FR2822369A1 - Blood vessel reinforcing ring comprises two continuous side bands with V-shaped bends, linked by cross-pieces - Google Patents

Abstract

The ring, e.g. of platinum and used in conjunction with others to form a tubular implant, consists of two continuous side bands (11, 12) with the same central axis (13), connected by two or more cross-pieces (21, 22) and having V-shaped bends (16, 17) between the cross-pieces. The bends are of the same shape and have their tips pointing towards one another; their branches (31, 32, 33, 34) are equal to about half the length of the cross-pieces. In a variant of the design at least one of the V bend branches has a thin middle portion. The rings are compressed for insertion with the aid of a catheter and expanded by means of an inflatable balloon when in the required position.

Description

<Desc / Clms Page number 1>

RING SUITABLE FOR MARRYING THE INTERIOR WALL OF A VESSEL
BLOOD
AND DEVICE COMPRISING SUCH RINGS
The present invention relates to rings for devices capable of marrying the inner wall of a blood vessel such as an artery, as well as devices comprising such rings, which find particularly advantageous applications for example for sealing an aneurysm, treating a stenosis or angioma, or perform angioplasty.

 There are already rings and devices for closing an aneurysm or the like in a blood vessel such as an artery, treating a stenosis or angioma, performing an angioplasty, etc.

 Such devices are for example described in EP-A 0 832 618, EPA-0 795 304, WO 96/18359, WO 98/16172, US-A-5 449 373 and FR-A-2 788 216.

 They are, in general, constituted by a catheter capable of sliding in translation in the blood vessel, a ring capable of deploying radially between a first section value and a second section value respectively less and substantially equal to the inner section of the blood vessel, the ring being threaded on the catheter in the configuration in which its section has the first value, and means for controlling the radial deployment of the ring to bring its section from its first to its second value.

 These devices are satisfactory in many cases. They can however have drawbacks when the blood vessels have many small radius curves, for example in the case of the arteries of the brain. Under these conditions, the ring of the device being too long and too rigid, it cannot always be brought to the level of the aneurysm because it cannot bend enough to pass certain arteries curvatures.

 In an attempt to overcome this drawback, weak points have been made, over the entire length of the ring and at regular intervals relatively close to one another, theoretically allowing the ring to bend more easily and therefore pass the small radius curvatures. But we then observe that, if the number of curvatures is large and the curvatures very

<Desc / Clms Page number 2>

 pronounced, the ring weakens at these points of weakness until it breaks.

 The present invention therefore aims to provide a ring for a device capable of marrying the interior wall of a blood vessel such as an artery, the structure of which facilitates implantation in the blood vessel, as well as a device comprising such rings.

 More specifically, the subject of the present invention is a ring for a device capable of marrying the internal wall of a blood vessel, characterized in that it comprises: - two lateral bands each forming a closed loop, the two closed loops being substantially centered on the same first axis, and - at least two spacers of substantially the same length connecting the two lateral strips, these two spacers being substantially parallel to said first axis, each portion of lateral strip lying between the two spacers being folded into at least one IrV .

 The present invention also relates to a device capable of marrying the inner wall of a blood vessel, characterized in that it comprises at least three first, second and third rings like those defined above, these three rings being substantially centered on the same second axis, and means for connecting the second ring, located between the other two. respectively to these other two.

Other characteristics and advantages of the invention will become apparent during the following description given with reference to the drawings annexed by way of illustration, but in no way limitative. wherein :
FIG. 1 represents, in a folded-down view in a plane, part of a first embodiment of a ring according to the invention, this figure illustrating two possible configurations of the ring during its use,
FIG. 2 represents an end view of a ring according to the embodiment illustrated in FIG. 1,
FIGS. 3 and 4 represent, in a folded-down view in a plane, part of two other embodiments of a ring according to the invention, these figures each illustrating two possible configurations of the rings during their use,

<Desc / Clms Page number 3>

FIG. 5 represents, seen in perspective view, a ring according to the invention in accordance with the embodiment according to FIG. 4, in its so-called "deployed" configuration,
Figure 6 shows, seen in perspective perspective. an embodiment of a device according to the invention consisting of five rings like that illustrated in FIG. 5, and
FIG. 7 represents a diagram making it possible to explain the operating mode and the use of a ring and a device according to the invention.

