CN101330877A - Instrument for effecting anastomosis of respective tissues defining two body lumens - Google Patents

Instrument for effecting anastomosis of respective tissues defining two body lumens Download PDF

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Publication number
CN101330877A
CN101330877A CNA2006800467915A CN200680046791A CN101330877A CN 101330877 A CN101330877 A CN 101330877A CN A2006800467915 A CNA2006800467915 A CN A2006800467915A CN 200680046791 A CN200680046791 A CN 200680046791A CN 101330877 A CN101330877 A CN 101330877A
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CN
China
Prior art keywords
anchoring piece
assembly
bar
end effector
fixed cover
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Pending
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CNA2006800467915A
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Chinese (zh)
Inventor
W·B·韦森伯格
C·J·赫斯
J·W·沃格勒
R·P·吉尔
M·M·伊萨
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Ethicon Endo Surgery Inc
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Ethicon Endo Surgery Inc
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Publication date
Priority claimed from US11/268,153 external-priority patent/US7708748B2/en
Application filed by Ethicon Endo Surgery Inc filed Critical Ethicon Endo Surgery Inc
Publication of CN101330877A publication Critical patent/CN101330877A/en
Pending legal-status Critical Current

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Abstract

The invention discloses an instrument which is used for respectively restricting the organism anastomosis of two body cavities, in particular,Disclosed is an instrument for use in a procedure to effect anastomosis of a patient's bladder and urethra following a prostatectomy having a tube assembly, and an end effector assembly operably supported by the tube assembly. The end effector assembly includes a positioner assembly, an anchor driver assembly and an anchor for insertion into and through the patient's bladder wall and pelvic floor and an anchor guide associated therewith. The end effector also includes a harness adapted to receive a balloon portion of a balloon catheter assembly.

Description

Be used to make the identical apparatus of tissue that limits two body cavitys respectively
Related application
The application is the part continuation application of following non-provisional application, and require the priority of described non-provisional application and by reference its integral body is incorporated into this paper, and described non-provisional application and the application's applicant is identical: the serial number of submitting on March 30th, 2005 is 11/094606, exercise question is the application of " METHOD AND INS TRUMENT FOR EFFECTINGANASTOMOSIS OF RESPECTIVE TISSUES DEFINING TWO BODYLUMENS ".
Technical field
The present invention relates in general to coincideing of two hollow organs, hollow organ and a vascular or two vasculars, is specifically related to realize in Wicresoft's mode the embodiment of described identical method and apparatus.More specifically, the invention still further relates to the particularly cut coinciding machine and the method for coincideing that can be used for bladder and urethra afterwards of patient's prostate in prostatectomy.
Background technology
Carcinoma of prostate is to come the malignant tumour of skin second modal malignant tumor afterwards among the male, and is the second the most common inducement of cancer mortality among the U.S. male.Carcinoma of prostate is mainly in elderly men, estimates that the absolute number of this case can increase along with the prolongation of global life expectancy.
Millin has introduced retropubic prostatectomy as the carcinoma of prostate therapy in nineteen forty-seven.The remarkable advantage that this operation is compared with perineal prostatectomy is, dissects behind the more familiar pubis of urologist.The carcinoma of prostate radical correction also provides this advantage of ability of carrying out abdomen adventitia pelvic lymph node dissection stage by stage behind the pubis.In the past during the decade, the improvement of carcinoma of prostate radical correction technology causes the two kind condition of illness (incontinence and sexual impotence) that most attract people's attention relevant with this operation sharply to descend with the neural introducing that keeps anatomic method behind the pubis.
Behind pubis in the carcinoma of prostate radical correction, the surgeon excises patient's all or most prostate.Because urethra passes prostate and advances, the top of urethra is cut in surgical operation.In order to recover normal urinary function, must reconnect bladder and urethra.
Because the limited and urethra of work space is small-sized, provide this connection difficulty especially.The size of urethra makes that being difficult to pass urethral wall accurately is provided with suture.So far, the suture operation that the surgeon uses ultra-fine pin to require great effort is to reconnect bladder and urethra.The use that has been found that the suture that is used for this purpose has caused some problems at rehabilitation course.These problems comprise suture tissue gangrene, hinder the urethral stricture that fluid flows through and the urethra-bladder of not fluid tight so to be connected.In addition, when being sewn onto urethra on the bladder, the surgeon may puncture near neurovascular bundle because of carelessness, and this can cause incontinence and sexual impotence.Find that also sewing process itself is very loaded down with trivial details, before carrying out meticulous stitching, need the surgeon to grasp bladder and urethra and bladder and urethra are stretched to together.Suture also may be torn urethra, causes further complication.
Along with the use of carcinoma of prostate radical correction behind the pubis becomes more and more general, need rapider easier mode reconnect bladder and urethra.Provide the instrument of a kind of identical urethra that does not need to use the suture that may damage and bladder may be more favourable.
In addition, exist other need connect the surgical operation of the tissue of vascular, hollow organ and other body cavity of qualification.In these organizational structuries some are bigger, and operated by the surgeon easilier, and it is littler to limit the organizational structure of other body cavity, for example more is being difficult to operate and be held in place in its terminal process of connection after the crosscut operation.Therefore, the quicker easier mode of other tissue of connection vascular, hollow organ and qualification body cavity will be more favourable.
Description of drawings
The accompanying drawing that is included in the description and forms the part of description is for example understood many aspects of the present invention, and with describe one and be used from and explain principle of the present invention, in the accompanying drawing:
Fig. 1 is human male's bladder, prostate and urethra and the local sectional elevation sketch map of the position relation of pelvic floor on every side before prostatectomy;
Fig. 2 is human male's bladder, prostate and urethra and the local sectional elevation sketch map of the position relation of pelvic floor on every side after prostatectomy;
Fig. 3 is the perspective view of the illustrative embodiments of the apparatus that comprises Handleset, pipe assembly and end effector assembly in the scope of the invention;
Fig. 3 A is that the end effector assembly of apparatus shown in Fig. 3 is installed in the longitudinal sectional view when holding in the cover;
Fig. 4 is the longitudinal sectional view after the end effector assembly of apparatus shown in Fig. 3 enters the bladder opening in insertion and through patient's urethra;
Fig. 4 A is the perspective view of the end effector assembly of apparatus shown in Fig. 3;
Fig. 5 is the longitudinal sectional view of the assembly of end effector shown in Fig. 3 when localizer arm is opened;
Fig. 5 A is the perspective view of the end effector assembly of apparatus shown in Fig. 5;
The longitudinal sectional view that Fig. 6 is the assembly of end effector shown in Fig. 3 when localizer arm is opened and pushed wall of urinary bladder to pelvic floor;
Fig. 7 is the assembly of end effector shown in Fig. 3 in localizer arm and drive arm is opened and longitudinal sectional view when pushing wall of urinary bladder to pelvic floor;
Fig. 7 A is the perspective view of the end effector assembly of apparatus shown in Fig. 7;
To be the assembly of end effector shown in Fig. 3 pass the longitudinal sectional view of wall of urinary bladder after entering pelvic floor in the drive arm proximal motion to drive anchoring piece to Fig. 8;
Fig. 8 A is the perspective view of the assembly of end effector shown in Fig. 8;
Fig. 9 be the assembly of end effector shown in Fig. 3 anchoring piece is discharged from drive arm and drive arm be returned to towards the distally its before driving the position and close after longitudinal sectional view;
Fig. 9 A is the perspective view of the assembly of end effector shown in Fig. 9;
Figure 10 be the assembly of end effector shown in Fig. 3 drive arm closed and localizer arm discharged the anchoring piece guiding piece and close after longitudinal sectional view;
Figure 10 A is the perspective view of the assembly of end effector shown in Figure 10;
Figure 11 is the longitudinal sectional view of mounted capsule fixed cover assembly;
Figure 12 is the longitudinal sectional view of the fixed cover of capsule shown in Figure 11 assembly, has to be shown as the ductus bursae that is inserted in the capsule fixed cover assembly;
Figure 13 is fixed cover assembly of capsule shown in Figure 12 and the longitudinal sectional view of ductus bursae after the capsule of described ductus bursae assembly is inflated;
Figure 14 is the longitudinal sectional view of the fixed cover of capsule shown in Figure 12 assembly, shown in capsule fixed cover assembly after the assembly of ductus bursae shown in Figure 12 is removed, be reversed so that be removed;
Figure 15 is the axial section that the line 21-21 in Figure 10 of a kind of embodiment of pipe assembly cuts open, and described pipe assembly has the actuator lever that is arranged on wherein or activates band;
Figure 16 is the perspective view of a kind of embodiment of anchoring piece, shows that have one illustrates and be set at anchoring piece guiding piece on the front end with cross section;
Figure 16 A is the forward perspective view of a kind of embodiment of anchoring piece, shows that have one illustrates and be set at anchoring piece guiding piece on the rear end with the cross section;
Figure 17 A is the perspective view of a kind of embodiment of exemplary capsule fixed cover within the scope of the present invention;
Figure 17 B is the perspective view of the another kind of embodiment of exemplary capsule fixed cover within the scope of the present invention;
Figure 17 C is the perspective view of the another kind of embodiment of exemplary capsule fixed cover within the scope of the present invention;
Figure 17 D is the perspective view of a kind of embodiment of the anchoring piece guiding piece that can use with within the scope of the present invention apparatus and/or method;
The partial lateral (level) of Figure 18 human male pelvis and pelvic floor structure (top) view of bowing has described to be used for installing with the method in the scope of the invention exemplary position of anchoring piece;
Figure 19 is the longitudinal sectional view of the distal part of the exemplary ductus bursae assembly in the scope of the invention;
Figure 20 is the longitudinal sectional view of the distal part of another the exemplary ductus bursae assembly in the scope of the invention;
Figure 21 is the longitudinal sectional view of the distal part of another the exemplary ductus bursae assembly in the scope of the invention;
Figure 22 is the longitudinal sectional view of the distal part of another the exemplary ductus bursae assembly in the scope of the invention;
Figure 23 is the perspective view of the near-end of ductus bursae assembly, and described near-end has the exemplary mechanisms that is used to pump into expansion fluid, extraction urine and is used to keep seal wire; With
Figure 24 is the vertical sectional view of the end effector of Fig. 9 A.
The specific embodiment
Now introduce the various alternate embodiments and the various alternative elements thereof of method and apparatus of the present invention illustrated in the accompanying drawings in detail.
Before the embodiment of disclosure and description method and apparatus of the present invention, should be understood that the present invention is not limited to disclosed in this article specific process step and material, because these processing steps and material can change to a certain extent.Scope of the present invention it will also be appreciated that the term that uses in this article only is used to describe specific implementations this purpose, rather than attempts to limit, because will only be limited by appending claims.
Unless otherwise defined, all technology of using in this article and scientific terminology have the identical implication of implication with those skilled in the art institute common sense.Although similar or be equal to herein any method, apparatus and the material described and implementing or checking also can be used when of the present invention, the specific implementations of describing method, apparatus and material now.
Must be noted that singulative " " and " being somebody's turn to do " comprise plural object, are not like this unless described content clearlys show as using in this description and the appending claims.
When describing and requiring right of the present invention, following term will use according to the definition of elucidated hereinafter.
The term of Shi Yonging " coincide " and refers to the surgery that limits body cavity and each self-organizing of other hollow body structure and be connected the particularly connection that foundation is interconnected between them of hollow vascular, passage or organ in this article.
The term of Shi Yonging " patient " refers to the mankind or the animal that it is carried out anastomosis in this article.
In this article the term of Shi Yonging " bio-compatible " comprise basic avirulence or harmless and do not cause immunologic rejection can with patient's the compatible any material of living tissue or system.What " biocompatibility " comprised development in the future may be the material of biocompatibility.
The term of Shi Yonging " biology can absorb " comprises that material is dissolved by health and/or the also absorbed ability of degrading in this article.
The term of Shi Yonging " shape memory " comprises the trend that returns to described reservation shape after by the reservation shape distortion of material in this article, such as but not limited to suitably prepd Nitinol (" Nitinol ").
