比利时专利BE1024922B1 SYSTEM FOR ESTABLISHING A BIFURKETED STENT

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专利摘要:
The present invention provides a delivery system (100) for a bifurcated stent (200) having a shaft (226) and a pair of arms (220, 222), including a delivery catheter (110) comprising a first elongate tube (102) having a proximal end (20) and a distal end (30) and a bifurcated portion (114) at the distal end (30) configured to receive the arms (220, 222), a longitudinal slot ( 140) disposed on the bifurcated portion (114) being configured for releasable passage of the bifurcated stent (200) therethrough. A method for placing the bifurcated stent at a treatment site using the delivery system (100) is also disclosed.
公开号:BE1024922B1
申请号:E2017/5043
申请日:2017-01-25
公开日:2018-08-22
发明作者:Omer Faruk Eker；Kamil Jerzy Chodzynski
申请人:Omer Faruk Eker；Kamil Jerzy Chodzynski；
IPC主号:

专利说明:

(73) Holder (s):
EKER Orner Faruk 69003, LYON France
CHODZYNSKI Kamil Jerzy
7000, MONS
Belgium (72) Inventor (s):
EKER Orner Faruk 34090 MONTPELLIER France
CHODZYNSKI Kamil Jerzy
7000 MONS
Belgium (54) SYSTEM FOR PLACING A BIFURCED STENT (57) The invention describes a system for placing (100) a bifurcated stent (200) comprising a rod (226) and a pair of arms ( 220, 222), comprising a delivery catheter (110) comprising a first elongated tube (102) having a proximal end (20) and a distal end (30) and a bifurcated portion (114) at the distal end ( 30) configured to receive the arms (220, 222), a longitudinal slot (140) disposed on the bifurcated part (114) being configured for the releasable passage of the bifurcated stent (200) through the latter. A method for delivering the bifurcated stent to a treatment site using the delivery system (100) is also described.
100.
- /

