CN103189002A

CN103189002A - Method and apparatus for forming stoma trephines and anastomoses

Info

Publication number: CN103189002A
Application number: CN2011800475077A
Authority: CN
Inventors: 诺曼·斯坦利·威廉姆斯; 翁志强
Original assignee: Queen Mary and Westfiled College University of London; FRANKENMAN INTERNATIONAL Ltd
Current assignee: Queen Mary University of London; FRANKENMAN INTERNATIONAL Ltd
Priority date: 2010-09-09
Filing date: 2011-09-09
Publication date: 2013-07-03

Abstract

The present invention relates to a stapler apparatus, comprising a stapler having a proximal end, a distal end and a longitudinal axis, the stapler further comprising a trigger, an anvil docking pin aligned substantially parallel with the longitudinal axis of the stapler, and a stapling means, the anvil docking pin and stapling means being at the distal end of the stapler, and a detachable anvil, comprising an anvil head and an anvil shaft, wherein the anvil shaft is adapted to receive the anvil docking pin and operation of the trigger causes the stapling means to be actuated, characterised in that the length of the anvil shaft is at least 4 cm. The present invention also relates to a method of forming an anastomosis between two surfaces using the stapler apparatus of the invention and a method of forming a stoma trephine in a subject using the stapler apparatus of the invention.; The present invention further relates to the use of the stapler apparatus or anvil for a stapler apparatus in such methods and a kit of parts comprising the stapler apparatus of the invention and additional components.

Description

Be used to form and make method and the device that choma bores and coincide

Technical field

The present invention relates to a kind of in traditional open surgery and laparoscopic surgery, in hollow organ, the generation and make method and the device that choma bores and coincide.

Background technology

A large amount of diseases needs sections to excise to remove the part of a certain organ.For example, inflammatory bowel (as Crohn disease, ulcerative colitis), colorectal carcinoma and intestinal obstruction etc. may need following digestion (gastrointestinal) road of cut-out.After the excision, the gastrointestinal two ends must connect to keep the organ functional operation each other again.This process that connects again is called surgical stapling.

Making mouth is between two hollow organs or a hollow organ and external artificial opening.Manually make the generation of mouth, as colostomy, ileostomy, urethrostomy, esophagostomy and gastrostomy, can be medical intervention of great use in disease treatment, especially must detour to allow refuse to excrete at normal internal organs passage or carry the situation of nutrition in the body.

Historically, coincideing and make mouth is to realize by traditional stitching.The choma brill structure of making of conventional art relates to passing the damaged stretching of stomach wall, with first finger and second width (Keighley M.R.B. and the WILLIAMS-DARLING Ton N.S. that refers to that holds surgeon's second interphalangeal joint, " anal orifice and rectal intestine and colonic operation ", the third edition, Sanders AG, 2008).This uncontrolled relatively stomach wall, especially rectus abdominis m. stretch, and cause stomach wall trepan position to become weak probably, and As time goes on, damaged expansion will cause the formation of hernia.

Surgical stapling is applied in once in a while to be made in mouthful structure.Surgical stapling is used for anastomosis more continually.

In general, the surgery anastomosis ring applicator is used for coincideing of cavity pipe, for example, and intestinal, esophagus and other tubular structures.Anastomosis ring applicator can provide the seam nail of the circumferential installation of two or more rows, make the relative both sides of pipe can sew up safety.Simultaneously, the inner annular blade that is installed in the anastomat shell will be created an inner inner chamber, make that the normal operation of inner chamber is reproduced after the lesion portion excision of pipe.

The anastomosis ring applicator of current use includes nail anvil and anastomat usually.This nail anvil is docked on the anastomat by the nail anvil butt joint pin of being located on the anastomat.Yet the structure of current stitching devices has limited the butt joint of these elements, namely in vivo in the chamber anastomat nail anvil to the butt joint of anastomat.If this butt joint can externalizing, the element of some new operation or current operation will be benefited at effectiveness and safety.

Described the example of anastomosis ring applicator among WO 2004/089225, US 4576167, US 7422138, US 7318830 and the US 7547312, wherein corresponding content will be incorporated into the present invention as a reference.

The knot operation on rectum in the present age is attempted to seek balance between the reservation of disease therapeuticing effect and organization of human body and function.Regrettably, in the treatment of Low Rectal, when anorectal (APER) excise fully and the formation of permanent colonic diversion normally necessary for optimizing oncotherapy, above-mentioned contradiction remains fairly obvious.In this class sufferer, to compare oncotherapy and cause permanent colostomy and the sacrifice of the anorectal of the consequence of the influential life of institute and normal anorectal function, guarantor's anus is less important, this has been recorded in medical science and public sphere.The solution of half-way house may become " Holy grail " of modern anorectal subject.

Had multiple technologies to help guarantee that low Low Level coincide, as through abdomen through sacrum, through the abdomen per anum, through abdomen through sphincter or internal sphincter.Yet these technology all are difficult to implement technically, and may significantly damage sphincter mechanism, restraining are caused serious harm thereupon.Therefore, these technology are not extensive use of.

Behind low level and low Low Level ileum or knot anastomosis of rectum, except losing sphincter function, the other hernia of colonic diversion also be a kind of after making interruption-forming unusual common complication, the sickness rate of reporting in 10 years is up to 48% in the past.Risk factor comprises the situation (Keighley and WILLIAMS-DARLING Ton, 2008) of obesity, malignant tumor, malnutrition, steroid therapy and raising intra-abdominal pressure.As if ring-type is made mouth and is occurred this complication especially easily, and the chances are makes the bigger abdominal part trepan of mouth because its structure need be compared port.Such hernia band is come sizable sickness rate, as, local pain and intestinal obstruction, wherein intestinal obstruction may need urgent surgical operation that intestinal is excised, and has higher fatality rate.

It is unusual to correct proctography in the operation process of rectum being drained the imbalance patient, the inventor has used a kind of anterior perineum method to show plane (WILLIAMS-DARLING Ton N.S. etc. between rectum and vagina (or prostate), Br J Surg, 2005,92:598-604).Clearly from such operation relatively easily near low rectal, and keep outside at the same time and situation that inner anal sphincter is complete under obtain anal canal.In fact, practicality and the safety of this method in open surgery that the inventor is verified, be called APPER(Anterior Perineal Plane for Anterior Resection, excision before the anterior perineum plane) technology (WILLIAMS-DARLING Ton N.S. etc., Ann Surg, 2008,247:750-758), as the additional step of carrying out traditional rectum resection operation under Low Rectal and the big villous adenoma situation.

In low rectal, last 10 centimetres of especially last rectum of 5 centimetres particularly; the excision of pathological changes pathology and l cavity subsequently coincide; adopt traditional suturing skill existing problems, perineum chamber extremely low or that create in the APPEAR operation does not have enough spaces to make relative anvil axle and fully butt joint of trocar (nail anvil butt joint pin) because the position of anus side excision is with respect to the anus position.

This area still needs a kind of surgical device and technology to make generation colorectum low level and low Low Level ileum keep the sphincter integrity when coincideing and therefore can control.This area also still needs a kind of surgical device and technology to make the structure of making mouth avoid such as problems such as the other hernias of colonic diversion.

Summary of the invention

The inventor confirms and has developed a kind of particular procedure that it increases anal canal or external docking capacity can provide tangible operative edge, in addition, has also developed a kind of the be equivalent to iteration of legacy equipment and the attached improvement of surgical practice method to promote to perform the operation.Other operations also may be benefited from the surgical stapling with anal canal or external docking capacity.

Therefore, the inventor has developed a kind of improved operation and new promotion equipment and remedies specially and dissect and surgical difficulty, i.e. a kind of anal canal or external surgical stapling apparatus.

This new anastomat device is suitable for creating identical and makes and reduce when choma bores such as losing side effect such as sphincter control, the other hernia of colonic diversion.

Therefore, a first aspect of the present invention provides a kind of anastomat device, comprising:

(a) have the anastomat of near-end, far-end and the longitudinal axis, this anastomat further comprises:

(i) trigger;

(ii) dock pin with the nail anvil of anastomat longitudinal axis in parallel alignment;

(iii) stitching devices, this nail anvil butt joint pin and stitching devices are arranged on the far-end of anastomat;

(b) include the detachable nail anvil of anvil head and anvil axle,

Wherein, this anvil axle is applicable to the trigger operated that receives nail anvil butt joint pin and cause stitching devices to start, and it is characterized in that the length of anvil axle is at least 4 centimetres.

Since the length-specific of anvil axle, the easier operation of nail anvil, and permission anal canal or external nail anvil are connected with anastomat.

The invention still further relates to a kind of nail anvil of surgical stapling, it comprises anvil head and anvil axle, is characterised in that the length of anvil axle is at least 4 centimetres.

The invention still further relates to the use of nail anvil in the formation that coincide to anastomat device of the present invention or surgical stapling.

The present invention further relates to the use of nail anvil in making the formation of choma brill of anastomat device of the present invention or surgical stapling.