The term of Shi Yonging " one " refers to described two or more parts by bonding, fastening or link together, so that move together or work as a complete integrated part in this article." one " includes but not limited to form continuous member on the meaning by identical continuous material, and comprise by any way be connected, the fastening or parts that bond together so that become Immobile substantially be bonded to each other and form substantially whole.
The term of Shi Yonging " nearside " (perhaps its any form) for the element of apparatus, refers to the generally the most close in use surgical part of element in this article, perhaps the part of the most close apparatus end that is gripped by the surgeon of element; And for the direct of travel of apparatus element, refer to when using generally the most close surgical end towards apparatus, perhaps towards the end that grips by the surgeon of apparatus.
The term of Shi Yonging " distally " (perhaps its any form) in this article, for the element of apparatus, refer to element in use generally away from surgical part, perhaps element away from the part of the apparatus end that is gripped by the surgeon; For the direct of travel of apparatus element, refer to generally the most close in use surgical end, perhaps away from the end that grips by the surgeon of apparatus away from apparatus.
The term of Shi Yonging " laterally " (or its any form) in this article for axis, refers to along line, plane or the direction of intersecting with described axis and extends, and that is to say, not with its conllinear or parallel." laterally " of Shi Yonging is not limited to " vertically " in this article.
The term of Shi Yonging " longitudinal axis " in this article, with respect to apparatus, refer to the accurate or approximate center axis that limits along its large-size (promptly along its length) from its distal-to-proximal (perhaps opposite) by described apparatus, and do not want it is defined as and impliedly refer to a straight line, wherein, for example, apparatus comprises bent angle as described in this article, " longitudinal axis " of Shi Yonging is applicable to described bent angle in this article, when being used in combination with end effector, term " longitudinal axis " refers to by extending along its large-size that described end effector limits, i.e. accurate or approximate center axis along its length from distal-to-proximal or opposite extension.
Coincideing of the tissue that method and apparatus of the present invention utilizes simple and effective mechanical arrangement to carry out to limit two body cavitys respectively for example connects bladder and urethra after prostatectomy.Owing to do not need more efforts and loaded down with trivial details suturing skill, improved anastomosis.In order in disclosed operation, to use, the various embodiments that improve apparatus are provided, be used for that wall of urinary bladder tissue is contacted with pelvic floor tissue and with their fix in position so that their combinations also heal together.
Disclosed technology of the application of the invention and apparatus, the number of steps in the anastomosis operation can be reduced, and has reduced cost and has shortened the required time of performing the operation.The present invention also can eliminate and other anastomosis complications associated with arterial system that needs manual suture.
The invention provides such system, it allows for example to use the apparatus that is inserted in the bladder through urethra (along the direction of driving in the wrong direction) that bladder and urethra are linked together, and does not operate and activate apparatus and do not need to enter bladder inside.Optionally, system and apparatus can be constructed such that it can be inserted in the bladder along the direct motion direction by the little otch of patient's abdominal part and bladder upper surface and be inserted in the urethra then.Equally, the operation of apparatus and activate and to carry out in that the patient is external by the surgeon.
Now in detail with reference to the accompanying drawings, wherein identical Reference numeral is represented components identical in institute's drawings attached, and Fig. 1 schematically shows the location of human male's bladder 1, wall of urinary bladder 2, prostate 3, pelvic floor 7 and urethra 5 before prostatectomy with sectional elevation.In the carcinoma of prostate radical correction, the bottom of prostate 3, wall of urinary bladder 2 and the top of urethra 5 are cut, and the fluid connection between the remainder of bladder cavity 8 and urethra is removed.The dotted line of approximate horizontal schematically shows prostate and adjacent bladder and urethral tissue along its cut line among Fig. 1.
Fig. 2 has schematically shown the carcinoma of prostate radical correction profile in abdominal cavity afterwards, and wherein the excision of the part of wall of urinary bladder 2 forms bladder opening 4, and prostatic excision forms urethra opening 6 in urethra 5.After this operation, the size of bladder opening 4 is dwindled by mode well known in the art usually, for example by " tennis racket " suturing skill.
The embodiment of the anchoring piece that is guided/capsule fixed cover
Fig. 3 has described a kind of illustrative embodiments of apparatus 3000 of the present invention, and apparatus 3000 is applicable to according to the inventive method bladder and urethral tissue are coincide.Apparatus can comprise Handleset 3100, pipe assembly 3200 and end effector assembly 3400.End effector assembly 3400 is suitable for impelling along the direction of driving in the wrong direction and is inserted through patient's urethra 5 and enters (see figure 2) in the bladder cavity 8 through bladder opening 4.It will be understood to those of skill in the art that, as an alternative, apparatus 3000 can be provided with and be configured in one embodiment to insert and carry out the step identical substantially effectively with step described herein via the direct motion direction, that is to say, through running through the otch of abdominal part and bladder upper surface (not shown), and be passed down through bladder opening 4 and enter in the urethra opening 6.Be shown in 11/094606 the U.S. Patent application co-pending at serial number and described the example of such apparatus.
Fig. 3 A to 10A is after inserting and entering in the bladder opening 4 through patient's urethra 5, is in the longitudinal sectional view of the end effector assembly 3400 in each position relevant with its use and relevant perspective view (Fig. 4 A, 5A, 7A, 8A, 9A and 10A).As can be seen, end effector assembly 3400 can comprise main body 3401, far-end cover assembly 3410, have capsule fixed cover 3430, anchoring piece actuator assembly 3460 and the localizer assembly 3440 of fixed cover end 3434.Capsule fixed cover 3430 can be formed by flexible polymer material or any suitable biocompatible materials, and can fold or be compressed in the far-end cover assembly 3410, the afterbody 3433 of capsule fixed cover 3430 is kept by the fixed cover hook 760 of anchoring piece 700, as shown in the figure.End effector assembly 3400 and included assembly thereof can be operably connected to Handleset 3100 (showing) and controlled by it via the movable part in the pipe assembly 3200 in Fig. 3, described movable part for example is band, bar and/or pipe.With reference to Figure 15, pipe assembly 3200 can comprise two-piece type ridge member 3210, seal wire 3230, localizer bar or with 3240, driver open bar or with 3260, the driver actuator lever or with 3261, reside in the anchoring piece guiding piece that keeps in the silk passage 3265 and keep silk 3250 and sheath 3270.Ridge member 3210 and end effector main body 3401 can be made two-piece type or more parts respectively, with the manufacturing and the assembling of facilitation apparatus.Each part of ridge member 3210 and end effector main body 3401 can be connected or keeps together by suitable means.Referring again to Figure 15, seal wire 3230 can have a free near-end and pass any segment length of apparatus, and the far-end of seal wire can be connected on the fixed cover end 3434 of capsule fixed cover 3430 and with fixed cover end 3434 by any suitable mode and make one (for example seeing Fig. 4).
With reference to Fig. 3 A to 10A and Figure 15, driver open bar or with 3260, driver actuator lever or with 3261 and localizer bar or with in 3240 passages or track that can on proximal direction and distal direction, longitudinally be arranged in ridge member 3210 and the end effector main body 3401, and can be relative to each other and with respect to ridge member 3210 and 3401 lengthwise movements of end effector main body.Bar or can make by rustless steel, Nitinol or any other material with suitable tension pressure degree and flexible nature with 3260,3261 and 3240, and can optimize its size and shape, make its as described herein have flexible and can transmit activate required longitudinal thrust and the pulling force of described apparatus.Its motion also can provide lubricant so that perhaps can provide examples of suitable lubricants at bar or in set passage or track at bar or on 3260,3261 and 3240 surface.Mode as an alternative, any bar or be with 3260,3261 and 3240 can make by combined material, for example metal and polymer jacket, wherein polymer jacket has very low surface friction and/or lubrication property.
End effector main body 3401 can be connected with ridge member 3210 and makes one with it by any suitable mode.Driver is opened bar or can be connected in the suitable mechanism that is included in the control device control in the Handleset 3100 by button 3103 or other in its proximal end with 3260, and can open screw pin 3263 through driver at its far-end and be connected on each drive arm post 3262.Driver actuator lever or can be connected in the suitable mechanism that is included in the control device control in the Handleset 3100 by lever 3102 or other in its proximal end with 3261, and can activate screw pin 3465 through driver at its far-end and be connected on the anchoring piece drive arm 3461.Open bar or open screw pin 3263 with 3260 lengthwise movement via driver in response to driver and act on the drive arm post 3262, anchoring piece drive arm 3461 can activate the part that screw pin 3465 rotates to as shown in the figure around driver and launch, launches fully and the stowed position.Driver activates screw pin 3465 and can vertically ride in each the driver actuation slot 3402 (seeing Fig. 5 A) that is located in the main body 3401.Therefore, in response to the driver actuator lever or act on driver with 3261 and activate lengthwise movements on the screw pin 3465, anchoring piece drive arm 3461 can vertically be advanced.Localizer bar or can be connected in its proximal end or be included in the suitable mechanism of other control member control in the Handleset 3100 with 3240 by button 3103, and can be connected on the localizer post 3445 through localizer actuator pin 3446 (Fig. 5) at its far-end.Localizer actuator pin 3446 can vertically be ridden in each the localizer actuation slot 3452 that is located at main body 3401.Thus, localizer bar or can make localizer actuator pin 3446 (Fig. 5) carry out corresponding sports with the lengthwise movement of 3240 (Figure 15), thus make localizer arm 3441 correspondingly launch and pack up.Other ends of localizer post 3445 are connected on the localizer arm 3441 through localizer pin 3447.
Anchoring piece drive arm 3461 can comprise anchoring piece yoke piece 3462 (for example seeing Fig. 5 A).Before being released as mentioned above, anchoring piece 700 can rotatably remain in the anchoring piece yoke piece 3462 by anchoring piece pivot pin 712 (sees Figure 16).
Can see that in Fig. 5 to 7A and Figure 16 before driving described anchoring piece 700, the front end 751 of anchoring piece 700 can be carried in the anchoring piece guiding piece 770.Anchoring piece guiding piece 770 can rotatably be carried in the guiding piece yoke piece 3448 of localizer arm 3441 through anchoring piece guiding piece pivot pin 771, and described anchoring piece guiding piece pivot pin 771 can be carried in the guiding piece pivot pin recess 3449 in the guiding piece yoke piece 3448.Anchoring piece guiding piece pivot pin 771 can keep silk 3250 to remain in the guiding piece pivot pin recess 3449 by the anchoring piece guiding piece.With reference to Figure 15 and Fig. 4 to 10, the anchoring piece guiding piece keeps silk 3250 (for example seeing Fig. 5 A) can be arranged in the passage 3265 of ridge member 3210 until end effector main body 3401, and pass through the maintenance silk hole 3451 in the localizer arm 3441 subsequently, be under the anchoring piece guiding piece pivot pin 771 that remains in the guiding piece pivot pin recess 3449.As will be further explained, in operation as herein described, the anchoring piece guiding piece keeps silk 3250 to regain from keeping silk hole 3451, so that anchoring piece guiding piece pivot pin 771 is discharged from guiding piece pivot pin recess 3449.Anchoring piece guiding piece maintenance silk 3250 can or have suitable anti-any other material of opening pressure degree and flexible nature by Nitinol to be made, so that effectively work as mentioned above.
Driver open bar or with 3260, the driver actuator lever or with 3261 with the localizer bar or with 3240 be used for activating being connected and interacting and will becoming clear of localizer assembly 3440 and anchoring piece actuator assembly 3460 in the description of using and operating of following described embodiment to apparatus.
