MXPA97003259A - Implanta bifurcado and method to make my - Google Patents

Implanta bifurcado and method to make my

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Publication number
MXPA97003259A
MXPA97003259A MXPA/A/1997/003259A MX9703259A MXPA97003259A MX PA97003259 A MXPA97003259 A MX PA97003259A MX 9703259 A MX9703259 A MX 9703259A MX PA97003259 A MXPA97003259 A MX PA97003259A
Authority
MX
Mexico
Prior art keywords
edge
sheet
leg
proximal end
rod
Prior art date
Application number
MXPA/A/1997/003259A
Other languages
Spanish (es)
Other versions
MX9703259A (en
Inventor
Richter Jacob
Pinchasik Gregory
Original Assignee
Medinol Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medinol Limited filed Critical Medinol Limited
Publication of MXPA97003259A publication Critical patent/MXPA97003259A/en
Publication of MX9703259A publication Critical patent/MX9703259A/en

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Abstract

The present invention relates to a bifurcated implant for insertion into a bifurcated vessel such as a blood vessel. In one embodiment, a first blade is formed within the first leg, a second blade is formed within a second leg, a third blade is formed within a rod, and the two legs are attached to the rod. In a second embodiment, a first blade is formed within a member having a first leg and half a shank, a second blade is formed within a second member having a second leg and half a shank and, the two halves of shank combine to form the bifurcated stem. In a third embodiment, the shank comprises two sections that are inserted serially and assembled inside the vessel at the site of the bifurcation to be treated.

Description

IMPLANTA BIFURCADO AND METHOD TO DO THE SAME Field of the Invention The present invention relates to implants and, more particularly, to bifurcated implants and methods for making bifurcated implants for insertion into a branching vessel.
Background of the Invention Implants are well known in the art. They are typically formed of a cylindrical metal mesh that can expand when pressure is applied internally. Alternatively, they can also be formed of cylindrically folded wire or sheets of material formed in cylindrical form. Implants are devices that are usually implanted within body canals that include the vascular system to reinforce the prostrate, partially obstructed, weakened or abnormally dilated sections of the blood vessel. The implants have also been successfully implanted in other areas, for example, the urinary tract or the bile duct to reinforce such bodily conduits. U.S. Patent No. 4,994,071 (acGregor) discloses a bifurcation, expaniole implant having a main cylindrical cross-link formed from flexible, interconnected material. Two additional cylindrical lattices, which have smaller diameters than the main lattice, are constructed in a similar manner. The main lattice includes a flexible wire that interconnects the main lattice to one of the additional lattices. A second flexible cable interconnects the main lattice to the other main lattice. The flexible wires form main structures that extend axially along the length of the main lattice and along each of the additional lattices. A disadvantage of this bifurcation implant is the complex nature of the interconnection of the flexible wires that form the main structures with the curl structure of each lattice.
Brief Description of the Invention The present invention solves these and other disadvantages of the prior art by providing bifurcated implants and fabricated bifurcated implant and fabrication methods that have a stem portion and two leg portions. In a first embodiment of the invention, a bifurcated implant is made by providing three patterned sheets according to a desired pattern, wherein two sheets are substantially the same size and the third sheet is wider than the first two sheets. Each of these sheets is formed in tubes by rotating the longitudinal edges and forming a joint by welding. The larger blade forms a tube that acts as the rod portion and the other blades form tubes that act as the leg portions of the bifurcated implant. The two leg portions are then attached to the rod portion to form the bifurcated implant. In a second embodiment of the invention, the bifurcated implant is formed by preparing two implant sheets. For each sheet, the longitudinal edges of a portion of the sheet are raised upward and secured to each other to form one of the two leg portions of the bifurcated implant. The remaining free edges of each of the two sheets are then joined to form the stem portion of the implant. In a third embodiment, the bifurcated implant comprises first and second tubular portions. The first portion has a proximal end that forms the rod portion and a distal end that forms one of the leg portions of the bifurcated rod. A branching opening is positioned between the proximal end and the distal end of the first portion. The second portion is inserted into the longitudinal hole of the rod portion of the first portion and advanced through the branch opening so that it protrudes beyond the branch opening to form a second leg. When the second portion expands, the proximal end of the second portion couples the material defining the branch opening to secure the second leg in the desired position.
