CA2617275C - Mechanical anastomosis system for hollow structures - Google Patents
Mechanical anastomosis system for hollow structures Download PDFInfo
- Publication number
- CA2617275C CA2617275C CA002617275A CA2617275A CA2617275C CA 2617275 C CA2617275 C CA 2617275C CA 002617275 A CA002617275 A CA 002617275A CA 2617275 A CA2617275 A CA 2617275A CA 2617275 C CA2617275 C CA 2617275C
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- Canada
- Prior art keywords
- arms
- applicator
- elements
- joining
- shank
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/115—Staplers for performing anastomosis in a single operation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1135—End-to-side connections, e.g. T- or Y-connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1139—Side-to-side connections, e.g. shunt or X-connections
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S227/00—Elongated-member-driving apparatus
- Y10S227/901—Surgical clip appliers
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S227/00—Elongated-member-driving apparatus
- Y10S227/902—Surgical clips or staples
Abstract
A system for making anastomoses between hollow structures by mechanical means is provided with a device in the shape of an annular or tubular element comprising circumferentially provided means, such as pin-shaped elements, for joining the abutting walls of the hollow structures together. An applicator is intended for moving said annular or tubular element in position and activating the joining means thereof, so as to make the anastomosis. Possibly, intraluminal joining means can be inserted without using an annular or tubular element.
Description
CA 2,617,27$
Agent Ref 68302J00005 ! 1ilfECNANICAL ANASTOMOSIS SYSTEM FOR HOLLOW STRUCTURES
Agent Ref 68302J00005 ! 1ilfECNANICAL ANASTOMOSIS SYSTEM FOR HOLLOW STRUCTURES
3 Background Of The tnvention 4 The present invention relates to a system for making anastomoses betwftn hollow structures by mechanical means, and also to a device and an applicator for use tftereuvith;
7 Such a system may for example be usedwi'ten making a bypass past narrowings or 8 ocdusidns of arteries caused by arteriosclerosis. There we now vaOous possibilities of 9 remedying such constrictions or occlusions.
11 tf the bdnstrictfori or occlusion takes t3tate in a coronary artery, the least radical nieihod 12 is to oitate the constfictit3n by means of aPTCA procedure (Percutaneous Traostuminat 13 Coronary Angioplasty), which may or may not be followed by the piacing or an intraluminal 14 stent. This is not always possible, however.
16 On theotherhar;d, as already mentioned befom, ~ is possible to make a bypass by 17 means of surgery. To this end an artery (artena marnmaria interna) or a vein fromthe leg (vena IS saphena magna) may be used, for example. An anastomosis 'rs thereby made in the coronary 19 artery, distally of the constriction or occlusion. The interconnection between the vessels is then manually sutured by means bf 8#o2Q stkhes. Said anastomosis rnay be a side-to-sicte or an 21 end-to-side anastomosis. The natural origin of the atteria maiinrn,aria interna is usually 22 preserved, so that such a bypass will directly be functional. A bypass made ofa vena saphena 23 magna will have to be sutured separately in the aorta (the so-oNled proximal anastomosis). Due 24 to the smali tliameter of coronary arteries (1 -3 mm), it is gene` raliy decided to stop the heart in order to be able to carry out the anastomosis precisely and safely. The blood ci:rculation is kept 26 going by a heart-lung machine during this time, Although this is a well-tried and reasonably safe 27 method, it has certain drawbacks. Thus, the use of the heart-lung machihe has a number of side 28 effects for the patient, as a result of which recovery following surgery takes more time.
29 Moreover, the necessary disposables for the heart-lung machine are costly:
31 At preserrt, techniques are available for a number of readily accesaibie coronary arteries 32 to make i<nanually sutured vascularbonnections to a beating, functiorting heart. Generally;: a 33 device which more orless immobilizes a small area of the heart by rriechanicat means is dsed 34 thereby. The clrawbactcs of said method are the fact that only a limited number of piarss on the 21851010.1 ~
,,.-.. . ,_ _ _ .. . , . .:...~_ _ _ CA 2:617,275 Agant Ref: 683021400U5 1 heart can be reached and the fact that part of the heart is temporatilyanaemic, because 'rt is 2 necessary to stop the circulation through the blood vessel to be treated far 8-15 minutes.
4 Sutnmarv ot'the Invention '1"''he object of the present inventign is to.,provide a system for making anastomoses 6 between hollow structures by mechan'tcal means, which wili make it..easier to make rnechanical 7 anastomoses.
9 In order to accompiistt that objective, the system sewrding to the inventlOn is characterized by a device in the shape of an annular or tubular eiement comprising joining 11 means provided circumferentialiy thereon for joining the abutting walls of #hf! hollow structures 12 together, as well as an applicator for moving said annular or tubUfar element in position and 13 activating the joining means thereof;
The system according to the invsr-tion makds it possitsie to effect an anaStomsr`s faster 16 and more eOsily by placing an annular or tubular element comprising joining nt$~ins with theaid 17 of said applioator, which joining means are also ac tivated by said applicator, in such a manner 18 that the anastomosis is made.
The system aocording to the irtveribon has a wida rang+a of applications, due to the fast 21 and accurate manner of making an anastornosis. Thus, the following sp.ptiqatiorts are 22 concei-rable.:
23 - "port access surgery" such as laparoscopio or thoracosoopic vascular 24 reconstructions;
- small, precise vascular connections to a MQVing 4rgan, as in heart surgery;
airxdj 26 vascular rsoonst:ructions whorein the circulation tt'iroughthe supp"g.
vessel'nnay 27 only be shut off for a very short period of time; as in rieurosurgery.
29 Of course, it is also possible to use the invention to make anastomoses txetwaerr other hollow structures.
32 The invention also comprises embodiments of devicesar-ci Oippticators lbr use in tt7e 33 above-tiescribed system for making anastomoses by mechanical means.
21851610:1 2 CR 2:617,275 Aorit RWf 683021Q0045 1 The device of the system according to the invertition can be used intraluminally as well 2 as extraluminally, and it can be adapted both for side-to-side enastomoses and for end-to-side 3 anastomoses. The joining means are preferably pin-sheped elements, whereby pairs of pin-4 shaped elements may be considered, which can function as staples, or independently operatng pin-shaped elements, which can be fixed to the uessel walls by being deftected, Preferably, the 6 tubular or annular elements for intraluminal use can expand from a smaller starting diameter to 7 a final joining diameter, whereby the joining means can be activated either automatically upon 8 expansion or individually. The elements may have a circular cross-seofion, but also an elliptical 9 cross-section, for example, so that the resulting enestonosis will also have a, circular or an elliptical oross-section.
12 The invention furthertnore comprises a method for meking:iritraltrminal side-to-side or 13 side-fo-end anas#omcses botwiseri hollcws#rix~tures by mechanical treans, which is 14 characterized by providing an applicator and associated joirring means for joiriinqthe abuft irig we11$ of the holiow structures together, placing said joining meerr~s round the appl'rcator, inserting 16 said applicator and said joining means iiito orte of said hollow structures to a locetiort fnterrtalRy 17 of the abutting walls of the hottow structures, and arotiveting said applicator, and tt'rus passing 18 said joining means through said abutting walls or clamping said joining means agains# sajcj 19 abutting walls for the purpose of keeping said sbutting walls in sealing contact w'ttn each other;
21 With this method, a number of loose staples may be used as the joining rrrneans.
23 Thus, in one aspect, the present invention provides an appiicator for use with a device 24 for intraluminally making anastompses between abutting walls of hollew structuresp the device incJuding joining efetnents toho1d the abutting walls of the hollow structures together, the 26 applicator comprising:
27 a staank-like e{ementY
28 a head located at a distal end of the shank-like element for supporting the device to be 29 positioned thereon and for activating the joining elarnents; the head being radially expandablet and having an axially c:ontra<tible elernent adapted to move the joining 31 elements af the device from a starting position to a joining position in order to ltold 32 the abutting wa11s of the hollow structures tcrgether;
33 a control element for corttrolfing the radial 8xpansipn of the head of the applicator, and 34 for controlling the axaatly~contractibfe element of the head;
218510t(k.i 3 CA 2,61,7.275 ~gdnF ~t+r~ 68302JOH?Q5 I whereinthe joining elements comprise a plurality of pin-shaped elements which 2 are provided in associated pairs on a hollow element, and each associated pair of the pin-3 sbaped elements has two free ends wWtch are spaced apart y-rhen the applicator is in a starting 4 posftion; and wherein the: a)(ially-contracfibta element of the applicator is adapted to move at least the free ends of each asso~ated pair.of pin-shaped elements towards each other to a 6 joining position, 8 In another aspect, the present inventiorr provides a system farconnecti:ng a first hoTfidvr 9 structure to a second hollow structure, comprising:
a connector including an element selected from the g.rtfup consisting of annular eiemerit 11 and a tubular olament that is expandable frorn a first diamater to a second, larger 12 diameter, and at least two deformable outer elements extending from the element;
13 and 14 an apptlcs:tor having a proximal end; adr'stal end; a longituatlinal axis;
:a movable element mfawable between at least a first posttion and a second position, the movabla:elernerkt 16 configured to expand the connector frorrt the first diameter to the:second diameter 17 when the connector is associated with the applicator when the movable e1emerd is 18 moved from the f<rst posifion to the second: position; and a slem at least parttaily 19 disposed about the mvable element of the applicator, the sleeve being movable between a first position and a second position whereby the sieeve causes at least a 21 portion of deformable elements of the conne-etor to deform outwardly away from the 22 longitudinal axis, and 23 wherein the at least two defo.rrnahle outer elements extend in a proximal direction when 24 the connector is associated with the applicator.
26 In and.ther aspect, the invention provides an applicator for use in a system including 27 joining elements for making an onastomasis between hoilaw struqturesj the applicator 28 comprising:
29 - a head provided with a plurality of arms, each the arm having aprvAmsil end and a distal end, and wherein each the arm is movable from a first posfflw at which th, e 31 distal ends of the arms are separated by a first distance which is Iess than a distmoe 32 of separation between the proximal ends of the amts when the arMs sre, in the fiOA
33 position, to a secohd pdsition, at Which the distal ends of the arms are separoteO by' 34 a second distance, the second distance being greater than the first distarice; and, zaas,n~o;~ 4-_.._ . . ,_ ,. _ .. ~....~ ~. ~..~ ,:,. ,~.. ,a . ,~..:.
CA 2,617,275 Agent Rof 683021OOD05.
