pubis (pubis) and ischium (ischium), and the genitals comprising bladder and urethra (urethra) is positioned at the rear of pubis and ischium.Retzius' space is had between genitals and pubis.
Thus nervous conversion equipment of the present invention is positioned at the bottom of urethra, be arranged on inside, Retzius' space.
Below, with reference to accompanying drawing, the present invention is described in detail.
Fig. 1 is the nervous conversion equipment schematic diagram of the present invention the 1st embodiment, and Fig. 2 is the nervous conversion equipment side schematic view of Fig. 1.
As shown in Figure 1 and Figure 2, the nervous conversion equipment of the present invention the 1st embodiment comprises; Urethral support structural portion 30, it is positioned at below urethra, distally portion's (figure mono-is bottom) is thinning gradually upwards can to support urethra, side section; Neck cervical region 20, it extends to Retzius' space from the both sides of above-mentioned urethral support structural portion; Mounting structure portion, Retzius' space 10, its Retzius' space (Retzius Space) inserted respectively about being positioned at above-mentioned urethra is inner, corresponding to the pressure of above-mentioned Retzius' space, revolving force is passed on to above-mentioned neck portion, above-mentioned urethral support structural portion is moved up, and there is elastic force decay hole 40 with the up-down vibration of above-mentioned Retzius' space of decaying.
Here, above-mentioned urethral support structural portion 30, for upwards supporting the part of urethra from below, preferably has reclinate concave shape.As long as but the angle formed with urethra is in allowed band, above-mentioned urethral support structural portion 30 also can have the outstanding shape be bent upwards, or does not have bending flat structures.
As shown in the figure, Retzius' space mounting structure portion 10 inserts respectively in the inside, Retzius' space being positioned at urethra about 100.Consider You Liangge Retzius' space, urethra both sides, in the present embodiment, mounting structure portion, Retzius' space 10 is provided with two.As long as but have and to link with Retzius' space or allow urethra lower muscle link with it the structure of being out of shape, mounting structure portion, above-mentioned Retzius' space 10 is not quantitatively limited at it.As shown in the figure, preferably, its outstanding position, mounting structure portion, this Retzius' space 10 is positioned at the ramus of ischium leading edge back lower place, and having can by the structure supported.
Mounting structure portion, each Retzius' space 10, namely, has each mounting structure portion, Retzius' space 10 of isolating construction, and as shown in the figure, extend to central authorities' convergence, forming Post operation will be positioned at the urethral support structural portion 30 below urethra.When above-mentioned urethral support structural portion 30 increases at abdominal pressure, Retzius' space pressure increases and/or Periurethral muscle pressure increases, link with it, upwards support urethra from below.Its principle describes in detail below with illustrating.
In addition, mounting structure portion, above-mentioned Retzius' space 10 has spherical form, can form the mounting groove 40 with hook-shaped with the position that above-mentioned neck cervical region 20 is combined.Above-mentioned mounting groove 40 inserts in mounting structure portion, Retzius' space 10, be arranged on inside, Retzius' space after prevent it from departing from.Certainly, can as required, allow above-mentioned mounting groove 40 be combined in ramus of ischium side around closed pore.
In addition, as shown in Figure 1, Figure 2, particularly shown in Fig. 2, the end in the side of urethral support structural portion 30 or side section distally portion's mounting structure portion 10, namely on the left of Fig. 2, lower end is thinning gradually, can mildly support urethra lower end.Between mounting structure portion, Retzius' space 10 and urethral support structural portion 30, preferably form the neck cervical region 20 being less than mounting structure portion, Retzius' space 10.
Here, mounting structure portion, two Retzius' spaces 10 is separately positioned on inside, two Retzius' spaces, maintains level.For this reason, mounting structure portion, above-mentioned Retzius' space 10 has the structure that the structure that suitably can be arranged on Retzius' space or filling insert setting.Because everyone Retzius' space size varies, in the present invention, the size design in Retzius' space mounting structure portion 10 is in the scope from 5mm to 40mm.But the diameter 2R in mounting structure portion, above-mentioned Retzius' space 101 is preferably 8mm to 11mm and is advisable.