 It is clearly specified that, in the figures, the same references designate the same elements, whatever the figure on which they appear and whatever the form of representation of these elements. Similarly, if elements are not specifically referenced in one of the figures, their references can be easily found by referring to another figure.

 The Applicant also wishes to specify that the figures represent several embodiments of the object according to the invention, but that there may be other embodiments which meet the definition of this invention.

It also specifies that, when, according to the definition of the invention, the object of the invention comprises "at least one" element having a given function, the embodiment described may include several of these elements
It also specifies that, if the embodiments of the object according to the invention as illustrated comprise several elements of identical function and that if, in the description, it is not specified that the object according to this invention must necessarily include a particular number of these elements, the object of the invention may be defined as comprising "at least one" of these elements.

seconde valeur de section S2, tandis que les autres parties II représentent les mêmes parties d'anneau, mais dans leur configuration dite "d'origine", c'est-à-dire It is first of all pointed out that FIGS. 1, 3 and 4 represent three embodiments of a ring according to the invention, these representations having been obtained by opening a ring by a cut along a generatrix, then by flattening it and projecting it partially on a plane. It is further specified that, on the same figure, the part 1 represents a ring part in its "deployed" configuration (partially in FIGS. 1 and 4, totally in FIG. 3), that is to say in referring to FIG. 2, when the ring has its

second section value S2, while the other parts II represent the same ring parts, but in their so-called "original" configuration, that is to say

<Desc / Clms Page number 4>

 before the ring is deployed, when it has its first section value Si (Figure 2).

 With reference to FIGS. 1 to 5, the ring according to the invention for device 1 capable of marrying the interior wall of a blood vessel 3 like an artery (FIG. 7), for example to close off an aneurysm or the like 2, or treat a stenosis, performing an angioplasty, etc., comprises: two lateral bands 11, 12 each forming a closed loop, the two closed loops being substantially centered on the same first axis 13, at least two spacers 21, 22 substantially of the same length connecting the two lateral strips 11,12, these two spacers being substantially parallel to the first axis 13, each portion of lateral strip 14,15 comprised between the two spacers 21,22 being further folded into at least one "V'16, 17.

 In a preferred embodiment, as illustrated in all the figures, the two "V 16, 17 are substantially identical.

 In addition, the two "V's are advantageously located substantially in the same plane parallel to the first axis 13, it being understood that, by plane, one must understand, within the meaning of the present invention, a flat or slightly curved surface.

 Preferably, as illustrated in all the figures, the two "V 16.17 of two lateral strip portions 14,15 comprised between two consecutive spacers 21,22 face each other by their vertices 18,19, and the branches 31, 32, 33.34 of these two'V are substantially equal to half the length of the two spacers 21.22.

 In order to obtain optimal operation so that the ring can deploy radially as easily as possible between a first section value and a second section value respectively less and substantially equal to the inner section of a blood vessel or the like , it is possible that at least one of the two branches 31-34, and advantageously all, of at least one of the two "V's is substantially thinned in its middle part 35-1, 35-2 ,. ... 35-m, ... (Figure 4) and / or that at least one of the folds 36-1, 36-2, .... 36-m, .... and advantageously all, portions of lateral strips 14, 15 forming the "V" 16, 17 comprises, in its concave part, a drop-shaped thinning 37-1, 37-2, .... 37-m, ... (figure 3).

<Desc / Clms Page number 5>

A ring with a structure like the one described above works as follows:
It is firstly specified that the ring is in its original configuration. in which all the parts between two spacers 21, 22 are like those referenced in II in FIGS. 1, 3 and 4. In this configuration, the ring has a section of value SI, FIG. 2, noting that the distance between two consecutive spacers 21,22 is then equal to the minimum value "1", FIG. 1. The two branches 31-34 of a "V 'overlap and are substantially in contact with the two consecutive spacers 21,22.

 Its section Si therefore has a radius "r" given by the formula ni = 2nr, if n is the number of spaces (all equal to each other) between two consecutive spacers.

 When the ring is deployed by any means, including for example that which will be described below, it has a configuration in which all the parts between two spacers 21, 22 are like those referenced in 1 in FIGS. 1, 3 and 4 , the distance between two consecutive spacers then being equal to "L".