The invention still further relates to anastomat device of the present invention and between two surfaces, form the method for coincideing, it comprises links the first surface of needs stitching on the nail anvil of anastomat device, nail anvil butt joint pin and anvil be coupling close, lay anastomat and make stitching devices engage with the second surface that needs to sew up, excite stitching devices that first surface and second surface are linked together by nail anvil.

The invention still further relates to a kind of method of making the choma brill that forms the patient on one's body, it is included in the patient needs to form otch of position formation of making mouth on one's body, the nail anvil of placing anastomat device of the present invention makes the anvil head enter in patient's body and the anvil shaft extension goes out otch, the anvil axle is docked on the nail anvil butt joint pin, excites stitching devices in the tissue that is sewn, to distribute a series of seam nails.

The invention still further relates to kit and the preventer of forming anastomat device of the present invention.

Description of drawings

Fig. 1 has showed an anastomat device, and it comprises the anastomat 50 that has traditional nail anvil butt joint pin 70 and traditional nail anvil 60;

Fig. 2 has showed the anastomat device of the present invention that includes anastomat 100 and nail anvil 200;

Fig. 3 has showed that traditional nail anvil 60 docks the butt joint of selling on 70 to traditional nail anvil of anastomat 50;

Fig. 4 has showed nail anvil 200 alignment of the present invention and has been ready to be docked on the nail anvil butt joint pin 130 of anastomat 100 of the present invention;

Fig. 5 has showed that traditional nail anvil 60 docks the pin 70 anastomat device of butt joint fully with traditional nail anvil;

Fig. 6 has showed anastomat device of the present invention, and its nail anvil 200 docks pin 130 butt joint fully with nail anvil;

Fig. 7 has showed anastomat device of the present invention, and its nail anvil 200 docks pin 130 butt joint fully with nail anvil, and the butt joint of this nail anvil is sold out and full reducedly advanced in the anastomat 100.The tissue that is sewn will be processed at the seam 250 of 150 of anvil head 220 and stitching devices;

Fig. 8 has showed nail anvil of the present invention 200 as shown in Figure 4, but this nail anvil has been rotated 90 °;

Fig. 9 has showed the cross section of the anastomosis tool that passes A-A line shown in Figure 7;

Figure 10 shows that nail anvil 200 of the present invention is attached to one section intestinal 340 by the purse string suture of the preceding appropriate location of butt joint operation.This nail anvil is by clamp 370 controls;

Figure 11 has showed that the enterotomy by implementing at far-end rectum stump 350 binds, fetches and drawing anvil axle 240 with tweezers 300 promptly;

Figure 12 a and 12b have showed that anvil axle 240 fetches fully by far-end stump 350 and expose external anal canal or external butt joint in order to anvil axle 240 and nail anvil butt joint pin 130;

Figure 13 a and 13b have showed nail anvil 200 and the anastomat 100 of butt joint fully.Can see a nail anvil butt joint indicant 132 by the visual windows on the anvil axle;

Figure 14 has showed cylindric abdominal skin and subcutaneous tissue 400 down to the excision of sheath of rectus abdominis 410, and forms in this position and to make choma and bore;

Figure 15 has showed the sheath of rectus abdominis of being opened by cross recess 410;

Figure 16 has showed the otch that struts with retractor (Cymbidium ensifolium (L.) Sw. root Bake formula retractor);

Figure 17 has showed and uses tweezers 300 by the otch on the stomach wall nail anvil 200 of the present invention to be fetched;

Figure 18 showed and docked pin 130 anastomats of the present invention 100 that have reinforcing network 138 that align with nail anvil, and nail anvil 200 docks with nail anvil to be sold 130 and align and carry out the preparation of joint.This nail anvil is fixing by clamp 370;

Figure 19 has showed the nail anvil 200 and the anastomat 100 that engage fully, in the nail anvil indentation anastomat;

Figure 20 showed that a row who generates defines and made choma and bore 450 seam nail 440 after exciting anastomat, subsequently with the not built-in edge 139 of reinforcing network 138;

Figure 21 has showed by the newly-generated choma of making and has bored 450 one section intestinal 342 fetching;

Figure 22 has showed that use clamp 370 is incorporated into stomach wall with nail anvil 200 of the present invention in laparoscopic surgery.Be formed with purse string suture 445 at the edge of otch;

Figure 23 has showed Intraabdominal anvil head 220 and surrounded the purse string suture 445 of anvil axle 240 before anastomat is combined;

Figure 24 has showed nail anvil 245 of the present invention, and it includes the passage 221 that a nail anvil with anastomat device of the present invention docks pin 130 butt joints;

Figure 25 has showed aspirator accessory 227 and the anastomat of linking on the aspirator 225 of the present invention 100;

Figure 26 has showed when linking on the aspirator, by one section intestinal 345 of nail anvil 245 operations.

The specific embodiment

Intestinal tube (or external) butt joint is a kind of supplementary technology that the inventor develops, and it helps in the low Low Level excision with according to the enforcement of patient's body constitution APPEAR under about 2 to the 10 centimetres identical situation in distance anus edge.Up to the development of APPEAR technology, be impossible in the past near the distal site of this anorectal (keeping complete anal sphincter mechanism and its somatic nerve simultaneously).By providing relatively easy mode to enter low rectal and anal canal, and keep inside and outside sphincter, in most of the cases can avoid creating the permanent demand of making mouthful.

Therefore, the present invention relates to Operation of Remaining Musculus Sphincter/low Low Level colon or ileum anus that a kind of basis such as APPEAR(develops recently coincide) and other potential operations that need anvil axle and the external butt joint of anastomat assembly and the firm of assembly and safety installation are had clear and accurate indication, for example make the interruption-forming technology, need Deng operation, be applicable to anastomat device external or that intestinal tube anvil axle docks with anastomat.

Anastomat device of the present invention comprises as shown in Figure 2:

A) have the anastomat 100 of near-end 120, far-end 140 and the longitudinal axis 180, this anastomat 100 further comprises:

(i) trigger 112;

(ii) dock pin 130 with the nail anvil of the anastomat longitudinal axis 180 parallel aligned;

(iii) stitching devices 150, and this nail anvil butt joint pin 130 and stitching devices 150 are arranged on the far-end 140 of anastomat 100;

(b) include the detachable nail anvil 200 of anvil head 220 and anvil axle 240,

Wherein, this anvil axle 240 is applicable to trigger 112 operations that receive nail anvil butt joint pin 130 and cause stitching devices 150 to start, and it is characterized in that the length of anvil axle 130 is at least 4 centimetres.

" far " of anastomat is with " closely " end is that the far and near distance of the anastomat relative user in two ends during with user operation anastomat device is reference.Near-end generally includes the control area of triggering the stitching devices running near user.Far-end is away from user, but near the applied patient of this anastomat device, so in general stitching devices and nail anvil butt joint pin are positioned at this part.

Usually, the longitudinal axis extends and passes basically the center of anastomat between near-end and far-end.

" circle " of citation comprises that substantial circle and other can say apparent structure to the those skilled in the art that can provide suitable seam nail to distribute.For example, as shown in Figure 9, the cross section of stitching devices can be circle, in order to the seam nail of basic circular configuration is provided, yet, also can use ellipse to arrange.Usually, the cross section of anvil head, anvil axle, nail anvil butt joint pin and anastomosis tool can be circle basically, yet, can provide other arrangements to make them form the seam nail that is fit to and arrange.

This anastomat has an elongate body usually, more preferably, and a cylinder-shaped body substantially.This is to allow it to insert the optimum shape of suitable tissue and organ.

The main body of anastomat comprises trigger 112 and stitching devices 150.More preferably, the main body of anastomat is straight substantially and is unbending.According to dissect and the anastomat device at organ, this shape is of great use.Be straight or substantially among the embodiment of straight (with respect to bending) in the main body of anastomat and since in operation influence coincide and make choma bore quality swing and mobile still less, this shape provides bigger anastomat handling.For example, than the anastomat of bending, the easier and rectal wall keeping parallelism of the anastomat of above-mentioned shape.

In certain embodiments, anastomat comprises a grip region 110, can hold this zone when the user uses anastomat.This grip region is usually located at execution that anastomat near-end 120(therefore sews up can the certain distance of distance users), although it may be positioned at other places of anastomat.

Anastomat device of the present invention can be used for various openings, endoscope or laparoscopic surgery and use, for example coincide, make mouth or make the formation that choma bores, they can still more be usually used in any pipe or hollow lumen between for example gastrointestinal (GI) road or gastrointestinal tract and body surface.Therefore, this anastomat device is suitable for as surgical stapling, perhaps, and at some more specifically among the embodiment, as anastomat in the tube chamber.In addition, consider that anastomat is annular in the some embodiments of the present invention, this device can be described as the anastomosis ring applicator device.

This anastomat device is normally disposable, after use with processed.In a preferred embodiment, this anastomat device is aseptic.