In addition, the spacing L between mounting structure portion, two Retzius' spaces 10 can be formed as 1mm to 100mm, and suitable spacing L is about 18mm to 24mm.Mounting structure portion, arbitrary Retzius' space 10 is 10mm to 80mm with the scope of the maximum spacing W of urethral support structural portion 30, preferably 30mm to 35mm.This nervous conversion equipment can be made up of silicone elastomer material, harmless elastomer, any one material be filled with in the epithelium material of fluid, hardness range at 10Ha to 90Ha, preferably 70Ha.Here hardness is the value detected by supporting (shore) durometer, and be the hardness detected by the SHOR DUROMETER of model LX-A, the hardness 70Ha of detection represents 1.925N (=202.125gcm/s 2).
The hardness of silica gel is an experimental data, suitable hardness its can offset the sense of touch caused owing to fitting with tissue and decline, contribute to improving postoperative psychological security.Therefore, as long as harmless, the hardness being more appropriate to human body can be designed.
In addition, the length between above-mentioned urethral support structural portion 30 and neck cervical region 20 terminal is 9mm to 11mm, and its amplitude is 7mm to 9mm, diminishes gradually towards projected direction, thickness, contributes to improving urethral support power.Above-mentioned urethral support structural portion 30 has the flexure plane to lower recess that Absorbable organic halogens supports urethra.
The sunk structure of above-mentioned urethral support structural portion 30, is as the criterion with sidepiece section, has the radius of 47mm to 57mm, preferably 52mm.The sunk structure of urethral support structural portion 30 upwards supports urethra 100 from below, and is maintaining elastic force at ordinary times.
Above-mentioned neck cervical region 20 extends from mounting structure portion, Retzius' space 10, is combined with the sidepiece of urethral support structural portion 30, its position, upside diameter extended from mounting structure portion 10, Retzius' space is 6mm to 8mm, be that 1.5mm to 2.5mm is advisable with position, the downside diameter that above-mentioned urethral support structural portion 30 is combined, but its size can change with certain analogy according to the size, spacing etc. in mounting structure portion, Retzius' space 10.
As shown in Figure 2, the neck cervical region 20 of nervous conversion equipment maintains 120 ° to 140 ° with the gradient (θ) of urethral support structural portion 30, but can according to the elastic force of material, and its inclination angle can be formed between 30 ° to 170 °.
As shown in Figure 3, the nervous conversion equipment of the present invention the 1st embodiment with said structure is arranged in the health of patient.That is, mounting structure portion, each Retzius' space 10 is inner by the Retzius' space inserted about patient's urethra respectively, and urethral support structural portion 30 is positioned at the below of urethra, can support urethra.
Fig. 4, Fig. 5 are the nervous conversion equipments with said structure when being made up of solids, along with abdominal pressure increase, carry out the view that links.
Moment, the abdominal pressure of urine incontinence such as sneeze or cough can rise, and the pressure of Retzius' space about urethra also can sharply rise.Meanwhile, periurethral muscle also can nervous, pressure rising.
At this moment, be positioned at the contraction of mounting structure portion, Retzius' space 10 due to Retzius' space of inside, Retzius' space, play and be fixed on thunder and help the rotating shaft effect in Si Shi space in distress, meanwhile, as shown in Figure 4, along with the muscular tone on the downside of urethra, urethral support structural portion 30 can be subject to bottom-up power.Here, the pressure that urethral support structural portion 30 is subject to, different by the shape of urethral support structural portion 30.That is, the arrow head part of accompanying drawing can by maximum pressure.Therefore, urethral support structural portion 30 with mounting structure portion, Retzius' space 10 for rotating shaft be pressed towards top.Thus as shown in Figure 5, urethral support structural portion 30 upwards can support urethra 100 from below.
That is, as shown in Figure 6 a, when urine incontinence motion, sneeze or cough, laugh, abdominal pressure can rise suddenly.Meanwhile, the pressure being positioned at the Retzius' space of urethra left and right sides can rise, and periurethral muscle also can nervous, pressure increase.
And the muscular tone that abdominal pressure causes can allow above-mentioned Retzius' space shrink, thus the front upper in the mounting structure portion, Retzius' space 10 be installed in Retzius' space and the back side are exerted pressure.As shown in Fig. 6 a " first ", be as the criterion with position on the upside of front, mounting structure portion 10, Retzius' space, with X-axis to Y direction, exert pressure to neck cervical region 20.Thus above-mentioned urethral support structural portion 30 can rotate in the direction of the clock.
