专利摘要:
Summary vascular prosthesis delivery device and method of use The present invention relates to a delivery device that includes a guide wire catheter and a delivery set that extends over the guide wire catheter. the sending set includes a locking mechanism that selectively engages a proximal rod of the sending set with a push rod to which the vascular prosthesis is directly or indirectly attached. When a trigger element selectively disengages the proximal stem from the stem body, the rotation of the proximal stem is independent of the longitudinal movement of the vascular prosthesis with respect to the stem body, with which the proximal stem can be moved along the rotating rod body.
公开号:BR112014025430A2
申请号:R112014025430-3
申请日:2013-03-14
公开日:2020-03-10
发明作者:Arbefeuille Samuel;Christian Fletcher;C. Canning John
申请人:Bolton Medical, Inc.;
IPC主号:
专利说明:

VASCULAR PROSTHETIC SHIPPING DEVICE AND METHOD OF USE
BACKGROUND OF THE INVENTION [0001] An aortic aneurysm is an enlargement or bulging in a section of the aorta, which can be life-threatening. The treatment of aortic aneurysms remains a challenge. Endovascular repairs have become a viable alternative to open repairs to an aortic aneurysm. An endovascular approach results in the insertion of an endovascular graft to exclude the aneurysm sac from the blood flow. Once in place, the endovascular graft is expanded to create a new path for blood flow. The endovascular graft remains inside the aorta permanently through the use of a metal stent that creates a tight fit and a seal against the wall of the aorta. Currently, endovascular delivery devices have limitations in relation to the precise control that a physician has in placing the graft in the aneurysm field. Therefore, there is a need to develop new and improved delivery devices and methods of using the delivery devices to treat aortic aneurysms.
SUMMARY OF THE INVENTION [0002] The present invention is generally directed to a delivery device for implanting a vascular prosthesis, and to a method of using the delivery device.
[0003] In one embodiment, the delivery device includes a guide wire catheter having a proximal end and a distal end, and a delivery set that extends over the guide wire catheter. The sending set includes a stem body, a sending catheter, a push rod, a proximal stem and a locking mechanism. The stem body has a longitudinal axis, a proximal end and a distal end. The delivery catheter has a distal end that extends from within the distal end of the stem body and over the guidewire catheter. The push rod extends over the guidewire catheter and into the delivery catheter. The push rod is attached to the guide wire catheter in a
2/27 proximal end of the guidewire catheter proximal to the nail body. The proximal stem extends over the stem body and is axially attached to the sending catheter, where the proximal stem is selectively attached to the push rod, and where the proximal stem is rotatable over the stem body and the rotation of the stem proximal over the stem body translates into longitudinal movement of the sending catheter and, selectively, of the push rod in relation to the stem body. The locking mechanism on the stem body selectively engages the proximal stem with the push rod.
[0004] In one embodiment, the sending device includes an actuating element on the proximal stem that selectively disengages the proximal stem from the stem body, whereby the rotation of the proximal stem is independent of the longitudinal movement of the sending catheter with respect to the stem body. In another embodiment, the proximal stem includes an end that defines portions of teeth that move transversely to the major longitudinal axis of the stem body when the proximal stem is rotated over the stem body. In said embodiment, the sending device additionally includes a gear rack that extends along the longitudinal axis of the stem body, a connecting gear that engages the teeth portions of the proximal end of the stem, the connecting gear being rotatable on an axis transverse to the axis of rotation of the proximal stem, and a pinion gear. The pinion gear engages the gear rack and the connecting gear, with which the rotation of the proximal stem over the stem body translates into the longitudinal movement of the sending catheter and, selectively, of the pushing rod relative to the body of the stem. stem. The drive element selectively disengages the connecting gear from the pinion gear, thereby selectively disengaging the rotation of the proximal stem from the longitudinal movement of the proximal stem along the stem body.
[0005] In yet another embodiment, the trigger element of the sending device includes a housing of the trigger element, a push button, a
3/27 pinion gear extension, a ball bearing and a frustoconical center pin. The housing of the driving element extends over the stem body and is rotationally connected to the proximal stem, with which the housing of the driving element is movable along the stem body without rotating on the stem body at the same time. the proximal stem rotates over the stem body. The push button is located in the drive element housing. The pinion gear extension defines a coaxial opening that is coaxial with the pinion gear and defines at least one side opening that extends laterally from the coaxial opening. The ball bearing settles at least partially inside the side opening and locks the relative rotation of the connecting gear and the pinion gear when displaced to extend radially beyond the extension of the pinion gear. The central frustoconic pin is oriented radially outwards from the longitudinal axis of the stem body and comes into contact with the clamping button, whereby the central frustoconic pin moves the ball bearing radially outwards through the lateral opening and lock the relative rotation of the connecting gear and the pinion gear by outward orientation, thereby promoting the longitudinal movement of the proximal stem along the stem body when the proximal stem is rotated over the stem body and, when the push button is pressed, selectively disengages the connecting gear from pinion gear, thereby selectively disengaging the rotation of the proximal stem from the longitudinal movement of the proximal stem along the stem body.
[0006] Another embodiment of the delivery device of the present invention includes a distal clamping element at the distal end of the stem body, and the locking mechanism includes a displacement button, a drive shaft, a drive gear and a first component locking. The displacement knob is located on the distal clamping element and is rotatable on the stem body and defines portions of teeth along the inside of the displacement knob that moves transversely to the
4/27 longitudinal axis of the stem body when the travel knob is turned on the stem body. The locking mechanism has at least two fixed positions with respect to the stem body. The drive shaft has a proximal end and a distal end, where the distal end defines portions of teeth that directly or indirectly engage the teeth portions of the displacement button, and extend along a larger longitudinal axis of the axis of drive. The drive gear is along the drive shaft and defines portions of teeth that directly or indirectly engage the tooth portions along the drive shaft, with which the travel button is engaged with the drive gear on all the positions of the scroll button. The first locking component extends over the push rod and is connected to the proximal rod and the drive gear, whereby, in a first position of the displacement button, the first locking component engages the proximal rod with the drive, and the rotation of the displacement button from the first position to the second position promotes the rotation of the drive shaft, which in turn causes the rotation of the drive gear and the disengagement of the first locking component from the rod to drive, thereby allowing independent movement of the sending catheter along the longitudinal axis of the stem body with respect to the driving rod when the proximal stem is moved along the longitudinal axis of the longest body.
[0007] In another embodiment of the present invention, the locking mechanism additionally includes a second locking component. The second locking component extends over the push rod, is attached to the rod body, and is connected to the displacement button via the drive shaft, with which the rotation of the displacement button from the first position to the second position promotes engagement between the stem body and the thrust rod, thereby preventing movement
5/27 longitudinal of the push rod with respect to the stem body when the proximal stem is moved along the longitudinal axis.
[0008] In yet another embodiment, the delivery device of the present invention includes an apex sending device that includes an apex clamp assembly and a proximal clamp assembly. The apex clamp assembly includes a distal capture component at a distal end of the guidewire catheter, a proximal capture component in relation to the distal capture component, and an apex release catheter having a proximal end, where the apex release catheter extends over the guidewire catheter and is attached to the proximal capture component. The proximal clamp assembly includes a fixed component at the proximal end of the guidewire catheter and an external coupling at the proximal end in the apex release catheter in a conjugable relationship with the fixed component of the proximal clamp assembly, according to which the movement of the external coupling with respect to the fixed component from a first position to the second position will cause a relative movement of the proximal capture component with respect to the distal capture component of the apex clamp assembly.