1 - a shank iike element assoeieted with the head such that relative movement of the 2 shank-like element andthe head causes arms to move from the first oositiori toward 3 second position;
4 - wherein the distal ends of the arms ere adapted to hotd and positionthe joining elements for makiru,} an anastomosis between ft hollow structures, 7 In a further Aspact, the present invention provides a system for making anastomoses 8; between hollow structures by mechanical nneenns, the system comprising;
9 - a device in the shape of an annular or tubular element camprisirg cirwmferentie(ty provided joining elsarnents for joining the abutting waEis of the hollow strudtures together; and, 11 - an applicator for moving the anriular or tdbuiac element in position and activating the 12 joining elements, the applidetvr comprising:
13 - a head provided with apIurality of arms, each the arm having a proximal end and a 14 distal end, and wherein each ths arm is movable from a furst position at v~aioh the distal ends of the arms are separated by a first distance which is iess than a distance 16 of separation between the proximal ends of the arms whenttie arms are'in thefiwst 17 position, to a second position, at which the distal ends of the armsare separated by 18 a second distance, the second distance being greater than the first distance; and;
19 - a shank like element associated with the head such that relative movement of the shank-like element and the head causes arms to move from the first position toward 21 second pasition;
22 - wherein the dista{ends of the arms hold the joining eisments artti are adapted to 23: position the joining elements for making an anastorbosis: befween the hnl!Ãaw structures by 24 moving the distal ends of the arms from the first position to the second position.
26 Brief aescf-Iptfion of the Finurõs, 27 The int+etatioln will be exptaiired in more detail hereafter with referenoe to the drawings;
28 which show embodir'nents ofthe invention.
29 Fig. I is a perspective view of a first embodiment ofthe device for mking anastomoses 30, by mechanical mearts according to the invention, showing the startirrg position thereof.
31 Fig. 2 is a side view of thedevice according to Fig. I 32 Fig. 3 is an axial view of the device according to Fig. 1.
33 i~ig. 4 is a perspective view of the device corresponding with Fig, 1, wherein the device 34 is shown in the joining positidn, however.
, . _.
CA 2,617,275 Agent Rel` 683021000Q5 1 Figs. 5 and 6 are a side view and an axial view, respectively, of the device of Fig. 4.
2 Figs. 7-12 are views corresponding with Figs. 1- 6 of asecrsnd embodiment of the 3 device according to the invention.
4 Fig.13 is a side view of an applicator for use with the devic:e according to 'Figs. 7 12:
showing_the starting positiQn thereof, 6 Fig. 14 is a perspective view of the applicator of Fig. 13, with the device aecording to 7 Figs. 7- 12, which is shown in the starting.position thereof, in mounted position thereon.
8 Fig. 15 is a side view corresponding with Fig, 13, wherein the applicator is shown in the 9 joining position, however.
Figs. 16 - 21 are views corresponding with Figs.1 W 6 of a third embodiment of the 11 device according to the invention.
12 Figs. 22 - 24 are views corresponding wi#h Figs. 13 - 15 of an applicator for use wfth the 13 device according to Figs. 16 - 21.
14 Fig. 25 is a schematic side view, partially in sectional view, of an aitemative appkcator for use with the device according to Figs. 1- 6 or 7 - 12.
16 Fig. 26is a partial front viewof the appEicator of Fig. 25.
17 Fig, 27 is a view corresponding with Fig. 25, wherein the appticator is shqwn in the 18 expanded position, however, 19 Figs. 28 - 30 are sectional views and elevational views respectively aairrespondirv vvqtb Figs. 25 - 27 ofa variant ofan appl'rcator for use with a device aiccor'ding to Figs. 16 - 21, 21 Figs. 31 - 33 are perttiaily cut-away side views of another variant c?f the applicator, fot 22 example for use with a device according to Figs: 1- 6 orr 7- 12, shoWirtgthree diftereint positions 23 therecaf.
24 Fig, 34 is a side view of a variant of the extendible arms of the applicator of Fiq. 31.
Figs_ 35, 36 are perspectiue views of the applicator of Fig. 31, stfowirig the two extreme 26 positions fttei=eof:
27 Figs. 37, 38'and 39, 40 are side views end perspective vi+sws:, respestively; of yet 28 another variant of the appiica#cr according to the invervtion for use wtth a device according to 29 Figs, 1- 6 or 7-12, for exampte, showing the two extreme positiorrs tilerreof.
3{f Fig, 41 is a high#y srhematic perspective view of blood vessels int$rcoonected by side-31 to-side anastomose vvith loose staples.
32 Figs. 1 -6 show a first embodirttent of aÃievice for making anastomoses between hollow 33 structures, in particular arterie"s or veins, by rrecharwicai tneans.
.. _,.. .
CA 2b17.275 Agent Ret U30214oQ05 I Do#aDed pesc.rigtiort gf the lnvent!<on 2 In the present case, the device ia. a one-pie<ae tubular or annular element "t.. Whioh is 3 made tsfa biocompatible and plasticaily defortnable material, for example a tantalum alloy oir 4 another material used in medical technology. Annular element 1, mAy be considered to be an assembly of two zigzag-like elongated elements 2 and 3 which extend substantiAtiy in 6 circumforential direction but not along the contour line, which elements are interconnected at the 7 facing vertices, thus forming a ring of diamond-shaped structures 4. Present on the verttces of 8 ft zigzag-like elements 2, 3 that face away from each other are pira-staaped elements 5, 6, 9 which arts provided with sharp tips 7Ot their ends facing away from annular element 1, whr~rein the tips 7 of two associated pin-sitaped elements 5, 6 forming a pair are direCted towards each 11 other. The pin-shaped elernents may be straight, but also curved or angular, fbr example, thus 12 formirtg staples which are G-shapeci, as it were, whilst the pin-shaped eiemer-ts may also be 13 shaped more like lips, Since annular element I isformed from elongated elements 2, 3, whose fength in 16 circ.umferential direction is greater than that of annular element I in the position as shaurn ira 17 Figs 't - 3, and since etements 2 and 3 are capable of sieÃorrnatidn, it is possible to expAnd 18 annular element I from the starting position as shown In Figs. `t - 3 to a final position, or joining 19 position, as shown in Figs. 4 - S. In said joining posi#ion, annularelement 1 has a dtameter which is associated with a diameter which is at most equal to the length of eiongated elements 21 2, 3, It would also be possibie, of course, to expartd annular element 1 only to a smaller 22 diameter.
24 As is apparent from a compadspri between Figs. 4- Band 1-3,, the diarnbnd-sfiapect structures 4 are deformed to a straighter shiape, seen in circumferential direction, where-n the 26 vertices comprising the pin-shaped elements 5, 6 have been moved closer together, st.tchthat 27 the points 7 of pin-shaped elements 5, 6 of one pair engage each oftr. This movement of 28 points 7 of pin-shaped elements 5 and 6 towards each other can be used for joirimg trgether or 29 clamping together the walls of the hollow structures for the purpose of making the anastorrtosis, as will be explained in rnor+s detail hereafter.
31 32 Since the joining means in the form of pin-shaped elemqr-ts 5, 6 comprising points 7 are 13 autc-maticalfiy a ctivated upon expansion of -annu1ar element i frt m thefirat start7ing diameter to 34 the second, iarger aaining diameter, it is possibteto use a very simpte aPptictitor, which consists 29851010;1 7 CA 2,617,275 Agent Ref 683021000p5 I of a shank-fike element for insertion and rnaniputation, at the distal end of Ywhiach a head is 2 present, whose diameter can be enlarged: The head may therefore consistof an inftatable 3 balloon, as is known from balloon catheters, or of a mechanically expandable head qr the like.
In this embodiment, the foilowing method is usedfor making an ansstorrrosis.
6.
7 In the case of a side-to-side anasttamosis,.incisions are made in the vessel to tae 8 bypassed and in the bypass at opposite bsationt. The applicator is inserted throuVh the open 9 free end of the bypass and passed through the incisions, possibly by maansof a guide wire.
Annular element I is thereby positioned so that one end of annular element 1!s positlorted in 11 one vessel and the other end of annular element is positioned In the oftr vessel, sothat pin-12 shaped elements 5 and 6 are positioned on either side of the vualls of the adjacertt vessals:
13 When expansion of the applicator causes annular element 1 to expand from the first starting 14 diameter to the second, larger joining diameter, annular element 1 is raclially, enlarged on ttte 1'5 one hand and axially shortened on the other end, whereir{ the pin-shape+d ai+sments 5 and 6 16 move together, eventually clarnping down the waCls of the vessels round the incisions, with 17 points 7 becoming fixed in the walls of the vessels. The faassao between the two vessels is 18 determined by the diameter of annular element 1, so that said element functions both toiceea 19 the walis of the two vessels together and to keep the passage open. When annular element I
has reached its joining position, the head of the applicator is reduced to a smaller diameter 21 again and the applicator is withdrawn from the bypass.lumen, after which theopen end of the 22 bypass is closed.
24 Figs. 7-12 show a second embodinrnent of the device for making an anastomosis by mecbanicai means, wherein annular element 1 is a single, sinusoidal, elongated element 8;
26 which expands in circu.mfarentiai direction. Just like the eiangafed elements 2 and 3 of the first 27 embodiment, the sinusoidal, elongated element 8 according to this second embodiment has a 28 tength dimension which is greater than the circumferential dimensiori of theanc-ufar element in 29 tMe startirtg position thereof, and said length dimension of element 8 is at loast equal to the circumferential dimension of the annular element in the joining position.
32 The sine sh" of elongated element 8is such that a number of vertices 9 is positioned 33 oentrstfy in annular element 1, seen in axial view, on which verticos 9 prn-shaped elemortts 10 34 and 11 are formed, with two pin-shaped elements 10, 11, which form a pair, being spaced. apart 2is5t09QA g _ _ , __ , CA 2,647,275 Agent Ftef 683021tHi405 1 at their free ends, seen in sixial view, and meeting on elongated eiement.8 attheir bottom ends.
2 P in-shaped elements 10 and 11 may be provided witha point or other projection 12 at their #ree 3 ends, on facing sides, so as to be fixed in:a vessel walt.
When said annular element I aocofding to Figs: 7 - 12 is expanded from the first starting 6 diameter to the second, larger diameter, the ends of the pin-shaped eternents 10, 11 of apa-r 7 are-not automatically moved together, so that it will be necessary to use an epplicatoi'=' Which is 8 capable of closing the pira-shaped elements 10, 11 prior to, simultaneously with or after the 9 expansion of annular element I so as to clamp down the wails of the adjacent vessels therebetween for making theanastamosis:
12 Figs. 13 - 15 show an embodiment of an applioator which can be useci for that purpose.
13 The applicator is provided with apreferabiyr rigid, shankAke element 73, omthe proximal end of 14 which means are pcovided for maniputating the applicator, such as a grip, and on the distel end:
of which a head 14 is formed. Head 14 is provided with two axially spaced-apart hubs 15, 16;
16 one of vuhich. for exarnpte hub 16, is capabte of axial movenner-t, which movement is con,trailed 17 from the proximal and of shank-like element 13. Rigid arms 17 are arranged:on hubs 15 and 16 18 irt a star-like fashion, wherein pairs of associated arms 17 of the trnro ttwias. 15 ond 10 present at 19 corresponding circumferential positions are pivotarliy interconnected: in a point some. distarilce away from their free ends. Arms 17 are also pivotally conneoed to hubs 15 and 16, with the 21 pivots extending tangentiaily with respect to shank-like element 13: In this manner crips are 22 formed, as it were.