As mentioned above and shown in Fig. 3 A and 5, end effector assembly 3400 can insert and urethra 5 by the patient enters bladder opening 4 along the direction of driving in the wrong direction, and enters subsequently in the bladder cavity 8.Fig. 4 has described to be in the end effector assembly that launches the front position, and Fig. 5 described same end effector assembly in being fully inserted into bladder cavity 8 and localizer arm 3441 by the form after being opened fully.From the difference of Fig. 4 and position shown in Figure 5 as can be seen, the proximal movement of localizer actuator pin 3446 (realizes by the localizer bar or with 3240 proximal movement, see Figure 24) be similar to process that reversing opens umbrella equally make localizer post 3445 through localizer pin 3447 downwards (with respect to figure) promote localizer arm 3441, cause localizer arm 3441 outwards and open downwards.Simultaneously, driver actuator lever or act on the proximal movement that driver activates on the screw pin 3465 (anchoring piece drive arm 3461 is connected thereto) with 3261 (seeing Figure 24) and can make the front end 751 of anchoring piece 700 can remain in the anchoring piece guiding piece 770 along the proximal direction anchoring piece drive arm 3461 that moves.As seen from Figure 5, after above-mentioned motion, the rear end 710 of anchoring piece 700 keeps more approaching than described front end 751 longitudinal axis of end effector.As mentioned above, impelling bladder to enter in the step process of pelvic floor, this have be beneficial to that the feature portion that as far as possible reduces anchoring piece 700 grasps or the retaining of stumbling in the lax structural probability of wall of urinary bladder.Localizer bar or can realize by any suitable controller and the mechanism related with Handleset 3100 with the driver actuator lever or with 3261 motion with 3240 for example activates the suitable related organization (seeing Fig. 3 and 15) that is in Handleset 3100 inside by knob 3103.
As understandable from Fig. 6, when localizer arm 3441 is opened up into position shown in Figure 5, the surgeon can control apparatus (with respect to figure) motion end effector downwards by gripping handle assembly 3100, so that localizer arm 3441 contacts with bladder opening 4 wall of urinary bladder 2 on every side, and the wall of urinary bladder 2 of ordering about subsequently around the bladder opening 4 is approaching with the pelvic floor 7 around the urethra opening 6, and the corresponding opening of bladder and urethra roughly aligns.
Referring now to Fig. 6 and 7 and it is compared, as can be seen, Fig. 7 has described to be in the anchoring piece drive arm 3461 of complete deployed position, anchoring piece 700 be brought into the parallel or approximate longitudinal axis that is parallel to end effector and approximately perpendicular to or position perpendicular to pelvic floor in.For anchoring piece drive arm 3461 being opened up into position as shown in Figure 7, driver actuator lever or be with 3260 can keep motionless substantially, and driver is opened bar or be with 3260 can move along distal direction (seeing Figure 24).Driver is opened bar or can be realized that with 3260 distal movement driver opens the distal movement of screw pin 3263, and this can make drive arm post 3262 promote anchoring piece drive arm 3461 upwardly and outwardly through drive arm pin 3264 (not shown) again.This can outwards move to position shown in Figure 7 with anchoring piece drive arm 3461 to be similar to the mode of opening umbrella.Driver is opened bar or can be realized by any suitable control device and the mechanism related with Handleset 3100 with 3260 distal movement, for example by rotation or come the suitable related organization (seeing Fig. 3 and 15) of actuation handle assembly 3100 inside by press button 3103.
Referring now to and comparison diagram 7 to 8A and 24, as can be seen, Fig. 8 has described downwards the open anchoring piece drive arm 3461 of (with respect to figure) motion and has entered and pass after wall of urinary bladder 2 enters in the pelvic floor, the described embodiment of apparatus to drive anchoring piece 700.For anchoring piece drive arm 3461 is moved to position shown in Figure 8, the driver actuator lever or be with 3261 and driver open bar or be with 3260 can be along proximal movement, this can realize that driver activates the proximal movement of screw pin 3465, realize the proximal movement of anchoring piece drive arm 3461 and anchoring piece 700 thus, thus drive anchoring piece 700 enter shown in the tissue.Driver actuator lever or open bar with driver or can realize by any suitable control device and the mechanism related with Handleset 3100 with 3260 proximal movement with 3261 is for example by pushing suitable related organization's (see figure 3) that anchoring piece driver lever 3102 comes actuation handle assembly 3100 inside.May wish anchoring piece driver lever 3102, driver actuator lever or with 3261 open bar with driver with 3260 in the direct mechanical linkages of existence between the two or be connected so that provide for the surgeon and in tissue, drive the tactile feedback relevant with supporting anchoring piece 700 by anchoring piece driver lever 3102.
From Fig. 8 also as can be seen, the afterbody 3433 of capsule fixed cover 3430 can maintain by the fixed cover hook 760 of anchoring piece 700.Therefore, when anchoring piece 700 was driven in the tissue, the afterbody 3433 of capsule fixed cover 3430 can be installed to each anchor point place, was near bladder inside and the bladder opening.Anchoring piece 700 can comprise agnail or other any suitable fixed structure on it, so that anchoring piece 700 is fixed in the pelvic floor tissue in case from the pelvic floor retraction of tissue.
In driving the process of anchoring piece 700 and (after driving or driving) with anchoring piece 700 from the process that anchoring piece drive arm 3461 discharges, be used for guiding the schematic mechanism of anchoring piece 700 to comprise in the present embodiment.Figure 16 and Figure 17 D have described schematic anchoring piece 700 and anchoring piece guiding piece 770.As mentioned above and as can be seen from Figure 5A, anchoring piece guiding piece pivot pin 771 can keep in the silk 3250 guiding piece pivot pin recesses 3449 that are held in place in the anchoring piece guiding piece yoke piece 3448 of localizer arm 3441 by the anchoring piece guiding piece.Referring again to Figure 16 and 17D, anchoring piece guiding piece 770 can comprise keyway feature portion 772, the vertical keyway mating feature portion 721 of anchoring piece 700 and 772 cooperations of described keyway feature portion, make and be driven in the process of tissue at anchoring piece 700, along with its downward motion, anchoring piece 700 can be conducted through anchoring piece guiding piece 770.Should be understood that anchoring piece 700 can be provided with keyway feature portion, and anchoring piece guiding piece 770 can be provided with the feature portion that matches with keyway.In another embodiment, anchoring piece guiding piece 770 and anchoring piece 700 can be provided with the feature portion that cooperates with keyway and the combination of keyway feature portion, so that guiding anchoring piece 700 is by anchoring piece guiding piece 770.As shown in figure 16, anchoring piece 700 also can comprise flexible tear-away portion 711.When anchoring piece 700 by (downwards, with regard to drawing) drive by anchoring piece guiding piece 770 when flexible tear-away portion 711 contacts with the side 773 of anchoring piece guiding piece 770, each flexible tear-away portion 711 can for example be extruded inward towards each other, reduces the distance between each flexible tear-away portion 711.Inwardly motion anchoring piece pivot pin 712 moves to A ' (shown in Figure 16 and 16A) from A thus, this can cause that anchoring piece pivot pin 712 throws off from the anchoring piece yoke piece 3462 of anchoring piece drive arm 3461, anchoring piece 700 is discharged from anchoring piece drive arm 3461.
With reference to Fig. 8 to 10 and 15, part as the anchoring piece release steps, the anchoring piece guiding piece keeps silk 3250 to make anchoring piece guiding piece pivot pin 771 to discharge from the guiding piece pivot pin recess 3449 the localizer arm 3441 along the proximal direction retraction by keeping silk hole 3451.Referring again to Figure 16 and 17D, anchoring piece 700 and anchoring piece guiding piece 770 can be formed with cooperation feature portion, make along with discharging anchoring piece 700 and anchoring piece guiding piece 770 from end effector, anchoring piece guiding piece 770 can play other structure that retentivity distributes and/or restriction penetrates around packing ring, anchoring piece head or anchoring piece 700 rear ends 710, sees Fig. 8 to 9A and 10.
As mentioned above, in this embodiment, the anchoring piece guiding piece keeps silk 3250 to bounce back so that anchoring piece guiding piece pivot pin 771 is discharged from localizer arm 3441, thus anchoring piece guiding piece 770 is discharged from localizer arm 3441.By comprising any suitable mode that is in the suitable mechanism that keeps silk 3250 to link with described anchoring piece guiding piece or be connected in the Handleset 3100, the anchoring piece guiding piece keeps silk 3250 to be retracted in the handle assembly 3100 by proximad.Should be understood that, in the embodiment described herein, before anchoring piece is driven into after the tissue and localizer arm 3441 can be closed, the anchoring piece guiding piece keep silk 3250 must retraction so that anchoring piece guiding piece 770 is discharged from localizer arm 3441, but the various mechanism that is used to discharge anchoring piece guiding piece 770 or is used for discharging from guide formation anchoring piece all is possible.
Still with reference to Fig. 8,9,10,15 and 24, in the above-described embodiment, anchoring piece 700 is by after anchoring piece drive arm 3461 discharges, by the driver actuator lever or with 3261 with actuator opens bar or with 3260 distal movement, this distal movement acts on the driver actuating screw pin 3465 and acts on thus on the anchoring piece drive arm 3461, can make anchoring piece drive arm 3461 distal motion.Then, by with the driver actuator lever or be with 3261 to keep motionless substantially, simultaneously open bar or be with 3260 along the proximal direction driver of moving, this opens screw pin 3263 downward (with respect to figure) also inwards pulling drive arm post 3262 and also spurs anchoring piece drive arm 3461 inwards downwards to be similar to the mode of closing umbrella via driver, thereby can close or regain anchoring piece drive arm 3461.At last, by distal direction kinematic location bar or be with 3240, this is via localizer actuator pin 3446 (with respect to figure) pulling localizer post 3445 upwards, to be similar to upwards (with respect to figure) pulling localizer arm 3441 of mode that inversion type closes umbrella, can close and regain localizer arm 3441 thus.After anchoring piece drive arm and localizer arm being closed to as shown in figure 10 the position, comprise that the part of end effector assembly of localizer assembly 3440 and anchoring piece actuator assembly 3460 and pipe assembly 3200 can be directed downwards (with respect to figure) along direct motion and withdraw in bladder, urethra and patient's body, only stay the capsule fixed cover 3430 that has seal wire 3230, as shown in figure 11, described capsule fixed cover 3430 is installed in bladder inside at afterbody 3433 places by anchoring piece 700.Should be appreciated that the bar that can use any right quantity or bring to activate described apparatus 3000, for example activate localizer assembly and with second bar or bring and operate the actuator assembly related with the ridge member by using a bar or bringing.
Those skilled in the art are to be understood that, Handleset 3100 can comprise that various mechanisms and these mechanisms are configured to be fit to longitudinal force (distally and nearside) and lengthwise movement are delivered to end effector assembly 3400, with realize power that the above-mentioned exemplary embodiment of actuating is required and motion and with described power and Motion Transmission in end effector assembly 3400.
Referring again to Figure 15, as can be seen, sheath 3270 can encase pipe assembly 3200.Sheath 3270 can be formed by the polymer of any suitable biocompatibility or the material of other biocompatibility, and can be provided with suitable hydrophilic, lubricated and/or antimicrobial coating.Sheath 3270 also can internal lubrication or is formed by the suitable low friction or the material of self-lubricating, and/or be designed to flexible in addition and can on apparatus, distad slide with nearside, make sheath 3270 to slip over end effector 3400 to encase the parts of end effector 3400 along distal direction, so that insert urethra and regain from urethra, and in the inner process that activates of bladder, sheath 3270 slides to expose the exercisable parts of end effector 3400 along proximal direction.
In another embodiment, end effector assembly 3400 can encase so that insert (Fig. 3 A) in the urethra by terminal sheath 3990.Terminal sheath 3990 can be the flexible pipe of end sealing, and described flexible pipe was radially rolled-up before using.When using, the closed end of described terminal sheath 3990 can be applied on the far-end of end effector assembly 3400, launch the length of flexible pipe subsequently along the length of end effector assembly 3400 at this, to encase all or part parts of end effector assembly 3400 basically.Terminal sheath 3990 can also comprise one or more sutures 3992 that extend along the length of flexible pipe.Suture 3992 can be outstanding from the untight end of terminal sheath 3990, make the exposed portions serve that nipper or other appropriate device via insertions such as sleeve pipes can grasp suture 3992, and roll and remove terminal sheath 3990 again by distad spurring suture.After removing terminal sheath 3990 via sleeve pipe etc., end effector assembly 3400 can be worked as disclosed herein.
