Anti-backspin components for vascular prosthesis delivery devices

Abstract

To provide a delivery device for implanting a vascular prosthesis that effectively prevents reverse rotation of the prosthesis under longitudinal compression within the delivery device caused by advancement of the prosthesis to a surgical site.SOLUTION: The delivery device prevents longitudinal extension of the aortic prosthesis under compression by engagement of the clutch with the pin upon release of a handle that rotates the transmission mechanism about the pin and advances the aortic prosthesis during endovascular implantation at a surgical site.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] Background of the Invention An aortic aneurysm is an enlargement or dilation of a section of the aorta that can be life-threatening. Treatment of aneurysms remains challenging. Endovascular repair has become a promising option for developing repairs for aortic aneurysms. The endovascular approach involves the insertion of an endovascular graft to exclude the aneurysm sac from the blood flow. Once in place, the endovascular graft expands, creating a new pathway for blood flow. The endovascular graft remains permanently inside the aorta through the use of a metal stent that creates a tight fit and seal against the aortic wall. Currently, endovascular delivery devices have limited control over the precise placement of the graft at the site of the aneurysm.

[0002] More specifically, endovascular implantation typically relies on delivery devices that use different combinations of translational forces and mechanical advantage to navigate the vasculature and then precisely target and deploy the endovascular prosthesis at the surgical site. During the deployment process, endovascular prostheses are exposed to a variety of physical forces that often distort the position of the prosthesis within the delivery device. Typically, the primary force affecting the placement of a prosthesis within an endovascular delivery device is longitudinal compression resulting from the advancement of the prosthesis from a sheath, which radially confines the prosthesis until it reaches the surgical site where it is deployed. Often, advancement is achieved by rotation of a handle by the surgeon about the body of the delivery device. The rotation is translated into a longitudinal force along the body of the delivery device by a transmission that advances the prosthesis within the patient's vasculature to the surgical site. Once the force advancing the prosthesis ceases, the prosthesis is forced against a counter force in a direction opposite to the direction of advancement of the prosthesis (i.e., in a proximal direction back toward the surgeon). This opposing force tends to restore the original longitudinal dimension of the prosthesis. The force applied to the handle is translated back by the transmission of the delivery device, causing the handle to "counter-rotate" in the opposite direction of rotation to that used by the surgeon to advance the prosthesis if the handle were held in place. This can pose at least three problems for the physician during implantation of the prosthesis: The first is the inability to accurately determine the location of the prosthesis at the surgical site. Regardless of the device view, even a momentary release of the handle used by the surgeon to advance the prosthesis to the surgical site results in a repositioning of the prosthesis, leaving the surgeon uncertain as to how much further the surgeon must advance the handle to continue advancing the prosthesis, as the prosthesis as a whole regains its longitudinally compressed position before continuing advancement of the prosthesis. The second problem, related to the first, concerns the impact of landing the prosthesis during delivery and, most importantly, during deployment and release of the prosthesis from the delivery device, which is generally part of an irreversible procedure. The third advantage is that the handle is rotated to move the protector. When advancing the prosthesis, gear teeth in the transmission assembly that converts handle rotation into longitudinal force may jam, causing the delivery device to become stuck until the surgeon can momentarily release the meshing between the gears, such as by some method that is not part of the prosthesis delivery method. Jamming of the delivery device during implantation of an arterial prosthesis, and methods such as sometimes shaking the delivery device, can be distracting to the surgeon and the patient, who is often conscious during such procedures, and can jeopardize the success of the prosthesis implantation and the patient's life.

[0003] As a result, there is a need to develop new and improved delivery devices for treating aortic aneurysms. Summary of the Invention

[0004] Summary of the Invention The present invention generally relates to a delivery device for implanting a vascular prosthesis that effectively prevents back-rotation of the prosthesis under longitudinal compression within the delivery device caused by advancement of the prosthesis to a surgical site.

[0005] In one embodiment, the delivery device of the present invention includes a handle body portion having a longitudinal axis, a proximal end, and a distal end. A gear rack extends within the handle body portion, and a proximal handle extends around the gear rack to define teeth. The proximal handle is rotatable around the handle body portion and the gear rack. A distal handle extends around the handle body portion at a distal end of the handle body portion, and a guidewire catheter having a proximal end and a distal end extends through the handle body portion, the proximal handle, and the distal handle along the longitudinal axis of the handle body portion. A delivery catheter is axially fixed relative to the proximal handle and has a distal end extending from within the distal end of the handle body portion and around the guidewire catheter. An outer catheter is axially fixed to the distal handle when the delivery catheter is in a first, retracted position. and extends distally from and around the delivery catheter. A gear assembly couples teeth on the proximal handle to the gear rack, and rotation of the proximal handle about the longitudinal axis moves the proximal handle and delivery catheter along the longitudinal axis relative to the gear rack. A clutch on the gear assembly engages the gear assembly and the proximal handle, thereby biasing longitudinal movement of the gear assembly and associated rotation of the proximal handle about the longitudinal axis.

[0006] In one particular aspect, the gear assembly of the delivery device includes a pinion gear assembly including an upper pinion gear mated with the proximal handle, where the upper pinion gear defines a non-circular pinion gear opening rotatable about a pinion gear axis. In this aspect, a lower pinion gear is axially aligned with the upper pinion gear and defines a lower pinion gear opening. The lower pinion gear is mated with a gear rack and selectively mated with the upper pinion gear, where a clutch engages with the lower pinion gear when the gear assembly is oriented proximally. In one particular example of this aspect, the lower pinion gear includes a lower portion extending toward the longitudinal axis of the handle body portion, a gear portion mated with the gear rack, and a pinion gear extension extending within the upper pinion gear opening, where the pinion gear extension defines the lower pinion gear extension opening. The pinion gear extension further defines a side opening. The side openings and the upper pinion gear opening together define an interference opening that, when occupied, prevents rotation of the upper and lower pinion gears relative to one another. This embodiment also provides a ball bearing in at least one of the respective side openings. The lower pinion gear opening includes a ball bearing, wherein the ball bearing has a diameter greater than a thickness of the wall defining the side opening. A center pin is movable along the pinion gear axis and within the lower pinion gear opening. The center pin within the lower pinion gear opening has a base portion having a first diameter and a second diameter. a second diameter smaller than the first diameter and including a frustoconical portion; A spring in the lower pinion gear provides a radially outward bias for the central pinion from the longitudinal axis of the handle body, and the ball bearings are directed radially outward through the side openings and into the interference opening, thereby creating an interference relationship between the rotation of the upper pinion gear and the lower pinion gear. Depressing the central pin removes the outward displacement of the ball bearings, eliminating the interference relationship between the rotation of the upper and lower pinion gears and allowing rotation of the proximal handle relative to the handle body, independent of longitudinal movement of the delivery catheter along the longitudinal axis.

[0007] In another aspect, a delivery device of the present invention includes a handle body portion having a longitudinal axis, a proximal end, and a distal end. The gear rack extends within the handle body portion, and the proximal handle The gear rack extends around the handle body portion and defines teeth, wherein the proximal handle is rotatable around the handle body portion and the gear rack. The distal handle extends around the handle body portion at a distal end of the handle body portion. A guidewire catheter having a proximal end and a distal end extends through the handle body portion, the proximal handle, and the distal handle and along the longitudinal axis. The delivery catheter is axially fixed relative to the proximal handle and has a distal end extending from within the distal end of the handle body portion and around the guidewire catheter. The outer catheter, in a first, retracted position, is distal from the distal handle and around the delivery catheter. The proximal handle extends around the guidewire catheter. The gear assembly couples teeth on the proximal handle to the gear rack, and rotation of the proximal handle about the longitudinal axis moves the proximal handle and delivery catheter along the longitudinal axis relative to the gear rack. The gear assembly includes a pinion gear assembly that mates with the gear rack, and an upper link gear that mates with teeth on the proximal handle and a lower link gear fixed to the upper link gear between the upper link gear and the longitudinal axis of the handle body, the link gear assembly having teeth that mate with the pinion gear assembly. The upper and lower link gears have a common axis of rotation perpendicular to the longitudinal axis of the handle body, and each of the upper link gears in the lower link gear defines a central opening along the common axis of rotation. The pusher rod extends around the guidewire catheter and into the delivery catheter, and is secured to the guidewire catheter at a proximal end and proximal to the handle body, and is selectively secured to the proximal handle. A locking mechanism assembly secures the pusher rod to the guidewire catheter. and extending around the push rod to secure the delivery catheter to the push rod when the locking mechanism is in the first locked position. a first locking mechanism for locking the housing, the first locking mechanism defining a first socket; defines a second socket, and opposite ends of the pins are connected to the first socket and the second socket. A second locking mechanism is secured to the proximal end of the handle body portion that secures the push rod to the handle body portion when the locking mechanism assembly is in the second locked position, wherein the second locking mechanism The locking functions of the first and second locking positions are mutually exclusive. The delivery device further includes a housing extending around the handle body portion, the housing having a proximal end defining a proximal opening and a distal end defining a distal opening, the housing further defining a bore between the proximal and distal openings. A central pin extends through the central openings of the upper and lower linkage gears. The pin includes opposite ends on the locking mechanism assembly and the housing. A clutch engages the gear assembly and the proximal handle, thereby biasing longitudinal movement of the gear assembly and associated rotation of the proximal handle about the longitudinal axis, wherein when the clutch is engaged, rotation of the proximal handle about the longitudinal axis biases the clutch and at least one of the gear assembly and the remainder of the delivery device. The clutch engages the pin and the connecting gear assembly when the gear assembly is oriented proximally, and rotation of the proximal handle to orient the gear assembly proximally is resisted by friction between the pin and at least one of the first and second sockets. It is resisted.

[0008] In yet another embodiment, a delivery device of the present invention includes a handle body portion having a longitudinal axis, a proximal end, and a distal end, and a gear rack extending within the handle body portion. The proximal handle extends around the gear rack and defines teeth. The proximal handle is rotatable around the handle body portion and the gear rack. The distal handle extends around the handle body portion at the distal end of the handle body portion, and a guidewire catheter has proximal and distal ends. A guidewire extends through the handle body portion, the proximal handle, the distal handle, and along the longitudinal axis. The delivery catheter is axially fixed relative to the proximal handle and has a distal end extending from within the distal end of the handle body portion and around the guidewire catheter. The outer catheter is retracted from the distal handle in a first, retracted position. The gear assembly extends distally and around the delivery catheter. A gear assembly couples teeth on the proximal handle to the gear rack, and rotation of the proximal handle about the longitudinal axis moves the proximal handle and delivery catheter along the longitudinal axis relative to the gear rack. The gear assembly includes a pinion gear assembly that mates with the gear rack and an upper link that mates with teeth on the proximal handle. The delivery catheter includes a gear assembly including a lower coupling gear secured to the upper coupling gear between the upper coupling gear and the longitudinal axis of the handle body portion, the lower coupling gear having teeth that mate with the pinion gear assembly. The upper coupling gear and the lower coupling gear have a common axis of rotation perpendicular to the longitudinal axis of the handle body portion, wherein the upper coupling gears on the lower coupling gear each define a central opening along the common axis of rotation. The pusher rod extends around the guidewire catheter and into the delivery catheter and is secured to the guidewire catheter at a proximal end of the guidewire catheter proximal to the handle body portion. The pusher rod is selectively secured to the proximal handle. The locking mechanism assembly extends around the pusher rod and is configured to lock the delivery catheter when the locking mechanism is in a first locked position. a first locking mechanism for securing the push rod to the handle body, and a second locking mechanism secured to the proximal end of the handle body for securing the push rod to the handle body when the locking mechanism assembly is in a second locked position, wherein the locking functions of the first and second locked positions are mutually exclusive. The actuator includes a gear assembly and further includes a housing extending around the handle body portion, the housing having a proximal end defining a proximal opening and a distal end defining a distal opening. The housing further defines a bore between the proximal and distal openings. A central pin of the actuator extends through the central openings of the upper and lower linkage gears and includes a locking mechanism and an opposite end located on the housing. A clutch engages the gear assembly and the proximal handle, thereby biasing longitudinal movement of the gear assembly and associated rotation of the proximal handle about the longitudinal axis, wherein rotation of the proximal handle about the longitudinal axis biases the clutch and at least one of the gear assembly and the remainder of the delivery device when the clutch is engaged. The clutch selectively engages the pin and the linking gear assembly when the gear assembly is oriented proximally. The pin is engaged with the linkage gear assembly when the pinion gear assembly is oriented distally along the gear rack during engagement of the linkage gear assembly with the pinion gear assembly. The switch is a coil spring that is fixed at one end to the first locking mechanism, and the pin passes through the coil spring. The coil spring extends and engages the pin when the pinion gear assembly is oriented distally along the gear rack during engagement of the linkage gear assembly and the pinion gear assembly.