24 Fig. 14 shows that annular efement 1 is piaced on thehead 14 of the applicator in suchd manner that pin-shaped elements 10 and 11 are positioned between ttm free.
enclsof arms 17, 26 past a pivot 18, as a resutt of which the arms are pressed outwards from the position shown ln 27 Fig. 13 to the position shown in Fig. 15 upon moven3ent of the hub, as a reauit of whieh 28 elongated element 8 is straightened to a shape which extends more in arcumferer?tiai t3iredion, 29 thereby enlarging thediameter, whilst the reduction of the angle between arms 17 of a pair of arms resuits in a reduced angle between pin-shaped slemer+ts 10 and 11, and the free ends of 31 pin-shaped elements 10 and 11 are moved together, eventually Llatnpi'ng the two walls of the 32 adjaoent vessels between them. The placement and removal of the appiicator is oarried out in a 33' manner which is oomperabie with the method described with referertce. to Figs: 1_ 8, 218510.10;9 9 . . . . .... _,..... ...,,s.:,.:.. .,., y..... ,..õe~ , . . .. ... . , ..
CA 2,617,275 Agok Ref: 68302100045 1 Figs. "{i~r - 21 show a third embodiment of the device acccardirtg to the invention, which 2 oan be used for intraluminal placement in the,oase of a side-to-side anaslcrmosis, but in 3 particular also for extrafuminal placement in the case of an ertd-to-sicfe anastornosis.
In this case, annular element 1 nsists of ra circular, elongated eiement 19, which i.s 6 circumferentially provided in a number pfi places with pin-shaped elements 10, which aXialiy 7 project to one side from said elongated element % Ttte pins may be providisd yrith- points 21 8 thereby, whilst the pin-shaped elements 20 may be flat, or possibly rotand or the 1ike. As is 9 shown in Figs. 19 -21, the pin-shaped elements 20 are in large measure berrt radially outwards in the joining positiort of the device; but they may a#so be bent tangentiaity;
12 In order to be able tddeform the pih-shaiped elements 20 from the starting position to the 13 joining pos9tton, the applicator according to Figs. :22 -24 is provided.
Also this applicator is 14 provided with a shank-like element 13 and a head 14, but in tt%is embodiment said head is provided with a detainer 23 in the form of a sleeve to be positiuned proximally with respect to 16 annular element 1, which is attached to<the head, and with defl.e.otor eleme,nts 24, which can be 17 moved at (east axially, but preferably axially aswel! as radiallyy, whidh deflector elements can be 18 manipalatad frorn the proximal end of shank-like element 13. Said deflector elements 24 consist 19 of a fixed hub 25, an axially movable hub 26 and arms 27 which are p'rvc>ted together and to hubs 25, 26, which arms can be brought into engagement with the pin-shaped elements Z0, and 21 which can be deflected from an aAal position to a radial position, wherein annular element I is 22 stopped by detainer 23.
24 When the device acpording to Figs. 15 - 21 and the applicator accordin.g:
to Figs: ZZ - 24 Zv are used for making a side-to-side anastoittosis, annular elemerit 1is plaaed intraluminally, and 26 the pin-shaped eiements 20 are passed through the vessel wags in places surroundir-g the 27 openings that have been formecf by ir-cisic-ns. When the pin-shaped elements 20 are, 28 subsequently bent radially outwards, it is no longer possible to remove annular element 1, 29 because elongated element 19 is positioned inwardly of the wall of one vessel and the radiatly projecting pin-shaped elements 20 are positioned inwardly of the wall of the other vessel.
32 tn the case of an and to-side anastomosis, the annular element 1 is stid over the bypass.
33 The bypass is everted round annraiar element I and the pin-shaped elements am p8ssed 34 through the wali of the bypass and through the wall of the vessel to be artastornosed tfor ..r.,..._ _ CA 2,617.275 AQOttt Ref 6$302100'3D5 I example the aorta). Pin-shaped elements 20 can be deflected by extension of the deflector 2 elements 24 of the applicator, and the vuails will be fixed with respect to each other.
4 Figs. 25 - 27 show a variant of the applicator according to i~igs, 13 -15 which is suitable for placing an annularaiement 1 of a device of the type as shown in Figs. 1-6 (shown at the 6 bottom of Figs. 25 and 27) or in Figs. 7-12 (shown at the top of Figs. 25 and 27). Also in this 7 embodiment, a#tead 14 is attached to the shank 13 of the applicator. Said head 14 possesses a 8 blunt end part 28 in this embodiment, which is fixed to shank 13 and also to a housirig 29. The 9 fixed connection between shank 13 and housing 29 is schematlcai#y illustrated by rrieansof pjn 30. A number of slots, eight in the illustrated embodiment, are circumferentially provided, in 11 regularly spaced-apart relationship, in end part 28 and in housing 29, Said slots 31 are wide 12 eriough for receiving wedges 32, w+herebyit is important that slots 31 in end part 28 have the 13 same angle of inolination as the distal front face 33 of wedges 32. Weog.es 32 are radially held 14 together by an elastic annular band 34. A control element 35 in the shape of a nollflw shaft which can be slid overshank 13 comprises a bev.elled frorit fiate.3fi at the distal era.tt, which is 16 capable of copperation w~th a: complementary bevel 36" on the proximal end of wedges 32. The 17 angle of inclinatian of bevel 36' and the front face 36 is smaller than that of the distal front face:
18 33 of wedges 32.
An annular element 1 positioned: in the applicator can be expanded from the starting 21 position to the joining position by pressing wedges 32 outwards. This can be effected by moving 22 control eDemen t 35 distally forwards, which control element presses wedges 32 outwards, via 23 bevels 36, with its inclined front face 36, whereby the directiortof the movement of v-redges 32 24 corresponds with the direction of front faces 33 and the cooperating surfaws of end part 28.
The combined axial and radial movement of wedges 32 causes the annular element 26 surrounding wedges 32 both to expahd radially and to be clamped together between the 27 adjacent housing surface and the wedge surface, as a result of which pira=st*sped elements 5. 6 28 and 10;11 respectively of anMufar element 1 are moved together, clamping the vessel walls 29 down between them. When controlelernent 35 moves back, the elastic band 34 causes wedges 32 to return to the starting position. Thus, the applicator can be wtthdrawn from annutar elemsrt 31 1 and be removed in a simple and reliable manner.
33 Figs: 28 - 30 show avariant of the applicator according to Figs. 22 -24, which can be 34 used in combination witl~==, an annular element 1 of the type accerding to Figs. 16 - 21. The head 2t851010.3 ,_ _ _ ...-...... ......:..,.W,.. ...:... ..........:..I... .. . ..... .. . .. .
CA 2,617,275 Agetnt Ref: 68302/00QQ5 1 14 of this variant comprises a hottow shaft 37, with ablunt end part 38 present atthe distart end 2 thereof. Reotanguter cpenngs 39 (eight, for example) are provided in regularly spaced-apert 3 relationship itt the circumference of hollow'shaft 37. Said hoik>w sie 37 can mo,ve a.ci2lly with 4 respect to a housing 40, whose distal end surface 41 can serve as an anvil for annular element 1. Wedges 42 are placed in opeKings 39, which wedgesare pivoted to tha hollow shaft by 6 means of restliently flexible plates 43, irlsuctt a manner that wedges 42 can move outwards 7 about a substantially tangentiai axis, from their starting lapsition (Fig.
28} in openingls 39 to a 8 joiningposition (Fig. 30) in the diredtion of housing 40. Said movement is efÃected by r-noving a 9 +controi element 44 in the form of a bar cflmprising a bevelled point 45 in forward direction, as a result of which the wedges are tilted atit.wards throogh 900, in which jaining position they ore 11 locked by. the circumference of said control element 44;When housing 40 is moved axially 12 forward with respect to hollow shaft 37, in the directiort of wedges 42, the piri4haped elements 13 20 ofannular element I will come into contact with the wedges 42, and the pin-shdped 14 eiements 20 will be deflected outwards in a desired manner by the specially formed cavitios 46 present in said wedges so as to fix annular element 1oftha device td the vesset walls< 1Nadges 16 42 wiil return to the starting position when corrtrdl Wemertt 44 is withdra"v-rn, and the applidatdr 17 can be removed. In prrir-cipte k would also be possible to effect direct deflection of pin-shaped 18 elements 20 through expansion of wedges 42.
19 20 F)gs. 31 - 35 show another variant of an applicator, which can for example be used for 21 inserting the device according to Figs. 1-6 or 7-12, The applicator is t'nerefore arranged for 22 effecting a radial expansion of annular element 1 of the device and subsequently clamping 23 together the joining means, such as pin-shaped elements 5,6 or 10, 11, in.axial direction or 24 defof'rming them in some other manner. The difference with the preoedirg embodiments of the applicator is the fact that the embodiment according to Figs. 31 - 36 is arranged for effecting the 26 radial and axial deformations of the device in two separate steps. First the annular elernent 1 is 27 radially expanded, and then the joining means are moved to thheir jaining position. The 28 advantage of this embodiment is the fact that the joining means are preuehted from closing 29 prematurely and thus missing part of the vessel wall.
31 ln Figs; 31 - 36, sherrk-fike element 13, head 14and detainer 23 can be distinguished.
32An end :p:ortion 47 having a convex end surface is formed on the distal end of shank-like 33 element 13, whilst end part 47 is wedge-shaped or oonisrat on proximal side 48. Besides shank-34 like element 13 and detainer 23, a third, relatively movable part 49 is provided, which car~ be 21951010:1 12 GA 2,617,274 Ag"Ã Ref 6$302J(lUS
1 moved both with respect to shank-like element 13 and with respect to detainex 23 from a contmi 2 position outside the body. Part 4$ andlor detainer 23 are prcumferentiaity, pprovided with a 3 number of radially extending slots 50 for movably accommodating, at least in part, an equal 4 number of arms 51. Arms 51 can move between the inrermost starting posftiota, in which they abut against a ccrr3ical surface 52 of mauable part 49, and an outermost joining poskion, in 6 which they abut against the inner wall of detainer 23 (Figs. 32, 33). Arms -51 camprise an 7 outwardly curved dettectinri: surface 53 nesr theic distal ends,.which istcs mate with pira-shi#ped 8 elements of annular element 1, which may be provided rocand arms 51, adjoicent{y to deft#ion 9 surfam 53. An elastic band 54 (see Figs. 35, 36) mayextertd through radiW
notches 55 present near the distal ends of arms 51, which band functions to cause arm's 51 ta spring back 11 to an inward pasition;
13 As is shown in Fig. 34, it is' also possible to use arrns which are inteFconneded by an 14 annular part 56 at their proximal ends instead of separate arms.51. This ane-piece.assernbty may for example be in the form of a plastic moulding, whereby the pivotirsg movement of arms 16 51 is made possibfe by the elastic properties of the relatively long arms.
