Anti-reverse rotation component for a vascular prosthesis delivery device - Patent Application 20070122997

Abstract

The delivery device rotates a transmission mechanism around the pin and prevents longitudinal extension of the aortic prosthesis under compression due to engagement of the clutch and pin upon release of a handle that advances the aortic prosthesis during endovascular implantation at the surgical site.

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 aortic aneurysms remains challenging. Endovascular repair has become a promising option for developing repair of aortic aneurysms. The endovascular approach involves the insertion of an endovascular graft to exclude the aneurysmal 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 delivery and deployment process, the endovascular prosthesis is 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 the prosthesis within the endovascular delivery device is longitudinal compression resulting from the advancement of the prosthesis from a sheath that radially confines the prosthesis until it reaches the surgical site where it is deployed. Often, advancement is achieved by the surgeon rotating a handle around 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 is stopped, the prosthesis tends to resume its original longitudinal dimension as an opposing force in a direction opposite to the direction of prosthesis advancement (i.e., in a proximal direction back toward the surgeon) is applied. This opposing force is translated back by the delivery device's transmission, causing the handle to "counter-rotate" in a direction of rotation opposite that which the surgeon would have used to advance the prosthesis if the handle had been maintained. This can pose at least three problems for the surgeon during prosthesis implantation. First, the inability to accurately know the position of the prosthesis at the surgical site. Regardless of fluoroscopic views, even a momentary release of the handle used by the surgeon to advance the prosthesis to the surgical site results in a dislocation of the prosthesis, leaving the surgeon uncertain as to how much further the surgeon needs to advance the handle to continue advancing the prosthesis, as the prosthesis as a whole will regain its longitudinally compressed position before continuing advancement of the prosthesis. The second problem is related to the first and consists of a lack of sensitivity in overall control of the prosthesis during delivery and, most importantly, when landing the prosthesis during deployment and release of the prosthesis from the delivery device, which is generally part of an irreversible procedure.Third, when advancing the prosthesis by rotating the handle, the gear teeth in the transmission assembly that converts the 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, sometimes ad hoc, such as 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, a 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 the 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 extends distally from the distal handle and around the delivery catheter when the delivery catheter is in a first, retracted position. 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 mates the gear assembly with 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 pinion gear and the lower pinion gear relative to one another. This embodiment also includes a ball bearing in at least one of the side openings, where 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 in the lower pinion gear opening includes a frustoconical portion between a base portion having a first diameter and a second diameter smaller than the first diameter and is disposed in the upper pinion gear opening, where movement of the frustoconical portion of the center pin causes radial outward displacement of the ball bearing into the interference opening, thereby creating an interference relationship between rotation of the upper pinion gear and the lower pinion gear.A spring on the lower pinion gear provides a radially outward bias to the central pin from the longitudinal axis of the handle body portion, and the ball bearings are directed radially outward through the side openings and into the interference openings, thereby creating an interference relationship between the rotation of the upper pinion gear relative to the lower pinion gear, and by depressing the central pinion, the outward displacement of the ball bearings is removed, eliminating the interference relationship between the rotation of the upper and lower pinion gears and causing rotation of the proximal handle relative to the handle body portion independent of longitudinal movement of the delivery catheter along the longitudinal axis.

[0007] In 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. A gear rack extends within the handle body portion, and a proximal handle extends around the gear rack to define teeth, where the proximal handle is rotatable around the handle body portion and the gear rack. A distal handle extends around the handle body portion at the 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. 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 extends distally from the distal handle and around the delivery catheter in a first, retracted position. A gear assembly couples teeth of 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 the upper link gears in the lower link gears 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 fixed at a proximal end to the guidewire catheter and proximal to the handle body, and is selectively fixed to the proximal handle. The locking mechanism assembly includes a first locking mechanism extending around the push rod and securing the delivery catheter to the push rod when the locking mechanism is in a first locked position, wherein the first locking mechanism defines a first socket, the housing defines a second socket, and opposite ends of the pin are disposed in the first socket and the second socket.The second locking mechanism is secured to the proximal end of the handle body portion to secure the push rod to the handle body portion when the locking mechanism assembly is in the second locked position, wherein the locking function of the first locking position in the second locked position is 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 defining an aperture between the proximal and distal openings. A central pin extends through the central openings of the upper and lower linkage gears. The pin has opposite ends in the locking mechanism assembly and the housing. The 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, where when the clutch is engaged, 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, and the clutch engages the pin and the connecting gear assembly when the gear assembly is oriented proximally, where rotation of the proximal handle that orients the gear assembly proximally is resisted by an interference relationship between the pin and at least one of the first and second sockets.