That is, when the Retzius' space be positioned between pelvis (pubis) and bladder shrinks by X-axis and Y direction, Retzius' space is under pressure on the certain position of pelvis.This allows the contact point of pelvis and Retzius' space become jointed shaft, and under the pressure effect on the upside of Retzius' space, urethral support structural portion 30 rotates with the clockwise direction of accompanying drawing.As shown in the figure, during muscle contraction, Retzius' space produces external pressure.Here, with above-mentioned corresponding power is the actual force that muscle produces, and with corresponding power is the indirect action power that muscle contraction causes.Thus, with offset to a certain degree, remaining downward pressure.In addition, active force is at above-mentioned pelvis (pubis) counteracting force effect under be cancelled.
But, above-mentioned external force between mounting structure portion, Retzius' space 10 and neck cervical region 20 or a part for neck cervical region 20, work as pressure.Finally, active force is exerted pressure towards the negative direction (-) of X-axis, and with exert pressure towards Y-axis negative direction with joint efforts.Thus mounting structure portion, above-mentioned Retzius' space 10 can be subject to the active force towards lower left (accompanying drawing is as the criterion).In addition, because mounting structure portion, Retzius' space 10 and the contact of pelvis (pubis) light jointed shaft effect, above-mentioned neck cervical region 20 can (accompanying drawing is as the criterion) rotate in a clockwise direction.
Certainly, except this revolving force, as shown in Fig. 6 a " second ", also there is the external force of exerting pressure to neck cervical region 20 outside left, this external force strengthens the revolving force of neck cervical region 20, allows urethral support structural portion 30 rotate from X axis Y-axis.Therefore, according to such operation principle, the urethral support structural portion 30 with recess curved surface is exerted pressure to urethra from bottom to top, by the support force of urethra bottom, thus can prevent urinary incontinence.
Action as above can be carried out, be because the material of nervous conversion equipment has elastic force, and there is the hardness of about about 70Ha.This contributes under external pressure effect, allows urethral support structural portion 30 move to urethra direction.
Such as, when hardness is little, external pressure can not pass to urethral support structural portion 30, causes urethral support structural portion 30 fully to exert pressure to urethra 100.Contrary much higher hard, can cause urethral support structural portion 30 according to external pressure action too continually.And during much higher hard, the comfort of nervous conversion equipment reduces greatly, allows patient feel bad, likely the solids being inserted into body interior is produced and repel sense.Thus the silica gel material hardness of nervous conversion equipment is that 10Ha to 90Ha is proper, preferred 70Ha, and this can reach the effect of multiplication constantly.
The nervous conversion equipment of the embodiment of the present invention utilizes hardness and the own form of material, allows abdominal pressure pass on better, fully supports urethra bottom.Finally, when the mounting structure portion, Retzius' space 10 being positioned at Retzius' space shrinks in Retzius' space, play the rotating shaft effect being fixed on Retzius' space, and the fluidity substance being filled in inside flow to urethral support structural portion 30, urethral support structural portion 30 is made to expand and support urethra.In addition, after the abdominal pressure caused due to external cause is removed, nervous conversion equipment of the present invention can set back.
Figure 13 is the figure that the nervous conversion equipment of the present invention the 1st embodiment is arranged.As shown in the figure, the urethral support structural portion 30 being positioned at urethra bottom of nervous conversion equipment supports the bottom of urethra.In addition, it is inner that mounting structure portion, above-mentioned Retzius' space 10 is arranged on not shown Retzius' space, and Retzius' space close contact is in the inner side of the certain position of pelvis, such as pubis.Thus the mounting structure portion, Retzius' space 10 of above-mentioned nervous conversion equipment supports the back side of pelvis, can, centered by contact site, nervous conversion equipment be allowed to rotate.
Because nervous conversion equipment of the present invention is positioned at inside, Retzius' space, when Retzius' space move up and down, such as irrelevant with abdominal pressure and because of patient moving causes Retzius' space move time, the urethral support power of the urethral support structural portion 30 of support urethra bottom likely with above-mentioned synchronized movement reduce.That is, there is a lot of urine incontinence because the muscle of urethra bottom loses nervous generation urinary incontinence phenomenon, being therefore necessary to exert pressure when Retzius' space moves up and down, to fully supporting urethra.
Therefore, mounting structure portion, Retzius' space of the present invention 10 is formed with the elastic force decay hole 40 running through forward lower part and sidepiece.And above-mentioned elastic force decay hole 40 allows mounting structure portion, Retzius' space 10 in hook-shaped, when Retzius' space moves down instantaneously, decaying, it moves down effect, reduces moving down of urethral support structural portion 30.