130,
136
BELGIAN INVENTION PATENT
FPS Economy, SMEs, Middle Classes & Energy
Publication number: 1024922 Deposit number: BE2017 / 5043
Intellectual Property Office International Classification: A61F 2/90 A61F 2 / 91A61F 2/966 A61F 2/97 A61F 2/06 A61F 2/95 Date of issue: 08/22/2018
The Minister of the Economy,
Having regard to the Paris Convention of March 20, 1883 for the Protection of Industrial Property;
Considering the law of March 28, 1984 on patents for invention, article 22, for patent applications introduced before September 22, 2014;
Given Title 1 “Patents for invention” of Book XI of the Code of Economic Law, article XI.24, for patent applications introduced from September 22, 2014;
Having regard to the Royal Decree of 2 December 1986 relating to the request, the issue and the maintenance in force of invention patents, article 28;
Given the patent application received by the Intellectual Property Office on 25/01/2017.
Whereas for patent applications falling within the scope of Title 1, Book XI of the Code of Economic Law (hereinafter CDE), in accordance with article XI. 19, §4, paragraph 2, of the CDE, if the patent application has been the subject of a search report mentioning a lack of unity of invention within the meaning of the §ler of article XI.19 cited above and in the event that the applicant does not limit or file a divisional application in accordance with the results of the search report, the granted patent will be limited to the claims for which the search report has been drawn up.
Stopped :
First article. - It is issued to
EKER Orner Faruk, 80 Rue Antoine CHARIAL, Résidence Jean SORNAY Apartment 9, floor 4,69003 LYON France;
CHODZYNSKI Kamil Jerzy, Digue des Peupliers 86A, 7000 MONS Belgium;
represented by
VANHALST Koen Victor Rachel, Ed. Gevaertdreef 10a, 9830, ST MARTENS LATEM;
DE CLERCQ Ann, Ed. Gevaertdreef 10a, 9830, ST MARTENS LATEM;
GOESAERT Hans, Ed. Gevaertdreef 10a, 9830, ST MARTENS LATEM;
a Belgian invention patent with a duration of 20 years, subject to the payment of the annual fees referred to in article XI.48, §1 of the Code of Economic Law, for: SYSTEM FOR ESTABLISHING A BIFURCED STENT .
INVENTOR (S):
EKER Orner Faruk, Rue de l'Aiguelongue 369 Apartment 11, 34090, MONTPELLIER;
CHODZYNSKI Kamil Jerzy, Digue des Peupliers 86A, 7000, MONS;
PRIORITY (S):
01/19/2017 EP 17290006.0;
DIVISION:
divided from the basic application: filing date of the basic application:
Article 2. - This patent is granted without prior examination of the patentability of the invention, without guarantee of the merit of the invention or of the accuracy of the description thereof and at the risk and peril of the applicant (s) ( s).
Brussels, 08/22/2018, By special delegation:
B E2017 / 5043
SYSTEM FOR PLACING A BIFURCED STENT
Field of the invention
We describe here a system for placing a bifurcated stent and a method for the treatment of an artery (for example in the case of an aneurysm or occlusion) located at the bifurcation of an artery. The system and method can be deployed for occlusions or aneurysms developed on bifurcations, with intracranial or extracranial localization (that is to say aortic or peripheral aneurysms).
Invention background
An intracranial aneurysm is a sacciform, or more rarely fusiform, dilation of a cerebral artery, due to biological structural alterations in the arterial wall. It is responsible for a weakening of the wall which risks breaking if it is not treated and consequently for intracranial hemorrhage (subarachnoid and / or intraparenchymal hemorrhage). In young populations, intracranial aneurysmal disease represents the most frequent predisposition to a fatal risk, with an estimated incidence of 5-7 cases per 100,000 people per year and a prevalence between 2 and 5%. It is the major cause of hemorrhagic stroke and is responsible for a decrease in life expectancy and potentially severe disabilities affecting quality of life. The death rate from subarachnoid hemorrhage following rupture of an intracranial aneurysm is estimated to be 45-50% at 30 days. The associated morbidity is estimated to be 25-30%, with dependence in almost 30% of patients at one year despite early and appropriate treatment. The risk of rupture of an unruptured intracranial aneurysm is difficult to estimate and varies between 0.4% and 17.8% at five years. It is increased by the following factors;
B E2017 / 5043 age, sex, hypertension, smoking, size of the aneurysm and its location in the posterior circulation. Finally, aneurysm rupture and its complications have a considerable economic impact in terms of costs related to the management of the acute phase, neurological deficits and / or subsequent dependence. In Europe alone, thirty-five to thirty-seven million people may have intracranial aneurysms. In France alone, six thousand intracranial hemorrhages following ruptured intracranial aneurysms appear each year.
The main objective of the treatment of intracranial aneurysm, whatever the method chosen, is to exclude malformative ectasia from the blood circulation. Most of the current practices for the treatment of intracranial aneurysms are based on methods based on endovascular catheters, essentially represented by the filling of the aneurysm with a filling material (the technique known as "coiling" (laying of turns) with turns in platinum and / or cellulose acetate polymer). The deployment of filling material inside the aneurysm can be associated with the inflation of a balloon inside the arterial lumen during the deployment of the filling material (method called "balloon remodeling" (reconstruction of the artery using a balloon)) or the deployment of a stent inside the artery, covering the neck of the aneurysm (method called "stent assisted coiling" (placement of turns assisted by stent )) in order to prevent its protrusion in the artery. It results in thrombus formation inside the aneurysm and its exclusion from the bloodstream. These techniques quickly became the standard methods of choice for intracranial treatment. The traditional clipping strategy
BE2017 / 5043 Surgical consists of placing an aneurysmal clip around the aneurysm to prevent the circulation of blood in the aneurysm. This technique is more invasive and less and less practiced because of its high risk, especially for elderly patients or patients with medical complications.
The methods described above are linked to a device remaining permanently in place in the body for the treatment of an aneurysm or linked device can autodissolution of its temporary deployment in the lumen of the arterial bifurcation and then its recovery for the treatment of arterial occlusion. For the first objective, the very recent invention of biodegradable polymers can solve a problem and be eliminated from the body by biopolymers over time or dissolution by means of chemical components. For the second objective, the stent can be deployed and remain permanently in the body in the case of arterial stenosis and therefore it has the same material characteristics as those indicated above, except for its design (laser cutting instead of lattice braided).
Despite significant advances and the paradigm shift introduced in the management of intracranial aneurysms by endovascular techniques, bifurcated aneurysms and in particular those with a wide neck or a neck encompassing one or both of the divisional branches remain a challenge for their treatment. Another possibility for these aneurysms is stenting techniques. Many strategies are currently being used to treat intracranial bifurcation aneurysms with the stent designs available today (stents either formed by laser cutting or braided mesh)
BE2017 / 5043 including: techniques of coiling assisted by stent, stent in Y, stent in T or “crush-stent”. With stents, a common approach is to place the stent (stent either formed by laser cutting or braided) in the main artery and one of its branches (more commonly the largest branch or the most affected branch by the aneurysm) before (method of imprisonment) or after coiling of the aneurysmal sac. If the first deployed stent is not effective enough to prevent protrusion of the coil into the arterial lumen, a second stent is deployed inside the first stent and the second branch (technique known as a Y stent). The latter technique can be used as the first option depending on the arterial anatomy and access difficulties. However, with methods, the quantity of material inside the arterial lumen and precisely on the arterial branch (s) are sources of thromboembolic complications, increased in Y stent techniques, stents in T and "crushstent". Recently, the flow diversion technique, based on the deployment of a flow diverting stent inside the mother artery and the flow interruption technique based on the deployment of an intrasaccular flow switch device at the interior of the aneurysm have also become options for these aneurysms which 'represent a challenge. Due to the greater amount of material in their design, flow deflecting stents are at higher risk for thromboembolic complications. In addition, in arterial bifurcation the flow deflecting stent inside the arterial lumen covers not only the lateral perforators, but also the dividing branch, which can compromise open bite in the long term. The flow interrupting device method consists of a frame, based on the same braided mesh as braided stents, which is deployed in the aneurysmal sac
B E2017 / 5043 in order to fill it, then to stop the circulation inside the aneurysmal sac and to promote intrasaccular thrombosis. This method is limited either by the incomplete occlusion of the aneurysm at the level of its collar, or by the protrusion of the frame in the arterial lumen, which requires the placement of a secondary recovery stent. These limitations are due to the design of the chassis which, in most cases, despite its compliance, does not allow the device to conform perfectly to the collar and the wall of the aneurysm.
An object of the invention is to overcome the problems encountered in the art. Another aim is to provide new therapies for a certain type of intracranial aneurysms localized at the bifurcation of an artery, for which current therapies are widely considered to be inadequate.
Summary of the invention
Here we describe a delivery system 100 of a bifurcated stent 200 comprising a rod 226 and a pair of arms 220, 222, comprising a delivery catheter 110 comprising a first elongated tube 102 having a proximal end 20 and a distal end 30 and a bifurcated portion 114 at the distal end 30 configured to receive the arms 220, 222, a longitudinal slot 140 disposed on the bifurcated portion 114 being configured for the releasable passage of the bifurcated stent 200 therethrough.
The longitudinal slot can extend from a first member 120 to a second member 122 of the bifurcated part 114.
The bifurcated portion 114 of the first tube 102 may include a first member 120 and a second member
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122, each configured for passage through a branch 422, 424 of a bifurcated body vessel.
The first member 120 and the second member 122 can each be configured to compress the bifurcated stent 200 radially.
