IMPLANTABLE DEVICE FOR SHAPING AN INTRACORPOREAL WALL, AND ASSOCIATED TREATMENT KIT
20190254823 ยท 2019-08-22
Inventors
Cpc classification
A61B17/0487
HUMAN NECESSITIES
A61F2/2445
HUMAN NECESSITIES
A61F2/2454
HUMAN NECESSITIES
A61B2017/0446
HUMAN NECESSITIES
A61B2017/0462
HUMAN NECESSITIES
A61B17/0401
HUMAN NECESSITIES
A61B2017/0435
HUMAN NECESSITIES
International classification
A61F2/24
HUMAN NECESSITIES
Abstract
An implantable device for shaping an intracorporeal wall includes: an elongate element which has a first end, a second end and a central filiform region between the first end and the second end; and a blocking member. The elongate element is mobile in relation to the blocking member between an unlocked position away from the blocking member and a locked position on the blocking member, in which the elongate element is connected to the blocking member. The blocking member includes a mechanism for selective adjustment of the length of the central region protruding towards the second end from the blocking member.
Claims
1. An implantable device (18) for shaping an intracorporeal wall (14) including: an elongate element (24) having a first end (30), a second end (32) and a central filiform region (28) between the first end (30) and the second end (32), a blocking member (26), the elongate element (24) being mobile in relation to the blocking member (26) between an unlocked position away from the blocking member (26) and a locked position on the blocking member (26), in which the elongate element (24) is connected to the blocking member (26), wherein the blocking member (26) includes a mechanism (52) for selective adjustment of the length of the central region (28) protruding towards the second end (32) from the blocking member (26).
2. The device (18) according to claim 1, wherein the blocking member (26) comprises a fixed base (50), delimiting a bearing surface (51) on an intracorporeal surface, the base (50) delimiting a passage orifice (62) for the elongate element (24), the central region (28) of the elongate element (24) protruding outside the blocking member (26) while passing through the passage orifice (62) in the locked position.
3. The device (18) according to claim 2, wherein the base (50) includes a deflector (210) protruding from the bearing surface (51) away from the selective adjusting mechanism (52), the deflector (210) guiding the central region (28) of the elongate element (24) from the passage orifice (62).
4. The device (18) according to claim 1, wherein the elongate element (24) is provided with at least one blocking stop (34), able to cooperate with the blocking member (26) in the locked position.
5. The device (18) according to claim 4, wherein the blocking stop (34) is mounted at the first end (30) or near the first end (30), and is maneuverable between an axial position for insertion in the blocking member (26) and a transverse position for connecting to the blocking member (26).
6. The device (18) according to claim 1, wherein the selective adjustment mechanism (52) includes a winder (64) able to wind part of the central region (28) of the elongate element (24) around a winding axis (A-A; B-B).
7. The device (18) according to claim 6, wherein the blocking member (26) comprises a fixed base (50), delimiting a bearing surface (51) on an intracorporeal surface, the winder (64) comprises a mobile member (68; 230), mounted rotating relative to the base (50) around the winding axis (A-A; B-B).
8. The device (18) according to claim 7, wherein the mobile member (68; 230) defines at least one through passage (72) through which the elongate element (24) passes in the locked position.
9. The device (18) according to claim 7, wherein the winder (64) includes an element (70) for fastening a maneuvering arm (82) rotatably to the mobile member (68).
10. The device (18) according to claim 6, wherein the selective adjustment mechanism (52) includes a unidirectional rotational blocking system (260) for the winder around the winding axis (A-A; B-B).
11. The device (18) according to claim 1, wherein the elongate element (24) is provided, at its second end (32), with a bearing plate (36) on an intracorporeal surface or a fastening clamp (200) on an intracorporeal surface.
12. The device (18) according to claim 1, wherein, in the locked position of the elongate element (24), the first end (30) and the second end (32) are mounted in the blocking member (26), the central region (28) forming a loop (130).
13. The device (18) according to claim 1, including a C-shaped tubular member (132), the elongate element (24) cooperating mechanically with the tubular member (132) to modify the shape of the tubular member (132) by selective adjustment of the length of the central region of the elongate element (24) using the selective adjustment mechanism (52) of the blocking member (26).
