FR2779634A1 - Surgical assembly for implanting in anatomical duct - Google Patents

Abstract

The assembly consists of a prosthesis (1), tubular or bifurcated in shape, which is capable of expansion after insertion into the anatomical duct and is held in place at its proximal end (1a) by a collar (29). The collar is made in the form of a split metal ring which is capable of radial deformation at least locally so that it can be fitted round the outer surface of the duct and cooperate with a reinforcing ring (150) on the end of the prosthesis inside it. In a variant of the design the collar can be in the form of a double open ring, with the inner ring fitting between the two outer rings, and the inner ring can have an abrasive or non-slip surface. The outer collar can be made from a springy plastics or metal such a stainless steel, especially Phynol(RTM) or a metal with a shape memory such as Nitinol (RTM).

Description

The invention relates to a medical assembly usable for treatment

  degeneration of the wall of an anatomical canal, such as

  especially a vascular aneurysm.

  The invention also relates to a collar belonging to this medical assembly, this collar being to be disposed around the concerned duct affected by degeneration, in particular for ensuring a seal between the wall of this duct and the implant (also called prosthesis) for aneurysm which has been previously placed there, while promoting the fixing of this implant to the conduit, this authorizing a minimally invasive installation and an adaptation of the sealing means according to the particular characteristics of the conduit

considered (diameter, shape, ...).

  It will be noted that examples of implant for aneurysm are

  presented in US-A-5,330,500 or EP-A-0 696 447.

  In this context, a first problem which the invention aims to solve relates to the definition of the means to be used to promote the positioning of the aforementioned collar around the anatomical duct to be treated, particular attention having been paid to the synergy between these means. to ensure a minimally invasive and safe procedure for the patient, while

  facilitating the conditions of intervention for the surgeon.

  To tend towards this aim, a first characteristic of the invention thus relates to a medical assembly comprising: - a collar to be placed around the anatomical duct affected by a degeneration of its wall, the collar comprising a split annular part, elastically deformable and naturally curved, this annular part extending by at least one flexible breakable section, - a sheath, or a trocar, for a laparoscopy (also called endoscopy or laparoscopy), allowing the introduction of the collar through this sheath or this trocar, towards the inside the patient's body, up to the vicinity of the outer wall of the conduit, - and a clamp operating clamp, this clamp being adapted to be slid into the sheath (or trocar), alongside the collar, the the split annular part is then opened in a deformed position under

constraint, substantially flat.

  With such an assembly, the introduction of the collar into the patient's body, then its operation around the duct to be treated, will be

practical and safe.

  In this regard, it will be noted now that one aspect of the invention relates to the use of this collar as an operating yaw for the conduit

  considered, especially if this conduit is a vessel.

  In the latter case, the surgeon will have, during his intervention, to seal one or more blood flow (s) out of the vessel. Also, another characteristic of the invention recommends that the aforementioned collar has a hemostatic structure, layer or coating, to reduce such blood flow, when the collar is

  applied against the vessel in question.

  A more detailed description of the invention will now be

  supplied in relation to the appended drawings in which: - Figure 1 is a schematic perspective view of a vessel with aneurysm and containing an aneurysmal prosthesis as well as two sealing rings (or collars) schematically represented, - Figure 2 is a sectional view of the collar according to II - II (FIG. 5), FIG. 3 schematically represents, in partial section, a laparoscopic trocar as well as a laparoscopic forceps used for the introduction of a collar conforming to the invention, - figure 4 shows the use of the collar as a "lake", then operated by two laparoscopic forceps, - and figure 5 shows the "lake" of figure 4 at the end of intervention, fixed tightly tightly around the vessel, in this case at the location

  of the upper neck of the aneurysm.

  It will now be noted that a "lace" is used to mean a lace or an elongated strip used in surgery to act on an organ or a duct (such as a vessel) by surrounding it, the practitioner acting on one and / or the other

end of the lace for this maneuver.