In certain embodiments, the length of anvil axle is 4,5,6,7,8,9 to 10 centimetres.In certain embodiments, the length of anvil axle is 4,5,6,7,8,9 to 10 centimetres at least.In some preferred embodiments, the length range of anvil axle is 4 to 50 centimetres, and more excellent is 4 to 25 centimetres, 4 to 20 centimetres, 4 to 15 centimetres, 4 to 12 centimetres, 5 to 50 centimetres, 5 to 25 centimetres, 5 to 20 centimetres, 5 to 15 centimetres, 5 to 12 centimetres, 5 to 10 centimetres, 6 to 50 centimetres, 6 to 25 centimetres, 6 to 29 centimetres, 6 to 15 centimetres, 6 to 12 centimetres or 6 to 10 centimetres.

In some embodiments of the invention, the overall work length of anastomat drops to 250 to 400 millimeters, preferably from 420 millimeters of industry standard, between 300 to 350 millimeters, more preferably, 310 to 340 millimeters, optimally, 320 to 330 millimeters or 325 millimeters.The overall work length that reduces anastomat provides better, more stable ergonomics platform, in operation with excite user's control of having reinforced anastomosis apparatus in the anastomat device.

The nail anvil of the anastomat device of the present invention nail anvil in field compared to existing technology is more elongated, and the elongation of this anvil axle has some advantage compared to existing technology.

For example, longer anvil axle has been arranged, the easier operation nail anvil of user, and the butt joint operation can be in anal canal or external execution.

The axle of elongation also makes the surgeon perhaps to make the surgeon clip nail anvil in vivo and again the anvil axle to be taken to anal canal portion or external at anal canal or the external nail anvil that clips.This makes the surgeon see that more clearly nail anvil is docked to nail anvil butt joint pin.The axle of elongation makes that also the surgeon can be at the external joint fully of seeing nail anvil and anastomat.Therefore, the axle of elongation has visual advantage compared to existing technology.For the anastomat of prior art, the anvil axle is organized to be covered or surrounds, and locate make to be difficult to for the anvil axle or holds that this moves to suitable position with it with a firm grip.Yet the anvil axle that prolongs present invention can overcome this problem.

In addition, since the surgeon easier see see that so the surgeon is easier guarantees that nail anvil butt joint pin goes up finishing of the complete butt joint of anvil axle.The anastomat in prior art field relies on " click is rattled away " sound that can hear to confirm butt joint.By comparison, anastomat of the present invention additionally provides the visual determination that butt joint takes place.Therefore, anastomat of the present invention provides extra safety guarantee for the patient.

The anvil axle of this elongation for the butt joint of anastomat provide from the body to anal canal or external passage.The length of extending only is subject to the anastomat inner drive shaft and docks the modification that the motion (contraction and stretching, extension) of the anvil axle turnover anastomat of pin and joint is made for the improvement nail anvil.

Before the extension anvil axle of realizing present invention, because the intrinsic limitation of prior art anastomat, implementing anal canal or external nail anvil is impossible to the butt joint that nail anvil docks pin.

Even because anastomat device of the present invention still allows establishment to have coincideing of anal canal or external butt joint under the situation of low Low Level excision and coincide in about 2 to 10 cm range in anus edge (as the APPEAR technology), therefore, it allows to excise one section bigger intestinal of excision under the sphincteral prerequisite.For example, under the situation of ulcerative colitis or rectal cancer, can excise the intestinal of big section, to avoid retaining rectal lesion, keep the defecation self-control simultaneously.

Nail anvil butt joint pin of the present invention can change length equally to adapt to the anvil axle of different length.Usually, nail anvil butt joint pin stretches into anastomat, when observing anastomat from the side (as shown in Figure 2) like this, has only one section nail anvil butt joint pin as seen.The diameter of this nail anvil butt joint pin makes nail anvil butt joint pin can insert the anvil axle less than the diameter of anvil axle.Especially, the diameter of nail anvil butt joint pin smaller or equal to the inner chamber 241(of anvil axle 240 as shown in Figure 4).In a preferred embodiment, the longitudinal axis of this nail anvil butt joint pin and anastomat be coaxial or substantially coaxial (for example, one section distance that is equal to or less than nail anvil butt joint pin width or diameter at interval, perhaps at interval any segment distance and make the seam nail around nail anvil butt joint pin, can have suitable space to distribute).

Nail anvil butt joint pin of the present invention can be blunt nosed, also can be the sleeve pipe syringe needle.The nail anvil of sleeve pipe syringe needle butt joint pin, as shown in Figure 4, have can penetrate tissue advantage.For example, when when low rectal create to coincide, may use suture or this rectum stump of seam nail sealing, the nail anvil butt joint pin of this sleeve pipe syringe needle can be used for penetrating rectum apical stitch line and dock with nail anvil.This placement of having guaranteed anastomat makes the seam nail that distributes can pass the far-end stump simultaneously and to link colon on the nail anvil with mode such as purse string suture in place.

The seam nail of stitching devices distribution can be arranged to arranging of circle substantially.This seam nail is arranged with reference to stitching thread.The suitable placement of seam nail can be so that they aim at the circumference of circular seams zygonema.Perhaps, they can aim at the radius of circular seams zygonema, perhaps aim at this circular radius and certain angle between circumference.May there be multirow seam nail, for example 2,3,4 or 5 row seam nails.In certain embodiments, the robotic suturing device seam nail annular that has optional two row, triplex row or how coaxial row is installed in the anastomat housing.

The shape of trigger 112 can be for shaft-like, as shown in Figure 2.In such embodiments, excite trigger will impel stitching devices to start in the mode of mechanical force or mechanical energy running.Perhaps, this trigger can be a button, can impel stitching devices to start automatically, for example, uses the electric energy of intraware.

The best user of the grip region of anastomat and spanner can trigger spanner simultaneously when holding the grip region of anastomat with a firm grip.For example, shown in Figure 2, spanner (being control stick in embodiment illustrated in fig. 2) invests the middle part of anastomat, and grip region can be to the proximal extension of anastomat.

In certain embodiments, the far-end of anastomat also comprises a constriction device 114, as shown in Figure 2.The user can rotate this constriction device makes nail anvil butt joint pin (and nail anvil, if nail anvil and nail anvil butt joint pin joint have closed) oppositely be recovered in the stapler main body along the longitudinal axis of anastomat.If nail anvil docks pin joint with nail anvil and closes, this will cause the anvil head to shift near stitching devices.Nail anvil 200 shown in Figure 7, fully and anastomat 100 engage and be fully retracted in the anastomat.The arrangement of anastomat device assembly can be so that the tissue that is sewn sinks between anvil head and the stitching devices.The tissue that is sewn is trapped in or is fixed on the seam 250 of nail anvil 200 and stitching devices 150.When using this equipment in operation, because the seam 250 between anvil head and stitching devices has one deck or a few layer tissue that needs processing, so the anvil head does not directly contact each other usually with stitching devices.

By rotating constriction device in the opposite direction, nail anvil butt joint pin (and nail anvil, if nail anvil and nail anvil butt joint pin joint have closed) can in anastomat, remove.In addition, the user can take off nail anvil from nail anvil butt joint pin easily.

In a preferred embodiment, only the rotation constriction device anvil head is moved on to be absorbed between anvil head and stitching devices near stitching devices and the tissue that is sewn after, just execution excites the operation of trigger.

Constriction device can reach the purpose that guiding nail anvil butt joint pin enters anastomat in the mode that is fit to arbitrarily along the longitudinal axis, for example, in the stapler main body constriction device is linked the bar of nail anvil butt joint pin, no matter is directly or by indirect assembly.This bar may have screw thread, makes can not cause rotation to nail anvil butt joint pin when nail anvil butt joint pin shunk anastomat.Can exist other contractile mechanisms apparent to one skilled in the art.

Above-mentioned constriction device can comprise that it is easier to make the user rotate constriction device from the groove of the outward extending flange of constriction device and/or incision constriction device.Constriction device 114 shown in Figure 2 comprises makes the user rotate the easier groove of constriction device.

For anastomat of the present invention, excite trigger will impel stitching devices to start.In certain embodiments, in use placing this device consequently needs one of them surface of stitching to be connected with nail anvil by anvil head.Place with respect to stitching devices so that stitching devices connects these two surfaces by the seam nail after starting on another surface that needs to sew up.Select excellently, the surface that sew up remains on the seam 250 of anvil head and stitching devices.

Be among the embodiment at some, lack constriction device, excite trigger to impel nail anvil butt joint pin (and nail anvil, if nail anvil and nail anvil butt joint pin joint have closed) to move towards the near-end of anastomat, then stitching devices starts.

In some embodiments of the invention, be circular substantially in the anvil head cross section of transverse plane, its diameter is according to the difference of the tissue that will sew up and difference.For example, the diameter range of anvil head can be 10 to 50 millimeters, more preferably, and 20 to 35 millimeters.In certain embodiments, the diameter of anvil head is 21,25,28 or 32 millimeters.

