ITMO20070050A1

ITMO20070050A1 - EQUIPMENT FOR ANASTOMOSIS INTERVENTIONS FOR THE FLUID LINK OF BODY TEXTILES SUCH AS BLOOD VESSELS, CABLE OR SIMILAR ORGANS

Info

Publication number: ITMO20070050A1
Authority: IT
Inventors: Carlo Angelo Adami; Roberto Calvi; Luciano Patorno; Giuseppe Tuscano
Original assignee: Carlo Angelo Adami; Roberto Calvi; Luciano Patorno; Giuseppe Tuscano
Priority date: 2007-02-15
Filing date: 2007-02-15
Publication date: 2008-08-16

Description

Descrizione di Brevetto per Invenzione Industriale avente per titolo: Description of Patent for Industrial Invention entitled:

“ATTREZZATURA PER INTERVENTI DI ANASTOMOSI PER IL COLLEGAMENTO FLUIDICO DI TESSUTI CORPOREI QUALI VASI SANGUIGNI, ORGANI CAVI O SIMILI”. “EQUIPMENT FOR ANASTOMOSIS INTERVENTIONS FOR THE FLUID CONNECTION OF BODY TISSUES SUCH AS BLOOD VESSELS, HOLLOW ORGANS OR SIMILAR”.

DESCRIZIONE DESCRIPTION

La presente invenzione si riferisce ad un’attrezzatura per interventi di anastomosi per il collegamento fluidico di tessuti corporei quali vasi sanguigni, organi cavi o simili. The present invention refers to an equipment for anastomosis operations for the fluidic connection of body tissues such as blood vessels, hollow organs or the like.

L’anastomosi dei vasi sanguigni è attualmente tra le procedure di chirurgia vascolare più praticate. Blood vessel anastomosis is currently one of the most widely practiced vascular surgery procedures.

Lo scopo principale dell’anastomosi vascolare è quello di creare o ristabilire un collegamento fluidico tra tessuti corporei quando questo è compromesso da un'occlusione, da una stenosi o da una patologia di altro tipo. The main purpose of the vascular anastomosis is to create or re-establish a fluid connection between body tissues when this is compromised by an occlusion, stenosis or other type of pathology.

E’ attualmente noto effettuare la maggior parte degli interventi di anastomosi mediante sutura manuale dei vasi da collegare. It is currently known to carry out most of the anastomotic interventions by manually suturing the vessels to be connected.

Nonostante il perfezionamento nel corso degli anni delle tecniche di esecuzione, delle attrezzature e dei materiali utilizzati per la sutura, tale metodo non risulta comunque privo di inconvenienti. Despite the improvement over the years of the execution techniques, equipment and materials used for suturing, this method is not without its drawbacks.

In particolare, si sottolinea il fatto che tale tipologia di intervento deve essere praticata mediante sistemi chirurgici invasi, ossia che prevedono il taglio dei tessuti epidermici del paziente dall’esterno, fino al raggiungimento della zona di intervento. In particular, it is emphasized that this type of intervention must be carried out using invasive surgical systems, that is, which involve cutting the patient's epidermal tissues from the outside, until the intervention area is reached.

Siffatta metodologia di applicazione risulta dunque particolarmente traumatica per i pazienti, sui quali restano evidenti ed inestetiche cicatrici al termine dell’operazione. This method of application is therefore particularly traumatic for patients, on whom scars remain evident and unsightly at the end of the operation.

Non bisogna dimenticare, inoltre, che l’applicazione manuale delle suture richiede tempi di esecuzione non trascurabili ed una notevole abilità ed esperienza da parte del medico chirurgo. Furthermore, it should not be forgotten that the manual application of the sutures requires significant execution times and considerable skill and experience on the part of the surgeon.

È necessario, del resto, che il paziente sia precedentemente sottoposto ad anestesia totale, con i conseguenti disagi e scomodità che essa comporta sia per il paziente sia per il personale medico. Moreover, it is necessary that the patient is previously subjected to total anesthesia, with the consequent discomfort and inconvenience that this entails both for the patient and for the medical staff.

Il crescente interesse verso una chirurgia cardiovascolare meno problematica ha portato allo studio di soluzioni alternative che non prevedono la sutura e che sono attuabili in modo più veloce, più semplice e meno traumatico per il paziente. The growing interest in a less problematic cardiovascular surgery has led to the study of alternative solutions that do not involve suturing and that are feasible in a faster, simpler and less traumatic way for the patient.

Tali soluzioni prevedono l’attuazione di particolari tecniche quali, ad esempio, la saldatura laser o la saldatura mediante collanti o, in alternativa, l'utilizzo di particolari dispositivi quali, ad esempio, anelli, stent o clips. These solutions provide for the implementation of particular techniques such as, for example, laser welding or welding using glues or, alternatively, the use of particular devices such as, for example, rings, stents or clips.

Anche queste soluzioni alternative, tuttavia, devono essere eseguite mediante interventi chirurgici invasivi in sala operatoria, che comportano tutti i sopraccitati inconvenienti connessi alla necessità di praticare tagli sul paziente e di sottoporlo ad anestesia totale. Even these alternative solutions, however, must be performed through invasive surgical interventions in the operating room, which involve all the aforementioned drawbacks connected with the need to make cuts on the patient and subject him to total anesthesia.

Nessuna delle soluzioni alternative attualmente sviluppate, inoltre, è risultata sufficientemente performante e clinicamente longeva da raggiungere una significativa diffusione nell’ambito della chirurgia vascolare. Furthermore, none of the alternative solutions currently developed have been found to be sufficiently performing and clinically long-lived to achieve significant diffusion in the field of vascular surgery.

Per tale motivo, la sutura manuale continua ad essere l’approccio in generale più utilizzato per gli interventi di anastomosi vascolare. For this reason, manual suturing continues to be the most commonly used approach in general for vascular anastomosis operations.