It is an object of the present invention to provide a method for making a bifurcated implant, comprising the steps of: a) preparing a first sheet having a first edge, a second edge, a third edge and a fourth edge; b) preparing a second sheet having a first edge, a second edge, a third edge and a fourth edge; c) preparing a third sheet having a first edge, a second edge, a third edge, and a fourth edge; d) fixing the second edge to the third edge of the first sheet to form a first tubular leg portion having a proximal end and a distal end; e) fixing the second edge to the third edge of the second sheet to form a second portion of tubular leg having a proximal end and a distal end; f) fixing the second edge to the third edge of the third sheet to form a third portion of tubular rod having a proximal end and a distal end; and g) fixing the proximal end of the first leg portion and the proximal end of the second leg portion to the distal end of the rod portion. It is another object of this invention to provide a method for making a bifurcated implant, comprising the steps of a) preparing a first sheet having a proximal end and a distal end; b) deforming the distal end of the first sheet to form a first leg and deforming the proximal end of the first sheet to form a first half of the rod; c) preparing a second sheet having a proximal end and a distal end; d) deforming the distal end of the second sheet to form a second leg and deforming the proximal end of the second sheet to form a second half of the rod; and e) joining the first half of the rod to the second half of the rod to form a rod. It is another object of this invention to provide a method for making a bifurcated implant comprising the steps of a) preparing a first expandable tubular member having a proximal end and a distal end and a longitudinal orifice therethrough, the first tubular member provided with a branching opening positioned between the proximal end and the distal end, the branching opening communicating with the longitudinal orifice and the aperture dimensioned and adapted to receive and secure a second expandable tubular member; b) supplying the first expandable tubular member to a bifurcation vessel having a first lumen and a second lumen such that the first expandable member is positioned within the first lumen and the branch opening communicates with the second lumen; c) expanding the first expandable member in an amount sufficient to secure the first expandable member in the first lumen; d) preparing a second expandable tubular member having a proximal end and a distal end and having a longitudinal hole therethrough; e) widen the branching opening; f) supplying the second expandable tubular member within the branch opening so that the distal end of the second expandable tubular member is positioned within the second lumen and the proximal end of the second expandable tubular member is positioned within the longitudinal orifice of the first longitudinal member; and g) expanding the second expandable tubular member in an amount sufficient to secure the second expandable tubular member within the second lumen and within the branch opening.
Brief Description of the Drawings Fig. 1 shows a bifurcated implant manufactured in accordance with the present invention; Fig. 2 shows the leaves used to form the legs and the stem of the implant shown in Fig. 1; Fig. 3 shows the sheets shown in Fig. 2 after they have been rolled into a tubular shape; Fig. 4 is a perspective view of the tubes shown in Fig. 3 before assembly; Fig. 5 is an end view of the tubes shown in Figs. 3 and 4 after they have been assembled to form an implant; Fig. 6 is a top view of the assembled apparatus shown in FIG. 5; Fig. 7 shows the sheets used to form another embodiment of an implant manufactured in accordance with the invention: The Fig. 7B shows the sheets used to form another embodiment of an implant manufactured in accordance with the invention; Fig. 8 shows the leaves of Fig. 7 with demarcation points; Fig. 9 shows the leaves of Fig. 8 after they have been rolled into a tubular form; Fig. 9B shows the leaves of Fig. 7B after they have been rolled into a tubular form; Fig. 10 shows the tubes of Fig. 9 just before assembly; Fig. 10B shows the tubes of Fig. 9B just before assembly; Fig. 1 1 is a side view of the tubes shown in Figs. 9 and 10 after assembly; Fig. 1 1 B is a side view of the tubes shown in FIGS.