[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, 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. An outer catheter extends distally from the distal handle and around the delivery catheter in a first, retracted position. The gear assembly couples the teeth of 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 the teeth of 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 having 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. The pusher rod 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. The pusher rod is selectively fixed to the proximal handle. The locking mechanism assembly 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 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 a second locked position, wherein the locking functions of the first and second locked positions are mutually exclusive.The actuator further includes a housing including the gear assembly and 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, 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 selectively engages the pin and linkage gear assembly when the gear assembly is oriented proximally. The second clutch engages the pin with the linkage gear assembly when the pinion gear assembly is oriented distally along the gear rack during mating of the linkage gear assembly and the pinion gear assembly. The second clutch is a coil spring secured at one end to the first locking mechanism, with the pin extending through the coil spring, and the coil spring engages the pin when the pinion gear assembly is oriented distally along the gear rack during mating 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 and defines 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 proximal and distal ends and 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. An outer catheter extends distally from the distal handle and around the delivery catheter in a first, retracted position. 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 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. The pusher rod 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 extending around the pusher rod and securing the delivery catheter to the pusher rod when the locking mechanism is in a first locked position, and a second locking mechanism secured to the proximal end of the handle body portion and securing the pusher rod to the handle body portion 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 including the gear assembly 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 openings in the distal opening. A central pin of the actuator extends through the central openings of the upper and lower linkage gears, the pin including an opposite end that is in the locking mechanism and 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 selectively engages the pin and linkage gear assembly when the gear assembly is oriented proximally. A second clutch engages the pin with the linkage gear assembly when the pinion gear assembly is oriented distally along the gear rack during mating of the linkage gear assembly and the pinion gear assembly, wherein the second clutch is a coil spring fixed at one end to the housing, the pin extends through the coil spring, and the coil spring engages the pin when the pinion gear assembly is oriented distally along the gear rack during mating 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 handle rotation and provides the surgeon with a mechanical advantage 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, for example, by static friction between the clutch and at least one of the pins around which the clutch extends, and by an interference fit between the clutch or 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. The 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 the clutch 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 FIG. 1. The delivery device 10 includes a guidewire catheter 12 (FIGS. 10 and 11) having a proximal end 14 and a distal end 16. As used herein with reference to the delivery device and its components, "proximal" means relatively close to the surgeon operating the delivery device. As used herein with reference to the delivery device and its components, "distal" means relatively distal to the surgeon operating the delivery device. As used herein with reference to the prosthesis, stent graft, and components, "proximal" means relatively close to the patient's heart. As used herein with reference to the prosthesis, stent graft, and components, "distal" means relatively distal from the patient's heart. Returning to FIG. 1, the delivery device 10 includes a delivery assembly 18 that extends around a guidewire catheter (not shown). The delivery assembly 18 includes a handle body portion 20 having a major longitudinal axis 22, a proximal end 24, and a distal end 26. Delivery catheter 28 (FIG. 9) has a distal end 30 (FIG. 27B) that extends from within distal end 26 of handle body portion 20 (FIG. 1) and over a guidewire catheter (not shown).

[0014] In one embodiment, the pusher rod 32 extends around the guidewire catheter 12 and into the delivery catheter 28 (FIGS. 10, 11). The pusher rod 32 is secured to the guidewire catheter 12 at the proximal end 34 of the pusher rod 32 proximal to the handle body with a pin 192 (FIG. 25). Referring back to FIG. 1, the proximal 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 FIGS. 12A and 12B. A first locking mechanism 38 (FIG. 15) on handle body portion 20 selectively mates push rod 32 with proximal handle 36 (FIGS. 12A and 12B).

[0015] A distal handle 40 extends around the handle body portion 20 at its distal end 26 and is distal to a shift knob 42 of a locking mechanism 37 including a first locking mechanism 38 and a second locking mechanism 132 ( FIG. 15 ). A distal handle nose 44 ( FIG. 1 ) extends distally from the distal handle 40 and 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, if necessary, hydrate contact between components of the delivery device 10 and a vascular prosthesis (not shown) within the subject 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 coupled to the drive gear 86 by a drive shaft 88. The drive shaft 88 has a proximal end 90 and a distal end 92 and travels 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, is coupled to the drive shaft 88 by an intermediate gear 94A, such that rotation of the shift knob 42 around the handle body portion 20 results in rotation of the drive shaft 88 due to the coupling between the shift knob 42 and the drive shaft 88 by the intermediate gear 94A. In this embodiment, the shift knob 42 is indirectly coupled to the drive shaft 88, as opposed to a direct coupling. A “direct coupling” is an optional embodiment and is direct contact between the shift knob 42 and the drive shaft 88. The shift knob 42 is rotatably coupled to the distal handle 40, which is fixed to the distal end 26 of the handle body portion 20, as shown in FIG. 1 .