Il compito principale del presente trovato è quello di escogitare un’attrezzatura per interventi di anastomosi per il collegamento fluidico di tessuti corporei quali vasi sanguigni, organi cavi o simili, che sia di ridotta invasività e non comporti la necessità di anestetizzare tutto il corpo del paziente. The main task of the present invention is to devise an equipment for anastomosis operations for the fluidic connection of body tissues such as blood vessels, hollow organs or the like, which is of reduced invasiveness and does not involve the need to anesthetize the patient's entire body. .

Nell’ambito di tale compito tecnico, altro scopo del trovato è quello di escogitare un’attrezzatura sicura, affidabile nel tempo e, al contempo, di facile e rapido utilizzo. Within the scope of this technical task, another object of the invention is to devise an equipment that is safe, reliable over time and, at the same time, easy and quick to use.

Ulteriore scopo del presente trovato è quello di escogitare un'attrezzatura che consenta di superare i menzionati inconvenienti della tecnica nota nell’ambito di una soluzione semplice, razionale e dal costo contenuto. Gli scopi sopra esposti sono tutti raggiunti dalla presente attrezzatura per interventi di anastomosi per il collegamento fluidico di tessuti corporei quali vasi sanguigni, organi cavi o simili, caratterizzata dal fatto che comprende almeno un catetere endovascolare inseribile nel corpo del paziente e prowisto di mezzi di anastomosi di almeno un primo vaso sostanzialmente tubolare del corpo del paziente con almeno un secondo vaso sostanzialmente tubolare del corpo del paziente. A further object of the present invention is to devise an equipment that allows to overcome the aforementioned drawbacks of the prior art within the context of a simple, rational and low cost solution. The above objects are all achieved by the present equipment for anastomosis operations for the fluidic connection of body tissues such as blood vessels, hollow organs or the like, characterized in that it comprises at least one endovascular catheter which can be inserted into the patient's body and is provided with anastomosis means. of at least a first substantially tubular vessel of the patient's body with at least a second substantially tubular vessel of the patient's body.

Altre caratteristiche e vantaggi del presente trovato risulteranno maggiormente evidenti dalla descrizione di una forma di esecuzione preferita, ma non esclusiva, di un’attrezzatura per interventi di anastomosi per il collegamento fluidico di tessuti corporei quali vasi sanguigni, organi cavi o simili, illustrata a titolo indicativo, ma non limitativo, nelle unite tavole di disegni in cui: Other characteristics and advantages of the present invention will become more evident from the description of a preferred, but not exclusive, embodiment of an equipment for anastomosis operations for the fluidic connection of body tissues such as blood vessels, hollow organs or the like, illustrated by way of title indicative, but not limiting, in the accompanying tables of drawings in which:

la figura 1 è una vista longitudinale del primo elemento tubolare dell’attrezzatura secondo il trovato in fase di applicazione in un primo vaso del corpo umano; Figure 1 is a longitudinal view of the first tubular element of the equipment according to the invention being applied in a first vessel of the human body;

la figura 2 è una vista longitudinale del secondo elemento tubolare dell’attrezzatura secondo il trovato in fase di applicazione nel primo vaso; la figura 3 è una vista in sezione lungo il piano III - III di figura 2. Figure 2 is a longitudinal view of the second tubular element of the equipment according to the invention in the application phase in the first vessel; Figure 3 is a sectional view along the plane III - III of Figure 2.

la figura 4 è una vista longitudinale del terzo elemento tubolare dell’attrezzatura secondo il trovato in fase di applicazione nel primo vaso; la figura 5 è una vista longitudinale del quarto elemento tubolare dell’attrezzatura secondo il trovato in fase di introduzione nel primo vaso; la figura 6 è una vista in sezione longitudinale di un particolare del quarto elemento tubolare di figura 5; Figure 4 is a longitudinal view of the third tubular element of the equipment according to the invention being applied in the first vessel; Figure 5 is a longitudinal view of the fourth tubular element of the equipment according to the invention in the phase of introduction into the first vessel; figure 6 is a longitudinal section view of a detail of the fourth tubular element of figure 5;

la figura 7 è una vista in sezione lungo il piano VII - VII di figura 5; Figure 7 is a sectional view along the plane VII - VII of Figure 5;

la figura 8 è una vista longitudinale del quarto elemento tubolare di figura 5 in fase di orientazione verso un secondo vaso; figure 8 is a longitudinal view of the fourth tubular element of figure 5 in the orientation phase towards a second vessel;

la figura 9 è una vista longitudinale del quarto elemento tubolare di figura 5 in fase di perforazione del secondo vaso; figure 9 is a longitudinal view of the fourth tubular element of figure 5 during the drilling step of the second vessel;

la figura 10 è una vista in sezione longitudinale del primo e del secondo vaso posti in comunicazione mediante l’attrezzatura secondo il trovato. Con particolare riferimento a tali figure, si è indicato globalmente con 1 un’attrezzatura per interventi di anastomosi per il collegamento fluidico di tessuti corporei quali vasi sanguigni, organi cavi o simili. Figure 10 is a longitudinal section view of the first and second vessels placed in communication by means of the equipment according to the invention. With particular reference to these figures, the number 1 globally indicates an equipment for anastomosis operations for the fluidic connection of body tissues such as blood vessels, hollow organs or the like.

L’attrezzatura 1 comprende una pluralità di cateteri 2a, 2b, 2c e 2d inseribili nel corpo del paziente per via endovascolare e provvisti di mezzi di anastomosi 3a, 3b, 3c e 3d atti al collegamento fluidico di un primo vaso Vi del corpo del paziente, di forma sostanzialmente tubolare, con un secondo vaso V2, anch’esso sostanzialmente tubolare e posto in prossimità del primo vaso \Λ] . The equipment 1 comprises a plurality of catheters 2a, 2b, 2c and 2d which can be inserted into the patient's body by endovascular route and provided with anastomosis means 3a, 3b, 3c and 3d suitable for the fluidic connection of a first vessel Vi of the patient's body , substantially tubular in shape, with a second vessel V2, also substantially tubular and placed in proximity to the first vessel \ Λ].

