Heart valve delivery system

[0001] The present invention relates to systems used for introducing a valve prosthesis into the heart. More specifically, the present invention relates to an improved, controllable delivery system for introducing a valve prosthesis into a human heart.

[0002] Catheters are known in the art that have been widely used to gain access to areas within the body that are not easily accessible by surgery or to which surgical access is not desired. The usefulness of catheters is greatly limited by the ability of the catheter to successfully maneuver through small vessels and around tight turns, such as along the aortic arch.

[0003] Various controllable catheters have been proposed over the years to facilitate maneuvering through the hard-to-reach vascular system. For example, some known devices use a series of interconnected segments, each of which has a shape that allows the catheter to create a bent configuration that is adaptable to specific needs. However, the use of multiple interconnected segments is complicated and expensive.

[0004] Also known in the art is a device in which parts have been removed from the hollow probe lead, thereby allowing bending of the hollow wire in the areas where these parts have been removed. However, known devices of this type are used as probes and have not been adapted for use as a controllable catheter.

[0005] A device is also known in the art in which spring bands are used in the controllable catheter, whereby one spring band has a natural curvature opposite the curvature in the bending direction of the device, thereby providing stability to the device. Nevertheless, these bands contribute to the additional complexity of the device and are therefore unsuitable for many applications.

[0006] WO-A-99/12483 discloses a surgical instrument suitable for use in endoscopic and open surgery to replace an implanted prosthesis. This instrument includes a gripping portion of an endoscopic tube section extending from said gripping portion, an articulated section pivotally connected to the distal end of the tubular section, as well as an implant adapter connected to the articulated section. A structure is thus provided for progressive manipulation of the articulated section of the instrument relative to the longitudinal axis of the handle portion, within a certain range of angular displacement. In addition, a structure is used to rotate manipulate the implant adapter relative to the extended longitudinal axis of the distal end of the articulated portion. During use, an implant such as a heart valve is attached and can be removed from the complementary surface of the implant's outer structure. This implant adapter, the articulated section in the fully extended position, as well as part of the rigid tubular section are then inserted through the access port to the destination surgical site in the patient's body. The instrument holder is then rotated so that the target implant site is in the angular plane of the articulated section. The bending elements are then operated so as to insert the implant adapter into the target surgical position. If needed, then the angular plane of the articulated section can be fine-tuned by further rotating the handle. When the implant adapter was introduced in doce1

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Iowa operating position, the articulated section is held in a position that fixes the angular position of the implant adapter in the angular plane relative to the longitudinal axis A of the handle. The rotary elements are then operated to rotate the implant adapter in such a way that the implant attached to it is inserted into the appropriate anatomical orientation at a predetermined surgical destination. Once the implant has been attached to this predetermined surgical destination, the implant adapter is separated from the implant. If the implant is threaded to the implant adapter, the rotatable elements are operated in such a way as to withdraw the threaded post of the implant adapter from the complementary thread. If the implant has a complementary surface structure, as in the case of a bayonet mount, the instrument is simply gently pulled back towards the access port until the complementary outer surface of the implant adapter separates from the implant.

[0007] The closest prior art WO-A-03/030776 discloses a cardiac valve prosthesis and a method of implanting this prosthesis mounted on a support apparatus that can deform between the first condition and the second condition. This delivery system for a valve prosthesis includes a balloon catheter and a tubular sleeve 734 with a bendable end. The prosthesis has a cross-sectional dimension in the second condition smaller than the cross-sectional dimension of the supported valve in the first condition. The prosthesis can be implanted into the patient's heart, as during a direct access procedure, through a tubular implantation apparatus that holds the prosthesis in its second state until unloaded from the tubular apparatus. The valve may be expanded with a balloon catheter.

[0008] Document WO-A-02/060352 discloses a medical apparatus suitable for remodeling of the mitral valve ring adjacent to the coronary sinus. This apparatus includes an elongated body having a proximal area and a distal area. Each of this proximal and distal areas is dimensioned so as to be completely within the vascular system. The elongated body can be moved from the first configuration for the introduction of transluminain into at least part of the coronary sinus to the second configuration for the reconstruction of the mitral valve ring adjacent to the coronary sinus. The forming element can be attached to the elongated body to manipulate the elongated body from the first transluminal configuration to the second reconstruction configuration. Furthermore, the elongated body may comprise a pipe having a plurality of transverse slots formed therein.

[0009] Although various bendable and controllable devices have been proposed over the years, each of these existing devices has some disadvantages that limit its effectiveness. Accordingly, there is a great need for an improved, controllable delivery system to facilitate movement of the implant / patient treatment through the patient's vascular system to the treatment site. It is desirable for such a system to eliminate the disadvantages associated with existing devices. It is also desirable for such a system to be universal, reliable and easy to use. The present invention satisfies this need. Summary of the Invention [0010] Preferred embodiments of the present invention relate to a cardiac valve introducing system for introducing a prosthesis (i.e. replacement) of a cardiac valve into a natural site for such a valve within the human vascular system. This delivery system includes an introduction sleeve assembly having a controlled section to facilitate navigation around arches. This system is great for

EP 1 903 989 przemieszcz1 displacement of the valvular prosthesis through the aorta (i.e. as part of the retrograde concept) to replace the narrowed aortic valve.

[0011] The invention relates to an insertion system for introducing a valvular prosthesis into a patient's heart as set out in claim 1.

[0012] In one embodiment, the sleeve of the heart valve delivery system includes first and second outer tubules extending along the side of the sleeve. A pull cord may pass through the first outer channel, through the controllable section of the distal end of this controllable section, and return through the controllable section and through the second outer channel.

In a further variant, the controllable section comprises a slotted pipe having a first straight part and a second curved part. This controllable section may be formed, at least in part, from a structure referred to as a hypotube made of stainless steel. In one preferred embodiment, the sleeve is formed from a polyether block amide known as Pebax®, and also has low-hardness Pebax® at its distal end.

[0014] The cover may be coupled to the distal end portion of the controllable section. The sheath surrounds at least part of the valvular prosthesis as it travels through the patient's vascular system.