[0018] In another embodiment shown in Figures 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 is connected to a connecting gear 98 that is coaxially connected to the drive shaft 88. Because of the gear reduction, the rotational speed of the shift knob 42 relative to the drive shaft 88 can be controlled by the relative dimensions of the reduction gear 96 and the connecting gear 98 (Figures 5, 6, 7). Typically, the rotational ratio or reduction ratio of the shift knob 42 to the drive shaft 88 is a ratio of about 1:2 to about 1:6. The relationship between the reduction gear 96 and the connecting gear 98 can be seen in more detail in Figure 6.

[0019] As can be seen in more detail in FIG. 7 , the delivery catheter 28 extends through the handle body 20, the distal handle 40, and the distal handle nose 44. Referring back to FIG. 5 , the outer catheter 48 is coupled to the base 102, such that the outer catheter 48 is rotatable independently of the handle body 20. As shown in FIG. 8 , a 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 that is greater than the width of the slot 84, and the contraction ring 104 prevents application of a longitudinal compressive force to the delivery catheter 28 by the proximal handle 36 from constricting the delivery catheter 28, thereby moving it through the slot 84 and out of the handle body 20. The contraction ring 104 also has an inner diameter slightly smaller than the outer diameter of the delivery catheter 28, and the contraction ring 104 has an interference fit with the delivery catheter 28 so that the contraction ring 104 can move longitudinally along the delivery catheter 28 when oriented, but otherwise remains in a fixed position relative to the delivery catheter 28. A gear rack 106 extends longitudinally within the handle body 20. A pin 108 at the distal end 26 of the handle body 20 extends from the distal end 26 of the handle body 20 and selectively fits into slots 110, 112, 114 in the shift knob 42. The shift knob 42 is movable longitudinally along the handle body 20 and is rotatable about the handle body 20 sufficiently such that rotation of the shift knob 42 moves the location of the pin 108 within any 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 rotates about a 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 mates with the drive shaft 88 at the drive gear 86 of the first locking mechanism 38. The first locking mechanism 38 is fixed relative to the proximal handle (not shown) at a distal bearing 120 through which the push rod 32 extends. The distal bearing 120 is connected to a first locking component housing 150 by a pin 122. A first locking component 124 of first locking mechanism 38 is fixed at a distal end 126 relative to distal bearing 120 and is coupled at a proximal end 128 to drive gear 86, such that rotation of drive shaft 88 and consequent rotation of drive gear 86 further or retracts the coil of first locking component 124, respectively, engaging or disengaging locking mechanism 38 and consequently proximal handle (not shown) with push rod 32. When first locking mechanism 38 is engaged with push rod 32, longitudinal movement of drive shaft 88 and therefore proximal handle (not shown) along handle body portion 20 results in longitudinal movement of push rod 32 along drive shaft 88 and handle body portion 20, as can be seen by comparing FIGS.

[0021] 10 and 11 , the drive shaft 88 is rotatably secured to the handle body 20 ( FIG. 9 ) at a proximal end 90 of the drive shaft 88 with a drive shaft bearing 130 that is part of a second 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 rotatably mates with a mechanism bearing 136 ( FIG. 11 ) that includes a proximal bearing 138 ( FIG. 10 ) and a distal bearing 140 ( FIG. 11 ), which is in turn secured to the handle body 20 with a pin 142. The proximal bearing 138 is radially and axially secured to the handle body 20. The distal bearing 140 is axially secured to the handle body 20. A second locking component 144 of the second locking mechanism 132 mates with one of the proximal bearings 138 at a proximal end 146 of the second locking component 144 and with the translation gear 134 at a distal end 148 of the second locking component 144, such that rotation of the drive shaft 88, and consequently rotation of the translation gear 134, tightens and engages or loosens and disengages the second locking component 144 and the push rod 32. When engaged with the push rod 32, the second locking component 144 secures the push rod 32 in a position relative to the handle body portion (not shown). When loosened and disengaged from the push rod 32, the push rod 32 is movable longitudinally relative to the handle body portion (not shown). The directions of the first and second locking components 124, 144 are reversed, and rotation of the drive shaft 88 in one direction simultaneously engages and disengages the first and second locking components 124, 144, respectively, from the push rod 32. Disengagement of the first locking component 124 from the push rod 32 occurs by movement of the shift knob 42 ( FIG. 9 ) from a first position defined by the pin 108 in a slot 110 in the shift knob 42 to a second position 112 defined by the pin 108 in a second slot 112 in the shift knob 42. This same movement of the shift knob 42 from the first position to the second position simultaneously engages the second locking component 144 with the push rod 32, and the push rod 32 is fixed in position relative to the handle body 20 by the second locking component 144, regardless of movement of the proximal handle 36 along the longitudinal axis 116 of the handle body 20.8 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. 11, the apex release catheter 154 extends into the pushrod 32, and 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 20. Rotation of the proximal handle 36 about the handle body 20, when the push button 82 is in a first position, results in longitudinal movement of the proximal handle 20 and the actuator 80 along the handle body 20, as shown in FIGS. 12A and 12B. Upon depression of the push button 82 to a second position, essentially flush with the actuator housing 81, rotation of the proximal handle 36 does not result in longitudinal movement of the proximal handle 36 or the actuator along the handle body 20. Rather, the proximal handle 36 and the actuator 80 are movable along the handle body 20 without rotation of the proximal handle 36 about the handle body 20.