A tale proposito si sottolinea il fatto che nella presente trattazione con il termine vaso si intende non solo un generico vaso sanguineo del corpo umano, ma anche un qualunque organo anatomico cavo di forma tubolare, come ad esempio la bocca dell’intestino e dello stomaco. In this regard, it is emphasized that in the present discussion the term vessel means not only a generic blood vessel of the human body, but also any tubular hollow anatomical organ, such as the mouth of the intestine and stomach.

In dettaglio, uno dei cateteri consiste in un primo elemento tubolare 2a inseribile nel primo vaso Vi, e i mezzi di anastomosi comprendono un elemento di occlusione 3a, che può essere trasportato dal primo elemento tubolare 2a ed è atto all’otturazione della luce di passaggio attraverso il primo vaso V 1. In detail, one of the catheters consists of a first tubular element 2a which can be inserted into the first vessel Vi, and the anastomosis means comprise an occlusion element 3a, which can be transported by the first tubular element 2a and is suitable for obstructing the passageway through the first vase V 1.

L’elemento di occlusione 3a consiste in un primo organo espandibile 4 associabile all’estremità libera del primo elemento tubolare 2a per interposizione di mezzi di attacco e di distacco 5, azionabili a comando. The occlusion element 3a consists of a first expandable member 4 that can be associated with the free end of the first tubular element 2a by interposition of attachment and detachment means 5, which can be operated on command.

Nella particolare forma di attuazione del trovato illustrata in figura 1, il primo organo espandibile 4 è definito da un primo palloncino gonfiabile, che a riposo è alloggiato all’interno di una nicchia ricavata sulla superficie del primo elemento tubolare 2a e che è associabile ad un primo condotto di alimentazione 6 di un fluido in pressione ricavato lungo il primo elemento tubolare 2a. In the particular embodiment of the invention illustrated in Figure 1, the first expandable member 4 is defined by a first inflatable balloon, which at rest is housed inside a niche formed on the surface of the first tubular element 2a and which can be associated with a first supply duct 6 for a pressurized fluid formed along the first tubular element 2a.

Utilmente, il primo condotto di alimentazione 6 comprende un ago di gonfiaggio 7, che è montato sull’estremità libera del primo elemento tubolare 2a ed è inseribile in un elemento valvolare 8 di tenuta, associato al primo organo espandibile 4. Conveniently, the first supply duct 6 comprises an inflation needle 7, which is mounted on the free end of the first tubular element 2a and can be inserted in a valve sealing element 8, associated with the first expandable member 4.

Tramite l’ago di gonfiaggio 7, l’elemento valvolare 8 è accoppiabile/separabile col/dal primo condotto di alimentazione 6. Through the inflation needle 7, the valve element 8 can be coupled / separable with / from the first supply duct 6.

Quando l’ago di gonfiaggio 7 è inserito nell’elemento valvolare 8, il fluido in pressione può essere spinto all’interno del primo organo espandibile 4 al fine di gonfiarlo contro la superficie interna del primo vaso Vi ed ostruirne il passaggio o, viceversa, può essere aspirato dal primo organo espandibile 4 al fine di sgonfiarlo. When the inflation needle 7 is inserted in the valve element 8, the pressurized fluid can be pushed inside the first expandable member 4 in order to inflate it against the internal surface of the first vessel Vi and obstruct its passage or, vice versa, it can be aspirated by the first expandable member 4 in order to deflate it.

Quando, invece, l’ago di gonfiaggio 7 è separato dall’elemento valvolare 8, quest’ultimo impedisce la fuoriuscita del fluido e mantiene in pressione il primo organo espandibile 4. When, on the other hand, the inflation needle 7 is separated from the valve element 8, the latter prevents the fluid from escaping and keeps the first expandable member 4 under pressure.

Non si eludono, tuttavia, alternative forme di attuazione del presente trovato in cui il primo organo espandibile 4 sia di forma e natura differente rispetto al primo palloncino gonfiabile illustrato in figura 1 e, ad esempio, consista in un diaframma in materiale elastico applicabile e prelevabile a comando dal primo elemento tubolare 2a. However, alternative embodiments of the present invention are not avoided in which the first expandable member 4 is of a different shape and nature with respect to the first inflatable balloon illustrated in Figure 1 and, for example, consists of a diaphragm made of elastic material that can be applied and taken away. on command from the first tubular element 2a.

Vantaggiosamente sono previsti mezzi di posizionamento temporaneo 9 atti a stabilizzare e mantenere il primo elemento tubolare 2a sostanzialmente coassiale al primo vaso V1. Advantageously, temporary positioning means 9 are provided which are suitable for stabilizing and maintaining the first tubular element 2a substantially coaxial to the first vessel V1.

I mezzi di posizionamento temporaneo 9 consistono in una pluralità di secondi organi espandibili 10 associati alla superficie laterale del primo elemento tubolare 2a ed atti a riscontrare contro la superficie interna del primo vaso V1. The temporary positioning means 9 consist of a plurality of second expandable members 10 associated with the lateral surface of the first tubular element 2a and adapted to abut against the internal surface of the first vessel V1.

I secondi organi espandibili 10 sono definiti da una serie di secondi palloncini gonfiabili, che a riposo sono alloggiati all’interno di corrispondenti nicchie ricavate sulla superficie laterale del primo elemento tubolare 2a e sono associati ad un secondo condotto di alimentazione 11 di un fluido in pressione ricavato lungo il primo elemento tubolare 2a. The second expandable members 10 are defined by a series of second inflatable balloons, which at rest are housed inside corresponding niches formed on the lateral surface of the first tubular element 2a and are associated with a second supply duct 11 for a pressurized fluid obtained along the first tubular element 2a.

Per mezzo dei secondi palloncini gonfiabili 10, il primo elemento tubolare 2a può essere centrato all’interno del primo vaso Vi per collocare con precisione il primo organo espandibile 4 al centro del vaso stesso. By means of the second inflatable balloons 10, the first tubular element 2a can be centered inside the first vessel Vi to accurately place the first expandable organ 4 in the center of the vessel itself.