  In what follows, we will only consider the case of the treatment of a vessel aneurysm, even if other anatomical conduits could receive the prosthesis and the sealing ring.

presented below.

  First of all, in FIG. 1, a "traditional" prosthesis for aneurysm is shown, 1, placed opposite the pocket.

aneurysm 27.

  This implant includes a flexible sheath 3 "usual", typically

  made of tissue and adapted to channel blood through it.

  A frame consisting of a stent structure (s) and marked as a whole 5 provides mechanical resistance to the sheath 3, by being linked to

  it by one or more surgical sutures 7.

  Structure 5 can occupy two states: - a first state of restricted diameter (not shown), for the introduction of the implant inside the receptor vessel (typically using the "SELDINGER" method), - or a second state of larger diameter (see FIG. 1) in which the implant is at least locally substantially applied against the

inner wall of the vessel.

  The structure in stent (s) 5 may consist of self-expanding stent (s), typically made of metal such as stainless steel, or else

  be expandable (s) via an inflatable balloon (not shown).

  An embodiment of shape memory material, in particular based on a

  nickel / titanium alloy (Nitinol, registered trademark) is also possible.

  In the example of FIG. 1, the stent structure 5 is staggered over several stages, in this case 5a, 5b, 5c, 5d. Each stage consists of a corrugated metal wire (such as a zigzag) closed on itself

  to form a cylindrical ring of variable diameter.

  The stages 5a and 5d are located respectively towards the ends

  free upstream (with respect to blood flow), the, and downstream, lb, of the implant.

  The structure 5 can be arranged inside or outside of the sleeve 3 which is itself tightened or radially deployed (relative to

  axis 9 of the implant), depending on the radial state of the structure 5.

  Note that a form other than corrugated wire (s) could be

retained for structure 5.

  For its attachment to the vessel 10 after being positioned inside, the implant I may include anchor hooks such as 11,

  having a tip adapted to penetrate the wall of the vessel.

  Typically, these hooks are metallic and welded or formed with the stent structure. In FIG. 1, they protrude from the upstream end 1a and

are linked to stage 5a.

  In addition to or in substitution for such hooks, however, the use of other fastening means associated with means is advised.

additional sealing.

  As described in FR 97 16625, filed on December 29, 1997, these are fixing means which will pass through the entire wall of the vessel 10, and / or which will be fixed therefrom from the outer wall of the vessel (unlike hooks 11 which are not supposed to pass through this wall and which hang on

  from inside the ship), such as rivets.

  Another effective fixation technique may consist in suturing (by one or more known surgical sutures) the implant to the vessel, a priori from outside the vessel, using a

  laparoscopic technique, or laparoscopy, extra-vascular.

  Whatever these transvascular fixation means, they will preferably be present both at the upstream end 23a and at the downstream end 23b of the aneurysm shown diagrammatically in FIG. 1. The sealing means shown consist of two elastic collars 29. As illustrated in FIG. 2, each collar may comprise a core 31 constituted in this case by two metal blades 310, 311, spaced from one another and each of curved shape, so that the core has the shape of a split ring (not completely closed on itself), arched and

has a spring effect.

  The annular frame 31 is coated with a protective layer of

  self-sealing material 33, such as a biocompatible silicone.

  The frame 31 / protective layer 33 assembly is doubled by a strap 35 which extends beyond the perimeter of the core, as can be seen

especially in Figures 3 and 5.

  The strap 35 can be made of fabric (such as Dacron, registered trademark), or even of biocompatible felt or another very flexible plastic material, so as to be able to occupy the shape desired by the practitioner and to be breakable by surgical forceps (laparoscopic in particular), including if the cutting of the strap must be done in the

patient's body.

  In FIG. 2, an additional layer 52 also doubles the assembly of the collar 29. It is a layer with a hemostatic characteristic, for example made of felt or Teflon foam (registered trademark), or else of a braiding. composite. In the art, such a hemostatic band intended to reduce flow is commonly called a "pledget"

  when this strip is applied against leakage.