[0009] In yet another aspect of the invention, a delivery device includes a handle body portion having a longitudinal axis, a proximal end, and a distal end. A gear rack extends within the handle body portion, and a proximal handle extends around the gear rack to define teeth. The proximal handle is rotatable about the handle body portion and the gear rack. A distal handle extends around the handle body portion at a distal end of the handle body portion. A guidewire catheter has a proximal end and a distal end and extends through the handle body portion, the proximal handle, and the distal handle and along the longitudinal axis. A delivery catheter is axially fixed relative to the proximal handle and has a distal end extending from within the distal end of the handle body portion and around the guidewire catheter. An outer catheter is in a first, retracted position, distal to the distal handle and connected to the delivery catheter. The proximal handle extends around the delivery catheter. A gear assembly couples teeth on the proximal handle to the gear rack, and rotation of the proximal handle about the longitudinal axis moves the proximal handle and delivery catheter along the longitudinal axis relative to the gear rack. The gear assembly includes a pinion gear assembly that mates with the gear rack, and a coupling gear assembly including an upper coupling gear that mates with teeth on the proximal handle and a lower coupling gear fixed to the upper coupling gear between the upper coupling gear and the longitudinal axis of the handle body. The lower coupling gear includes teeth that mate with the pinion gear assembly. The upper and lower coupling gears have a common axis of rotation perpendicular to the longitudinal axis of the handle body, and the upper and lower coupling gears each define a central opening along the common axis of rotation. A pushrod extends around the guidewire catheter and into the delivery catheter and is fixed to the guidewire catheter at a proximal end of the guidewire catheter proximal to the handle body and is selectively fixed to the proximal handle. The locking mechanism includes a first locking mechanism that extends around the push rod and secures the delivery catheter to the push rod when the locking mechanism is in a first locked position, and a second locking mechanism that secures the push rod to the handle body when the locking mechanism assembly is in a second locked position. and a second locking mechanism secured to the proximal end of the handle body portion, wherein the locking functions of the first locking position and the second locking position are mutually exclusive. The actuator further includes a housing extending around the handle body portion. The housing has a proximal end defining a proximal opening and a distal end defining a distal opening, the housing further defining a bore between the proximal opening and the distal opening. A central pin of the actuator extends through the central openings of the upper and lower linkage gears, the pin including a locking mechanism and an opposite end located on the housing. A clutch on the gear assembly engages the gear assembly and the proximal handle, thereby biasing longitudinal movement of the gear assembly and associated rotation of the proximal handle about the longitudinal axis, where rotation of the proximal handle about the longitudinal axis is resisted by friction between the clutch and at least one of the gear assembly and the remainder of the delivery device when the clutch is engaged, and the clutch prevents the gear assembly from rotating in a proximal direction. a second clutch selectively engages the pin with the linkage gear assembly when the pinion gear assembly is oriented distally along the gear rack during engagement of the linkage gear assembly with the pinion gear assembly, The second clutch is a coil spring fixed to the housing at one end, and the pin The coil spring extends through the pin and engages the pin when the pinion gear assembly is oriented distally along the gear rack during engagement of the linkage gear assembly and the pinion gear assembly.

[0010] The delivery device and method of use of the present invention have many advantages. For example, longitudinal extension of the prosthesis after removal of a force advancing the prosthesis from the sheath, such as may occur upon release of a handle that is rotated about the delivery device to control delivery to the surgical site, is minimized or eliminated by the clutch. The clutch is engaged only when the gear assembly converts the force of the handle rotation and provides a mechanical advantage to the surgeon to advance the prosthesis along the longitudinal axis of the delivery device. Resistance to proximal movement or longitudinal extension of the prosthesis can be overcome by the mechanical advantage applied by the surgeon rotating the proximal handle, again in a direction opposite to the direction of advancement. Resistance can be overcome by, for example, static friction between the clutch and at least one of the pins around which the clutch extends and by the clutch or This can be overcome by an interference fit between the pin and another component of the delivery device that does not rotate with rotation of the handle or longitudinal advancement of the prosthesis to the delivery site. Selective engagement of the clutch and static friction can thereby provide the surgeon with greater control during advancement of the prosthesis to the surgical site and while targeting the landing of the prosthesis at the surgical site prior to deployment and release from the delivery device. The selective use of clutches and static friction, either separately or in combination, can also reduce the likelihood of interference and jamming of gears, which would otherwise jam the delivery device or prevent delivery of the prosthesis altogether. [Brief explanation of the drawings]

[0011] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1] FIG. 1 is a perspective view of one embodiment of a delivery device of the present invention. [Figure 2] FIG. 2 is a perspective view of one embodiment of the shift knob, drive shaft, and actuator of the present invention. [Figure 3] FIG. 3 is a perspective view of the shift knob and drive shaft of the embodiment shown in FIG. [Figure 4] FIG. 4 is a perspective view of a shift knob, distal handle, distal handle nose, and a partial cross-sectional view of a handle body and delivery catheter of another embodiment of the present invention. [Figure 5] FIG. 5 is a partial cutaway view of a portion of the embodiment of the delivery device of the present invention shown in FIG. [Figure 6] FIG. 6 is a partial cutaway view of details of a handle body portion, an intermediate gear, a reduction gear, and a portion of a connecting gear, all of which connect the shift knob and drive shaft of the embodiment of the present invention shown in FIG. [Figure 7] FIG. 7 is a partial cutaway view of the embodiment of FIG. 4 showing a cross-sectional view of the distal handle and base where the outer catheter is connected at the distal handle nose. [Figure 8] FIG. 8 is a partial cutaway of the embodiment of FIG. 4 showing a constriction ring extending around the delivery catheter. [Figure 9] FIG. 9 is another embodiment of the partial cutaway of the delivery device of FIG. 1 showing an actuator and push button at the proximal end of a slot defined by the handle body portion. [Figure 10] FIG. 10 is a perspective view of the first and second locking components and their relationship to the drive shaft of the embodiment shown in FIG. [Figure 11]FIG. 11 is another view of the first and second locking components, and the first and second locking component housings that stabilize the spatial relationship between the first and second locking components, relative to the drive shaft of the embodiment of FIG. [Figure 12] Figure 12A is another perspective view of the embodiment of Figure 1 showing displacement of the proximal handle and actuator along the handle body as a result of rotating the proximal handle about the handle body or depressing a push button on the actuator, thereby allowing longitudinal movement of the actuator and proximal handle without rotation of the proximal handle. Figure 12B is another perspective view of the embodiment of Figure 1, where the proximal handle has advanced along the handle body of the delivery system. [Figure 13] FIG. 13 is a detail of the proximal handle and actuator at the handle body portion of the embodiment of the invention shown in FIG. 1, without the actuator housing. [Figure 14-1] 14 is a perspective view of the detail of FIG. 13 without the push button of the actuator shown in FIG. 13. FIG. [Figure 14-2] 14A is a perspective close-up view of the linkage gear assembly associated with the actuator of FIG. 14. FIG. [Figure 15] FIG. 15 is a partial cutaway of the embodiment of FIG. 1 showing the relationship of the pinion and linkage gear assembly to the first locking component housing and the relationship of the first locking component housing to the delivery catheter within the housing. [Figure 16] FIG. 16 is a perspective exploded view of the first locking mechanism, linkage gear, pin and coil spring clutch of one embodiment of a delivery device of the present invention. [Figure 17] FIG. 17 is a perspective, partial cutaway view of the housing and first locking mechanism, connecting gear, pin and coil spring of FIG. 16 when assembled. [Figure 18] FIG. 18 is a perspective exploded view of a first locking mechanism, one-way needle roller bearing clutch, and pin of another embodiment of a delivery device of the present invention. [Figure 19]FIG. 19 is a side view of the linkage gear assembly, pin, and one-way needle roller bearing clutch at the base of the pin when assembled in another embodiment of a delivery device of the present invention. [Figure 20] FIG. 20 is a side view of the linkage gear assembly, pin, and one-way needle roller bearing clutch at the top portion of the pin when assembled in yet another embodiment of a delivery device of the present invention. [Figure 21] FIG. 21 is a perspective exploded view of a linkage gear, a pin, a one-way needle roller bearing clutch as a first clutch, and a coil spring as a second clutch in yet another embodiment of a delivery device of the present invention. [Figure 22] FIG. 22 is a perspective view of the components shown in FIG. 21 in an assembled configuration, with the pin aligned with the socket of the first locking mechanism of the delivery device of the present invention. [Figure 23] 23 is a side view of the cluster link gear, pin, clutch and aligned first locking mechanism of FIG. 22. FIG. [Figure 24] FIG. 24 is a plan view of the interior portion of the housing component of one embodiment of a delivery device of the present invention, showing where the ends of the spring coil second clutch are located when assembled. [Figure 25] FIG. 25 is an exploded view of a linkage gear assembly of the present invention including a first clutch that is a one-way needle roller bearing clutch and a second clutch that is a coil spring. [Figure 26] 26 is a partially exploded perspective view of the linkage gear assembly of FIG. 25 in combination with the first locking component housing of the present invention. [Figure 27] 27 is a side view of the linkage gear assembly and first locking component housing combination of FIG. 26. FIG. [Figure 28] 28 is a top view of the first locking component housing of FIG. 27. FIG. [Figure 29]FIG. 29 is an exploded view of another embodiment of a linkage gear assembly of the present invention including two one-way needle roller needle bearing clutches. [Figure 30] FIG. 30 is a side view of the linkage gear assembly of the present invention shown in FIG. 29 when assembled. [Figure 31] FIG. 31 is a perspective view of the first and second locking component housings within a cutaway view of the handle body portion, along with a perspective view of the linkage gear assembly and pinion gear assembly of the actuator. [Figure 32] FIG. 32 is a side view of the view of the invention as shown in FIG. [Figure 33] FIG. 33 is a partial cutaway of the distal end of the handle body portion and second locking component shown in FIGS. [Figure 34] 34 is a perspective view of a partial cutaway of the actuator shown in FIG. 32. FIG. [Figure 35] 35 is a perspective view of an alternative embodiment of an actuator of the present invention lacking the rack and proximal handle and linking gear assembly of the embodiment shown in FIG. [Figure 36] 36 is a partially transparent perspective view of an embodiment of the pinion gear assembly of FIG. 35. FIG. [Figure 37] FIG. 37 is another view of the embodiment shown in FIG. [Figure 38] FIG. 38 is a perspective view of the embodiment shown in FIGS. 36 and 37, lacking the upper pinion gear shown in those figures. [Figure 39] FIG. 39 is an alternative embodiment of the diagram shown in FIG. [Figure 40]Figure 40A is a cross-sectional view of the pinion gear assembly of Figures 36-39, where the pin is not depressed, thereby causing the upper and lower pinion gears to be in an interference relationship with one another due to the radially outward displacement of the ball bearings, and further showing the lower extension of the lower pinion gear of the pinion gear assembly and the one-way needle roller clutch in which the lower extension is disposed. Figure 40B is a cross-sectional view of the pinion gear assembly of Figure 40A, where the center pin is depressed, thereby compressing the bias spring and removing the radially outward displacement of the ball bearings to allow independent rotation of the upper and lower pinion gears due to the otherwise independent rotation interference relationship of the upper and lower pinion gears. Figure 40C is a cross-sectional view of the pinion gear assembly of Figures 36-39, where the pin is not depressed, whereby the upper and lower pinion gears are in an interference relationship with each other due to the radially outward displacement of the ball bearings, further showing the one-way needle roller clutch in which the upper extension and upper extension of the lower pinion gear of the pinion gear assembly are disposed. Figure 40D is a cross-sectional view of the pinion gear assembly of Figure 40C, where the center pin is depressed, whereby the bias spring is compressed and the removal of the radially outward displacement of the ball bearings allows the upper and lower pinion gears to rotate independently, which would otherwise result in an interference relationship of independent rotation of the upper and lower pinion gears. [Figure 41] FIG. 41 is a perspective exploded view of the pinion gear assembly of FIG. 40 aligned with a first locking mechanism that defines a socket in which the one-way needle roller bearing clutch is disposed, such as by press-fitting the one-way needle roller bearing clutch into the socket. [Figure 42] FIG. 42 is a perspective view of the linkage gear assembly of FIGS. 40 and 41. [Figure 43] 43 is a side view of the assembled linkage gear assembly of FIGS. 40-42 when assembled with the first locking mechanism of FIG. 41. FIG. [Figure 44] FIG. 44 is a perspective view of one embodiment of a proximal clasp assembly according to one embodiment of the present invention. [Figure 45] FIG. 45 is a partial cutaway of the proximal clasp assembly shown in FIG. [Figure 46] 46A-46C are perspective cross-sectional views of the distal end of the delivery device shown in FIG. [Figure 47] Figure 47A is a perspective view of the shift knob in a first position where the push rod is secured to the proximal handle and the prosthesis is undeployed, Figure 47B is a detailed perspective view of the proximal clasp assembly in a first position where the apical clasp assembly is unopened, and Figure 47C is a detailed perspective view of the shift knob in a first position. [Figure 48] Figure 48A is a perspective view of the delivery device of Figures 47A-47C showing advancement of the delivery sheath containing the prosthesis when the shift knob is in a second position, where the push rod is secured to the handle body portion. Figure 48B is a detailed perspective view of the advancement of the delivery sheath of Figure 48A. [Figure 49] Figure 49A is a perspective view of the delivery device of Figures 48A and 48B showing the advancement of the delivery sheath. Figure 49B is a detailed perspective view of the shift knob of Figure 49A in a second position. [Figure 50] Figure 50A is a perspective view of the delivery device of Figures 49A and 49B, where the delivery sheath is partially retracted from the prosthesis, and Figure 50B is a view of the apex clasp assembly of one embodiment of the invention in a closed position. [Figure 51] Figure 51A is a perspective view of the delivery device of Figure 50A, where the apex clasp assembly has been opened by actuation of the proximal clasp assembly, thereby releasing the apex of the proximal stent of the prosthesis shown in Figure 51C. Figure 51B is a view of the proximal clasp assembly of Figures 44 and 45, with the apex clasp assembly opened, not shown. Figure 51C is a view of the apex clasp assembly of one embodiment of the invention in the open position. [Figure 52]Figure 52A is a perspective view of the delivery device of Figure 51A, where the shift knob has been moved to a third position, the pusher rod has been released from the proximal handle and handle body portion, and the pusher rod has been retracted from the fully deployed prosthesis. Figure 52B is a perspective view of the shift knob in the third position as shown in Figure 52A. DETAILED DESCRIPTION OF THE INVENTION

[0012] Detailed Description of the Invention While the present invention has been particularly shown and described with reference to illustrative embodiments thereof, it will be understood by those skilled in the art that various changes in form and details can be made therein without departing from the scope of the invention encompassed by the appended claims.