[0024] As can be seen in FIGS. 13-15, teeth 156 of proximal handle 36 mate with upper link gear 160 of link gear assembly 158. Link gear assembly 158 mates with pinion gear assembly 164. Lower link gear 162 of link gear assembly 158 mates with upper pinion gear 166 of pinion gear assembly 164. Pinion gear assembly 164 is coupled to first locking component housing 150 (FIG. 11) through slot 84. Referring to FIG. 1, link gear assembly 158 and pinion gear assembly 164 are components of actuator 80. As can be seen in FIGS. 14 and 14A, coil spring 210 is disposed around pin 214 and secured at distal end 212 within recess 216 of upper link gear 160.

[0025] 16 is a perspective exploded view of first locking component housing 150, pin 214, upper link gear 160, and coil spring 210, showing how coil spring 210 is wound around or around pin 214 and how extension 218 at one end 212 of coil spring 210 engages and secures coil spring 210 in opening 217 in upper link gear 160 against rotation about pin 214 when upper link gear 160 is rotated in a direction that tightens spring 210 around pin 214. In this case, pin 214, when assembled, is aligned with and disposed within socket 174 (FIG. 11) of first locking component housing 150. When assembled, the pins 214 cause unidirectional rotation of the upper liking gear 160, tightening the coil spring 210 around the pin 214, thereby bringing the coil spring 210 into sufficient contact with the coil spring 210 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 liking gear 160 around the pin 214 causes the coil spring 210 to tighten around the pin 214, thereby securing the pin 214 using a clutch mechanism and causing the pin 214 to rotate with the upper liking gear assembly 158 upon continued clockwise rotation of the upper liking gear 160. This clutching mechanism, in which pin 210 clamps around and secures with pin 214, can be caused by the proximal (toward the surgeon) orientation of first locking mechanism 38 (FIG. 15) due to longitudinal extension of vascular prosthesis 58 (FIG. 47A, below) during implantation, facilitated, for example, by the surgeon releasing proximal handle 36 after advancing the prosthesis to the surgical site. Conversely, when proximal handle 36 is rotated by the surgeon in a clockwise direction, upper linkage gear 160, whose teeth mating with those of proximal handle 36, rotates in a counterclockwise direction, causing coil spring 210 to expand in diameter around pin 214, thereby releasing pin 214 from rotation of upper linkage gear 160.