Slots 50are no longer 17 required in this manner, since annular part 56 holds arms 51 in pcsition;
19 The operation of the applicator is as fotlcws. !n .the pasition as shown In Fig. 31, the applicator and the annular element I of the device, which is present thereon (not shown), am 21 moved to their destination, a,nd then the shank-like element 13 and the end part 47 are 22 withdrawn in proximal direction with respect to part 49 (or part 49 is e~d.ed), and arms 51 are 23 pressed radially outwards by the mating cooperatipn between the wedge-shap.ed proximal side 24 48 of end part 47 and the,associated wedge-shaped surfaces bf arms, tecouse arms 51 are supported against a shoulder of part 49 (see Fig.-32). Annular elernent 1 is ttweby deformed 26 radially outwards by arms 51 to a larger diameter. Detainer 23 is then moved relative to sftank-27 tike element 13 and part 49, as a result of which the end face of detainer 23 is moved in the 28 direction of the deflection surfaces and the joining means are deformed in such a manner that 29 the vessel v-ralis of the hollow structures are interconnecked. When shar>ic-1ike eiem:ertt 13 and part 49 are moved apart again, elastic band 54 wiii return arms 51 to their starting positiort as 31 shown in Fig. 31, 33 With the appiicator according to Figs. 37 - 40, the isqvolumatnt+ behaviour of some 34 elastic and readily defQrimabie material, such as rubber, is +stiiized for the radsai expansion of 21853010.1 13 CA 2,$1T,275 Agent Ref 663t)?1O0t106 I annular element I of the deviee: The axial compression of the materiat will resul# !n axial 2 conttaction and, if inward defvrrnation is not possible, to radially outw.ard expansion. !rt the 3 illustrated embodiment, an isovolumetric core 57" is provided, on which annular element I of the 4 device can be placed. Head 14 of said applicator furthermore comprises a sleeve 58 which is axially movable with respect to shank-like element 13, which sleeve comprises an end part 59 6 capable of cooperation with an end part 60 of shank-like element 13. Pivoted radial supports 61 7 are connected to the associated end parts 59, 60, they support circumferrsntially provided plates 8 62, wl'rich are held together by an associated elastic band 63, which also providss the return 9 force. By moving the end parts 59, 60 together, the plates 62 are moved from the original sloping position as shown in Figs. 38, 40 to an eventual joining positon as Shown inFigs. 37, 11 39, wherein said plates extend practically perpendicuiarly to shank-like element 13. The facing 12 surfaces of plates 62 are then capable of deforming the joining means upon further movement 13 of enwd parts $9, 60 towards each other when the isovolumetric cote 57 is compressed and ttie:.
14 annular element is expanded thereby and; as already mentioned before, the joining means are 16 moved to their joining position. This embodiment of the applicator Is suitable for dt'astic 16 miniatutisation.
18 Fig. 41 shows the result of a side-to-side anastomosis of two hotlow structures, such as 19 bloodvessels, wherein loose staples 64 are used as joining means torthe vessel r+valls: One of, the above-described applicators may be used, providingthat rneansare usod t&
holding the 21 staples 64 correctly spaced apart when said staples 64 are ber'rig inserted and rnoved to their 22 joining pflsition. Also in this embodiment the staples are placed intraluminally, whilst a guide 23 wire may be used for moving the applicator to its correct. position:
From the above it will have become apparent that the invention provides a systam for 26 making anasto.moses between hollow structures by mechanical means, by means of which 27 system an anastomosis can be made in a quick and reliable manner, as a result of which the 28 negative effects of an anastomosis for the.patit$nt are minimized and the system is suitable far 01 29 large number of applications.
31 The invention is not timited to the above-described ernbodimeft as shownin the 32 drawing, which can be varied in several ways within the scape of ttle istverttion. Thus, the 33 expandable version of ttedeitice might also be made of a resilient material or of a sh,ape-34 memorizing metal, so that the de"vir.e can move to the expantled pdsitiort without extemal forces CA 2,677,275 Agent f3ef. 6830210000S
1 being exerted when the device is being provided. The elongated eiements may not be ~ recognizable as such, but they may be encountered in a different type of sfructure, _,..._
7 Such a system may for example be usedwi'ten making a bypass past narrowings or 8 ocdusidns of arteries caused by arteriosclerosis. There we now vaOous possibilities of 9 remedying such constrictions or occlusions.
11 tf the bdnstrictfori or occlusion takes t3tate in a coronary artery, the least radical nieihod 12 is to oitate the constfictit3n by means of aPTCA procedure (Percutaneous Traostuminat 13 Coronary Angioplasty), which may or may not be followed by the piacing or an intraluminal 14 stent. This is not always possible, however.
16 On theotherhar;d, as already mentioned befom, ~ is possible to make a bypass by 17 means of surgery. To this end an artery (artena marnmaria interna) or a vein fromthe leg (vena IS saphena magna) may be used, for example. An anastomosis 'rs thereby made in the coronary 19 artery, distally of the constriction or occlusion. The interconnection between the vessels is then manually sutured by means bf 8#o2Q stkhes. Said anastomosis rnay be a side-to-sicte or an 21 end-to-side anastomosis. The natural origin of the atteria maiinrn,aria interna is usually 22 preserved, so that such a bypass will directly be functional. A bypass made ofa vena saphena 23 magna will have to be sutured separately in the aorta (the so-oNled proximal anastomosis). Due 24 to the smali tliameter of coronary arteries (1 -3 mm), it is gene` raliy decided to stop the heart in order to be able to carry out the anastomosis precisely and safely. The blood ci:rculation is kept 26 going by a heart-lung machine during this time, Although this is a well-tried and reasonably safe 27 method, it has certain drawbacks. Thus, the use of the heart-lung machihe has a number of side 28 effects for the patient, as a result of which recovery following surgery takes more time.
29 Moreover, the necessary disposables for the heart-lung machine are costly:
31 At preserrt, techniques are available for a number of readily accesaibie coronary arteries 32 to make i<nanually sutured vascularbonnections to a beating, functiorting heart. Generally;: a 33 device which more orless immobilizes a small area of the heart by rriechanicat means is dsed 34 thereby. The clrawbactcs of said method are the fact that only a limited number of piarss on the 21851010.1 ~
,,.-.. . ,_ _ _ .. . , . .:...~_ _ _ CA 2:617,275 Agant Ref: 683021400U5 1 heart can be reached and the fact that part of the heart is temporatilyanaemic, because 'rt is 2 necessary to stop the circulation through the blood vessel to be treated far 8-15 minutes.
4 Sutnmarv ot'the Invention '1"''he object of the present inventign is to.,provide a system for making anastomoses 6 between hollow structures by mechan'tcal means, which wili make it..easier to make rnechanical 7 anastomoses.
9 In order to accompiistt that objective, the system sewrding to the inventlOn is characterized by a device in the shape of an annular or tubular eiement comprising joining 11 means provided circumferentialiy thereon for joining the abutting walls of #hf! hollow structures 12 together, as well as an applicator for moving said annular or tubUfar element in position and 13 activating the joining means thereof;
The system according to the invsr-tion makds it possitsie to effect an anaStomsr`s faster 16 and more eOsily by placing an annular or tubular element comprising joining nt$~ins with theaid 17 of said applioator, which joining means are also ac tivated by said applicator, in such a manner 18 that the anastomosis is made.
The system aocording to the irtveribon has a wida rang+a of applications, due to the fast 21 and accurate manner of making an anastornosis. Thus, the following sp.ptiqatiorts are 22 concei-rable.:
23 - "port access surgery" such as laparoscopio or thoracosoopic vascular 24 reconstructions;
- small, precise vascular connections to a MQVing 4rgan, as in heart surgery;
airxdj 26 vascular rsoonst:ructions whorein the circulation tt'iroughthe supp"g.
vessel'nnay 27 only be shut off for a very short period of time; as in rieurosurgery.
29 Of course, it is also possible to use the invention to make anastomoses txetwaerr other hollow structures.
32 The invention also comprises embodiments of devicesar-ci Oippticators lbr use in tt7e 33 above-tiescribed system for making anastomoses by mechanical means.
21851610:1 2 CR 2:617,275 Aorit RWf 683021Q0045 1 The device of the system according to the invertition can be used intraluminally as well 2 as extraluminally, and it can be adapted both for side-to-side enastomoses and for end-to-side 3 anastomoses. The joining means are preferably pin-sheped elements, whereby pairs of pin-4 shaped elements may be considered, which can function as staples, or independently operatng pin-shaped elements, which can be fixed to the uessel walls by being deftected, Preferably, the 6 tubular or annular elements for intraluminal use can expand from a smaller starting diameter to 7 a final joining diameter, whereby the joining means can be activated either automatically upon 8 expansion or individually. The elements may have a circular cross-seofion, but also an elliptical 9 cross-section, for example, so that the resulting enestonosis will also have a, circular or an elliptical oross-section.
12 The invention furthertnore comprises a method for meking:iritraltrminal side-to-side or 13 side-fo-end anas#omcses botwiseri hollcws#rix~tures by mechanical treans, which is 14 characterized by providing an applicator and associated joirring means for joiriinqthe abuft irig we11$ of the holiow structures together, placing said joining meerr~s round the appl'rcator, inserting 16 said applicator and said joining means iiito orte of said hollow structures to a locetiort fnterrtalRy 17 of the abutting walls of the hottow structures, and arotiveting said applicator, and tt'rus passing 18 said joining means through said abutting walls or clamping said joining means agains# sajcj 19 abutting walls for the purpose of keeping said sbutting walls in sealing contact w'ttn each other;
21 With this method, a number of loose staples may be used as the joining rrrneans.
23 Thus, in one aspect, the present invention provides an appiicator for use with a device 24 for intraluminally making anastompses between abutting walls of hollew structuresp the device incJuding joining efetnents toho1d the abutting walls of the hollow structures together, the 26 applicator comprising:
27 a staank-like e{ementY
28 a head located at a distal end of the shank-like element for supporting the device to be 29 positioned thereon and for activating the joining elarnents; the head being radially expandablet and having an axially c:ontra<tible elernent adapted to move the joining 31 elements af the device from a starting position to a joining position in order to ltold 32 the abutting wa11s of the hollow structures tcrgether;
33 a control element for corttrolfing the radial 8xpansipn of the head of the applicator, and 34 for controlling the axaatly~contractibfe element of the head;
218510t(k.i 3 CA 2,61,7.275 ~gdnF ~t+r~ 68302JOH?Q5 I whereinthe joining elements comprise a plurality of pin-shaped elements which 2 are provided in associated pairs on a hollow element, and each associated pair of the pin-3 sbaped elements has two free ends wWtch are spaced apart y-rhen the applicator is in a starting 4 posftion; and wherein the: a)(ially-contracfibta element of the applicator is adapted to move at least the free ends of each asso~ated pair.of pin-shaped elements towards each other to a 6 joining position, 8 In another aspect, the present inventiorr provides a system farconnecti:ng a first hoTfidvr 9 structure to a second hollow structure, comprising:
a connector including an element selected from the g.rtfup consisting of annular eiemerit 11 and a tubular olament that is expandable frorn a first diamater to a second, larger 12 diameter, and at least two deformable outer elements extending from the element;
13 and 14 an apptlcs:tor having a proximal end; adr'stal end; a longituatlinal axis;
:a movable element mfawable between at least a first posttion and a second position, the movabla:elernerkt 16 configured to expand the connector frorrt the first diameter to the:second diameter 17 when the connector is associated with the applicator when the movable e1emerd is 18 moved from the f<rst posifion to the second: position; and a slem at least parttaily 19 disposed about the mvable element of the applicator, the sleeve being movable between a first position and a second position whereby the sieeve causes at least a 21 portion of deformable elements of the conne-etor to deform outwardly away from the 22 longitudinal axis, and 23 wherein the at least two defo.rrnahle outer elements extend in a proximal direction when 24 the connector is associated with the applicator.