[0013] One embodiment of a delivery device 10 of the present invention is shown in Figure 1. The delivery device 10 has a proximal end 14 and a distal end 16. 1 includes a guidewire catheter 12 (FIGS. 10, 11) having a distal end 16. As used herein with reference to the delivery device and its components, "proximal" means relatively close to the surgeon manipulating the delivery device. As used herein with reference to the delivery device and its components, "distal" means relatively distal to the surgeon manipulating the delivery device. As used herein with reference to the prosthesis, stent grafts and components, "proximal" means relatively close to the patient's heart. As used herein with reference to the prosthesis, stent grafts and components, "distal" means relatively distal from the patient's heart. Returning to FIG. 1 , delivery device 10 is a delivery device that extends around a guidewire catheter (not shown). The delivery assembly 18 includes a handle body portion 20 having a main longitudinal axis 22, a proximal end 24, and a distal end 26. A delivery catheter 28 (FIG. 9) has a distal end 30 (FIG. 27B) that extends from within the distal end 26 of the handle body portion 20 (FIG. 1) and around a guidewire catheter (not shown). It has.

[0014] In one embodiment, the push rod 32 extends around the guidewire catheter 12 and into the delivery catheter 28 (FIGS. 10, 11). The push rod 32 is attached to the proximal push rod portion of the handle body with a pin 192 (FIG. 25). The proximal end 34 of the rod 32 is secured to the guidewire catheter 12. Referring back to FIG. A handle 36 extends around the handle body 20 and is axially fixed relative to the delivery catheter 28. The proximal handle 36 is selectively fixed to the pusher rod 32, wherein the proximal handle 36 is rotatable around the handle body 20, and rotation of the proximal handle 36 around the handle body 20 translates into longitudinal movement of the delivery catheter 28 along the longitudinal axis 22, and optionally, of the pusher rod 32 relative to the handle body 20, as can be seen by comparing Figures 12A and 12B. A first locking mechanism 38 (Figure 15) on the handle body 20 selectively mates with the proximal handle 36 (Figures 12A and 12B).

[0015] Distal handle 40 extends around handle body portion 20 at distal end 26 thereof and is connected to shift knob 42 of locking mechanism 37, which includes first locking mechanism 38 and second locking mechanism 132 (FIG. 15). A distal handle nose 44 (FIG. 1) extends distally from the distal handle 40 and The delivery device 10 includes a flush port 46 for providing fluid communication between a solution source (not shown) and the internal components of the delivery device 10 to hydrate contact between the components of the delivery device 10 and the vascular prosthesis (not shown) within the subject, if necessary, prior to implantation of the vascular prosthesis in the subject. An outer catheter 48 extends from the distal handle nose 44 (FIG. 1).

[0016] Actuator 80 is coupled to proximal handle 36, which may rotate about handle body 20 while a push button 82 on housing 81 of actuator 80 remains aligned with a slot 84 defined by handle body 20. Depression of push button 82 of actuator 80 selectively releases rotation of proximal handle 36 from handle body 20, such that rotation of proximal handle 20 is independent of longitudinal movement of delivery catheter 28 along longitudinal axis 22 relative to handle body 20.

[0017] As can be seen in FIG. 2, the shift knob 42 is connected to a drive gear 86 by a drive shaft 88. The drive shaft 88 has a proximal end 90 and a distal end 92 and runs along the interior of the handle body portion 20 (not shown). As can be seen in FIG. 3, the shift knob 42, in one embodiment, has an intermediate The gear 94A is connected to the drive shaft 88 and the shift knob 42 is rotated around the handle body 20. The rotation is transmitted through the drive shaft 88 due to the connection between the shift knob 42 and the drive shaft 88 by the intermediate gear 94A. Shift knob 42 rotates in an indirect manner, as opposed to a direct connection, to drive shaft 88. In this embodiment, shift knob 42 is indirectly connected to drive shaft 88, as opposed to a direct connection. A "direct connection" is an optional embodiment, and is direct contact between shift knob 42 and drive shaft 88. Shift knob 42 is rotatably connected to distal handle 40, which is secured to distal end 26 of handle body portion 20, as shown in FIG. 1. can be.

[0018] In another embodiment shown in FIGS. 4 and 5, the connection between the shift knob 42 and the drive shaft 88 includes a gear reduction with an intermediate gear 94B connected to a coaxial reduction gear 96, which in turn Shift knob 42 is coupled to connecting gear 98, which is coaxially coupled to drive shaft 88. Due to the gear reduction, the rotational speed of shift knob 42 relative to drive shaft 88 is reduced by the relative speed of reduction gear 96 and connecting gear 98 (FIGS. 5, 6, and 7). Typically, the rotation ratio of the shift knob 42 to the drive shaft 88 or The reduction ratio is about 1:2 to about 1:6. The relationship between the reduction gear 96 and the connecting gear 98 is shown in FIG. can be seen in more detail.

[0019] As can be seen in more detail in FIG. 7, the delivery catheter 28 includes a handle body portion 20, a distal Extending through the handle 40 and distal handle nose 44. Referring back to FIG. The side catheter 48 is connected to the base 102, and the outer catheter 48 is separate from the handle body 20. As shown in FIG. 8, the contraction ring 104 extends along the delivery catheter 28 within the handle body 20. As shown in FIGS. 8 and 9, the contraction ring 104 has an outer diameter greater than the width of slot 84, and contraction ring 104 is secured by proximal handle 36. Application of a longitudinal compressive force to the delivery catheter 28 causes the delivery catheter 28 to pinch, thereby preventing it from moving through the slot 84 and out of the handle body portion 20. The contraction ring 104 also has an inner diameter that is slightly smaller than the outer diameter of the delivery catheter 28, and because the contraction ring 104 has an interference fit with the delivery catheter 28, the contraction ring 104 is oriented The gear rack 106 is longitudinally movable along the delivery catheter 28 if it is attached to the handle body 20, but otherwise remains in a fixed position relative to the delivery catheter 28. The pin 108 at the distal end 26 of the handle body portion 20 extends in the distal direction. Extending from the shift end 26, the shift knob 42 is selectively inserted into slots 110, 112, 114 of the shift knob 42. The shift knob 42 is movable longitudinally along the handle body portion 20 and is rotatable about the handle body portion 20 sufficiently that rotation of the shift knob 42 moves the location of the pin 108 within one of the slots 110, 112, 114 of the shift knob 42, thereby causing rotation of the intermediate gear 94. As a result, the drive shaft 88 is rotated about the longitudinal axis 116 (FIG. 10) of the drive shaft 88. The shift knob 42 is biased against the pin 108 by a spring 118 (FIG. 7).

[0020] As can be seen in Figure 9, the gear rack 106 and drive shaft 88 extend the length of the slot 84. Figure 10 shows the relationship between the drive shaft 88, push rod 32 and first locking mechanism 38. The push rod 32 extends through the first locking mechanism 38 and then engages the drive shaft 88 at the drive gear 86 of the first locking mechanism 38. The first locking mechanism 38 is connected to the distal end of the push rod 32 through which it extends. The first locking mechanism 38 is fixed to the proximal handle (not shown) by a bearing 120. The distal bearing 120 is connected to the first locking component housing 150 by a pin 122. A lock component 124 is fixed at a distal end 126 relative to the distal bearing 120 and coupled at a proximal end 128 to the drive gear 86, such that rotation of the drive shaft 88 and consequently rotation of the drive gear 86 activates a first lock. Furthering or retracting the coil of component 124 results in engagement or disengagement, respectively, of locking mechanism 38 and consequently proximal handle (not shown) and push rod 32. First locking mechanism 38 When the drive shaft 88 is engaged with the push rod 32, longitudinal movement of the drive shaft 88 and therefore the proximal handle (not shown) along the handle body portion 20 results in longitudinal movement of the push rod 32 along the drive shaft 88 and the handle body portion 20, as can be seen by comparing FIGS. 12A and 12B.

[0021] 10 and 11, the drive shaft 88 is coupled to a second drive shaft 88 at a proximal end 90 of the drive shaft 88. The second locking mechanism 132 includes a translation gear 134 that mates with the drive shaft 88 at the proximal end 90 of the drive shaft 88 and is rotatably secured to the handle body portion 20 (FIG. 9) by a drive shaft bearing 130 that is part of the proximal locking component housing 152. The second locking mechanism 132 includes a translation gear 134 that mates with the drive shaft 88 at the proximal end 90 of the drive shaft 88 and is secured to the handle body portion 20 (FIG. 10) by a proximal bearing 138 (FIG. 11) and a distal bearing 139 (FIG. 12). The proximal bearing 138 is rotatably mated with a mechanism bearing 136 (FIG. 11) that includes bearing 140 (FIG. 10), which is in turn fixed relative to the handle body portion 20 with pins 142. The proximal bearing 138 is radially and axially fixed relative to the handle body portion 20. The distal bearing 140 is fixed relative to the handle body portion 20. The second locking component 144 of the second locking mechanism 132 is axially fixed to the drive portion 20. A proximal end 146 of the locking component 144 engages one of the proximal bearings 138 and a distal end 148 of the second locking component 144 engages the translation gear 134 to regulate the rotation of the drive shaft 88 and, consequently, the translation gear 134. Rotation either tightens or loosens the second locking component 144 and push rod 32. When mated with the push rod 32, the second locking component 144 is secured to the handle body portion (not shown). When released from the push rod 32, the push rod 32 is fixed in position relative to the push rod 32. The locking rod 32 is movable longitudinally relative to the handle body (not shown). The orientation of the first locking component 124 and the second locking component 144 is reversed, and the unidirectional drive shaft 88 Rotation of the first locking component 124 and the second locking component 144 simultaneously engages and disengages, respectively, the push rod 32. Disengagement of the first locking component 124 from the push rod 32 is achieved by movement of the shift knob 42 (FIG. 9) from a first position defined by the pin 108 in a slot 110 of the shift knob 42 to a second position 112 defined by the pin 108 in a second slot 112 of the shift knob 42. The same movement of the shift knob 42 from the first position to the second position also activates the second locking component 144. and the push rod 32 simultaneously engage with the handle body 20, and the push rod 32 moves along the longitudinal axis 116 of the handle body 20. Regardless of movement of the proximal handle 36, the second locking component 144 is fixed in position relative to the handle body portion 20. Referring back to Figures 8 and 9, positioning the shift knob 42 so that the pin 108 is in the intermediate slot 114 between the first slot 110 and the second slot 112 of the shift knob 42 causes both the first locking component 124 and the second locking component 144 to be released from the push rod 32.

[0022] 11, the first locking component housing 150 secures the first locking component 124 and the drive shaft 88 against lateral movement, and the second locking component housing 152 secures the position of the second locking component 144 and the bearings 138, 140, respectively, relative to the proximal end 90 of the drive shaft 88. Additionally, as can also be seen in FIG. The guidewire catheter 12 extends into the apex release catheter 154 .

[0023] 12A and 12B illustrate the relative movement of the actuator 80 and the proximal handle 36 along the handle body portion 20. Rotation of the proximal handle 36 about the handle body portion 20 causes longitudinal movement of the proximal handle 20 and the actuator 80 along the handle body portion 20, as shown in FIGS. 12A and 12B, when the push button 82 is in the first position. Upon depression to the second position, essentially flush with the jaw 81, rotation of the proximal handle 36 does not result in longitudinal movement of the proximal handle 36 or actuator 80 along the handle body portion 20. Rather, the proximal handle 36 and actuator 80 are movable along the handle body portion 20 without rotation of the proximal handle 36 about the handle body portion 20.

[0024] As can be seen in Figures 13-15, the teeth 156 of the proximal handle 36 mate with an upper link gear 160 of a link gear assembly 158. The link gear assembly 158 mates with a pinion gear assembly 164. The lower link gear 162 of the link gear assembly 158 is fitted over the pinion gear assembly 164. The pinion gear assembly 164 is threaded through the slot 84 to mate with the first pinion gear 166. 14 and 14A, the locking component housing 150 (FIG. 11) is coupled to the locking component housing 150. Referring to FIG. 1, the linkage gear assembly 158 and the pinion gear assembly 164 are components of the actuator 80. As can be seen, the coil spring 210 is disposed around the pin 214 and fits into a recess in the upper link gear 160. It is secured at its end 212 within the recess 216 .

[0025] FIG. 16 is a perspective exploded view of the first locking component housing 150, pin 214, upper linkage gear 160, and coil spring 210, showing how the coil spring 210 moves around or around the pin 214. and how extension 218 catches on one end 212 of coil spring 210 when upper linkage gear 160 is rotated in a direction that causes spring 210 to tighten around pin 214. 11 shows how the coil spring 210 is secured against rotation about the pin 214 in the opening 217 of the upper linkage gear 160. In this case, the pin 214, when assembled, is aligned with and disposed within the socket 174 (FIG. 11) of the first locking component housing 150. The pin 214, when assembled, is When the upper liking gear assembly 158 rotates, it causes rotation of the upper liking gear 160 in one direction, tightening the coil spring 210 around the pin 214, thereby contacting the coil spring 210 sufficiently to act as a clutch, where further rotation of the liking gear assembly 158 also causes rotation of the pin 214. For example, as shown in FIG. 16, clockwise rotation of the upper link gear 160 around the pin 214 causes the coil spring 210 to tighten around the pin 214, thereby is used as a clutch mechanism to lock the upper connecting gear 160 in place, and the upper connecting gear 160 is rotated clockwise When the proximal handle 36 is rotated by the surgeon in a clockwise direction, the upper link gear 160 engages the teeth of the proximal handle 36. This clutching mechanism, in which the pin 210 clamps around and secures the pin 214, may result from the proximal (toward the surgeon) orientation of the first locking mechanism 38 (FIG. 15) due to longitudinal extension of the vascular prosthesis 58 (FIG. 47A, below) during implantation, facilitated, for example, by the surgeon releasing the proximal handle 36 after advancing the prosthesis to the surgical site. Conversely, when the proximal handle 36 is rotated by the surgeon in a clockwise direction, the upper link gear 160 engages the teeth of the proximal handle 36. The teeth of the spring 210 rotate in a counterclockwise direction, causing the spring 210 to expand in diameter around the pin 214, thereby releasing the pin 214 from rotating with the upper link gear 160.