The delivery system 100 may further comprise an access catheter 300 comprising a second elongated tube 302 having a proximal end 20 and a distal end 30, having a second lumen 330 adapted to receive by sliding the first tube 102, and configured for adjustment of a gradual opening or gradual folding of the bifurcated portion 114 of the first tube 102 in response to a sliding, responding, relative movement of the first tube 102 and the second tube 302.
The delivery catheter 110 can be configured for a quick-change or over-the-wire procedure.
The delivery system 100 may further include the bifurcated stent 200 which is self-expanding. The bifurcated stent 200 may be provided with an active pharmaceutical component which can be eluted, having optionally an antithrombotic activity, or an anticoagulant property, or an endothelization property, or which is a stimulant of cell migration, or a stimulant of cell growth. The bifurcated stent 200 can be produced by laser cutting or braiding.
The delivery system 100 may further comprise a pusher 500 comprising an elongated flexible rod 510 having a proximal end 20 and a distal end 30, and a capture element 520 at the distal end 30 for the releasable attachment to the
B E2017 / 5043 bifurcated stent 200 at its proximal end 20, which capture element 520 is radially self-expanding to adopt an open or folded configuration, the folded configuration being configured for passage through the first lumen 230 of the first tube 102 and the peripheral edges of the capture element 520 being brought closer to one another to grip the proximal end 20 of the bifurcated stent 200, and the open configuration being configured for the release of the bifurcated stent 200.
The delivery system 100 may further include a charger 600 for loading the bifurcated stent 200 into the delivery catheter 110, comprising a third elongated tube 602 having a proximal end 20 and a distal end 30, provided with a third lumen 630 adapted to slide the bifurcated stent 200 in the folded configuration, the distal end 30 of the third tube 602 being configured to connect to the proximal terminal end of the delivery catheter 110 so that the first lumen 130 and third lumen 630 are connected to form a continuous path for advancement of the bifurcated stent 200 in the folded state, from the charger 600 to the delivery catheter 110.
A kit is described here comprising the delivery catheter 110 as defined here, and one or more of the following:
an access catheter 300 as defined here,
- a bifurcated stent 200 as defined here,
a pusher 500 as defined here,
- a charger 600 as defined here and
- one or more guide wires.
We describe here a process for the placement of a bifurcated stent at a treatment site, using the
B E2017 / 5043 positioning system 100 as defined here, comprising the steps:
- intravascular advancement of the delivery catheter 110 loaded with the bifurcated stent 200 to the treatment site through the access catheter 300,
- gradual opening of the delivery catheter 110 by withdrawal of the access catheter 300, and
deployment of the bifurcated stent 200 through the slot 140 by withdrawal of the delivery catheter 110. The treatment can be an arterial aneurysm or an arterial occlusion.
Legends of figures
FIG. 1 Schematic view of a delivery catheter as described here. Parts A, B and B 'show a cross-sectional view through the members at the planes B and B', and of the main part at the plane A, respectively. Parts B-1 and B'-1 show a slit with facing edges, and parts B-2 and B'-2 show a slit with overlapping edges.
FIG. 2 Schematic view of a bifurcated stent as described here.
FIG. 3 Parts A to C Sequence of gradual unfolding (opening) of the delivery catheter by sliding movement of the access catheter.
FIG. 4 Parts A to D Sequence of placement and unfolding (opening) of the delivery catheter at the treatment site, and deployment of the bifurcated stent.
FIG. 5 shows a pusher comprising a capture element in an open configuration.
FIG. 6 shows the pusher of FIG. 5 in alignment abutting with a bifurcated stent.
FIGS. 7A to 7C show a loading sequence for loading a bifurcated stent into the limbs of a delivery catheter.
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FIGS. 8A to 8E show a loading sequence for loading a bifurcated stent into a first lumen of a delivery catheter.
Parts A and B of FIG. 9 show a sequence of deployment of the bifurcated stent using the pusher.
Parts A to H of FIG. 10 show different configurations of bifurcated stents.
Detailed description of the invention
Before describing the present system and the present method of the invention, it should be understood that the present invention is not limited to the particular systems and methods described or particular combinations described, since these systems and methods and combinations can, naturally, vary. It should also be understood that the terminology used here should not be considered as limiting, since the scope of the present invention will only be limited by the claims appended hereto.
As used herein, the singular forms "one", "one" and "the" include both singular and plural referents, unless the context clearly indicates otherwise.
As used "includes" and "including", "contains" and here, the "compound" includes "are inclusive terms" comprising ", of" are synonymous or "containing", or flexible and not excluding additional members, elements or process steps, not stated. Note that the terms "comprising", "comprises" and "composed of", as used herein, include the terms "consisting of", "consists" and "consisting of".
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The statement of numerical ranges by endpoints includes all the numbers and fractions subsumed in the respective ranges, in the same way as the stated endpoints.
As used herein, the term "approximately" or "approximately", when referring to a measurable value such as a parameter, quantity, duration and the like, should be understood to include variations of ± 10% or less, preferably ± 5% or less, more particularly preferably ± 1% or less and even more particularly preferred ± 0.1% or less of and from the specified value, insofar as such variations are appropriate for the implementation in the invention described. It should be understood that the value to which the modifier "about" or "approximately" refers is itself specifically, and preferably, described.
Whereas, as used here, the expressions "one or more" or "at least one", such as one or more or at least one (s) member (s) of a group of members, it is clear in itself, by way of further exemplification, that the expression includes inter alia a reference to any one of said members, or to two or more of any two of said members, such as for example at> 3 ,> 4,> 5,> 6 or> 7, etc. any of said members, and up to all of said members.
All the references cited in the present description are incorporated here in their entirety by reference. In particular, the teachings of all references specifically mentioned here are incorporated by reference.
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Unless otherwise indicated, all terms used in the description of the invention, including scientific and technical terms, have the meaning as commonly understood by the ordinary person skilled in the art to which the present invention belongs. For further information, definitions of terms are included for a better appreciation of the teachings of the present invention.
In the following passages, various aspects of the invention are defined in more detail. Each aspect thus defined can be combined with another aspect or other aspects, unless clearly indicated otherwise. In particular, any feature indicated as being preferred or advantageous can be combined with any other feature or any other feature indicated (s) as being preferred or advantageous.
Throughout this description, a reference to "an embodiment" or "a (number) embodiment" means that a particular feature, structure or characteristic, described in relation to the embodiment is included in at least one embodiment of the present invention. The appearances of the phrases "in one embodiment" or "in one (number) embodiment" in various places throughout this description therefore do not all refer to the same embodiment, but may refer to it. Furthermore, the particular features, structures or features can be combined in any suitable manner, as will be apparent to those skilled in the art from the present disclosure, in one or more embodiments. In addition, while some embodiments described herein include certain features but not others, in other embodiments,
B E2017 / 5043 combinations of features of different embodiments should be understood as being included within the scope of the invention and constitute different embodiments, as will be understood by those skilled in the art. For example, in the appended claims, any of the claimed embodiments can be used in any combination.
In the present description of the invention, reference is made to the appended drawings, which form part of it, and in which are shown by way of illustration only particular embodiments in which the invention can be put into practice. The reference numbers in parentheses or in bold affixed to respective elements only exemplify the elements by way of example, with which it is not intended to limit the respective elements. It should be understood that other embodiments may be used and that structural or logical modifications may be made thereto without departing from the scope of the present invention. The detailed description below should therefore not be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.
"Distal (e) terms
The "," distally "or" distal to "and" proximal "," proximally "or" proximally to "are used throughout the description, and are terms generally heard in the area means directed towards the (proximal) or opposite to the (distal) surgeon's side of the device. Thus, "proximal", "proximally" or "proximal to" means directed to the side of the surgeon and, therefore, opposite to the side of the patient, conversely, "distal", "distally "Or" distal by
BE2017 / 5043 compared to ”means directed on the patient's side and, therefore, opposite to the surgeon's side.
A first aspect relates to a delivery system 100 for a bifurcated stent 200 comprising a rod 226 and a pair of arms 220, 222, comprising:
a delivery catheter 110 comprising a first elongated tube 102 having a proximal end 20 and a distal end 30 and a bifurcated portion 114 at the distal end 30, configured to receive the arms 220, 222, a longitudinal slot 140 disposed on the bifurcated part 114 being configured for the jettisonable passage of the bifurcated stent 200 through it.
Used in the treatment of a body vessel, particularly a vascular vessel such as an artery.
The bifurcated stent 200 is a stent having a proximal end 20 and a distal end 30, comprising a part consisting of a rod 226 at the proximal end 20, bifurcating in a pair of arms 220, 222 at the distal end, as illustrated , for example, in FIG. 2. A light from. stent 230 extends from the proximal end 232 of the rod to the distal end of each arm 234, 236. The ends of the bifurcated stent 200 are preferably open for the passage of bodily fluid in situ. The bifurcated stent 200 is flexible and can be provided with compliance.