[0026] 17 is a perspective, partial cutaway view of a portion of housing 81 and first locking mechanism 38 in combination with linkage gear assembly 158. Pinion gear assembly 164 is not shown for purposes of clarity of linkage gear assembly 158. As can be seen from the embodiment of the invention shown in FIG. 17, 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. In this embodiment, pin 214 is disposed in at least one of socket 222 and socket 174 by an interference fit such that pin 214 resists rotation about its longitudinal axis. The resistance is sufficient to prevent longitudinal extension of the delivered stent graft along longitudinal axis 22 (FIG. 1) when proximal handle 36 (FIGS. 1, 13, 14) is released by the surgeon after at least partial advancement of the vascular prosthesis, thereby preventing back-rotation. The resistance to rotation of pin 214 is not significant, but cannot be overcome by the surgeon in the event that the vascular prosthesis is intentionally moved back toward the surgeon (prior to deployment of the vascular prosthesis) by rotating proximal handle 36 in a direction opposite to the direction of advancement (e.g., in a counterclockwise direction, as opposed to the clockwise direction of rotation of proximal handle 36 described above). In one embodiment, the amount of force exerted by housing 81 as resistance to rotation ranges from about 2.0 lbf. inches to about 12.0 lbf. inches. In another embodiment, the amount of force exerted by housing 81 as resistance to rotation ranges from about 5.0 lbf. inches to about 7.0 lbf. inches. Preferably, housing 81 or at least the portion of housing 81 defining socket 222 is made of a medical-grade machined plastic that is gamma radiation compatible. Preferably, housing 81 is an injection-molded machined plastic. Socket 222 may also be an injection-molded machined plastic. Preferably, first locking mechanism 38 defining socket 174 is made of stainless steel, anodized aluminum, or a 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 devices of the present invention, at least one of the sockets 174, 222, the pin 214, or the needle of the 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 the socket 174, the second clutch 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 replaced with a one-way needle roller bearing clutch 226, such as those known in the art. A one-way needle roller bearing clutch is a clutch including "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 is a perspective exploded view of the first locking mechanism 38, pin 214, and linkage gear assembly 158, in which 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 press-fit into an opening 240 defined by the upper and lower linkage gears of the linkage gear assembly 158. Similar to the embodiment shown in FIG. 16 , the embodiment of FIG. 18 allows for clockwise rotation of the proximal handle 36, such as that shown in FIGS. 13 and 14 , and consequent counterclockwise rotation of the linkage gear assembly 158 about the pin 214, which is in an interference fit with the socket 222 defined by the housing 81 and at least one of the sockets 174 of the first locking component housing 150 of the first locking mechanism 38, thereby advancing the vascular prosthesis to the surgical site. However, the one-way needle roller bearing clutch 226 secures around the pin 214 and, due to the interference fit between the pin 214 and at least one of the sockets 222 and 174, resists proximal movement of the gear assembly 230 (FIGS. 13 and 14), consisting of the linkage gear assembly 158 and the pinion gear assembly 164, toward the surgeon, such as would result from longitudinal extension of the vascular prosthesis when the surgeon releases the proximal handle 36 (FIGS. 13 and 14) after at least partially advancing the vascular prosthesis to the surgical site.16 , the resistance to rotation of pin 214 provided by interference between pin 214 and at least one of socket 222 and socket 174 can be overcome by the surgeon by forcefully rotating proximal handle 36 in a counterclockwise direction, thereby retracting 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. It is also understood that other arrangements of resistance to rotation of linkage gear assembly 158 can be used when one-way needle roller bearing clutch 226 is fixed. For example, in embodiments where pin 214 is fused or fixed in place with either the housing or the first locking mechanism, an interference fit that resists reverse rotation but allows the surgeon to retract the vascular prosthesis by rotating the proximal handle 36 in a direction around the delivery device in a direction opposite to the direction of advancement could be achieved, for example, by an interference fit between the one-way needle roller bearing clutch 226 and the linkage gear assembly 158, or by overcoming friction between pin 214 and a component needle within the one-way needle roller bearing clutch 226.

[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 either fused to or has an interference fit with upper linkage gear 160 and lower linkage gear 162. In FIG. 19, one-way needle roller bearing clutch 232 is on one end of pin 214; although not shown, one-way needle roller bearing clutch 232 is disposed in socket 174 of first locking component housing 150, such as by being press-fit into socket 174. In FIG. 20, one-way needle roller bearing clutch 234 is on the opposite end of pin 214; again, although not shown, one-way needle roller bearing clutch 234 is disposed in socket 222 of housing 81 (FIG. 17), such as by being press-fit into socket 222 of housing. In either case, when first locking component housing 150 is urged in the proximal direction (toward the surgeon) ( FIGS. 12A and 12B ), resistance to reverse rotation may be resisted or caused by any one or combination of friction between pin 214 and linkage gear assembly 158, between pin 214 and one-way needle roller bearing clutch 232 or between one-way needle roller bearing clutch 234 and socket 222 ( FIGS. 16 and 17 ), and between one-way needle roller bearing clutch 234 and a socket in which it is disposed, such as socket 174 or 222. It is understood that the amount of torque applied to resist reverse rotation may vary among the components contributing to the overall resistance, depending on the application and the specific configuration and needs of the delivery device for implantation of a particular vascular prosthesis.