Figs. 9B and 10B after assembly; Fig. 12 is an end view of the assembled apparatus shown in Fig. eleven; Fig. 12B is an end view of the assembled apparatus shown in Fig. 1 1 B; Fig. 12C is an alternative embodiment of a model that can be used in place of the models shown in Figs. 7 and 7B; Fig. 13 shows a rod and a first leg portion and a second leg portion used to form another embodiment of a bifurcated implant made in accordance with the present invention; Fig. 14 shows guiding wires placed in the main lumen and the branching lumen to be treated; Fig. 15 shows the rod and the first leg portion shown in Fig. 13 placed on the catheters and the guide wires before insertion into the lumen to be treated; Fig. 16 shows the rod and the first leg portion shown in Fig. 13 after they have been supplied to the bifurcation to be treated and before its expansion; Fig. 17 shows the second leg portion shown in Fig. 16 after it has been expanded; Fig. 18 shows the expansion of the branching opening; Fig. 19 shows the second unexpanded leg portion positioned in the branch opening; Fig. 20 shows the expansion of the second leg portion shown in Fig. 19; and Fig. 21 shows the assembled bifurcated implant placed in the bifurcated lumen to be treated.
Detailed description in the embodiment illustrated in Fig. 1, the bifurcation implant 5 comprises a first leg 10, a second leg 15 and a rod 20. Fig. 2 shows a first sheet 25 that is used to form the first leg 10, a second sheet 30 that is used to form the second leg 15, and a third sheet 35 that is used to form the rod 20. The first sheet 25 and the second sheet 30 are substantially planar and are dimensioned to a predetermined length and width. For many applications, the first sheet 25 and the second sheet 30 will have substantially the same dimensions to produce the legs 10 and 15 which are substantially of the same size, although, the legs 10 and 15 and the sheets 25 and 30 used to produce them, can be of variable sizes as dictated by specific applications. The implants of this invention can be sized so that when they are assembled they are in their final size, although, in a preferred embodiment the implants are expandable and are sized and adapted to assume their final dimensions upon expansion. The implant blades 70 and 75 can be shaped or engraved with perforations that form a variety of models as dictated by specific applications to achieve the required expandable characteristics as previously described. The third sheet 35 is dimensioned such that when it is wound in a tube its internal cross section can be made to accommodate the external diameters of cross section of the first leg 10 and second leg 15. The first leg 25 has a first edge 26, a second edge 27, a third edge 28 and a fourth edge 29. The second sheet 30 has a first edge 31, a second edge 32, a third edge 33 and a fourth edge 34. The third sheet 35 has a first edge 36, a second edge 37, a third edge 38, and a fourth edge 39. After the sheet metal has been cut to form the sheets 25, 30 and 35, is deformed and rolled to cause the two opposite edges to come together and create a cylinder. In the example shown in Figs. 2 and 3, the edge 27 is attached to the edge 29 by means of welding 14 to form the first leg 10. The edge 32 is joined to an edge 34 by means of the weld 19 to form the second leg 15. The edge 37 is attached to the edge 39 by means of the weld 29 to form the rod 20. The edges may be joined in a wide variety of ways well known to those skilled in the art as are suitable for this purpose, for example, screwing, bending, welding, although in a preferred embodiment welding is used. In a particularly preferred embodiment, spot welding is used. As shown in Fig. 3, the first leg 10 has a proximal end 1 1, a distal end 12 and defines a longitudinal hole 13. The second leg 15 has a proximal end 16, a distal end 17, and defines a longitudinal hole 18. The shank 20 has a proximal end 26, a distal end 27 and, defines a longitudinal hole 28. Fig. 4 shows the first leg 10, the second leg 15 and the rod 20 just before assembly. To form the bifurcated implant 5, the proximal end 1 1 of the first leg 10 and the proximal end 16 of the second leg 15 are joined to the distal end 27 of the stem portion 20 so that the longitudinal holes 13, 1 8 and 28 are in communication with each other. Fig. 5 is an end view and Fig. 6 is a side view of the assembled apparatus. Fig. 1 1 shows a second embodiment of a bifurcation implant manufactured in accordance with this invention. The implant 50 is provided with a first leg 55 and a second leg 60 fixed to a portion of rod 65. The bifurcation implant 50 is formed from a first leaf 70 and a second leaf 75 as shown in Fig. 7 The implant blades 70 and 75 can be shaped or engraved with perforations forming a variety of models as dictated by specific applications to obtain the required expandable characteristics as previously described. The sheets 70 and 75 are substantially flat