As shown in figure 12, after as mentioned above the capsule fixed cover being engaged with bladder and parts is regained in patient's body, ductus bursae assembly 3500 with the centre gangway that runs through wherein can be directed to the proximal end of seal wire 3230, upwards (along the direction of driving in the wrong direction) inserted and entered bladder through urethra, side contacts in the capsule fixed cover flange 3431 of capsule 3520 and capsule fixed cover 3430.With reference to Figure 13, capsule 3520 can come distending with any suitable fluid.When capsule 3520 during by distending, its upper surface can be resisted against capsule fixed cover flange 3431 inboards and form fluid-tight basically, its upwards and lateral expansion can be limited by capsule fixed cover 3430.Therefore, can make capsule 3520 expansions downwards along with expansion, contact is in the wall of urinary bladder in bladder opening 4 peripheral regions and applies the downward pressure that approximates intraluminal pressure greatly thereon thus.Further the result is, is in bladder opening 4 wall of urinary bladder 2 on every side and can be compressed on the pelvic floor 7 that is in urethra opening 6 peripheral regions, and the opening separately of bladder 4 and urethra 6 aligns substantially.In addition, bladder opening 4, pelvic floor 7 and urethra opening 6 can be sealed, enter abdominal cavity from the bladder effusion with urine and other material that prevents to collect in the bladder in rehabilitation and agglutination.
Then, capsule fixed cover 3430 and ductus bursae assembly 3500 can be held in place (if necessary, the ductus bursae assembly can and expand as mentioned above with new ductus bursae assembly periodic replacement), continue one section and make parameatal separately wall of urinary bladder 2 tissues and the pelvic floor that are in bladder 4 and urethra 6 organize the required time that effectively is joined together.The appropriate time that is used to engage can be about two weeks, but also can change along with patient's human needs and health condition and surgeon and patient's individual preference.This time interim, urine and other material can be crossed the tap 3435 of the fixed cover end 3434 that is arranged in capsule fixed cover 3430, discharge through the centre gangway of conduit then from urinary bladder channel.In rehabilitation and agglutination, conduit can be connected on the urine collecting bag (not shown) in the proximal end.
Through after the tissue of wall of urinary bladder and pelvic floor being organized effectively be joined together the required time, can dwindle capsule 3520 and ductus bursae assembly 3500 is regained and removed.Then, with reference to Figure 14, seal wire 3230 is recoverable to.Because the far-end of seal wire 3230 can be connected in the fixed cover end 3434 of capsule fixed cover 3430, the withdrawal of seal wire 3230 may cause 3430 upsets of capsule fixed cover.Be as described in 11/094606 the pending application application as serial number, to allow capsule fixed cover afterbody 3433 to discharge from anchoring piece 700 by the releasable suitable connected mode between capsule fixed cover afterbody 3433 and the anchoring piece 700, and capsule fixed cover 3430 can be left in patient's body by regaining seal wire 3230 by (along the direct motion direction) withdrawal downwards along with upset.Thus, only stay anchoring piece 700.Be as described in 11/094606 the pending application application as serial number, but anchoring piece 700 can form by the material of bio-absorbable, but if formed by the material of bio-absorbable, anchoring piece can dissolve in vivo so.
Should be understood that, as this paper show and as described in, be anchored on the pelvic floor, restriction and keep the combination of the expansible capsule fixed cover of ductus bursae structure can have desired effects, promptly in the required time that coincide restricted conduit in urethra substantially axially or longitudinally motion.Capsule fixed cover 3430 as herein described makes every effort in the process of carrying out anastomosis to provide effectively for ductus bursae assembly 3500 and support pattern efficiently.
With reference to Figure 12,13 and 17A, capsule fixed cover 3430 can be anchored on intravesical (Figure 16) by the fixed cover afterbody 3433 that is connected on the anchoring piece 700.Then, capsule fixed cover 3430 can be used to keep ductus bursae assembly 3500, and allows the tap 3435 of urine in fixed cover end 3434 by ductus bursae assembly 3500.By capsule 3520 being bearing on capsule fixed cover flange 3431 and the skirtboard 3436, capsule fixed cover 3430 also can provide restrictive supporting for the capsule 3520 that remains in the capsule fixed cover 3430 of ductus bursae assembly 3500, can be applied to downward pressure size on the wall of urinary bladder through capsule so that concentrate and increase.This paper will describe the embodiment and the feature of capsule fixed cover 3430.
Capsule fixed cover 3430 can by any suitable biocompatible materials for example polymeric material form.For example, immerse in the containers of the liquid polyurethane product that uncured is housed by plug suitable shape and size, can form the body of capsule fixed cover 3430, described polyurethane products for example for but be not limited to the Pellethane 236390AE that makes by the DowPlastics company of Michigan, USA Midland.Circulating air and/or hot-air dry technology can be used to control wall thickness.Mode as an alternative, the body of described fixed cover can form with suitable polymeric material molding, in moulding process wall thickness is controlled.
In order to cut out and/or form various feature portion, and finish the manufacturing of the schematic capsule fixed cover 3430 shown in Figure 17 A thus, can adopt low power laser cut out the feature portion of submerged body, perhaps molding technology can be combined in the employed body moulding technology, maybe can adopt any other suitable mode.In order to utilize laser to cut out feature portion, can use the pattern computer documents in conjunction with low power laser, described file provides the amount of feeding for the linear axes and the rotary actuator of laser, thereby go up the fusing outbound path at body (remaining on the plug), form for example tap, inflation port, fixed cover length, fixed cover afterbody, anchoring piece dog hole and/or skirtboard shape.
If the thickness of the capsule fixed cover that forms is too small, may cause the intensity and the capsule limitation capability deficiency of fixed cover.On the contrary, excessive wall thickness may cause the flexible not enough of fixed cover, can not make its folding and/or upset easily in end effector reach the purpose of withdrawing in patient's body.
Still with reference to Figure 12,13 and 17A, capsule fixed cover 3430 can be provided with hollow capsule fixed cover terminal 3434 in case urine discharge from bladder.In one embodiment, the size of fixed cover end 3434 can effectively be enclosed within on the distal part of the ductus bursae assembly 3500 that can insert in the capsule fixed cover 3430.For example, described ductus bursae assembly 3500 can insert and remain in capsule fixed cover flange 3431 and the skirtboard 3436, and the distal part of ductus bursae assembly 3500 extends into fixed cover end 3434.The size of fixed cover end 3434 for example can effectively be enclosed within on a 14Fr or the 18Fr conduit.
Fixed cover end 3434 may be suitable for allowing urine to cross ductus bursae assembly 3500 discharges of inserting the capsule fixed cover 3430 from urinary bladder channel.For this reason, fixed cover end 3434 can be provided with one or more taps 3435 so that fluidic entering.Tap 3435 can comprise the one or more holes that for example are positioned at wholly or in part on capsule fixed cover flange 3431 and/or the fixed cover end 3434.For can be for any suitable ductus bursae assembly 3500 that capsule fixed cover 3430 uses, tap 3435 can have all size and/or shape and can be constructed to be permeable to form effective discharging.In a kind of alternative structure, the embodiment of tap 3435 can for example be circular and/or oval so that fluidic efficient discharge.In the embodiment shown in Figure 17 A, tap 3435 can comprise the holes that four about 90 degree of the circle spacings around fixed cover end 3434 are provided with, and can change between ellipse and circle and can axially interlock.Should be understood that the shape of tap 3435, structure, position and/or design can change along with the thickness of the used material of fixed cover terminal 3434, material and size.
With reference to Figure 17 A, in one embodiment, capsule fixed cover flange 3431 can be the adjacent radius augmenting portion in the bottom with fixed cover end 3434 of capsule fixed cover 3430, described radius augmenting portion can from fixed cover end bottom stretch out not stretching radius up to capsule fixed cover 3430 roughly become constant till.In said embodiment, capsule fixed cover flange 3431 is parts of the transition between fixed cover terminal 3434 and skirtboard 3436 of capsule fixed cover 3430.Capsule fixed cover flange 3431 can provide supporting force for the capsule 3520 that keeps ductus bursae assembly 3500, and described supporting force is substantially equal to and is in reverse to by capsule 3520 and is applied to power on the wall of urinary bladder that is positioned at the position that coincide.Prevent as far as possible that preferably any tap or inflation port from roughly extending into lug area, because this power that holds down that may cause fixed cover to apply reduces.
Described capsule fixed cover has skirtboard 3436, the part of the nadir that extend to capsule fixed cover 3430 (with respect to Figure 17 A) adjacent with capsule fixed cover flange 3431 that described skirtboard comprises capsule fixed cover 3430.Capsule fixed cover 3430 can provide the pressurization of hoop formula so that capsule 3520 is limited in the capsule fixed cover.For example, when capsule 3520 expanded, skirtboard 3436 can have sufficient length so that skirtboard edge (for figure) is in below the vertical direction mid point of capsule 3520, thereby prevents that capsule 3530 from skidding off from capsule fixed cover 3430 belows.Mode as an alternative, skirtboard 3436 can be provided with the radius of variation to reach similar purpose.
Skirtboard 3436 also can be provided with the inflation port 3437 that is formed in the skirtboard.The size of inflation port 3437 and position can make capsule part 3520 outwards heave by inflation port 3437 along with expanding, for the capsule 3520 that remains in the capsule fixture provides extra supporting and restriction, and prevent that capsule fixture 3430 from throwing off or slip off capsule 3520, or prevent that capsule 3520 from throwing off from the fixed cover below or slip off.Inflation port 3437 can comprise the one or more holes that are arranged in a row or arrange more, and can level or vertically be set to circumferential notch, oval breach or its combination.The size of inflation port 3437 and position can be selected according to the required degree of bloating.For example, with eight less vertical inflation port 3437 are set for skirtboard 3436 to compare, four bigger vertical inflation port 3437 are set to skirtboard 3436 bigger heaving can be provided.By size that changes inflation port 3437 and the degree that bloats that the position changes capsule 3520, the rami capsulares that can be customized be applied to the expectation on the wall of urinary bladder by capsule holds the size of size and downforce.For example, bloat in a large number if allow, this may have the effect that the restriction capsule may be applied to the downforce size on the wall of urinary bladder, if inflation port 3437 centers on the skirtboard setting equably and/or symmetrically, this may make the even expansion and the uniform inflated configuration of the capsule in the zone that capsule fixed cover 3430 promotes and/or influence is in wall of urinary bladder contacts.
Still with reference to Figure 17 A, the skirtboard 3436 of capsule fixed cover 3430 can be provided with at least one extension 3438.Described extension 3438 can be oval-shaped and have the length that is enough to reach the vertical mid point of capsule below.An extension 3438 that reaches the vertical mid point below of capsule is set can assists to prevent that capsule from sliping off from capsule fixed cover 3430, when capsule 3520 expanded, extension 3438 supported capsule 3520 under mid point.Should be understood that extension 3438 can have any suitable shape and/or structure that is suitable for rami capsulares held and remain on wherein.
Figure 17 A shows and is configured to capsule 3520 is ridden or be bearing in therebetween extension 3438.Junction point at extension 3438 can be provided with the fixed cover afterbody 3433 that is suitable for being connected on the anchoring piece 700.Fixed cover afterbody 3433 can be with skirtboard 3436 form one and from skirtboard downwards (for figure) extend.In illustrated embodiment, fixed cover afterbody 3433 is set at 3439 places, junction surface of skirtboard extension 3438 can provides extra supporting for the capsule that is between the skirtboard extension 3438.For example, when capsule 3520 expanded between skirtboard 3436, fixed cover skirtboard 3436 may be out of shape and support capsule 3520 in process pushed outwards.The length of fixed cover afterbody 3433 will influence the cross-over connection performance.Short tail length can reduce capsule expansive degree below fixed cover, has limited the zone of can tunica exerting pressure of tissue thus.On the contrary, the capsule that long tail length can allow more to be under the fixed cover outwards expands, and has increased the zone that can exert pressure on its that organize, but has reduced the maximum pressure that can apply.When expansible capsule is limited, the size of afterbody also will influence afterbody clamping plate will be remained on tensile strength on the anchoring piece.Should consider the tensile strength (or combination tensile strength of afterbody) of afterbody, be the multiple that required maximum holds down power, so that acceptable safety coefficient to be provided.