[0009] In yet another embodiment, the present invention includes the sending device which includes a gear rack, a rod extending over the gear rack defining portions of teeth at one end of the rod, the rod being rotatable over the rack of gear, the pinion gear that is rotatable on an axis that intersects with the axis of rotation of the rod and engages the gear rack, the connecting gear that selectively rotates with the rotation of the pinion gear, a driving element that engages selectively the pinion gear with the connecting gear, and a sending catheter fixed to the stem, with which the rotation of the stem selectively moves a sending catheter with respect to the gear rack with the coupling of the
6/27 pinion gear with the link gear by the drive element.
[0010] In yet another embodiment, the present invention is a method for sending a vascular prosthesis to an individual's treatment field. The method includes advancing the vascular prosthesis, while it is mounted on a proximal end of the prosthesis to an apex sending device fixed to a distal end of a guidewire catheter, to a position distal to a vascular treatment field. of the individual. A proximal stem is rotated in a first direction over a stem body, having a distal end, of a delivery device through which the guidewire catheter extends. The guidewire catheter is disposed inside a pushing rod which also extends through the rod body, in which the guide wire catheter is attached to the pushing rod, whereby the rotation of the proximal rod causes the longitudinal movement of the rod. guide wire catheter and push rod along the stem body to thereby at least partially advance the prosthesis into the treatment field, the prosthesis being advanced from within an external catheter extending from one end distant from the stem body and over the prosthesis. The position of a first locking member that secures the proximal rod to the push rod is moved from a first position to the second position, where the first locking member disengages the proximal rod from the pushing rod and a second locking component engages the push rod with the stem body. The proximal rod is then rotated in a second direction, whereby a sending catheter, having a distal end and extending over the pushing rod, is removed along the pushing rod, and a sending sheath extending from the distal end of the sending catheter it is at least partially retracted from over the prosthesis. The proximal end of the prosthesis is then released from the apex sending device. The second locking component is moved to disengage the stick
7/27 to push from the stem body, and the push rod and guide wire catheter are removed from within the prosthesis, thereby sending the vascular prosthesis to the treatment field.
[0011] The sending device and the method of its use of the present invention have many advantages. For example, the rotation of the proximal nail to thereby advance the push stick and the vascular prosthesis at the end of the push stick provides greater control over the movement of the vascular prosthesis during implantation in the treatment field. Additionally, the selective engagement of the proximal rod and the pushing rod allows the disengagement of the proximal rod from the pushing rod to thereby provide controlled retraction of a sheath from the vascular prosthesis by rotating the proximal rod in one direction opposite to that used to advance the vascular prosthesis into the treatment field. In addition, a drive element of the sending device allows the selective disengagement of the proximal stem from the stem body, with which the proximal stem can be moved along the stem body without rotation of the proximal stem, thereby providing another degree of freedom of movement of the vascular prosthesis during the advancement of the vascular prosthesis into the treatment field and during retraction of the sheath from the prosthesis once the prosthesis has been advanced into the treatment field. The delivery device of the present invention also has the advantage of engaging the push rod with the rod body by disengaging the proximal rod from the pushing rod, thereby allowing removal of the sheath from the prosthesis vascular without dragging the vascular prosthesis at the same time that the sending sheath is being retracted from the vascular prosthesis by movement of the proximal nail. In addition, the apex delivery device is controllable at a proximal end of the pushing stick and guidewire catheter, thereby allowing the selective release of a proximal end of the vascular prosthesis into the treatment field at the same time as the components
Remaining 8/27 of the sending device remain stationary. In addition, the push rod can be disengaged from not only the rod body but also the proximal rod, thereby allowing retraction of the push rod, guidewire catheter and apex sending device from inside the shaft. vascular prosthesis once it was implanted in the sending device, thereby minimizing the potential rupture of the vascular prosthesis once it was implanted.
BRIEF DESCRIPTION OF THE DRAWINGS [0012] Figure 1 is a perspective view of an embodiment of the delivery device of the present invention.
[0013] Figure 2 is a perspective view of a modality of a displacement button, the driving axis and the driving element, of the present invention.
[0014] Figure 3 is a perspective view of the displacement button and the drive axis of the modality shown in figure 2.
[0015] Figure 4 is a perspective view of a displacement button, distal stem, nose portion of the distal stem, and a cross-sectional view, in part, of a stem body and delivery catheter of another modality of present invention.
[0016] Figure 5 is a partially sectioned section of the modality portion of the sending device of the present invention shown in figure 4. [0017] Figure 6 is the partially sectioned section of a detail of a portion of the stem, gear body intermediate gear, reduction gear and connection gear, all of which connect the travel button with the drive axis of the present invention shown in figure 4.
[0018] Figure 7 is a partial sectional view of the modality of figure 4, showing the cross-sectional view of the distal nail and the base to which the external catheter is connected in the nose portion of the distal nail.
9/27 [0019] Figure 8 is a partially sectioned view, as shown in Figure 4 showing the restriction rings that extend over a delivery catheter.
[0020] Figure 9 is another embodiment of a partially sectioned view of the sending device of Figure 1 showing a trigger element and a push button at the proximal end of a slot defined by the stem body.
[0021] Figure 10 is a perspective view of the first locking component, and the second locking component, and their relationship to the drive axis of the mode shown in Figure 1.
[0022] Figure 11 is another representation of a first locking component and a second locking component, and a housing of the first locking component and a housing of the second locking component stabilizing the spatial relationship between the first locking component and the second locking component, respectively, with respect to the driving axis of the modality of figure 1.
[0023] Figure 12A is another perspective view of the modality of figure 1, showing the displacement of the proximal stem and the driving element along the consequent stem body to rotate the proximal stem over the stem body or press the push button the driving element to thereby allow longitudinal movement of the driving element and the proximal stem without rotation of the proximal stem.
[0024] Figure 12B is another perspective view of the modality of figure 1, in which a proximal stem has been advanced along the stem body of the sending system.
[0025] Figure 13 is a detail of the proximal stem and the driving element in the stem body of the embodiment of the present invention shown in figure 1, without the housing of the driving element.
[0026] Figure 14 is a perspective view of the detail in Figure 13, without the push button of the trigger element shown in Figure 13.
10/27 [0027] Figure 15 is a partially sectioned view of the mode in Figure 1 showing the relationship of pinion assemblies and the connecting gear with respect to the housing of the first locking component and the relationship of the housing of the first locking component to the sending catheter inside the housing.
[0028] Figure 16 is a perspective view of the housing of the first locking component and the housing of the second locking component within the sectional view of the stem body, together with a perspective view of the connecting gear assembly and the assembly of pinion gear of the driving element.
[0029] Figure 17 is a side view of the representation of the present invention, as shown in figure 16.
[0030] Figure 18 is a partially sectioned view of the distal end of the stem body and the second locking component shown in Figures 16 and 17.
[0031] Figure 19 is a perspective view of a partially sectioned view of the driving element shown in figure 17.
