FR2779939A1 - Tubular mesh-support for a vein or artery insertion device - Google Patents

Abstract

The device comprises a tubular mesh-support (10) attached to a release head (14) which has a central tube (30) connected to an external controller. The support is inserted into a guide tube in a compressed form and introduced via the tube into the patient's blood vessel. The end cap (35) has conical section to facilitate insertion in the guide (16). The end of the support has parts of the mesh wire (19) engaging four flexible, thin locating wires (40) engaging side grooves (37) in the head (32). On insertion of the support to the correct position in the blood vessel, the wires (40) are retracted using an external sliding guide. This allows the full length of the support to engage the inner walls of the vessel. The head (32) and the entry guide cap (35) can then be extracted through the center of the support by extraction of the central tube using the external controller.

Description

The present invention relates to a device for processing a vessel.

  blood bucket, of the type comprising on the one hand a tubular stent

  the distal end of which is connected to a stake by liberated retaining means

  rables extending along said stake, which releasable retaining means are provided with maneuvering means arranged at a distance from its end

  distal, and on the other hand a sleeve for guiding the stent linked to the

  tor for its establishment in a living organism.

  Such a device is known for example from the patent application

  French FR-94-05034 filed in the name of the Applicant.

  In this patent application, the releasable retaining means

  are formed by a flexible wire engaged through the meshes of the trellis

  titling the tubular stent. The two end strands extend

the length of the hollow stake.

  To release the distal end of the stent, the surgeon pulls on one of the strands until the wire is completely out of the stake. Thus, the free strand travels along the entire length of the stake, before crossing the meshes at the distal end of the stent, then circulating again

  the other way through the tutor.

  The very long path taken by the free strand of the stent retaining wire is the source of many risks of blockage of the wire in the

  guardian, which can make it difficult to separate the stent from the tu-

  tor. The object of the invention is to provide a device for treating a blood vessel comprising reliable means for retaining and releasing

  from the distal end of the stent, after positioning it.

  To this end, the invention relates to a device for treating a

  blood vessel, of the aforementioned type, characterized in that the means for

  releasable outfit comprise at least one filiform member mounted movable to slide along said tutor, the tutor comprising, behind his

  distal end, a radial notch delimited axially by a section

  distal segment and a proximal segment of the tutor, which filiform organ is displaced

  cable between a retaining position, in which it axially crosses the

  said notch and defines a stent retaining bridge between the two distal and proximal sections delimiting the notch, and a position of

  release of the stent, in which the free end of the filamentary organ

  shape is away from the distal section of the tutor thus interrupting in said

  notch the stent retaining bridge.

  According to particular embodiments, the device comprises one or more of the following characteristics:

  - the tutor crosses axially right through the tubular endoprosthesis

  laire, and the tubular endoprosthesis comprises a wire mesh in the meshes of which is engaged the or each filiform organ; - the tutor extends outwardly along the endoprosthesis, and the releasable retaining means further comprise a link surrounding said

  endoprosthesis, which link is engaged in said notch and retained at-

  turn of said filiform organ; - the tutor has a hollow tube in the side wall of which is

  formed at least one lumen forming said notch, the or each or-

  filamentary gane being movable to slide in the hollow tube;

  - the tutor has a soul which is surrounded by a sheath, delimiting

  both an annular space through which the or each filiform member is slidably mounted, and the core carries at its distal end a sleeve

  adapted to cooperate with the free end of or each filamentary member

  shape, said notch being delimited axially between the sheath and said sleeve;

  - Said sleeve has at least one longitudinal groove for re-

  ception of the distal end of or each filiform retaining member, the sleeve being covered by a sheath closing laterally the grooves and

  - the sheath has on its internal lateral surface at least one ner-

  guide of the or each filiform member.

  The invention will be better understood on reading the description which will

  to follow, given only as an example and to do with reference to the

  sins, on which: - Figure 1 is an elevational view of a treatment kit packaged in the same package; Figure 2 is an exploded perspective view of the distal end of the tutor carrying the stent before release thereof - Figure 3 is a sectional view of the sheath covering the tutor of the kit of Figure 1; Figure 4 is an elevational view of the control means provided at the proximal end of the tutor; - Figure 5 is an end view of the proximal end of the sheath contained in the kit;

  - Figure 6 is a view similar to that of Figure 2, after release-

  tion of the end of the stent in a blood vessel; - Figure 7 is an elevational view of an alternative embodiment of the distal end of the support, to which the tubular stent is connected; and

  - Figure 8 is a sectional view along line VIII-VIII of the figure

  gure 7 showing the releasable retaining means of the endoprosthesis on the

tor.