The bifurcated stent 200 can be used for the treatment of an aneurysm located at the bifurcation of a body vessel, the body vessel having a wall and a bifurcation in two branches of division. The aneurysm presenting a collar can be localized at the level of the arterial bifurcation communicating with the lumen of the body vessel at the level of the bifurcation, and communicating
BE2017 / 5043 or not with mainly a division branch or both. The aneurysm can encompass one or both of the branches of division.
The bifurcated stent 200 can be used to treat an occlusion of the vessel wall. The occlusion may include one or both branches.
According to one aspect, an arm of the bifurcated stent 200 is made to penetrate into the occlusive material (for example clot, thrombus, embolus), then the bifurcated stent 200 is removed, thereby eliminating at least part of the occlusive material from the treatment site.
In another aspect, the occlusion is opened by means of an inflatable balloon. The opening can be done before deployment of the bifurcated stent 200 or can be done at the same time as the expansion of the bifurcated stent 200. When performed simultaneously, the delivery catheter can receive an additional tube or lumen for inflating the inflatable balloon; and the bifurcated stent may be expandable by balloon (not self-expanding).
The bifurcated stent 200 can take an expanded or compressed configuration. The compressed configuration is for passage through a delivery catheter 110 into a body vessel, the arms 220, 222 and the stem 226 of the stent having a narrowed cross-sectional profile. The expanded configuration is adopted after deployment; the arms and stem of the stent have an enlarged cross-sectional profile. The expanded configuration contacts the inner walls of the lumen of the body vessel. It should be understood that in situ the bifurcated stent 200 may not be fully expanded; it is generally placed in a state of transition between fully expanded and fully compressed, the stent
BE2017 / 5043 bifurcated 200 exerting a radial force on the wall of the vessel. In general, the expanded configuration, when discussed here, can also be taken to mean the aforementioned transition state, without total expansion.
The bifurcated stent is preferably self-expanding. It preferably tends to be in the expanded configuration; no force application is required to maintain the expanded configuration. When an external radial force is applied, the arms 220, 222 and the rod 226 of the bifurcated stent can each be compressed radially, which reduces the profile of the cross-sectional section (for example the diameter) of the arms and the rod of the stent in the compressed configuration. The self-expanding bifurcated stent can be maintained in the compressed configuration within the first lumen 130 of the first tube 102, as described later below. The bifurcated stent in the compressed configuration is exemplified in part A of FIG. 4, and in the expanded configuration in part D of FIG. 4. The self-expanding bifurcated stent is preferably formed from a shape memory material, such as NiTinol, a cobalt-chromium alloy, or a biodegradable material.
In one aspect, the bifurcated stent may be balloon expandable (not self-expanding). A balloon expandable bifurcated stent may be mounted on a balloon for delivery to the treatment site and to initiate expansion.
The bifurcated stent 200 may further adopt an open or folded configuration. The folded configuration is for passage inside an access catheter 300 in a body vessel, the arms 220, 222 of the stent being brought together,
BE2017 / 5043 characteristically presenting a profile essentially in the shape of an "I". The open configuration is adopted after deployment inside the body vessel, the arms 220, 222 of the stent being separated, typically having a profile essentially in the shape of a "Y".
The bifurcated stent 200 can be provided with compliance and tends to adopt the open configuration (in the shape of a "Y"). Under the application of a force the stent passes into the folded configuration. With the release of force, the bifurcated stent 200 returns to the open configuration ("Y" shape). The bifurcated stent 200 can be maintained in the closed configuration ("I" shaped profile) inside the second lumen 330 of the second tube 302 as described later below. The bifurcated stent 200 in the closed configuration is exemplified in part A of FIG. 4, and in the open configuration on part B of FIG. 4.
A bifurcated stent wall extends along the rod 226 at the proximal end 20 toward each of the arms 220, 222 at the distal end 30 by defining a stent lumen. The stent lumen 230 is sized in the expanded configuration for the circulation of body fluid, for example blood. The stent lumen can be sized in the compressed configuration for the sliding passage of one or more, preferably two, guide wires. More particularly, the stent lumen 232 in the rod portion 226 can be sized in the compressed configuration for the sliding passage of two guide wires, and the stent lumen 234, 236 of the arms 220, 222 can be sized in the compressed configuration for the sliding passage of a guide wire each.
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The arms of the bifurcated stent may be of equal length when unfolded. Alternatively, the arms of the bifurcated stent may be of unequal length when unfolded. Bifurcated stent configurations given as examples are shown in FIG. 10, parts A to G.
The wall of the stent may or may not be permeable to blood flow. It can have a variable porosity along the length of the stent, allowing the use of the stent as scaffolding for filling the aneurysm (for example as a stent assisted coiling technique) or as a flow deflecting stent. The porosity may vary depending on its compression or its stretching during its deployment. A configuration, given by way of example, of a bifurcated stent comprising an arm 224 ′ with variable porosity is shown in FIG. 10, part H.
The bifurcated stent 200 may or may not be eluting with active principle. In one aspect, the bifurcated stent is provided with an active pharmaceutical component having an antithrombotic property, or an anticoagulant property, or an endothelizing property, or being a stimulant of cell migration, or a stimulant of cell growth. The active pharmaceutical component can be deposited on an internal surface and / or an external surface of the bifurcated stent
200.
A different active pharmaceutical component may be deposited on an internal surface as compared to an external surface of the bifurcated stent 200. For example, an internal surface may be provided with an active pharmaceutical component which promotes the bite of the vessel, while a surface external can be provided
BE2017 / 5043 of an active pharmaceutical component which promotes thrombosis, coagulation or recovery.
According to one aspect, the bifurcated stent is provided on its internal surface with an active pharmaceutical component having an antithrombotic property, or an anticoagulant property, or a proendothelization property, or which is a stimulator of cell migration, or a stimulant of cell growth, and on its external surface of an active pharmaceutical component having a pro-thrombotic property, or a procoagulant property, or a pro-endothelization property, or which is a stimulant of cell migration, or a stimulant of growth cellular.
The bifurcated stent 200 can be made by wire braiding or by laser cutting techniques, as is known in the art. For the treatment of aneurysms, the stent allows the redirection (that is to say the deviation) of the blood flow and consequently promotes the formation of a thrombus inside bifurcated aneurysms and their occlusion.
The delivery catheter 110 typically includes a first elongated tube 102 having a proximal end 20 and a distal end 30 and a bifurcated portion 114 at the distal end 30. The bifurcated portion 114 includes a first member 120 and a second member 122 The first member 120 and the second member 122 are connected to each other at a bifurcation point point 124 and to the rest of the first tube 102 proximally to the bifurcation point 124. The rest of the first proximal tube 102 by compared to the bifurcated part 114 is also known as the main part 112 of the first tube 102.
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The first tube 102 is provided with a first lumen 130. The first lumen 130 is in fluid connection with a proximal end 20 of the main part 112 of the first tube 102 and branches off (134, 136) at the distal end 30, corresponding at the bifurcation of the first tube 120. The bifurcated part 114 of the first lumen 134, 136 is configured to receive the arms 220, 222 of the bifurcated stent 200. The main part 112 of the first lumen 232 is configured to receive the rod 226 of the bifurcated stent 200, in particular in an position immediately distal to the bifurcation point 124. The main part of the first lumen 232 can also be configured for the passage of one or more guide wires, preferably two guide wires. guide, one for each of the bifurcated members 120, 122. The ends of the delivery catheter 110 are preferably open for the passage of said one or more mistletoe wires dage.
The bifurcated portion 114 of the first tube 102 receives the arms 220, 222 of the bifurcated stent 200. When the bifurcated stent 200 is self-expanding, the first tube 102 is designed to maintain the bifurcated stent 200 in a contracted state. The resistance of the walls of the first tube to expansion, in particular in the bifurcated part 114, prevents the expansion of the bifurcated stent, by keeping it in the contracted state before deployment. After the bifurcated stent 200 is released from the first tube 102 through the slot 140, 140 ',
140 '', the stent expands and occupies the lumen of the bifurcated vessel.
The bifurcated portion 114 of the first tube 102 is provided with a slot 140, 140 ', 140' ', configured for the passage of the bifurcated stent 200 therethrough. The slot connects the bifurcated parts of the first lumen 134, 136 to the outside of the first tube 102. The
BE2017 / 5043 slot 140, 140 ', 140' 'can be radial with respect to the central axis of each member. The bifurcated portion of the first tube 102 releasably retains the bifurcated stent for deployment after the first member 120 and the second member 122 have been positioned within the bifurcation of the body vessel. The slot 140, 140 ', 140' 'can also be configured for the passage of a guide wire through it.
Preferably the slot 140, 140 ', 140' 'extends from the first member 120 to the second member 122. More particularly preferably, the slot extends in a proximal direction 20 from the distal terminal end 30 of the first member 120 and in a proximal direction 20 from the distal terminal end of the second member 122 and meets where the respective members 120, 122 are connected. The slot 140, 140 ', 140' 'can cross the central axis of the main part 112 of the first tube 102. The slot 140', 140 '' on each member can face each other. The slot 140 ', 140' 'can be straight and parallel to the central axis of the corresponding member, or inclined relative to the central axis, or be partially helical. The slit can be continuous.