[0015] The method of introducing a valvular prosthesis into a natural valve destination includes placing a reversible valvular prosthesis on a balloon along a distal end of the balloon catheter, placing a balloon catheter within the delivery sleeve assembly having a controllable section that is actuated by a pull tube, and moving the valve the supply sleeve assembly towards the natural valve destination, essentially as a single unit while the curvature of the controllable section is selectively adjusted to facilitate displacement. When the valvular prosthesis is displaced using a retrograde concept (i.e. along the aortic arch), the valvular prosthesis is displaced out of the delivery sleeve assembly after being averaged through the aortic arch. More specifically, the valvular prosthesis may be moved from the delivery sleeve assembly to the natural valve destination. The balloon is inflated to activate the openable prosthetic valve.

Brief Description of the Drawings [0016] The features and benefits of the present invention will become more pronounced when better understood with reference to the description, claims and the attached drawings, in which:

[0017] Fig. 1 is a side view of a system that introduces a heart valve to a natural valve destination, according to one preferred embodiment of the present invention;

[0018] Fig. 2 is a cross-sectional view of the handle used in this delivery system;

[0019] Figures 3A and 3B are respectively a perspective view and a cross-sectional view of the first core member which forms part of the handle;

[0020] Figures 4A and 4B are, respectively, a perspective view and a cross-sectional view of a partially threaded member that is disposed around the core member;

[0021] Figures 5A and 5B are a side view and a cross-sectional view, respectively, of the handle of the turning element;

[0022] Figures 6A and 6B are, respectively, a perspective view and a cross-sectional view of the second core member, which is another part of the handle;

EP 1 903 989 Β1 [0023] Figures 7A and 7B are respectively a perspective view and a cross-sectional view of the cup, which is arranged around the second core member;

[0024] Fig. 8 is a side view of a guide tube having a passage for slidably receiving a pull cord;

[0025] Fig. 9 is a perspective view of a central tubular sleeve;

[0026] Fig. 10 is a cross-sectional view of a distal portion of the supply sleeve assembly;

[0027] Fig. 11 is a side view of a flexible pipe that is a controllable section, the flexible pipe being laid flat for illustrative purposes;

[0028] Fig. 12 is a cross-sectional view of a portion of the supply sleeve assembly according to an alternative embodiment;

[0029] Fig. 13 is a cross-sectional view of the shroud section in the supply sleeve assembly;

[0030] Figures 14A and 14B are respectively a perspective and cross-sectional view of the cover forming part of the cover section of Fig. 13;

[0031] Figures 15A, 15B, and 15C are, respectively, a perspective view, a cross-sectional view and a bottom view of the ring forming part of the cover section according to Fig. 13;

[0032] Fig. 16 is a cross-sectional view of a balloon catheter configured for use with a heart valve delivery system;

[0033] Figures 17A and 17B are respectively a perspective view and a cross-sectional view of a balloon which forms part of the balloon catheter according to Fig. 16;

[0034] Figures 18A and 18B are cross-sectional views of the distal end of the delivery system, Fig. 18A illustrates a first embodiment with a heart valve prosthesis located at a distance from the sheath, while Fig. 18B shows a second embodiment with a heart valve prosthesis located inside covers;

[0035] Fig. 19 is a side view of the chain cover assembly;

[0036] Fig. 20 is an exploded perspective view of the loading assembly used to load the balloon catheter and valvular prosthesis into the chain cover assembly;

[0037] Figures 21A and 21B are side views illustrating the insertion of the delivery system in the loading unit;

[0038] Fig. 22 is a side view illustrating the relationship between the delivery system, the guide shell assembly, and the loading assembly; and [0039] Fig. 23 is a side view of the delivery system in use showing the actuation of a heart valve prosthesis at a natural valve site to replace the function of a defective natural valve.

Detailed Description of Preferred Embodiments [0040] With reference to Fig. 1, one of the preferred embodiments of a cardiac valve introducing system 10 for inserting a prosthetic valve 11 into a malfunctioning aortic valve 12 of a human heart is shown for illustrative purposes. This delivery system is suitably adapted to insert the valvular prosthesis 11 through the patient's vasculature and along the aortic arch 13 to a location adjacent to the inoperative valve 12.

[0041] The delivery system 10 comprises a guide wire 14 and a balloon catheter 15, configured to be able to be moved in the guide wire 14. Prosthesis

EP 1 903 989 k1 is guided along the distal end portion of the balloon catheter. This balloon catheter 15 comprises a tubular section 16 and a handle / bracket 17 at the proximal end of the tubular section 16. The tubular section 16 of the balloon catheter 15 is received within the supply sleeve assembly 18. The supply sleeve assembly generally includes a sleeve 19, a controllable section 20, and a protective section 21. The proximal end of the supply sleeve assembly 18 is mounted on the handle 22. The delivery system 10 passes through the guide shield assembly 400 and the loading assembly 500, which will be described in more detail below, and thus enter the body vessel and the valve 11 is introduced. [0042] With reference to Fig. 2, handle 22 at the proximal end the supply sleeve assembly 18 generally includes an end cap 23, an adjustable portion 24, and also a hemostatic portion 25. The adjustable portion 24 includes a first core member 26, a partially threaded member 27 around the first core member 26, and a handle 28 of the rotating member around the partially threaded member 27. The hemostatic part 25 includes a second core member 29 and a cup 30 around the second core member 29. The hemostatic tube 31 extends outwardly from the cup 30. A guide tube 32 is placed inside the handle 22, as will be described in more detail below.

[0043] With reference to Figures 3A and 3B, the first core member 26 is generally in the shape of a pipe having a corridor 33 extending longitudinally therethrough. The annular flange 34 forms the proximal end 36 of the first core member 26. The first slot opening 38 allows communication from the outer surface of the first core member 26 to the corridor 33, and along the length course of the first core member 26. The second slot 40 extends along the length of the outer surface of the first core member 26 from the distal end 42 towards the flange 34. The flange 34 includes a first mounting hole 44 extending radially from the outer surface of the first core member 26. The longitudinally extending access hole 46 at the proximal end of the slot 40 extends. from the wall 47 the proximal end of the gap 40 to the first mounting hole 44.