[0026] 17 is a perspective partial cutaway view of a portion of the housing 81 and first locking mechanism 38 in combination with the linkage gear assembly 158. The pinion gear assembly 164 is For purposes of clarity, the assembly 158 is not shown. 1, 2, and 3. Pin 214 extends through linkage gear assembly 158 and is secured at one end 220 of socket 222 defined by housing 81 and at the opposite end 224 of socket 174 defined by first locking mechanism 38, such that pin 214 is secured at one end 220 of socket 222 defined by housing 81 and at the opposite end 224 of socket 174 defined by first locking mechanism 38. In this embodiment, pin 214 is disposed in at least one of socket 222 and socket 174 by an interference fit, and pin 214 resists rotation about its longitudinal axis. The resistance occurs when proximal handle 36 (FIGS. 1, 13, 14) is secured to at least a portion of the vascular prosthesis. The stent is delivered along the longitudinal axis 22 (FIG. 1) where it is released by the surgeon after the intended advancement. The resistance to rotation of the pin 214 is not significant, but is sufficient to prevent longitudinal extension of the graft, thereby preventing back-rotation. by rotating the proximal handle 36 in the direction opposite to the direction of travel (e.g., by rotating the proximal handle 36 as described above). Counterclockwise rotation (as opposed to the clockwise rotation of the vascular prosthesis) In the event that the housing 81 is intentionally moved back into the surgical field, the force exerted by the housing 81 cannot be overcome by the surgeon. In one embodiment, the amount of force exerted as resistance to rotation by the housing 81 ranges from about 2.0 lbf. inches to about 12.0 lbf. inches. In another embodiment, the amount of force exerted by the housing 81 as resistance to rotation by the housing 81 ranges from about 2.0 lbf. inches to about 12.0 lbf. inches. The amount of force exerted as resistance to the housing 81 ranges from about 5.0 lbf. inches to about 7.0 lbf. inches. Preferably, the housing 81 or at least the portion of the housing 81 defining the socket 222 The housing 81 is preferably made of injection molded plastic. The socket 222 is also made of injection molded plastic. Preferably, first locking mechanism 38 defining socket 174 is made of stainless steel, anodized aluminum, or medical-grade machined plastic. Preferably, only socket 222 of housing 81 provides resistance to rotation of pin 214. Depending on where resistance to counter-rotation is overcome in the delivery device of the present invention, at least one of sockets 174, 222, pin 214, or the needle of a one-way needle roller bearing clutch described below may be formed of stainless steel to partially control the torque force required to overcome the static friction of the interference fit. In another embodiment not shown in which a second clutch is used, such as socket 174, the second clutch is It provides resistance to rotation of the pin 214 .

[0027] In another embodiment of the invention shown in FIG. 18, the coil spring 214 of FIGS. 16 and 17 is 1. Replaced by a one-way needle roller bearing clutch 226 such as is known in the art. A one-way needle roller bearing clutch is a clutch that includes "needles" aligned on the inner surface of a cylinder, where the needles roll freely around a pin that is rotated in one direction within the cylinder, but are stationary, thereby providing torque when the pin is oriented in the opposite direction of rotation about its axis. FIG. 18 shows a first locking mechanism 38, 1 is a perspective exploded view of the pin 214 and linkage gear assembly 158, where a one-way needle roller bearing clutch 226 is used in place of the coil spring 214. In this embodiment, when assembled, the one-way needle roller bearing clutch 226 is 16, the embodiment of FIG. 18 is adapted to rotate the proximal handle 36 clockwise, such as that shown in FIGS. 13 and 14, and consequently, to rotate the proximal handle 36 clockwise, such as that shown in FIGS. 13 and 14, into the socket 222 defined by the housing 81 and into the socket 174 of the first locking component housing 150 of the first locking mechanism 38. Counterclockwise rotation of linkage gear assembly 158 around pin 214 in an interference fit with the other However, one-way needle roller bearing clutch 226 secures around pin 214, allowing pin 214 and socket The vascular prosthesis is secured to the prosthesis due to an interference fit between the prosthesis 222 and at least one of the sockets 174. After at least partially advancing the vascular prosthesis to the surgical site, the surgeon may release the proximal handle 36 (FIGS. 13 and 14) and the gear assembly 230 (FIGS. 13 and 14) comprised of the linkage gear assembly 158 and the pinion gear assembly 164, resulting in longitudinal extension of the vascular prosthesis. 16, resistance to rotation of pin 214 is provided by interference between pin 214 and at least one of socket 222 and socket 174. Resistance can be overcome by the surgeon by forcefully rotating the proximal handle 36 in a counterclockwise direction, thereby drawing the vascular prosthesis toward or back into the delivery device. It should be understood that in alternative embodiments, the component parts of the delivery device can be constructed such that the above-described functions can be performed counterclockwise using the clockwise rotation described above, and clockwise using the counterclockwise rotation. Also, when the one-way needle roller bearing clutch 226 is locked, the linkage gear assembly It will be appreciated that other arrangements of resistance to rotation of the sleeve 158 may be used. For example, the pin 214 may be fused or fixed in place on either the housing or the first locking mechanism. In some embodiments, an interference fit that resists counter-rotation but allows the surgeon to retract the vascular prosthesis by rotating the proximal handle 36 around the periphery of the delivery device in a direction opposite to the direction of advancement may be provided, for example, by a one-way needle roller bearing clutch 226. and the linkage gear assembly 158, or by overcoming friction between the pin 214 and the component needle within the one-way needle roller bearing clutch 226. It could be done.

[0028] 19 and 20 show side and perspective views, respectively, of another embodiment of the linkage gear assembly of the present invention in combination with a one-way needle roller bearing clutch. In this embodiment, pin 214 is fused to or attached to upper linkage gear 160 and lower linkage gear 162. 19, the one-way needle roller bearing clutch 232 is at one end of the pin 214, and although not shown, the one-way needle roller bearing clutch 232 is secured to the first locking component, such as by being press-fit into the socket 174. 20, a one-way needle roller bearing clutch 234 is at the opposite end of the pin 214, and although again not shown, the one-way needle roller bearing clutch 234 is disposed in the socket 222 of the housing 81 (FIG. 17), such as by being press-fit into the socket 222. In either case, when the first locking component housing 150 is urged in the proximal direction (toward the surgeon) (FIGS. 12A and 12B), the resistance to counter-rotation is such that the surgeon may press the proximal handle after advancing the vascular prosthesis. As a result of releasing the handle 36, a unidirectional force is generated between the pin 214 and the linkage gear assembly 158. Needle roller bearing or one-way needle roller bearing between the clutch 232 Friction between clutch 234 and socket 222 (FIGS. 16 and 17) and the friction between one-way needle roller bearing clutch 234 and a socket such as socket 174 or 222 in which it is placed. can be resisted or caused by any one or combination of friction between the It is understood that the amount of torque applied to resist counter-rotation may vary among the components contributing to the overall resistance, depending on the application and the particular configuration and needs of the delivery device for implantation of a particular vascular prosthesis.

[0029] 21-30 are diagrams of embodiments of the present invention in which the delivery device of the present invention includes the same pin 214 each in rotation about pin 214 in a direction opposite to the direction of engagement of the others around In each of these embodiments, the pin 214 does not need to be in an interference fit with a socket in either the housing 81 or the first locking mechanism 38. Instead, a first clutch 236, which may be a one-way roller needle bearing clutch shown in FIG. 21, prevents reverse rotation as described above, while a second clutch 238, such as a coil spring extending around pin 214 of linkage gear assembly 158, engages when linkage gear assembly 158 mates with pin 214 and proximal handle 36 (FIGS. 12A and 12B) is rotated to advance the vascular prosthesis in a distal direction, away from the surgeon and toward the surgical site. During engagement of the second clutch 238, the pin 214 rotates within the second clutch 238 while the second clutch 238 engages to overcome static friction between the second clutch 238 and the pin 214. The torque required to overcome the resistance to rotation of pin 214 in second clutch 238 while engaging latch 238 is determined by the torque between pin 214 and socket 222 in housing 81 or first locking component. The second clutch 238 may reverse the interference fit between the housing 150 and the socket 174. The second clutch 238 may thereby enhance surgeon control during surgery by enabling the manufacture of a delivery device that is less dependent on variability in the construction of the socket in either the housing 81 or the first locking component housing 150, specifications that generally require very low resistance to function within performance limits during use. Alternatively, the pin 214 and linkage gear assembly 158 may not interlock during rotation of the linkage gears 160, 162 that advance the vascular prosthesis. Rather, the linkage gears 160, 162 are free to rotate about the pin 214 when the linkage gears 160, 162 rotate in a direction that advances the vascular prosthesis. Such alignment may be achieved, for example, by 21-24 or a coil spring between the linkage gear and pin, first clutch 236 engages linkage gears 160, 162 and pin 214 only when first locking mechanism 38 is directed proximally (toward the surgeon) by release of proximal handle 36 (FIGS. 12A and 12B). In this embodiment, second clutch 238 has no function in advancing the vascular prosthesis by rotation of proximal handle 36, but does not function in advancing the vascular prosthesis by orientation of first locking mechanism 38 in the proximal direction or by pulling the vascular prosthesis. Resistance to rotation of pin 214 (FIG. 21) during any counter-rotation of linkage gears 160, 162 and proximal handle 36 caused by intentional rotation of proximal handle 36 by the surgeon to engage In one embodiment, the linking gears 160, 162 engage the pin 214 during advancement of the vascular prosthesis. The force required to overcome the friction created by the second clutch 238 is less than that created by the first clutch 236, regardless of whether the second clutch 238 is free to rotate around the center of gravity.

[0030] In one particular embodiment of the invention that includes two clutches, FIG. 21 shows the pin 214, the upper connecting gear 160, the first clutch 236, which is a one-way needle roller bearing clutch, and the coil 22 is an exploded view of the assembly of the present invention, including a perspective view of the second clutch 238, which is a spring clutch. When partially assembled as shown in FIG. 22, the first clutch 236 is press-fit into an opening 240 defined by the upper connecting gear 160, and one end 242 of the coil spring 238 is secured in a slot 244 in the housing 81, as shown in FIG. 24. FIG. 23 is an exploded view of the assembly of the present invention, including a perspective view of the second clutch 238, which is a spring clutch. When partially assembled as shown in FIG. 22, the first clutch 236 is press-fit into an opening 240 defined by the upper connecting gear 160, and one end 242 of the coil spring 238 is secured in a slot 244 in the housing 81, as shown in FIG. 24. The pin 214 extends through the first clutch 236 and the second clutch 238. 24 is a top view of housing 81 showing slot 244 into which end 242 of coil spring 238 is positioned upon assembly of linkage gear assembly 158, pin 214, coil spring 238, and housing 81. During assembly, the opposite end of pin 214 is inserted into the housing as described above. 1. The first locking component 150 is positioned in the socket 222 of the stud 81 and the socket 174 of the first locking component housing 150. During advancement of the vascular prosthesis by clockwise rotation of the handle 36 as described above, the first Because clutch 236 is not engaged, upper link gear 160 and lower link gear 162 rotate freely about pin 214. Upon counterclockwise or clockwise rotation of upper link gear 160, such as by longitudinal extension of a partially longitudinally compressed vascular prosthesis urging link gear assembly 158 in a proximal direction, first clutch 236 provides a force proportional to the rotation of upper link gear 160. The rotation of the pin 214 in the second clutch 238 is prevented by the clutch 236 rotating around the pin 214. The latch is loosened while providing additional frictional resistance to rotation of the pin 214 in the second clutch 238. In a preferred embodiment, the force required to overcome the frictional resistance to rotation of the pin 214 in the first clutch 236 when the first clutch 238 is locked is The force required to rotate pin 214 in the same direction as the force required to overcome the frictional resistance to rotation of pin 214 within second clutch 238 is greater than the force required to rotate pin 214 in the same direction as the force required to overcome the frictional resistance to rotation of pin 214 within second clutch 238.

[0031] In another specific embodiment of the present invention including two clutches, FIG. 25 shows pin 214, linkage gear assembly 158, first clutch 236 which is a one-way needle roller bearing clutch, and 2 is an exploded view of the assembly of the present invention, including a perspective view of the second clutch 246, which is a coil spring. When at least partially assembled, as shown in FIG. 25, the first clutch 236 is press-fit into the opening 240 defined by the upper connecting gear 160, and the coil spring 246 is 25 in assembled form. As shown in perspective view FIG. 26, one end 248 of the coil spring 246 is connected to the first locking component housing. 25 and 26. FIG. 28 is a side view of the embodiment shown in FIG. 1, showing the socket 174 and slot 247 into which the end 248 of the coil spring 246 fits. 26 is a plan view of the component housing 150. As shown in FIG. 26, the pin 214 is 26. The second clutch 236 extends through the second clutch 246. FIG. 28 is a side view of the subassembly of FIG. The pin 214 and one end of the coil spring 246 are in the first application when fully assembled. The opposite end of pin 214 may be disposed within socket 174 of lock component housing 150. As described above, first clutch 236 is disengaged during advancement of the vascular prosthesis by clockwise rotation of handle 36. Thus, the linkage gear assembly 158 rotates freely about the pin 214. During reverse or clockwise rotation of the upper linkage gear, the first clutch 236 engages the upper linkage gear 160. Rotation of pin 214 is locked, and rotation of pin 214 within second clutch 238 loosens second clutch (a coil spring shown in FIGS. 25-28) 238 around pin 214 while providing additional frictional resistance to rotation of pin 238. In a preferred embodiment, rotation of pin 214 within first clutch (which is a one-way needle roller bearing clutch) 236 when first clutch 236 is locked The force required to overcome the frictional resistance to rotation of the pin 214 in the second clutch 238 is greater than the force required to overcome the frictional resistance to rotation of the pin 214 in the second clutch 238 when the pin 214 is rotated in the same direction that secures the first clutch 236.