  The kit shown in Figure 1 includes a tubular endoprosthesis 10 whose distal end is connected to a stake 12 by releasable retaining means 14. It further comprises a sheath 16 adapted for guiding the endoprosthesis 10 linked to the stake 12 with a view to its installation

  in a living organism. The kit finally includes a pair of ci-

  buckets 18 intended for cutting the proximal end of the tubular stent 10 in order to adjust the length thereof

  characteristics of the vessel to be treated.

  The three elements of the treatment kit are conditioned

  in the same package 20 consisting, for example, of a sealed pocket

  tick. The stent consists of a tubular mesh embedded in a film

  stretchy and liquid tight such as an elastomer. The trellis is cons-

  made of stainless steel with spring properties, so that

  The stent 10 is self-expanding. Such a stent is commonly

  denoted by the English term "stent".

  As known per se, the stent is liable to deform

  spontaneously from a compressed state, in which it has a small diameter

  tre, in an expanded state, in which it has a larger diameter, this state

  dilated constituting its state of rest.

  In the embodiment shown, the mesh of the stent

  present at the distal end thereof, i.e. at the end through which

  the endoprosthesis is linked to the tutor 12, interlaced wires folded in loops. Thus, at its distal end, the endoprosthesis comprises a succession of

  cusps of the same wires defining angles of substantially 90.

  These cusps therefore define loops 19 formed in the current part of the wires constituting the tubular lattice. In Figures 2 and 6, only

  the loops 19 of the trellis are shown.

  The stent presents, when it is packaged in the package,

  lage 20, a total length greater than the length necessary for the

  patient treatment. In particular, the endoprosthesis comprises, at its end

  proximal mite, that is to say at its end opposite to the end by which it is linked to the stake, an excess of length intended to be cut

  by the surgeon before placement of the stent.

  So, for example, during its packaging, a stent

  having a diameter of 2 cm has a total length of about 20 cm. In practice

  that a stent of such a diameter implanted in a blood vessel

  guin has a length of the order of 8 cm to 12 cm.

  As shown in Figures 2 to 4, the guardian 12 has a core 30 formed of a flexible metal tube. The internal diameter of the core 30 is adapted to thread the latter onto a filiform surgical guide installed on the

  patient prior to placement of the tubular stent.

  At its distal end, a sleeve or olive 32 is engaged and glued

  on the core 30. This sleeve has, on its side wall substantially cy-

  lindrique, four longitudinal grooves 34 regularly distributed at its

riphery.

  The sleeve 32 is capped with a flexible end piece 35 which extends beyond

  beyond the sleeve by a flexible skirt 35A in diameter progressively

  decreasing towards its free end. The latter is open for delimi-

  ter a circulation passage of the surgical guide. The tip 35 constitutes a

  end guide for the introduction of the stake 12 into the sheath 16.

  In its main part, the core 30 is covered with a flexible sheath 36. As shown in FIG. 3, the sheath 36 has on the inside a generally circular section. It has longitudinally, on its internal surface, four longitudinal grooves 37 regularly distributed angularly. The distal end of the sheath 36 is located at a distance from the sleeve 32, so that the sleeve 32 and the sheath 36 delimit axially on the

tutor 12 a notch 38.

  As shown in FIG. 2, four filiform members or strands 40 are mounted to be movable by sliding in the conduits defined by the

  grooves 37, between the core 30 and the sheath 36. These strands 40 constitute or-

  retaining glands releasable from the distal end of the stent 10.

  The strands 40 are made of a semi-rigid material, that is to say a material capable of elastically following the deformation of the core and of

  the sheath, while being rigid enough to resist transverse traction

  under the action of the elasticity of the stent 10.

  Before the distal end of the stent is released, i.e.

  say in the state of conditioning of the tubular endoprosthesis carried by the tutor, the strands 40 have their distal end, or free end, engaged in the longitudinal ribs 34 of the sleeve. Thus, in this position, the strands 40 form bridges axially passing through the notch 38 and

  connecting the distal and proximal sections of the stake delimiting this notch.

  As shown in Figure 2, the strands 40 are engaged in the meshes defined by the loops 19 of the distal end of the endoprosthesis

10.

  Thus, this end is tightened, the end loops 19 being retained against the core 30 by the strands 40, themselves maintained from

  on either side of the notch 38 by the sheath 36 and the guide end piece 35.