26 In and.ther aspect, the invention provides an applicator for use in a system including 27 joining elements for making an onastomasis between hoilaw struqturesj the applicator 28 comprising:
29 - a head provided with a plurality of arms, each the arm having aprvAmsil end and a distal end, and wherein each the arm is movable from a first posfflw at which th, e 31 distal ends of the arms are separated by a first distance which is Iess than a distmoe 32 of separation between the proximal ends of the amts when the arMs sre, in the fiOA
33 position, to a secohd pdsition, at Which the distal ends of the arms are separoteO by' 34 a second distance, the second distance being greater than the first distarice; and, zaas,n~o;~ 4-_.._ . . ,_ ,. _ .. ~....~ ~. ~..~ ,:,. ,~.. ,a . ,~..:.
CA 2,617,275 Agent Rof 683021OOD05.
1 - a shank iike element assoeieted with the head such that relative movement of the 2 shank-like element andthe head causes arms to move from the first oositiori toward 3 second position;
4 - wherein the distal ends of the arms ere adapted to hotd and positionthe joining elements for makiru,} an anastomosis between ft hollow structures, 7 In a further Aspact, the present invention provides a system for making anastomoses 8; between hollow structures by mechanical nneenns, the system comprising;
9 - a device in the shape of an annular or tubular element camprisirg cirwmferentie(ty provided joining elsarnents for joining the abutting waEis of the hollow strudtures together; and, 11 - an applicator for moving the anriular or tdbuiac element in position and activating the 12 joining elements, the applidetvr comprising:
13 - a head provided with apIurality of arms, each the arm having a proximal end and a 14 distal end, and wherein each ths arm is movable from a furst position at v~aioh the distal ends of the arms are separated by a first distance which is iess than a distance 16 of separation between the proximal ends of the arms whenttie arms are'in thefiwst 17 position, to a second position, at which the distal ends of the armsare separated by 18 a second distance, the second distance being greater than the first distance; and;
19 - a shank like element associated with the head such that relative movement of the shank-like element and the head causes arms to move from the first position toward 21 second pasition;
22 - wherein the dista{ends of the arms hold the joining eisments artti are adapted to 23: position the joining elements for making an anastorbosis: befween the hnl!Ãaw structures by 24 moving the distal ends of the arms from the first position to the second position.
26 Brief aescf-Iptfion of the Finurõs, 27 The int+etatioln will be exptaiired in more detail hereafter with referenoe to the drawings;
28 which show embodir'nents ofthe invention.
29 Fig. I is a perspective view of a first embodiment ofthe device for mking anastomoses 30, by mechanical mearts according to the invention, showing the startirrg position thereof.
31 Fig. 2 is a side view of thedevice according to Fig. I 32 Fig. 3 is an axial view of the device according to Fig. 1.
33 i~ig. 4 is a perspective view of the device corresponding with Fig, 1, wherein the device 34 is shown in the joining positidn, however.
, . _.
CA 2,617,275 Agent Rel` 683021000Q5 1 Figs. 5 and 6 are a side view and an axial view, respectively, of the device of Fig. 4.
2 Figs. 7-12 are views corresponding with Figs. 1- 6 of asecrsnd embodiment of the 3 device according to the invention.
4 Fig.13 is a side view of an applicator for use with the devic:e according to 'Figs. 7 12:
showing_the starting positiQn thereof, 6 Fig. 14 is a perspective view of the applicator of Fig. 13, with the device aecording to 7 Figs. 7- 12, which is shown in the starting.position thereof, in mounted position thereon.
8 Fig. 15 is a side view corresponding with Fig, 13, wherein the applicator is shown in the 9 joining position, however.
Figs. 16 - 21 are views corresponding with Figs.1 W 6 of a third embodiment of the 11 device according to the invention.
12 Figs. 22 - 24 are views corresponding wi#h Figs. 13 - 15 of an applicator for use wfth the 13 device according to Figs. 16 - 21.
14 Fig. 25 is a schematic side view, partially in sectional view, of an aitemative appkcator for use with the device according to Figs. 1- 6 or 7 - 12.
16 Fig. 26is a partial front viewof the appEicator of Fig. 25.
17 Fig, 27 is a view corresponding with Fig. 25, wherein the appticator is shqwn in the 18 expanded position, however, 19 Figs. 28 - 30 are sectional views and elevational views respectively aairrespondirv vvqtb Figs. 25 - 27 ofa variant ofan appl'rcator for use with a device aiccor'ding to Figs. 16 - 21, 21 Figs. 31 - 33 are perttiaily cut-away side views of another variant c?f the applicator, fot 22 example for use with a device according to Figs: 1- 6 orr 7- 12, shoWirtgthree diftereint positions 23 therecaf.
24 Fig, 34 is a side view of a variant of the extendible arms of the applicator of Fiq. 31.
Figs_ 35, 36 are perspectiue views of the applicator of Fig. 31, stfowirig the two extreme 26 positions fttei=eof:
27 Figs. 37, 38'and 39, 40 are side views end perspective vi+sws:, respestively; of yet 28 another variant of the appiica#cr according to the invervtion for use wtth a device according to 29 Figs, 1- 6 or 7-12, for exampte, showing the two extreme positiorrs tilerreof.
3{f Fig, 41 is a high#y srhematic perspective view of blood vessels int$rcoonected by side-31 to-side anastomose vvith loose staples.
32 Figs. 1 -6 show a first embodirttent of aÃievice for making anastomoses between hollow 33 structures, in particular arterie"s or veins, by rrecharwicai tneans.
.. _,.. .
CA 2b17.275 Agent Ret U30214oQ05 I Do#aDed pesc.rigtiort gf the lnvent!<on 2 In the present case, the device ia. a one-pie<ae tubular or annular element "t.. Whioh is 3 made tsfa biocompatible and plasticaily defortnable material, for example a tantalum alloy oir 4 another material used in medical technology. Annular element 1, mAy be considered to be an assembly of two zigzag-like elongated elements 2 and 3 which extend substantiAtiy in 6 circumforential direction but not along the contour line, which elements are interconnected at the 7 facing vertices, thus forming a ring of diamond-shaped structures 4. Present on the verttces of 8 ft zigzag-like elements 2, 3 that face away from each other are pira-staaped elements 5, 6, 9 which arts provided with sharp tips 7Ot their ends facing away from annular element 1, whr~rein the tips 7 of two associated pin-sitaped elements 5, 6 forming a pair are direCted towards each 11 other. The pin-shaped elernents may be straight, but also curved or angular, fbr example, thus 12 formirtg staples which are G-shapeci, as it were, whilst the pin-shaped eiemer-ts may also be 13 shaped more like lips, Since annular element I isformed from elongated elements 2, 3, whose fength in 16 circ.umferential direction is greater than that of annular element I in the position as shaurn ira 17 Figs 't - 3, and since etements 2 and 3 are capable of sieÃorrnatidn, it is possible to expAnd 18 annular element I from the starting position as shown In Figs. `t - 3 to a final position, or joining 19 position, as shown in Figs. 4 - S. In said joining posi#ion, annularelement 1 has a dtameter which is associated with a diameter which is at most equal to the length of eiongated elements 21 2, 3, It would also be possibie, of course, to expartd annular element 1 only to a smaller 22 diameter.
24 As is apparent from a compadspri between Figs. 4- Band 1-3,, the diarnbnd-sfiapect structures 4 are deformed to a straighter shiape, seen in circumferential direction, where-n the 26 vertices comprising the pin-shaped elements 5, 6 have been moved closer together, st.tchthat 27 the points 7 of pin-shaped elements 5, 6 of one pair engage each oftr. This movement of 28 points 7 of pin-shaped elements 5 and 6 towards each other can be used for joirimg trgether or 29 clamping together the walls of the hollow structures for the purpose of making the anastorrtosis, as will be explained in rnor+s detail hereafter.
31 32 Since the joining means in the form of pin-shaped elemqr-ts 5, 6 comprising points 7 are 13 autc-maticalfiy a ctivated upon expansion of -annu1ar element i frt m thefirat start7ing diameter to 34 the second, iarger aaining diameter, it is possibteto use a very simpte aPptictitor, which consists 29851010;1 7 CA 2,617,275 Agent Ref 683021000p5 I of a shank-fike element for insertion and rnaniputation, at the distal end of Ywhiach a head is 2 present, whose diameter can be enlarged: The head may therefore consistof an inftatable 3 balloon, as is known from balloon catheters, or of a mechanically expandable head qr the like.
In this embodiment, the foilowing method is usedfor making an ansstorrrosis.
6.
7 In the case of a side-to-side anasttamosis,.incisions are made in the vessel to tae 8 bypassed and in the bypass at opposite bsationt. The applicator is inserted throuVh the open 9 free end of the bypass and passed through the incisions, possibly by maansof a guide wire.
Annular element I is thereby positioned so that one end of annular element 1!s positlorted in 11 one vessel and the other end of annular element is positioned In the oftr vessel, sothat pin-12 shaped elements 5 and 6 are positioned on either side of the vualls of the adjacertt vessals:
13 When expansion of the applicator causes annular element 1 to expand from the first starting 14 diameter to the second, larger joining diameter, annular element 1 is raclially, enlarged on ttte 1'5 one hand and axially shortened on the other end, whereir{ the pin-shape+d ai+sments 5 and 6 16 move together, eventually clarnping down the waCls of the vessels round the incisions, with 17 points 7 becoming fixed in the walls of the vessels. The faassao between the two vessels is 18 determined by the diameter of annular element 1, so that said element functions both toiceea 19 the walis of the two vessels together and to keep the passage open. When annular element I
has reached its joining position, the head of the applicator is reduced to a smaller diameter 21 again and the applicator is withdrawn from the bypass.lumen, after which theopen end of the 22 bypass is closed.