[0032] In yet another specific embodiment of the present invention including two clutches, FIG. 29 is a perspective view of pin 214, linkage gear assembly 158, first clutch 236 which is a one-way needle roller bearing clutch, and second clutch 250 which is a one-way needle roller bearing clutch. 1 is an exploded view of another assembly of the present invention including a first clutch 236 and a second clutch 250. In another embodiment, first clutch 236 and second clutch 250 are both disengaged during distal advancement and engaged when directed proximally. In this alternative embodiment, the force required to overcome the frictional resistance to rotation of pin 214 in first clutch 236 when first clutch 236 is locked is less than the force required to overcome the frictional resistance to rotation of pin 214 in second clutch 250 when pin 214 is rotated in the direction in which first clutch 236 is locked. The force required to overcome the frictional resistance to rotation of the

[0033] When assembled, the first clutch 236 opens the upper connecting gear 160, as shown in FIG. The first one-way needle roller bearing clutch 250 is press-fit into the mouth 241 of the first locking component housing 150 (FIG. 18), and the second one-way needle roller bearing clutch 250 is press-fit into the socket 174 of the first locking component housing 150 (FIG. 18). It will be understood that the positions of the first and second one-way needle roller bearing clutches may be reversed. The pin 214 extends through the first clutch and the second clutch. The opposite end of the pin 214 is disposed within the socket 222 of the housing 81 (FIG. 17) and the second one-way needle roller bearing clutch 250. The vascular prosthesis is secured by clockwise rotation of the handle 36 as described above. During the advancement of the needle, the first one-way needle roller bearing clutch 236 is not engaged, but torque applied to the proximal handle by the surgeon engages the second one-way needle roller bearing. The frictional resistance is sufficient to overcome the frictional resistance provided by the second one-way needle roller bearing clutch 250 against the pin 214. The frictional resistance is sufficient to overcome the frictional resistance provided by the second one-way needle roller bearing clutch 250 and the first locking component housing. This may be the result of friction between the socket 174 of the bearing 150 or between the needle and pin 214 of the second one-way needle roller bearing clutch 250. During reverse or clockwise rotation of the assembly 158, the first clutch 236 rotates the pin 214. The rotation of the pin 214 in the second clutch 250 locks the upper linkage gear 160 in rotation, and the rotation of the pin 214 in the second clutch 250 disengages the second clutch 250 from the pin 214. In one embodiment, the surgeon overcomes the frictional force provided by the first one-way needle roller bearing clutch 236. The friction force can be adjusted by rotating the proximal handle 36 in a direction that retracts the vascular prosthesis. , between the first one-way needle roller bearing clutch 236 and the opening 241 of the linkage gear assembly 158 into which it is press-fitted, and the needles of the one-way needle roller clutch 236 The frictional force between the roller and the pin 214 can be at least one of: frictional resistance to rotation of the pin 214 within the first clutch 236 when the first clutch 236 is locked; The force required to overcome the resistance is generated when the pin 214 is rotated in a direction that locks the first clutch 236. The force required to overcome the frictional resistance to rotation of the pin 214 in the second clutch 250 when The relative torque force required to overcome the friction between the pin 214 and the first and second one-way needle roller clutches 236 and 250 is , for example, by using metal needle rollers in the first one-way needle roller bearing clutch 236 and plastic needles in the second one-way needle roller bearing clutch 250.

[0034] 31 is a perspective view of the actuator 80 of FIG. 1 (without the housing 81 or the push button 82) of the first locking component housing 150 and the second locking component housing 152. Coil spring 210 extends around pin 214. End 218 of coil spring 210 is disposed within a recess in the upper linkage gear. This embodiment of pin 214, clutch 210, linkage gear assembly 158, and first locking component housing 150 is the same as that shown in FIG. 16.

[0035] In another embodiment shown in FIG. 32, which uses the assembly shown in FIGS. 25-28, upper pinion gear 166 is coaxial with lower pinion gear 168, which in turn is 31 and 32, the delivery catheter 28 is fitted with the rack 106. As shown here, the first clutch is a one-way needle roller bearing clutch 236 that is press-fit into an opening 240 defined by the linkage gear assembly 158, and the second clutch is a coil spring 246 that is disposed within a socket 174 through which the pin 214 extends. In both the embodiments of FIGS. , coupled to the first locking component housing 150, and therefore, regardless of whether the first locking component 124 (FIG. 19) is mated with the push rod 32 (FIGS. 33 and 34), the proximal handle 124 as shown in FIG. It moves longitudinally along the housing 150 with the movement of the handle 36 and the actuator 80. Therefore, when upper pinion gear 166 mates with lower pinion gear 168, rotation of proximal handle 36 (shown in FIG. 1) about handle body portion 20 rotates linkage gear assembly 158 (FIGS. 1 and 34). rotation of the pinion gear assembly 164 (FIG. 34) and the gear rack. 12A and 12B) along the handle body portion 20. Additionally, while first locking component 124 (FIGS. 10, 11, 33, and 34) is mated with pusher rod 32, rotation of proximal handle 36 results in longitudinal translation of pusher rod 32 along handle body 20. In all cases, translation of proximal handle 36 and actuator 80 along handle body 20 always occurs together, resulting in translation of delivery catheter 28 longitudinally along handle body 20.

[0036] However, as explained further below, depression of the center pin 170 The upper pinion gear 166 disengages from the lower pinion gear 168. When disengaged from gear 168, rotation of proximal handle 36 about handle body 20 rotates the handle. The actuator 80 is moved longitudinally along the handle body 20 without causing longitudinal movement of the proximal handle 36 and actuator 80 along the handle body 20. Furthermore, longitudinal movement of the proximal handle 36 and actuator 80 along the handle body 20 can be achieved without rotation of the proximal handle 36 about the handle body 20 (FIGS. 1, 12A, and 12B). This can be achieved simply by moving the proximal handle 36 and actuator 80 along the handle body portion 20 .

[0037] FIG. 34 is another perspective view of linkage gear assembly 158 and pinion gear assembly 164 of actuator 80 (FIGS. 1 and 31).

[0038] In an alternative embodiment shown in FIG. 35, the push button 82 is driven through an upper pinion gear 166. 35 and 36, the lower pinion 170 is located at the top of the extending central pin 170. The gear 168 is mated with the gear rack 106 and has a lower pinion gear 168 that is axially aligned with the upper pinion gear 166. The pinion gear 168 includes a pinion gear extension 265 axially aligned with the pinion gear 168. The lower portion 172 extends into an opening 174 (FIG. 11) defined by the first locking component housing 150 (FIG. 11), thereby forming a first locking component housing 150 as shown in the previous embodiment of FIG. 11, the distal bearing 120 (FIG. 11), the first locking component 124, and the pinion gear assembly 164 relative to the drive gear 86.

[0039] 36 is a perspective view showing the engagement of the lower pinion gear 168 with the gear rack 106 and the frusto-conical portion 176 of the center pin 170. As can be seen in FIGS. 37 and 38, the ball bearing 178 , extending through a side opening 180 defined by pinion gear extension 265, and center pin 170 37, the frusto-conical portion 176 of the center pin 170 has ball bearings 178 on the outside and through side openings 183 and upper pinion gear opening 182 (FIG. 36). The upper pinion gear opening 182 is defined by the upper pinion gear 166 (FIGS. 36 and 37). The interference opening 183 is urged into interference relationship with the ball bearing 178. When occupied, upper pinion gear 166 mates with lower pinion gear 168 .

[0040] As can be seen in the transition from FIG. 40A to FIG. 40B, by depressing button 82 (FIG. 1), When the center pin 170 is actuated, the center pin 170 moves within the lower pinion gear opening 263. The ball bearing 178 rotates around the axis 269 of the upper pinion gear relative to the lower pinion gear 168. The rotation of the pinion gear 166 forces the upper and lower shafts 264 inward through the side openings 180 of the pinion gear 265. Upper pinion gear 166 no longer mates with lower pinion gear 168. Center pin 170 is biased to an outward position by biasing spring 184 and frustoconical portion 176, and upper pinion gear 166 is positioned at the base of center pin 170 within pinion gear extension opening 263 of pinion gear extension 265. 40A and 40B, clutch 260 is urged into engagement with lower pinion gear 168 by spring 184, which engages clutch 260. As can be seen in FIGS. 40A and 40B, clutch 260 is urged into engagement with lower pinion gear 168 by spring 184, which engages clutch 260. As can be seen in FIGS. When switch 260 is placed in socket 174, it is in lower extension 262. In another embodiment, the clutch is on pinion gear 265 on lower pinion gear 164. In this embodiment, clutch 260 is disposed within a socket (not shown) in the opening in housing 81 through which center pin 170 extends.

[0041] FIG. 41 is an exploded view of the embodiment shown in FIGS. 35-40A and B, showing the one-way needle roller bearing clutch 260 at the lower extension 262 of the pinion gear assembly 164. The long portion 262 is placed in a one-way needle roller bearing clutch 260, which is then press fit into the socket 174 shown in FIG. 41 of the first locking component housing 150. A side view of the pinion gear assembly 164 when assembled with the one-way needle roller bearing clutch 260 and the first locking mechanism 38 is shown in FIG. During this procedure, the surgeon presses down on the central pin 170, compressing the bias spring 184 and causing the center pin 170 to rotate. Releasing frustum portion 176 releases ball bearing 178 from its outer position, thereby releasing lower pinion gear 168 from upper pinion gear 166. By doing so, the surgeon can advance a vascular prosthesis delivered by the delivery device of the present invention to a location distal to the surgical site without rotating proximal handle 36, thereby releasing lower pinion gear 168 (FIGS. 40-42). continues to rotate because it remains engaged with the pinion rack 106 (FIGS. 36-38). As the upper pinion gear 166 disengages from the lower pinion gear 168, the upper pinion gear 166 The longitudinal movement of the proximal handle 36 and the first locking mechanism 38 along the handle body portion 20 The proximal handle 36 is not rotated during movement. When handle 36 is pulled (toward the prosthesis), lower pinion gear 168 spins in a direction opposite to the direction of longitudinal advancement of the vascular prosthesis. Rotation of lower pinion gear 168 in the direction opposite to the advancement of the vascular prosthesis rotates one-way needle roller bearing clutch 260 to lower extension 262. The proximal handle 36 is rotated in a counterclockwise direction, whereby the lower pinion gear extension 262 engages the clutch needle roller 36. ... As the one-way needle roller bearing clutch 260 rotates and slips, the resistance to rotation is greater within the interference fit of the clutch 260 and socket 174. Further resistance to rotation is provided by at least the one-way needle roller bearing clutch 260 and the socket 1744 into which the one-way needle roller bearing clutch 260 is press-fitted and the lower end disposed within the one-way needle roller bearing clutch 260. The friction between the lower extension 262 of the pinion gear 168. Upon approaching the vascular prosthesis to the surgical site where the vascular prosthesis will be deployed, the surgeon releases the central pin 170 and The upper pinion gear 168 and the lower pinion gear 166 may then be re-engaged.

[0042] Once the upper pinion gear 166 is re-engaged with the lower pinion gear 168, the proximal handle 36 (e.g., As the proximal handle 36 ( FIG. 1 ) is rotated in a direction, such as a clockwise direction from the surgeon's perspective, the vascular prosthesis can be advanced to the surgical site in a more controlled manner. During advancement of the vascular prosthesis by rotation of the proximal handle 36, the vascular prosthesis is typically longitudinally compressed within the delivery device 10. When the surgeon releases the proximal handle 36, the vascular prosthesis is locked by the first locking mechanism 36 and consequently exerts a proximal longitudinal force (toward the surgeon) on the linkage gear assembly 158. Because the lower pinion gear mates with the gear rack 106, the proximal longitudinal force on the pinion gear assembly 164 urges the lower pinion gear 168 to rotate, thereby locking the one-way needle roller bearing clutch 260 to the lower extension 262 of the lower pinion gear 168. and prevents further rotation in the same direction. Also, since the center pin 170 is not actuated, the lower pin The pinion gear 168 and upper pinion gear 166 are fixed, and the ball bearing 178 is The rotation of the vascular prosthesis is then interfering with the rotation of the anion gear 166, thus rotating the vascular prosthesis toward the surgical site. The proximal handle 36 prevents counter-rotation of the proximal handle 36 in a direction opposite to the direction of directional advancement and prevents longitudinal stretching of the vascular prosthesis caused by the release of longitudinal compression of the vascular prosthesis, such as that which may result from the surgeon releasing the proximal handle 36 after rotation by the surgeon in a direction, such as a clockwise direction, that advances the vascular prosthesis to the surgical site. The surgeon can overcome friction between the one-way needle roller bearing clutch 260 and at least one of the socket 174 and the lower extension 262 of the lower pinion gear 168 by rotating the proximal handle 36 in a direction opposite to the direction that causes advancement, such as a counterclockwise direction. At any time before or after approaching the center pin 170, the center pin 170 may be depressed to allow the lower pin The pinion gear 168 can be disengaged from the upper pinion gear 166, thereby again allowing the surgeon to longitudinally advance or retract the vascular prosthesis by directing the proximal handle 36 distally or proximally without rotating the proximal handle 36.

[0043] As can be seen in FIG. 46A, the nosecone 50 is attached to the distal end 16 of the guidewire catheter 12. 50. The guidewire catheter 12 is secured to the guidewire catheter 12 at a distal end thereof. A vascular prosthesis component 58 is positioned within the delivery device 10 proximal to the nosecone 50.