  Of course, it will be understood that the hemostatic layer 52 will be disposed on the inner face (INT) of the collar 29, to be applied

  directly on the outer wall 10a of the vessel 10 (FIG. 5).

  For the introduction of (each) collar 29, one can use a sheath 40, commonly called "trocar" in the fields of endoscopy

or laparoscopy.

  It is also with this minimally invasive intervention technique

  that we are going to introduce, use and fix the (each) collar 29.

  Thus, in FIG. 3, the trocar 40 contains the collar 29 and a laparoscopic forceps 54, the jaws 56 of which hold one end of the strap 35 to pull towards the inside of the patient's body (arrow 58 ) the collar shown which is then in a deformed position substantially flat, with its annular part split 31 completely

  open, under elastic stress.

  Laparoscopy being a known intervention technique, we will not describe it here, it is simply noted that several ways of transcutaneous bodily access (or with denudation) can be carried out, on the one hand for the introduction of the collar (s) (s) and on the other hand, for the installation of the necessary laparoscopic surgical tools, such as for example a

  second clamp marked 60 in FIG. 4.

  In Figure 4, the collar 29 is already in place around the vessel 10 to be treated. Under the traction of the clamp 54, it was first extracted from the trocar (inside the patient's body) where a second clamp (such as the clamp) was already waiting for it to engage the collar if possible around the vessel (it being specified that this operation of passage of the collar around the vessel can be delicate, even impossible, in particular in the case of the aorta, taking into account the presence of the tissues of attachment to the spinal column, here

shown schematically in 44).

  Anyway, if it is possible to pass the collar 29 around the anatomical duct to be treated (or even an annexed organ), this collar may

  be used as a "lake", in order to facilitate the work of the surgeon.

  For this, the latter may in particular use the clamps 54, 60 (FIG. 4), or even other laparoscopy tools, in order to act on the duct or organ concerned, via the strands of the collar, the flexibility of which, possibly associated with the relative rigidity of the frame 31, will facilitate the

  desired movement of the duct or organ.

  Once this function of "means of maneuvering the conduit or the organ" provided by the collar has been completed, the latter will be placed at the location of the upper collar (or of the lower collar) of the vessel 10, since it

  it is a question here of treating an aneurysm.

  In Figure 5, the collar is already in place, its annular frame having closed itself around the outer wall 10a of the vessel, after it has been released from any opening constraint. imposed

by clamps 54, 60.

  Then the practitioner came, if necessary, cut to length

  straps 35, then fixed this collar 29 to the vessel, in the appropriate places.

  In this case, there are shown in 62, 64 and 66 three locations provided for the establishment of the transvascular fixing means between the collar

  29 and implant 1 (sutures or rivet, in particular).

  As a variant, it will be noted that the hemostatic layer 52 could be replaced by a surface treatment (coating in particular) with a coagulating product, or even a product

  dispersed, or embedded, in the covering 33 and / or the strap 35.

Claims (3)

  1. Medical assembly comprising: - a collar (29) to be disposed around an anatomical conduit (10) affected by a degeneration of its wall, the collar comprising a split annular part (33), elastically deformable and naturally curved, this annular part extending by at least one flexible section (35) breakable, - a sheath, or a trocar, (40), for an endoscopy or a laparoscopy, allowing the introduction of the collar in this sheath or this trocar, towards the inside the patient's body, up to the vicinity of the external wall (10a) of the conduit, - and an operating clamp (54) of the collar, this clamp being adapted to be slid into the sheath or the trocar, alongside the collar the split annular part of which is then open in a deformed position, substantially flat.   2. Necklace belonging to the assembly according to claim 1, characterized in that it has a structure, a layer or a hemostatic coating (52), to reduce a blood flow, when said   conduit is a vessel against which the collar (29) is applied.   3. Use of the necklace belonging to the set according to the   claim 1, as an operating yaw of said conduit.