14. A treatment kit (10) comprising: a shaping device (18) according to claim 1, a device (20) for actuating the selective adjustment mechanism (52), maneuverable reversibly between an engaged configuration for actuating the selective adjustment mechanism (52) and a configuration detached from the selective adjusting mechanism (52).
15. The treatment kit (10) according to claim 14, wherein the actuating device (20) is intended to be introduced by the endoluminal route.
16. The kit (10) according to claim 14, wherein the actuating device (20) includes a catheter (80), able to be applied over the blocking member (26), and a mobile arm (82), able to grasp a fastening element (70) of the selective adjustment mechanism (52).
17. The kit (10) according to claim 14, comprising a device (22) for placement of the shaping device (18), the placement device (22) including a traction guide (90) for the first end (30) of the elongate element (24), able to be reversibly fixed on a fastening site (38) of the elongate element (24).
18. The device according to claim 2, wherein the elongate element is provided with at least one blocking stop, able to cooperate with the blocking member in the locked position.
19. The device according to claim 3, wherein the elongate element is provided with at least one blocking stop, able to cooperate with the blocking member in the locked position.
20. The device according to claim 2, wherein the selective adjustment mechanism includes a winder able to wind part of the central region of the elongate element around a winding axis.
Description
[0057] The invention will be better understood upon reading the following description, provided solely as an example and done in reference to the appended drawings, in which:
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[0065]
[0066]
[0067]
[0068] A first treatment kit 10 according to the invention is illustrated schematically in
[0069] This kit 10 is in particular intended to treated patients suffering from heart disease by valvular annuloplasty. The kit 10 is in particular intended to treat heart valves, particularly the mitral valve 12, visible in
[0070] The intracorporeal wall 14 here is a wall located around a native annulus from which leaflets 16 of the valve 12 extend. In the case of the mitral valve, the wall 14 is the wall of the left atrium situated around the native annulus. Alternatively, the intracorporeal wall is the native annulus directly.
[0071] In reference to
[0072] The shaping device 18 comprises a deformable elongate element 24, and a member 26 for blocking the elongate element 24 against an intracorporeal surface. The blocking member 26 is initially disassembled from the elongate element 24, the elongate element 24 being able to be locked in the blocking member 26 during the implantation of the shaping device 18, as will be seen later.
[0073] As illustrated by
[0074] In the example illustrated in
[0075] The elongate element 24 includes, at its first end 30, a mobile stop 34 for engaging in the blocking member 26. It includes, at its second end 32, a plate 36 for bearing on the intracorporeal surface.
[0076] The mobile stop 34 here is in the shape of a grain of rice. It is able to pivot around the first end 30 around at least two axes, between an axial position, oriented axially relative to the local axis of the central region 28 at the first end 30, and a transverse position, oriented transversely relative to the local axis of the region 28 at the first end 30.
[0077] The mobile stop 34 is provided with a site 38 for fastening of a traction guide of the placement device 22. The fastening site 38 is off-centered relative to the local axis of the central region 28 at the first end 30.
[0078] The bearing plate 36 is able to pivot around the second end 32 around at least two axes. Here, it has a transverse expanse greater than that of the mobile stop 34.
[0079] The filiform region 28 connects the mobile stop 34 to the bearing plate 36. It is made up of a wire, able to deform without variation in its total length.
[0080] The total length of the filiform region 28 is for example between 0.5 cm and 10 cm.
[0081] The blocking member 26 includes a base 50 having a bearing surface 51 on an intracorporeal surface, the base 50 having local axis A-A, and a mechanism 52 for selective adjustment of the length of the central region 28 protruding from the blocking member 26 toward the second end 32.
[0082] In this example, the base 50 includes a stationary plate 54, and a patch 56 protruding radially relative to the stationary plate 54 in order to increase the cooperation area between the base 50 and the intracorporeal surface.
[0083] The base 50 further includes a guide tube 58 and a collar 60 for application of the actuating device 20.