and have a predetermined length and widths. The first sheet 70 has a first edge 71, a second edge 72, a third edge 73 and a fourth edge 74. The second sheet 75 has a first edge 76, a second edge 77, a third edge 78 and a fourth edge 79. To form the legs of the implant an edge portion 72 is wound to an edge portion 74 and an edge portion 77 is wound to an edge portion 79. The demarcation points 80, 81, 82 and 83 are selected on the sheets 70 and 75 as shown in Fig. 8. Those demarcation points 80, 81, 82 and 83 are selected to meet the requirement of specific applications and can be adjusted depending on the length required for legs 55 and 60 and the required length for the stem 65. The demarcation points 80 and 81 that are equidistant from the edges 73 and 71 and the demarcation points 82 and 83 that are equidistant from the edges 76 and 78 will result in an implant in which the legs 55 and 60 they have a length that is subst substantially equal to the shank portion 65. If the demarcation points are selected to be closer to the edges 73 and 78 than to the edges 71 and 76 the shank will have a length that is greater than the length of each of the legs . If the demarcation points are selected to be closer to the edges 71 and 76 than of the edges 73 and 78, each of the legs 60 and 65 will have a length that is greater than the length of the rod 65. However, in a preferred embodiment, the demarcation points 80, 81, 82, and 83, are selected so that the proximal edges 72", 74", 77"and 79" are about 1/3 the length of the edges 72, 74, 77 and 79. As shown in Fig. 8, the demarcation point 80 divides the edge 72 approximately at its midpoint into a distant edge 72 'and a proximal edge 72. "The demarcation point 81 divides the edge 74 approximately at its midpoint into a distant edge 74. 'and a near edge 74". The demarcation point 82 divides the edge 77 approximately at its midpoint into a distal edge 77 'and a proximal edge 77"and the demarcation point 83 divides the edge 79 approximately at its midpoint into a distal edge 79' and a near edge 79". To form the implant, the edge 72 'is connected to the edge 74' by means of the weld 90 to form the first member having a first leg portion 55 and a first stem half 65 'as shown in Fig. 9. The edge 77 'is connected to the edge 79' by means of welding 91 to form the second member 100 having a second leg portion 60 and a second half of the rod 65. As previously described, the edges can be connected in a A variety of shapes well known to those skilled in the art Fig. 10 shows the first member 95 and the second member 100 shown in Fig. 9 in alignment just prior to assembly To produce the bifurcated implant 50 shown in Figs. 1 1 and 12, the edge 72"is connected to the edge 79" by means of welding 92 and the edge 74"was connected to the edge 77" by means of the weld 93 so that the first half of the stem 65 'and the second half of rod 65"form the rod 65. Fig. 12 is an end view in cross section of the implant shown in Fig. 1 1. In the embodiment shown in Fig. 7, the sheets 70 and 75 are squares or rectangles. However, the sheets 70 and 75 are not limited to this configuration, as shown in Fig. 7B. Fig. 1 1 B shows a bifurcation implant fabricated using the blades 270 and 275 shown in Fig. 7b. The implant 250 is provided with a first leg 255 and a second leg 260 fixed to a portion of rod 265. The bifurcation implant 250 is formed from a first leaf 270 and a second leaf 275 as shown in Fig. 7B . The implant sheets 270 and 275 can be sized and engraved as previously described. As shown in Fig. 7B, the first sheet 270 has a first edge 271, a second edge 272, a third edge 273, a fourth edge 274, a fifth edge 275 and a sixth edge 276, a seventh edge 146 and a eighth edge 147. The second sheet has a first edge 277, a second edge 278, a third edge 279, a fourth edge 280, a fifth edge 281, a sixth edge 282, a seventh edge 148 and an eighth edge 149. As shown in FIG. shown in Fig. 9B, the edge 274 is connected to the edge 276 by means of the weld 290 to form the first member having a first leg portion 255 and a first rod half 265 '. The edge 280 is connected to the edge 282 by means of the weld 291 to form the second member 300 having a second leg portion 260 and a second half of the rod 265. As previously described, the edges may be connected in a variety in ways well known to those skilled in the art Fig. 10B shows the first member 295 and the second member 300 shown in Fig. 9B in alignment just prior to assembly To produce the bifurcated implant 250 shown in Figs. 1 1 B and 12B, the edge 272 was connected to the edge 149 by means of the weld 292 and the edge 278 was connected to the edge 147 by means of the weld 293 so that the first half of the rod 265 'and the second half of rod 265"form the rod 265. Fig. 12B is an extreme cross-sectional view of the implant shown in Fig. 1 1 B. Fig. 12C shows an alternative model that can be used in place of the models shown in Figs. 7 and 7B.