[0032] Figure 20 is a perspective view of a rack and proximal rod of the embodiment shown in figure 1, and an alternative embodiment of the driving element of the present invention, devoid of a connection gear assembly.
[0033] Figure 21 is a perspective view, partially transparent, of the pinion gear set of figure 20.
[0034] Figure 22 is another view of the modality represented in figure 21.
[0035] Figure 23 is a perspective view of the modality shown in figures 21 and 22, devoid of the upper pinion gear shown in said figures.
[0036] Figure 24 is another modality of the representation shown in figure 23.
11/27 [0037] Figure 25 is a perspective view of an embodiment of a proximal clip assembly of an embodiment of the present invention.
[0038] Figure 26 is a partially sectioned view of the proximal clamp assembly shown in Figure 25.
[0039] Figures 27A-27C are seen in sectioned perspectives of the distal end of the sending device shown in figure 1.
[0040] Figure 28A is a perspective view of the displacement button in the first position, in which the push rod is attached to the proximal stem and the prosthesis is not implanted.
[0041] Figure 28B is a detailed perspective view of the proximal clamp assembly in a first position, with which the apex clamp assembly is not open.
[0042] Figure 28C is the detailed perspective view of the scroll button in the first position.
[0043] Figure 29A is a perspective view of the sending device of figures 28A-28C showing the advance of the sending sheath containing the prosthesis when the displacement button is in a second position, in which the push rod is fixed to the rod body.
[0044] Figure 29B is a detailed perspective view of the advancement of the shipping sheath of figure 29A.
[0045] Figure 30A is a perspective view of the sending device of figures 29A, 29B showing the advance of the sending sheath.
[0046] Figure 30B is the detailed perspective view of the displacement button of figure 30A in the second position.
[0047] Figure 31A is a perspective view of the delivery device of figures 30A, 30B, in which the delivery sheath has been partially retracted from the prosthesis.
[0048] Figure 31B is the representation of an apex clamp assembly of one embodiment of the present invention in a closed position.
12/27 [0049] Figure 32A is a perspective view of the delivery device of figure 31 A, in which the apex clamp assembly is opened by activating the proximal clamp assembly to thereby release the apexes of the proximal stent from the prosthesis shown in figure 32C.
[0050] Figure 32B is a representation of the proximal clamp assembly of figures 25, 26, with which an apex clamp assembly, not shown, was opened.
[0051] Figure 32C is a representation of the apex clamp assembly of an embodiment of the present invention, in an open position.
[0052] Figure 33A is a perspective view of the sending device of figure 32A, in which the displacement button was moved to the third position, whereby the push rod was released from the proximal rod and the body of rod and, in which the push rod was retracted from the prosthesis completely positioned.
[0053] Figure 33B is a perspective view of the scroll button in a third position as shown in figure 33A.
DETAILED DESCRIPTION OF THE INVENTION [0054] While the present invention has been particularly shown and described with reference to the exemplary modalities of it, it will be understood by those skilled in the art that various changes in shape and details can be produced in them without deviate from the scope of the present invention encompassed by the appended claims.
[0055] One embodiment, of the delivery device 10 of the present invention is shown in figure 1. The delivery device 10 includes a guide wire catheter 12 (figures 10, 11) having a proximal end and a distal end. “Proximal,” as a term used here with reference to the sending device and its components, that is to say with relative proximity to the surgeon who is operating the sending device. “Distai,” as a term used here with reference to the sending device and its components, that is
13/27 relatively distal from the surgeon who is operating the sending device. “Proximal,” as a term used here with reference to the prosthesis, stent graft and components, that is to say with relative proximity to the patient's heart. “Distai,” as a term used here with reference to the prosthesis, stent graft and components, that is to say relatively distal from the patient's heart. Returning to figure 1, the delivery device 10 includes the delivery assembly 18 which extends over the guidewire catheter (not shown). The sending assembly 18 includes the stem body 20 having a major longitudinal axis 22, a proximal end 24 and a distal end 26. The sending catheter 28 (figure 9) has a distal end 30 (figure 27A) that extends to from within the distal end 26 of the stem body 20 and over the guidewire catheter (not shown). The push stick 32 extends over the guide wire catheter 12 and into the sending catheter 28 (figures 10, 11). The push rod 32 is attached to the guide wire catheter 12 at the proximal end 34 of the push rod 32 proximal to the stem body at pin 192 (figure 25). Referring back to figure 1, the proximal rod 36 extends over the rod body 20 and is axially attached to the sending catheter 28. The proximal rod 36 is selectively attached to the push rod 32, where the proximal rod 36 is rotatable on the stem body 20 and the rotation of the proximal stem 36 on the stem body 20 translates into a longitudinal movement of the sending catheter 28 along the longitudinal axis 22 and, selectively, of the pushing rod 32 with respect to the stem body 20, as can be seen by comparing figures 12A with figure 12B. The first locking mechanism 38 (figure 15) on the stem body 20 selectively engages the proximal stem 36 (figures 12A and 12B) with the push rod 32.
[0056] The distal stem 40 extends over the stem body 20 at the distal end 26 of the stem body 20 and is distal to the displacement button 42 of the first locking mechanism 38 (figure 15). The nose portion of distal stem 44 (figure 1) extends distally from
14/27 distal rod 40 and includes flow port 46 to provide fluid communication between a solution source (not shown) and the internal components of the sending device 10, as needed, to hydrate the contact between components of the sending device 10 and the vascular prosthesis (not shown) within the individual during implantation of the vascular prosthesis in the individual. External catheter 48 extends from the nose portion of distal stem 44 (figure 1).
[0057] The actuator element 80 is connected to the proximal rod 36, with which the proximal rod 36 can rotate on the rod body 20 at the same time that the push button 82 in the housing 81 of the actuator element 80 remains aligned with the slot 84 defined by the stem body 20. The depression of the push button 82 of the actuator element 80 selectively disengages the proximal stem 36 from the stem body 20, whereby the rotation of the proximal stem 20 is independent of the longitudinal movement of sending catheter 12 with respect to the stem body 20 along a longitudinal axis 22.
[0058] As can be seen in figure 2, the displacement button 42 is connected to the drive gear 86 by the drive shaft 88. The drive shaft 88 has a proximal end 90 and a distal end 92, and runs along the inside the stem body 20 (not shown). As can be seen in figure 3, the travel button 42 is connected to the drive shaft 88, in one embodiment, by the intermediate gear 94A, with which the rotation of the travel button 42 on the stem body 20 promotes the rotation of the drive shaft 88 due to the connection between travel button 42 and drive shaft 88 by intermediate gear 94A. In said mode, the travel button 42 is connected to the drive shaft 88 indirectly, as opposed to the direct link. "Direct connection" would be a direct contact with each other. The displacement button 42 is rotationally connected to the distal stem 40, which is attached to the distal end 26 of the stem body 20, as shown in figure 1.
15/27 [0059] In another embodiment, shown in figures 4 and 5, the connection between the travel button 42 and the drive shaft 88 includes a gear reduction in the intermediate gear 94B which is connected to the coaxial reduction gear 96 which , in turn, is connected to the connection gear 98 which is coaxially connected to the drive shaft 88. Due to the gear reduction, the rotation coefficient of the displacement button 42 with respect to the drive shaft 88 can be controlled by the dimensions reduction gear 96 and connection gear 98 (figures 5, 6, 7). Typically, the rotation ratio, or reduction ratio, of the travel button 42 and the drive axis 88 is in a ratio of between about 1: 2 and about 1: 6. The relationship between the reduction gear 96 and the connecting gear 98 can be seen in greater detail in figure 6.