In certain embodiments, nail anvil has color mark, for user provides instant visual information about anvil head diameter.Usually, the diameter of anvil head is corresponding with the diameter of stitching devices, makes that anvil head and stitching devices can align when nail anvil butt joint pin took in the anastomat.This anastomat also can have corresponding color mark, for user provides diameter information about anastomat.The diameter range of stitching devices can be 10 to 50 millimeters, more preferably, and 20 to 35 millimeters.In certain embodiments, the diameter of anastomosis tool is 21,25,28 or 32 millimeters.

In some embodiments of the invention, anastomat also comprises a safety catch 116, as shown in Figure 2.This safety catch is pulled by the user, and can oppositely arrange and make it in running order.When this safety catch has been set up, it will prevent that trigger from being excited by the user.Therefore, this safety catch can prevent that anastomat from being triggered because of carelessness.When this safety catch in the time of the free time, trigger can be excited, so stitching devices also can be activated.

Above-mentioned stitching devices comprises seam nail groove and the driving blade that an anastomat housing, an annular or cylindrical blade, a row circumferentially arrange around the annular blade outer surface.This annular blade and driving blade are movably in the direction of the parallel anastomat longitudinal axis substantially.The diameter of stitching devices typically refers to the diameter of anastomat housing.

When using this anastomat device, seam nail groove is equipped with the seam nail.The seam nail that anastomat device of the present invention uses comprises a deformable continuous metal or plastic sheet usually.The metal that this is continuous or plastic sheet are bent to form nail titled with reaching two sharp or sharp keen nail lower limbs being preced with perpendicular to this nail substantially.This nail lower limb pierces through the tissue that will sew up.Length of these nail lower limbs have determined the height of seam nail, and the difference of the thickness of tissue of sewing up as required and difference.For example, the length (determined seam nail height) of nail lower limb comprises 2,3,4,4.2,5.6,7,8,9,10,15,20,25,30,35,40 and 50 millimeters, preferably, and between 2 to 30 millimeters, between 3 to 20 millimeters or between 4 to 15 millimeters.Be installed on the anastomat when stitching nail, this nail lower limb points to the far-end of anastomat.

The length of above-mentioned nail hat also can be different, and for example, the length of nail hat can be 2,3,3.8,4,5,6,7,8,9,10,11,12,13,14 or 15 millimeters.Preferably, the length of nail hat is between 3 to 15 millimeters or 3 to 10 millimeters.The length of nail hat has determined between the nail lower limb distance each other.

Above-mentioned seam nail can be made by any suitable material, for example other metals or the plastics of titanium, titanium alloy (as Nitinol, be also referred to as Nitinol, it is the alloy of titanium and nickel), rustless steel or suitable operation purposes.In addition, also can use biodegradable seam nail, for example, mainly be made by the polylactic acid prescription.

Above-mentioned seam nail is initially " U " shape or similar shape before use usually, for example rectangle or square, and its centre joint nail forms rectangle or foursquare three limits (for example, the nail lower limb arranges substantially perpendicular to the nail hat).

When user excites the trigger 112 of anastomat 100, annular blade and seam nail will stretch out from the anastomat housing.The seam nail stretches out under the promotion of far-end driving blade, and one or more layers tissue or the material that is positioned at anvil head and stitching devices interface place 250 discharged and passed to the seam nail along the longitudinal axis of anastomat.The nail lower limb of seam nail pierces through material or the tissue that will sew up.In case the seam nail has pierced through material, the nail lower limb is pressed to the anvil head and is made that the seam nail is inside or outwardly-bent, and keeps the seam nail in the fixed position.The nail lower limb can bend to parallel or be parallel to the nail hat substantially.When the nail lower limb curves inwardly, will form typical " B " shape, identical with many seam nails that once used.The seam nail forms flat by the distortion of extruding nail anvil, and tissue or material layer are linked together by flat seam nail.

In the actuating or emission process of stitching devices, above-mentioned annular blade or trepan will advance along the longitudinal axis of anastomat, the tissue that the resection and anastomosis device is related or material.Therefore, an annular or discoid tissue will be excised by anastomat.After removing, this anastomat device will between the surface that is stitched together or tissue, set up a continuous inner chamber.For example, this can keep the cavity that an Excreta can be passed through simultaneously so that one section intestinal is attached to other end intestinal or rectum stump.In addition, this annular blade can be created one and make mouth between inner chamber (as perineum chamber or gastrointestinal tract inner chamber) and body surface.The diameter of this annular blade is followed closely the diameter that groove is arranged less than driving blade and seam, and therefore, only the end tissue in stitching thread can be cut.Stitching thread is stayed intactly to guarantee that two surfaces link together.

The stitching apparatus that is suitable for anastomat device of the present invention is described in detail in US 4576167 and US 5758814, and this part content will be incorporated into the present invention with for referencial use.

In addition, when using this equipment, can between being sewn to together two organized layers, needs place reinforcing network or other reinforcement materials.Optionally, or additional, this reinforcing network also can be provided in want suture tissue above or below.Because the seam of using nail passes organized layer and reinforcing network, this reinforcing network or other materials have been strengthened coincideing or making the shaping that choma bores.This net has also improved the sealing between two organized layers, helps to prevent that the material in any organ lumen from leaking in the body cavity.Reinforce webpage and help to prevent adverse consequencess such as the other hernia of colonic diversion.

This net can be made by any suitable material, as synthetic or biomaterial.When this equipment of operation, this net will be placed on before stitching devices starts on nail anvil butt joint pin or the anvil axle.

This Netcom is often wideer than the width of anvil head and stitching devices.This guarantees to stitch nail can include this net in.This net can be any suitable shape, and is for example, circular, square or avette etc.If this net is circular, diameter that so should net is usually greater than the diameter of this nail anvil and/or this stitching devices.Usually, this net has suitable size and shape to cover wholely to coincide or make choma and bore periphery.

The synthetic material that is applicable to this net comprises polyethylene, polyester and politef (PTFE, for example, compression, that expand or electrospinning).Polypropylene has stability, tenacity, inertia and good handling.Polypropylene net is made of the polypropylene fibre that is arranged in the net with different size aperture.The PTFE netting gear has slickness, flexibility, tenacity and favorable tissue growth property.

Biological net comprises the pericardium that takes off from cattle, pig and horse etc. on one's body, or other organ-tissues such as dermal tissue.

In one embodiment, above-mentioned anvil axle can comprise one or more circumferential notch 242, as Fig. 4 and shown in Figure 8.This makes at the easier nail anvil of catching of intra-operative, and more flexible and more continuous movement is provided between user and nail anvil.Therefore these breach are used by tool for gripping.This anvil axle can comprise one or several breach, for example 2,3,4,5,6,7,8,9,10 or more breach, and so that above-mentioned advantage to be provided.For example, this anvil axle can comprise 1 to 2,1 to 3,1 to 4,1 to 5,1 to 6,1 to 7,1 to 8,1 to 9 or 1 to 10 breach.These breach can for example form annular groove along circumferentially being fully extended of anvil axle, and perhaps they may be limited in the end circumference of anvil axle (as Fig. 4 and shown in Figure 8).This breach can occur in pairs, so that they need not circumferentially extend around whole anvil axle, but they need alignment, make them just be positioned at the relative both sides of anvil axle.An anvil axle can comprise 1,2,3,4,5,6,7,8,9 or 10 pair, or 1 to 2 pair, 1 to 3 pair, 1 to 4 pair, 1 to 5 pair relative breach.

In embodiment further, as shown in Figure 4, this anvil axle 240 can comprise a visual windows 246.This nail anvil butt joint pin 130 also can comprise a butt joint indicant 132.When nail anvil 200 docks pin 130 butt joint fully with nail anvil, can see butt joint indicant 132 by visual windows 246.Fig. 6 and 13a have showed that the butt joint of nail anvil and nail anvil sells out under the situation of full joint, see butt joint indicant 132. by visual windows 246

This visual windows is learned nail anvil for user and is provided information with engaging of anastomat.This visual windows and butt joint indicant only be set to when nail anvil with after anastomat engages fully, user could be seen this butt joint indicant by this visual windows.The combination of the anvil axle of this visual windows, butt joint indicant and elongation compared with prior art has more advantage, because the appearance of anvil axle of elongation makes anal canal and external butt joint more convenient, and when using this anastomat device, surgeon or other user can be seen this visual windows and butt joint indicant.

This butt joint indicant can be a visible labelling that docks other parts differentiations of pin with nail anvil.For example, this butt joint indicant can be nail anvil butt joint pin colouring (as redness) one section, making can provide visual confirmation fast when nail anvil docks with anastomat.This butt joint indicant can extend to the whole circumference of nail anvil butt joint pin, even relative the rotation sold in nail anvil and nail anvil butt joint like this, still can see the butt joint indicant by this visual windows.This butt joint indicant is positioned on the nail anvil butt joint pin, and so only with being docked to fully when nail anvil in the nail anvil butt joint pin, the butt joint indicant just aligns with visual windows.