Fixed cover afterbody 3433 can be provided with from its at least one anchoring piece dog hole 3432 that passes to allow the fixed cover hook 760 (Figure 10 to 11) that inserts anchoring piece 700.The variation of fixed cover afterbody 3433 length can allow to be used to control capsule 3520 and be applied to downward making a concerted effort on the wall of urinary bladder 2 in the degrees of expansion under the skirtboard 3436 and by expansible capsule.May mechanism as being used for that fixed cover afterbody 3433 is connected to a kind of on the anchoring piece 700, in fixed cover afterbody 3433, can cut out or form anchoring piece dog hole 3432.The size of anchoring piece dog hole 3432 can be expanded and allow the fixed cover hook 760 that inserts suitable size.Fixed cover hook 760 can be inserted and pass anchoring piece dog hole 3432 before using, and can use suitable card between anchoring piece dog hole 3432 and the fixed cover hook 760 to end feature portion in the anastomosis operation process or frictional fit remains in the anchoring piece dog hole 3432.Along with finishing and final withdrawal that ductus bursae uses, by on seal wire, applying enough pulling force/recovery power, fixed cover afterbody 3433 and capsule fixed cover 3430 with described exemplary bindiny mechanism can be thrown off from the fixed cover hook of anchoring piece, and capsule fixed cover and the upset of fixed cover afterbody and the card that overcomes between anchoring piece dog hole 3432 and the fixed cover hook 760 end and/or frictional resistance.Capsule fixed cover 3430 can be regained from bladder thereupon, stays anchoring piece 700.Should be understood that, can adopt any suitable system and method between anchoring piece 700 and capsule fixed cover 3430, to provide dismountable connection.For example, fixed cover afterbody 3433 can not be formed with anchoring piece dog hole 3432, and by being formed by the material of suitably fixed cover hook 760 punctures of shape in the position of needs.If anchoring piece dog hole or perforation connection method are used for capsule fixed cover afterbody, the size of hole or perforation and shape will influence the stretching maintenance intensity of afterbody so.
Still with reference to Figure 17 A, measure the far-end of fixed cover end from the bottom of skirtboard extension, the length of fixed cover can for example be about 0.925 inch.The length of skirtboard can be for example from about 0.45 inch to about 0.65 inch, and can be preferably when capsule is inflated suitable pressure, and the bottom of skirtboard extension is lower than the vertical mid point of capsule.Internal diameter when skirtboard does not open can be about 0.75 inch, or the diameter that has any other constant or change.The length of fixed cover afterbody 3433 can for example be about 0.13 inch.The diameter of anchoring piece dog hole 3432 can be about 0.013 inch.Wall thickness is approximately the feature portion that 0.009 inch (supposition is formed by the material that this paper determines specially) can allow the capsule fixed cover to have to reach appropriate balance between intensity and flexibility, so that use as described herein.Inflation port 3437 for example can comprise eight inflation port that are provided with around the circumference of skirtboard 3436, makes expansion along with capsule 3520, though the aperture to bloat unnecessary symmetry roughly even.Basically consistent bloating can be eliminated the distortion of capsule 3520 when expanding, thus on wall of urinary bladder and the bladder around openings pressure area of homogeneous more is provided.The size of tap 3435 can provide haply the fluid intake with the inlet correspondence of 18Fr conduit.
After anastomosis operation, as the alternative that anchoring piece must be removed and regains the capsule fixed cover, the capsule fixed cover can be formed by the material of suitable biocompatibility, has and effective suitable time corresponding degradation characteristic of conjunctive tissue required time in anastomosis operation.With regard to discharge the capsule fixed cover from anchoring piece with regard to, this will eliminate the necessity of using relieving mechanism machinery or structural, and reduce after effective conjunctive tissue, must bounce back downwards in order to finish operation and leave patient's number of elements by urethra.
Should be understood that capsule fixed cover 3430 can pass through autoclave, EtO and/or use the gamma ray sterilization before using, wherein can consider the influence of this sterilization technology to material in the manufacturing of capsule fixed cover 3430.
With reference to Figure 17 B, the form of capsule fixed cover assembly is that the another kind of embodiment of bead flippering grip assembly 3622 is shown as and has bead flippering cover 3630, and at least one anchoring piece 700 is connected on the described bead flippering cover 3630.Anchoring piece 700 can be provided with rear end 710 and front end 751.Bead flippering cover 3630 can comprise that first is with 3660 and second to be with 3662, and they are formed in the process of anastomosis operation capsule is remained suitable cooperation shape.With reference to Figure 17 B, first can be connected on the rear end 710 of anchoring piece 700 at nearside with an end of 3662 with 3660 and second.
The other end with 3660,3662 can be in the junction 3664 be connected with seal wire 3230.Be with 3660,3662 can form one, or can mechanically or bondingly be connected on the seal wire with seal wire.When bead flippering grip assembly 3622 when launching with the essentially identical mode of capsule fixed cover assembly of other type as herein described, ductus bursae assembly 3500 can enter bladder by seal wire 3230 guiding.Ductus bursae assembly 3500 can insert bladder along seal wire 3230, is assemblied in up to ductus bursae assembly 3500 and is with in 3660,3662.
Can form by any suitable biocompatible materials with 3660,3662, include but not limited to polymeric material and/or suture material.Be with 3660,3662 can mechanically pull down from anchoring piece 700, or for example describedly be with 3660,3662 can partly or wholly constitute by biocompatible materials, described biocompatible materials for example is New Jersey, Somerville, the Vicryl that Ethicon Inc. produces, it will dissolve in the suitable time, only need seal wire 3230 is removed when finishing anastomosis operation.Should be understood that, the various embodiments of this paper comprise be used for with 3660,3662 from anchoring piece 700 mechanically discharge, degradation material is used for any suitable element of belt capsule fixed cover assembly 3622 and with one or more with 3660,3662 and being used in combination of one or more anchoring piece 700, wherein form the capsule of suitable shape so that be engaged in the described belt capsule fixed cover assembly.
With reference to Figure 17 C, the form of capsule fixed cover assembly is that the another kind of embodiment of net formula fixed cover assembly 3722 can comprise net formula fixed cover 3730, and at least one anchoring piece 70 is connected on the described net formula fixed cover 3730.Anchoring piece 700 can be provided with rear end 710 and front end 751.Net formula fixed cover 3730 can comprise for example by suture or other suitable formed reticular component of material that keeps described capsule after constructing.But net formula fixed cover 3730 for example can use the material (for example Vicryl) as binding agent connection, mechanical connection and/or use bio-absorbable to be connected on the rear end 710 of anchoring piece 700 at nearside.As shown in the figure, but seal wire 3230 can use the material (for example Vicryl) of for example binding agent connection, Construction integration, mechanical connection or use bio-absorbable to be connected on the far-end summit of net formula fixed cover 3730.
Referring again to Figure 17 A, seal wire 3230 can for example be a rustless steel, and diameter is 0.0115 inch, and has the polytetrafluoroethylene (PTFE) lubricant coating.Fixed cover end 3434 can be formed with hole or any other proper device that is used for seal wire 3230 far-ends are placed or are connected fixed cover end 3434 at its far-end.Described hole can be used for seal wire 3230 is placed, installed and/or be connected in the fixed cover end 3434.Seal wire 3230 can for example intert and is arranged in the hole of terminal 3434 far-ends of fixed cover and by the feature portion that grasps or the limited section that forms in described hole seal wire 3230 far-ends remained on described hole.In case in place, seal wire 3230 can be as shown terminal 3434 extends along proximal direction from fixed cover, when the capsule fixed cover when anchoring is in place in bladder the length of seal wire 3230 enough to reach the patient external.Seal wire 3230 can make in the ductus bursae assembly 3500 easier insertion bladders and improve precision and the efficient of inserting, and retraction mechanism can also be provided, and is used for regaining capsule fixed cover 3430 from bladder along urethra and leaves patient body.Ductus bursae assembly 3500 interted on seal wire 3230, can allow will the ductus bursae assembly 3500 to insert in patient's bodies and location, fundamental optimum ground, and need not to conjesture.When not having the hole on the far-end of fixed cover end 3434, seal wire 3230 can connect (potted loop attachment), binding agent by sealing ring for example and connect, remains on stitching stitch in the fixed cover terminal 3434, for good and all or removably is connected on the far-end of fixed cover end 3434 by puncture fixed cover terminal 3434 or by any other suitable bindiny mechanism.
The conduit embodiment that can be used as the suitable parts of ductus bursae assembly as described herein includes but not limited to have the Carolina from North, Apex, Polyzen, the Minnesota of the silicones capsule of Inc., Stewartville, 18Fr Rochester Medical catheters.Can use the size that conforms to herein embodiment or construct suitable any conduit.Capsule fixed cover assembly 3500 and/or capsule fixed cover 3430 can apply hydrophilic, lubricated and/or antimicrobial coating.
With reference to Figure 23, a kind of embodiment of ductus bursae assembly 3500 comprises (by the order towards far-end) seal wire keeper 3900, urine outlet 3902 and expansion hatch 3904.Seal wire keeper 3900 can be that seal wire 3203 passes described seal wire keeper 3900 from catheter tube 3510 extended assemblies.On the blind plug 3906, described middle blind plug 3906 works to be connected to ductus bursae assembly 3500 to seal wire keeper 3900 in its far-end can be connected to.At nearside more, seal wire keeper 3900 can comprise sealing member 3908, and described sealing member 3908 allows seal wires to pass from it to stop urine to be passed through simultaneously.Guide wire fixture 3910 is configured to operationally keep and the basic lengthwise movement that limits ductus bursae assembly 3500 along seal wire 3230, and guide wire fixture 3910 can be arranged near the sealing member 3908 and can for example be needle pliering.Should be understood that, the multiple modification consistent with content disclosed herein of seal wire keeper 3900 can be provided.As shown in the figure, the permission that is provided with of seal wire keeper 3900 keeps in place substantially safely with ductus bursae assembly 3500 during anastomosis operation.
Still with reference to Figure 23, urine outlet 3902 and can comprise any appropriate device that is used to discharge and/or keep urine in its far-end can be connected to obliquely on the blind plug 3906.During seal wire keeper 3900 and urine outlet 3902 are installed in integratedly on the blind plug 3906, middle blind plug 3906 is configured to operationally to combine in the mode of frictional fit with a branch of adapter 3912 at its far-end.Adapter 3912 can be for example for having the ramose polymer Y shape connecting elements of inclination, described inclination branch operationally is configured to expansion hatch 3904.Expansion hatch 3904 can comprise the check valve 3914 that permeate chamber is wherein arranged, expansion fluid can pass through described permeate chamber by for example syringe or other fluid pumping apparatus pumping, and described other fluid pumping apparatus links to each other so that fluid, gas and/or gas pressure are delivered to capsule 3520 with expansion chamber 3511 fluid isolation formulas.Adapter 3912 can also comprise the 3rd branch that is connected on catheter tube 3510 far-ends, so that expansion hatch 3904, urine outlet 3902 and seal wire keeper 3900 are connected on the catheter tube 3510.
The another kind of embodiment of expansion hatch 3904 can comprise and bonded two-way valve of expansion chamber and/or relief valve mechanism, by discharge that fluid discharges or the confined expansion chamber in pressure be no more than required amount, two-way valve and/or relief valve can limit the fluid pressure in the capsule.Two-way valve or pop off valve so are set can allow capsule to expand into the pressure limit of known unanimity, so as when to reduce actual the use in expansion process required precision.Another leg of Y shape connecting portion can be communicated with and be used for the urine discharge with the main channel or the centre gangway formation fluid isolation formula of conduit.Should be understood that the numerous embodiments of seal wire keeper 3900, urine outlet 3902 and/or expansion hatch 3904 meets embodiment disclosed herein.
With reference to Figure 19-22, what may need is that capsule 3520 is a pyriform in ductus bursae assembly extremity office, the far-end than the most close ductus bursae assembly of major diameter of pyriform.Can be expanded to than major diameter along with expanding at first to make in the uppermost component (for figure) of capsule 3520 at capsule fixed cover 3430 like this, thereby under situation about not inserting fully, capsule self be drawn in the bladder in the place of more close distal end of catheter.As an alternative, capsule 3520 can form any other suitable shape.