[0060] As can be seen in greater detail in figure 7, the sending catheter 28 extends through the stem body 20, the distal stem 40 and the nose portion of the distal stem 44. With reference back to figure 5, the external catheter 48 is connected to the base 102, whereby the external catheter 48 is rotatable independently of the stem body 20. As shown in figure 8, the restraining rings 104 extend along the sending catheter 28 inside the stem body shank 20. As shown in figures 8 and 9, restraint rings 104 have an outside diameter greater than the slot width 84, whereby restraint rings 104 will prevent the application of a longitudinal compressive force by proximal stem 36 in the sending catheter 28 causing the sending catheter 28 to clamp and thereby move through slot 84 and outside the stem body 20. Restriction rings 104 also have a relatively smaller internal diameter than the catheter outside diameter from env io 28, whereby the restraint rings 104 will have an interference fit with the sending catheter 28, so that the restraint rings 104 can move longitudinally along the sending catheter 28 if directed, but otherwise they will remain in place with respect to sending catheter 28. The
16/27 gear rack 106 extends longitudinally within stem body 20. Pin 108 at distal end of stem body 20 extends from distal end 26 of stem body 20 and is selectively notched within slots 110, 112, 114 of the displacement button 42. The displacement button 42 is longitudinally movable along the stem body 20 and is rotatable over the stem body 20 enough to allow rotation of the displacement button 42 to move the pin placement 108 inside any of the slots 110, 112, 114 of the displacement button 42, which thus promotes the rotation of the intermediate gear 94. As a consequence, the drive shaft 88 rotates about the longitudinal axis 116 of the drive shaft 88. The Shift button 42 is oriented against pin 108 by spring 118 (figure 7).
[0061] As can be seen in figure 9, the gear rack 106 and the drive shaft 88 extend along the length of the slot 84. Figure 10 shows the relationship between the drive shaft 88, the push rod 32 and the first locking mechanism 38. The push rod 32 extends through the first locking mechanism 38 which, in turn, is engaged with the drive shaft 88 in the drive gear 86 of the first locking mechanism 38. The first locking mechanism 38 locking 38 is fixed with respect to the proximal rod (not shown) in distal bearings 120 through which the push rod 32 extends. The distal bearings 120 are connected to the housing of the first locking component 150 by pins 122. The first locking component 124 of the first locking mechanism 38 is fixed with respect to the distal bearings 120 at the distal end 126 and connected to the drive gear 86 in the proximal end 128, whereby the rotation of the drive shaft 88 and the consequent rotation of the drive gear 86 will additionally spiral, or reduce the spiral, of the first locking component 124, resulting in the engagement or disengagement, respectively, of the mechanism locking 38 and, consequently, the
17/27 proximal rod (not shown), with the push rod 32. When the first locking mechanism 38 is engaged with the push rod 32, the longitudinal movement of the proximal rod (not shown) along the drive shaft 88 and, thus, of the stem body 20, it will promote the longitudinal movement of the push rod 32 along the drive axis 88 and of the stem body 20, as can be seen by comparison of figures 12A and 12B.
[0062] With reference back to figures 10, 11, the drive shaft 88 is rotationally fixed to the rod body 20 (figure 9) in the drive shaft bearing 130, which is part of the second housing of the locking component proximal 152 at the proximal end 90 of the drive shaft 88. The second locking mechanism 132 includes a drive gear 134 that engages with the drive shaft 88 at the proximal end 90 of the drive shaft 88 and is rotationally engaged with mechanisms of bearing 136 (figure 11), including proximal bearing 138 (figure 10) and distal bearing 140 (figure 10) which, in turn, are fixed with respect to the stem body 20 on pins 142. The proximal bearing 138 is radially and axially attached to the stem body 20. The distal bearing 140 is axially attached to the stem body 20. The second locking component 144 of the second locking mechanism 132 is engaged with a proximal bearing 138 at the proximal end 146 of the second locking component 144, and engaged with translational gear 134 at the distal end 148 of the second locking component 144, whereby the rotation of the drive shaft 88 and, consequently, the rotation of the translational gear 134 will tighten and engage, or loosen and disengage, the second locking component 144 with the push rod 32. When engaged with the push rod 32, the second locking component 144 causes the push rod 32 to be fixed in place with respect to the body of rod (not shown). When loosened and disengaged from the 32 push stick, the 32 push stick is
18/27 longitudinally movable with respect to the stem body (not shown). The orientation of the first locking component 124 and the second locking component 144 are reversed, whereby the rotation of the drive shaft 88 in one direction will simultaneously promote the engagement and disengagement of the first locking component 124 and the second locking component 144 with the push rod 32, respectively. Disengagement of the first locking member 124 from the push rod 32 is caused by the movement of the displacement button 42 from a first position defined by pin 108 in slot 110 of the displacement button 42 to the second position 112, defined by pin 108 in the second slot 112 of the displacement button 42 (figure 9). The same movement from the first to the second position of the displacement button 42 will simultaneously engage the second locking component 144 with the push rod 32, whereby the push rod 32 will be fixed in position with respect to the body rod 20 in the second locking component 144 independent of the proximal rod movement 36 along the longitudinal axis 116 of the rod body 20. With reference back to figures 8 and 9, the positioning of the displacement button 42, so that the pin 108 is in the intermediate slot 114 between the first slot 110 and the second slot 112 of the displacement button 42, it will cause not only the first locking component 124 but also the second locking component 144 to be disengaged from the push rod 32 .
[0063] As can be seen in figure 11, the housing of the first locking component 150 secures the lateral movement of the first locking component 124 and the drive shaft 88, and the housing of the second locking component 152 fixes the position of the second locking component 144 and bearings 138, 140 with respect to the proximal end 90 of the drive shaft 88, respectively. Additionally, as can also be seen in figure 11, the catheter of
19/27 apex release 154 extends into the push rod 32 and the guide wire catheter 12 extends into apex release catheter 154. [0064] Figures 12A and 12B indicate the relative movement of the driving element 80 and of the proximal stem 36 along the stem body 20. The rotation of the proximal stem 36 over the stem body 20, when the push button 82 is in a first position, as shown in figures 12A and 12B, will promote the longitudinal movement of the proximal rod 20 and the drive element 80 along the rod body 20. When pressing the push button 82 to the second position essentially flush with the housing of the driving element 81, rotation of the proximal rod 36 will not cause the longitudinal movement of the proximal rod 36 or the driving element along the rod body 20. Instead, the proximal rod 36 and the driving element 80 will be movable along the rod body 20 without rotation of the proximal rod 3 6 on stem body 20.
[0065] As can be seen in figures 13-15, the tooth portions 156 of the proximal rod 36 engage the upper link gear 160 of the link gear set 158. The link gear set 158 is engaged with the set of links pinion gear 164. Lower link gear 162 of link gear set 158 engages upper pinion gear 166 of pinion gear set 164. Pinion gear set 164 is connected to the housing of the first locking member 150 (figure 11) through slot 84. Link gear assembly 158 and pinion gear assembly 164 are drive element components 80, referenced with reference to figure 1. Figure 16 is a perspective view of drive element 80 of figure 1 (without the housing 81 or the push button 82), the housing of the first locking component 150 and the housing of the second locking component 152.