[0044] Referring to Figures 4A and 4B, the partially threaded member 27 has a proximal end 48 and a distal end 50. This partially threaded member 27 has essentially the shape of a pipe having a passage 52 extending longitudinally therethrough. Towards the proximal end 48, the outer surface of the partially threaded member 27 has an outer thread 54. This thread 54 includes a radially extending hole 56 for a locating pin extending into the passage 52 of the partially threaded member 27. Towards the distal end 50, the outer surface of the partially threaded member 27 forms an annular groove 58. The outer surface of the partially threaded member 27 also forms a tapered surface 60 located at a distance from the annular groove 58 towards the distal end 50. Sharpened annular end 61 forms the distal end 50 of the partially threaded member 27.

[0045] With reference to Figures 5A and 5B, the handle 28 of the rotating element preferably comprises an elongated cylinder having a proximal end 62 and a distal end 63, and also includes a passage 64 extending longitudinally therethrough. On its outer surface, the handle 28 of the rotating element comprises grooved parts 66 extending along its length. On its inner surface, the turning element holder 28 includes a threaded portion 68 that extends inwardly from the distal end 63, the first ring-shaped recess 70, in close proximity to the threaded portion 68, the annular flange 72, located in the vicinity of the first ring-shaped recess. 70, extending inwardly from the outer surface, as well as a second annularly shaped depression 5

EP 1 903 989 ienie1 bions 74, adjacent the proximal end 62 of the handle 28 of the turning element. The mounting holes 75 extend from the outer surface to the inner surface of the turning element holder 28, in the region of the passage 64 located in close proximity to the second annular recess 74, at a distance from the proximal end 62 of the turning element holder 28. The access opening 76 passes from the outer surface to the inner surface of the handle 28 of the rotating element, in the region of the corridor 64, at a distance from the second ring-shaped recess 74 and in close proximity to the ring-shaped flange 72. The second access hole 77 also extends from the outer surface to the inner surface handle 28 of the turning element at the proximal end of the threaded portion 68.

[0046] With reference to Figures 6A and 6B, the second core member 29 is generally tubular in shape and includes a passage 78 passing through it. The flat portion 80 of the second core member 29 further defines its outer surface. The outer surface of the second core member 29 includes a slot 82 that extends along its length. This second core member 29 also includes a longitudinally extending slot 84 extending through the flat portion 80 of the outer surface into the corridor 78 of the second core member 29.

[0047] With reference to Figures 7A and 7B, the cup 30 is formed by the first and second cylindrical sections 85, 86, connected by the tapering section 87. The corridor 88 runs through the cup 30. This corridor 88 increases its size in the tapering section 87 as it passes from the first cylindrical section 85 to the second cylindrical section 86. The hemostatic opening 90 of the valve extends obliquely from the outer surface of the second cylindrical section 86 to its inner surface. At the proximal end 92 of the cup 30, the inner surface includes a ring-shaped main recess 94 that forms a projection at the proximal end of the corridor 88. An additional semi-cylindrical recess 96 is located around the circumference of the ring-shaped main recess 94. A second annular shaped recess 98 extends around the inner surface of the cup 30, in the area in which the semi-cylindrical recess 96 is located, leaving single flanges 100 running radially inward along the inner surface at the proximal end 92 of the cup 30.

[0048] The guide tube 32, shown in Fig. 8, is a shaped tube and has a corridor extending longitudinally through it. Both these sections, proximal section 110 and distal section 112, are straight and form a certain angle between them. The intermediate section 113 is curved and connects the proximal section to the distal section 110, 112. [0049] The components of the handle 22 are preferably connected as shown in Fig. 2. The first thrust washer 114 is located on the outer surface of the first core member 26, at a distance from the flange 34 (see Fig. 3A) of the first core member 26, while the first core member 26 is inserted into the handle 28 of the rotating element, via the proximal end 62 (see Fig. 5A) of the turning element holder 28. The second thrust washer 116 is located near the proximal end 36 of the first core member 26. The first thrust washer 114 is closed between the annular flange 72 and the rotating member holder 28 and the flange 34 of the first core member 26. The flange 34 settles in the area between the ring shaped flange 72 and the second ring shaped recess 74 of the rotating member 28. The latch ring 118 is located in a second ring-shaped recess 74 (see Fig. 5B) and comes in contact with the second thrust washer 116, thereby positioning the first core member 26.

EP 1 903 989 Β1 [0050] The first securing element of the core member (not illustrated) is coupled to the opening 44 of the first securing element (see Fig. 3B) of the first core member 26. The ball bearing 122 is located in the opening 44 of the first securing element, Access hole 76 (see Fig. 5B) of the rotating member retainer 28 allows access to the first fastener of the core member.

[0051] The partially threaded member 27 is screwed into the turning element holder 28, from the distal end side 63 of this turning element holder 28. The external thread 54 of the partially threaded member 27 is engaged with the threaded portion 68 of the inner surface of the turning member holder 28. The first core member 26 settles within the passage 52 of the partially threaded member 27. When the partially threaded member 27 is fully engaged inside the rotating member grip 28, as shown in Fig. 2, the proximal end 48 of the partially threaded member 27 rests against the annularly shaped collar 72 of the rotating member grip 28, [0052] The retaining pin 124 remains engaged with the hole 56 for the locating pin of the partially threaded member 27 (see Fig. 4B) and extends from the outer surface of the partially threaded member 27 to the first slotted hole 38 of the first core member 26. When the partially threaded member 27 is fully engaged in the rotating member holder 28, the locating pin 124 is located in the area of ​​the passage 64 of the rotating member holder 28 corresponding to the first ring-shaped recess 70 (see Fig. 5B). This locating pin 124 is placed in the hole 56 for the locating pin in the partially threaded member 27 through the second access hole 77 of the rotating member 28 when the partially threaded member 27 is screwed into the rotating member 28 and then the hole 56 for the locating pin the access hole 77 as well as the first slit hole 38 of the first core member 26 are aligned.

[0053] The end cap 23 is attached to the proximal end 62 of the handle 28 of the rotating element. This end cap 23 includes a cylindrical shaped first contact surface 126 that contacts the inner surface of the rotating member handle 28 and a second contact surface 128 that contacts the proximal end 62 of the turning member handle 28. The corridor 130 extends through the end cap 23 and is located in communication with the passageway 64 of the rotating element holder 28. The first contact surface 126 of the end cap 23 is aligned with the mounting holes 75 of the turning element holder 28. The set screws (not shown) engage the mounting holes 75 to attach the end cap 23 to the rotating element holder 28.