When Fig. 6 b is Retzius' space up-down vibration, nervous conversion equipment operation principle schematic diagram.As shown in the figure, urine incontinence does vigorous exercise, when causing muscle up-down vibration, Retzius' space also can up-down vibration, and now, vertical tremor is also synchronously carried out therewith in Retzius' space.Here, as shown in Fig. 6 b " first ", when Retzius' space moves down, the position, upside in mounting structure portion, Retzius' space 10 and Retzius' space upper contact, and Ru shown in " second ", the elastic force decay hole 40 in mounting structure portion, Retzius' space 10 shrinks, buffer spring.
That is, when Retzius' space moves down, neck cervical region 20 and urethral support structural portion 30 should move down.But above-mentioned elastic force decay hole 40 allows mounting structure portion, Retzius' space 10 bend by certain angle.This make mounting structure portion, Retzius' space 10 can resiliency supported move with Retzius' space and the pressure that produces, thunder helps the motive force up and down in Si Shi space in distress, is transmitted to above-mentioned urethral support structural portion 30 tinily and maybe can not passes to urethral support structural portion 30.Thus, during urine incontinence motion, the urethra bottom of above-mentioned urethral support structural portion 30 meeting continued support patient.
Illustrate that the nervous conversion equipment silica gel material of the present invention the 1st embodiment manufactures above.But after also can forming shell with silica gel material, fill fluidity substance (such as, being filled with the whippy silica gel pack arrangement of saline solution) in inside.When adopting this structure, when Retzius' space changes, except the elasticity of silica gel itself, above-mentioned fluidity substance can also be utilized, more effectively support urethra.Fig. 7, Fig. 8 are the nervous conversion equipment schematic diagrams being filled with fluidity substance, illustrate along with abdominal pressure increase, carry out the state that links.
This is identical with the operation principle of the nervous conversion equipment of the present invention the 1st embodiment, and the fluidity substance being just filled in nervous conversion equipment inside can improve the support force of urethra bottom.Here, nervous conversion equipment comprises silica gel crust and filling fluidity substance therein.And the face material of the urethral support structural portion 30 of above-mentioned nervous conversion equipment can reduce its hardness.Thus, except the revolving force centered by mounting structure portion, Retzius' space 10 illustrated above, fluidity substance can also be utilized to cause urethral support structural portion 30 and to be out of shape, the support force to urethra bottom can be improved further.
After abdominal pressure is removed, set back under the intrinsic elastic force effect of nervous conversion equipment, original state, after reply, and the fluidity substance being projected into urethral support structural portion 30 front also can be back to mounting structure portion, Retzius' space 10.In the present invention, the material be filled in nervous conversion equipment can be air, saline solution, hydrogel (cohesive gel).
Fig. 9 is the nervous conversion equipment schematic diagram of the present invention the 2nd embodiment.As shown in the figure, the nervous conversion equipment of the present invention the 2nd embodiment is narrowed, for supporting the urethral support structural portion 130 of above-mentioned urethra gradually by the direction being positioned at urethra bottom, side section distally portion; From the neck cervical region 120 that two side direction Retzius' spaces of above-mentioned urethral support structural portion 130 extend; Be inserted into respectively be positioned at Retzius' space about urethra inner, corresponding to above-mentioned Retzius' space pressure, pass on revolving force to above-mentioned neck portion, allow above-mentioned urethral support structural portion move up, there is dull and stereotyped hook formation, the elastic extenuation portion 110 of the above-mentioned Retzius' space up-down vibration that can decay forms.
Above-mentioned urethral support structural portion 30 preferably upwards supports the part of urethra from below, is bent downwardly, has concave shape.As long as but allow with the angle that urethra is formed, above-mentioned urethral support structural portion 30 also can have the outstanding shape be bent upwards, or does not have bending flat structures.
The nervous conversion equipment of the present embodiment can be formed with silica gel material, or fills the fluidity substances such as air, saline solution or high gelation silica gel (cohesive gel) to its inside after forming epithelium with silica gel material.