Capsule 3520 can form as follows, for example immersing by the DP9646-T14 plug with polishing will be from North Carolina in the Raw material pail, Apex, Polyzen, the Rhodia of Inc. (cellulose acetate) V4000 silicones is coated to the capsule epidermis that formation has pear shape on this plug.After immersing, apply the epidermal thickness that homogeneous was controlled and promoted to form to rotation and hot air drying.About 0.01 ± 0.0015 inch epidermal thickness may be suitable.The size of the near-end that diameter is less can fit snugly in around the selected catheter tube and can not open substantially, so that can be bonded in reliably around the pipe with binding agent, catheter tube can be for example 14Fr or 18F r.The near-end of epidermis can be by forming around the plug cutting in the appropriate location that has corresponding to the required diameter of selecting catheter tube.The epidermis far-end that diameter is bigger can cut out around plug, so that form the Len req of capsule epidermis.Inflatable length (along the longitudinal axis of conduit) can be formed by the epigenetic structure of preparation like this for about 0.65 inch capsule of suitably finishing.The capsule epidermis can be removed from plug by the injection air.Then, each end of epidermis can be used from Connecticut, Torrington, and the Novagard RTV 800-306UV/Dual Cure Class VI Paste of DymaxCorporation bonds on the catheter tube.Each end of capsule epidermis can bond on the catheter tube by the adhesive phase that is applied on the body circumference.
In embodiment as herein described, when anchoring piece 700 is separated by the end effector inter-module after driving, the size of capsule can be assemblied between the anchoring piece 700, with filling capsule fixed cover 3420, and provides enough tissue contact region and pressure when being inflated suitable pressure.When expanding, the horizontal diameter of capsule 3520 for example can be about 0.75 inch, along with the bulbs of pressure change with being pumped into the variation of the expansion flow scale of construction in the capsule.In one embodiment, capsule 3520 may be expanded to about 3.2psi, is expanded to about 8.3psi from about 3.2psi, and/or is expanded to 3.2psi from about 0.1psi.In addition, when being expanded to the required pressure of anastomosis operation, the processing diameter of capsule can be selected according to the space that anchoring piece is set up.As mentioned above, the total length of capsule 3520 can be for example about 0.65 inch before expansion.When unlike the constraint that is subjected to fixed cover described herein, the capsule that produces 3520 as described herein can be elongated along with the interpolation of expansion fluid, may reach about 1.63 inches maximum swelling diameter (before the explosion), and the explosion maximum swelling pressure before that may keep about 4.4psi, when being subjected to the constraint of fixed cover like that, maximum swelling pressure is approximately 8.3psi when as described herein.Expand repeatedly and shrink and to cause capsule forfeiture partial pressure ability to bear.
Figure 19 illustrates the embodiment of ductus bursae assembly 3500 with catheter tube 3510.A kind of embodiment of shown capsule 3520 circumferentially surrounds catheter tube 3510 near the far-end of catheter tube, and capsule 3520 can expand via expansion chamber 3511 and expansion hatch 3512.In the embodiment shown in Figure 19, at least a portion of the outer surface 3800 of capsule epidermis has been reversed and has bonded on the catheter tube 3510 so that form capsule 3520.So the capsule that forms can reduce the quantity of the abrupt change raised edges that appears at ductus bursae assembly far-end, and these abrupt change raised edges may be damaged, stimulate urethra and/or be disturbed the ductus bursae assembly to insert urethra.
Figure 20 shows the another kind of embodiment of ductus bursae assembly 3500, and wherein capsule 3520 circumferentially surrounds catheter tube 3510 near catheter tube 3510 near-ends, and can expand via expansion chamber 3511 and expansion hatch 3512.In the embodiment shown in Figure 21, catheter tube 3510 can be provided with circumferential recess or step 3820, and as shown in the figure, the near-end of capsule epidermis can be provided with and be bonded in and form capsule 3520 in described groove or the step 3820.To catheter tube groove 3820 is set as shown in figure and the capsule epidermis is bonded in this groove, can further reduce the quantity of the abrupt change raised edges that appears at ductus bursae assembly far-end, these abrupt change raised edges may be damaged, stimulate urethra and/or be disturbed the ductus bursae assembly to insert urethra.
Figure 21 shows the another kind of embodiment of ductus bursae assembly 3500, and wherein capsule 3520 circumferentially surrounds catheter tube 3510 near catheter tube 3510 far-ends, and can expand via expansion chamber 3511 and expansion hatch 3512.In the embodiment shown in Figure 21, the far-end of catheter tube 3510 can be provided with annular groove or step 3850, and as shown in the figure, the far-end of capsule epidermis can overturn and be bonded in and form capsule 3520 in described groove or the step 3850.To catheter tube groove or step 3850 are set as shown in figure and the capsule epidermis is bonded in this groove, can further reduce the quantity of the abrupt change raised edges that occurs at ductus bursae assembly far-end, these abrupt change raised edges may be damaged, stimulate urethra and/or be disturbed the ductus bursae assembly to insert urethra.
Figure 22 shows the another kind of embodiment of ductus bursae assembly 3500, and wherein capsule 3520 circumferentially surrounds catheter tube 3510 near catheter tube 3510 near-ends, and can expand via expansion chamber 3511 and expansion hatch 3512.Figure 22 illustrates the combination of the nearside capsule epidermis connected mode of the distally capsule epidermis connected mode of Figure 21 and Figure 20, in this case, can further reduce the quantity of abrupt change raised edges, these abrupt change raised edges may be damaged, stimulate urethra and/or be disturbed the insertion urethra of ductus bursae assembly.
Still with reference to the capsule shown in Figure 19 to 22 3520, anastomosis operation may require the ductus bursae assembly to keep the in place of fortnight.According to embodiment as herein described, but the capsule 3520 that has by permeable or the epidermis that semipermeable materials forms be can provide, sterilized water, saline solution, air, gas or any other suitable expansion fluid or its combination wherein can be filled.When capsule 3520 is formed by this material, as time passes, because urine, fluid, gas and/or the air in the bladder, used expansion fluid and the reciprocal action of capsule epidermis, capsule 3520 can pass through infiltration or change in volume takes place in diffusion and the bulbs of pressure change.For example material is slowly selected the pressure that may reduce gradually the bladder in the capsule 3520 from capsule, and reduces thus by capsule 3520 and be applied to pressure on the wall of urinary bladder 2.After tissue bond began, As time goes on pressure reduced, and this can allow blood to flow into more and more in pelvic floor and the wall of urinary bladder as time passes.Can from capsule, overflow quickly than sterilized water or saline solution as air or other gas that expansion fluid uses, and therefore be not suitable for some occasion.The difference of salinity will penetrate into capsule or infiltrate from capsule and seepage velocity exerts an influence water between expansion fluid and the environment (being made up of urine substantially).If use salinity sterilized water or the saline solution lower than the salinity of patient urine, water may infiltrate from capsule so, and permeability can be controlled by the salinity of selecting expansion fluid.
One skilled in the art will appreciate that manufacture method as described herein, material therefor and be combined in capsule and the capsule fixed cover in feature portion can change, but this variation does not exceed scope of the present invention.Particularly, the purpose of described embodiment provides the capsule fixed cover and the capsule of suitable coupling, can be used on the wall of urinary bladder in the around openings zone of bladder and urethra, applying suitable downward pressure in bonded mode, be resisted against on the wall of urinary bladder to order about capsule, thus capsule kept and be limited in the capsule fixed cover.An object of the present invention is in each organizes effectively in conjunction with the required time wall of urinary bladder to be resisted against forms basic effective seal, drains in the abdominal cavity to prevent urine on the pelvic floor.Another purpose is to promote bladder and parameatal each pelvic floor tissue of urethra and the effective combination of bladder body.Simultaneously, need avoid applying too much pressure unacceptably to reduce circulation for a long time organizationally with the mode that unacceptably increases downright bad probability, described circulation is helpful to combination and healing.By using the techniques described herein or other proper technology, capsule fixed cover and capsule modular design can be applied the pressure that for example is reduced to about 32mmHg from about 100mmHg with manufacturing to can be used in 48 hours to tissue.Should be understood that, can use any suitable pressure and/or any abundant conjunctive tissue of suitable persistent period.
Anchoring piece
As described herein, anchoring piece 700 or other suitable fasteners are carried out and are kept function, and wall of urinary bladder is remained to pelvic floor and/or fixed cover is remained to wall of urinary bladder and/or pelvic floor.Each anchoring of Tao Luning and/or fastenings only are the possible within the scope of the invention a large amount of designs and the example of structure herein.
Anchoring piece 700 or other securing member can have one or more suitable fixed structure, are used for causing that anchoring piece is fixed on tissue after being driven in the tissue, withdraw from from tissue so that prevent.Described fixed structure can comprise agnail, circumferential ridge, projection or cause that effectively anchoring piece is fixed on any other part in the tissue in being driven into tissue the time.The size of suitable fixed structure, shape and number can change.In addition, the inventor determines, no matter when agnail is included on the anchoring piece, be ideally when producing such anchoring piece, need to give projecting end (observing) rounding of agnail or make it slick and sly, insert and open during the anchoring piece actuator assembly that is mounted with anchoring piece agnail and draw and hang over the inner lax structural probability of wall of urinary bladder of bladder so that be reduced in from the front end of anchoring piece.
Anchoring piece or other securing member also can have head or other suitable puncture limiting structure, and can be used for limiting anchoring piece or other securing member can driven degree of depth, and can be used for helping proximal tissue is connected to following distal tissue.Should be appreciated that the rear end that such puncture limiting structure needn't be arranged on the anchoring piece axle just works.
Can expect, the front end of anchoring piece be point or have chisel-shape so that the more effective and/or injury tissue that punctures littlelyr.In addition, the inventor determines, the tip that comprises three clinoplains in the plane that intersects each other with equal angles that forms on the front end of cylindrical anchoring piece axle is convenient to anchoring piece and is punctured in the tissue, and its mode is for departing from objectives anchoring piece during driving or the minimizing possibility of offset direction.
When being used for wall of urinary bladder is connected with pelvic floor, wish the length that anchoring piece has to be enough to through the fascia layer puncture of wall of urinary bladder and pelvic floor.For example but as restriction, the length of described anchoring piece is not preferably approximately 1/ 2Inch is to 2 1/ 2Inch.For near the anchoring piece will being installed in rectum, wish that they are positioned at the less end value place of the preferable range of length.
Anchoring piece 700 or other suitable fasteners can be by biocompatible polymer or metal are made substantially.When needs shape memory and elasticity, can use the element of making by elastomeric material to produce anchoring piece, for example elastic metallic alloy or thermal actuation or actuatable alloy, such as Nitinol (for example Nitinol) or stainless steel alloy, make anchoring piece or other securing member preform and be subjected to bias voltage, have shaping end or agnail along axle, anchoring piece can be launched, when they enter target tissue, make them in target tissue, take their shape by they being pulled out apparatus.
Biocompatibility if desired, anchoring piece 700 or other suitable fasteners can be roughly biocompatibility and biological absorptive material is made by suitable.The inventor has determined that (polydioxanone polymer for example perhaps contains the polymer of lactide, Acetic acid, hydroxy-, bimol. cyclic ester, lactide glycolide copolymer etc., for example from Johnson﹠amp to flexible absorbable polymer; The trade mark that Johnson and/or Ethicon Inc. sell is the polymer of " Vicryl " and " PDS II ") be potential suitable material.Other bioabsorbable material with required physical characteristic also can use.
When being used for the anchoring piece fixed cover band of capsule or fixed cover system, for example illustrate in this article and describe, biology can absorb anchoring piece and can be used for providing biology can absorb the fixed cover relieving mechanism, avoids mechanically fixed cover being connected to anchoring piece and discharges the needs of the structure of fixed cover or device or reduce its importance from anchoring piece then.As an example but not as restriction, referring to Figure 16, be appreciated that, if for example the structure of the fixed cover hook 760 on the anchoring piece 700 is biological absorbable, and have a time time corresponding degradation characteristic required with anastomosis operation, fixed cover hook 760 will be used to discharge capsule fixed cover 3430 (referring to Figure 14) through the degraded and the dissolving of bio-absorbable, discharge from the patient with promotion.