[0054] The second core member 29 is placed in the corridor 88 of the cup 30. The slit hole 84 (see Fig. 6B) of the second core member 29 is aligned with the hemostatic opening 90 of the valve 90 (see Fig. 7B) of the cup 30. The plate 134 is placed in the main annularly shaped recess 94 of the cup 30, in close proximity to the second core member 29. This plate 134 is preferably made of polyisoprene, and also includes a central hole 136 located in communication with the passageway 88 of the second core member 29, as well as a guide pipe hole 138 that is located in communication with the slot 82 of the second core member 29. The plate 126 can be glued to the inner surface of the cup 30.

EP 1 903 989 Β1 [0055] A proximal section 110 (see Fig. 8) of the guide tube 32 is inserted into the slot 40 of the first core member 26. The guide tube 32 passes through the plate 134. The further section 112 of the guide tube 32 is inserted into the slot 82 of the second core member 29.

[0056] The pointed ring end 61 (see Fig. 4B) of the partially threaded member 27 is pressed into the plate 134, while the individual flanges 100 (see Fig. 7A) at the proximal end 92 of the cup 30 are engaged in a ring shaped groove 58 of the partially threaded member 27 to connect the cup 30 to the partially threaded member 27. The flanges 100 move along the tapered surface 60 of the partially threaded member 27 before they engage the ring shaped groove 58 of the partially threaded member 27. After the connection between the partially threaded member 27 and the socket 30 has been made, and also when the partially threaded member 27 is fully engaged in the turning element holder 28, the proximal end 92 of the cup 30 rests against the turning element holder 28. Furthermore, as shown in Fig. 2, the middle section 113 of the guide tube 32 passes through the plate 134.

[0057] Referring to Fig. 9, the sleeve 19 is preferably an elongated tubular structure formed with the middle channel 139 and the first and second outer channels 140, 141. This sleeve includes proximal end 142 and distal end 143, outer surface 144 and inner surface 145 . This sleeve 20 can be made of any suitable material for this purpose, but is preferably made of thermoplastic elastomers prepared from block polyether polyamide, commercially available as Pebax®. Towards the distal end 143, this sleeve 19 includes a low hardness, bendable section. This low hardness section in the sleeve 19 is preferably made of 55D Pebax® material, and can be bent as described below. The remaining part of the sleeve 19 is preferably made of 72D Pebax®, which is stiffer than 55D Pebax®. The rigidity of the 72D Pebax material prevents excessive bending of the sleeve, giving the operator the ability to push the delivery system 10 through potentially narrowed body vessels, and also allows this delivery system 10 to more efficiently wander to the natural valve destination as described below. The sleeve 19 can also be made of a braided cable of any length. The braided wire may also contribute to the stiffness and the ability of the delivery system to squeeze through the winding vessels.

[0058] Referring to Fig. 10, the controllable section 20 of the supply sleeve assembly is shown in cross section. This controllable section comprises a flexible tube 146 and a cover 148. This flexible tube 146 preferably has the shape of a tube, and also has an inner surface 150, an outer surface 152, and a passageway 154 through it. This flexible tube 146 is defined by the proximal end 156, the section middle 158, as well as distal end 160. Referring to Fig. 11, a plurality of V-shaped notches 162, such as by laser cutting, in the flexible tube 146, adjacent the proximal end 156. These notches 162 are shaped to provide sharp serrations 164. Along the central section 158 of the flexible tube 146 , circumferentially extending oblong holes 166 are used. Each such oblong hole 166 preferably includes two elongated portions 168 connected by a curved portion 170. Round parts 172 are used at the ends of the elongated holes. The tubular portions 174 remain substantially intact and will be described in more detail below. The notch 176 is made at the distal end 160 of the flexible pipe 146. In one preferred embodiment, the flexible pipe 146 is made of a structure known as hypotube and made of stainless steel.

EP 1 903 989 Β1 [0059] Referring again to Fig. 10, the cover 148 preferably has the shape of a tube, and also has a proximal and distal end 178, 180, and also includes an outer surface 182 and an inner surface 184, with a passageway 186 extending through not longitudinally. In one preferred embodiment, the cover 148 is formed of a material of low hardness, such as 55D Pebax®. Such a low 55D hardness Pebax® cover material 148 allows it to stretch and flex as described below.

[0060] The controllable section 20 is mounted by placing the flexible tube 146 inside the cover 148. This cover 148 can be stretched before assembly to give the controllable section 20 the desired features, as outlined below. The outer surface of the flexible tube 146 comes into contact with the inner surface of the cover 148. The proximal end 178 of the cover 148 extends proximal to the proximal end 156 of the flexible tube 146, while the distal end 180 of the cover 148 extends away from the distal end 160 of the flexible tube 146.

[0061] Referring to Fig. 12, an alternative embodiment of controllable section 20 includes a connector 188 having a proximal end 190 and a distal end 192. The connector 188 has the shape of a pipe having a passage 194 extending longitudinally through it. The ring-shaped collar 196 projects from the inner surface 198 of the connector 188.

[0062] To assemble an alternative embodiment of the controllable section 20 comprising the connector 188, the proximal end 156 of the flexible pipe 146 is inserted into the passage 194 of the connector 188 until it rests against the ring-shaped collar 196. The outer surface of the flexible pipe 146 comes into contact with the inner surface 198 of the connector 188, and may also adhere to it by means of a binder. The cover 148 is placed on the flexible pipe 146 and on the connector 188. The proximal end 190 of the fitting 188 extends proximal to the proximal end 178 of the cover 148, while the distal end 180 of the cover 148 extends away from the distal end 160 of the flexible tube 146 (see Fig. 10).

[0063] Referring to Fig. 13, the cover section 21 is shown in section. This casing section 21 generally includes a casing 200 and a ring 202. Referring to Figures 14A and 14B, the casing 200 preferably has a cylindrical shape and includes three continuous cylindrical sections: a rim 204 near the proximal end 206, a main body 208 near the distal end 210, and a neck 212 located between them. Corridor 213 extends through sheath 200, which includes inner surface 216 and outer surface 218. Slots 214 extend from the proximal end 210 of sheath 200 to neck 212. Neck 212 has a smaller circumference than rim 204 and main body 208, resulting in a groove 220 along the surface outer 218 of the cover 200.