This anvil axle 240 can comprise a visual windows (as Fig. 4 and shown in Figure 8, in Fig. 8, nail anvil has rotated 90 °, therefore can't see visual windows).Optionally, this anvil axle can comprise a plurality of visual windows, for example, 2,3,4,5,6,7,8,9 or 10, or more, can see the butt joint indicant when making the anvil axle dock with nail anvil to sell out full joint.Therefore this anvil axle can comprise 1 to 2,1 to 3,1 to 4,1 to 5,1 to 6,1 to 7,1 to 8,1 to 9 or 1 to 10 visual windows.Optionally, this anvil axle can comprise one section transparent or semitransparent material, can see the butt joint indicant when making the anvil axle dock with nail anvil to sell out full joint.Therefore " visual windows " of citation comprise that part transparent or semitransparent on the anvil axle is as hole or the opening of anvil head side reality.

In one embodiment, because nail anvil butt joint pin will be inserted in the anvil axle, so nail anvil butt joint pin further comprises a holding device 134, when nail anvil docks with nail anvil when selling out full butt joint nail anvil reversibly is fixed on the appropriate location.This anvil axle comprises an inner chamber 241 that is suitable for receiving nail anvil butt joint pin.Fig. 4 showed nail anvil 200 alignment of the present invention and preparation dock with nail anvil the pin 130 the butt joint.Figure 24 is inserted into the cross-sectional view of the inner chamber 241 of anvil axle 240 for nail anvil butt joint pin 130.

This holding device can show as narrow and wide portion of the nail anvil butt joint pin that links to each other with narrow of anvil axle inner chamber.The shape of this nail anvil inner chamber is docked the shape complementarity of pin with nail anvil, therefore, when nail anvil docks with nail anvil when selling out full joint, narrow of anvil axle inner chamber docks narrow of selling and aligns with nail anvil, cause nail anvil to be detachably fixed to the position.

As shown in Figure 4, this holding device can comprise the outside holding device 248 that is positioned on the anvil axle and be positioned at the inside holding device 134 that the nail anvil butt joint is sold.This outside holding device can be a section of anvil axle, and when aliging with outside holding device from the radially outer power in anvil axle center, the circumference that this outside holding device is crossed the anvil axle oppositely extends.This outside holding device is also corresponding with narrow of anvil axle inner chamber.For example, when inner holding device 134 comprises narrow of nail anvil butt joint pin and wide (as shown in Figure 4), and this nail anvil butt joint pin docks with the anvil axle, and the narrow portion of these anvil axle 240 inner chambers 241 causes the holding device 248 of anvil axle 240 pushed outwards.When inner holding device 134 pushes through the narrow portion that is located at anvil axle inner chamber 241 on the outside holding device 248, this outside holding device is got back to its initial position, with the side in alignment of anvil axle.Externally narrow of holding device 248 locational anvil axle 240 inner chambers 241 with corresponding at narrow of the diameter of inner holding device 134 locational nail anvils butt joint pins, thereby make this nail anvil be detachably fixed to the position.

Such holding device is sometimes used the click spring berthing mechanism.It is apparent can using other holding devices for those skilled in the art.

Except nail anvil reversibly is fixed on the appropriate location, this exist holding device another benefit be can send audible sound when nail anvil engages with anastomat, for user confirms that nail anvil provides auditory information with engaging fully of anastomat.

This holding device makes that also nail anvil can not come off from anastomat when operation anastomat device.Therefore, this holding device is a favourable security feature of this anastomat.

Preferably, above-mentioned anvil head has circular cross-section at transverse plane.This anvil head comprises two apparent surfaces 222 and 224.One the center of anvil axle from these two surfaces stretches out, and vertically or substantially perpendicular to the plane on the surface of extending the butt joint pin.Therefore an end of this anvil axle links to each other with the anvil head or integrates with the anvil head.In certain embodiments, this anvil head comprises a flat surface of extending the anvil axle.Its facing surfaces is arc, taper or taper shape.Usually the shape of anvil head is modelled as, by intestinal cutting operation (entering the surgical incision of small intestinal) or when passing through the own channel operation nail anvil of hollow organ (as stomach, intestinal, esophagus or other hollow organs), and for nail anvil provides Non-Invasive top,

Alternatively, one among the

apparent surface

222 or 224 can be concave surface, and another is convex surface, and these two apparent surfaces are complementary mutually, and the thickness of anvil head is by these two apparent surfaces' distance decision.In this embodiment, the anvil axle extends from the center of concave surface 222.Usually, at least part of concave surface is flat, and to dock pin joint fashionable when anvil axle and nail anvil, and it is perpendicular to the longitudinal axis of anastomat.

The anvil head surface 222 that extends the anvil axle comprises a plurality of recesses or pit usually, and when nail anvil docked in pin joint merging and the nail anvil butt joint pin withdrawal anastomat with nail anvil, it alignd with the seam nail groove of stitching devices 150.It is inside or outwardly-bent that these recesses cause stitching devices to start back seam nail.Therefore, in case passing, seam ailing lower limb needs the tissue sewed up and inside or outwardly-bent by nail anvil, this seam nail is fixed in position, and two tissues are fixed together (for example, create when coincideing or establishment is made the choma of sewing up in the journey of making a slip of the tongue of making and bored two inner chamber internal organs in creating).Recess on anvil head 222 surfaces can be shaped by modes such as mechanical compaction or engravings.

In one embodiment of the invention, the anvil axle also comprises hollow channel 221, as shown in figure 24 except comprising the inner chamber 241 that is suitable for receiving nail anvil butt joint pin.This hollow channel can extend and pass the whole thickness of anvil head 220 from the inner chamber 241 of anvil axle 240, ends at the hole 223 on anvil head 220 surfaces 224.This anvil axle can comprise a plurality of such passages, and each passage ends at holes different on the anvil head surface 224.Alternatively, this nail anvil 245 can comprise a hollow channel in the anvil axle, and it tells a plurality of or network channel at the anvil head, and each passage ends at a hole of anvil head surface 224.Figure 24 has showed nail anvil 245 according to an embodiment of the invention, and wherein, this nail anvil comprises hollow channel 221, and it tells a plurality of passages, and each passage ends at the hole 223. on anvil head 220 surfaces 224

When nail anvil 245 was attached on the aspirator 225, these passages made air can pass through the anvil head.When application of suction to nail anvil, use aspirator to cause to organize reversibly to inhale by above-mentioned passage and link the anvil head, this nail anvil can be used for handling biological tissue or other materials.This suction can cause vacuum, has promoted to be organized into the reversible adsorption of anvil head.When the tissue place maybe can use in place, for example, pliers or other surgical devices or surgical finger can remove this suction so.

This aspirator can have accessory 227, and it can be coupling with the mode identical with nail anvil butt joint pin and anvil and close.This nail anvil 245 can comprise sealing gasket 229, and it provides hermetic seal at aspirator and nail anvil interchannel.The sealing pad can place in the anvil head a plurality of passages to converge the place of making a passage, and when this aspirator engages with nail anvil, it also can down place the terminal of anvil axle aspirator accessory.

Alternatively, this nail anvil butt joint pin 130 also can be equipped with one or more hollow passageway 136, as shown in figure 24.Should in mouthful passage make inhaled air can pass this nail anvil butt joint pin to pass passage 221 and hole 223 on the anvil head 220.Therefore, close when nail anvil docks pin joint with nail anvil, anastomat can be linked aspirator, engages with anastomat even work as nail anvil, also can operate tissue to be processed.As shown in Figure 25.Anastomat 100 of the present invention is linked on the aspirator 225, and this aspirator sucks air by the central passage 136 in the nail anvil butt joint pin 130 and makes air flow through this nail anvil butt joint pin 130.

Preferably, have among the embodiment of one or more passages at some anvil heads, this aspirator is controlled, and it can be various therefore using structural a large amount of application of suction, and prevents the damage (to organizing atraumatic operation) to tissue thus.The operation of tissue is included in the various surgical operations movement and excision to organ in tissue and the human body, and for example, the preventing damaging fixed and put back to of the establishment midgut of making mouthful in stitching, the particularly correct orientation of intestinal are so that mouth is made in its external formation.Figure 26 has showed the operation to an end intestinal.

In having adopted an embodiment of anastomat device of the present invention, further comprised quantifier on the stapler main body, it sells the range information that is withdrawn in coincideing for user provides the nail anvil butt joint.When user rotation constriction device, this quantifier is sold the contract by distance length in anastomat along with this nail anvil butt joint and is moved up and down.This quantifier can comprise certain upper limit and lower limit.Be lower than this lower limit, then this nail anvil butt joint pin not have enough withdrawals and fixes in place so that seam is followed closely to be bent by the recess in the anvil head.Surpass this upper limit, then this nail anvil butt joint pin withdrawal too much and may cause damage to being positioned at two tissues that anvil head and stitching devices interface just handling.

In a preferred embodiment, this quantifier is positioned at the end of this anastomat, and therefore, when user was held this anastomat, the hands of user can not block this quantifier.