[0066] As can be seen in figure 17, the upper pinion gear 166 is coaxial with the lower pinion gear 168 which, in turn,
20/27 engages gear rack 106. With reference back to figures 16 and 17, the sending catheter 28 is connected to the housing of the first locking component 150 and thus will move longitudinally along the housing 150, with the movement of the proximal rod 36 and the driving element 80, as shown in figure 1, regardless of whether the first locking member 124 is engaged with the push rod 32. Therefore, when the upper pinion gear 166 engages the lower pinion gear 168 , the rotation of the proximal stem 36 (as shown in figure 1) on the stem body 20 will promote the rotation of the connecting gear set 158 (figure 13) and, consequently, the rotation of the pinion gear set 164 (figure 13 ) and the movement of the pinion gear assembly 164 (figure 13) along the gear rack 106 (figures 16 and 17), and the movement of the proximal rod 36 (figure 1) and the driving element 80 (figure 17) along the stem body 20. Additionally, at the same time that the first locking member 124 is engaged with the push rod 32, proximal rod rotation 36 will promote the longitudinal movement of the push rod 32 along the body of rod 20. In all cases, the movement of the proximal rod 36 and the driving element 80 along the rod body 20 will always occur together, and will promote the movement of the sending catheter 28 longitudinally along the rod body 20.
[0067] However, as will be further explained below, when pressing the central pin 170, the upper pinion gear 166 is disengaged from the lower pinion gear 168. When the upper pinion gear 166 is disengaged from the pinion gear lower 168, the rotation of the proximal stem 36 over the stem body 20 does not cause the longitudinal movement of the proximal stem 36 and the driving element 80 along the stem body 20. Additionally, the longitudinal movement of the proximal stem 36 and the driving element 80 along the stem body 20 can be obtained simply by moving the proximal stem 36 and the driver / element 80 along the stem body 20 without rotating the proximal stem 36 over the stem body 20 (figures 1, 12A and 12B).
[0068] Figure 18 shows the placement of the housing of the second locking component 152 within the proximal end 24 of the stem body 20 and the second locking component 144 which extends between bearings 138, 140. As determined above, the rotation of the translation gear 134 due to the rotation of the drive shaft 88 (figures 10, 11) will engage or disengage the second locking member 144 with the push rod 32 extending through the second locking member 144 and, consequently, engaging and disengaging the push rod 32 with the proximal end 24 of the stem body 20.
[0069] Figure 19 is another perspective view of the connecting gear set 158 and the pinion gear set 164 of the driving element 80 (figure 1).
[0070] As an alternative modality, shown in figure 20, the push button 82 is located on top of the central pin 170, which extends through the upper pinion gear 166. As can also be seen in figures 20 and 21, the lower pinion gear 168 is engaged with gear rack 106 and includes the extension of pinion gear 169 which is axially aligned with lower pinion gear 168 which is axially aligned with the upper pinion gear 166. The lower portion 172 of the pinion gear 168 extends into opening 174 (figure 11) defined by the housing of the first locking component 150 (figure 11), thereby fixing the position of the pinion gear assembly 164 with respect to the housing of the first locking component 150 (figure 11), the distal bearing 120 (figure 11), the first locking component 124 and the drive gear 86, all of which are shown, in one previous modality, in figure 11.
22/27 [0071] Figure 21 is a perspective view showing the engagement of the lower pinion gear 168 with the gear rack 106 and the frustoconical portion 176 of the central pin 170. As can be seen in figures 22 and 23, the ball bearing 178 extends through the openings 180 defined by the extension of the pinion gear 169 and, when the central pin 170 is in an extended position, as shown in figure 22, the frustoconical portion 176 of the central pin 170 forces the ball bearing 178 outwards and for an interference relationship with the openings 182 (figure 21) defined by the upper pinion gear 166 (figures 21 and 22) thereby engaging the upper pinion gear 166 with the lower pinion gear 168. When the pin center 170 is activated by pressing button 82 (figure 1), as shown in figure 23, ball bearing 178 is forced inward by the rotation of upper pinion gear 166 (figure 22) with re connection to the lower pinion gear 168 (figure 22), whereby the upper pinion gear 166 is no longer engaged with the lower pinion gear 168. The central pin 170 is oriented in an outward position, whereby the gear upper pinion gear 166 is oriented in engagement with the lower pinion gear 168 by means of spring 184 located at the base of central pin 170 (not shown in figure 22 or 23).
[0072] As can be seen in figure 32C, the nose-shaped cone 50 is attached to the guidewire catheter 12 at a distal end 16 of the guidewire catheter 12. The vascular prophetic component 58 is disposed within the delivery device 10 proximal to the nose-shaped cone 50 (figure 27A).
[0073] Figures 25 and 26 show perspective and sectional views, respectively, of the proximal clip assembly component 184 of the present invention. As can be seen in figure 25, the external coupling 186 is slidable along the proximal end 34 of the push rod 32. The fixed component 188 is fixed to the proximal end of the guidewire catheter by pin 192. The external coupling 186 and the fixed component 188 are
23/27 in a conjugated relationship at junction 190. Spring 194 inside outer coupling 186 guides outer coupling 186 against fixed component 188. Proximal clamp assembly 184 is moved from a first position, shown in figures 25, 28B for the second position, shown by applying pressure to the tabs 196 on each side of the outer coupling 186, and directing the outer coupling 186 distally by a sufficient degree to allow rotation of the outer coupling 186 by ninety (90) degrees and then retracting the outer coupling 186 so that the tabs 196 of the outer coupling 186 align between the tabs 198 of the fixed component 188, as shown in figure 32B. The movement of the external coupling 186 from the first position, shown in figure 25, to the position shown in figure 32B, promotes the opening of the apex clamp assembly 52, with which the proximal capture component is retracted from a first position which is in a conjugated relation to the distal capture component 56 of the apex clamp assembly 52 shown in figure 31B, for the second position, shown in figure 32C, in which the proximal capture component 54 is no longer in a relationship conjugated to the distal capture component 56. The proximal external coupling movement 186 of the proximal clip assembly 184 (figures 25, 28B, 32B) with respect to a fixed component 188 to separate the proximal capture component 54 (figure 31B) a from the distal capture component 56 (figures 31B, 32C) releases the apices 68 of the stent 66 at the proximal end 60 of the vascular prophetic component 58.