[0044] 44 and 45 are perspective and cutter views of the proximal clasp assembly 184 components of the present invention. As can be seen in FIG. 44, the outer coupling 186 is slidable along the proximal end 34 of the pushrod 32. The fixed component 188 is guided by a pin 192. The outer coupling 186 and the fixed component are fixed to the proximal end of the wire catheter. The elements 188 are in mating relationship at a joint 190. A spring 194 within the outer coupling 186 biases the outer coupling 186 against the fixed component 188. Proximal clasp assembly 184 44, 47B, as shown in FIG. 51B, by applying pressure to tongues 196 on either face of outer coupling 186 and orienting outer coupling 186 distally enough to permit ninety (90) degrees of rotation of outer coupling 186; and then 44 to the position shown in FIG. 51B. The outer coupling 186 is then moved to the second position shown by withdrawing the outer coupling 186 so that the tongues 196 of the outer coupling 186 are aligned between the tongues 198 of the fixed component 188. The movement of the outer coupling 186 from the first position shown in FIG. 44 to the position shown in FIG. 51B This causes the opening of the apical clasp assembly 52 and the proximal capture component to the apical position shown in FIG. 50B. from a first position in mating relationship with the distal capture component 56 of the clasp assembly 52. 51C, where the proximal capturing component 54 is no longer in mating relationship with the distal capturing component 56. A proximal clasp to the fixed component 188 for separation from element 56 (FIGS. 50B, 51C) Proximal movement of outer coupling 186 of assembly 184 (FIGS. 44, 47B, 51B) releases apex 68 of stent 66 at proximal end 60 of vascular prosthesis component 58. As shown in FIG.

[0045] 46A-46C show an undeployed vascular prosthesis configuration within the distal end 202 of the delivery device 10. 46A is a cross-sectional view of a portion of the delivery device 10 of the present invention showing element 58. As shown, the vascular prosthesis component 58 is within the delivery sheath 200. The distal end 62 of the element 58 is adjacent to the buttress 204. The buttress 204 then extends to the distal end 206. Engaging with the pushrod 32, the proximal end 60 of the vascular prosthesis component 58 is secured to the proximal end 60 as shown in FIG. 46A. , is captured by the apex clasp assembly 52 at the apex 68 of the proximal stent 66 when the apex clasp assembly 52 is in the closed position. At the distal end 16 of the guidewire catheter 12 is a distal capturing component 56, and the proximal capturing component 54 is in matable relationship with the distal capturing component 56 and is attached to the distal end 210 of the apex release catheter 154. The apex release catheter 154 extends around the guidewire catheter 12 and Both the distal release catheter 154 and the guidewire catheter 12 are vascular prosthesis components. 46C, delivery sheath 200 is secured at its proximal end to distal end 30 of delivery catheter 28. 46A, the nosecone 50 is attached to the guidewire catheter 12 and extends around the vascular prosthesis component 58 toward the apical clasp assembly 52. The outer catheter 48 extends from the distal handle nose 44 (FIG. 1), around the delivery catheter 28 and delivery sheath 200, to a nosecone 50.

[0046] As shown in Figures 47A-52B, a method for delivering a vascular prosthesis to a treatment site in a subject using a delivery device of the present invention includes advancing the vascular prosthesis 58 while mounting the prosthesis 58 to the apex clasp assembly 52 at the proximal end 60 of the prosthesis 58. The proximal apex clasp assembly 184 is in a first position shown in Figure 47B, and the apex clasp assembly 52 is in a second position shown in Figure 47C. The apex of the vascular prosthesis 58 is secured with the apex clasp assembly 52 when the proximal clasp assembly 184 is in the first position. Pusher assembly 52 is secured to distal end 16 of guidewire catheter 12, and shift knob 42 is in a first position when pin 108 is within slot 110 (FIG. 47C), and longitudinal movement of proximal handle 36 moves pusher rod 32. Prosthesis 58 is advanced to a position distal to a vascular treatment site in a subject by rotation of proximal handle 36 in a first direction about handle body portion 20 of delivery device 10, which has distal end 26 through which guidewire catheter 12 extends. The guidewire catheter 12 is disposed within a pushrod 32 that also extends through the handle body portion 20, where the guidewire catheter 12 is secured to the guidewire catheter by a pin 192 (FIG. 44). Optionally, push button 82 of actuator 80 may be depressed to release rotation of proximal handle 36 from longitudinal movement of proximal handle 36 along handle body 20, thereby allowing manual advancement of vascular prosthesis 58 to a vascular treatment site in a subject, without rotation of proximal handle 36 about handle body 20.

[0047] The shift knob 42 shifts from a first position in which the first locking component 124 (FIGS. 10 and 11) secures the proximal handle 36 to the push rod 32 to a second position in which the first locking component 124 (FIGS. 10 and 11) releases the proximal handle 36 from the push rod 32 and the second locking component 144 (FIGS. 10 and 11) engages the push rod 32 and the handle body portion 20 at the proximal end 24 of the handle body portion 20.

[0048] As can be seen in FIGS. 50A and 50B, the proximal handle 36 can then be rotated in a second direction without depressing the actuator push button 82, causing the delivery catheter 28 having the distal end 30 (FIG. 53A) and extending around the push rod 32 to be withdrawn along the push rod 32, and the delivery sheath 200 extending from the distal end of the delivery catheter (FIGS. 4-9) to be at least partially retracted from around the prosthesis 52. Optionally, push button 82 of actuator 80 can be depressed, thereby releasing rotation of proximal handle 36 from handle body portion 20, thereby rotating the handle, as can be seen in FIG. Without rotation of the proximal handle 36 around the distal body 20, the delivery sheath 200 is inserted into the vascular prosthesis 58. You will be completely drawn in.

[0049] The proximal clasp assembly 184 is then attached to the outer coupling 186 as shown in FIG. 10, 11) and actuated by compressing the outer coupling 186 to first move the outer coupling 186 distally, then rotating the outer coupling 186 90°, and then retracting the outer coupling 186 to a second position, thereby retracting the apex release catheter 154 into the pushrod 32 (FIGS. 10 and 11) and into the proximal capture configuration. The element 54 is retracted from the distal capture component 56. The apex 68 of the stent 66 is released from the apex clasp assembly 52 at the proximal end 60 of the vascular prosthesis 58, thereby allowing for the release of the apex clasp assembly 52, as can be seen in FIG. Thus, the prosthesis 58 is released from the delivery device 10. The shift knob 42 is then 52A. Push rod 32 is then moved from the first position to a third position, where pin 108 is disposed within slot 114 between first slot 110 and second slot 112, as can be seen in FIG. 52B, thereby releasing push rod 32 from handle body portion 20. Push rod 32 and guidewire catheter 12 are then withdrawn from vascular prosthesis 58 by pulling push rod 32 through handle body portion 20, thereby completing delivery of vascular prosthesis 58 to the treatment site, as can be seen in FIG. 52A. will be done.

[0050] While the present invention has been particularly shown and described with reference to illustrative embodiments thereof, it will be understood by those skilled in the art that various changes in form and details can be made therein without departing from the scope of the invention encompassed by the appended claims.