Anastomat of the present invention and stapler main body can be made by any suitable material known to those skilled in the art.For example, the material of making anastomat can comprise plastics (as polyamide, polystyrene, polrvinyl chloride, polypropylene, polyurethane, Merlon or polyether-ether-ketone), metal (as rustless steel or titanium) or pottery.Nail anvil also can be made by these materials.

A second aspect of the present invention provides the nail anvil 200 that is used for the anastomat device, and it comprises anvil head 220 and anvil axle 240, it is characterized in that the length of anvil axle is at least 4 centimetres.

This anvil axle is applicable to and receives nail anvil butt joint pin and it is engaged with surgical stapling.This surgical stapling is suitable for forming identical, and is generally the intracavity anastomosis ring applicator.

A third aspect of the present invention provides anastomat device of the present invention or nail anvil coincideing or making choma and bore application in forming.

Should coincide or make the choma brill can be formed in the patient's that can sew up any ideal surfaced or biological tissue.Suitable biological tissue comprises organ walls, entoderm, ectoderm, mesoderm, digestive tract, small intestinal, large intestine, duodenum, jejunum, ileum, caecum, colon, rectum, connective tissue, muscular tissue, epithelial tissue, stomach, esophagus, trachea, peritoneum, sheath of rectus abdominis, far-end rectum stump, endothelium, enteral skin, skin and stomach wall.Coincide or make the choma brill and can be formed between two or more above-mentioned biological tissues.For coincideing, two organize to have usually and can be combined together to form identical inner chamber.For example, coincideing may be formed between two intestinal of patient, or between intestinal and the far-end rectum stump.The identical end-to-end anastomotic that is commonly referred to like this.Make choma bore can be formed on patient's abdominal part or any want to form make the place that choma bores.

A fourth aspect of the present invention provides uses anastomat device of the present invention to form or create the method for coincideing between two surfaces or tissue, it comprises on the nail anvil 200 that first surface that needs are sewed up or tissue link the anastomat device, nail anvil butt joint pin 130 is engaged with anvil axle 240, lay anastomat 100 and make stitching devices 150 engage with the second surface that needs to sew up or tissue, excite trigger by the seam nail first and second surfaces or tissue to be linked together.This method can be referred to as to form between the inner chamber of first and second surfaces or tissue coincide, and also can be to coincide end to end.This inner chamber can be the intestinal inner chamber, and this depends on identical position.

In one embodiment of the invention, form the method for coincideing and further comprise the step of regaining the anvil axle by the stitching thread of second surface.This method can comprise that also operating a constriction device regains nail anvil butt joint pin in anastomat.This nail anvil can be attached to first surface (for example of rectum or intestinal section) by purse string suture or other any suitable methods well known by persons skilled in the art.

In using the embodiment of purse string suture, first tissue closely centers on the anvil axle in the mode of purse string suture, so the anvil head is wrapped into inner chamber of this first tissue.This anvil axle passes purse string suture and exposes in order to selling tapping into the nail anvil butt joint.Make this sutural material and comprise polydioxanone (PDS), polyglycolic acid, polylactic acid, nylon and polypropylene.

This anvil axle can be handled by tweezers.These tweezers can be used for regaining the anvil axle and make its stitching thread of crossing second surface, so first surface is pulled and crosses the stitching thread of second surface.After starting stitching devices, this stitching thread refers to the position of seam nail expectation.

In certain embodiments, second tissue can pierce through with the nail anvil butt joint pin of anastomat.Such nail anvil butt joint pin comprises a sleeve pipe syringe needle, and it is applicable to and pierces through second surface.This second surface is pierced about the position at circular stapler line (or the stitching thread of other suitable shapes, specifically arranging according to the seam nail of using) center greatly.This second surface comprises a hole or centers on the otch of stitching thread assigned address, and this method may further include uses stitching thread or closed this hole of seam nail, and the surgical stapling with band sleeve pipe syringe needle of the present invention pierces through this stitching thread then.For example, coincide when between one section intestinal or far-end rectum stump, creating one, before the anastomat that uses band sleeve pipe syringe needle or other instruments pierce through this far-end rectum stump, can use stitching thread or seam nail closed or excise this far-end rectum stump.Alternatively, can create an otch at the far-end stump (or its hetero-organization) at stitching thread center, in order to can catch and regain nail anvil by this otch.Can guarantee two surfaces (intestinal a section and far-end rectum stump) like this in the location at anvil head and stitching devices interface place, so that the seam nail can pass this two surfaces when starting stitching devices.

In case the nail anvil butt joint pin of band sleeve pipe syringe needle punctures second surface, in case perhaps the anvil axle is by the stitching thread retraction of second surface, nail anvil just can be docked on the anastomat.Using constriction device is optional operation (as required), excites trigger then.Therefore stitching devices is unlocked, and two surfaces are fixed together by the seam nail.The annular blade of stitching devices has also guaranteed between first and second inner chambers of organizing continuous inner chamber is arranged.

Reinforcing network can be provided on anvil axle or the nail anvil butt joint pin, on this net also is stitched into and coincide like this.This net can place between two surfaces or tissue that are sewn.Optionally, this net can place be sewn on the surface or under.In certain embodiments, use one or more net, for example, used 2,3,4,5 or more.

If used net, the annular blade of anastomat device will cut this net so, and making has continuous inner chamber between two surfaces of handling.For guaranteeing net fully in place, need to sew up the outer rim of net.

The step of setting the position of anastomat can comprise first and second surfaces are engaged with seam 250 between anvil head and stitching devices.This first and second surface sinks into and is processed between anvil head and stitching devices 150 surfaces 222, therefore works as by exciting trigger 112 to start stitching devices 150, and the nail lower limb of anastomat pierces through this surface and with the seam nail they connected together.Annular blade will be created a continuous inner chamber along the propelling of the longitudinal axis between these two surfaces or tissue.

Figure 10 has described to use anastomat of the present invention coincideing near creating in the intestinal at anus edge to Figure 13.

Figure 10 has showed the placement that is about to dock the preceding extension anvil axle of the present invention of operation.This nail anvil is placed via the purse string suture appurtenance in the near-end intestinal, moves it to perineum chamber by the anvil vice 370 that uses special repacking, and this anvil vice is set in order to catch the anvil axle along the direction of the parallel anastomat longitudinal axis with appendicular angle.Catch this anvil axle by one of them breach or breach along the setting of anvil axle to 242.Alternatively, can use the clamp of standard.This anvil axle is positioned on the far-end rectum stump 350 of reservation, and this position is in advance by linear stitching devices or stitching thread excision.

Therefore, the present invention further extends to clamp 370, and it comprises two at one end by the interconnective long element of flexible connector (for example hinge or pivot), and the other end of this long element is crooked.The part of this long element bending can be at 45 to 135 ° of angles (for example, 90 °) with the unbending part of this long element.This long element normally is mutually symmetrical.The curved end of this long element comprises one or more arc grooves, and wherein, the groove on the long element relative position is alignment mutually.Leaving certain gaps uncovered by the economic plan on clamp when this alignment makes this clamp of user closure, the groove that aligns in the long element is determining these breach relatively.This groove is suitable for holding the anvil axle of anastomat device of the present invention, can be reversibly when this jaws close fixing nail anvil.More optimizedly, this clamp is clamped the anvil axle by the breach 242 that is positioned on the anvil axle of the present invention.Preferably, long element curved portions degree can be so that the nail anvil that clamps moves along the direction of the parallel anastomat longitudinal axis.

When operating nail anvil in the surgical operation, suitable clamp provides greater flexibility for the surgeon.This clamp can be used in the steps such as above-mentioned joint and location.

Figure 11 has showed by tweezers 300 fixing, the withdrawal anvil axles that pass far-end rectum apical stitch line, and the anvil axle has been pulled through the intestinal otch of creating on the far-end stump.

Figure 12 a and 12b have showed that nail anvil fetches fully by far-end stump intestinal otch and expose external anal canal or external butt joint in order to anvil axle and anastomat.Clamp this nail anvil with the nail anvil pincers 370 that reappose, with firm and promotion butt joint.Figure 12 a and 12b have clearly showed butt joint indicant on the nail anvil butt joint pin and visual windows on the anvil axle, observe butt joint indicant by this window and can confirm whether butt joint is finished.

Figure 13 a and 13b have showed nail anvil and the nail anvil butt joint pin of butt joint fully, can know by visual windows and see nail anvil butt joint indicant.By exciting trigger that two tissues are linked together, then close this anastomosis apparatus, seam nail body shell is passed intestinal tube and is entered into the anorectal stump like this, notes passing through sphincter mechanism and anorectal stump 350 whole segment length simultaneously.Place in place when nail anvil and anastomat, it is identical to create to start stitching devices.

The unique property of equipment of the present invention and design make this nail anvil butt joint pin-anvil shaft assembly can be applied in the many aspects that have anatomic differences without restriction, for example, obese patient and other extra operations, for example, need be at the bariatric surgery of external joint close ailing anvil assembly and anastomat.