[0074] Figures 27A-27C are seen in cross-section of a portion of the delivery device 10 of the present invention showing a vascular prophetic component 58 in an unimplanted state within a distal end 202 of the delivery device 10. Specifically, how shown in figure 27A, the vascular prophetic component 58 is within the shipping sheath 200. The distal end 62 of the vascular prophetic component 58 contacts support 204. Support 204, in turn, is
24/27 coupled to the push rod 32 at the distal end 206, the proximal end 60 of the vascular prosthetic component 58 captured at the apices 68 of the proximal stent 66 with the apex clamp assembly 52 when the apex clamp assembly 52 is in one closed position, as shown in figure 27A. The apex class set 52 includes distal capture component 56 at distal end 16 of guide wire catheter 12, and proximal capture component 54 is in conjugable relation to distal capture component 56, and attached to distal end 210 of the apex release catheter 154. apex release catheter 154 extends over guidewire catheter 12, and both apex release catheter 154 and guidewire catheter 12 extend through vascular prosthetic component 58 and the push rod 32 for the proximal clamp set 184 (figure 26). The delivery sheath 200 is attached at its proximal end to the delivery catheter 28 at the distal end 30 and extends over the vascular prosthetic component 58 to the apex clamp assembly 52, as can be seen in figure 27C. Returning to figure 27, the nose-shaped cone 50 is attached to the guide wire catheter 12 distally to the distal capture component 56 of the apex clamp assembly 52. The external catheter 48 extends from the nose portion of the stem distal 44 (figure 1), and on the sending catheter 28 and the sending sheath 200, to the nose-shaped cone 50.
[0075] As shown in figures 28A-33B, a method for sending the vascular prosthesis to a subject's treatment field employing a delivery device of the present invention includes advancing the vascular prosthesis 58, at the same time as the prosthesis 58 is mounted to the apex clamp assembly 52 at the proximal end 60 of the prosthesis 58. The proximal apex clamp assembly 184 is in a first position shown in figure 28B, with which the apex clamp assembly 52 is closed (figure 31B) . The apexes of the vascular prosthesis 58 are attached to the apex clamp assembly 52 when the proximal clamp assembly 184 is in the first position. The apex clamp assembly 52 is, in turn, attached to the distal end 16 of the
25/27 guide wire 12, displacement button 42 is in a first position when pin 108 is in slot 110 (figure 28C), causing the push rod 32 to move with the longitudinal movement of the proximal rod 36. A prosthesis 58 is advanced to the distal position to an individual's vascular treatment field by rotating the proximal stem 36 in a first direction over the stem body 20, having the distal end 26, of the delivery device 10 through which the catheter of guide wire 12 extends. The guidewire catheter 12 is disposed within the push rod 32 which also extends through the stem body 20, wherein the guidewire catheter 12 is attached to the push rod 32, such as at a proximal end of the lead catheter. guide wire 12 or the push rod 32 by pin 192 (figure 25), whereby the rotation of the proximal rod 36 promotes the longitudinal movement of the guide wire catheter 12 and the push rod 32 along the rod body 20 to thereby at least partially advancing prosthesis 58 from external catheter 48 as can be seen in figures 29A29B. Optionally, the push button 82 of the actuator element 80 can be pressed to disengage the rotation of the proximal stem 36 from the longitudinal movement of the proximal stem 36 along the stem body 20, thereby allowing manual advancement of the vascular prosthesis 58 for the vascular treatment field of the individual without rotation of the proximal nail 36 over the nail body 20.
[0076] The displacement button 42 is moved from a first position, in which the first locking component 124 (figures 10, 11) fixes the proximal rod 36 to the push rod 32, for the second position, the first locking component 124 (figures 10, 11) disengages the proximal rod 36 from the pushing rod 32 and the second locking component 144 (figures 10, 11) engages the pushing rod 32 with the rod body 20 in the proximal end 24 of stem body 20. [0077] As can be seen in figures 31A and 31B, proximal stem 36 can then be rotated in a second direction, at the same time as the
26/27 the push-button actuator element 82 is not pressed, whereby the sending catheter 28, having a distal end 30 (figure 24A) and which extends over the push rod 32, is removed along the push rod 32, and the delivery sheath 200 extending from the distal end of the delivery catheter (figures 4 to 9) is at least partially retracted from over the prosthesis 52. Optionally, the push button 82 of the driving element 80 it can be pressed, thereby disengaging the rotation of the proximal nail 36 from the nail body 20, to thereby completely retract the delivery sheath 200 from the vascular prosthesis 58 without the rotation of the proximal nail 36 on the nail body 20, as seen in figure 32A.
[0078] The proximal clamp assembly 184 is then actuated by compressing the external coupling 186 and moving the external coupling 186 first distally, and then rotating the external coupling 186 ninety degrees, and after retracting the external coupling 186 to the second position, shown in figure 32B, thereby retracting the apex release catheter 154 into the push rod 32 (figures 10, 11) and retracting the proximal capture component 54 from distal capture component 56. The apices 68 of stent 66 in the proximal end 60 of vascular prosthesis 58 is released from the apex clamp assembly 52, and prosthesis 58 is thereby released from the delivery device 10, as can be seen in figure 32C. The displacement button 42 is then moved from the second position to the third position, where the pin 108 is located in the slot 114 between the first slot 110 and the second slot 112, as can be seen in figure 33B, thereby disengaging the push stick 32 from the stem body 20. The push stick 32 and the guide wire catheter 12 are then removed from vascular prosthesis 58 by pulling the push stick 32 through the stem body 20, thereby completing the sending of vascular prosthesis 58 to the treatment field, as can be seen in figure 33A.
27/27 [0079] Although the present invention has been particularly shown and described with reference to the exemplary modalities of it, it will be understood by those skilled in the art that various changes in shape and details can be made therein without departing from the scope of the present invention encompassed by the appended claims.
POWER OF ATTORNEY
LETTER OF ATTORNEY
Name '. BOLTON MEDICAL, INC.
Address'. 799 International Parkway
Sunrise, Florida 33325
United States of America
Hereby appoint and constitute their legal proxies, with full powers:
M C ARAÚJO CONSULTORIA EM PROPRIEDADE INDUSTRIAL LTDA., Industrial property official agency, registered at the INPI under n °. 1726 and brazilian limited company, established at Rua Pedro Lessa, 35 - Suites 1201 to 1206, Rio de Janeiro, State of Rio de Janeiro, duly registered at the National Registry of Legal Entities of the Ministry of Finance (CNPJ), under n ° . 05.754.196 / 0001-23, at the Fiscal Registry of the City of Rio de Janeiro under n ° 33.374-30;
MARIA CRISTINA DE ARAÚJO, brazilian, single, lawyer, registered at the Board of the Brazilian Lawyers, Section of the State of São Paulo under n °. 114,553, at the Registry of Physical Persons of the Ministry of Finance (CPF), under no. 761.405.048-72;
UILSON RICARDO DOS SANTOS MOREIRA, brazilian, single, industrial property agent, registered at the INPI under n °. 1872 and at the Registry of Physical Persons of the Ministry of Finance (CPF) under n °. 885.167.847-20;
in order that they may jointly or separately apply for in the name and on behalf of the Grantor and obtain at the NATIONAL INSTITUTE OF INDUSTRIAL PROPERTY (INPI) of the Federative Republic of Brazil, patents of invention, certificates of addition of inventions, patents of utility models, registrations of industrial designs, registration of software, trademarks, service marks, certification marks, collective marks and of geographical indications, all of which in accordance with the legislation in force, with powers also to comply with all legal formalities, to sign petitions, apply for renewals, to give up applications, to renounce registered trademarks, software registration, industrial designs and patents, to apply for the shelving and restoration of proceedings in general, to accomplish official actions, to pay annuities of patents and quinquennial fees of industrial designs, taxes or duties, to receive and to give quittance, to start administrative nullity procedures, to offer pa tents to license, to apply for compulsory licenses, forfeiture of rights, restoration of rights, record of assignment, change of name and address, registration of trademark or patent license agreements, franchising agreements and of technology transfer agreements, to withdraw them, as well as to produce evidence of use of patents and trademarks. Furthermore, the Grantor grants special powers to the Grantees to file oppositions, to rebut, to sub rebut, to contest, to file appeals, to withdraw them, including powers to submit and to reply Judicial and Extra-Judicial notifications and to do everything deemed necessary in the interests of rights of the Grantor, being also authorized to subrogate said powers entirely or in part.