[0064] With reference to Figures 15A to 15C, the ring 202 has a proximal end 222, a distal end 224 and a corridor 225 longitudinally extending through it. This ring 202 includes a proximal outer surface 226, a distal outer surface 228, as well as an inner surface 230. The outer surface 232 extends perpendicular to the proximal and distal outer surface 226, 228 of the ring 202, and connects the proximal and distal outer surface 226, 228, which run substantially parallel to each other. The inner surface 230 includes an angular surface 234 towards the distal end 224 causing the ring passage 225 to increase in diameter near the distal end 224 of the ring 202.

[0065] The gap 236 extends to the distal end of the ring 202 and through the distal outer surface 228 to the inner surface 230, in parallel with the central axis of the ring 202, forming a slotted surface 238 opposite to the outer surface 232. The first channel

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240 and the second channel 242 extends from the slotted surface 238 to the outer surface 232 of the ring 202. The proximal outer surface 226 also includes a first semi-cylindrical recess 244 and a second semi-cylindrical recess 246 that run parallel to the central axis of the ring 202 and extends from the proximal end 222 to outer surface 232 of ring 202. This first cylindrical recess 244 is aligned with the first channel 240, while the second cylindrical recess 246 is aligned with the second channel 242.

[0066] The sheath section 21 is formed by inserting the proximal end of the sheath 200 into the ring 202 according to Fig. 13. The crown 204 bends to allow this operation. The ring 202 fits smoothly into the groove 220 (see Fig. 14B) in such a way that the inner surface 230 and the proximal and distal ends 222, 224 of the ring 202 (see Fig 15A) come into contact with the outer surface 218 of the cover 200. The ring 202 is positioned such that each of the slots 214 of the cover 200 (see Fig. 14A) is aligned with the slot 236 of the ring 202.

[0067] Referring to Fig. 16, the balloon catheter 15 comprises a tubular section 16 and a bracket 17. The tubular section 16 comprises a guide wire pin 248 and a balloon rod 250, both of which stems are connected to the bracket 17 and balloon 252. Stem 248 the guide wire having a proximal end 256 and a distal end 258 includes an inner surface 260, an outer surface 262, and a passage 264 extending longitudinally therethrough. The guide wire mandrel 248 can be formed from nylon, braided stainless steel wires or Pebax® material, in various lengths along its length, depending on the requirements of rigidity and flexibility. Teflon® can be used to form the inner surface 260 of the mandrel 248 of the guide wire. The balloon mandrel 250, having a proximal end 266 and a distal end 268, includes an inner surface 270, an outer surface 272, and a passage 274 extending longitudinally therethrough. The balloon stem 250 can be made of any combination of nylon, Pebax® material, or braided stainless steel wires, at various lengths of its length, according to the needs of rigidity and flexibility.

[0068] Referring to Figures 17A and 17B, balloon 252 has a proximal end 276 and a distal end 278, and also includes an inner surface 280, an outer surface 282, and a corridor 284 longitudinally extending therethrough. In the direction from the proximal end 276 to the distal end 278, the balloon 252 comprises five parts: a first narrow part 286, a first conical part 288, a main cylindrical part 290, a second conical part 292, and a second narrow part 294. The balloon 252 can be made of nylon and is developed with a burst pressure of 6-8 atm. In preferred embodiments, the balloon diameter after stretching is in the range of about 20 to 28 mm, and more preferably is about 23 mm.

[0069] Referring to Fig. 16, the bracket 17 includes a conduit inlet 296, a fluid inlet 298, and a main stem 300. The inlet opening 296 of the conduit includes an inner surface 302, and the main bore 300 similarly includes an inner surface 304. The apertures 296,298, 300 are arranged so that they can communicate with each other.

[0070] The balloon catheter 15 is assembled as shown in Fig. 16. The guide wire mandrel 248 is inserted into the main stem hole 300. The proximal end of the guide wire mandrel 248 is positioned in the wire inlet opening 296, while the outer surface 262 of the guide wire mandrel 248 is attached to the surface

EP 1 903 989 wewnętrznej1 inner 302 of the inlet opening 296 of the conduit, for example by gluing. The guide wire mandrel 248 has a smaller diameter than the main stem hole 300 and therefore does not come into contact with the inner surface 304 of the main stem hole 300.

[0071] The balloon rod 250 is placed on the guide wire rod 248. The proximal end 266 of the balloon mandrel 250 is placed in the mandrel main hole 300 in the support 17, while the outer surface 272 of the balloon mandrel 250 is attached to the inner surface 304 of the mandrel main hole 300. As shown in Fig. 16, the guide wire pin 248 has a smaller diameter than the balloon rod 250, and the outer surface 262 of the guide wire rod 248 does not contact the inner surface 270 of the balloon rod 250 to allow air flow.

[0072] The proximal end 256 of the guide wire mandrel 248 extends proximal to the proximal end 266 of the balloon mandrel 250, while the distal end 258 of the guide cord mandrel extends away from the distal end 268 of the balloon mandrel 250.

[0073] The proximal end 276 of the balloon 252 is located above the distal end 268 of the balloon stem 250. The inner surface 280 of the balloon 252 in the region of the first narrow portion 286 is attached to the outer surface 272 of the balloon stem 250. The distal end 278 of the balloon 252 is located above the distal end 258 guide wire pin 248. The inner surface 280 of the balloon 252 in the region of the second narrow portion 294 is attached to the outer surface 262 of the guide wire pin 248. The balloon 252 may be attached to the balloon mandrel 250 and the guide wire mandrel 248 using a process including curing the binder by ultraviolet light or by laser welding.

[0074] The first and second indicator band 306, 308 are located along the guide wire mandrel 248, inside the balloon corridor 284 252. These indicator bands 306, 308 can be attached to the outer surface 262 of the guide wire mandrel 248 by means of a binder by profiling. The position of the first indicator band 306 roughly corresponds to the intermediate area between the first conical portion 288 and the main cylindrical portion 290 of balloon 252 (see Fig. 17B). The position of the second indicator band 308 roughly corresponds to the intermediate area between the main cylindrical part 290 and the second conical part 292 of the balloon 252 (see Fig. 17B). These indicator bands 306, 308 can be formed of 90% platinum and 10% iridium to indicate by fluoroscopy, a process known in the art, the position of the balloon catheter 19 within the patient's body. A soft tip 310 located at a distance from the balloon 252 is placed at the distal end 258 of the guide wire pin 248.