[0029] 21-30 are illustrations of an embodiment of the invention in which a delivery device of the invention includes two clutches 236, 238 that each engage in rotation about pin 214 in an opposite direction to the direction of engagement of the other about the same pin 214. In each of these embodiments, pin 214 need not be in an interference fit with a socket in either housing 81 or first locking mechanism 38. Instead, first clutch 236, which may be a one-way roller needle bearing clutch shown in FIG. 21, prevents reverse rotation as described above, while second clutch 238, such as a coil spring extending around pin 214 of linkage gear assembly 158, engages when linkage gear assembly 158 engages 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 second clutch 238 in this embodiment, pin 214 rotates within second clutch 238 while second clutch 238 is engaged, overcoming static friction between second clutch 238 and pin 214. The torque required to overcome resistance to rotation of pin 214 within second clutch 238 while engaging second clutch 238 may counteract that created by the interference fit between pin 214 and socket 222 of housing 81 or socket 174 of first locking component housing 150. Second clutch 238 may thereby provide increased control to the surgeon during surgery by enabling the manufacture of a delivery device that is less dependent on variability in the construction of sockets in either housing 81 or first locking component housing 150, specifications that generally require very low resistance to function within performance limits during use. Alternatively, pin 214 and linkage gear assembly 158 may not interlock during rotation of linkage gears 160, 162 that advances the vascular prosthesis. Rather, linkage gears 160, 162 are free to rotate about pin 214 when linkage gears 160, 162 rotate in a direction that advances the vascular prosthesis.Such alignment may be the result of a first clutch 236, such as the one-way needle roller bearing clutch shown in Figures 21-24 or a coil spring between the linkage gear and pin, so that the first clutch 236 engages the linkage gears 160, 162 and the pin 214 only when the first locking mechanism 38 is directed proximally (toward the surgeon) upon release of the proximal handle 36 (Figures 12A and 12B). In this embodiment, the second clutch 238 has no function during advancement of the vascular prosthesis by rotation of the proximal handle 36, but provides resistance to rotation of the pin 214 (Figure 21) during any counter-rotation of the linkage gears 160, 162 and the proximal handle 36 caused by the orientation of the first locking mechanism 38 in the proximal direction or by intentional rotation of the proximal handle 36 by the surgeon to retract the vascular prosthesis. In one embodiment, 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 linking gears 160, 162 rotate freely around the pin 214 during advancement of the vascular prosthesis.

[0030] In one particular embodiment of the invention including two clutches, FIG. 21 is an exploded view of the assembly of the invention, including a perspective view of pin 214, upper linkage gear 160, first clutch 236, which is a one-way needle roller bearing clutch, and second clutch 238, which is a coil spring clutch. When partially assembled as shown in FIG. 22, first clutch 236 is press-fit into opening 240 defined by upper linkage gear 160, and one end 242 of coil spring 238 is secured in slot 244 in housing 81, shown in FIG. 24. FIG. 23 is a side view of the partial assembly shown in FIG. 22. Pin 214 extends through first clutch 236 and second clutch 238. FIG. 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 disposed in socket 222 of housing 81 and socket 174 of first locking component housing 150, as described above. During advancement of the vascular prosthesis by clockwise rotation of handle 36 as described above, first clutch 236 is not engaged, so that upper linkage gear 160 and lower linkage gear 162 rotate freely about pin 214. Upon reverse or clockwise rotation of upper linkage gear 160, such as by urging linkage gear assembly 158 in the proximal direction due to longitudinal extension of a partially longitudinally compressed vascular prosthesis, first clutch 236 locks the rotation of pin 214 relative to the rotation of upper linkage gear 160, and rotation of pin 214 within second clutch 238 loosens the clutch about pin 214 while still providing frictional resistance to rotation of pin 214 within second clutch 238. In a preferred embodiment, the force required to overcome the frictional resistance to rotation of pin 214 in first clutch 236 when first clutch 238 is locked is greater than the force required to overcome the frictional resistance to rotation of pin 214 in second clutch 238 when rotating pin 214 in the same direction that locks first clutch 236.