Appoints and constitutes its quite proxies, with wide powers:
M C ARAÚJO CONSULTORIA EM PROPRIEDADE INDUSTRIAL LTDA., Official industrial property agency, registered with the INPI under no. 1726 and, a Brazilian limited liability company, established in the city of Rio de Janeiro, State of Rio de Janeiro, at Rua Pedro Lessa, n ° 35 - 12th floor, rooms 1201 to 1206 part, registered with CNPJ under n ° 05.754.196 / 0001-23 and in the Tax Register of the Municipal Finance Department, of the City of Rio de Janeiro under number 33.374-30;
MARIA CRISTINA DE ARAÚJO, Brazilian, single, lawyer, registered with the Brazilian Bar Association, São Paulo State Section under no. 114,553 and in the Individual Taxpayer Registry of the Ministry of Finance (CPF) under no. 761.405.048-72;
UILSON RICARDO DOS SANTOS MOREIRA, Brazilian, single, industrial property agent, registered at INPI under number. 1872 and in the Individual Taxpayer Registry of the Ministry of Finance (CPF) under no. 885.167.847-20;
to jointly or separately, on behalf of the grantor, apply for and obtain from the NATIONAL INSTITUTE OF PROPERTY INDUSTRIAL (INPI), of the Federative Republic of Brazil, patents of inventions, certificates of addition of inventions, patents of utility models, industrial design records , registration of computer programs, product brands, service, certification, collective, and geographical indications, all in accordance with the legislation in force, being able to complete all legal formalities, sign petitions, request extensions, withdrawal of processes , waiver of patents, trademark registrations, industrial designs and software registration, request the filing and unarchiving of processes, satisfy requirements, pay annuities for patents and quinquennials of industrial designs, fees or taxes, receive and give discharge, institute administrative nullity processes, offer patents for licenses, apply for licenses compulsory, forfeiture, restorations, notes on transfer of titleholder, name change and change of headquarters, registration of trademark and patent license agreements, franchise and technology transfer agreements, including presenting their withdrawal, as well as making proof of effective use of trademarks and patents. It also grants special powers to make oppositions, replies, rejoinders, disputes and appeal, withdraw them, submit their withdrawal, including to submit and respond to judicial and extrajudicial notifications and, finally, to perform all acts that are necessary in the interests of interests. and rights of the Grantor, being able to substitute all or part of the aforementioned powers.
Place (Local)
Sunrise, Florida (USA)
Date
July 30, 2008
Print Name
Title
Ôjcar Rospigliosi CEO
CLARIFICATION IN PETITION OF MODIFICATIONS
Patent Application No. BR 11 2014 025430 3 of 14/03/2013
PCT National Phase No. PCT / US2013 / 065622
Title: VASCULAR PROSTHESIS SUBMISSION DEVICE AND
METHOD OF USE
Depositor: BOLTON MEDICAL, INC. [US]
BOLTON MEDICAL, INC., For its undersigned attorney-in-fact, presents, under the terms of article 32 of the LPI and of Resolution 093/2013:
(i) a new claim table containing 17 claims, in which reference numerals have been inserted and claims 18-30, originally submitted, have been deleted; as well as (ii) a new summary, with the insertion of reference numerals.
The applicant points out that minor corrections were applied to remedy typographical errors, harmonizing the text of the claims with the technical report, however, no new material was added in relation to the one originally filed.
Finally, it requests the Claimant that the technical examination of the present application be made based on the claim table presented here.
In these terms, it requests the respective attached for the proper purposes.
Rio de Janeiro, March 11, 2015.
权利要求:
Claims (17)
[1]
1. A SHIPPING DEVICE (10), characterized by comprising:
a) a guide wire catheter (12) having a proximal end and a distal end; and
b) a shipping assembly (18) that extends over the guidewire catheter (12), including:
i) a rod body (20), having a major longitudinal axis (22), a proximal end (24) and a distal end (26), ii) a delivery catheter (28) having a distal end (30) which extends from within the distal end (30) of the stem body (20) and over the guide wire catheter (12), iii) a push rod (32) extending over the guide wire catheter (12 ) and inside the sending catheter (28), the push rod (32) being attached to the guide wire catheter (12) at the proximal end (24) of the guide wire catheter (12) proximal to the stem body (20) , iv) a proximal rod (36) that extends over the rod body (20) and axially fixed to the sending catheter (28), the proximal rod (36) being selectively fixed to the push rod (32), in which the proximal nail (36) is rotatable on the nail body (20) and the rotation of the proximal nail (36) on the nail body (20) translates into a longitudinal movement of the sending catheter (28) and, selectively, and, the push rod (32) in relation to the stem body (20), and
v) a first locking mechanism (38) on the rod body (20) which selectively engages the proximal rod (36) with the push rod (32).
[2]
2. SHIPPING DEVICE, according to claim 1, characterized in that it additionally includes a driving element (80) in the proximal stem (36) that selectively disengages the proximal stem (36) from the stem body (20), whereby the rotation of the proximal nail (36) is independent of the longitudinal movement of the sending catheter (28) in relation to the nail body (20).
2/7
[3]
SENDING DEVICE, according to claim 2, characterized in that the proximal stem (36) includes an end that defines portions of teeth (156) that move transversely to the longitudinal axis (22) of the stem body (20) when the proximal stem (36) is rotated over the stem body (20), and additionally including:
a) a gear rack (106) extending along the major longitudinal axis (22) of the stem body (20);
b) a connecting gear (160) which engages the teeth portions of the proximal end (24) of the rod, the connecting gear (160) being rotatable on an axis transverse to the axis of rotation of the proximal rod (36); and
c) the pinion gear assembly (164) that engages the gear rack (106) and the connecting gear (160), with which the rotation of the proximal rod (36) over the rod body (20) translates in the longitudinal movement of the sending catheter (28) and, selectively, of the pushing rod (32) in relation to the rod body (20), with which the actuating element (80) selectively disengages the connection gear (160 ) from the pinion gear (164), thereby selectively disengaging the rotation of the proximal stem (36) from longitudinal movement of the proximal stem along the stem body (20).