A third embodiment of this invention comprises two portions that are deployed in series in two stages and assembled within the patient to form a bifurcated implant. Fig. 13 shows the rod and the first leg portion 10 provided with a longitudinal hole 131 and having a proximal end 15 defining a rod portion and a distal end 120 defining a first leg portion 130. The second portion of Leg 140 is provided with a hole 132 and has a proximal end 145 and a distal end 150. The shank and first leg portion 10 and the second leg portion 140 can be sized and shaped or recorded as previously described. A branching opening 135 is positioned between the proximal end 15 and the distal end 120 of the rod and the first leg portion 10. The branching opening 135 is sized to receive the second leg portion 140 and is adapted to engage and securing the second leg portion 140 when it has expanded within the branch opening 135. The second leg portion 140 is dimensioned and adapted to engage and be secured within the branch opening 135 to the expansion. Figs. 14 to 21 show how the bifurcated implant is assembled within a bifurcated lumen. As shown in Figs. 14 to 21, the area to be treated is a bifurcated lumen having a first or main lumen 190 and a second or branching lumen 195. As shown in Fig. 14, a first guidewire 1 55 is inserted. Within the main lumen 190 and a second guide wire 156 is inserted into the branch lumen 195. As shown in FIG. 15, a balloon expandable implant and first leg portion 10 is positioned on the tip of a first balloon catheter 170 so that balloon 1 75 is positioned within longitudinal hole 131. A second balloon catheter 171 is then inserted into the longitudinal hole 131 of the rod and the first leg portion 10 and advanced so that the balloon 176 is positioned within the opening 135. The first catheter 171 is mounted on the second. guide wire 156. As shown in Fig. 16, the unexpanded rod and the first leg portion 10 is guided to the area to be treated so that the first leg portion 130 is positioned within the main lumen and the branch opening 135 communicates with the lumen. branch 195. Guiding wire 156 facilitates orientation of branching opening 135 with branching lumen 195. The size of the catheters is conventional and the balloons are not to scale and the details well known to those experienced in The technique has been omitted for clarity. The balloon 175 is inflated which causes the rod and the first leg portion 10 to expand, as shown in FIG. 17, to secure it in the desired position. After expansion, the external wall of the rod and the first leg portion 10 would make contact with the internal walls of the main lumen 190, although a space for clarity has been left intentionally. The balloon 175 on the first catheter 170 is left inflated and the balloon 176 on the second catheter 171 is inflated to elongate the branch opening 135 as shown in Fig. 18. As the branch opening 135 is lengthened a portion of the rod defining the branching opening 135 that is pushed outward to form a securing flange 180. The balloons 175 and 176 deflate, the second catheter 171 is withdrawn and the second guide wire 156 is left in place in the branching lumen. 195. The second leg portion 140 is then applied to the second catheter 171 so that the first balloon 176 is placed in the longitudinal hole 132 and the second catheter 171 is then applied to the second guide wire 156. The second leg portion 140 is then guided to and introduced in, the longitudinal hole 131 of the rod and the first leg portion 10 and is advanced and passed through the branch opening 135 so that the distal end 150 of the second leg portion 140 protrudes into the branch lumen 195 and the proximal end 145 communicates with the longitudinal hole 131, as shown in Fig. 19. The balloon 176 on the second catheter 171 is partially inflated and the balloon 175 on the first catheter 170 is partially inflated to a pressure substantially equal to the pressure in the balloon 176. Both balloons 175 and 176 are then inflated simultaneously to substantially equal pressures. As shown in Fig. 20, inflation of the balloon 176 over the second catheter 171 causes the second leg member 140 to expand such that its outer walls engage and secure the area surrounding the opening 135. Inflation of the balloon 175 over the first catheter 170 it prevents the rod and the first leg portion 10 from being impacted when the balloon 176 is inflated. After expansion, the outer walls of the second leg 140 would contact the inner wall of the lumen 195, although, it has been left intentionally a space for clarity. The balloons 175 and 176 are deflated, the catheters 170 and 171 and the guide wires 155 and 156 are removed and the assembled bifurcated implant 160 is left in place as shown in Fig. 21.