Un altro dei cateteri dell’attrezzatura 1 consiste in un secondo elemento tubolare 2b inseribile nel primo vaso V1 , i cui mezzi di anastomosi comprendono una testa di taglio 3b associata all’estremità libera del secondo elemento tubolare 2b ed atta a praticare un’apertura A attraverso il primo vaso V1. Another of the catheters of the equipment 1 consists of a second tubular element 2b which can be inserted in the first vessel V1, the anastomosis means of which comprise a cutting head 3b associated with the free end of the second tubular element 2b and capable of making an opening A through the first vessel V1.

La testa di taglio 3b è provvista di una lama 12, che può essere posizionata trasversalmente alla parete del primo vaso V1 tramite mezzi di movimentazione della lama 12 tra una configurazione di riposo, in cui essa è retratta all’interno della testa di taglio 3b, ed una configurazione di lavoro, in cui la lama 12 è in aggetto dalla superficie laterale della testa di taglio 3b. The cutting head 3b is provided with a blade 12, which can be positioned transversely to the wall of the first vessel V1 by means of moving the blade 12 between a rest configuration, in which it is retracted inside the cutting head 3b, and a working configuration, in which the blade 12 projects from the lateral surface of the cutting head 3b.

Tali mezzi di movimentazione non sono illustrati nelle figure. These handling means are not shown in the figures.

Utilmente, il secondo elemento tubolare 2b è provvisto di mezzi di avvicinamento ed allontanamento 13 della testa di taglio 3b rispetto alla superficie interna del primo vaso V1 , che permettono di mettere la lama 12 in contatto con il primo vaso V1. Conveniently, the second tubular element 2b is provided with means 13 for approaching and moving away the cutting head 3b with respect to the internal surface of the first vessel V1, which allow the blade 12 to be put in contact with the first vessel V1.

Tali mezzi di avvicinamento/allontanamento comprendono una pluralità di terzi organi espandibili 14 associati alla superficie laterale della testa di taglio 3b ed atti a riscontare contro la superficie interna del primo vaso Vi. I terzi organi espandibili 14 sono definiti da una serie di terzi palloncini gonfiabili che, a riposo, sono alloggiati all'interno di corrispondenti nicchie ricavate sulla testa di taglio 3b da parte diametralmente opposta rispetto alla lama 12, e che sono associati ad un terzo condotto di alimentazione 15 di un fluido in pressione ricavato lungo il secondo elemento tubolare 2b. Said approach / removal means comprise a plurality of third expandable members 14 associated with the lateral surface of the cutting head 3b and adapted to abut against the internal surface of the first vessel Vi. The third expandable members 14 are defined by a series of third inflatable balloons which, at rest, are housed inside corresponding niches formed on the cutting head 3b on the diametrically opposite side with respect to the blade 12, and which are associated with a third duct supply 15 of a pressurized fluid formed along the second tubular element 2b.

Un altro dei cateteri dell’attrezzatura 1 consiste in un terzo elemento tubolare 2c inseribile nel primo vaso V1, i cui mezzi di anastomosi comprendono una prima guaina 3c, in materiale elastico ed espandibile, che è associabile all'estremità libera del terzo elemento tubolare 2c e rilasciabile, in configurazione espansa, in corrispondenza del'apertura A del primo vaso V1. Another of the catheters of the equipment 1 consists of a third tubular element 2c which can be inserted in the first vessel V1, the anastomosis means of which comprise a first sheath 3c, made of elastic and expandable material, which can be associated with the free end of the third tubular element 2c and releasable, in an expanded configuration, at the opening A of the first vessel V1.

In dettaglio, all’estremità libera del terzo elemento tubolare 2c è montata una capsula 16 per il contenimento della prima guaina 3c in configurazione retratta. In detail, a capsule 16 is mounted at the free end of the third tubular element 2c to contain the first sheath 3c in the retracted configuration.

La capsula 16 può essere aperta a comando per il rilascio, e la contemporanea espansione, della prima guaina 3c all’interno del primo vaso V1. The capsule 16 can be opened on command for the release, and the simultaneous expansion, of the first sheath 3c inside the first vessel V1.

La prima guaina 3c consiste in un primo tratto 17a di condotto tubolare che, in configurazione espansa, è posizionabile a contatto contro la superficie interna del primo vaso V1 per aderire ad esso, e in un secondo tratto 17b di condotto tubolare che è associato trasversalmente al primo tratto 17a e che, in configurazione espansa, è posizionabile passante attraverso l’apertura A ricavata nel primo vaso V1. The first sheath 3c consists in a first section 17a of tubular duct which, in an expanded configuration, can be positioned in contact against the internal surface of the first vessel V1 to adhere to it, and in a second section 17b of tubular duct which is transversely associated with the first section 17a and which, in an expanded configuration, can be positioned passing through the opening A obtained in the first vessel V1.

In particolare, in configurazione espansa il secondo tratto 17b è inclinato rispetto al primo tratto 17a e rivolto verso il secondo vaso V2. In particular, in the expanded configuration the second section 17b is inclined with respect to the first section 17a and facing the second vessel V2.

Un altro dei cateteri dell’attrezzatura 1 consiste in un quarto elemento tubolare 2d, inseribile nel primo vaso V1 e provvisto di mezzi di orientazione 18 atti ad indirizzare il catetere stesso attraverso l’apertura A. Tali mezzi di orientazione comprendono una pluralità di fessure longitudinali 19 ricavate lungo la parete del quarto elemento tubolare 2d, ed una pluralità di fili 20 disposti all’interno delle fessure longitudinali 19. I fili 20 sono fissati all’estremità libera del quarto elemento tubolare 2d ed atti ad essere messi in trazione dall’esterno in modo indipendente uno dall’altro, così da far piegare concordemente il quarto elemento tubolare 2d. Another of the catheters of the equipment 1 consists of a fourth tubular element 2d, which can be inserted in the first vessel V1 and is provided with orienting means 18 able to direct the catheter itself through the opening A. Such orienting means comprise a plurality of longitudinal slits 19 obtained along the wall of the fourth tubular element 2d, and a plurality of threads 20 arranged inside the longitudinal slots 19. The threads 20 are fixed to the free end of the fourth tubular element 2d and are able to be put in traction from the outside independently of each other, so as to cause the fourth tubular element 2d to be folded in agreement.