A fifth aspect of the present invention provides a kind of usefulness anastomat device of the present invention to form or create the patient on one's body and has made the method that choma bores, and it comprises:

Make the position of mouth in formation;

The nail anvil 200 of placing anastomat device of the present invention makes anvil head 220 enter in patient's body and anvil axle 240 stretches out otch; Anvil axle 240 is docked on the nail anvil butt joint pin 130;

Excite trigger 112 in the tissue that is sewn, to distribute a series of seam nails.

In certain embodiments, form the method for making mouth and can further comprise the step of using withdrawal anvil axles such as clamp by otch.This clamp is used for operating the anvil axle makes it pass the stitching thread that forms in the tissue of making the choma brill.This anvil head can be linked certain organ, surface or tissue, and for example one of intestinal or skin section, the anvil head just is included in the inner chamber of organ like this, and the anvil axle leans out from this tissue.Then, this anvil axle is prepared to dock pin joint with nail anvil and is closed.Therefore, method of the present invention can comprise and adopts purse string suture etc. by the anvil head nail anvil to be attached to step on the organ.

In an alternative embodiment of the invention, this method may be included on nail anvil butt joint pin or the anvil axle and use one or more reinforcing network.

As for the method for form coincideing, this net can be placed with any order, thus this net can be positioned on the tissue of stitching or under, when a plurality of organized layers need be stitched together, this net can be placed in these organized layers.If used net, the annular blade of anastomat device will cut this net, to guarantee to form to make between inner and this organ outside of organ that choma bores continuous inner chamber be arranged.Need to sew up the outer rim of this net, in order to be fixed in place.

In another embodiment of the present invention, form the step that the method for making the choma brill further comprises the constriction device of operating anastomat, be recoverable to nail anvil butt joint pin by this step, and nail anvil is engaged with anastomat.

Operation or location nail anvil may relate to the use of tweezers or clamp 370 in operation, or both the time use.

To cause the distribution of seam nail and will place anvil head and the fixation of tissue that the stitching devices seam is handled to be in the same place by this seam nail by exciting trigger to start stitching devices.Will be at internal cavity (for example abdominal cavity) and external formation trepan along the annular blade that the longitudinal axis advances.The distortion that distributes the seam nail by organized layer is fixed together, it is fixing to make the trepan periphery also obtain.

Figure 14 to 23 has described to create with anastomat of the present invention and has made mouth and change brill.

In open surgery, form make mouthful (or make mouth and change brills) excise from abdominal skin and subcutaneous tissue 400 to sheath of rectus abdominis 410 earlier usually one cylindric, as shown in figure 14.This sheath is opened a cross recess then, and rectus abdominis m. separates (Figure 15) along its single.Then introduce the nail anvil 200 of suitable size by opening abdomen.The diameter of anastomat and nail anvil depends on makes the diameter that choma bores the intestinal that finally runs through.

Then, insert tweezers 300 by the stomach wall trepan, make it pass posterior rectus sheath and peritoneum (Figure 17).These tweezers are used for gripping anvil axle and are designed to can not cause damage to the anvil axle.In certain embodiments, these tweezers are blunt, but enough sharp one penetrate the organized layer that it will be crossed.Therefore, when passing stomach wall, it can see that its tip is optimum.

In case gripping this anvil axle, nail anvil then will take out the trepan on appearing at stomach wall.

The clamp 370 of external use is in order to clamping the anvil axle, and is fixed, and helps the anvil axle to dock the joint of selling (Figure 18) with nail anvil on the stitching devices.Optional reinforcing network 138 is designed to circle, and its diameter is more than or equal to the diameter of nail anvil, and alternatively, when it prepared, a little breach can be created in its center.This this online breach back can be used for this net is inserted on the nail anvil butt joint pin 130, as shown in figure 18.

The anvil axle docks pin 130 and engages by clamp 370 grippings and with the nail anvil of anastomat.In case lock successfully, the operation pucker tool seals this reinforcing network, and is positioned at posterior rectus sheath and peritoneum (Figure 19) between anvil head and stitching devices.Then, excite trigger to start stitching devices, remove anastomat 100 again, and take away reinforcing network, posterior rectus sheath and the peritoneum of plate-like, stay the trepan 450 of the stitching of the accurate reinforcement of being determined by stitching thread 440.Then, the edge 139 of this net 138 is alternatively by being interrupted 0 PDS(polydioxanone) stitching thread or seam nail be sewn onto preceding sheath of rectus abdominis, and make it be adjacent to protheca and pass meat fiber separately fully around trepan (Figure 20).

Then, colon or ileum be by this trepan, and form in the mode of being used to have and to make a mouthful (Figure 21; Prior art is described the formation of making mouth, for example, and Keighley M.R.B and WILLIAMS-DARLING Ton N.S., " anal orifice and rectal intestine and colonic operation ", the third edition, Sanders AG,, chapter 5,175-278 page or leaf in 2008).

In laparoscopic surgery, make the choma brill and be formed under the posterior rectus sheath to open art as previously mentioned, but still keep pneumoperitoneum.If for an independent incision of abdominal wall is created in the specimen section, this anvil axle can insert the abdominal cavity and take out from abdomen in the mode identical with open art.If not this situation, the rectus abdominis m. meat fiber is recoverable to (as shown in figure 16), generates a little otch by the stomach wall trepan in posterior rectus sheath and the peritoneum.The venting that this causes the abdominal cavity naturally loses pneumoperitoneum.

Then, prolene suture or PDS purse string suture 445 will insert the edge (Figure 22) of the otch in peritoneum and the posterior rectus sheath.Use has the clamp 370 that takes out axle in the abdomen makes the anvil head of nail anvil 200 pass this otch, and pocket thorn 445 is firmly tied up on the axle 240 (Figure 23).

Then, alternatively, nets circular or other shapes are inserted on the anvil axle as mentioned above.Then, the anvil axle docks with nail anvil sells out into described joint, and the operation pucker tool is regained nail anvil butt joint pin (essential).

Before starting stitching devices, reproduce pneumoperitoneum usually, and the position of inspection trepan and sealing rifle is to guarantee not having certain section outside intestinal to be absorbed between the stitching main body of nail anvil and instrument.In case excite trigger to start stitching devices, this anastomat will withdraw, and make up in the mode of being used to have and to make mouth (Keighley and a WILLIAMS-DARLING Ton).

Reinforcing network is incorporated into this technology is developed by the inventor, it is called as SMART (sew up net and make a mouthful Reinforcement).The past research that net is incorporated into has directive significance to open surgery, and this Netcom crosses the abdomen route and is placed under the peritoneum.Though this technology is simple relatively, it has significantly increased the operating time, and is difficult to carry out peritoneoscope, and the reorganization that needs to stretch is knitted.Use anastomat device of the present invention can implement the SMART technology quickly and easily, and it is placed on net in the correct layer of stomach wall, to prevent adhesion.This technology is reproducible, can easily carry out in open surgery and laparoscopic surgery.This anastomat allows to make the establishment that choma bores, and has reinforced this with net simultaneously and has made the choma brill.It can be used for generating various types of mouths of making, and comprises generating in ileostomy and the colostomy making mouth.This SMART technology can also avoid organizing unnecessary stretching, has therefore reduced the sickness rate of hernia.

Use has the nail anvil 245 of one or more hollow channels, as previously mentioned and the suction shown in Figure 24 and 25 improve, helping to guarantee to constitute the intestinal of making mouthful can take out from trepan easily, and by correct guidance.Owing to entering the limited of abdominal cavity, therefore make in the interruption-forming at peritoneoscope in such operation, this strategy is difficult especially.

This method can be carried out in patient's (no matter being the mankind or non-human patients) body.This method can also be the stripped method that tissue samples is carried out.

Method of the present invention can adopt any anastomat device of the present invention.For example, this method can adopt the nail anvil 245 that comprises one or more hollow channels, and this hollow channel extends through the whole thickness of anvil head from the anvil axle.Therefore, this method may further include and aspirates the surface that is sewn by nail anvil behaviour or the step of organizing.To tissue or the surperficial operation that is sewn it is placed in place, is convenient to the formation that coincide or make mouth.

The 6th part of the present invention provides the kit that comprises anastomat device of the present invention, and preventer.This preventer is made by plastics, metal or other suitable materials, and it is placed in stitching devices and has in transport process between the nail anvil butt joint pin of nail anvil of joint.It is by preventing that thereby stitching devices from not pushed protection anastomat device by the anvil head and being without prejudice.This preventer can also prevent that stitching devices from being started because of carelessness, for example, in certain embodiments, has only when nail anvil butt joint pin shrinks one section sufficiently long distance of anastomat to start stitching devices.

This preventer can be columniform, and preferably, this preventer comprises a centre bore, can be connected on the nail anvil butt joint pin, makes nail anvil butt joint pin can pass the centre bore of this preventer.This preventer can also comprise a passage from the preventer outer to the preventer centre bore, even make and to have engaged when nail anvil, this preventer still can be placed into nail anvil butt joint pin and go up or remove from nail anvil butt joint pin.