[0084] The stationary plate 54 in this example defines an orifice 62 for passage of the elongate element 24.
[0085] The guide tube 58 protrudes away from the patch 56 from the stationary disc 54 along the axis A-A. It defines an inner passage 63 for receiving the adjustment mechanism 52.
[0086] The application collar 60 is arranged around the free edge of the guide tube 58.
[0087] The selective adjustment mechanism 52 here includes a winder 64 able to wind part of the central region 28 of the elongate element around a winding axis collinear with the axis A-A.
[0088] The winder 64 in this example comprises a threaded rod 66, a rotary member 68, mounted on the threaded rod 66, and a fastening element 70 intended to cooperate with the actuating device 20 in order to rotate the rotary member 68.
[0089] The threaded rod 66 protrudes along the axis A-A inside the guide tube 58.
[0090] The rotary member 68 is mounted moving on the threaded rod 66 rotating about the axis A-A and moving in translation along the axis A-A. It defines a through passage 72 for engagement of the central region 28, intended to rotate the central region 28 and the winder about the rod 66.
[0091] The through passage 72 is off-centered relative to the axis A-A. It emerges axially on either side of the rotary member 68.
[0092] As will be seen below, the elongate element 24 is able to be inserted in the blocking member 26, from an unlocked position, initially separated from the blocking member 26, toward a locked position, in which the first end 30 of the blocking member 26 is locked on the blocking member 26.
[0093] To that end, the mobile stop 34 is able to be inserted successively in its axial position through the passage orifice 62, then through the through passage 72, and to enter its transverse position to stay bearing against the rotary member 68 in the locked position.
[0094] As illustrated by
[0095] The rotation of the rotary member 68 in a first direction causes the winding of an increasing length of the central region 28 in the blocking member 26, and the decrease of the length of the central region 28 protruding toward the second end 32 outside the blocking member 26.
[0096] On the contrary, the rotation of the rotary member 68 in a second direction causes the unwinding of the central region 28 and the increase of the length of the central region 28 protruding toward the second end 32 outside the blocking member 26.
[0097] Thus, the length of the central region 28 protruding toward the second end 32 outside the blocking member 26 is able to vary selectively between 0% and 90% of the total length of the filiform central region 28, for example between 0.3 cm and 9.5 cm.
[0098] In the example shown in
[0099] In reference to
[0100] In the example shown in
[0101] The actuating device 20 is maneuverable reversibly between an engaged configuration for actuating the selective adjustment mechanism 52 and a configuration detached from the selective adjusting mechanism 52.
[0102] In reference to
[0103] It also includes a first probe 94 engaged on the guide 90, and a first intracorporeal wall passage needle 96 for bringing the guide 90 to the implantation region of the shaping device 18.
[0104] The placement device 22 further includes a second probe 98 engaged around the traction member 92 and a second intracorporeal wall passage needle 100 for bringing the traction member 92 to the implantation region of the shaping device 18.
[0105] The guide 90 here is able to be bent in a cross shape at its free end 102.
[0106] The traction member 92 includes, at its free end, a grasping member 104, for example a lasso, able to grasp the free end 102 of the guide 90 in order to exert a traction force on said end 102.
[0107] The implantation and operation of the treatment kit 10 according to the invention will now be described, in reference to
[0108] Initially, the elongate element 24 and the blocking member 26 are provided disassembled outside the patient's body, the elongate element 24 being in its unlocked position relative to the blocking member 26.
[0109] In reference to
[0110] The free end 102 of the guide 90 is then wound in a cross shape.
[0111] In reference to
[0112] Then, the second needle 100 is successively introduced through the superior vena cava 110, and the interatrial septum 122, for the placement of the second probe 98 and the traction member 92.
[0113] The traction member 92 is then maneuvered so that the grasping member 104 grasps the free end 102 of the guide 90. The traction member 92 is then manipulated to pull the guide 90 toward the second probe 98, and through it.
[0114] The traction on the guide 90 causes the elongate element 24 to rise in the first probe 94, then outside it, as illustrated by
[0115] On the contrary, the bearing plate 36 remains blocked in the coronary sinus 114, bearing against the wall 14 around the native annulus.