[0051] All references cited herein, as well as relevant portions of U.S. Patent Nos. 8,070,790, 9,101,506, 9,364,314, 9,554,929, and 10,299,951 and U.S. Patent Application No. 16 / 413,916 (Publication No. 2019 / 0269539), are incorporated by reference in their entirety. The present invention includes the following aspects. Item 1 a) a handle body portion (20) having a longitudinal axis (22), a proximal end (24) and a distal end (26); b) a gear rack (106) extending into the handle body portion (20); c) a proximal handle (36) extending around the gear rack (106) and defining teeth (156), the proximal handle (36) being rotatable around the handle body portion (20) and the gear rack (106); d) a distal handle (40) extending around the handle body portion (20) at the distal end (26) of the handle body portion (20); e) a guidewire catheter (12) having a proximal end (14) and a distal end (16), the guidewire catheter (12) extending through a handle body portion (20), a proximal handle (36), and a distal handle (40) and along a longitudinal axis (22); f) a delivery catheter (28) having a distal end (30) axially fixed to the proximal handle (36) and extending from within the distal end (26) of the handle body portion (20) and around the guidewire catheter (12); g) When the delivery catheter (28) is in the first, retracted position, the distal handle (40) is an outer catheter (48) at the location and extending around the delivery catheter (28); h) a gear assembly connecting the teeth (156) of the proximal handle (36) to the gear rack (106), wherein rotation of the proximal handle (36) about the longitudinal axis (22) causes the proximal handle (36) and delivery catheter (28) to move along the longitudinal axis (22) relative to the gear rack (106); and i) a clutch on the gear assembly, which engages the gear assembly and the proximal handle, thereby biasing longitudinal movement of the gear assembly and relative rotation of the proximal handle (36) about the longitudinal axis; A delivery device (10). Section 2 When the clutch is engaged, rotation of the proximal handle (36) about the longitudinal axis (22) creates friction between the clutch and at least one of the gear assembly and the remainder of the delivery device (10). Item 1. The delivery device of item 1, which is resisted by Section 3 Item 3. The delivery device of item 2, wherein the clutch engages when the gear assembly is oriented proximally along the longitudinal axis. Section 4 The gear assembly a) an upper pinion gear (166) mated with the proximal handle (36), the upper pinion gear (166) defining a non-circular pinion gear opening (182) and rotatable about a pinion gear axis (269); and b) a lower pinion gear (168) axially aligned with the upper pinion gear (166) and defining a lower pinion gear opening (263), the lower pinion gear (168) mating with the gear rack (106) and the clutch (260) selectively engages the upper pinion gear (166), where the clutch (260) engages the lower pinion gear (168) when the gear assembly is oriented in the proximal direction; Item 4. The delivery device of item 3, comprising a pinion gear assembly (164) comprising: Section 5 Item 5. The delivery device of paragraph 4, wherein the clutch comprises a one-way needle roller clutch. Section 6 Item 6. A delivery device as described in item 5, wherein the gear assembly defines a gear assembly socket, the one-way needle roller clutch is press-fit into the gear assembly socket, and the one-way needle roller clutch engages the gear assembly socket and the lower pinion gear when the pinion gear assembly is oriented proximally along the gear rack. Section 7 7. The delivery device of claim 6, wherein the resistance to rotation of the one-way needle roller bearing clutch within the gear assembly socket is greater than the resistance to rotation of the lower pinion gear within the one-way needle roller clutch when the one-way needle roller clutch is engaged. Section 8 Item 6. The delivery device of item 5, further comprising a housing extending around the handle body portion (20) and having a proximal end defining a proximal opening and a distal end defining a distal opening, the housing (81) further defining a hole between the proximal opening and the distal opening, the housing being rotatably coupled to the proximal handle, the housing also defining a housing socket, and the one-way needle roller clutch being press-fit into the housing socket. Section 9 Item 9. The delivery device of item 8, wherein when the one-way roller clutch is engaged, the resistance to rotation of the one-way needle roller clutch within the socket is greater than the resistance to rotation of the lower pinion gear within the one-way needle roller clutch. Section 10 The lower pinion gear (168) a) a lower portion extending toward the longitudinal axis (22) of the handle body portion (20); b) a gear portion that mates with the gear rack (106); c) a pinion gear extension (265) extending into the upper pinion gear opening (182), wherein the pinion gear extension (265) defines a side opening (180) and when the side opening (180) and the upper pinion gear opening (182) of the upper pinion gear (166) are together occupied, the upper pinion gear An interference opening (183) is defined that prevents rotation of the gear (166) and the lower pinion gear (168) relative to one another. do; d) a ball bearing (178) within at least one of each side opening (180), said ball bearing The ring (178) has a diameter greater than the thickness of the wall defining the side opening (180); e) a center pin (170) movable along the pinion gear axis and within the upper pinion gear opening, the lower pinion gear opening, and the pinion gear extension opening, the center pin (170) having a base portion with a first diameter within the lower pinion gear opening and a second diameter smaller than the first diameter; The center pin (170) includes a frusto-conical portion (176) disposed within the upper pinion gear opening, and movement of the frusto-conical portion (176) of the center pin (170) drives the ball bearings (178) radially outward into the interference openings (183). , thereby creating an interference relationship between the rotation of the upper pinion gear (166) and the lower pinion gear (168); and f) providing the center pin (170) with a radially outward offset from the longitudinal axis (22) of the handle body portion (20); The spring (184) and ball bearing (178) on the lower pinion gear (168) are directed radially outward through the side opening (180), thereby allowing the upper pinion gear (166) and the lower pinion gear (168) to rotate. By depressing the center pin (170), the outer displacement of the ball bearings (178) is eliminated, eliminating the interference between the rotation of the upper pinion gear (166) and the lower pinion gear (168) along the longitudinal axis (22) relative to the handle body portion (20). 5. The delivery device of claim 4, wherein rotation of the proximal handle (36) occurs independent of longitudinal movement of the delivery catheter (28). Section 11 The gear assembly a) a pinion gear assembly (164) that mates with the gear rack (106); and b) an upper linkage gear (160) that mates with the teeth (156) of the proximal handle (36) and a linkage gear assembly (158) including an upper linkage gear (160) and a lower linkage gear (162) fixed between the upper linkage gear (160) and the longitudinal axis (22) of the handle body portion (20), the linkage gear assembly (158) having mating teeth with a pinion gear assembly (164), the upper linkage gear (166) and the lower linkage gear (162) having a common axis of rotation perpendicular to the longitudinal axis (22) of the handle body portion (20); Item 4. The delivery device of item 3, comprising: an upper linkage gear (160) and a lower linkage gear (162) each defining a central opening along a common axis of rotation. Section 12 a) a pushrod (32) extending around the guidewire catheter (12) and into the delivery catheter (28), the pushrod (32) being secured to the guidewire catheter (12) at its proximal end proximal to the handle body portion (20) and selectively secured to the proximal handle (36); and b) a locking mechanism assembly extending around the push rod, the locking mechanism comprising: i. a first locking mechanism that secures the delivery catheter to the push rod when the locking mechanism is in the first locked position; a locking mechanism (38), and ii. a second locking mechanism (132) secured to the distal end (26) of the handle body portion (20) that secures the push rod (32) to the handle body portion (20) when the locking mechanism assembly is in the second, locked position; wherein the first locked position and the second locked position are mutually exclusive. Item 12. The delivery device of item 11, further comprising: Item 13 a gear assembly; a) a housing (81) extending around the handle body portion (20) and having a proximal end defining a proximal opening and a distal end defining a distal opening, the housing (81) further defining a bore between the proximal and distal openings; and b) a central pin extending through central openings in the upper linkage gear (160) and the lower linkage gear (162), the pin including opposite ends residing in the locking mechanism assembly and the housing (81), wherein a clutch selectively engages the pin and the linkage gear assembly, the engagement being dependent upon the direction of rotation of the proximal handle (36) about the handle body portion (20); Item 13. The delivery device of item 12, further comprising an actuator (80) comprising: Item 14 The pin is integral with at least one of the locking mechanism assembly and the housing (81) Item 14. The delivery device according to item 13, wherein the delivery device is fused to the membrane. Item 15 The first locking mechanism (38) defines a first socket (174), the housing (81) defines a second socket, and opposite ends of the pin are disposed in the first socket (174) and the second socket. Item 14. The delivery device according to item 13. Item 16 Item 16. The delivery device of item 15, wherein the clutch engages the pin when the gear assembly is oriented proximally. Item 17 Rotation of the proximal handle (20) which orients the gear assembly proximally engages the pin and the first socket. Item 17. The delivery device of item 16, wherein the interference is resisted by an interference relationship between at least one of the first socket and the second socket. Section 18 18. The delivery device of paragraph 17, wherein the clutch is a one-way needle roller bearing clutch. Section 19 20. The delivery device of paragraph 18, wherein the one-way needle roller bearing clutch is press-fit onto the upper linkage gear. Section 20 18. The delivery device of paragraph 17, wherein the clutch is a coil spring that stretches around the pin. Section 21 21. The delivery device of paragraph 20, wherein the coil spring is fixed at one end to the upper linkage gear. Section 22 Rotation of the proximal handle (20) which directs the gear assembly in a proximal direction activates the clutch and the first Item 17. The delivery device of item 16, wherein the contact is resisted by an interference relationship between at least one of the first socket and the second socket. Section 23 17. The delivery device of paragraph 16, wherein rotation of the proximal handle (20) to direct the gear assembly in a proximal direction is resisted by an interference relationship between the clutch and the pin. Section 24 24. The delivery device of paragraph 23, wherein the clutch is a coil spring. Section 25 24. The delivery device of paragraph 23, wherein the clutch comprises a one-way needle roller clutch. Section 26 When the pinion gear assembly (164) is oriented distally along the gear rack (106) during mating of the linkage gear assembly (158) and the pinion gear assembly (164), the linkage gear assembly (158) further engages a second clutch that engages the linkage gear assembly (158) and the pinion gear assembly (164). Item 14. The delivery device of item 13, comprising: Section 27 A second clutch is press-fit into the first or second socket through which the pin extends. a second one-way needle roller clutch bearing configured to engage a pin with the linkage gear assembly (158) when the pinion gear assembly (163) is oriented proximally along the gear rack (106) during engagement of the linkage gear assembly (158) and the pinion gear assembly (164), and wherein the resistance to proximal movement of the pinion gear assembly while the second one-way needle roller clutch is engaged is provided by a second roller needle clutch in a socket into which the one-way needle roller bearing is press-fitted. Resistance to rotation of the bearing or pin and second one-way needle roller clutch 27. The delivery device of claim 26, wherein the resistance is caused by at least one of interference between the first roller needle clutch and the pin, and the resistance is less than the resistance between the first roller needle clutch and the pin. Section 28 Item 27. A delivery device as described in item 26, wherein the second clutch is a coil spring fixed at one end to the first locking mechanism (38), a pin extends through the coil spring, and the coil spring engages with the pin when the pinion gear assembly (164) is oriented distally along the gear rack (106) during engagement of the linking gear assembly (158) and the pinion gear assembly (164). Section 29 The second clutch is a coil spring fixed at one end to the housing (81) and a pin Item 27. A delivery device as described in item 26, wherein the coil spring extends through the coil spring and engages with the pin when the pinion gear assembly (164) is oriented distally along the gear rack (106) during engagement of the linkage gear assembly (158) and the pinion gear assembly (164). Section 30 Item 14. A delivery device as described in item 13, wherein the pinion gear assembly (164) and the linking gear assembly (158) are selectively engaged with each other, and actuation of the pinion gear assembly (164) releases rotation of the linking gear assembly (158) and movement of the pinion gear assembly (164) along the gear rack (106). Item 31 A pinion gear assembly (158) a) an upper pinion gear (166) mated with the lower connecting gear (162), the upper pinion gear defining a non-circular pinion gear opening (182) and rotatable about a pinion gear axis; and b) Axial alignment with the pinion gear axis of the upper pinion gear (166) and the lower pinion gear opening a lower pinion gear (168) defining a portion; The lower pinion gear (168) i. a lower portion extending toward the longitudinal axis of the handle body; ii. a gear portion that mates with the gear rack (106); and iii. a pinion gear extension extending into the upper pinion gear opening, where the pinion gear The extension defines a pinion gear extension opening and at least one side opening (180), and the side opening (180) and the non-circular pinion gear opening (182) of the upper pinion gear (166) together form a thereby defining an interference opening (183) which, when occupied, allows the upper pinions to fit relative to one another. Prevents rotation of the on gear (166) and lower pinion gear (168), iv. a ball bearing (178) within at least one of each side opening (180), said ball The bearing has a diameter greater than the thickness of the wall defining the side opening (180). v. Along the pinion gear axis and through the upper pinion gear opening and the lower pinion gear opening and a central pin (170) movable within the pinion gear extension opening, the central pin (170) including a frusto-conical portion (176) between a base portion having a first diameter within the lower pinion gear opening and a second diameter smaller than the first diameter, the central pin (170) being disposed within the upper pinion gear opening, the movement of the frusto-conical portion (176) of the central pin (170) radially displacing the ball bearing into the interference opening (183). causing an outward displacement in the direction of the rotation of the upper and lower pinion gears, thereby creating an interference relationship between the rotation of the upper and lower pinion gears; and vi. The center pin (170) is offset radially outward from the longitudinal axis (22) of the handle body portion (20). The spring (184) at the lower pinion gear (168) provides at least one ball bearing (178). and directing the ball bearings (178) radially outward through their respective side openings (180) into the interference openings (183), thereby creating an interference relationship between the upper pinion gear (166) and the lower pinion gear (168), and depressing the central pin (170), thereby removing the outward displacement of the ball bearings (178) and eliminating the interference relationship between the rotation of the upper pinion gear (166) and the lower pinion gear (168), thereby causing rotation of the proximal handle (20) independent of longitudinal movement of the delivery catheter (28) along the primary longitudinal axis (22) relative to the handle body portion (20). 31. The delivery device of paragraph 30, comprising: Section 32 a) a shift knob (42) at the distal handle (40) that is rotatable about the handle body portion (12); and b) A drive shaft (88) connecting the shift knob (42) and the first locking mechanism (38), The rotation activates the first locking mechanism (38), which locks the proximal handle (36) and the push rod (32). is engaged or disengaged, and engagement of the proximal handle (36) with the pusher rod (32) results in distal movement of the proximal handle (36), moving the pusher rod (32) and delivery catheter (28) to a first, retracted position. to a second extended position distal to the outer catheter (48). 32. The delivery device of paragraph 31, further comprising: Item 33 Rotation of the shift knob (42) in a direction that releases the proximal handle (36) from the push rod (32) initiates a second operation. Subsequent proximal movement of the proximal handle (36) causes the locking mechanism (132) and push rod (32) to engage. 33. The delivery device of claim 32, wherein the delivery catheter (28) is retracted from the rod (32). Section 34 Fixing the first locking mechanism (38) to the push rod (32) and fixing the second locking mechanism (132) to the push rod (32) Rotation of the shift knob (42) to a predetermined intermediate position activates the push rod (32) to engage the first locking mechanism (38) or 33. The delivery device of claim 32, wherein the push rod (32) is not secured to either the first or second locking mechanism (132) and can be retracted independently of movement of the proximal handle (36). Item 35 a) an apex release catheter (154) having a distal end (210), the apex release catheter (154) extending around the guidewire catheter (12) and into the pushrod (32); and b) i. a distal capture component (56) proximal to the distal end (16) of the guidewire catheter (12); and ii. a proximal capturing component (54) secured to the distal end (210) of the apex-release catheter (154) and mateable with the distal capturing component (56); a top clasp assembly (52) including 35. The device of paragraph 34, further comprising: Section 36 The device further includes a proximal clasp assembly (184) at the proximal end (34) of the pusher rod (32) proximal to the handle body portion (20), the proximal clasp assembly (184) comprising: a) a fixed component (188) fixed to the distal end (16) of the guidewire catheter (12); and b) an outer coupling (186) distal to the fixation component (188), said outer coupling (186) , which is secured to the apex-release catheter (154) and is in interference relationship with a first position fixation component (188) that secures the proximal capturing component (54) in mating relationship with the distal capturing component (56) in the first position, and moves the proximal capturing component (54) away from the distal capturing component (56) to displace the distal capturing component (56). a fixed component (188) that is not in meshing relationship with the capture component (56) from a first position to a second position; movable into position, 36. The device of paragraph 35, comprising: Section 37 The proximal capture component (54) includes distally extending tines, the distal capture component (56) defines recesses for receiving the tines in mating relationship, and an apex end (68) of an exposed stent (66) of a vascular prosthesis component (58) loaded within the delivery device (10) is captured by the apex clasp assembly (52) prior to implantation, and a first outer coupling (186) of the proximal clasp assembly (184) is inserted between the apex clasp assembly (52) and the distal capture component (56) defines recesses for receiving the tines in mating relationship. The movement from the first position to the second position allows implantation of the vascular prosthesis component (58) at the surgical site. 37. The delivery device of paragraph 36, wherein the exposed stent (66) is released during implantation. Section 38 38. The delivery device of paragraph 37, further comprising a nosecone (50) at the distal end (16) of the guidewire catheter (12) and distal to the distal capture component (56). Item 39 a) a handle body portion (20) having a longitudinal axis (22), a proximal end (24) and a distal end (26); b) a gear rack (106) extending into the handle body portion (20); c) a proximal handle (36) extending around the gear rack (106) and defining teeth (156), the proximal handle (36) being rotatable around the handle body portion (20) and the gear rack (106); d) a distal handle (40) extending around the handle body portion (20) at the distal end (26) of the handle body portion (20); e) a guidewire catheter (12) having a proximal end (14) and a distal end (16), the guidewire catheter (12) extending through a handle body portion (20), a proximal handle (36), a distal handle (40) and along a longitudinal axis (22); f) a delivery catheter (28) having a distal end (30) axially fixed to the proximal handle (36) and extending from within the distal end (26) of the handle body portion (20) and around the guidewire catheter (12); g) distally from the distal handle (40) and the delivery catheter (28) in a first, retracted position. an outer catheter (48) extending around the h) a gear assembly connecting the teeth (156) of the proximal handle (36) to the gear rack (106), such that rotation of the proximal handle (36) about the longitudinal axis (22) rotates the gear rack (106) along the longitudinal axis (22); The proximal handle (36) and delivery catheter (28) are moved, where the gear assembly i. a pinion gear assembly (164) that mates with the gear rack (106); and ii. a linkage gear assembly (158) including an upper linkage gear (160) that mates with the teeth (156) of the proximal handle (36) and a lower linkage gear (162) fixed to the upper linkage gear (160) between the upper linkage gear (160) and the longitudinal axis (22) of the handle body portion (20), the linkage gear assembly (158) having teeth that mate with a pinion gear assembly (164); Here, the upper connecting gear (166) and the lower connecting gear (162) have a common rotation axis perpendicular to the longitudinal axis (22) of the handle body portion (20), The upper linkage gear (160) and the lower linkage gear (162) each define a central opening along a common axis of rotation; i) a pushrod (32) extending around the guidewire catheter (12) and into the delivery catheter (28), the pushrod (32) being secured to the guidewire catheter (12) at its proximal end proximal to the handle body portion (20) and selectively secured to the proximal handle (36); j) a locking mechanism assembly extending around the push rod, said locking mechanism comprising: i. a first locking mechanism that secures the delivery catheter to the push rod when the locking mechanism is in the first locked position; a locking mechanism (38), wherein the first locking mechanism (38) defines a first socket (174) and is connected to a housing (81); defines a second socket, opposite ends of the pin being disposed within the first socket (174) and the second socket; and ii. When the locking mechanism assembly is in the second locked position, the push rod (32) is inserted into the handle body portion ( a second locking mechanism (132) secured to the distal end (26) of the handle body portion (20); wherein the first locked position and the second locked position are mutually exclusive; k) an actuator (80) including a gear assembly, said actuator comprising: i. a proximal end and a distal opening extending around the handle body portion (20) and defining a proximal opening; a housing (81) having a distal end defining a proximal opening and a distal opening, the housing (81) further defining an aperture between the proximal opening and the distal opening; ii. a central pin extending through central openings in the upper linkage gear (160) and the lower linkage gear (162), the pin including opposite ends residing in the locking mechanism assembly and the housing (81); and l) a clutch on the gear assembly, which engages the gear assembly and the proximal handle, thereby biasing longitudinal movement of the gear assembly and associated rotation of the proximal handle (36) about the longitudinal axis, wherein rotation of the proximal handle (36) about the longitudinal axis (22) when the clutch is engaged is resisted by friction between the clutch and at least one of the gear assembly and the remainder of the delivery device (10), and when the gear assembly is oriented in the proximal direction; When engaged, the clutch engages the pin and the linking gear assembly, and rotation of the proximal handle (20) to direct the gear assembly in a proximal direction is resisted by an interference relationship between the pin and at least one of the first socket and the second socket. A delivery device (10). Section 40 40. The delivery device of paragraph 39, wherein the clutch is a one-way roller needle clutch. Section 41 41. The delivery device of paragraph 40, wherein the one-way roller needle clutch is press-fit onto the upper connecting gear. Section 42 40. The delivery device of paragraph 39, wherein the clutch is a coil spring. Section 43 A coil spring extends around the pin and is secured at one end to the upper connecting gear. The delivery device described. Section 44 a) a handle body portion (20) having a longitudinal axis (22), a proximal end (24) and a distal end (26); b) a gear rack (106) extending into the handle body portion (20); c) a proximal handle (36) extending around the gear rack (106) and defining teeth (156), the proximal handle (36) being rotatable around the handle body portion (20) and the gear rack (106); d) a distal handle (40) extending around the handle body portion (20) at the distal end (26) of the handle body portion (20); e) a guidewire catheter (12) having a proximal end (14) and a distal end (16), the guidewire catheter (12) extending through a handle body portion (20), a proximal handle (36), a distal handle (40) and along a longitudinal axis (22); f) a delivery catheter (28) having a distal end (30) axially fixed to the proximal handle (36) and extending from within the distal end (26) of the handle body portion (20) and around the guidewire catheter (12); g) an outer catheter (48) extending distally from the distal handle (40) and around the delivery catheter (28) in a first, retracted position; h) a gear assembly connecting the teeth (156) of the proximal handle (36) to the gear rack (106), such that rotation of the proximal handle (36) about the longitudinal axis (22) rotates the gear rack (106) along the longitudinal axis (22) The gear assembly moves the proximal handle (36) and delivery catheter (28). i. a pinion gear assembly (164) that mates with the gear rack (106); and ii. a linkage gear assembly including an upper linkage gear (160) that mates with the teeth (156) of the proximal handle (36) and a lower linkage gear (162) fixed to the upper linkage gear (160) between the upper linkage gear (160) and the longitudinal axis (22) of the handle body portion (20), the linkage gear assembly having teeth that mate with a pinion gear assembly (164); (158) Here, the upper connecting gear (166) and the lower connecting gear (162) have a common rotation axis perpendicular to the longitudinal axis (22) of the handle body portion (20), The upper linkage gear (160) and the lower linkage gear (162) each define a central opening along a common axis of rotation; i) a pushrod (32) extending around the guidewire catheter (12) and into the delivery catheter (28), the pushrod (32) being secured to the guidewire catheter (12) at its proximal end proximal to the handle body portion (20) and selectively secured to the proximal handle (36); j) a locking mechanism assembly extending around the push rod, said locking mechanism comprising: i. a first locking mechanism that secures the delivery catheter to the push rod when the locking mechanism is in the first locked position; A locking mechanism (38), and ii. a second locking mechanism (132) secured to the distal end (26) of the handle body portion (20) for securing the push rod (32) to the handle body portion (20) when the locking mechanism assembly is in the second, locked position; wherein the first locked position and the second locked position are mutually exclusive; k) an actuator (80) including a gear assembly, said actuator comprising: i. a proximal end and a distal opening extending around the handle body portion (20) and defining a proximal opening; a housing (81) having a distal end defining a proximal opening and a distal opening, the housing (81) further defining an aperture between the proximal opening and the distal opening; ii. a pin extending through central openings in the upper linkage gear (160) and the lower linkage gear (162), the pin including opposite ends residing in the locking mechanism assembly and the housing (81); l) a clutch on the gear assembly, the clutch engaging the gear assembly and the proximal handle, thereby biasing longitudinal movement of the gear assembly and associated rotation of the proximal handle (36) about the longitudinal axis, wherein rotation of the proximal handle (36) about the longitudinal axis (22) when the clutch is engaged is resisted by friction between the clutch and at least one of the gear assembly and the remainder of the delivery device (10), the clutch selecting the pin and the interlocking gear assembly; the engagement is dependent on the direction of rotation of the proximal handle (36) around the handle body portion (20); and m) a second clutch that engages a pin with the linkage gear assembly (158) when the pinion gear assembly (164) is oriented distally along the gear rack (106) during engagement of the linkage gear assembly (158) and the pinion gear assembly (164), wherein the second clutch is a coil spring secured at one end to the first locking mechanism (38), the pin extending through the coil spring, and the coil spring engaging the pin when the pinion gear assembly (164) is oriented distally along the gear rack (106) during engagement of the linkage gear assembly (158) and the pinion gear assembly (164); a delivery device comprising: Section 45 a) a handle body portion (20) having a longitudinal axis (22), a proximal end (24) and a distal end (26); b) a gear rack (106) extending into the handle body portion (20); c) a proximal handle (36) extending around the gear rack (106) and defining teeth (156), the proximal handle (36) being rotatable around the handle body portion (20) and the gear rack (106); d) a distal handle (40) extending around the handle body portion (20) at the distal end (26) of the handle body portion (20); e) a guidewire catheter (12) having a proximal end (14) and a distal end (16), the guidewire catheter (12) extending through a handle body portion (20), a proximal handle (36), a distal handle (40) and along a longitudinal axis (22); f) a delivery catheter (28) having a distal end (30) axially fixed to the proximal handle (36) and extending from within the distal end (26) of the handle body portion (20) and around the guidewire catheter (12); g) distally from the distal handle (40) and the delivery catheter (28) in a first, retracted position. an outer catheter (48) extending around the h) a gear assembly connecting the teeth (156) of the proximal handle (36) to the gear rack (106), such that rotation of the proximal handle (36) about the longitudinal axis (22) rotates the proximal handle (36) along the longitudinal axis (22) relative to the gear rack (106); The gear assembly moves the proximal handle (36) and the delivery catheter (28). i. a pinion gear assembly (164) that mates with the gear rack (106); and ii. an upper linkage gear (160) that mates with the teeth (156) of the proximal handle (36) and a linkage gear assembly (158) fixed to the upper linkage gear (160), the linkage gear assembly (158) including a lower linkage gear (162) between the upper linkage gear (160) and the longitudinal axis (22) of the handle body portion (20), the lower linkage gear (162) having teeth that mate with a pinion gear assembly (164); Here, the upper connecting gear (166) and the lower connecting gear (162) have a common rotation axis perpendicular to the longitudinal axis (22) of the handle body portion (20), The upper linkage gear (160) and the lower linkage gear (162) each define a central opening along a common axis of rotation; i) a pushrod (32) extending around the guidewire catheter (12) and into the delivery catheter (28), the pushrod (32) being secured to the guidewire catheter (12) at its proximal end proximal to the handle body portion (20) and selectively secured to the proximal handle (36); j) a locking mechanism assembly extending around the push rod, said locking mechanism comprising: i. a first locking mechanism that secures the delivery catheter to the push rod when the locking mechanism is in the first locked position; A locking mechanism (38), and ii. a second locking mechanism (132) secured to the distal end (26) of the handle body portion (20) for securing the push rod (32) to the handle body portion (20) when the locking mechanism assembly is in the second, locked position; wherein the first locked position and the second locked position are mutually exclusive; k) an actuator (80) including a gear assembly, said actuator comprising: i. a proximal end and a distal opening extending around the handle body portion (20) and defining a proximal opening; a housing (81) having a distal end defining a proximal opening and a distal opening, the housing (81) further defining an aperture between the proximal opening and the distal opening; ii. a pin extending through central openings in the upper linkage gear (160) and the lower linkage gear (162), the pin including opposite ends residing in the locking mechanism assembly and the housing (81); l) a clutch on the gear assembly, the clutch engaging the gear assembly and the proximal handle, thereby biasing longitudinal movement of the gear assembly and associated rotation of the proximal handle (36) about the longitudinal axis, wherein when the clutch is engaged, rotation of the proximal handle (36) about the longitudinal axis (22) is resisted by friction between the clutch and at least one of the gear assembly and the remainder of the delivery device (10), and the clutch biases the gear assembly in the proximal direction. selectively engaging the pin and the linkage gear assembly when oriented; m) a second clutch for engaging a pin with the linkage gear assembly (158) when the pinion gear assembly (164) is oriented distally along the gear rack (106) during engagement of the linkage gear assembly (158) with the pinion gear assembly (164), the second clutch being attached at one end to the housing (81); a coil spring secured to the linkage gear assembly (158), the pin extending through the coil spring, the coil spring engaging the pin when the pinion gear assembly (164) is oriented distally along the gear rack (106) during engagement of the linkage gear assembly (158) and the pinion gear assembly (164).