Above-mentioned urethral support structural portion 130, neck cervical region 120 and elastic extenuation portion 110 are integrated, and preferably have the same rigidity as described in the 1st embodiment.That is, the nervous conversion equipment of the present embodiment, its material, hardness, specification can be same or similar.As shown in the figure, the spacing L between two elastic extenuation portions 110 can be formed as 1mm to 100mm, and suitable spacing L is about 18mm to 24mm.Arbitrary elastic extenuation portion 110 is 10mm to 80mm with the scope of the maximum spacing W of urethral support structural portion 130, preferably 30mm to 35mm.
The amplitude T with the above-mentioned elastic extenuation portion 110 of flat structure can in 2mm to 50mm scope, preferred 10mm to 15mm.In addition, the thickness t in above-mentioned elastic extenuation portion 110 is 1mm to 5mm, preferred 1mm to 1.5mm.
This nervous conversion equipment can be made up of silicone elastomer material, harmless elastomer, any one material be filled with in the epithelium material of fluid, hardness range at 10Ha to 90Ha, preferred 70Ha (1.925N).
And the neck cervical region 120 of nervous conversion equipment and the gradient θ of urethral support structural portion 130 maintain 120 ° to 140 °, but can according to the elastic force of material, its angle can be formed between 30 ° to 170 °.
The hardness of silica gel is the factor affecting postoperative sensation, and the suitable sense of touch can offset when merging with tissue of hardness, contribute to improving postoperative psychological security, above-mentioned data are exactly the experimental data obtained based on as above considering.Therefore, as long as harmless, the hardness being more appropriate to human body can be designed.
In addition, it is structure for forming nervous conversion equipment that the epithelium material of the nervous conversion equipment of the present embodiment comprises inductor, and identical with the explanation carried out in the 1st embodiment, having more than is the structure allowing urethral support structural portion 130 carry out outstanding action.
The nervous conversion equipment of the present embodiment is implanted to after in urine incontinence body, patient moving, sneeze, coughs or laughs at, and when abdominal pressure rises, the Retzius' space pressure about urethra can rise.Meanwhile, periurethral muscle also can nervous, pressure increase.
That is, as shown in Figure 10 a " first ", be as the criterion with position on the upside of front, elastic extenuation portion 110, with X-axis to Y direction, exert pressure to neck cervical region 120.When the Retzius' space be positioned between pelvis (pubis) and bladder shrinks by X-axis and Y direction, Retzius' space is under pressure on the certain position of pelvis.This allows the contact point of pelvis and Retzius' space become jointed shaft, and under the pressure effect on the upside of Retzius' space, urethral support structural portion 130 rotates for benchmark carries out clockwise direction with accompanying drawing center.As shown in the figure, during muscle contraction, Retzius' space produces external pressure.Here, with above-mentioned corresponding power is the actual force that muscle produces, and with corresponding power is the indirect action power that muscle contraction causes.Thus, with offset to a certain degree, remaining downward pressure.In addition, active force above-mentioned pelvis (pubis) counteracting force (with corresponding power) effect under be cancelled.
But, above-mentioned external force as between elastic extenuation portion 110 and neck cervical region 20 or a part of pressure of neck cervical region 20 work.Finally, active force is exerted pressure towards the negative direction (-) of X-axis, and with exert pressure towards Y-axis negative direction with joint efforts.Thus above-mentioned elastic extenuation portion 110 can be subject to the active force towards lower left (accompanying drawing is as the criterion).In addition, because elastic extenuation portion 110 and the contact of pelvis (pubis) light jointed shaft effect, above-mentioned neck cervical region 20 can (accompanying drawing is as the criterion) rotate in a clockwise direction.
Certainly, except this revolving force, as shown in Figure 10 a " second ", also there is the external force of exerting pressure to neck cervical region 20 outside left, this external force strengthens the revolving force of neck cervical region 20, allows the urethral support structural portion 30 extending to neck cervical region 20 rotate from X axis Y-axis.Therefore, according to such operation principle, the urethral support structural portion 30 with recess curved surface is exerted pressure to urethra from bottom to top, thus can prevent urinary incontinence.
Nervous conversion equipment operation principle schematic diagram when Figure 10 b is Retzius' space up-down vibration.As shown in the figure, urine incontinence does vigorous exercise, when causing muscle up-down vibration, and Retzius' space also can synchronous up-down vibration therewith.Here, as shown in Figure 10 b " first ", when Retzius' space moves down, the position, upside in elastic extenuation portion 110 and Retzius' space upper contact, and elastic force decay hole 40 that is as shown in " second ", elastic extenuation portion 110 shrinks, buffer spring.Thus identical with the 1st embodiment above, the present embodiment shrinks in Retzius' space or when moving up and down, urethral support structural portion 130 also can be allowed fully to support urethra bottom.