[0116] This being done, the second probe 98 is removed.
[0117] The blocking member 26 is then mounted on the actuating device 20. The free end of the catheter 80 is engaged on the collar 60. The hook 84 is inserted in the hoop of the fastening element 70.
[0118] The free end 124 of the guide 90 is successively inserted into the passage orifice 62, then in the through passage 72 in order to allow the blocking member 26 and the actuating device 20 to rise along the guide 90 up to the cavity opposite the septum 122, through the superior vena cava 110.
[0119] The mobile stop 34 is placed in its axial position to successively enter the passage orifice 62 and the through passage 72. It then enters its transverse position, which locks the elongate element 24 relative to the blocking member 26. The filiform central region 28 then extends from the blocking member 26 through the septum 122, the left atrium 116, and through the wall 14 to its second end 32.
[0120] The length of the central region 28 protruding toward the second end 32 outside the blocking member 26 is then adjusted by maneuvering the arm 82 in order to rotate the rotary member 68 about the axis A-A. This winds or unwinds part of the central region 28 from the winder 64, in order to adjust the desired length of the central region 28 outside the blocking member 26.
[0121] The adjustment of this length adjusts the distance between the blocking member 26 and the bearing plate 36, controlling the deformation of the wall 14 and adjusting it to the desired shape.
[0122] Once the adjustment is done, the arm 82 is separated from the fastening element 70. The catheter 80 is detached from the blocking member 26 and is removed from the patient. The guide-90 is then freed from the mobile stop 34 and is removed from the patient.
[0123] The shaping device 18 is then installed, as illustrated by
[0124] Later, if an adjustment to the shape of the wall 14 is required, the catheter 80 provided with the arm 82 is reintroduced into the patient, through the superior vena cava 110 to reach the blocking member 26. The hook 84 at the end of the arm 82 is then reengaged in the fastening element 70 to maneuver the adjusting mechanism 52, as previously described.
[0125] The shaping device 18 according to the invention is therefore particularly easy to place through the endoluminal route and allows an adjustable adjustment of the shaping of an intracorporeal wall 14. This adjustment can be modified easily over time using an actuating device 20 also inserted through the endoluminal route.
[0126] This greatly limits the risks for the patient, and guarantees adaptability to the anatomical configuration of the patient, which can change over time.
[0127] In the alternative shown in
[0128] This makes it possible to adjust the shaping of the wall 14 precisely.
[0129] In the variant shown in
[0130] In the variant shown in
[0131] In this example, a tubular member 132 is engaged around the central region 28 in the form of a loop 130.
[0132] The tubular member 132 has separated ends 134, 136. Opposite strands of the loop 130 respectively leave the tubular member 132 at the first end 30 and the second end 32.
[0133] The tubular member 132 is thus C-shaped. The tubular member 132 here is substantially closed. The distance separating the ends 134, 136 is less than 80% of the maximum distance separating two opposite points located on the tubular member 132, on a line parallel to the line passing through the ends 134, 136.
[0134] The tubular member 132 thus forms a prosthetic valvular annulus able to be implanted surgically on the native mitral annulus.
[0135] As previously described, the shape of the native mitral annulus can be changed by actuating the adjusting mechanism 52 of the blocking member 26 in order to adjust the length of the central region 28 protruding outside the blocking member 26.
[0136] In the variant shown in
[0137] The T-shaped guide 138 is inserted through the interatrial septum. It guides the two opposite strands of the loop 130 toward the blocking member 26.
[0138] The shaping device 18 shown in
[0139] The distance separating the ends 134, 136 is greater than 80% of the maximum distance separating two opposite points situated on the tubular member 132, on a line parallel to the line passing through the ends 134, 136, and is advantageously equal to the maximum distance separating two opposite points situated on the tubular member 132 on a line parallel to the line passing through the ends 134, 136.
[0140] In the variant illustrated by
[0141] The adjustment of the length of the filiform central region 28 protruding outside the blocking member 26 causes the adjustment of the distance separating the ends 134, 136 of the tubular member 132 and therefore the shape of the prosthetic semi-annulus.