The slot 140, 140 ', 140' 'can, in a native state, be open or closed. When closed, the edges of the slit are provided with compliance to allow the passage of the bifurcated stent between them. In the closed state, the edges of the slot can touch each other (for example FIG. 1, parts B'-l, 142 'and Bl, 142' ') or overlap (for example FIG. 1, parts B'— 2, 144 'and B-2, 144).
When the slit is open, the width of the slit can be adapted to allow ease of passage through the bifurcated stent, while providing sufficient resistance to the expansion of the walls to maintain
B E2017 / 5043 in a closed state a self-expanding bifurcated stent. The slot 140, 140 ', 140' 'can occupy between 1 and 30% of the circumference of the member 120, 122.
The slot 140, 140 ', 140' 'can be provided with one or more frangible seals, configured to prevent the passive passage of the bifurcated stent through it and / or to prevent the expansion of an auto bifurcated stent - expandable. The frangible joint can be broken when the delivery catheter 110 is removed from the bifurcated stent 200 or when the bifurcated stent 200 is advanced by means of the pusher 500. The frangible joint can be formed by a region of reduced thickness of the wall the first tube 102; the region of reduced thickness of the wall may cover part or all of the slot. The frangible joint can be formed by a region in which the slit is interrupted, that is to say where the edges of the slit are bridged by an uncut part.
The slot can be formed by laser cutting, water jet cutting or milling the wall of the first tube in the bifurcated part 114 which also allows the formation of the frangible joint, for example, by partial cutting to a certain depth. and / or by provision of breaks (bridges) in the slot.
The bifurcated portion 114 of the first tube 102 has compliance and tends to adopt an open configuration (V-shaped). Upon application of an external force, the bifurcated portion 114 can change to a folded configuration, in which the respective distal ends of the first member 120 and the second member 122 are brought closer to each other. With the release of force, the bifurcated portion 114 returns to the open configuration (V-shaped). The folding ability allows the sliding passage to
BE2017 / 5043 through a constricting lumen 330 of an access catheter 300. The bifurcated portion 114 of the first tube 102 in the closed configuration is exemplified in FIG. 3 part A, and in the open configuration in FIG. 3 part C.
The gradual and controlled opening and / or the gradual and controlled folding of the bifurcated part 114 of the first tube can be carried out by withdrawing one or advancing through a second constricting lumen 330 of an access catheter 300 described in more detail later below, namely a cladding or a stripping of the bifurcated part 114 of the first tube. Preferably, the access catheter 300 is removed while the first tube 102 is maintained in an essentially fixed relationship with the treatment site. Advantageously, the bifurcated part 114 of the first tube can be sheathed and repositioned where it has not been deployed or placed satisfactorily.
The first tube 102 may preferably be dimensioned to allow sliding passage, for example, through the operational channel of an endoscope or a second lumen of the second tube (described below). As a general recommendation, for vascular applications, the maximum external diameter of the main part 112 of the first tube 102 can be equal to or not exceed 0.1 F to 0.3 F (0.05 mm to 0.10 mm) .
As a general recommendation, the maximum diameter of the first lumen 132 of the main part 112 of the first tube 102 may be equal to or not exceed 0.1 F to 0.2 F (0.04 mm to 0.07 mm).
As a general recommendation, the length of the main part 112 of the first tube 102 can be from 120 to 160 cm, depending on the application. Diameters
BE2017 / 5043 respective and the respective lengths can be adapted according to the location with regard to the point of entry, the dimensions of the vessel to be treated, for example the size of the artery, the size of the collar of aneurysm, and anatomy.
The maximum external diameter of the main part 112 of the first 102 can be greater than the maximum external diameter of the first member 120 and of the second member 122. The maximum external diameter of the first member 120 can be identical to or different from the maximum external diameter of the second member 122. The respective diameters can be adapted according to the dimensions of the vessel to be treated, for example the size of the artery, the size of the neck of the aneurysm.
As a general recommendation, for vascular applications (for example, intracranial) the maximum external diameter of the first member 120 or the second member 122 of the first tube 102 can be equal to or not exceed 0.1 F to 0.2 F (0 , 04 mm to 0.07 mm).
As a general recommendation, the maximum diameter of the first lumen 136, 134 of the first member 120 or of the second member 122 of the first tube 102 may be equal to or not exceed 0.09 F to 0.18 F (0.03 mm to 0.06 mm).
The length of the first member 120 can be identical to or different from the length of the second member 122. The respective lengths can be adapted according to the dimensions of the vessel to be treated, for example the size of the artery, the size of the collar of the aneurysm.
The lengths of the first member 120 and the second member 122 may be greater than the respective lengths of the first arm 220 and the second arm 222.
B E2017 / 5043
The first tube 102 can be made using an extrusion process or a non-extrusion process. A first tube can be produced from a biocompatible material providing the required flexibility, "pushability" and mechanical strength. It may also have little or no radial expansion. Suitable biocompatible materials include, but are not limited to, a polymer such as polypropylene, polyethylene, polyurethanes, polyamide, polyimide, poly (ethylene terephthalate) (PET) or polyesters and their copolymers, a metal (stainless steel, NiTinol) or a combination of metal and polymer. In a preferred embodiment, it is produced from a polymeric material which is a polyamide, polyimide, stainless steel or NiTinol or a combination or an alloy thereof. The first tube can be produced from a polymer material (for example polyimide) reinforced with a metal (stainless steel or NiTinol) wound or braided, placed inside the polyimide wall. As regards a first tube produced by extrusion, it is preferably produced from polyamide. As regards a first tube produced by non-extrusion, it is preferably produced from polyimide. The inner surface can be coated to reduce friction during insertion or removal. An example of a friction reducing coating, which is suitable, includes Teflon.
The main part 112 of the first tube 102 can be provided with a coiled spring arranged at least partially over a length to increase rigidity and pushability, while maintaining flexibility. The coiled spring is preferably disposed adjacent to an inner wall of the first lumen. A layer of rubber can be
B E2017 / 5043 designed to protect the coiled spring. The rubber layer can be provided with a friction-reducing coating, for example a hydrophilic polymer, to facilitate the passage of a guide wire through the first lumen. One aspect is that the bifurcated part of the first tube is devoid of the coiled spring; rigidity can be ensured by the presence of the bifurcated stent.
The delivery catheter 110 may further be provided with one or more expandable balloons. The expandable balloon can be used for the treatment of an occlusion and / or for the opening of the bifurcated stent which is expandable by balloon. The expandable balloon can be advanced to the treatment site via the first lumen 230 of the first tube 102. The expandable balloon and the associated catheter can be slidable relative to the delivery catheter 110. In a particular example, one can use a Expandable balloon for performing intra-stent angioplasty in the event of incomplete deployment of the bifurcated stent due to anatomical complexity. The bifurcated stent can be mounted on balloons - one for each arm of the stent - allowing deployment of an expandable stent by balloon.
The first tube 102 may include one or more additional lumens, for example, for the deployment of an expandable balloon, which can be used to perform intra-stent angioplasty.
Treatment of an arterial occlusion can be done by 1) deploying the bifurcated stent through the clot (or thrombus), 2) pausing for a period of time to allow the clot to enter the struts of the bifurcated stent and 3) removing (recovery) of the bifurcated stent with the clot which has entered its spacers.
BE2017 / 5043
The delivery catheter 110 may further be provided with a flexible and sliding pusher 500 to facilitate the introduction of the bifurcated stent through the slot 140, as shown, for example, in FIGS. 5 and 6. The pusher 500 comprises an elongated flexible rod 510 having a proximal end 20 and a distal end 30, configured for passage through the first lumen 130 of the first tube 102. The pusher 500 can be slidable relative to the catheter of implementation.
The rod 510 of the pusher can be manufactured from a biocompatible material which confers the flexibility, the unpopility and the mechanical strength required. Suitable biocompatible materials include, but are not limited to, a polymer such as polypropylene, polyethylene, polyurethanes, polyamide, polyimide, poly (ethylene terephthalate) (PET) or polyesters and their copolymers. The outer surface of the rod can be coated to reduce friction during passage through the first lumen 230 of the first tube 102. Examples of a friction reducing coating, which is suitable, include Teflon. The push rod can be formed from a hollow tube or can be at least partially, preferably fully solid.
In one aspect, the distal end 30 of the plunger rod 500 can be permanently attached to the bifurcated stent 200 at its proximal end 20; for example, when the bifurcated stent is used to treat a vascular occlusion by removing some of the occlusive material, it is not necessary to detach the bifurcated stent 200.
BE2017 / 5043
According to one aspect, the distal end 30 of the rod of the pusher 500 is provided with a capture element 520 for the release attachment to the bifurcated stent 200 at its proximal end 20. The capture element 500 can be placed in relation fixed sliding and preferably rotational with the distal end of the push rod. The capture element 520 can be radially self-expanding, for example a radially self-expanding net or clamp which can adopt an open or folded configuration. The folded configuration is for passage through the first lumen 130 of the first tube 102 where the peripheral edges of the capture element 520 are brought together, typically having a profile essentially in the shape of an "I". In the folded configuration, the capture element 520 is capable of grasping the proximal end 20 of the bifurcated stent 200; after grasping, the translations and preferably the rotations of the push rod are transferred to the bifurcated stent 200. The open configuration is adopted after deployment of the bifurcated stent 200, the peripheral edges being disposed apart, typically having a conical shape or domed. The capture element 520 in the open configuration releases the gripping of the proximal end 20 of the bifurcated stent 200.