In addition, may need control degradation and absorption distribution and/or the biological fission particle size that can absorb anchoring piece or other suitable fasteners in some cases.For example, if one or many biologies can absorb anchoring piece (such as the anchoring piece head) and under the fracture of bulk ground, then may cause obstruction along with the anchoring piece material degradation after the expansion.Therefore, can be provided with and make biology as follows and can absorb anchoring piece, anchoring piece guiding piece or other suitable fasteners, wherein the big I of degradation rate and fission particle is controlled.For example, biology can absorb anchoring piece or other securing member can be formed with cut, perforation or groove setting by casting, molding, embossing or machine-tooled method, these are arranged on part in the select location and form thickness and reduce the zone that increases with stress, thereby promote fracture more early, so that the size of the part that when material degradation, reduces to break away near described zone.As an alternative or additional, biological anchoring piece or other securing member of can absorbing can or comprise that binding member makes by the bond material with different degraded/absorptions distributions, thereby form faster in described part and the zone of degraded more slowly, the fragment that makes very conference form the probability of obstruction or other unfavorable effect breaks away from body cavity and the probability that discharges reduces.
In another embodiment, anchoring piece can be formed by two kinds of metals or other combination with two kinds of materials of different expansion characteristics at least, and described material can cause the shape of for example being taked needs by its parts that form after heating by patient's body.Under these circumstances, anchoring piece can be provided under cold or room temperature state, then in the shape that allows to reach final needs after the installation when heating by patient body.
Because its physical characteristic and the long history aspect implantable medical device thereof, Nitinol can be used to this service, because it is using or conceiving together comprehensive suitability of using with nuclear magnetic resonance (MRI) technology, it is also applicable to as anchoring piece.
As shown and described herein, be used for behind prostatectomy effectively the coincideing embodiment of method of bladder and urethra relates to anchoring piece driven and enters pelvic floor.In a kind of like this operation, thereby may need anchoring piece driven to enter is in those and avoids the sensitizing range and reduce in the pelvic floor in the place of potential complication.For example with reference to Figure 18, need avoid driving anchoring piece and enter zone near the identical feature portion of penis back vein D, other neurovascular bundle N, rectum R or other sensitivity.Therefore, with reference to Figure 18, the inventor determines preferably anchoring piece to be driven and enters in the pelvic floor in the zone that is in about 8 to 10 o'clock, about 2 to 4 o'clock around the urethra U, shown in " A " among Figure 18 and " B " distinguishes.More preferably, may be this situation, for example, use capsule shown and described herein and fixed cover system, with reference to Figure 18, what two anchoring pieces were driven into pelvic floor is near the urethra about 9 and about 3 o-clock position.
When using apparatus of the present invention that anchoring piece is installed, avoiding driving anchoring piece, to enter, pass or cross the defeated urine hole of bladder also very important.The exemplary embodiment of apparatus described herein can be avoided the generation of this incident easily.
Handle
The inventor has developed the illustrative embodiments of the Handleset that is used for apparatus, and Handleset plays the purpose that realizes the inventive method in the use of apparatus.With reference to Fig. 3, Handleset 3100 can comprise hands support 3101 and the anchoring piece activation lever 3102 of moving around balance pivot 3104, and has the shape that roughly meets human factor engineering.Anchoring piece activation lever 3102 can be connected to direct mechanical anchoring piece driver actuator lever or be with on 3261 and (see Figure 15), anchoring piece driver actuator lever or be with 3261 can be directly connected to anchoring piece drive arm 3461 (seeing for example Fig. 7) again, this can provide the tactile feedback that drives and be provided with about anchoring piece by lever 3102 in tissue for the surgeon.With reference to Fig. 3, when the bent angle of pipe assembly 3200 shown in comprising (and in serial number is 11/096606 pending application, further describing), hands support 3101 auxiliary doctor's operating apparatuss, utilize the basin bone structure especially pubic arch (comprising pubic crest, pubic tubercle, pubic symphysis and/or associated tissue) assist to pull down the executor of moved end portion 3400 (promptly along retrograde direction) as fulcrum (pipe assembly 3200 be resisted against on the described fulcrum be operated) so that after intravesical is opened localizer arm and before the driving anchoring piece, bladder is pulled to pelvic floor.Handleset 3100 can also be connected on the pipe assembly 3200 in any suitable manner, makes between Handleset 3100 and pipe assembly 3200 without any rotation (around the longitudinal axis of pipe assembly 3200).Should be understood that, in this case, lever 3102 and hands support 3101 with respect to the direction of the bent angle of pipe in the assembly make the surgeon pass through only to observe Handleset 3100 just can be easily from definite end effector assembly 3400 visually in intravesical direction, make the surgeon to be driven to required angle and position to guarantee anchoring piece with respect to urethra by operating apparatus, for example shown in Figure 180 and the following position that will further describe " A " and " B ".When the both sides shown in the figure are seen, the feature that this simple visualization of the facilitation of Handleset 3100 is measured can be the inhomogeneous or asymmetric profile of Handleset 3100.Mode as an alternative, Handleset 3100 can be provided with one or more labellings or other visual properties portion, as indication end actuator assembly in the direction of the degree of depth of the intravital direction of patient, conduit, end effector assembly, executor's position and/or inserting the indicator of the degree of depth of rear anchor piece in the tissue.
The above-mentioned embodiment of various parts is embodiment of apparatus each several part, and it can be one or more in the following step: bladder is contacted with pelvic floor and kept, wherein the opening of bladder and urethra aligns substantially; Drive anchoring piece and enter pelvic floor through wall of urinary bladder; The capsule fixed cover is fixed in the bladder cavity; Swelling bag also is applied to pressure on the wall of urinary bladder thus in the capsule fixed cover, so that realize the combination of wall of urinary bladder and pelvic floor; And discharge urine from bladder in rehabilitation with in required time of healing, so that realizing coincideing between bladder and the urethra behind the prostatectomy.
One skilled in the art will appreciate that above-mentioned parts can have realizing useful other structure and the embodiment of same steps as.One skilled in the art will appreciate that as an alternative, can and be configured to the above-mentioned parts design to realizing that along direct motion direction rather than aforesaid retrograde direction above-mentioned steps is useful.
Therefore, those skilled in the art are to be understood that, the mechanism that comprises the bladder positioning function of localizer assembly 3440 and execution localizer assembly 3440 can have various mapped structures, include but not limited to that the embodiment of describing (and includes but not limited to wherein said localizer assembly 400 thus in serial number is 11/094606 pending application, the reciprocating motion assembly 800 (Figure 17-21) that has localizer lobe 830, the umbrella shape assembly 900 (Figure 22 to 27) that has the localizer lobe 930 of counter-rotating, or wherein said localizer 2017 (Figure 122 to 126), 2090 (Figure 110 to 118), 2122 (Figure 95,96,103 to 109) and 2168 (Figure 83,84,89 to 94) (all these obtains describing therein)), but the device of cross-direction shrinkage and extension is set, help entering bladder opening 4 through urethra 5 along retrograde direction, in bladder cavity 8, launch and expansion, wall of urinary bladder 2 around grasping bladder opening 4 and bladder opening 4 being ordered about in operation contacts each corresponding register with the pelvic floor 7 around the urethra opening 6; Or mode as an alternative, insert through the otch in the upper surface of abdominal part and bladder 1, bladder cavity 8 in, extend or expand, grasp the wall of urinary bladder 2 that bladder opening 4 and operation order about around the bladder opening 4 and contact with the direct motion direction, and each respective openings is alignd with urethra opening 6 pelvic floor 7 on every side.Usually, localizer assembly can comprise and use any amount of optionally extensible and projection of shrinking, lobe, arm, pawl or other to be used to grasp the wall of urinary bladder 2 around the bladder opening 4 and obtain clamping or gripping member to its control.Localizer assembly can have at least one member on the longitudinal member that is operably connected to apparatus, along with the input of surgeon at the apparatus near-end, localizer assembly can be alternatively from the longitudinal axis horizontal expansion of the longitudinal member of apparatus and can be towards the longitudinal axis withdrawal of the longitudinal member of apparatus.As optional mode, can design apparatus, make localizer arm itself can not have function as herein described or carry out the function as herein described of localizer arm in addition by other parts that for example the member of feature portion by the anchoring piece drive arm or extension or other and Handleset mechanical connection is realized.
In view of the structure of apparatus as described herein that is suitable for carrying out anastomosis operation and step is varied, scope of the present invention only limits by the claims submitted to below and the equivalent of all permissions.

Claims (56)

1. apparatus that is used for realizing in operation patient's bladder and urethra anastomosis behind prostatectomy comprises:
The pipe assembly, it comprises ridge member, first bar and second bar, wherein said first bar and second bar can move relative to each other and can be with respect to described ridge component movement;
The end effector assembly, it is operationally supported by described pipe assembly, and described end effector assembly also comprises:
Localizer assembly, it has localizer arm, described localizer arm and described first bar operationally mechanical connection so that activated by of the motion of described first bar with respect to described ridge member, wherein said first bar makes the post motion that is connected on the described localizer arm, and the motion of described post makes described localizer arm be switched to deployed position and closed position;
Anchoring piece actuator assembly, itself and described second bar operationally mechanical connection so that activated by of the motion of described second bar with respect to described ridge member;
Anchoring piece, it is kept releasedly by described anchoring piece actuator assembly, is used for inserting pelvic floor from bladder cavity is inner through wall of urinary bladder.
2. apparatus according to claim 1, also comprise the anchoring piece guiding piece that keeps by described end effector assembly, when described anchoring piece was driven owing to the actuating of described anchoring piece actuator assembly, described anchoring piece guiding piece was passed in described anchoring piece motion.
3. apparatus according to claim 2, wherein, described anchoring piece guiding piece is kept by described localizer assembly.
4. apparatus according to claim 3, wherein, described anchoring piece guiding piece is kept by described localizer arm.
5. apparatus according to claim 1, wherein, described pipe assembly also comprises the 3rd bar, and wherein said the 3rd bar and described end effector assembly be mechanical connection operationally, and wherein said the 3rd bar can be with respect to described first bar, described second bar and described ridge component movement.
6. apparatus that is used for realizing in operation patient's bladder and urethra anastomosis behind prostatectomy comprises:
The pipe assembly, it comprises ridge member, first bar and second bar, wherein said first bar can move relative to each other with second bar and can relative described ridge component movement;
The end effector assembly, it is operationally supported by described pipe assembly, and described end effector assembly also comprises:
Localizer assembly, itself and described first bar operationally mechanical connection so that activated by of the motion of described first bar with respect to described ridge member;
The anchoring piece actuator assembly, it has drive arm, described drive arm and described second bar operationally mechanical connection so that activated by of the motion of described second bar with respect to described ridge member, wherein said second bar makes the post motion that is connected on the described drive arm, and the motion of described post makes described drive arm be switched to deployed position and closed position; With
Anchoring piece, it is kept releasedly by described anchoring piece actuator assembly, is used for inserting pelvic floor from bladder cavity is inner through wall of urinary bladder.
7. apparatus according to claim 6, also comprise the anchoring piece guiding piece that keeps by described end effector assembly, when described anchoring piece was driven owing to the actuating of described anchoring piece actuator assembly, described anchoring piece guiding piece was passed in described anchoring piece motion.
8. apparatus according to claim 6, wherein, described anchoring piece guiding piece is kept by described localizer assembly.
9. apparatus according to claim 6, wherein, described pipe assembly also comprises the 3rd bar, and wherein said the 3rd bar and described end effector assembly be mechanical connection operationally, and wherein said the 3rd bar can be with respect to described first bar, described second bar and described ridge component movement.