[0142] In the variants shown in
[0143] In
[0144] In
[0145] In the variant illustrated in
[0146] The patch 56 here includes a deployable framework 150. The framework 150 is made up of a plurality of filiform loops 152 movable between an axial configuration, substantially parallel to the axis A-A, and a transverse idle configuration, substantially perpendicular to the axis A-A.
[0147] In the variant illustrated by
[0148] The guide 90 is thus able to be separated from the mobile stop 34 by unscrewing.
[0149] In the variant illustrated by
[0150] The mobile shaft 160 extends transversely in the axial passage 63 arranged in the guide tube 58. The axial passage 63 emerges through the passage orifice 62 on the one hand, and through an opposite orifice 164.
[0151] The fastening element 70 is arranged at an end of the mobile shaft 160 protruding outside the base 50.
[0152] The mobile stop 34 and the first end 30 of the filiform central region 28 are inserted through the axial passage to allow the winding around the shaft 160 by the rotational driving of the shaft 160 about the axis B-B.
[0153] The rotation axis B-B is transverse to the local axis of the filiform central region 28 at the outlet of the blocking member 26.
[0154] In the variant illustrated in
[0155] The blocking system 172 is able to move away during traction in a first direction (to the right in the figure) on the first end 30 to cause a stop 170 to pass beyond the blocking system 172. It is able to prevent the passage of each stop 170 when the filiform central region 28 moves in a second direction opposite the traction in the first direction.
[0156] The blocking system 172 here is formed by a plurality of resilient tabs 174 able to bend so as to converge toward the axis A-A when idle, and to move away from the axis A-A during the passage of the stop 170 in the first direction.
[0157] Unlike the device 18 shown in
[0158] The adjustment of the length of the central region 28 protruding from the blocking member 26 toward the second end 32 is therefore done by traction on the elongate element 24 from the first end 30, to decrease the length of the central region 28 protruding outside the blocking member toward the second end 32.
[0159] In the variant shown in
[0160] The operation is also similar to that of the device 18 of
[0161] In the variant illustrated by
[0162] Unlike the device 18 described in
[0163] The intracorporeal clamp 200 is for example described in international application no. PCT/EP2015/077783 by the applicant. The second end 32 is fixed on the clamp 200, either before the implantation of the shaping device 18 in the patient, or during the placement of the clamp 200 on the intracorporeal wall. The second end 32 advantageously has no bearing plate 36.
[0164] The blocking member 26 is in turn applied on the inter-ventricular septum 201 on the side of the right ventricle.
[0165] In the variant illustrated by
[0166] The deflector 210 receives and guides an intermediate segment 212 of the central region 28. Thus, a first segment of the central region 28 comprising the first end 30 is received in the selective adjustment mechanism 52, as previously described. A second segment of the central region 28 comprising the second end 32, with a length adjustable by the selective adjusting mechanism 52, protrudes from the deflector 210.
[0167] In the example shown here, the deflector 210 is formed by a tube emerging at a first end opposite the passage orifice 62 and emerging transversely at a free end through a lateral opening 214.
[0168] In reference to
[0169] Furthermore, the deflector 210 here extends along an inclined direction relative to a normal N to the bearing surface 51, taken at the passage orifice 62. The incline angle I is for example between 1 and 45.
[0170] During operation, the free end of the guide 90 is successively introduced into the deflector 210 by its free end 214, then into the blocking member 26. The elongate element 24 is partially introduced by its free end 30 through the free end 214 of the deflector 210, up to the passage orifice 62, then into the adjusting mechanism 52, as previously described.
[0171] The bearing surface 51 of the base 50 is then wedged against the septum 122 in the right atrium 123, while the deflector 212 protrudes in the left atrium 116 through the septum 122, in the vicinity of the mitral-aortic junction 216.
[0172] Thus, the segment of the elongate element 24 protruding outside the blocking member 26 from the deflector 212 extends substantially perpendicular to the separating line 218 between the leaflets 16, thus guaranteeing an excellent coaptation of the leaflets 16.