[0075] The supply sleeve assembly 18 is formed by joining the sleeve 19 and the controllable section 20. The distal end 143 of the sleeve 19 is inserted into the corridor 186 of the cover 148 and the corridor 154 of the flexible tube 146, as shown in Fig. 10. The sleeve 19 is located relative to controllable section 16 in such a way that the first t second outer channel 140, 141 are aligned with the curved portions 170 of the elongate holes 166 of the flexible tube 146. The outer surface 144 of the sleeve 19 is attached to the inner surface 150 of the flexible tube 146, for example by thermal or glued connection. In addition, the seals 164 may engage the distal end 143 of sleeve 19 to accomplish this connection. The inner surface 184 of the cover 148 is also attached to the outer surface 144 of the sleeve 19 at the proximal end 178 of the cover 148 by adhesive or thermal connection.

EP 1 903 989 Β1 [0076] In an alternative embodiment (see Fig. 12) including the connector 188, the outer surface 144 of the sleeve 19 is attached at its distal end 143 to the inner surface 198 of the connector 188 towards the proximal end 190 of the connector 188. Distal end 143 of sleeve 19 rests against annularly shaped collar 196 of connector 188.

[0077] The covering section 21 is also connected to the controllable section 20 to form the supply sleeve assembly 18 (see Fig. 10). The proximal end 206 of the cover 200 is inserted into the corridor 186 of the cover 148 at the distal end 180 of the cover 148. The closer end 206 of the cover 200 is further inserted into the corridor 154 of the flexible tube 146 at the distal end 160 of this flexible tube 146. The slot 214 of the cover 200 is aligned with the notch. 176 of the flexible tube 146 (see also Figures 11 and 14A).

[0078] The outer surface 218 of the skirt 200 in the area of ​​the rim 204 is attached to the inner surface 150 of the flexible tube 146. The proximal outer surface 226 of the flexible tube 146 is attached to the inner surface 150 of flexible tube 146 adjacent the distal end 160 of this flexible tube 146. The distal end 160 the flexible pipe 146 rests on the outer surface 232 of the ring 202. The sheath section 21 can be attached to the flexible tube 146 by a mechanical connection and a binder.

[0079] The inner surface 184 of the cover 148 is attached to the distal outer surface 228 of the ring 202. The inner surface 184 of the cover 148 is also attached to the outer surface 218 of the cover 200 in the area of ​​the main body 208. These connections can be made by means of a binder or heat bonding, or both. Main body 208 of shield 200 extends away from distal end 180 of cover 148.

[0080] The supply sleeve assembly 18 is connected to the handle 22 of the turning element when the proximal end 142 of the sleeve 19 is inserted into the corridor 88 of the cup 30 and the outer surface 144 of the sleeve 19 is attached to the inner surface of the cup 30, for example by means of a binder.

[0081] The pull cord 312 shown in Fig. 2 is inserted into the insertion system 10. The first end of the pull cord 312 is placed in the first mounting hole 44 of the first core member 26. The fastener of the first core member (not shown) rests on a ball bearing 122 which secures pull cord 312 in the first mounting hole 44. Pull cord 312 passes through the longitudinally extending access hole 46 (see Fig. 3B) of the first core member 26. The pull cord 312 passes through the passage in the guide tube 32, which is located in the slot 40 of the first core member 26, the opening 138 for the guide tube in the plate 134, as well as the slot 82 of the second core member 29, and then through corridor 88, cup 30, Then pull cord 312 passes through first channel 140 of sleeve 19 (see Fig.

9). The pull tube 312 exits the sleeve 19 and passes through the passage 154 of the flexible tube 146 (see Fig.

10). The pull tube 312 passes through the first semi-cylindrical recess 244 and the first channel 240 of the ring 202. The pull tube 312 is pressed against the surface 238 of the gap in the ring 202. The pull tube 312 is then recycled through the second channel 242 and the second semi-cylindrical recess 246 in the ring 202. The pull tube 312 passes again through the passage 154 of the flexible tube 146. The pull tube 312 passes through the second outer channel 141 of the supply sleeve 19, through the passage 88 of the cup 30 (again); through the passage of the guide tube 32 (again) as well as through the access opening 46 of the slot 40 of the first core member 26. The second end of the pull cord 312 is secured to the first core member 26 due to the pressure applied by the fastener of the first core member (not shown) on ball bearing 122, 12

EP 1 903 989 Bl, which causes the pull cord 312 to be attached. Pull cord 312 may be formed of nitinol or stainless steel.

[0082] With reference to Figures 1 and 16, a preferred method of using the heart valve delivery system 10 will now be described in more detail. The devices and methods disclosed herein are particularly suitable for performing aortic valve replacement. Those skilled in the art will be aware that it may be necessary to pre-spread the contracted flaps of the aortic valve before operating the valve in the aortic valve. Pre-dilatation increases the area of ​​flow through the aortic valve and creates an opening in the petals sufficiently large for the prosthetic valve to be accepted. Pre-dilating is preferably achieved using an expandable member, such as a balloon dilatation catheter. Additional details regarding pre-dilatation and valve replacement can be found in US 2003/014 104 A1. [0083] The assembly and operation of the heart valve delivery system 10 will now be described. During assembly, the balloon catheter 15 is inserted into the operating hole formed by the handle assembly 22 and the supply sleeve assembly 18. The bracket 17 of this balloon catheter 15 is located near the handle 22. The balloon rod 250 and the guide wire rod 248 pass through the passage 130 of the end cap 23 (see Fig. 2), corridor 33 of the first core member 26, central hole 136 in plate 134, corridor 78 of the second core member 29, corridor 88, cup 30, central channel 139 of sleeve 19, as well as corridor 154 of flexible tube 146. Balloon stem 250 goes to corridor 213 the sheath 200 according to Fig. 18A, while the guide wire mandrel 248 passes through the passageway 213 of the sheath 200. The proximal end 276 of balloon 252 is located in corridor 213 of shield 200, while balloon 252 extends away from distal end 210 of shield 200.

[0084] The valvular prosthesis 11 is mounted on the main cylindrical portion 290 of the balloon 252, away from the distal end 210 of the sheath 200, as shown in Fig. 18A. Valve 11 is known in the art and can collapse into first position on balloon 252, as shown in Fig. 1. Alternatively, valve 11 may be mounted on balloon 252 and positioned within shield 200, as shown in Fig. 18B.