Utilmente, il quarto elemento tubolare 2d è provvisto di mezzi di stabilizzazione temporanea 21, che permettono di dare stabilità all’elemento stesso all'interno del primo vaso Vi al fine di controllare con maggiore sensibilità e precisione l’orientazione della sua estremità libera verso l’apertura A. Conveniently, the fourth tubular element 2d is provided with temporary stabilization means 21, which allow to give stability to the element itself inside the first vessel Vi in order to control with greater sensitivity and precision the orientation of its free end towards the opening A.

I mezzi di stabilizzazione temporanea 21 comprendono una pluralità di quarti organi espandibili 22 associati alla superficie laterale del quarto elemento tubolare 2d ed atti a riscontrare contro la superficie interna del primo vaso V1. The temporary stabilization means 21 comprise a plurality of fourth expandable members 22 associated with the lateral surface of the fourth tubular element 2d and adapted to abut against the internal surface of the first vessel V1.

I quarti organi espandibili 22 sono definiti da una serie di quarti palloncini gonfiabili che a riposo sono alloggiati all’interno di corrispondenti nicchie ricavate sulla superficie laterale del quarto elemento tubolare 2d e sono associati ad un quarto condotto di alimentazione 23 di un fluido in pressione ricavato lungo il quarto elemento tubolare 2d. The fourth expandable members 22 are defined by a series of fourth inflatable balloons which at rest are housed inside corresponding niches formed on the lateral surface of the fourth tubular element 2d and are associated with a fourth supply duct 23 for a pressurized fluid obtained along the fourth tubular element 2d.

I mezzi di anastomosi 3d di cui è provvisto il quarto elemento tubolare 2d comprendono mezzi di perforazione 24 del secondo vaso V2, montati all'estremità libera del quarto elemento tubolare 2d ed atti a praticate sul secondo vaso V2 una fenditura F di passaggio, ed una seconda guaina 25, in materiale elastico ed espandibile, che è associabile all’estremità libera del quarto elemento tubolare 2d e rilasciabile in una configurazione espansa atta a mettere in collegamento fluidico l’apertura A con la fenditura F. The anastomosis means 3d with which the fourth tubular element 2d is provided comprise perforating means 24 of the second vessel V2, mounted at the free end of the fourth tubular element 2d and adapted to make a passage slit F on the second vessel V2, and a second sheath 25, made of elastic and expandable material, which can be associated with the free end of the fourth tubular element 2d and can be released in an expanded configuration capable of putting the opening A in fluidic connection with the slit F.

I mezzi di perforazione 24 sono costituiti, ad esempio, da un corpo appuntito posizionabile sostanzialmente sporgente dall’estremità libera del quarto elemento tubolare 2d. The drilling means 24 consist, for example, of a pointed body which can be positioned substantially protruding from the free end of the fourth tubular element 2d.

La seconda guaina 25 è costituita da un segmento di condotto, di forma tubolare, che è alloggiabile all’interno dell’estremità libera del quarto elemento tubolare 2d e, in configurazione espansa, è atta ad essere posta a contatto e a tenuta contro la superficie interna del secondo tratto 17b della prima guaina 3c. The second sheath 25 consists of a tubular-shaped duct segment, which can be housed inside the free end of the fourth tubular element 2d and, in an expanded configuration, is able to be placed in contact and sealed against the internal surface of the second section 17b of the first sheath 3c.

In corrispondenza dell’estremità distale, la seconda guaina 25 presenta mezzi di giunzione e sigillo 26 del segmento di condotto 25 al bordo della fenditura F. At the distal end, the second sheath 25 has means of junction and seal 26 of the segment of the duct 25 at the edge of the slot F.

I mezzi di giunzione e sigillo 26 consistono, ad esempio, in un sistema di attacco analogo a quello descritto nella domanda di brevetto internazionale No. PCT/IT99/00189. The joining and sealing means 26 consist, for example, of an attachment system similar to that described in the international patent application No. PCT / IT99 / 00189.

Il funzionamento del presente trovato è il seguente. The operation of the present invention is as follows.

Nel primo vaso Vi è introdotto Innanzitutto il primo elemento tubolare 2a, con il primo ed i secondi organi espandibili 4 e 10 in configurazione di riposo. First of all, the first tubular element 2a is introduced into the first vessel Vi, with the first and second expandable members 4 and 10 in the rest configuration.

Il primo elemento tubolare 2a è spinto lungo il primo vaso V1 fino al raggiungimento della zona di lavoro in prossimità del secondo vaso V2 dove, tramite il gonfiaggio dei secondi organi espandibili 10, viene stabilizzato alle pareti del primo vaso V1 e mantenuto ad esso coassiale. In tale configurazione si procede al gonfiaggio del primo organo espandibile 4 fino all’occlusione completa del primo vaso V1, così da impedire il passaggio di fluidi corporei che potrebbero ostacolare le successive fasi dell’intervento (figura 1). The first tubular element 2a is pushed along the first vessel V1 until it reaches the working area near the second vessel V2 where, by inflating the second expandable members 10, it is stabilized to the walls of the first vessel V1 and kept coaxial with it. In this configuration, the first expandable organ 4 is inflated until the first vessel V1 is completely occluded, so as to prevent the passage of body fluids that could hinder the subsequent stages of the operation (Figure 1).