10. apparatus that is used for realizing in operation patient's bladder and urethra anastomosis behind prostatectomy comprises:
The pipe assembly, it comprises ridge member, first bar and second bar, wherein said first bar can move relative to each other with second bar and can relative described ridge component movement;
The end effector assembly, it is operationally supported by described pipe assembly, and described end effector assembly also comprises:
Localizer assembly, itself and described first bar operationally mechanical connection so that activated by of the motion of described first bar with respect to described ridge member;
Anchoring piece actuator assembly, itself and described second bar operationally mechanical connection so that activated by of the motion of described second bar with respect to described ridge member;
Anchoring piece, it is kept releasedly by described anchoring piece actuator assembly, is used for inserting pelvic floor from bladder cavity is inner through wall of urinary bladder; With
The anchoring piece guiding piece, it is kept by described end effector assembly, and when described anchoring piece was driven owing to the actuating of described anchoring piece actuator assembly, described anchoring piece passed described anchoring piece guiding piece motion.
11. apparatus according to claim 10, wherein, described anchoring piece guiding piece is kept by described localizer assembly.
12. apparatus according to claim 10, wherein, described pipe assembly also comprises the 3rd bar, and wherein said the 3rd bar and described end effector assembly be mechanical connection operationally, and wherein said the 3rd bar can be with respect to described first bar, described second bar and described ridge component movement.
13. apparatus according to claim 10, wherein, described anchoring piece guiding piece is kept releasedly by described end effector assembly.
14. apparatus according to claim 2, wherein, described anchoring piece guiding piece is kept releasedly by described end effector assembly.
15. apparatus according to claim 3, wherein, described anchoring piece guiding piece is kept releasedly by described localizer assembly.
16. apparatus according to claim 4, wherein, described anchoring piece guiding piece is kept releasedly by described localizer arm.
17. apparatus according to claim 7, wherein, described anchoring piece guiding piece is kept releasedly by described end effector assembly.
18. an apparatus that is used for realizing in operation patient's bladder and urethra anastomosis behind prostatectomy comprises:
The pipe assembly, it comprises ridge member and bar, wherein said bar can described relatively ridge component movement;
The end effector assembly, it is operationally supported by described pipe assembly, and described end effector assembly comprises:
Anchoring piece actuator assembly, itself and described bar operationally mechanical connection also can activated by the motion of described bar, so that drive anchoring piece;
Anchoring piece, it can be pivoted by described anchoring piece actuator assembly and keep releasedly, is used for inserting pelvic floor from bladder cavity is inner through wall of urinary bladder; With
The anchoring piece guiding piece, it is kept by described end effector assembly;
Wherein, when described anchoring piece was driven by described anchoring piece actuator assembly, described anchoring piece guiding piece guided described anchoring piece.
19. apparatus according to claim 18, wherein, described anchoring piece comprises a pair of flexible disengaging part, and when described anchoring piece was driven by described anchoring piece actuator assembly, described flexible disengaging part can contact with described anchoring piece guiding piece and interact.
20. apparatus according to claim 19, wherein, described a pair of flexible each that breaks away from the part comprises the anchoring piece pivot pin, in the wherein said anchoring piece pivot pin each engages pivotly with described anchoring piece actuator assembly, and when in driving the process of described anchoring piece by with described anchoring piece guiding piece contact and during the described a pair of flexible disengaging part of the inwardly promotion that interacts, described anchoring piece pivot pin can be thrown off, and discharges described anchoring piece from described end effector assembly thus.
21. apparatus according to claim 18, wherein, described anchoring piece guiding piece has keyway feature portion, and described anchoring piece has keyway mating feature portion.
22. apparatus according to claim 21, wherein, described anchoring piece guiding piece can discharge from described end effector assembly, described anchoring piece and described anchoring piece guiding piece have the feature portion that matches, described thus anchoring piece guiding piece can be connected with described anchoring piece, to form the head of anchoring piece.
23. apparatus according to claim 18, wherein, described anchoring piece comprises the puncture limiting structure.
24. apparatus according to claim 18, wherein, described anchoring piece comprises fixed structure.
25. apparatus according to claim 18, wherein, but described anchoring piece is formed by the material of bio-absorbable.
26. apparatus according to claim 22, wherein, but described anchoring piece and described anchoring piece guiding piece are formed by the material of bio-absorbable.
27. an apparatus that is used for realizing in operation patient's bladder and urethra anastomosis behind prostatectomy comprises:
The pipe assembly, it comprises ridge member, first bar and second bar, wherein said first bar can move relative to each other with second bar and can relative described ridge component movement;
The end effector assembly, it is operationally supported by described pipe assembly, and described end effector assembly comprises:
Localizer assembly, itself and described first bar operationally mechanical connection so that activated by of the motion of described first bar with respect to described ridge member;
Anchoring piece actuator assembly, itself and described second bar operationally mechanical connection so that activated by of the motion of described second bar with respect to described ridge member;
Anchoring piece, it is kept releasedly by described anchoring piece actuator assembly, is used for inserting pelvic floor from bladder cavity is inner through wall of urinary bladder; With
Fixed cover, it is kept releasedly by described end effector assembly, and wherein said fixed cover is connected on the described anchoring piece and can keeps the capsule part of ductus bursae assembly.
28. apparatus according to claim 27, wherein, but the adapter of described fixed cover by bio-absorbable is connected on the described anchoring piece.
29. apparatus according to claim 27, wherein, described fixed cover comprises the seal wire that is connected thereto.
30. apparatus according to claim 27 wherein, has a plurality of inflation port in the described fixed cover.
31. apparatus according to claim 30, wherein, described fixed cover has a circumference, and described inflation port is substantially symmetrically around described circumference setting.
32. apparatus according to claim 27, wherein, described fixed cover comprises the fixed cover end, and described seal wire is connected to described fixed cover end and has tap in described fixed cover end.
33. apparatus according to claim 29, wherein, can to extend to the patient external for described seal wire after described fixed cover is installed.
34. apparatus according to claim 27, wherein, but at least a portion of described fixed cover comprises bioabsorbable material.
35. one kind is placed on the assembly that is used for carrying out patient's bladder and urethra anastomosis in patient's bladder behind prostatectomy, comprises:
Anchoring piece, it passes wall of urinary bladder and is installed in the pelvic floor;
Fixed cover, it is connected on the described anchoring piece; With
Ductus bursae, it has capsule part and catheter tube part;
Wherein said capsule partly is inserted in the described fixed cover and is inflated.
36. assembly according to claim 35, wherein, described capsule is expanded by saline solution.
37. assembly according to claim 35, wherein, described capsule is expanded by water.
38. assembly according to claim 35, wherein, described capsule partly is connected on the described catheter tube part, makes the surface of described capsule part flush basically with the surface of described catheter tube part.
39. assembly according to claim 35, wherein, described capsule part is essentially pyriform before expansion.
40. assembly according to claim 35 also comprises the seal wire that is connected on the described fixed cover.
41. assembly according to claim 35, wherein, described capsule partly comprises permeable material.
42. assembly according to claim 36, wherein, described capsule partly comprises semi permeable material.
43. one kind is used to realize patient's bladder and the identical method of pelvic floor, may further comprise the steps behind prostatectomy:
Push near the wall of urinary bladder the bladder opening near to the urethra opening pelvic floor;
The anchoring piece that driving is connected with fixed cover enters and passes described wall of urinary bladder, enters in the pelvic floor, thus described fixed cover is fixed on intravesical and is positioned near the described bladder opening;
Swelling bag in described fixed cover is applied to pressure near the wall of urinary bladder the bladder opening thus, so that the pushing wall of urinary bladder makes it to contact with near the position of the pelvic floor urethra opening;
Keep described fixed cover and described capsule in patient's body one section in place be enough to make wall of urinary bladder tissue and pelvic floor to organize effective bonded time; With
Described capsule is removed from patient body.
44. according to the described method of claim 43, wherein, described expansion step comprises uses the saline solution described capsule that expands.
45. according to the described method of claim 43, wherein, described expansion step comprises makes the water described capsule that expands.
46. according to the described method of claim 43, wherein, described maintenance step comprises that the passing along with the described time reduces the pressure in the described capsule.
47. an apparatus that is used for realizing in operation patient's bladder and urethra anastomosis behind prostatectomy comprises:
The pipe assembly, it comprises ridge member, first bar and second bar, wherein said first bar can move relative to each other with second bar and can relative described ridge component movement;
Handle, wherein said handle links to each other with described pipe assembly; With
The end effector assembly, it is operationally supported by described pipe assembly, and described end effector assembly also comprises:
Localizer assembly, itself and described first bar operationally mechanical connection so that activated by of the motion of described first bar with respect to described ridge member;
The anchoring piece actuator assembly, it is operably connected with described second bar so that activated by the motion of described second bar with respect to described ridge member;
At least one anchoring piece, it is kept releasedly by described anchoring piece actuator assembly, is used for inserting pelvic floor from bladder cavity is inner through wall of urinary bladder.
48. according to the described apparatus of claim 47, wherein, described apparatus can insert in patient's urethra along retrograde direction, and wherein said handle also comprises the hands support, and described hands support can assist a physician pubic arch with the patient as fulcrum in the anastomosis operation process.
49. according to the described apparatus of claim 48, wherein, described pipe assembly comprises bent angle, and described hands support is in the direction of basic fixed with respect to described bent angle.
50. according to the described apparatus of claim 49, wherein, described bent angle is between about 80 degree are spent to about 90.
51. according to the described apparatus of claim 47, wherein, described pipe assembly comprises bent angle, described handle is in fixed basically direction with respect to described bent angle, and described handle comprises visual properties portion, in the time of in being inserted into patient's bladder, described visual properties portion is as the direction indicator of described end effector assembly.
52. according to the described apparatus of claim 47, wherein, described handle also comprises the anchoring piece driver lever that is connected on the fulcrum, wherein, described anchoring piece driver lever is around described support motion and be mechanically connected on the described end effector assembly, and provides tactile feedback about the operation of described end effector assembly for the surgeon.
53. according to the described apparatus of claim 47, wherein, described handle also comprises the button that is mechanically connected on the described end effector assembly.
54. according to the described apparatus of claim 47, wherein, described pipe assembly comprises the 3rd bar, wherein said the 3rd bar can be with respect to described first bar, described second bar and described ridge component movement.
55. a method that is used to realize patient's bladder and urethra anastomosis behind prostatectomy may further comprise the steps:
A kind of coinciding machine is provided, and described apparatus comprises:
Handle, wherein said handle comprises the hands support;
The pipe assembly, it is connected on the described handle and comprises bent angle;
The end effector assembly, it is connected on the described pipe assembly, and wherein said end effector assembly is via described pipe assembly and described handle mechanical connection operationally;
Described end effector assembly is inserted patient's urethra and intravesical along the direction of driving in the wrong direction;
Open the localizer that is arranged on the described end effector assembly at patient's intravesical;
Near described hands support, grasp described hands handle;
Use described handle and described hands support to operate described apparatus, wherein said pipe assembly is pushed against on patient's pubic arch, make pubic arch be used as fulcrum, around described the described pipe assembly of point operation, described pipe assembly makes described localizer towards patient's pelvic floor pushing patient wall of urinary bladder around the motion of described fulcrum; With
Use described handle further to activate described coinciding machine.
56. according to the described method of claim 55, wherein, described bent angle is between about 80 degree are spent to about 90.
CNA2006800467915A 2005-11-07 2006-11-02 Instrument for effecting anastomosis of respective tissues defining two body lumens Pending CN101330877A (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US11/268,137 2005-11-07
US11/268,153 US7708748B2 (en) 2005-03-30 2005-11-07 Anastomosis device
US11/268,337 2005-11-07
US11/268,001 2005-11-07
US11/268,153 2005-11-07

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102639069A (en) * 2009-10-15 2012-08-15 I.B.I以色列生物医学创新有限公司 Urethral anastomosis device
CN108348256A (en) * 2015-10-20 2018-07-31 柯惠有限合伙公司 Circular stapler with tissue space indicator assemblies

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102639069A (en) * 2009-10-15 2012-08-15 I.B.I以色列生物医学创新有限公司 Urethral anastomosis device
CN108348256A (en) * 2015-10-20 2018-07-31 柯惠有限合伙公司 Circular stapler with tissue space indicator assemblies
CN108348256B (en) * 2015-10-20 2020-08-28 柯惠有限合伙公司 Circular stapler with tissue gap indicator assembly
US10973522B2 (en) 2015-10-20 2021-04-13 Covidien Lp Circular stapler with tissue gap indicator assembly

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