[0085] Valve 11 may take a variety of different forms. In preferred embodiments, the valve generally includes an expandable stent portion that supports the valve structure. This stent part has radial strength sufficient to hold the valve at the target site of treatment and resists re-action after deformation of the compressed valve flakes. Additional details regarding preferred embodiments of the balloon dilated valve can be found in the patents US 6 730 118 and US 6 893 460 granted to the Applicant in the present case, each of which is entitled IMPLANTABLE PROSTHETIC VALVE [Implantable prosthetic valve]. It will also be understood that this delivery system can be used with self-expanding valve prostheses. For example, in the case of a self-opening valve, the pusher may replace a balloon catheter to eject the self-opening valve from the delivery sleeve assembly.

[0086] With reference to the embodiment illustrated here, the guide wire 14 is located in the passage 264 of the guide wire rod 248 in such a way that it extends away from the distal end 258 of the guide wire rod 248 and in a direction closer to the wire inlet 296 in the bracket 17 balloon catheter 15. The process of inserting the catheter into the human body through

EP 1 903 989 prowadzenie1 guidance is known in the art, e.g. from US Patent 5,968,068 entitled ENDOVASCULAR DELIVERY SYSTEM [Intravascular injection system].

[0087] The guide wire 14 is located in the body via a retractor (not shown) which opens the inner diameter of the body vessel to insert the guide shield assembly 400 shown in Fig. 19 in the guide wire 14. The preferred diameters of the retractor are in the range between 4 and 7.3 mm (on a French scale between 12 and 22). The guide shield assembly 400 includes a guide sleeve 402 and a guide housing 404 attached to the proximal end of the guide sleeve 402. The chain guide assembly diameters of 7.3 or 8 mm (French scale 22 or 24) are preferred.

[0088] A series of valves are positioned within the guide housing 404. An end element 406 is attached at the proximal end of the guide housing 404, said end element having an opening extending into the interior of the guide housing 404 in the region of the series of valves, and a ridge 408 facing the distal end of the guide housing 404. The guide sleeve 402 extends into the interior of the body vessel, with the guide housing 404 located outside the body vessel at the front end of the guide sleeve 402. In one preferred embodiment, the guide bushing 402 is coated with a hydrophilic coating and extends into the body vessel about 22.9 cm (9 inches), just behind the iliac bifurcation and into the patient's abdominal aorta. The guide sheath assembly 400 is a mechanism for moving the valvular prosthesis inside the aorta in a safe and effective manner. [0089] Referring to Fig. 20, the loading assembly 500 includes a loading member 502, a loading member cap 504, and a sealing member 506. The charging element 502 has the shape of a pipe, and also has an external thread 508 at the proximal end, intended to be connected to the charging element cap 504. The loading element 502 includes flexible flanges 510 running parallel to it and having clamping ridges 512 facing the proximal end of the loading element 502. The loading element cap 504 includes an opening 514 of the loading element cap at its front end, as well as a threaded inner surface 516 intended for coupling to external thread 508 of charging element 502. The loading element seal 506 is attached to the loading element cap 504, while the loading element seal hole 518 is aligned with the loading element cap hole 514.

[0090] With reference to Fig. 21 A, the loading member 504 and the loading member seal 506 are introduced into the insertion system 10 when the sleeve 19 engages with the opening of the loading member of the loading element and the opening 518 of the loading element sealing. The distal end of the delivery system 10 passing through the guide wire 14 is inserted into the proximal end of the charging element 502, as shown in Fig. 21B. The charging element cap 504 is screwed onto the proximal end of the charging element 502.

[0091] Referring to Fig. 22, the flexible flanges 510 of the loading element 502 are clamped on the end element 406 of the guide housing 404. In this position, the ridge 408 of the end member 406 rests on the clamping ridge 512 of flexible flanges 510, while the charging element 502 passes through a series of valves located inside the guide housing 404, whereby the introducer system 10 is positioned in communication with the inner corridor of the guide shell, thereby same with

EP and 903 989 B1 a body vessel. The loading assembly 500 preferably allows insertion of the delivery system 10 into the chain cover sheath assembly 400, without causing substantial patient blood loss.

[0092] The valvular prosthesis 11, balloon catheter 15, and supply sleeve assembly 18 are moved on the guide wire 14 through the guidewire sheath, preferably as a single unit, while traveling through the body vessel to the correct valve destination (see Fig. 1). As part of one advantageous feature, the delivery system 10 provides an excellent ability to squeeze through the tortuous vessels to facilitate the movement of the valvular prosthesis 11 through the guide sheath. In one embodiment, the delivery system 10 provides sufficient squeezing capacity to push through the guidewire sheath having an internal circumference of 0.7 mm (French scale 2) smaller than the outer circumferences of the valve 11 or shield 200. [0093] When the valvular prosthesis 11 reaches the aortic arch 13, as shown in Fig. 1, the function of controlling the delivery system 10, described below, is activated to facilitate the passage of the valve 11 through this arch. More specifically, the bending of the controllable section 20 assists the control of the valve 11 and / or the distal end 210 of the sheath 200 (see Fig. 14A) away from the inner surface of the aortic arch 13. As a result, retrograde movement of valve 11 through the aortic arch 13 can be obtained without causing damage to the aorta 13 or valve 11. In one preferred manner, the valve is displaced along the aortic arch with little or no contact between the valve and the aorta.

[0094] In the embodiment illustrated here, the function of controlling the delivery system 10 is performed when the operator rotates the handle 28 of the rotating element (see Fig. 2). When the rotating element holder 28 is rotated, the threaded portion 68 operates in conjunction with the external thread 54 of the partially threaded member 27 (see Fig. 4A), which does not rotate. Therefore, the handle 28 of the rotating element moves linearly relative to the partially threaded member 27. The first core member 26 also moves linearly relative to the partially threaded member 27 (see Fig. 2). The locating pin 124 prevents relative rotation from occurring between the first core member 26 and the partially threaded member 27.