 Section 82 of the ring then has a radius "R" given by the formula nL = 21ru, n being the number of spaces all equal defined above.

 When the ring is deployed, the two "Vs between two spacers 21, 22 open by increasing the angle defined between their two arms 31-34, to a maximum possible position as that illustrated in the figure 3, in which the two branches of each "V" are in line with one another. Figures 1 and 4 show! es "V open corresponding to both maximum deployment of the ring to an intermediate deployment, depending in particular on the nature and geometry of the two lateral bands 11 and 12.

 In view of the representations given in FIGS. 1, 3 and 4, it can be seen that, by its structure, the ring retains the same width, whatever the amplitude of its deployment between its two first and second sections Si and S2, this value being imposed by the length of the spacers 21, 22 which is invariable.

 It should be noted that such rings are commonly made of a material such as platinum which is a biocompatible material

<Desc / Clms Page number 6>

The present invention also relates to a device, FIG. 6, capable of marrying the internal wall of a blood vessel such as an artery, for the purpose for example of closing an aneurysm or the like, of treating a stenosis or an angioma, or of performing angioplasty. This device comprises at least three first, second and third rings A1, A2, A3 such as those described above, these three rings being substantially centered on the same second axis 40 which can be the same as the first axis 13 defined above, and means 41 for connecting the second ring A2, located between the other two Ai, As, respectively to these two other Ai, As.

 In an advantageous embodiment, the means 41 for connecting the second ring respectively to the other two, are constituted by two legs Pi, P2 respectively connecting the two lateral strips 11, 12 facing each other. on the one hand of the first Ai and second A2 rings, and on the other hand of the second A2 and third As rings.

 To obtain greater flexibility of the device, it is more preferable for these two tabs to be situated on two straight lines 42.43 substantially parallel to the second axis 40 and not merged.

 Advantageously, these two straight lines 42, 43 passing respectively through the two legs Pi,? 2 are respectively located in alignment with two spacers 21, 22 so that, whatever the amplitude of the deployment of the rings, the device always has the same length along the axis 40.

 It is obvious that a device may include more than three rings like those described above, to respond to the different possible cases of aneurysms, stenoses. angioma. etc .. knowing that it is always possible to shorten the length of the device at the time of its use depending on the case to be treated.

entre eux des angles égaux à 27r n- For this purpose, the device according to the invention can therefore comprise n Aï-An rings, n being greater than three, connected to each other by n-1 legs Pi-Pn-i respectively located successively on n-1 straight lines 42, 43 not merged and substantially parallel to the second axis 40, the straight n-1s being regularly distributed around this second axis and therefore located in radial planes making 2: T

between them angles equal to 27r n-

<Desc / Clms Page number 7>

La figure 6 représente un mode de réalisation d'un tel dispositif qui comporte à titre d'exemple cinq anneaux Ai-As reliés par quatre pattes P1-P4 situées à 1,57 radian les unes des autres.

FIG. 6 represents an embodiment of such a device which comprises, by way of example, five Ai-As rings connected by four legs P1-P4 located 1.57 radians apart from each other.

 It is also pointed out that such a device according to the invention may also include a sheath like that described in FR-A-2 788 216 mentioned in the preamble of this description for closing an aneurysm 2, while this sheath does not is not necessarily necessary for the other uses of the device mentioned above by way of example.

 The device consisting of a plurality of rings according to the invention has a very significant advantage compared to the devices of the prior art, in particular those defined in the preamble CI this description. In fact, when the rings are deployed passing from their first section Si to their second section S2, FIG. 2, the width of the rings given by the length of the spacers and the length of the legs between two consecutive rings remaining constant, the total length of the The device does not undergo any variation either.

 This advantage greatly facilitates the work of the practitioner who must for example seal an aneurysm, treat a stenosis or perform an angioplasty as mentioned above, because he does not then have to take into account the variation in length of the device during its dilation , especially since it is almost impossible to know the maximum section 82 that the device will take once dilated, because the practitioner cannot know, for example, the degree of elasticity of the artery 3, for example at level of aneurysm 2 or stenosis, etc.