In addition, Figure 11 is the schematic diagram of the nervous conversion equipment illustrating the present invention the 3rd embodiment.As shown in the figure, disclosed in the present embodiment, nervous conversion equipment has the structure be combined with mesh sheet, and this is the situation that the nervous conversion equipment mentioned in the 1st embodiment is combined with mesh sheet.Certainly, the nervous conversion equipment of the present invention the 2nd embodiment also can be combined with mesh sheet described below, and this combined structure is covered by the technology of the present invention thought range.
The structure symbol of the present embodiment is as the criterion with the symbol of the 1st embodiment and is described.First, as shown in the figure, the present embodiment nervous conversion equipment by be positioned at urethra bottom, side section distally portion direction gradually thinning, to support the urethral support structural portion 30 of above-mentioned urethra; The neck cervical region 20 (figure slightly) of Retzius' space is extended to from the both sides of above-mentioned urethral support structural portion 30, be inserted into the Retzius' space be positioned at about urethra respectively inner, corresponding to above-mentioned Retzius' space pressure, pass on revolving force to above-mentioned neck portion, allow above-mentioned urethral support structural portion move up; Mounting structure portion, described Retzius' space 10 has the elastic force decay hole 40 (figure slightly) of the above-mentioned Retzius' space up-down vibration that can decay; And encircle each neck cervical region from the above-mentioned urethral support structural portion back side with U-shape, the mesh sheet 50 that overlapping part is heat-bonded is formed.In addition, the side section of above-mentioned urethral support structural portion is from mounting structure portion, above-mentioned Retzius' space to the structure that distal portion is thinning gradually.
Here, above-mentioned urethral support structural portion 30, for upwards supporting the part of urethra from below, preferably has reclinate concave shape.If but can urethra be supported, above-mentioned urethral support structural portion 30 also can have the outstanding shape be bent upwards, or does not have bending flat structures.
In addition, above-mentioned mesh sheet 50 has the network structure be made into by polypropylene material, and the length of mesh sheet 50 can be identical with the spacing of Retzius' space end with urethra.Thus above-mentioned mesh sheet 50 length can be 5mm to 200mm, there is mesh sheet 50 when encircling neck portion 20 with U-shaped structure, length that each end section does not exceed mounting structure portion, above-mentioned Retzius' space 10 is advisable.
Here, if the length of above-mentioned mesh sheet 50 is close to 5mm, when being such as defined as 5mm to 10mm, its curtailment is to encircle above-mentioned neck cervical region 20, when this is due to nervous conversion equipment of the present invention is inserted in human body, meeting be fitted with tissue thus mesh sheet 50 is fixed.Therefore, the mesh sheet 50 in the embodiment of the present invention can be pasted onto urethral support structural portion 30 bottom surface or be set to the state of winds portions, thus can use nervous conversion equipment of the present invention.
The length of above-mentioned mesh sheet 50 in short-term, above-mentioned mesh sheet 50 can be engaged with the bottom surface of urethral support structural portion 30 by thermal bonding or be bonded on embedding be formed at urethral support structural portion 30 bottom surface groove (scheming slightly) on.
That is, above-mentioned mesh sheet 50 can be encircled in the length of neck cervical region 20 is 10mm to 200mm, and when the lower bond of mesh sheet 50 and urethral support structural portion 30 or embed engages, its length can be 5mm to 10mm.
In addition, the loom braiding of above-mentioned mesh sheet 50, the structure combined with the side of each single mesh sheet, braiding screen cloth.Limit is received with single line in the joint portion that mesh sheet sidepiece combines and formed, and when the sidepiece of single mesh sheet is combined, both meshes can completely align.
That is, the structure that the mesh being formed at mesh sheet limit, side A sidepiece aligns mutually with the mesh being formed at opposite side mesh sheet B avris portion accordingly, therefore arranges point-blank at the mesh of joint portion C central authorities, alignment mutually.In addition, there is the single line D allowing above-mentioned each mesh combine.