The capture element 520 can be provided with compliance and tend to adopt the open configuration (conical or domed shape). Upon application of a radial force, the capture element 520 changes to the folded configuration. The capture element 520 can be maintained in the closed configuration (“I” shaped profile) inside the first lumen 130 of the first tube 102. With the release of the radial force, the capture element 520 returns to the open configuration. The capture element 520 can adopt the open configuration after having been advanced through the slot 140 of the bifurcated part 114 of the
BE2017 / 5043 first tube. The capture element 520 in the closed configuration is exemplified in FIGS. 7A to C, and in the open configuration in FIGS. 5 and
6.
Advancing the pusher 500 in a distal direction 30 while the position of the delivery catheter 110 is maintained, or removal of the delivery catheter 110 while the position of the pusher 500 is maintained allows the bifurcated stent 200 d 'be deployed, that is to say ejected from the slot. Parts A and B of FIG. 9 show a sequence in which the pusher 500 is maintained in a constant position while the delivery catheter 110 is withdrawn proximally, thereby deploying the bifurcated stent 200.
Note that the pusher 500 can be used for loading the bifurcated stent 200 into the members 120, 122 of the delivery catheter 110. A loading sequence is shown, for example, in FIGs. 7A to 7C. In the folded configuration, the bifurcated stent 200 can be introduced into the proximal end 20 of the first lumen 130 of the main part 112 of the first tube 102, where, by being gripped by the capture element 520 in the closed configuration, it is advanced in a distal direction 30 along the first lumen 130 of the main portion 112 as shown in FIG. 7A. When it reaches the bifurcated part 114 of the first tube 102, the arms 220, 222 of the bifurcated stent 200 unfold and occupy the lumen 134, 136 in the bifurcated part 114 of the first tube 102 (FIG. 7B and 7C). Note that the loading of the bifurcated stent 200 into the delivery catheter 110 can be accomplished by means of a pair of guide wires.
BE2017 / 5043
The delivery system 100 for the bifurcated stent may further include an access catheter 300 for delivery of the delivery catheter 110 to the treatment site, as shown, for example, in parts A to C of FIG. 3.
The access catheter 300 comprises a second elongated tube 302 having a proximal end 20 and a distal end 30, provided with a second lumen 330 adapted to receive by sliding the delivery catheter 110 or first tube 102. The second tube 302 is configured to slide the bifurcated portion 114 of the first tube 102 into a folded configuration.
The proximal 20 and distal 30 end ends of the second tube 302 are open. The second tube 302 may be cylindrical, having a generally uniform external shape in the proximal region. Note that an open proximal end can be configured for connection to one or more connectors. One or more connectors, such as a Y-type connector, optional with Luer fittings, can be connected to the proximal terminal end of the access catheter or second tube to facilitate passage of the first delivery tube or catheter place, guide wire, equipment to exert a longitudinal / torsional force via the first tube.
As will be understood by a person skilled in the art, the second tube 302 can preferably be dimensioned for sliding passage through, for example, the operational channel of an endoscope or through a body lumen, in particular a vascularization (via an introducer). As a general recommendation, for vascular (e.g. intracranial) applications, the maximum external diameter
B E2017 / 5043 of the second tube 302 towards the distal end (in situ) may be equal to or not exceed 4 F to 6 F (1.33 mm to 2 mm).
As a general recommendation, the maximum diameter of the second lumen (330) at the distal end (in situ) may be equal to or not exceed 3.9 F to 5.9 F (1.30 mm to 1.97 mm ).
As a general recommendation, the length of the second tube 302 can be 110 to 150 cm depending on the application.
product preference
The second tube 302 can be made using an extrusion process or a non-extrusion process. A second tube 302 can be produced from a biocompatible material which provides the required flexibility, pushability and mechanical strength. Suitable biocompatible materials include, but are not limited to, a polymer such as polypropylene, polyethylene, polyurethanes, polyamide, polyimide, poly (ethylene terephthalate) (PET) or polyesters and their copolymers, a metal (stainless steel, NiTinol) or a combination of metal and polymer. In a preferred embodiment, it is produced from a polymeric material which is a polyamide, polyimide, stainless steel or NiTinol or a combination or alloy thereof. The second tube 302 can be produced from a polymeric material (for example polyimide) reinforced with a metal (stainless steel or NiTinol) wound or braided, placed inside the polyimide wall. As regards a second tube 302 produced by extrusion, it is preferably produced from polyamide. As for a second tube 302 produced by non-extrusion, it from polyimide.
is of We can coat the outer surface to reduce friction
B E2017 / 5043 during insertion or removal. An example of a friction reducing coating, which is suitable, includes Teflon.
The second tube 302 can be provided with a coiled spring arranged at least partially over a length to increase rigidity and pushability, while maintaining flexibility. The coiled spring is preferably disposed adjacent to an inner wall of the second lumen. A layer of rubber may be provided to protect the coiled spring. The rubber layer may be provided with a coating reducing friction, for example a hydrophilic polymer, to facilitate the passage of the first tube through the second lumen.
The second tube 302 may include one or more additional lumens, for example, for the deployment of an expandable balloon for the treatment of an occlusion.
The delivery system 100 may further include a charger 600 configured for loading the bifurcated stent 200 into the delivery catheter 110, as shown, for example, on parts A to
E of FIG. 8.
The loader 600 comprises a third elongated tube 602 having a proximal end 20 and a distal end 30, provided with a third lumen 630 adapted to receive by sliding the bifurcated stent 200 in the folded configuration.
The distal end 30 of the third tube 602 is configured for connection to the proximal terminal end of the delivery catheter 110, so that the first lumen 130 and the third lumen 630 are connected to form a continuous passage for
BE2017 / 5043 the advancement of the bifurcated stent 200 in the folded state, from the charger 600 to the delivery catheter 110. The proximal 20 and distal 30 terminal ends of the third tube 602 are open. The distal end 30 of the third tube 602 can be provided with a connection 640 (for example a Luer connection, a push-in connector, a narrowed region of the third tube 602) configured for connection to a complementary connection 140 placed on the terminal end of the first tube 102, such as a connector.
The third tube 602 can be cylindrical, having an generally uniform external shape in the distal region.
The proximal end (stem portion 226) of the bifurcated stent 200 is inserted into the distal end of the third lumen 630, and the bifurcated stent 200 is removed proximally (20), so as to fold the arms 220, 222 as the third tube 602 covers them (FIG. 8, parts A to C).
Then, the distal end 30 of the third tube 602 is connected to the proximal end of the first tube 102, so that the respective lumens 630, 130 form a continuous passage (FIG. 8, part D). The bifurcated stent 200 is then advanced distally (30), so that it enters the first lumen 130 of the first tube 102 (FIG. 8, part E). The loader 600 thus facilitates the loading of the bifurcated stent 200 from the proximal end of the delivery catheter 110, the arms 120, 122 being oriented in a distal direction 30.
Note that it is possible to use the pusher 500 or another type of rod to advance and remove the bifurcated stent 200 ′ with respect to the charger 600.
BE2017 / 5043
The positioning system 100 may be provided with at least one guide wire, preferably two guide wires. The guidewire may have a moldable distal end for intraluminal navigation.
There are two main types of catheters that are commonly used - rapid exchange (monorail) and over-the-wire (OTW). Wire catheters use a long guidewire lumen from the proximal end to the distal end of the catheter. Rapid exchange catheters use a distal guidewire lumen, having a side port for the exit of the guidewire to the distal end. The fact that the guide wire is received only in a distal part allows rapid exchange of the catheter without the need for guide wire extenders or an excessively long guide wire. The present positioning system can be easily adapted for the deployment of guide wires using one or the other mode. The figures show an OTW mode, but it is easily within the reach of those skilled in the art to adapt it for the fast exchange operating mode.
The delivery system 100 may include the delivery catheter 110 and one or more of the following:
the bifurcated stent 200 the access catheter 300, one or more, preferably 2 guide wires.
The delivery system 100 can be supplied as a kit comprising the delivery catheter 110 and one or more of the following:
the bifurcated stent 200 the access catheter 300,
BE2017 / 5043 one or more, preferably 2 guide wires.
The delivery system 100 may include the delivery catheter 110 and one or more of the following:
the bifurcated stent 200 the access catheter 300, the pusher 500, the charger 600 and
- one or more, preferably 2 guide wires.
The delivery system 100 can be supplied as a kit comprising the delivery catheter 110 and one or more of the following:
- the bifurcated stent 200, the access catheter 300, the pusher 500,
- the charger 600 and
- one or more, preferably 2 guide wires.
Note that the delivery system 100 or the kit can be provided while the delivery catheter 110 and one or more of the elements are not assembled together.
Another aspect described here concerns a method for placing a bifurcated stent at a treatment site, using the delivery system 100 described here, comprising:
the intravascular advancement of the access catheter 300 placed with the delivery catheter 110 loaded with the bifurcated stent 200, towards the treatment site, through the access catheter 300,
BE2017 / 5043 the gradual opening of the delivery catheter 110 by withdrawal of the access catheter 300 and the deployment of the bifurcated stent 200 through the slot 140 by withdrawal of the delivery catheter 110.
The intravascular advancement of the delivery system 100 can be effected along one or more, preferably a pair of guide wires. Normally, there is one guidewire per arterial branch. The placement of the guide wires precedes the advancement of the positioning system 100.
Another aspect described here relates to a method for the treatment of an arterial aneurysm located at the level of a vascular bifurcation, using the delivery system 100 described here, comprising:
intravascular advancement of the delivery catheter 110 loaded with the bifurcated stent 200 towards the site of the aneurysm, through the access catheter 300,
the gradual opening of the delivery catheter 110 by withdrawal of the access catheter 300, so that each member 120, 122 of the delivery catheter 110 is positioned inside a branch of the vascular bifurcation , and
- Deployment of the bifurcated stent 200 through the slot by withdrawal of the delivery catheter 110, so that each arm 220, 222 of the bifurcated stent 200 is positioned inside a branch of the vascular bifurcation.
After deployment, the bifurcated stent 200 is detached from the delivery system 100, for example, from the pusher 500, and the bifurcated stent 200 remains in situ.
BE2017 / 5043
Another aspect described here relates to a method for the treatment of a localized arterial occlusion at the level of a vascular bifurcation, using the delivery system 100 described here, comprising:
the intravascular advancement of the delivery catheter 110 loaded with the bifurcated stent 200 towards the site of the occlusion, through the access catheter 300,
the gradual opening of the delivery catheter 110 by withdrawal of the access catheter 300, so that each member 120, 122 of the delivery catheter 110 is positioned inside a branch of the vascular bifurcation , deploying the bifurcated stent 200 through the slot 140 by withdrawing the delivery catheter 110, so that each arm 220, 222 of the bifurcated stent 200 is positioned inside a branch of the vascular bifurcation and l one or both arms or both 220, 222 is / are positioned inside the occlusive material (for example clot, thrombus, embolus), the removal of the bifurcated stent 200 together with at least part of the occlusive material .
The bifurcated stent 200 can be removed by a push rod attached to the bifurcated stent 200.
Arterial aneurysm or arterial occlusion may be intracranial.
BE2017 / 5043
Another aspect described here relates to a method for loading a bifurcated stent 200 into the delivery catheter 110, comprising the steps:
insertion of the proximal end 20 of the bifurcated stent 200 into the distal end 30 of the third lumen 630 of the charger 600,
- removal of the proximally bifurcated stent 200 (20) so as to fold the arms 120, 122 as the third tube 602 covers them,
connection of the distal end 30 of the third tube 602 to the proximal end of the first tube 102 of the delivery catheter 110 so that the respective lumens 630, 130 form a continuous passage,
advancement of the bifurcated stent 200 distally (30) so that it enters the first lumen 130 of the first tube 102.
Using the method, the bifurcated stent 200 is loaded at the proximal end of the delivery catheter 110 and the arms 120, 122 are oriented in a distal direction 30 for later deployment. The method can use a pusher 500 for advancing or withdrawing the bifurcated stent 200 relative to the loader 600.
Figures
FIG. 1 shows a delivery catheter 110 in an open configuration, having a proximal end 20 and a distal end 30, comprising a first tube 102 having a first lumen 130, 132, 134, 136. The first tube 102 is bifurcated at the distal end 30 at a bifurcation point 124, forming a main part
BE2017 / 5043 proximal 112 presenting the first lumen 132 and a bifurcated part 114 where the first lumen 134, 136 advances inside each of the members 120, 122 of the bifurcated part 114. The bifurcated part 114 is provided with a slot longitudinal 140 for the passage of the bifurcated stent 200.
Parts B and B 'of FIG. 1 illustrate a cross section through the first member 120 and the second member 122, respectively, together with the respective slots 140 ', 140' 'and the respective parts of the first lumen 134, 136. Part C illustrates a section in cross section passing through the main part 112 of the first tube 102.
FIG. 2 shows a bifurcated stent 200 in an open configuration (Y), having a proximal end 20 and a distal end 30 and comprising at the proximal end 20 a rod portion 226 bifurcating at a bifurcation point 224 in a pair of arm 220, 222 at the distal end 30. A stent lumen 230 extends from the proximal end 232 of the rod portion 226 to the distal end of each arm 234, 236.
Parts A to C of FIG. 3 show an access catheter 300 having a proximal end 20 and a distal end 30, comprising a second tube 302 provided with a second lumen 330, the second lumen 330 slidingly receiving the first tube 102. On part A, the bifurcated part 114 of the first tube 102 is completely set back inside the second lumen 330, forcing the bifurcated part 114 to adopt the folded configuration. On part B, the bifurcated part 114 of the first tube 102 is partially set back inside the second lumen 330, which allows the bifurcated part 114 to adopt an open configuration. On part C, the bifurcated part 114 of the first tube 102 is completely stripped of the second lumen 330, which
B E2017 / 5043 allows the bifurcated part 114 to adopt a fully open configuration.
Parts A to D of FIG. 4 represent a sequence of installation and deployment in a part of an artery 400 having a proximal end 20 and a distal end 30, which is at the distal end 30 bifurcated in two branches 422, 424 which start from a main part 426 of the artery. An arterial lumen 430 has a corresponding major lumen portion 432 and lumen branches 434, 436. An anomaly which is an aneurysmal sac 430 has formed where the arms 422, 424 branch off. On part A, the delivery system 100 has been advanced along the main part 426 of the artery and in a position proximal to the bifurcated part of the artery 400. The delivery system 100 comprises a bifurcated stent 200 loaded into the bifurcated portion of the delivery catheter 110, and an access catheter 300 in which the delivery catheter 110 is recessed to maintain the limbs in a collapsed configuration. Normally the delivery system 100 is advanced along two guide wires (not shown), one guide wire for each arm of the bifurcated stent, and passed through each of the arterial branches. On part B, the access catheter 300 has been set back relative to the delivery catheter 110, which unsheaths the delivery catheter 110 and opens the members 120, 122, each of which has been positioned in lumen 434, 436 of a branch 422, 424 of the bifurcated artery 400.
In practice, the stripping is carried out gradually and in tandem with positioning. The delivery catheter 110 can be re-sheathed and sheathed repeatedly for optimum placement. On Part C, the delivery catheter 110 has been partially removed from the bifurcated stent 200, making
BE2017 / 5043 partially pass the bifurcated stent 200 through the slot 140.
Each arm 220, 222 of the bifurcated stent 200 is disposed in the lumen 434, 436 of a branch 422, 424 of the bifurcated artery 400. When they are used, the guide wires are preferably immobilized during passage. On Part D, the delivery catheter 110 has been removed more than the bifurcated stent 200. Each arm 220, 222 of the bifurcated stent 200 is fully deployed inside the lumen 434, 436 of a branch arterial 422, 424, and the rod 226 is partially deployed. The mesh of the stent covers the wide neck of the aneurysmal sac.
FIG. 5 depicts a pusher 500 having a proximal end 20 and a distal end 30 and comprising an elongated flexible rod 510 provided at the distal end 30 with a capture element 520 in an open configuration for the releasable attachment to the bifurcated stent 200 to its proximal end 20.
FIG. 6 shows the pusher 500 of FIG. 5 where the capture element 520 in an open configuration is in abutment relationship with the bifurcated stent 200, and before the capture.
FIGS. 7A and 7C show a loading sequence for loading the bifurcated stent 200 into the members 120, 122 of the delivery catheter 110. In FIG. 7A, the bifurcated stent 200 in a folded configuration is gripped by the capture element 520 in the closed configuration and advanced in a distal direction 30 along the first lumen 130 of the main part 112 of the first tube 102, by pushing the flexible rod elongated 510 in a distal direction. In FIG. 7B, the arms 220, 222 of the bifurcated stent 200 begin to unfold at
B E2017 / 5043 inside of and occupying the lumen 134, 136 in the bifurcated part 114 of the first tube 102. In FIG. 7C, the bifurcated stent 200 is fully loaded in the bifurcated part 114 of the first tube 102.
configuration 500 is removed distal from the
Parts A to E of FIG. 8 show a loading sequence for loading the bifurcated stent 200 into the delivery catheter 110 so that the arms 220, 222 are aligned in a distal direction. The proximal end (stem part 226) of the bifurcated stent 200 is inserted into a capture element 520 of the pusher 500 when open (part A). The proximally pusher 20 in the third lumen end 630 so as to fold the capture element 520 and to grip the rod part 226 of the bifurcated stent 200 (part B). The pusher 500 is withdrawn more proximally 20 so as to fold the arms 220, 222 of the bifurcated stent 200 as the third tube 602 covers them (FIG. 8, parts A to C). After closing the arms 220, 222 of the bifurcated stent 200, the distal end 30 of the third tube 602 is connected by a connection 640 to the proximal end of the first tube 102 provided with a complementary connection 140, so that the lumens respective 630, 130 form a continuous passage (FIG. 8, part D). Then, the bifurcated stent 200 is advanced distally by pushing the pusher 500 forward, so that the bifurcated stent 200 enters the first lumen 130 of the first tube 102 (FIG. 8, part E).
Parts A and B of FIG. 9 show a deployment sequence inside part of an artery 400, related to the sequence shown in FIG. 4, in which the bifurcated stent 200 is maintained or advanced relative to the delivery catheter 110 using the pusher 500. On part A,
BE2017 / 5043 the members 120, 122 of the delivery catheter 110 have been positioned inside the lumen 434,
436 of a branch 422, 424 of the bifurcated artery 400.
The delivery catheter 110 has been partially removed from the bifurcated stent 200 which is held in position with the pusher rod 500 fixed relative to the treatment site, which partially passes the bifurcated stent 200 through the slot 140. On part B, the delivery catheter 110 has been withdrawn more relative to the rod of the pusher 500 and to the bifurcated stent 200. Each arm 220, 222 of the bifurcated stent 200 is fully deployed inside lumen 434, 436 of an arterial branch 422, 424, and the rod 226 is partially deployed. The mesh of the stent covers the wide collar of the 430 aneurysmal sac.
Parts A to H of FIG. 10 show different configurations of bifurcated stent 200 as a function of the dimension of the arterial branches 422, 424. In comparison with part A, on parts B and C, the lengths of the arms of the bifurcated stent are different; on part D, the length of the bifurcated stent rod is different; on the part E, the angle of the branches is different as well as the diameter of the left branch of the bifurcated stent; on part F, the angle of the branches is different as well as the diameter of the right branch of the bifurcated stent; on part G, the angle of the branches is different, as well as the diameters and lengths of the branches. On the H part, as on the G part, the porosity of the right branch of the stent varies in the region 224 '.
BE2017 / 5043