24 Figs. 7-12 show a second embodinrnent of the device for making an anastomosis by mecbanicai means, wherein annular element 1 is a single, sinusoidal, elongated element 8;
26 which expands in circu.mfarentiai direction. Just like the eiangafed elements 2 and 3 of the first 27 embodiment, the sinusoidal, elongated element 8 according to this second embodiment has a 28 tength dimension which is greater than the circumferential dimensiori of theanc-ufar element in 29 tMe startirtg position thereof, and said length dimension of element 8 is at loast equal to the circumferential dimension of the annular element in the joining position.
32 The sine sh" of elongated element 8is such that a number of vertices 9 is positioned 33 oentrstfy in annular element 1, seen in axial view, on which verticos 9 prn-shaped elemortts 10 34 and 11 are formed, with two pin-shaped elements 10, 11, which form a pair, being spaced. apart 2is5t09QA g _ _ , __ , CA 2,647,275 Agent Ftef 683021tHi405 1 at their free ends, seen in sixial view, and meeting on elongated eiement.8 attheir bottom ends.
2 P in-shaped elements 10 and 11 may be provided witha point or other projection 12 at their #ree 3 ends, on facing sides, so as to be fixed in:a vessel walt.
When said annular element I aocofding to Figs: 7 - 12 is expanded from the first starting 6 diameter to the second, larger diameter, the ends of the pin-shaped eternents 10, 11 of apa-r 7 are-not automatically moved together, so that it will be necessary to use an epplicatoi'=' Which is 8 capable of closing the pira-shaped elements 10, 11 prior to, simultaneously with or after the 9 expansion of annular element I so as to clamp down the wails of the adjacent vessels therebetween for making theanastamosis:
12 Figs. 13 - 15 show an embodiment of an applioator which can be useci for that purpose.
13 The applicator is provided with apreferabiyr rigid, shankAke element 73, omthe proximal end of 14 which means are pcovided for maniputating the applicator, such as a grip, and on the distel end:
of which a head 14 is formed. Head 14 is provided with two axially spaced-apart hubs 15, 16;
16 one of vuhich. for exarnpte hub 16, is capabte of axial movenner-t, which movement is con,trailed 17 from the proximal and of shank-like element 13. Rigid arms 17 are arranged:on hubs 15 and 16 18 irt a star-like fashion, wherein pairs of associated arms 17 of the trnro ttwias. 15 ond 10 present at 19 corresponding circumferential positions are pivotarliy interconnected: in a point some. distarilce away from their free ends. Arms 17 are also pivotally conneoed to hubs 15 and 16, with the 21 pivots extending tangentiaily with respect to shank-like element 13: In this manner crips are 22 formed, as it were.
24 Fig. 14 shows that annular efement 1 is piaced on thehead 14 of the applicator in suchd manner that pin-shaped elements 10 and 11 are positioned between ttm free.
enclsof arms 17, 26 past a pivot 18, as a resutt of which the arms are pressed outwards from the position shown ln 27 Fig. 13 to the position shown in Fig. 15 upon moven3ent of the hub, as a reauit of whieh 28 elongated element 8 is straightened to a shape which extends more in arcumferer?tiai t3iredion, 29 thereby enlarging thediameter, whilst the reduction of the angle between arms 17 of a pair of arms resuits in a reduced angle between pin-shaped slemer+ts 10 and 11, and the free ends of 31 pin-shaped elements 10 and 11 are moved together, eventually Llatnpi'ng the two walls of the 32 adjaoent vessels between them. The placement and removal of the appiicator is oarried out in a 33' manner which is oomperabie with the method described with referertce. to Figs: 1_ 8, 218510.10;9 9 . . . . .... _,..... ...,,s.:,.:.. .,., y..... ,..õe~ , . . .. ... . , ..
CA 2,617,275 Agok Ref: 68302100045 1 Figs. "{i~r - 21 show a third embodiment of the device acccardirtg to the invention, which 2 oan be used for intraluminal placement in the,oase of a side-to-side anaslcrmosis, but in 3 particular also for extrafuminal placement in the case of an ertd-to-sicfe anastornosis.
In this case, annular element 1 nsists of ra circular, elongated eiement 19, which i.s 6 circumferentially provided in a number pfi places with pin-shaped elements 10, which aXialiy 7 project to one side from said elongated element % Ttte pins may be providisd yrith- points 21 8 thereby, whilst the pin-shaped elements 20 may be flat, or possibly rotand or the 1ike. As is 9 shown in Figs. 19 -21, the pin-shaped elements 20 are in large measure berrt radially outwards in the joining positiort of the device; but they may a#so be bent tangentiaity;
12 In order to be able tddeform the pih-shaiped elements 20 from the starting position to the 13 joining pos9tton, the applicator according to Figs. :22 -24 is provided.
Also this applicator is 14 provided with a shank-like element 13 and a head 14, but in tt%is embodiment said head is provided with a detainer 23 in the form of a sleeve to be positiuned proximally with respect to 16 annular element 1, which is attached to<the head, and with defl.e.otor eleme,nts 24, which can be 17 moved at (east axially, but preferably axially aswel! as radiallyy, whidh deflector elements can be 18 manipalatad frorn the proximal end of shank-like element 13. Said deflector elements 24 consist 19 of a fixed hub 25, an axially movable hub 26 and arms 27 which are p'rvc>ted together and to hubs 25, 26, which arms can be brought into engagement with the pin-shaped elements Z0, and 21 which can be deflected from an aAal position to a radial position, wherein annular element I is 22 stopped by detainer 23.
24 When the device acpording to Figs. 15 - 21 and the applicator accordin.g:
to Figs: ZZ - 24 Zv are used for making a side-to-side anastoittosis, annular elemerit 1is plaaed intraluminally, and 26 the pin-shaped eiements 20 are passed through the vessel wags in places surroundir-g the 27 openings that have been formecf by ir-cisic-ns. When the pin-shaped elements 20 are, 28 subsequently bent radially outwards, it is no longer possible to remove annular element 1, 29 because elongated element 19 is positioned inwardly of the wall of one vessel and the radiatly projecting pin-shaped elements 20 are positioned inwardly of the wall of the other vessel.
32 tn the case of an and to-side anastomosis, the annular element 1 is stid over the bypass.
33 The bypass is everted round annraiar element I and the pin-shaped elements am p8ssed 34 through the wali of the bypass and through the wall of the vessel to be artastornosed tfor ..r.,..._ _ CA 2,617.275 AQOttt Ref 6$302100'3D5 I example the aorta). Pin-shaped elements 20 can be deflected by extension of the deflector 2 elements 24 of the applicator, and the vuails will be fixed with respect to each other.
4 Figs. 25 - 27 show a variant of the applicator according to i~igs, 13 -15 which is suitable for placing an annularaiement 1 of a device of the type as shown in Figs. 1-6 (shown at the 6 bottom of Figs. 25 and 27) or in Figs. 7-12 (shown at the top of Figs. 25 and 27). Also in this 7 embodiment, a#tead 14 is attached to the shank 13 of the applicator. Said head 14 possesses a 8 blunt end part 28 in this embodiment, which is fixed to shank 13 and also to a housirig 29. The 9 fixed connection between shank 13 and housing 29 is schematlcai#y illustrated by rrieansof pjn 30. A number of slots, eight in the illustrated embodiment, are circumferentially provided, in 11 regularly spaced-apart relationship, in end part 28 and in housing 29, Said slots 31 are wide 12 eriough for receiving wedges 32, w+herebyit is important that slots 31 in end part 28 have the 13 same angle of inolination as the distal front face 33 of wedges 32. Weog.es 32 are radially held 14 together by an elastic annular band 34. A control element 35 in the shape of a nollflw shaft which can be slid overshank 13 comprises a bev.elled frorit fiate.3fi at the distal era.tt, which is 16 capable of copperation w~th a: complementary bevel 36" on the proximal end of wedges 32. The 17 angle of inclinatian of bevel 36' and the front face 36 is smaller than that of the distal front face:
18 33 of wedges 32.
An annular element 1 positioned: in the applicator can be expanded from the starting 21 position to the joining position by pressing wedges 32 outwards. This can be effected by moving 22 control eDemen t 35 distally forwards, which control element presses wedges 32 outwards, via 23 bevels 36, with its inclined front face 36, whereby the directiortof the movement of v-redges 32 24 corresponds with the direction of front faces 33 and the cooperating surfaws of end part 28.
The combined axial and radial movement of wedges 32 causes the annular element 26 surrounding wedges 32 both to expahd radially and to be clamped together between the 27 adjacent housing surface and the wedge surface, as a result of which pira=st*sped elements 5. 6 28 and 10;11 respectively of anMufar element 1 are moved together, clamping the vessel walls 29 down between them. When controlelernent 35 moves back, the elastic band 34 causes wedges 32 to return to the starting position. Thus, the applicator can be wtthdrawn from annutar elemsrt 31 1 and be removed in a simple and reliable manner.
33 Figs: 28 - 30 show avariant of the applicator according to Figs. 22 -24, which can be 34 used in combination witl~==, an annular element 1 of the type accerding to Figs. 16 - 21. The head 2t851010.3 ,_ _ _ ...-...... ......:..,.W,.. ...:... ..........:..I... .. . ..... .. . .. .
CA 2,617,275 Agetnt Ref: 68302/00QQ5 1 14 of this variant comprises a hottow shaft 37, with ablunt end part 38 present atthe distart end 2 thereof. Reotanguter cpenngs 39 (eight, for example) are provided in regularly spaced-apert 3 relationship itt the circumference of hollow'shaft 37. Said hoik>w sie 37 can mo,ve a.ci2lly with 4 respect to a housing 40, whose distal end surface 41 can serve as an anvil for annular element 1. Wedges 42 are placed in opeKings 39, which wedgesare pivoted to tha hollow shaft by 6 means of restliently flexible plates 43, irlsuctt a manner that wedges 42 can move outwards 7 about a substantially tangentiai axis, from their starting lapsition (Fig.
28} in openingls 39 to a 8 joiningposition (Fig. 30) in the diredtion of housing 40. Said movement is efÃected by r-noving a 9 +controi element 44 in the form of a bar cflmprising a bevelled point 45 in forward direction, as a result of which the wedges are tilted atit.wards throogh 900, in which jaining position they ore 11 locked by. the circumference of said control element 44;When housing 40 is moved axially 12 forward with respect to hollow shaft 37, in the directiort of wedges 42, the piri4haped elements 13 20 ofannular element I will come into contact with the wedges 42, and the pin-shdped 14 eiements 20 will be deflected outwards in a desired manner by the specially formed cavitios 46 present in said wedges so as to fix annular element 1oftha device td the vesset walls< 1Nadges 16 42 wiil return to the starting position when corrtrdl Wemertt 44 is withdra"v-rn, and the applidatdr 17 can be removed. In prrir-cipte k would also be possible to effect direct deflection of pin-shaped 18 elements 20 through expansion of wedges 42.