Mesh is prismatic shape, the maximum 1.5mm of catercorner length.Braiding has the mesh sheet of this mesh, and make it have single layer structure, thickness is 0.5mm to 1mm, is preferably 0.7mm, when inserting human body, can improve the adhesiveness with inside of human body tissue.In addition, above-mentioned mesh sheet 50 is formed by polypropylene material, its composition is 100%, also can as required, with the mixture braiding of the copolymer of the copolymer of admixtured polyether urethane and polydimethylsiloxane (PDMS), styrene and polyamine, block Polyurethane (Segmented Polyurethane) and silica gel.It is nervous that above-mentioned mesh sheet 50 can prevent tissue in human body from losing, namely can allow periurethral muscular tone, contribute to reducing urinary incontinence phenomenon.
There is the nervous conversion equipment of above-mentioned mesh sheet 50 in patient moving, sneeze, cough, when abdominal pressure rises suddenly, utilize the pressure of Retzius' space to increase, allow urethral support structural portion 30 pairs of urethra area exert pressure.And above-mentioned mesh sheet 50 allows muscle remain nervous at ordinary times, suppress because muscle loses the nervous unexpected urinary incontinence occurred.
The nervous conversion equipment of the present embodiment, by being combined with mesh sheet 50, reduces urinary incontinence phenomenon at ordinary times greatly, and the muscle of urethra area can be allowed to keep tense situation.In addition, nervous conversion equipment of the present invention is only to after the very little wound of incision minimal below urethra 100, to mounting structure portion, insertion Retzius' space, Retzius' space 10, can complete operation.Therefore, do not need to use the needle-like saddle causing damage, owing to adopting microinvasion method, associated injury can be reduced to greatest extent.And be easy to remove, as poor effect can easily carry out other various operations.
1st embodiment of the present invention is applied to the nervous conversion equipment of the 3rd embodiment by simple clinical trial.Its result, patient's reflection imperceptible foreign body sensation at all, represents curative effect and feels quite pleased.And spinal anesthesia, sleep anesthesia etc. need not be carried out in operation process, the malaise symptoms owing to excessively anaesthetizing initiation can be avoided.

Claims (23)

1. an Infra-obturator tension transfer device, is characterized in that, is made up of such as lower part:
Urethral support structural portion (30), the direction in its side section distally portion is thinning gradually, thus from urethra described in urethra lower support;
Neck cervical region (20), from the both sides of above-mentioned urethral support structural portion, extends to Retzius' space;
Mounting structure portion, Retzius' space (10), it is spherical, is inserted into the Retzius' space be positioned at about urethra respectively inner, corresponding to above-mentioned Retzius' space pressure, pass on revolving force to above-mentioned neck portion, thus described urethral support structural portion is moved up.
2. Infra-obturator tension transfer device according to claim 1, is characterized in that, mounting structure portion, described Retzius' space (10) has elastic force decay hole (40), in order to the up-down vibration of described Retzius' space of decaying.
3. Infra-obturator tension transfer device according to claim 1 and 2, is characterized in that:
Mounting structure portion, described Retzius' space (10) has to the outstanding structure in front, Retzius' space.
4. Infra-obturator tension transfer device according to claim 1 and 2, is characterized in that: described nervous conversion equipment is biocompatibility (biocompatible) solids.
5. Infra-obturator tension transfer device according to claim 4, is characterized in that: described biocompatibility solids is silica gel material solids.
6. Infra-obturator tension transfer device according to claim 1 and 2, is characterized in that: inner at above-mentioned nervous conversion equipment, is filled with fluid.
7. Infra-obturator tension transfer device according to claim 6, is characterized in that: described fluid is any one in air, saline solution, hydrogel.
8. Infra-obturator tension transfer device according to claim 1 and 2, is characterized in that: described urethral support structural portion (30) has reclinate concave shape, the outstanding shape be bent upwards and without any one in bending flat structures.
9. Infra-obturator tension transfer device according to claim 1 and 2, it is characterized in that: the diameter (2R) of mounting structure portion, described Retzius' space (10) is 5mm to 40mm, spacing L between mounting structure portion, two Retzius' spaces (10) is 1mm to 100mm, and mounting structure portion, arbitrary Retzius' space (10) is 10mm to 80mm with the maximum spacing (W) of urethral support structural portion (30); Angle between the neck cervical region (20) of above-mentioned nervous conversion equipment and urethral support structural portion (30) is 30 ° to 170 °.