Claims

1. a) a handle body portion (20) having a longitudinal axis (22), a proximal end (24) and a distal end (26); b) a gear rack (106) extending into the handle body portion (20); c) a proximal handle (36) extending around the gear rack (106) and defining teeth (156), wherein the proximal handle (36) is rotatable around the handle body portion (20) and the gear rack (106); d) a distal handle (40) extending around the handle body portion (20) at the distal end (26) of the handle body portion (20); e) a guidewire catheter (12) having a proximal end (14) and a distal end (16), wherein the guidewire catheter (12) extends through a handle body portion (20), a proximal handle (36), and a distal handle (40) and along a longitudinal axis (22); f) a gear assembly connecting the teeth (156) of the proximal handle (36) to the gear rack (106), wherein rotation of the proximal handle (36) about the longitudinal axis (22) causes the proximal handle (36) and delivery catheter (28) to move along the longitudinal axis (22) relative to the gear rack (106), the gear assembly i. a pinion gear assembly (164) that mates with the gear rack (106); and ii. a linkage gear assembly (158), wherein the linkage gear assembly (158) includes an upper linkage gear (160) that mates with the teeth (156) of the proximal handle (36), and a lower linkage gear (162) fixed to the upper linkage gear (160) between the upper linkage gear (160) and the longitudinal axis (22) of the handle body portion (20), the lower linkage gear (162) having teeth that mate with a pinion gear assembly (164); Includes; g) an actuator (80) including a gear assembly, wherein the actuator (80) comprises: i. a housing (81) extending around the handle body portion (20) and having a proximal end defining a proximal opening and a distal end defining a distal opening, the housing (81) further defining a bore between the proximal and distal openings; and ii. a pin extending through a central opening in the upper linkage gear (160) and the lower linkage gear (162), said pin including opposite ends residing in the locking mechanism assembly and housing (81); Further comprising: h) a first clutch (236) on the gear assembly, wherein the first clutch engages the gear assembly and the proximal handle, thereby biasing longitudinal movement of the gear assembly and relative rotation of the proximal handle (36) about the longitudinal axis; When the first clutch is engaged, rotation of the proximal handle (36) about the longitudinal axis (22) is resisted by friction between the first clutch and at least one of the gear assembly and the remainder of the delivery device (10); and i) a second clutch (238) that mates the linkage gear assembly (158) with the pinion gear assembly (164) when the pinion gear assembly (164) is oriented distally along the gear rack (106) during mating of the linkage gear assembly (158) with the pinion gear assembly (164); a delivery device comprising:

2. The delivery device of claim 1 , wherein the first clutch is a one-way needle roller clutch.

3. 3. The delivery device of claim 2, wherein the one-way needle roller clutch is press-fit onto the upper connecting gear.

4. 10. The delivery device of claim 1, wherein a first clutch selectively engages the pin and the linkage gear assembly, the engagement being dependent on the direction of rotation of the proximal handle (36) about the handle body portion (20).

5. The delivery device of claim 1 , wherein the second clutch is a coil spring.

6. The delivery device of claim 5 , wherein a coil spring extends around the pin and is secured at one end to the upper linkage gear.

7. 6. The delivery device of claim 5, wherein the coil spring is fixed at one end to a first locking mechanism (38), and the pin extends through the coil spring.

8. 6. The delivery device of claim 5, wherein during engagement of the linking gear assembly (158) and the pinion gear assembly (164), the coil spring is engaged with the pin when the pinion gear assembly (164) is oriented distally along the gear rack (106).

9. 2. The delivery device of claim 1, wherein resistance to proximal movement of the pinion gear assembly while the second clutch is engaged is caused by at least one of resistance to rotation of the second clutch bearing within a socket in which the one-way needle roller bearing is press-fit or interference between the pin and the second clutch, and the resistance is less than the resistance between the first clutch and the pin.

10. 10. The delivery device of claim 9, wherein the resistance is less than the resistance between the first clutch and the pin.

11. a) a delivery catheter (28) having a distal end (30) axially fixed to the proximal handle (36) and extending from within the distal end (26) of the handle body portion (20) and around the guidewire catheter (12); b) an outer catheter (48) extending distally from the distal handle (40) and around the delivery catheter (28) in a first, retracted position; The delivery device of claim 1 , further comprising:

12. 2. The delivery device of claim 1, wherein the upper link gear (166) and the lower link gear (162) have a common axis of rotation perpendicular to the longitudinal axis (22) of the handle body portion (20), and the upper link gear (160) and the lower link gear (162) each define a central opening along the common axis of rotation.

13. 10. The delivery device of claim 1, further comprising a push rod (32) extending around the guidewire catheter (12) and into the delivery catheter (28), the push rod (32) secured to the guidewire catheter (12) at a proximal end of the guidewire catheter (12) proximal to the handle body portion (20) and selectively secured to the proximal handle (36).

14. a) a delivery device further comprising a locking mechanism assembly extending around the push rod, the locking mechanism comprising: i. a first locking mechanism (38) that secures the delivery catheter to the push rod when the locking mechanism is in a first locked position; and ii. a second locking mechanism (132) secured to the distal end (26) of the handle body portion (20) that secures the push rod (32) to the handle body portion (20) when the locking mechanism assembly is in a second, locked position, wherein the first and second locked positions are mutually exclusive; The delivery device of claim 1 , comprising:

15. 2. The delivery device of claim 1, wherein the first clutch (236) is press-fit into an opening in the upper connecting gear (160).

16. 2. The delivery device of claim 1, wherein the pin (214) extends through the first clutch (236) and the second clutch (238).

17. The delivery device of claim 1 , wherein the first clutch rotates around the pin in a first direction.

18. 18. The delivery device of claim 17, wherein the second clutch (238) rotates around the pin (214) in the second direction.

19. 20. The delivery device of claim 18, wherein the first direction of rotation is opposite to the second direction of rotation.

20. The force required to overcome the friction caused by the second clutch (238) is less than the force caused by the first clutch (236). The delivery device of claim 1 , wherein the force required to overcome friction is less than that required to overcome friction.

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