  The proximal end of the strands 40 projects beyond the sheath 36, as shown in FIG. 4. At this end, the strands 40 are linked to

  an operating member 50 which is slidably mounted on a proxi-

  badly of the core 30. The proximal end of the core is provided with a support 52 facilitating the manual sliding movement of the operating member 50. The sheath 16 shown in FIGS. 1 and 5 is intended for the placement of the stent in the blood vessel. To this end, it includes a flexible tube 54 for holding the stent in its compressed state. The tube 54 is open at its two ends. It has at its end

  proximal a tip 56 provided with constriction means suitable for

  rer the radial tightening of the stent during its introduction into the furnace-

  water from the proximal end of it.

  These constriction means comprise for example a diaphragm 58 made of an elastic material. This diaphragm is notched from its central passage 59 by radial cutouts 60 delimiting thereon deformable tongues 62 elastically distributed at the periphery of the passage.

  The kit shown in Figure 1 is used as follows

  boasts. While the surgeon has previously implanted a surgical guide

  into the area of the vein or artery in which the

  planted the tubular stent, the package 20 is open.

  The surgeon then removes the stent 12 carrying the stent 10. Using the pair of scissors 18, he cuts off an excess section of the proximal end of the tubular stent, which he eliminates in order to reduce the length of that -this. It thus adjusts the length of the stent 10 according to the needs of the patient. When cutting the proximal section,

  the surgeon takes care not to damage the sheath 36 of the tutor.

  The stent now has a satisfactory length, the chi-

  rurgien inserts, intraoperatively, the distal end of the stake 12 into the

  reau 16. For this purpose, it first engages the guide end piece 35. This

  last, being made of a flexible material and having a progressive section

  gradually increasing to the diameter of the sleeve 32, promotes the engagement of the distal end of the stake in the proximal opening

scabbard 16.

  After engagement of the tip 35, the surgeon continues to depress

  the stake 12 in the sheath 16 thus gradually compressing the endo-

  prosthesis 10 as it enters the sheath 16. The radial compression of the stent 10 is facilitated by the constriction means 54 provided at the end of the sheath. Once the stent 10 is fully inserted inside the sheath

  16, the end of the previously installed surgical guide is inserted through the

  towards the stake 12 by the perforated end of the end piece 35.

  Then, as known per se, the sheath 16 containing the endoprosthesis 10 linked to the tutor 12 is conveyed by following the surgical guide until

  location of the stent 10.

  By a relative sliding movement between the stake 12 and the furnace-

  reau 16, the surgeon gradually releases the stent 10 from the sheath by the distal end of the latter. The stent 10 then deploys and is applied against the internal lateral wall of the blood vessel in which

it is established.

  Only the distal end of the stent 1.0 remains compressed and can

  that it is held by the strands 40.

  After correct positioning of the stent, its distal end

is released from tutor 12.

  To this end, the surgeon causes the strands 40 to slide in

  moving the maneuvering member 50 towards the proximal end of the guide 30.

  During this sliding, the strands 40 leave the ribs 34 and their ends

  free mity is recalled towards the sheath 36. Thus, as shown in the figure

  gure 5, the strands 40 are in a position for releasing the tubular stent. Their free end is then away from the distal section of the support formed by the sleeve 32 and the end loops 19 of the stent are therefore released, since the retaining bridges initially formed by

the strands 40 are interrupted.

  The stent 10 is then completely applied against the internal lateral wall of the blood vessel noted V. The surgical guide, the tutor 12 and the sheath 16 are then extracted by traction from their proximal end. It is understood that with such a kit, in which the endoprosthesis carried by the tutor 12 is initially outside the sheath 16, this

  endoprosthesis with excess length or excess length at its ex-

  proximal end, it is easy for the surgeon to adjust the length of the intraoperative stent. Thus, the number of references in the range of treatment kits is reduced, since only the diameter of the stent must be determined beforehand, the length of the stent being adjusted by the

surgeon during the operation.

  In FIG. 7 is shown another alternative embodiment of the tutor 12 and releasable retaining means 14 of the stent 10 to

its distal end.

  In this embodiment, the guardian designated by the reference 112 comprises a flexible tube 114. In its side wall, are formed in the vicinity of its distal end 116, two diametrically opposite openings 118. A threadlike member 120 is mounted to be movable by sliding at

  inside the tube 114. The free end, or distal end, of the filiform organ

  shape 114 extends beyond the notches 118.

  In this embodiment, the endoprosthesis 10 is arranged laterally.

  along the stake 112, which extends outside the defined conduit

by endoprosthesis.

  The releasable retaining means of the endoprosthesis 10 comprise a loop 122 encircling, at its distal end, the endoprosthesis 10. This

  loop is engaged through a light 118 constituting an exchange

  crust of the tutor and is retained there by the filiform organ 120.