[0031] In another specific embodiment of the invention including two clutches, FIG. 25 is an exploded view of the assembly of the invention including 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 246, which is a coil spring. When at least partially assembled, as shown in FIG. 25, first clutch 236 is press-fit into opening 240 defined by upper linkage gear 160, and coil spring 246 extends around one end of pin 214. As shown in FIG. 26, which is a perspective view of the combination of the subassemblies of FIG. 25 in assembled form, one end 248 of coil spring 246 is secured to first locking component housing 150. FIG. 27 is a side view of the embodiment shown in FIGS. 25 and 26. FIG. 28 is a top view of first locking component housing 150 showing socket 174 and slot 247 into which end 248 of coil spring 246 fits. As shown in FIG. 26, pin 214 extends through first clutch 236 and second clutch 246. FIG. 28 is a side view of the subassembly of FIG. 26. One end of pin 214 and coil spring 246 may be disposed within socket 174 of first locking component housing 150 when fully assembled. The opposite end of pin 214 is disposed within socket 222 of housing 81 (FIG. 17), as described above. As described above, during advancement of the vascular prosthesis by clockwise rotation of handle 36, first clutch 236 is not engaged, so linkage gear assembly 158 is free to rotate about pin 214. Upon reverse or clockwise rotation of the upper linking gear, the first clutch 236 locks the rotation of the pin 214 relative to the rotation of the upper linking gear 160, and the rotation of the pin 214 within the second clutch 238 loosens the second clutch (coil spring shown in FIGS. 25-28) 238 around the pin 214 while providing additional frictional resistance to the rotation of the pin 238.In a preferred embodiment, the force required to overcome the frictional resistance to rotation of pin 214 in first clutch 236 (which is a one-way needle roller bearing clutch) when first clutch 236 is locked is greater than the force required to overcome the frictional resistance to rotation of pin 214 in second clutch 238 when pin 214 is rotated in the same direction that locks first clutch 236.

[0032] 29 is an exploded view of another assembly of the present invention including 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. 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 within first clutch 236 when first clutch 236 is locked can be greater than the force required to overcome the frictional resistance to rotation of pin 214 within second clutch 250 when pin 214 is rotated in the direction in which first clutch 236 is locked.

[0033] When assembled, as shown in FIG. 30, the first clutch 236 is press-fit into the opening 241 in the upper linkage gear 160, and the second one-way needle roller bearing clutch 250 is press-fit into the socket 174 in 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 in the housing 81 (FIG. 17) and the second one-way needle roller bearing clutch 250. During advancement of the vascular prosthesis by clockwise rotation of the handle 36 as described above, the first one-way needle roller bearing clutch 236 does not engage, but the torque applied by the surgeon to the proximal handle is sufficient to overcome the frictional resistance provided against the pin 214 by the second one-way needle roller bearing clutch 250. The frictional resistance can be the result of friction between the second one-way needle roller bearing clutch 250 and the socket 174 of the first locking component housing 150 or between the needle of the second one-way needle roller bearing clutch 250 and the pin 214. Upon counterclockwise or clockwise rotation of the upper linkage gear 160 (or linkage gear assembly 158), the first clutch 236 locks the rotation of the pin 214 to the rotation of the upper linkage gear 160, and the rotation of the pin 214 within the second clutch 250 disengages the second clutch 250 from the pin 214. In one embodiment, the surgeon can rotate the proximal handle 36 in a direction to retract the vascular prosthesis by overcoming the frictional force provided by the first one-way needle roller bearing clutch 236. For example, the friction force can be at least one of the friction force 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 friction force between the needle rollers of the one-way needle roller clutch 236 and the pin 214.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 236 is locked is greater than the force required to overcome the frictional resistance to rotation of the pin 214 in the second clutch 250 when the pin 214 is rotated in a direction that locks the first clutch 236. The relative torque forces required to overcome the friction between the pin 214 and the first and second one-way needle roller clutches 236, 250 can be manipulated, 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 push button 82) of the first locking component housing 150 and the second locking component housing 152. A coil spring 210 as a clutch extends around a pin 214. An end 218 of the coil spring 210 is disposed within a recess in the upper link gear. This embodiment of the pin 214, clutch 210, link 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 mates with gear rack 106. As shown here, the first clutch is a one-way needle roller bearing clutch 236 that is press-fit into opening 240 defined by linkage gear assembly 158, and the second clutch is a coil spring 246 that is disposed within socket 174 through which pin 214 extends. In both the embodiments of FIGS. 31 and 32, delivery catheter 28 is coupled to first locking component housing 150 and therefore moves longitudinally along housing 150 with movement of proximal handle 36 and actuator 80 as shown in FIG. 1, regardless of whether first locking component 124 ( FIG. 19 ) is mated with pushrod 32 ( FIGS. 33 and 34 ). Thus, 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 causes rotation of linkage gear assembly 158 (FIGS. 1 and 34) and consequent rotation of pinion gear assembly 164 (FIG. 34) and movement of pinion gear assembly 164 along gear rack 106 (FIGS. 31, 32 and 34), as well as movement of proximal handle 36 (FIG. 1) and actuator 80 (FIGS. 12A and 12B) along handle body portion 20. Additionally, first locking component 124 (FIGS. 10, 11, 33 and 34) is mated with pusher rod 32, but rotation of proximal handle 36 causes longitudinal movement of pusher rod 32 along handle body portion 20. In all cases, movement of the proximal handle 36 and actuator 80 along the handle body 20 always occurs together, resulting in movement of the delivery catheter 28 longitudinally along the handle body 20 .