19 20 F)gs. 31 - 35 show another variant of an applicator, which can for example be used for 21 inserting the device according to Figs. 1-6 or 7-12, The applicator is t'nerefore arranged for 22 effecting a radial expansion of annular element 1 of the device and subsequently clamping 23 together the joining means, such as pin-shaped elements 5,6 or 10, 11, in.axial direction or 24 defof'rming them in some other manner. The difference with the preoedirg embodiments of the applicator is the fact that the embodiment according to Figs. 31 - 36 is arranged for effecting the 26 radial and axial deformations of the device in two separate steps. First the annular elernent 1 is 27 radially expanded, and then the joining means are moved to thheir jaining position. The 28 advantage of this embodiment is the fact that the joining means are preuehted from closing 29 prematurely and thus missing part of the vessel wall.
31 ln Figs; 31 - 36, sherrk-fike element 13, head 14and detainer 23 can be distinguished.
32An end :p:ortion 47 having a convex end surface is formed on the distal end of shank-like 33 element 13, whilst end part 47 is wedge-shaped or oonisrat on proximal side 48. Besides shank-34 like element 13 and detainer 23, a third, relatively movable part 49 is provided, which car~ be 21951010:1 12 GA 2,617,274 Ag"Ã Ref 6$302J(lUS
1 moved both with respect to shank-like element 13 and with respect to detainex 23 from a contmi 2 position outside the body. Part 4$ andlor detainer 23 are prcumferentiaity, pprovided with a 3 number of radially extending slots 50 for movably accommodating, at least in part, an equal 4 number of arms 51. Arms 51 can move between the inrermost starting posftiota, in which they abut against a ccrr3ical surface 52 of mauable part 49, and an outermost joining poskion, in 6 which they abut against the inner wall of detainer 23 (Figs. 32, 33). Arms -51 camprise an 7 outwardly curved dettectinri: surface 53 nesr theic distal ends,.which istcs mate with pira-shi#ped 8 elements of annular element 1, which may be provided rocand arms 51, adjoicent{y to deft#ion 9 surfam 53. An elastic band 54 (see Figs. 35, 36) mayextertd through radiW
notches 55 present near the distal ends of arms 51, which band functions to cause arm's 51 ta spring back 11 to an inward pasition;
13 As is shown in Fig. 34, it is' also possible to use arrns which are inteFconneded by an 14 annular part 56 at their proximal ends instead of separate arms.51. This ane-piece.assernbty may for example be in the form of a plastic moulding, whereby the pivotirsg movement of arms 16 51 is made possibfe by the elastic properties of the relatively long arms.
Slots 50are no longer 17 required in this manner, since annular part 56 holds arms 51 in pcsition;
19 The operation of the applicator is as fotlcws. !n .the pasition as shown In Fig. 31, the applicator and the annular element I of the device, which is present thereon (not shown), am 21 moved to their destination, a,nd then the shank-like element 13 and the end part 47 are 22 withdrawn in proximal direction with respect to part 49 (or part 49 is e~d.ed), and arms 51 are 23 pressed radially outwards by the mating cooperatipn between the wedge-shap.ed proximal side 24 48 of end part 47 and the,associated wedge-shaped surfaces bf arms, tecouse arms 51 are supported against a shoulder of part 49 (see Fig.-32). Annular elernent 1 is ttweby deformed 26 radially outwards by arms 51 to a larger diameter. Detainer 23 is then moved relative to sftank-27 tike element 13 and part 49, as a result of which the end face of detainer 23 is moved in the 28 direction of the deflection surfaces and the joining means are deformed in such a manner that 29 the vessel v-ralis of the hollow structures are interconnecked. When shar>ic-1ike eiem:ertt 13 and part 49 are moved apart again, elastic band 54 wiii return arms 51 to their starting positiort as 31 shown in Fig. 31, 33 With the appiicator according to Figs. 37 - 40, the isqvolumatnt+ behaviour of some 34 elastic and readily defQrimabie material, such as rubber, is +stiiized for the radsai expansion of 21853010.1 13 CA 2,$1T,275 Agent Ref 663t)?1O0t106 I annular element I of the deviee: The axial compression of the materiat will resul# !n axial 2 conttaction and, if inward defvrrnation is not possible, to radially outw.ard expansion. !rt the 3 illustrated embodiment, an isovolumetric core 57" is provided, on which annular element I of the 4 device can be placed. Head 14 of said applicator furthermore comprises a sleeve 58 which is axially movable with respect to shank-like element 13, which sleeve comprises an end part 59 6 capable of cooperation with an end part 60 of shank-like element 13. Pivoted radial supports 61 7 are connected to the associated end parts 59, 60, they support circumferrsntially provided plates 8 62, wl'rich are held together by an associated elastic band 63, which also providss the return 9 force. By moving the end parts 59, 60 together, the plates 62 are moved from the original sloping position as shown in Figs. 38, 40 to an eventual joining positon as Shown inFigs. 37, 11 39, wherein said plates extend practically perpendicuiarly to shank-like element 13. The facing 12 surfaces of plates 62 are then capable of deforming the joining means upon further movement 13 of enwd parts $9, 60 towards each other when the isovolumetric cote 57 is compressed and ttie:.
14 annular element is expanded thereby and; as already mentioned before, the joining means are 16 moved to their joining position. This embodiment of the applicator Is suitable for dt'astic 16 miniatutisation.
18 Fig. 41 shows the result of a side-to-side anastomosis of two hotlow structures, such as 19 bloodvessels, wherein loose staples 64 are used as joining means torthe vessel r+valls: One of, the above-described applicators may be used, providingthat rneansare usod t&
holding the 21 staples 64 correctly spaced apart when said staples 64 are ber'rig inserted and rnoved to their 22 joining pflsition. Also in this embodiment the staples are placed intraluminally, whilst a guide 23 wire may be used for moving the applicator to its correct. position:
From the above it will have become apparent that the invention provides a systam for 26 making anasto.moses between hollow structures by mechanical means, by means of which 27 system an anastomosis can be made in a quick and reliable manner, as a result of which the 28 negative effects of an anastomosis for the.patit$nt are minimized and the system is suitable far 01 29 large number of applications.
31 The invention is not timited to the above-described ernbodimeft as shownin the 32 drawing, which can be varied in several ways within the scape of ttle istverttion. Thus, the 33 expandable version of ttedeitice might also be made of a resilient material or of a sh,ape-34 memorizing metal, so that the de"vir.e can move to the expantled pdsitiort without extemal forces CA 2,677,275 Agent f3ef. 6830210000S
1 being exerted when the device is being provided. The elongated eiements may not be ~ recognizable as such, but they may be encountered in a different type of sfructure, _,..._
Claims (31)
1. An applicator for use with a device for intraluminally making anastomoses between abutting walls of hollow structures, said device including joining elements to hold the abutting walls of the hollow structures together, said applicator comprising:
a shank-like element;
a head located at a distal end of the shank-like element for supporting the device to be positioned thereon and for activating the joining elements, said head being radially expandable, and having an axially-contractible element adapted to move said joining elements of the device from a starting position to a joining position in order to hold the abutting walls of the hollow structures together;
a control element for controlling the radial expansion of the head of the applicator, and for controlling the axially-contractible element of the head;
wherein the joining elements comprise a plurality of pin-shaped elements which are provided in associated pairs on a hollow element, and each associated pair of said pin-shaped elements has two free ends which are spaced apart when said applicator is in a starting position; and wherein the axially-contractible element of said applicator is adapted to move at least the free ends of each associated pair of pin-shaped elements towards each other to a joining position.
a shank-like element;
a head located at a distal end of the shank-like element for supporting the device to be positioned thereon and for activating the joining elements, said head being radially expandable, and having an axially-contractible element adapted to move said joining elements of the device from a starting position to a joining position in order to hold the abutting walls of the hollow structures together;
a control element for controlling the radial expansion of the head of the applicator, and for controlling the axially-contractible element of the head;
wherein the joining elements comprise a plurality of pin-shaped elements which are provided in associated pairs on a hollow element, and each associated pair of said pin-shaped elements has two free ends which are spaced apart when said applicator is in a starting position; and wherein the axially-contractible element of said applicator is adapted to move at least the free ends of each associated pair of pin-shaped elements towards each other to a joining position.
2. A system for connecting a first hollow structure to a second hollow structure, comprising:
a connector including an element selected from the group consisting of annular element and a tubular element that is expandable from a first diameter to a second, larger diameter, and at least two deformable outer elements extending from the element;
and an applicator having a proximal end; a distal end; a longitudinal axis; a movable element movable between at least a first position and a second position, the movable element configured to expand the connector from the first diameter to the second diameter when the connector is associated with the applicator when the movable element is moved from the first position to the second position, and a sleeve at least partially disposed about the movable element of the applicator, said sleeve being movable between a first position and a second position whereby the sleeve causes at least a portion of deformable elements of the connector to deform outwardly away from the longitudinal axis, and wherein said at least two deformable outer elements extend in a proximal direction when said connector is associated with said applicator.
a connector including an element selected from the group consisting of annular element and a tubular element that is expandable from a first diameter to a second, larger diameter, and at least two deformable outer elements extending from the element;
and an applicator having a proximal end; a distal end; a longitudinal axis; a movable element movable between at least a first position and a second position, the movable element configured to expand the connector from the first diameter to the second diameter when the connector is associated with the applicator when the movable element is moved from the first position to the second position, and a sleeve at least partially disposed about the movable element of the applicator, said sleeve being movable between a first position and a second position whereby the sleeve causes at least a portion of deformable elements of the connector to deform outwardly away from the longitudinal axis, and wherein said at least two deformable outer elements extend in a proximal direction when said connector is associated with said applicator.
3. The system of claim 2, wherein the connector further comprises at least two deformable inner elements extending from the element in a distal direction when said connector is associated with said applicator, and wherein at least a portion of the inner elements is deformable outwardly away from the longitudinal axis when said connector is associated with said applicator.
4. The system of claim 3, wherein the outer elements and inner elements are configured to clamp the first and second hollow tissue structures between the inner elements and the outer elements when the sleeve moves to the second position.
5. The system of claim 4, wherein the movable element comprises a plurality of arms that move from a first position to a second position to thereby expand the connector.
6. The system of claim 5, wherein each of the arms comprises a deflection surface at a distal portion thereof.
7. The system of claim 6, wherein each deflection surface is positioned such that when said movable element is in the second position, at least some of the inner and outer elements abut against said deflection surfaces during at least a part of said movement of said sleeve.
8. The system of claim 6, wherein each of said arms comprises a notch in a distal portion thereof, and the system further comprises an elastic band located in said notches.