  As shown in Figure 8, the loop 122 consists of a

  flexible strand closed on itself. The loop thus formed is flattened and

  swaged around the distal end of the stent 10 to cause local transverse compression thereof. The ends of the loop 122 are superimposed on each other to define a closed passage in which

is engaged the filiform organ 120.

  The filiform member 120 is provided at its proximal end with means

  operating allowing its sliding relative to the tube 114.

  It can be seen that the ends of the loop 122 engaged on the member

  filiform 120 being retained in the notch 118 delimited between the sections

  distal and proximal tutor 112, the stent 10 is held without

  loop122 cannot be released.

  After insertion of the stent into a sheath such as the four-

  water 16 and placing it in a blood vessel, its end

distal mite is released.

  For this purpose, the filiform member 120 is moved by sliding at

  inside the tube 114 until its distal end is in ar-

  loop of loop 122. Thus, loop 122 is released, allowing

  the distal end of the stent to deploy.

  According to a variant embodiment not shown, the tutor 114

  has lights forming notches spaced longitudinally-

  along the entire length of the stent. The latter is com-

  award-winning at each notch by a belt loop

  the stent. Each loop is retained around the filiform member 120.

  In this embodiment, the stent is compressed radially-

  along most of its length, which facilitates its insertion into the oven-

  reau. The stent is released by sliding the filiform member 120 which gradually releases each retaining loop as it passes from its distal end to the right of

the corresponding notch.

  Whatever the embodiment of the prosthesis release means, the distal end of the stent is released

  by sliding of a threadlike organ inside the structure of the tutor.

  The free end of the filiform organ retains the stent as long as it is engaged in the distal section of the delimiting stent

  the notch. By simply sliding the distal end of the filiform organ

  shape, the distal end of the stent is free to deploy as soon as

  the end of the filiform member is moved away from the distal section of the support 114.

  Thus, the stent is released simply by sliding a filiform organ, which sliding is very simple to

  ensure and presents little risk of malfunction.

Claims (7)

  1.- Device for treating a blood vessel, of the type comprising on the one hand a tubular stent (10), the distal end of which is connected to a stake (12; 112) by releasable retaining means (14) s extending along said stake, which releasable retaining means (14) are provided with maneuvering means (50, 52) arranged at a distance from its distal end, and on the other hand a sheath (16) for guiding the stent (10)   linked to the tutor (12; 112) with a view to setting up in a living organization   front, characterized in that the releasable retaining means (14) comprise   tent at least one filiform member (40; 120) mounted movable to slide-   ment along said tutor, the tutor (12; 112) comprising, behind its distal end, a radial notch (38; 118) delimited axially by a distal section and a proximal section of the tutor, which filiform member   (40; 120) is movable between a retaining position, in which it travels   axially pours said notch (38; 118) and defines a stent retaining bridge (10) between the two distal and proximal sections delimiting the notch, and a stent release position (10), in   which the free end of the filiform member (40; 120) is away from the section   distal lesson of the tutor (12; 112) thus interrupting in said notch (38   118) the stent retaining bridge.   2.- Device according to claim 1, characterized in that the support (12) passes axially right through the tubular endoprosthesis (10), and in that the tubular endoprosthesis (10) comprises a wire mesh in the   meshes of which is engaged the or each filiform member (40).   3.- Device according to claim 1, characterized in that the tutor (112) extends externally along the endoprosthesis (10), and in that the releasable retaining means further comprise a link (122) surrounding said endoprosthesis, which link (122) is engaged in said notch   (118) and retained around said filiform member (120).   4.- Device according to any one of claims 1 to 3, charac-   terized in that the stake (112) comprises a hollow tube (114) in the side wall of which is formed at least one lumen (118) forming said notch, the or each filiform member (120) being movable to slide in the hollow tube (114).   5.- Device according to any one of claims 1 to 3, charac-   terized in that the stake (12) comprises a core (30) which is surrounded by a sheath (36), delimiting an annular space through which the or each filiform member (40) is slidably mounted, and in this that the core (30) carries at its distal end a sleeve (32) adapted to cooperate with the free end of the or each filiform member (40), said notch (38)   being delimited axially between the sheath (36) and said sleeve (32).   6.- Device according to claim 5, characterized in that said sleeve (32) comprises at least one longitudinal groove (34) for receiving the distal end of or each filiform retaining member (40), the sleeve (32 ) being covered by a sheath (35) closing laterally the grooves (34).   7.- Device according to claim 5 or 6, characterized in that the sheath (36) has on its internal lateral surface at least one rib   (37) for guiding the or each filiform member (40).