[0173] In the variant illustrated by
[0174] Unlike the shaping device 18 previously described, the blocking member 26 is arranged directly in the left atrium 116 to connect the elongate element 24 and the additional elongate element 24A to one another by their first ends 30.
[0175] To that end, the first ends 30 provided with moving stops 34 are inserted into the blocking member 26 as previously described, by one or several passage orifices 62.
[0176] As illustrated by
[0177] In the variant illustrated in
[0178] In the variant illustrated by
[0179] The rotary shaft 230 is equipped at its free end with a fastening device 232 on a corporeal wall, here formed by the left atrium.
[0180] As illustrated in
[0181] The rotary shaft 230 is provided with at least one passage 72 for engagement of the central region 28 of an elongate element 24.
[0182] In the example shown in
[0183] The fastening device 232 includes at least one radially deployable anchor 234, provided here at its end with a hook 236. The anchor 234 is able to go spontaneously from a retracted configuration to a deployed configuration during the placement of the blocking member 26.
[0184] The fastening device 232 includes a skirt 238 for guiding the rotation of the shaft 230, which rotatably receives the free end of the shaft 230.
[0185] The blocking member 26 (in particular the rotary shaft 230 and the fastening device 232) advantageously delimits, over its entire length, an inner aperture for allowing the guide to pass, which allows its insertion into the patient.
[0186] During operation, the free end 124 of the guide 90, 90A associated with each elongate element 24, 24A is inserted through a respective passage 72 before the insertion of the blocking member 26 into the patient.
[0187] The blocking member 26 is then guided in the patient to place the base 50 bearing against the interatrial septum 122 in the right atrium 123.
[0188] The shaft 230 is inserted through the septum 122 in the left atrium 116. The fastening device 232 is then placed by deployment of the anchors 234, which fasten on the left atrium.
[0189] The rotation of the shaft 230 by actuation of the fastening element 70 then causes the winding or unwinding of a length of the central region 28 protruding from the blocking member 26 toward the second end 32.
[0190] In the example shown in
[0191] In the variant shown in
[0192] These devices 18 are very effective for guaranteeing a good coaptation of the leaflets 16 of the valve 12.
[0193] In the variant illustrated by
[0194] The strips 250 are transversely deformable to open the passage 72, allowing the insertion of at least one engagement stop 34 of an elongate element 24.
[0195] To keep the strips 250 in their deformed position, a temporary wedge 252 is inserted between the strips 250 during the placement of the blocking member 26, as illustrated by
[0196] Thus, once the shaft 230 is installed protruding in the left atrium 116, each end 30 of an elongate element 24 is inserted through the passage 72, the wedge 252 extending in place.
[0197] Then the wedge 252 is removed. The strips 250 return to their idle position, and lock each stop 34 in position between the strips 250, as illustrated by
[0198] In the variant illustrated by
[0199] In the variants illustrated by
[0200] Such a blocking system 260 is for example a ratchet system. It is able to allow the rotation of the winder 64 in a first direction and to prevent the rotation of the winder 64 in a second direction.
[0201] This blocking system 260 can advantageously be installed on all of the blocking members 26 previously described.
[0202] The locking of the first end 30 of the elongate element 24 relative to the blocking member 26 and the adjustment by the adjusting mechanism 52 allow an adjustment of the length of the elongate element 24. For example, the adjustment is done by rotating the winder.
[0203] The blocking member 26 allows both the adjustment by the adjusting mechanism 52 and the locking making it possible to maintain this adjusting length.
[0204] Furthermore, the locking and the adjustment of the length are reversible.
[0205] Advantageously, the elongate element and the blocking member are radiopaque. The adjustment is made easier by the radiopacity of the elongate element 24 and the blocking member 26.
[0206] The blocking device 26 allowing both the setting and the adjustment is thus deployed by the endoluminal route. Furthermore, it remains accessible by the endoluminal route for later adjustments that may be repeated.
[0207] The adjustment mechanism 52 remains accessible and manipulatable using an actuating device 20 introduced by the endoluminal route. The selective adjustment mechanism 52 is an integral part of the blocking member 26.