9. The system of claim 6, wherein said arms are connected at a proximal portion by an annular part.
10. The system of claim 9, wherein said arms comprise a material with elastic properties.
11. An applicator, for use in a system including joining elements for making an anastomosis between hollow structures, said applicator comprising:
- a head provided with a plurality of arms, each said arm having a proximal end and a distal end, and wherein each said arm is movable from a first position at which the distal ends of the arms are separated by a first distance which is less than a distance of separation between the proximal ends of said arms when said arms are in the first position, to a second position, at which the distal ends of said arms are separated by a second distance, the second distance being greater than the first distance, and, - a shank like element associated with said head such that relative movement of said shank-like element and said head causes arms to move from said first position toward second position;
- wherein the distal ends of the arms are adapted to hold and position said joining elements for making an anastomosis between the hollow structures.
- a head provided with a plurality of arms, each said arm having a proximal end and a distal end, and wherein each said arm is movable from a first position at which the distal ends of the arms are separated by a first distance which is less than a distance of separation between the proximal ends of said arms when said arms are in the first position, to a second position, at which the distal ends of said arms are separated by a second distance, the second distance being greater than the first distance, and, - a shank like element associated with said head such that relative movement of said shank-like element and said head causes arms to move from said first position toward second position;
- wherein the distal ends of the arms are adapted to hold and position said joining elements for making an anastomosis between the hollow structures.
12. The applicator according to claim 11, wherein a proximal portion of each said arm is attached to an attachment member.
13. The applicator according to claim 12, wherein at locations of attachment of said arms to said attachment member, said arms are arranged around a portion of said shank-like element such that relative movement of said head and said shank-like element expand the arms radially outwardly, relative to an axis of said shank-like element.
14. The applicator according to claim 13, wherein said arms expand from said first position to said second position by deformation.
15. The applicator according to claim 11, wherein the shank-like element comprises a part located proximate to a distal end of said shank-like element for causing movement of the arms from the first position toward the second position.
16. The applicator according to claim 15, wherein the part proximate to the distal end of the shank-like element comprises a surface portion in engagement with each said arm such that relative movement between the shank-like element and the head results in movement of the arms from the first position toward the second position.
17. The applicator according to claim 16, wherein the arms move from the first position to the second position by deformation.
18 18. The applicator according to claim 11, wherein said applicator further comprises a detainer for controlling movement of said joining elements.
19. The applicator according to claim 18, wherein the detainer comprises a plurality of surface portions positioned to engage surface portions of said joining elements to thereby limit the movement of said joining elements relative to the detainer.
20. The applicator according to claim 18, wherein said detainer is axially moveable relative to said arms.
21. The applicator according to claim 20, wherein said detainer is associated with said arms such that axial movement of said detainer results in positioning of said joining elements for making anastomosis by engagement between a surface of each said joining element and a surface of each said arm.
22. The applicator according to claim 21, wherein said surface portions of said arms which engage said joining elements are arranged such that said joining elements deform towards a joining position as said detainer is moved axially relative to said terms.
23. The applicator according to claim 21, wherein said surface portions of said detainer are arranged such that said joining elements can become disengaged from said detainer when said joining elements are in the joining position.
24. The applicator according to claim 18, further comprising a plurality of surface portions positioned to limit the extent of movement of said arms.
25. The applicator according to claim 24, wherein said surface portions positioned to limit the extent of movement of said arms form part of said detainer.
26. The applicator according to claim 24, wherein said surface portions positioned to limit the extent of movement of said arms form part of said head.
27. The applicator according to claim 11, wherein each of said arms includes a deflection surface at a distal portion thereof and wherein said deflection surfaces cooperate with the joining elements for positioning said joining elements in a joining position.
28. The applicator according to any one of claims 11 to 27 wherein the joining elements comprise a plurality of pin-shaped elements which are provided in associated pairs on a hollow element, and each associated pair of said pin-shaped elements has two free ends which are spaced apart when said applicator is in a starting position; and wherein the axially-contractible element of said applicator is adapted to move at least the free ends of each associated pair of pin-shaped elements towards each other to a joining position.
29. A system for making anastomoses between hollow structures by mechanical means, the system comprising:
- a device in the shape of an annular or tubular element comprising circumferentially provided joining elements for joining the abutting walls of the hollow structures together and, - an applicator for moving said annular or tubular element in position and activating the joining elements, the applicator comprising:
- a head provided with a plurality of arms, each said arm having a proximal end and a distal end, and wherein each said arm is movable from a first position at which the distal ends of the arms are separated by a first distance which is less than a distance of separation between the proximal ends of said arms when said arms are in the first position, to a second position, at which the distal ends of said arms are separated by a second distance, the second distance being greater than the first distance;
and, - a shank like element associated with said head such that relative movement of said shank-like element and said head causes arms to move from said first position toward second position;
- wherein the distal ends of the arms hold said joining elements and are adapted to position said joining elements for making an anastomosis between the hollow structures by moving the distal ends of the arms from the first position to the second position.
- a device in the shape of an annular or tubular element comprising circumferentially provided joining elements for joining the abutting walls of the hollow structures together and, - an applicator for moving said annular or tubular element in position and activating the joining elements, the applicator comprising:
- a head provided with a plurality of arms, each said arm having a proximal end and a distal end, and wherein each said arm is movable from a first position at which the distal ends of the arms are separated by a first distance which is less than a distance of separation between the proximal ends of said arms when said arms are in the first position, to a second position, at which the distal ends of said arms are separated by a second distance, the second distance being greater than the first distance;
and, - a shank like element associated with said head such that relative movement of said shank-like element and said head causes arms to move from said first position toward second position;
- wherein the distal ends of the arms hold said joining elements and are adapted to position said joining elements for making an anastomosis between the hollow structures by moving the distal ends of the arms from the first position to the second position.
30. The system of claim 29 wherein each of the arms of said applicator include a deflection surface at distal portion thereof and wherein said deflection surfaces cooperate with the joining elements for positioning said joining elements in a joining position.
31. The system of claim 29 or 30 wherein the joining elements comprise a plurality of pin-shaped elements which are provided in associated pairs on a hollow element, and each associated pair of said pin-shaped elements has two free ends which are spaced apart when said applicator is in a starting position; and wherein the axially-contractible element of said applicator is adapted to move at least the free ends of each associated pair of pin-shaped elements towards each other to a joining position.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| NL1007349A NL1007349C2 (en) | 1997-10-24 | 1997-10-24 | System for the mechanical production of anastomoses between hollow structures; as well as device and applicator for use therewith. |
| NL1007349 | 1997-10-24 | ||
| CA002347767A CA2347767C (en) | 1997-10-24 | 1998-10-22 | Mechanical anastomosis system for hollow structures |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002347767A Division CA2347767C (en) | 1997-10-24 | 1998-10-22 | Mechanical anastomosis system for hollow structures |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2617275A1 CA2617275A1 (en) | 1999-05-06 |
| CA2617275C true CA2617275C (en) | 2010-01-05 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002617275A Expired - Fee Related CA2617275C (en) | 1997-10-24 | 1998-10-22 | Mechanical anastomosis system for hollow structures |
| CA002347767A Expired - Fee Related CA2347767C (en) | 1997-10-24 | 1998-10-22 | Mechanical anastomosis system for hollow structures |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002347767A Expired - Fee Related CA2347767C (en) | 1997-10-24 | 1998-10-22 | Mechanical anastomosis system for hollow structures |
Country Status (10)
| Country | Link |
|---|---|
| US (5) | US6485496B1 (en) |
| EP (2) | EP1808135B1 (en) |
| JP (2) | JP2001520908A (en) |
| AT (2) | ATE433713T1 (en) |
| AU (1) | AU742208B2 (en) |
| CA (2) | CA2617275C (en) |
| DE (2) | DE69837554T2 (en) |
| DK (1) | DK1808135T3 (en) |
| NL (1) | NL1007349C2 (en) |
| WO (1) | WO1999021491A1 (en) |
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-
1997
- 1997-10-24 NL NL1007349A patent/NL1007349C2/en not_active IP Right Cessation
-
1998
- 1998-10-22 DK DK07007362T patent/DK1808135T3/en active
- 1998-10-22 WO PCT/NL1998/000605 patent/WO1999021491A1/en active IP Right Grant
- 1998-10-22 JP JP2000517658A patent/JP2001520908A/en active Pending
- 1998-10-22 EP EP07007362A patent/EP1808135B1/en not_active Expired - Lifetime
- 1998-10-22 CA CA002617275A patent/CA2617275C/en not_active Expired - Fee Related
- 1998-10-22 DE DE69837554T patent/DE69837554T2/en not_active Expired - Lifetime
- 1998-10-22 EP EP98951819A patent/EP1024754B1/en not_active Expired - Lifetime
- 1998-10-22 AT AT07007362T patent/ATE433713T1/en not_active IP Right Cessation
- 1998-10-22 US US09/529,900 patent/US6485496B1/en not_active Expired - Lifetime
- 1998-10-22 AU AU97662/98A patent/AU742208B2/en not_active Ceased
- 1998-10-22 CA CA002347767A patent/CA2347767C/en not_active Expired - Fee Related
- 1998-10-22 DE DE69840924T patent/DE69840924D1/en not_active Expired - Lifetime
- 1998-10-22 AT AT98951819T patent/ATE359030T1/en not_active IP Right Cessation
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2002
- 2002-06-04 US US10/162,261 patent/US8182498B2/en not_active Expired - Fee Related
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2003
- 2003-04-01 US US10/405,677 patent/US7022127B2/en not_active Expired - Fee Related
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2004
- 2004-03-22 US US10/805,714 patent/US7666198B2/en not_active Expired - Fee Related
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2008
- 2008-10-15 JP JP2008266773A patent/JP2009045475A/en active Pending
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2009
- 2009-12-31 US US12/651,095 patent/US20100106172A1/en not_active Abandoned
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| AU9766298A (en) | 1999-05-17 |
| EP1024754A1 (en) | 2000-08-09 |
| DE69837554D1 (en) | 2007-05-24 |
| US7666198B2 (en) | 2010-02-23 |
| ATE433713T1 (en) | 2009-07-15 |
| CA2347767C (en) | 2008-04-01 |
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| US7022127B2 (en) | 2006-04-04 |
| JP2009045475A (en) | 2009-03-05 |
| EP1024754B1 (en) | 2007-04-11 |
| US8182498B2 (en) | 2012-05-22 |
| EP1808135B1 (en) | 2009-06-17 |
| DE69840924D1 (en) | 2009-07-30 |
| CA2347767A1 (en) | 1999-05-06 |
| NL1007349C2 (en) | 1999-04-27 |
| AU742208B2 (en) | 2001-12-20 |
| ATE359030T1 (en) | 2007-05-15 |
| US6485496B1 (en) | 2002-11-26 |
| JP2001520908A (en) | 2001-11-06 |
| DE69837554T2 (en) | 2007-12-27 |
| US20030055441A1 (en) | 2003-03-20 |
| CA2617275A1 (en) | 1999-05-06 |
| US20040215221A1 (en) | 2004-10-28 |
| EP1808135A1 (en) | 2007-07-18 |
| DK1808135T3 (en) | 2009-10-05 |
| WO1999021491A1 (en) | 1999-05-06 |
| US20030195534A1 (en) | 2003-10-16 |
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