[4]
4. SHIPPING DEVICE, according to claim 3, characterized in that the driver includes:
a) a housing of the actuating element (81) that extends over the stem body (20) and is rotationally connected to the proximal stem (36), with which the housing of the actuating element (81) is movable along the stem body (20) without turning on the stem body (20) at the same time as the proximal stem (36) rotates on the stem body (20);
b) a push button (82) in the housing of the actuating element (81);
c) an extension of the pinion gear (169) that defines a coaxial opening that is coaxial with the pinion gear (164) and defines at least
3/7 minus a side opening that extends laterally from the coaxial opening;
d) a ball bearing (178) that sits at least partially inside the side opening and locks the relative rotation of the connecting gear (160) and the pinion gear (164) when displaced to extend radially beyond the gear extension pinion (169); and
e) a frustoconical portion (176) of the central pin (170) which is oriented radially outwards from the longitudinal axis (22) of the stem body (20) and comes into contact with the tightening button (82), with the frustoconical portion (176) of the central pin (170) moves the ball bearing (178) radially out through the side opening and locks the relative rotation of the connecting gear (160) and the pinion gear (164) by the outward orientation, thereby promoting longitudinal movement of the proximal stem (36) along the stem body (20) when the proximal stem (36) is rotated over the stem body (20) and, when the push button ( 82) is pressed, selectively disengages the connecting gear (160) from the pinion gear (164), thereby selectively disengaging the rotation of the proximal rod (36) from longitudinal movement of the proximal rod (36) to the along the stem body (20).
[5]
SENDING DEVICE, according to claim 4, characterized in that it additionally includes a distal clamping element (40) at the distal end of the stem body (20), and wherein the locking mechanism includes:
a) a displacement button (42) on the distal clamping element (40) which is rotatable on the stem body (20) and defines portions of teeth (156) along the inside of the displacement button (42) which move transversely to the major longitudinal axis (22) of the stem body (20) when the travel knob (42) is turned on the stem body (20), and where the locking mechanism has at least two fixed positions with relation to the stem body (20);
4/7
b) a drive shaft (88) having a proximal end (90) and a distal end (92), wherein the distal end (92) defines portions of teeth that engage the portions of teeth (156) of the displacement button ( 42), and extend along a major longitudinal axis (22) of the drive axis (88);
c) a drive gear (86) along the drive shaft (88) and which defines portions of teeth that engage the portions of teeth along the drive shaft (88), with which the displacement button (42) it is engaged with the drive gear in all positions of the travel button (42); and
d) a first locking component (124) that extends over the push rod (32), with the first locking component being connected to the proximal rod (36) and the drive gear, whereby, in a first position the displacement button (42), the first locking component engages the proximal rod (36) with the push rod (32), and rotation of the displacement button (42) from the first position to the second position causes the rotation of the drive shaft (88) which, in turn, causes the drive gear to rotate and the first locking component to disengage from the push rod (32), thereby allowing independent movement of the sending catheter ( 28) along the longitudinal axis of the stem body (20) with respect to the push rod (32) when the proximal stem (36) is moved along the longitudinal axis (22) of the stem body (20).
[6]
SENDING DEVICE, according to claim 5, characterized in that the locking mechanism additionally includes a second locking component (144), the second locking component (144) extending over the push rod (32), fixed to the stem body (20) and connected to the travel button (42) via the drive shaft (88), whereby the rotation of the travel button (42) from the first position to
5/7 the second position causes the engagement between the rod body (20) and the push rod (32), thereby avoiding the longitudinal movement of the push rod (32) in relation to the rod body (20) when the proximal rod (36) is moved along the longitudinal axis (22).
[7]
7. SHIPMENT DEVICE, according to claim 6, characterized in that it additionally includes an apex sending device, including:
a) an apex clamp assembly (52) having,
i) a distal capture component (56) at a distal end of the guidewire catheter (12), ii) a proximal capture component (54) in relation to the distal capture component, and iii) a apex (154) having a proximal end, the apex release catheter (154) which extends over the guidewire catheter (12) and attached to the proximal capture component; and
b) a set of proximal clamp (184), having
i) a fixed component (188) at the proximal end of the guidewire catheter (12), and ii) an external coupling (186) at the proximal end of the apex release catheter and in conjugable relation with the fixed component of the clamp assembly proximal (184), whereby the movement of the external coupling with respect to the fixed component from a first position to the second position will promote the relative movement of the proximal capture component (54) with respect to the distal capture component ( 56) of the apex clamp assembly (52).
[8]
SENDING DEVICE, according to claim 7, characterized in that the displacement button (42) includes a third position, wherein the first locking component and the second locking component are disengaged from the push rod (32 ), with which the
6/7 push (32) can be moved longitudinally with respect to the stem body (20) and the proximal stem (36) by longitudinal movement of the push rod (32), thereby moving the guide wire catheter (12) independently the proximal nail (36) and the nail body (20).
[9]
SENDING DEVICE, according to claim 8, characterized in that the push rod (32) can be rotated radially.
[10]
SENDING DEVICE, according to claim 8, characterized in that the stem body (20) defines a slot (110) through which the driving element (80) extends, and additionally includes a plurality of restraining rings ( 104) extending over the delivery catheter (28) within the stem body (20), the restraining rings (104) having an outside diameter larger than that of the slit, with which the rings will prevent the application of force longitudinal compression by the proximal stem (36) in the sending catheter (28) and preventing the sending catheter (28) from bending and thereby moving through the slot and out of the stem body.
[11]
11. SHIPMENT DEVICE, according to claim 10, characterized in that the restriction rings (104) define an internal diameter that is smaller than the outer diameter of the sending catheter (28), thereby forming an interference fit between the same, and with which the restriction rings (104) can move longitudinally along the delivery catheter (28).
[12]
SHIPMENT DEVICE, according to claim 10, characterized in that it additionally includes an external catheter (48) fixed to, and extending from the distal end of the stem body (20).
[13]
13. SHIPPING DEVICE, according to claim 12, characterized in that the external catheter (48) is rotatable with respect to the stem body (20).
[14]
DELIVERY DEVICE, according to claim 13, characterized in that it additionally includes a delivery sheath (200) which extends distally from the distal end of the delivery catheter (28).
7/7
[15]
SENDING DEVICE, according to claim 14, characterized in that it additionally includes the vascular prosthetic component (58) radially restricted within the delivery sheath (200), and releasably fixed at a proximal end of the prosthesis to the sending device apex.
[16]
SENDING DEVICE, according to claim 15, characterized in that it additionally includes at least one proximal stent (66) at the proximal end of the prosthesis, whereby the proximal end of the prosthesis is releasably attached to the apex sending device on the stent.
[17]
17. A SHIPPING DEVICE, characterized by understanding,
a) a gear rack (106);
b) a rod extending over the gear rack (106) and defining portions of teeth at one end of the rod, the rod being rotatable over the gear rack (106);
c) a pinion gear assembly (164) rotating on an axis that intersects with the axis of rotation of the rod and engages the gear rack (106);
d) a connection gear assembly (158) which selectively rotates with the rotation of the pinion gear (164);
e) a driving element (80) which selectively engages the pinion gear with the connecting gear (160); and
f) a delivery catheter (28) attached to the stem, whereby rotation of the stem selectively moves the sending catheter (28) with respect to the gear rack (106) with the pinion gear engagement (164) with the connecting gear (160) by the actuating element (80).
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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
2020-04-07| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
2020-09-15| B11B| Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements|
2021-10-13| B350| Update of information on the portal [chapter 15.35 patent gazette]|
优先权:
申请号 | 申请日 | 专利标题
US201261623235P| true| 2012-04-12|2012-04-12|
US61/623,235|2012-04-12|
PCT/US2013/031702|WO2013154749A1|2012-04-12|2013-03-14|Vascular prosthetic delivery device and method of use|
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