[0095] As the first core member 26 moves away from the partially threaded member 27, the pull cord 312, connected to the first core member 26 via ball bearing 122, exerts a certain force on the surface 238 of the gap in the ring 202 (see Fig. 15A ). Pull cord 312 pulls ring 202 toward handle 22. The side of the delivery system 10 along which the pull tube 312 passes bends along the controllable section 20 when the elongate holes 166 of the flexible tube 146 converge (see Fig. 11). The controllable section 20 bends until the tension of the pull cord 312 subsides. The additional rotation of the rotating member handle 28 therefore causes additional bending. The friction occurring between the threaded portion 68 of the rotatable member 28 and the external thread 54 of the partially threaded member 27 (see Figures 4A and 5B) is sufficient to hold the pull cord 312 under tension, thereby maintaining the bend shape in the controllable section 20 when the operator releases the turning member handle 28.

[0096] The natural stiffness of the cover 148 (see Fig. 10), as well as the natural stiffness of the balloon catheter 15 (see Fig. 16), act in opposition to the bending of the control section 20. The force acting on the pull cord 312 causes the control section 20 to bend, while the stiffness of the cover 148 and the balloon catheter 15 described above is opposed to bending and thereby "blocks" the system 15

EP 1 903 989 wprowadz1 introducer 10 in one place within the whole range of positions from straight to completely bent, according to the rotation range of the turning element holder 28. Cover 148 also protects the body vessel from a flexible tube 146 (see Fig. 10), which in the absence of cover 148 may scratch or otherwise damage the body vessel.

[0097] When the balloon catheter 15 is moved to the natural valve destination, the operator uses indicator bands 306, 308 (see Fig. 16) to determine the location of the valve 20, according to a fluoroscopy process that is well known in the art. The operator can adjust the position of the valve 11 by actuating the handle 28 of the rotating element, while simultaneously holding the cup 30 stationary (see Fig. 2). Further control of valve position can be obtained by turning the cup 30. The sleeve 19 is attached to the cup 30, while the delivery system 10 is rigid enough to carry the torsional movement to the distal end. This torsional movement is transmitted through the controllable section 20 when the tube portions 174 of the flexible tube 146 come into contact with each other (see Fig. 11). This type of contact occurs when the flexible tube is completely bent or it can occur during twisting when the curved portions 170 of the elongate hole close in such a way that the tubular portions 174 come into contact with each other. [0098] Supply sleeve assembly 18 (see Fig. 1) achieves the highest stiffness when all other tubular parts 174 of the flexible tube 148 (see Fig. 11) are in contact with each other while the control section 20 is completely bent. In this position, the shape of the steerable section 20 preferably closely matches the shape of the aortic arch 13 (as shown in Fig. 1) to facilitate guidance. When pushing through the compressed flakes 12, the controllable section 20 is located in the patient's ascending aorta, and the low-rigidity section in the sleeve 19 bends and rests against the aortic arch 13 (see Fig. 1), thereby preventing damage to the inner wall of the aorta.

[0099] After the delivery system 10 has been moved to such an extent that the valve 11 is located adjacent to the natural valve, the balloon catheter 15 can be moved further relative to the supply sleeve assembly 18 to better position the valve 11 within the natural flakes. To achieve this effect, the balloon catheter 15 is slidably displaced through the sleeve 19 and the control section 20. As a further advantageous feature, the supply sleeve assembly 18 preferably allows the physician to adjust the curvature of the controllable section 20 to properly align the valve prosthesis 11 with the natural valve. As a result, when the balloon catheter 15 is moved further and further, the valvular prosthesis moves into the center of the natural valve. Moreover, the delivery system 10 provides sufficient capacity to squeeze through the tortuous vessels to be able to push the balloon catheter 15 and valve 11 through the squeezed petals 12, or alternatively - to push only the balloon catheter 15 through these squeezed petals 12. Cover 200 (see Fig. 14A) can also pass through the squeezed petals 12 during this process.

[0100] When these squeezed petals 12 have been pushed off, then the delivery system 10 actuates the valve 11 at the natural valve target site, as shown in Fig. 23. The low hardness section of the sleeve 19 rests against the aortic arch 13, while the controllable section 20 passes the ascending aorta and is adjusted to position the valve 11. The valve 11 can be expanded with a balloon and after positioning the balloon 252 is inflated to fix the position of the valve 11 at the natural valve's destination. Then the balloon 252 is emptied and the entire delivery system 10 is retracted as it passes back through the guide wire 14 and

EP 1 903 989 także1 also exits the body's vascular system through the guidewire sheath. The guide wire 14 is then retracted, followed by a guide wire cover.

[0101] In an alternative embodiment of the invention, in which the valve 11 is located inside the shield 200, the supply sleeve assembly 18 (see Fig. 1) is retracted when the valve 11 has reached the position of the natural valve destination. The supply sleeve assembly 18 is retracted when the operator holds the bracket 17 stationary and pulls back (in the proximal direction) the handle 22, which causes the supply sleeve assembly 18 to be retracted in the proximal direction, exposing the valve 11 at the natural valve and allowing the balloon to be inflated 252, as shown in Fig. 23, and thereby actuates the valve 11 as described above.

[0102] It will be understood that embodiments of the cardiac valve delivery system relate to improved devices and methods for moving a cardiac valve prosthesis through a patient's vascular system. In one preferred embodiment, the collaboration of the components described herein enables safe movement of the uncovered valvular prosthesis through the patient's vascular system and along the aortic arch. Accordingly, this delivery system allows the valve to move along the aortic arch without having to insert the outer sheath into the aortic arch. This is advantageous because the use of a sheath would increase the diameter of the delivery system and thereby complicate valve insertion. In addition to providing an improved control mechanism to overcome the aortic arch without causing damage to the inner wall of the aorta, it will be understood by those skilled in the art that this introducer system provides excellent ability to squeeze through tortuous vessels in such a way that the physician has complete control over the displacement and placement of the prosthesis valve when moving to a natural valve. This feature is particularly beneficial when overcoming compressed valve flaps. Accordingly, embodiments of the present invention show an improved delivery system for moving a valvular prosthesis to a natural aortic valve site using a controllable assembly that excludes the need for an external sheath in the aorta while providing sufficient squeezing capacity through tortuous vessels to be pushed through a narrow vascular system and / or squeezed valve flakes. Therefore, embodiments of the present invention show improved devices and methods for transdermally ballooning a balloon-dilated valvular prosthesis to a compressed aortic valve destination using a retrograde concept.