Claims (3)

1 . A method for making a bifurcated implant, comprising the steps of: a) preparing a first sheet having a first edge, a second edge, a third edge and a fourth edge; b) preparing a second sheet having a first edge, a second edge, a third edge and a fourth edge; c) preparing a third sheet having a first edge, a second edge, a third edge and a fourth edge; d) joining the second edge to the third edge of the first sheet to form a first tubular leg portion having a proximal end and a distal end; e) joining the second edge to the third edge of the second sheet to form a second portion of tubular leg having a proximal end and a distal end; f) joining the second edge to the third edge of the third sheet to form a tubular rod portion having a proximal end and a distal end; and g) attaching the proximal end of the first leg portion and the proximal end of the second leg portion to the distal end of the rod portion.
2. A method for making a bifurcated implant, comprising the steps of: a) preparing a first blade having a proximal end and a distal end; b) deforming the distal end of the first sheet to form a first leg and deforming the proximal end of the first sheet to form a first half of the rod; c) preparing a second sheet having a proximal end and a distal end; d) deforming the distal end of the second sheet to form a second leg and deforming the proximal end of the second sheet to form a second half of the rod; and e) joining the first half of the rod with the second half of the rod to form a rod.
3. A method for making a bifurcated implant, comprising the steps of: a) preparing a first expandable tubular member having a proximal end and a distal end and a longitudinal orifice therethrough, the first tubular member provided with an opening branching positioned between the proximal end and the distal end, the branching opening communicating with the longitudinal orifice and the aperture dimensioned and adapted to receive and secure a second expandable tubular member; b) supplying the first expandable tubular member to a bifurcation vessel having a first lumen and a second lumen such that the first expandable member is positioned within the first lumen and the branch opening communicates with the second lumen; c) expanding the first expandable member in an amount sufficient to secure the first expandable member in the first lumen; d) preparing a second expandable tubular member having a proximal end and a distal end and having a longitudinal hole therethrough; e) widen the branching opening; f) supplying the second expandable tubular member within the branch opening so that the distal end of the second expandable tubular member is positioned within the second lumen and the proximal end of the second expandable tubular member is positioned within the longitudinal orifice of the first longitudinal member; and g) expanding the second expandable tubular member in an amount sufficient to secure the second expandable tubular member within the second lumen and within the branch opening.
MX9703259A 1996-05-03 1997-05-02 Bifucarted stent and method of making same. MX9703259A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US64229796A 1996-05-03 1996-05-03
US642,297 1996-05-03
US642297 1996-05-03

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MXPA97003259A true MXPA97003259A (en) 1998-04-01
MX9703259A MX9703259A (en) 1998-04-30

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JP (4) JP3532730B2 (en)
KR (1) KR970073534A (en)
CN (1) CN1154449C (en)
AR (3) AR007008A1 (en)
AT (2) ATE299359T1 (en)
AU (1) AU729227B2 (en)
BR (1) BR9703057A (en)
CA (2) CA2393663C (en)
CZ (1) CZ130097A3 (en)
DE (3) DE69733722T2 (en)
EE (1) EE03739B1 (en)
HK (1) HK1032899A1 (en)
IL (6) IL207912A (en)
MX (1) MX9703259A (en)
NO (2) NO311681B1 (en)
NZ (1) NZ314698A (en)
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