Tramite i mezzi di attacco e di distacco 5, il primo elemento tubolare 2a si separa dall'elemento di occlusione 3a e, una volta sgonfiati i secondi organi espandibili 10, è estratto dal corpo del paziente lasciando il primo, organo espandibile 4 ad occludere il primo vaso V1. By means of the attachment and detachment means 5, the first tubular element 2a separates from the occlusion element 3a and, once the second expandable members 10 have been deflated, is extracted from the patient's body leaving the first expandable member 4 to occlude the first vase V1.

A questo punto è introdotto nel primo vaso V1 il secondo elemento tubolare 2b che trasporta la testa di taglio 3b, con la lama 12 in configurazione di riposo, fino in prossimità del primo organo espandibile 4. At this point the second tubular element 2b is introduced into the first vessel V1, which carries the cutting head 3b, with the blade 12 in the rest configuration, up to the proximity of the first expandable member 4.

Il secondo elemento tubolare 2b, dunque, può essere ruotato attorno al proprio asse al fine di indirizzare la lama 12 verso la parete del primo vaso V1 prospiciente al secondo vaso V2. The second tubular element 2b, therefore, can be rotated around its own axis in order to direct the blade 12 towards the wall of the first vessel V1 facing the second vessel V2.

A questo punto si comanda l’estrazione della lama 12 dalla testa di taglio 3b ed il gonfiaggio dei terzi organi espandibili 14, così da forzare la lama 12 a penetrare attraverso la parete del primo vaso V1. At this point, the extraction of the blade 12 from the cutting head 3b and the inflation of the third expandable members 14 are commanded, so as to force the blade 12 to penetrate through the wall of the first vessel V1.

Il trascinamento del secondo elemento tubolare 2b lungo il primo vaso V1 determina la formazione dell’apertura A, che si estende sostanzialmente parallela alla direzione longitudinale del primo vaso V1 (figura 2). The dragging of the second tubular element 2b along the first vessel V1 determines the formation of the opening A, which extends substantially parallel to the longitudinal direction of the first vessel V1 (Figure 2).

Una volta estratto il secondo elemento tubolare 2b, è possibile inserire il terzo elemento tubolare 2c che, all’interno della capsula 16, trasporta la prima guaina 3c fino in prossimità dell’apertura A. Once the second tubular element 2b has been extracted, it is possible to insert the third tubular element 2c which, inside the capsule 16, carries the first sheath 3c to the vicinity of the opening A.

All’apertura della capsula 16, la prima guaina 3c si espande in maniera controllata e si posiziona con il primo tratto 17a a contatto contro la superficie interna del primo vaso V1, e con il secondo tratto 17b che fuoriesce attraverso l’apertura A (figura 4). When the capsule 16 opens, the first sheath 3c expands in a controlled manner and is positioned with the first portion 17a in contact against the internal surface of the first vessel V1, and with the second portion 17b which emerges through the opening A (figure 4).

In seguito si procede con l’introduzione del quarto elemento tubolare 2d nel primo vaso V1, il gonfiaggio dei quarti organi espandibili 22 (figura 5) e la messa in trazione dei fili 20 per piegare l’estremità libera del quarto elemento tubolare 2d verso l’apertura A (figura 8). Then one proceeds with the introduction of the fourth tubular element 2d in the first vessel V1, the inflation of the fourth expandable members 22 (figure 5) and the traction of the wires 20 to bend the free end of the fourth tubular element 2d towards the opening A (figure 8).

Successivamente, il quarto elemento tubolare 2d viene spinto all’interno del secondo tratto 17b, previo sgonfiaggio dei quarti organi espandibili 22, fino a mettere in contatto i mezzi di perforazione 24 con il secondo vaso V2 e praticare su di esso la fenditura F. Subsequently, the fourth tubular element 2d is pushed inside the second section 17b, after deflation of the fourth expandable members 22, until the perforation means 24 come into contact with the second vessel V2 and make the slit F on it.

Durante la penetrazione del corpo appuntito 24 nel secondo vaso V2, la seconda guaina 25 viene trascinata all’esterno del quarto elemento tubolare 2d e si espande elasticamente, prendendo contatto con il bordo della fenditura F tramite i mezzi di giunzione e di sigillo 26 (figura 9). During the penetration of the pointed body 24 into the second vessel V2, the second sheath 25 is dragged outside the fourth tubular element 2d and expands elastically, making contact with the edge of the slit F through the joining and sealing means 26 (figure 9).

Una volta estratto il quarto elemento tubolare 2d, si reintroduce il primo elemento tubolare 2a nel primo vaso V1 e, con l’ausilio dei secondi organi espandibili 10, si collocano i mezzi di attacco e di distacco 5 sostanzialmente combacianti con l’elemento valvolare 8 per consentirne l’accoppiamento con l’ago di gonfiaggio 7. Once the fourth tubular element 2d has been extracted, the first tubular element 2a is reintroduced into the first vessel V1 and, with the aid of the second expandable members 10, the attachment and detachment means 5 are positioned substantially mating with the valve element 8 to allow coupling with the inflation needle 7.

Il successivo sgonfiaggio del primo e dei secondi organi espandibili 4 e 10 e la rimozione del primo elemento tubolare 2a dal corpo del paziente lasciano il primo ed il secondo vaso V1 e V2 in comunicazione fluidica tra loro (figura 10). The subsequent deflation of the first and second expandable members 4 and 10 and the removal of the first tubular element 2a from the patient's body leave the first and second vessels V1 and V2 in fluid communication with each other (Figure 10).

Si è in pratica constatato come il trovato descritto raggiunga gli scopi proposti. In practice it has been found that the described invention achieves the intended aim and objects.

Il trovato così concepito è suscettibile di numerose modifiche e varianti tutte rientranti nell’ambito del concetto inventivo. The invention thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the inventive concept.

Inoltre tutti i dettagli sono sostituibili da altri elementi tecnicamente equivalenti. Furthermore, all the details can be replaced by other technically equivalent elements.