A seventh aspect of the present invention provides the kit that comprises anastomat device of the present invention, and reinforcing network 138.Because the seam of using nail passes organized layer and this net simultaneously, so this net or other are reinforced material and can be strengthened coincideing of formation or make choma and bore.This net also can be reinforced the sealing of two organized layers, prevents that any material from draining to the body cavity from organ lumen.This net can be made by any suitable material, as synthetic material or biomaterial.

The synthetic material that is applicable to this net comprises polypropylene, polyester and politef (PTFE, for example compress, expansion or electrospinning).Polypropylene has stability, tenacity, inertia and good handling.Polypropylene net is made of the polypropylene fibre that is arranged in the net with different size aperture.The PTFE netting gear has slickness, flexibility, tenacity and favorable tissue growth property.

Alternatively, external member of the present invention may comprise anastomat device of the present invention, net and preventer.

External member of the present invention may further include operation instruction.This external member also may further include to handle the tweezers of anvil axle.For example, when the choma brill is made in establishment, can shrink the anvil axle by the otch on the stomach wall with these tweezers.In addition, these tweezers can help the butt joint of anvil axle and nail anvil butt joint pin.External member of the present invention can comprise clamp 370, or other property combination, for example, and anastomat device, preventer, net 138 and clamp 370.

In certain embodiments, this external member is aseptic.This external member also can be disposable.

Of the present invention second and the characteristic of follow-up aspect all be to make necessary modifications with reference to a first aspect of the present invention.

Embodiment

Will the present invention is described further with reference to following examples, these embodiment are just in order to illustrate the present invention, rather than limit the scope of the invention.

The low Low Level anterior resection of rectum on anterior perineum plane (APPEAR technology)

14 patients of typing, wherein, 7 is tumor, and 5 is ulcerative colitis, and 2 is traumatic rectal injury.Before art and postoperative median 2 years, the patient is assessed.

Among 14 patients 9 have accepted ileostomy and have reversed and experience at least one year follow up a case by regular visits to, and one of them patient waits for closure.Owing to make a mouthful perineum fistula, four patients do not consider that as yet ileostomy reverses.3 records that the transient state sexual dysfunction is arranged among 14 patients, but do not have the generation of diseases of urinary system.

When being that tumor or trauma patient are carried out the APPEAR operation, postoperative patient meta incontinence (Wexner) scoring is 5(scope 0-8, and n=6), average stool is 3(scope 1-8/ days).All cancers are all excised no local recurrence fully.For patients of ulcerative colitis is carried out restorative proctocolectomy, meta incontinence scoring is 2(scope 0-6, and n=3), on average every day, stool was 3(scope 1-5).SF-36 score (weighing 36 brief investigation questionnaires of quality of life) does not obviously change before the art behind closure of ileostomy, and after perineum was dissected, the anorectal physiological test did not change.

Therefore, but this APPEAR operation mouthful provides a kind of selecting technology for realizing that the low Low Level Operation of Remaining Musculus Sphincter is made, and this is impossible for traditional operation.This is a kind of promising new operation, even present situation also might reduce the permanent needs of making mouth.In operations such as APPEAR, use anastomat device of the present invention, allow nail anvil and anastomat intestinal tube or external joint, make the surgeon can be more clearly visible nail anvil and be docked in the nail anvil butt joint pin.The axle of elongation makes that also the surgeon can be at the external joint fully of seeing nail anvil and anastomat.

Sew up net and make a mouthful reinforcement technique (AMART)

The other hernia of colonic diversion (PH) has very high sickness rate.Three randomized controlled trials show that reinforcing network can significantly reduce its sickness rate.Yet this technology is very consuming time, is difficult to carry out in laparoscopic surgery, and relies on the manual stretching of trepan.SMART can address these problems.

SMART uses anastomat device of the present invention to create accurate trepan in posterior rectus sheath and peritoneum, simultaneously net circumferentially is fixed to trepan under peritoneum.Stretching minimizes.9 examples of randomized controlled trial (M:F 2:7,55 years old mean age, scope 24-77 year) PH high-risk patient, SMART(7 open surgery, 2 laparoscopic surgeries are carried out in taboo).

The disease that operation back (30 days) is not relevant with making mouth is sent out.So it is normal to make mouthful function in 48 hours.The intestinal obstruction irrelevant with making interruption-forming appears in patient back of leaving hospital, another patient provisional mouthful pain and swelling of making that happens suddenly behind the cardiopulmonary resuscitation of success.In 13 weeks (2-14) of following up a case by regular visits to, do not find the other hernia of colonic diversion.

SMART is that a kind of new simple accurately establishment in open surgery and laparoscopic surgery reinforced the method for making the choma brill, and it has reduced the sickness rate of colon pour hernie parastomiale.

Claims

1. anastomat device comprises:

(i) trigger;

(iii) stitching devices, described nail anvil butt joint pin and stitching devices are arranged on the far-end of anastomat; With

(b) detachable nail anvil, it includes anvil head and anvil axle,

Wherein, described anvil axle is suitable for receiving described nail anvil butt joint pin, and the operation of described trigger causes stitching devices to be activated, and it is characterized in that the length of anvil axle is at least 4 centimetres.

2. anastomat device according to claim 1 is characterized in that described anvil axle comprises one or more breach.

3. according to the described anastomat device of above-mentioned arbitrary claim, it is characterized in that described anvil axle comprises visual windows, described nail anvil butt joint pin comprises the butt joint indicant, when nail anvil docks with nail anvil when selling out full butt joint, can see this butt joint indicant by this visual windows.

4. according to the described anastomat device of above-mentioned arbitrary claim, the length that it is characterized in that the anvil axle is 6 centimetres to 20 centimetres.

5. according to the described anastomat device of above-mentioned arbitrary claim, it is characterized in that described nail anvil butt joint pin can be inserted in the described anvil axle, this nail anvil butt joint pin further comprises holding device, and when nail anvil docked the pin butt joint with nail anvil, described holding device was with the nail anvil fix in position.

6. according to the described anastomat device of above-mentioned arbitrary claim, it is characterized in that stitching devices comprises anastomat housing, annular blade, driving blade and a row or multi-row seam nail groove that circumferentially arranges around the annular blade outer surface.

7. according to the described anastomat device of above-mentioned arbitrary claim, it is characterized in that described anvil head is arc, taper or taper shape.

8. according to the described anastomat device of above-mentioned arbitrary claim, it is characterized in that described nail anvil comprises one or more hollow channels, described hollow channel extends through the whole thickness of anvil head from the anvil axle.

9. be used for the nail anvil of anastomat device, comprise anvil head and anvil axle, it is characterized in that the length of anvil axle is at least 4 centimetres.

10. the described anastomat device of any one claim of front or nail anvil are coincideing or are making purposes in the formation that choma bores.

11. use the described anastomat device of above-mentioned arbitrary claim to form the method for coincideing between two surfaces, it comprises:

The first surface of needs stitching is connected to the nail anvil of anastomat device;

Nail anvil butt joint pin and anvil be coupling close;

Anastomat is positioned, so that stitching devices engages with the second surface that needs to sew up;

Activate described trigger, in order to the seam nail first surface and second surface are linked together.

12. method according to claim 11 comprises that further the operation constriction device is retracted to step in the anastomat with nail anvil butt joint pin and the nail anvil that engages.

13. according to claim 11 or 12 described methods, it is characterized in that by purse string suture first surface being connected to nail anvil.

14. according to each described method in the claim 11 to 13, it is characterized in that: further comprise net is applied on nail anvil butt joint pin or the anvil axle.

Make the method that choma bores 15. use the described anastomat device of above-mentioned arbitrary claim in patient's body, to form, comprising:

In the tissue of needs formation making-port, form otch;

Nail anvil to the anastomat device positions, thereby makes the anvil head be positioned at patient's body and the anvil shaft extension goes out otch;

The anvil axle is docked on the nail anvil butt joint pin of anastomat; And

Excite described trigger, in the tissue that is sewn, to distribute a series of seam nails.

16. method according to claim 15 is characterized in that, further comprises the step of regaining the anvil axle by otch.

17. according to claim 15 or 16 described methods, it is characterized in that, further comprise net is applied to nail anvil butt joint pin or anvil axle.

18. according to each described method in the claim 15 to 17, it is characterized in that, further comprise the operation constriction device, nail anvil butt joint pin and the nail anvil that engages are retracted to the step in the anastomat.

19. according to each described method in the claim 11 to 18, it is characterized in that, described nail anvil comprises one or more hollow channels, and described hollow channel extends through the whole thickness of anvil head from the anvil axle, and described method further comprises the step of aspirating by this anvil head.

20. kit comprises according to each described anastomat device in the claim 1 to 9, also comprises safety device.

21. kit comprises according to each described anastomat device in the claim 1 to 9, also comprises net.

22. according to claim 20 or 21 described kits, it is characterized in that, further comprise clamp.

23. kit according to claim 22, it is characterized in that, described clamp comprises the long element of a pair of symmetry, this a pair of long element at one end is connected to each other by hinge or flexible connector, the other end of described long element be crooked and comprise one or how with relative long element groove opposite.