10. Infra-obturator tension transfer device according to claim 9, it is characterized in that: the diameter (2R) of mounting structure portion, above-mentioned Retzius' space (10) is 8mm to 11mm, spacing (L) between mounting structure portion, two Retzius' spaces (10) is 18mm to 24mm, and any one mounting structure portion, Retzius' space (10) is 30mm to 35mm with the maximum spacing (W) of urethral support structural portion (30); Gradient (θ) between the neck cervical region (20) of above-mentioned nervous conversion equipment and urethral support structural portion (30) is 120 ° to 140 °.
11. Infra-obturator tension transfer devices according to claim 1 and 2, is characterized in that: described nervous conversion equipment is made up of silica gel material, and hardness is 10Ha to 90Ha.
12. Infra-obturator tension transfer devices according to claim 1 and 2, is characterized in that: described nervous conversion equipment is made up of harmless elastomer, any one material be filled with in the epithelium material of fluid, and hardness is 10Ha to 90Ha.
13. Infra-obturator tension transfer devices according to claim 2, is characterized in that,
Also comprise mesh sheet (50), described mesh sheet (50) encircles each neck cervical region from the described urethral support structural portion back side with U-shape, and overlapping part is thermally bonded.
14. Infra-obturator tension transfer devices according to claim 13, is characterized in that: mesh sheet (50) length of braiding is 10mm to 200mm.
15. Infra-obturator tension transfer devices according to claim 2, is characterized in that,
Also comprise mesh sheet, be close to described urethral support structural portion (30) back side, after being inserted into human body, described urethral support structural portion (30) and tissue are fitted.
16. Infra-obturator tension transfer devices according to claim 15, is characterized in that: described netting length is 5mm to 10mm.
17. Infra-obturator tension transfer devices according to claim 15, is characterized in that:
Described mesh sheet thermal bonding is in described urethral support structural portion (30) bottom or be bonded in the groove being formed at described urethral support structural portion (30) bottom with embedding.
18. Infra-obturator tension transfer devices according to any one of claim 13 to 17, is characterized in that: described urethral support structural portion (30) has reclinate concave shape, the outstanding shape be bent upwards and without any one in bending flat structures.
19. Infra-obturator tension transfer devices according to any one of claim 13 to 17, it is characterized in that: the diameter (2R) of mounting structure portion, described Retzius' space (10) is 5mm to 40mm, spacing (L) between mounting structure portion, two Retzius' spaces (10) is 1mm to 100mm, and mounting structure portion, arbitrary Retzius' space (10) is 10mm to 80mm with the maximum spacing (W) of urethral support structural portion (30); Angle between the neck cervical region (20) of described nervous conversion equipment and urethral support structural portion (30) is 30 ° to 170 °.
20. Infra-obturator tension transfer devices according to claim 19, it is characterized in that: the diameter (2R) of mounting structure portion, described Retzius' space (10) is 8mm to 11mm, spacing (L) between described mounting structure portion, two Retzius' spaces (10) is 18mm to 24mm, and mounting structure portion, arbitrary Retzius' space (10) is 30mm to 35mm with the maximum spacing (W) of urethral support structural portion (30); Gradient (θ) between the neck cervical region (20) of described nervous conversion equipment and urethral support structural portion (30) is 120 ° to 140 °.
21. Infra-obturator tension transfer devices according to any one of claim 13 to 17, is characterized in that: described nervous conversion equipment is made up of silica gel material, and hardness is 10Ha to 90Ha.
22. Infra-obturator tension transfer devices according to any one of claim 13 to 17, it is characterized in that: described nervous conversion equipment is made up of harmless elastomer, any one material be filled with in the epithelium material of fluid, and hardness is 10Ha to 90Ha.
23. Infra-obturator tension transfer devices according to any one of claim 13 to 17, it is characterized in that: described mesh sheet (50) is formed by polypropylene material, or form with any one braiding in the mixture of the copolymer of the copolymer of admixtured polyether urethane and polydimethylsiloxane, styrene and polyamine, block Polyurethane (Segmented Polyurethane) and silica gel.
CN201180000441.6A 2010-03-05 2011-03-07 Infra-obturator tension transfer device Expired - Fee Related CN102438547B (en)

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CN105769380B (en) 2016-05-30 2017-09-22 周建 Fundus of bladder support arm and method for implantation in pelvis
BR112019001392B1 (en) * 2016-07-25 2023-04-25 Ovala, Inc INCONTINENCE DEVICE

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