In pratica i materiali impiegati, nonché le forme e le dimensioni contingenti, potranno essere qualsiasi a seconda delle esigenze senza per questo uscire dall’ambito di protezione delle seguenti rivendicazioni. In practice, the materials used, as well as the contingent shapes and dimensions, may be any according to requirements without thereby departing from the scope of the protection of the following claims.

Claims

CLAIMS 1) Equipment for anastomosis operations for the fluidic connection of body tissues such as blood vessels, hollow organs or the like, characterized in that it comprises at least one endovascular catheter that can be inserted into the patient's body and provided with anastomosis means of at least one substantially tubular first vessel of the patient's body with at least a second substantially tubular vessel of the patient's body.

2) Equipment according to claim 1, characterized in that it comprises a plurality of said catheters.

3) Equipment according to one or more of the preceding claims, characterized in that at least one of said catheters comprises a first tubular element that can be inserted in said first vessel, said anastomosis means comprising at least one element for occluding the passage opening through said first associable vessel at the free end of said first tubular element.

4) Equipment according to one or more of the preceding claims, characterized in that said occlusion element comprises at least a first expandable member that can be associated at the free end of said first tubular element.

5) Equipment according to one or more of the preceding claims, characterized in that said first expandable member comprises a first inflatable balloon which can be associated with at least a first supply duct for a pressurized fluid formed along said first tubular element.

6) Equipment according to one or more of the preceding claims, characterized in that said first supply duct comprises at least one inflation needle associated with said first tubular element.

7) Equipment according to one or more of the preceding claims, characterized in that said first expandable member comprises at least one valve sealing element which can be coupled with and separable from said first supply duct.

8) Equipment according to one or more of the preceding claims, characterized in that said first expandable member can be associated with said first tubular element by interposition of attachment and detachment means which can be operated on command.

9) Equipment according to one or more of the preceding claims, characterized in that said first tubular element comprises means for the temporary positioning of the substantially coaxial element itself within said first vessel.

10) Equipment according to one or more of the preceding claims, characterized in that said temporary positioning means comprise at least a second expandable member associated with the lateral surface of said first tubular element and adapted to abut against the internal surface of said first vessel.

11) Equipment according to one or more of the preceding claims, characterized in that said second expandable member comprises a second inflatable balloon associated with at least a second supply duct for a pressurized fluid formed along said first tubular element.

12) Equipment according to one or more of the preceding claims, characterized in that at least one of said catheters comprises a second tubular element which can be inserted in said first vessel, said anastomosis means comprising at least one cutting head associated with the free end of said second element tubular and suitable for making an opening on said first vessel.

13. Equipment according to one or more of the preceding claims, characterized in that said opening is substantially parallel to the longitudinal direction of said first vessel.

14) Equipment according to one or more of the preceding claims, characterized in that said cutting head comprises at least one blade which can be positioned substantially transversal to the wall of said first vessel.

15) Equipment according to one or more of the preceding claims, characterized in that said cutting head comprises means for moving said blade between a rest configuration, in which said blade is substantially retracted inside said cutting head, and a working configuration, in which said blade substantially protrudes from the lateral surface of said cutting head.

16) Equipment according to one or more of the preceding claims, characterized in that said second tubular element comprises means for approaching / moving away said cutting head with respect to the internal surface of said first vessel.

17) Equipment according to one or more of the preceding claims, characterized in that said approach / removal means comprise at least a third expandable member associated with the lateral surface of said cutting head and able to abut against the internal surface of said first vessel.

18) Equipment according to one or more of the preceding claims, characterized in that said third expandable member comprises a third inflatable balloon associated with at least a third supply duct for a pressurized fluid formed along said second tubular element.

19) Equipment according to one or more of the preceding claims, characterized in that at least one of said catheters comprises a third tubular element which can be inserted in said first vessel, said anastomosis means comprising at least a first expandable sheath, which can be associated with the free end of said third tubular and releasable element, in an expanded configuration, in correspondence with said opening of the first vessel.

20) Equipment according to one or more of the preceding claims, characterized in that said third tubular element comprises at least one containment capsule of said first sheath mounted at the free end of the element itself.

21) Equipment according to one or more of the preceding claims, characterized in that said first sheath is made of elastic material.

22) Equipment according to one or more of the preceding claims, characterized in that said first sheath comprises a first portion of conduit which can be positioned, in an expanded configuration, substantially in contact with the internal surface of said first vessel, and a second portion of conduit associated transversely said first section can be positioned, in an expanded configuration, substantially passing through said opening.

23) Equipment according to one or more of the preceding claims, characterized in that, in an expanded configuration, said second section is inclined with respect to said first section and turned towards said second vessel.

24) Equipment according to one or more of the preceding claims, characterized in that at least one of said catheters comprises a fourth tubular element which can be inserted in said first vessel and provided with orientation means suitable for directing the catheter itself through said opening, said anastomosis means comprising perforating means for said second vessel, mounted at the free end of said fourth tubular element and adapted to make a passage slit on said second vessel, and at least a second expandable sheath, which can be associated with the free end of said fourth tubular element and releasable in an expanded configuration adapted to put in fluidic connection said opening and said slit.

25) Equipment according to one or more of the preceding claims, characterized in that said orientation means comprise a plurality of longitudinal slots formed along the wall of said fourth tubular element, and a plurality of wires arranged inside said slots, associated with the free end of said fourth tubular element and adapted to be put in traction and to bend said fourth tubular element.

26) Equipment according to one or more of the preceding claims, characterized by the fact that said fourth tubular element comprises means of temporary stabilization of the element itself inside said first vessel.

27) Equipment according to one or more of the preceding claims, characterized in that said temporary stabilization means comprise at least a fourth expandable member associated with the lateral surface of said fourth tubular element and able to abut against the internal surface of said first vessel.

28) Equipment according to one or more of the preceding claims, characterized in that said fourth expandable member comprises a fourth inflatable balloon associated with at least a fourth supply duct for a pressurized fluid formed along said fourth tubular element.