权利要求:
Claims (9)
[1]
Claims
1. System for placing (100) a bifurcated stent (200) comprising a rod (226) and a pair of arms
5 (220, 222), comprising a delivery catheter (110) comprising a first elongated tube (102) having a proximal end (20) and a distal end (30) and a bifurcated portion (114) at the end distal (30), configured to receive the arms (220,
10 222), a longitudinal slot (140) disposed on the bifurcated portion (114) being configured for the releasable passage of the bifurcated stent (200) therethrough.
iemi de mu.
Ice (100) according to claim 1, in which the extension of a first member (120) (122) of the bifurcated part (114).
f e n t e 1 ο n g i t u d i n a 1 e to a second member
The positioning system according to claim 1 or 2, in which the bifurcated part (114) of the first tube (102) comprises a first member (120) and a second member (122), each configured for passage through a branch (422, 424) of a body vessel
25 forked.
[2]
4. Positioning system according to claim 3, in which the first member (120) and the second member (122) are each configured to compress radially.
30 the bifurcated stent (200).
[3]
5. delivery system (100) according to any one of claims 1 to 4, further comprising an access catheter (300) comprising a second
Elongated tube (302) having a proximal end (20) and a distal end (30), having a second lumen (330) adapted to receive by sliding the first tube (102), and configured for adjusting an opening gradual or a gradual withdrawal of
BE2017 / 5043 the bifurcated part (114) of the first tube (102) in response to a sliding relative movement of the first tube (102) and the second tube (302).
[4]
6. Installation system according to claim 5,
in whichone cathet st bet e n p1a c e (110) e s t conf i gu re for u ' n mode operative quick-change or known y ...! -7} ... -É -i i System of stake in place (100) according to one that the are we resells ications 1 to 6, including
in addition to the bifurcated stent (200) which is self-expanding.
[5]
8. delivery system (100) according to claim 7, wherein the bifurcated stent (200) is provided with an active pharmaceutical component which can be eluted, optionally having an antithrombotic activity, or an anticoagulant property, or a property endothelization, or which is a stimulant of cell migration, or a stimulant of cell growth.
[6]
9. delivery system (100) according to claim 7 or 8, wherein the bifurcated stent (200) is produced by laser cutting or braiding.
[7]
10. positioning system (100) of any of claims 1 to 9, in addition to a pusher (500) comprising an elongate (510) having a proximal end (20) and a distal end (30), and a capture element according to one comprising a flexible rod with a distal end (30) p <
ir. '' releasable attachment to the bifurcated stent (200) at its proximal end (20), which capture element (520) is self-expanding configuration open or radially to adopt a folded, the folded configuration being configured for passage in the first light (230) of the premia (102) and the
BE2017 / 5043 peripheral edges of the capture element (520) being brought together to grip the bifurcated end (200), and the t configured for the release of the bifurcated stent (200).
proximal (20) of the open stent confiquration and (100) according to one to 10, comprising the loading of the stent
[8]
11. Any delivery system of claims 1 in addition to a charger (600) for bifurcated (200) in the delivery catheter (110), comprising a third elongated tube (602) having a proximal end (20) and a distal end (30), provided with a third lumen (630) adapted to receive by sliding the bifurcated stent (200) in the folded configuration, the distal end (30) of the third tube (602) being configured to connect to the proximal terminal end of the delivery catheter (110) so that the first lumen (130) and the third lumen (630) are connected to form a continuous passage for the bifurcated advancement (200) folded state, from the charger (600) to the delivery catheter (110).
[9]
12. A kit comprising the delivery catheter (110) as defined in any one of claims 1 to 4, and one or more of the following:
an access catheter (300) as defined in claim 5 or 6, a bifurcated stent (200) as defined in claims 7 to 9, claim 10, a charger (600) as defined in claim 11, and jn or more guide wires.
BE2017 / 5043
100
AT
130,
136
BE2017 / 5043
200
232
BE2017 / 5043
BE2017 / 5043
BE2017 / 5043
κ.
BE2017 / 5043
BE2017 / 5043
130
BE2017 / 5043
BE2017 / 5043
BE2017 / 5043
BIFURCAL STENT DELIVERY SYSTEM
Descriptive abstract
The invention describes a delivery system (100) for a bifurcated stent (200) comprising a rod (226) and a pair of arms (220, 222), comprising a delivery catheter (110) comprising a first elongated tube (102) having a proximal end (20) and a
0 distal end (30) and a bifurcated part (114) at the distal end (30) configured to receive the arms (220, 222), a longitudinal slot (140) disposed on the bifurcated part (114) being configured for the jettable passage of the bifurcated stent (200) through
5 this one. A method for delivering the bifurcated stent to a treatment site using the delivery system (100) is also described.
PATENT COOPERATION TREATY

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法律状态:
2018-10-22| FG| Patent granted|Effective date: 20180822 |

优先权:

申请号 | 申请日 | 专利标题

EP17290006|2017-01-19|

EP17290006.0|2017-01-19|JP2019560463A| JP2020506025A|2017-01-19|2018-01-10|Delivery system for bifurcated stents|

US16/478,923| US11229538B2|2017-01-19|2018-01-10|Delivery system for a bifurcated stent|

CN201880014820.2A| CN110461278A|2017-01-19|2018-01-10|Delivery system for bifurcated stent|

PCT/EP2018/050554| WO2018134097A1|2017-01-19|2018-01-10|Delivery system for a bifurcated stent|

EP18701270.3A| EP3570790A1|2017-01-19|2018-01-10|Delivery system for a bifurcated stent|

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