The device formed by a plurality of rings according to the invention operates and is used in the following way with reference to FIG. 7:
It is firstly specified that the rings Ai-An and the device 1 are produced, for example, as illustrated in FIGS. 1 to 6, the rings in their original configuration in which their section has the first value Si, FIG. 2. being arranged around for example an inflatable balloon 50 mounted in association, in a manner known from the prior art, with a catheter 51.

 In a manner also known in itself by practitioners, the catheter is introduced into the blood vessel 3 which must be treated, from an easily accessible place from this blood vessel. The catheter 51 is introduced by its

<Desc / Clms Page number 8>

 end which carries the balloon 50 surrounded by the device 1, the rings constituting this device having their first section value Si.

 The catheter 51 is then pushed into the artery 3 until the device 1 arrives opposite the location of the artery which is to be treated. It should be noted that this translation of the catheter is possible, even in curvatures of small radius, because the rings can pivot relative to each other essentially thanks to the connecting lugs P1-Pn-1.

 In fact, the plurality of Aï-An rings can undulate like a creeping snake, the elasticity of the legs in flexion allowing both the rotation of the rings with respect to each other and their return to their position. initial when a curvature is exceeded and the device is in a portion of rectilinear artery.

 When the device 1 has arrived opposite the point to be treated, the balloon 51 is inflated. By swelling, it pushes on the inner wall of the rings which deploy radially until they take their second value of section S2 and thus seal or close the aneurysm 2, dilate the vessel in the case of a stenosis, etc.

 When the rings are deployed radially, the balloon is deflated and the catheter is removed from the artery. Only the device is left in place.

Claims (12)

 CLAIMS 1. Ring for device (1) capable of marrying the inner wall of a blood vessel (3), characterized in that it comprises: - two lateral bands (11,12) each forming a closed loop, both closed loops being substantially centered on the same first axis (13), - at least two spacers (21, 22) substantially of the same length connecting the two lateral strips (11,12), these two spacers being substantially parallel to said first axis (13 ), each side strip portion (14,15) between the two spacers (21,22) being folded into at least one "V '(16,17).  2. Ring according to claim 1, characterized in that the two "\ / '(16,17) are substantially identical.  3. Ring according to one of claims 1 and 2, characterized in that the two "V'sont located substantially in the same plane parallel to said first axis (13).  4. Ring according to claim 3, characterized in that the two "V (16,17) face each other by their vertices (18,19).  5. Ring according to one of claims 1 to 4, characterized in that the branches (31,32, 33,34) of the two "V'sont are substantially equal to half the length of the two spacers (21, 22 ).  6. Ring according to one of claims 1 to 5, characterized in that at least one of the two branches (31-34) of at least one of the two "V is thinned substantially in its part median (35-1, 35-2, .... 35-m, ...) <Desc / Clms Page number 10>

 7. Ring according to one of claims 1 to 6, characterized in that at least one of the folds (36-1, 36-2, .... 36-m, ...) of the portions of lateral bands (14,15) forming the "V '(16,17) comprises, in its concave part, a thinning in the form of a drop (37-1, 37-2, ..., 37-m, ... ).  8. Device capable of matching the inner wall of a blood vessel, characterized in that it comprises at least three first, second and third rings (A1, A2, A3) according to one of the preceding claims, these three rings being substantially centered on the same second axis (40), and means (41) for connecting the second ring (A2), located between the other two (Ai, A3), respectively to these two others (Ai, A3).  9. Device according to claim 8, characterized in that the means (41) for connecting the second ring respectively to the other two are constituted by two tabs (Pi P2) respectively connecting the two lateral bands (11,12) facing each other , on the one hand of the first (Ai) and second (A2) rings, and on the other hand of the second (A2) and third (A3) rings.  10. Device according to claim 9, characterized in that the two legs are located on two straight lines (42,43) not merged substantially parallel to said second axis (40).  11. Device according to claim 10, characterized in that the two straight lines (42,43) passing respectively through the two said legs (Pi, P2) are respectively located in alignment with two spacers (21, 22).  12. Device according to one of claims 9 to 11, characterized in that it comprises n rings (Aï-An) connected to each other by n-1 tabs (P1-Pn-1) respectively located successively on n -1 straight lines (42, 43) not merged and substantially parallel to said second axis (40), said n-1 straight lines being regularly distributed around the second axis.