29) Equipment according to one or more of the preceding claims, characterized by the fact that said drilling means comprise at least a pointed body that can be positioned substantially protruding from the free end of said fourth tubular element.

30) Equipment according to one or more of the preceding claims, characterized in that said second sheath is made of elastic material.

31) Equipment according to one or more of the preceding claims, characterized in that said second sheath can be housed inside the free end of said fourth tubular element.

32) Equipment according to one or more of the preceding claims, characterized in that said second sheath comprises a segment of conduit which can be positioned, in an expanded configuration, substantially in contact with the internal surface of said second section of the first sheath.

33) Equipment according to one or more of the preceding claims, characterized in that said second sheath comprises means for joining and sealing said segment at the edge of said slot.

34) Catheter for endoscopic surgical interventions, particularly inside blood vessels, hollow organs or the like, characterized in that it comprises at least one tubular element that can be inserted in a substantially tubular vessel of the patient's body, and at least one element for occluding the opening passage through said vessel which can be associated with the free end of said tubular element by interposition of attachment and detachment means which can be operated on command.

35) Catheter according to claim 34, characterized in that said occlusion element comprises at least a first expandable member.

36) Catheter according to one or more of claims 34 and 35, characterized in that the first expandable organ comprises a first inflatable balloon which can be associated with at least a first supply duct for a pressurized fluid formed along said tubular element.

37) Catheter according to one or more of claims 34 to 36, characterized in that said first supply duct comprises at least one inflation needle associated with said tubular element.

38) Catheter according to one or more of claims 34 to 37, characterized in that said first expandable member comprises at least one valve sealing element which can be coupled with and separable from said first supply duct.

39) Catheter according to one or more of claims 34 to 38, characterized in that it comprises means for the temporary positioning of said tubular element substantially coaxial inside said vessel.

40) Catheter according to one or more of claims 34 to 39, characterized in that said temporary positioning means comprise at least a second expandable member associated with the lateral surface of said tubular element and able to abut against the internal surface of said vessel.

41) Catheter according to one or more of claims 34 to 40, characterized in that said second expandable member comprises a second inflatable balloon associated with at least one second supply duct for a pressurized fluid formed along said tubular element.

42) Catheter for endoscopic surgical interventions, particularly inside blood vessels, hollow organs or the like, characterized in that it comprises at least one tubular element that can be inserted into a substantially tubular vessel of the patient's body, and at least one cutting head associated with the free end of said tubular element and adapted to make an opening on said vessel.

43) Catheter according to claim 42, characterized in that said opening is substantially parallel to the longitudinal direction of said vessel.

44) Catheter according to one or more of claims 42 and 43, characterized in that said cutting head comprises at least one cutting blade which can be positioned substantially transverse to the wall of said vessel.

45) Catheter according to one or more of claims 42 to 44, characterized in that said cutting head comprises means for moving said blade between a rest configuration, in which said blade is substantially retracted inside said cutting head , and a working configuration, in which said blade substantially protrudes from the lateral surface of said cutting head.

46) Catheter according to one or more of claims 42 to 45, characterized in that said tubular element comprises means for approaching / moving away said cutting head with respect to the wall of said vessel.

47) Catheter according to one or more of claims 42 to 46, characterized in that said approach / removal means comprise at least one expandable member associated with the lateral surface of said cutting head and able to abut against the internal surface of said vessel.

48) Catheter according to one or more of claims 42 to 47, characterized in that said expandable member comprises an inflatable balloon associated with at least one supply duct for a pressurized fluid formed along said tubular element.

49) Catheter for endoscopic surgical interventions, particularly inside blood vessels, hollow organs or the like, characterized in that it comprises at least one tubular element that can be inserted in a first substantially tubular vessel of the patient's body and provided with orientation means suitable for directing said tubular element through a lateral opening obtained in said first vessel.

50) Catheter according to claim 49, characterized in that said orientation means comprise a plurality of longitudinal slits formed along the wall of said tubular element, and a plurality of wires arranged inside said slots, associated with the free end of said tubular element and adapted to be put in traction and to fold said tubular element in concordance.

51) Catheter according to one or more of claims 49 and 50, characterized by the fact that said tubular element comprises means of temporary stabilization of the element itself inside said first vessel.

52) Catheter according to one or more of claims 49 to 51, characterized in that said temporary stabilization means comprise at least one expandable member associated with the lateral surface of said tubular element and able to abut against the internal surface of said first vessel.

53) Catheter according to one or more of claims 49 to 52, characterized in that said expandable member comprises an inflatable balloon associated with at least one supply duct for a pressurized fluid formed along said tubular element.

54) Catheter according to one or more of claims 49 to 53, characterized by the fact that it comprises means for perforating a second substantially tubular vessel of the patient's body, mounted at the free end of said tubular element and suitable for practicing on said second vessel a passage slit.

55) Catheter according to one or more of claims 49 to 54, characterized in that said perforation means comprise at least one pointed body which can be positioned substantially protruding from the free end of said tubular element.

56) Catheter according to one or more of claims 49 to 55, characterized in that at least a first expandable sheath is arranged in correspondence with said opening of the first vessel, comprising a first portion of duct positioned substantially in contact against the internal surface of said first vessel, and a second portion of duct associated transversely to said first portion and positioned substantially passing through said opening.

57) Catheter according to one or more of claims 49 to 56, characterized in that it comprises at least a second expandable sheath, associable with the free end of said tubular element and releasable in an expanded configuration suitable for putting said opening and said slit.

58) Catheter according to one or more of claims from 49 to 57, characterized in that said second sheath is made of elastic material.

59) Catheter according to one or more of claims 49 to 58, characterized by the fact that said second sheath can be housed inside the free end of said tubular element.

60) Catheter according to one or more of claims 49 to 59, characterized in that said second sheath comprises a segment of conduit which can be positioned, in an expanded configuration, substantially in contact with the internal surface of said second section of the first sheath.

61) Catheter according to one or more of claims from 49 to 60, characterized in that said second sheath comprises means for joining and sealing said segment at the edge of said slit.