[0036] However, as explained further below, depression of the center pin 170 disengages the upper pinion gear 166 from the lower pinion gear 168. When the upper pinion gear 166 disengages from the lower pinion gear 168, rotation of the proximal handle 36 about the handle body 20 does not result in 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 obtained simply by moving the proximal handle 36 and actuator 80 along the handle body 20 without rotating the proximal handle 36 about the handle body 20 (FIGS. 1, 12A, and 12B).

[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 atop a center pin 170 that extends through the upper pinion gear 166. As can also be seen in FIGS. 35 and 36, the lower pinion gear 168 includes a pinion gear extension 265 that mates with the gear rack 106 and is axially aligned with the lower pinion gear 168, which is axially aligned with the upper pinion gear 166. A lower portion 172 of the pinion gear 168 extends into an opening 174 ( FIG. 11 ) defined by the first locking component housing 150 ( FIG. 11 ), thereby fixing the position of the pinion gear assembly 164 relative to the first locking component housing 150 ( FIG. 11 ), distal bearing 120 ( FIG. 11 ), first locking component 124, and drive gear 86, all of which are shown in the previous embodiment in FIG. 11 .

[0039] FIG. 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 extends through a side opening 180 defined by the pinion gear extension 265, and when the center pin 170 is in the extended position shown in FIG. 37, the frusto-conical portion 176 of the center pin 170 urges the ball bearing 178 outward and into an interference relationship with an interference opening 183 defined by the side opening 183 and the 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 ). When the interference opening 183 is occupied by the ball bearing 178, the upper pinion gear 166 mates with the lower pinion gear 168.

[0040] 40A to 40B, when center pin 170 is actuated by depressing button 82 (FIG. 1), center pin 170 moves within lower pinion gear opening 263, and ball bearings 178 are forced inward through side openings 180 in pinion gear 265 by rotation of upper pinion gear 166 about axis 269 relative to lower pinion gear 168, and 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 urged into engagement with lower pinion gear 168 by spring 184 located at the base of center pin 170 within pinion gear extension opening 263 in pinion gear extension 265. 40A and 40B, clutch 260 resides on lower extension 262 when clutch 260 is disposed in socket 174, not shown but described below. In another embodiment, shown in FIGS. 40B and 40C, clutch 260 resides on pinion gear 265 on lower pinion gear 164. In this embodiment, clutch 260 resides in a socket (not shown) with an 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 lower extension 262 is disposed within the one-way needle roller bearing clutch 260, which is then disposed, such as by a press fit, within the socket 174 shown in FIG. 41 of the first locking component housing 150. A side view of the pinion gear assembly 164 as assembled with the one-way needle roller bearing clutch 260 and first locking mechanism 38 is shown in FIG. 43. In use, the surgeon depresses the center pin 170 to compress the bias spring 184 and release the frusto-conical portion 176 of the center pin 170, thereby releasing the ball bearing 178 from its outer position, thereby disengaging the lower pinion gear 168 from the 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 position distal to the surgical site without rotating the proximal handle 36; the lower pinion gear 168 (FIGS. 40-42) continues to rotate because it remains engaged with the pinion rack 106 (FIGS. 36-38). However, because the upper pinion gear 166 is disengaged from the lower pinion gear 168, the upper pinion gear 166 does not rotate during longitudinal movement of the proximal handle 36 and first locking mechanism 38 along the handle body portion 20. When the surgeon releases or pulls the proximal handle 36 proximally (toward the surgeon), the lower pinion gear 168 spins in a direction opposite to the direction of longitudinal advancement of the vascular prosthesis. Rotation of the lower pinion gear 168 in a direction opposite to the advancement of the vascular prosthesis causes the one-way needle roller bearing clutch 260 to lock onto the lower extension 262, thereby providing resistance to further rotation of the lower pinion gear 168 and, consequently, further proximal longitudinal movement of the first locking mechanism 38 and the vascular prosthesis toward the surgeon. The resistance to further rotation of the lower pinion gear can be overcome by the surgeon pulling the proximal handle 36 proximally.Alternatively, the proximal handle 36 can be rotated in a counterclockwise direction, where the resistance to rotation is greater within the interference fit of the clutch 260 and socket 174 as the lower pinion gear extension 262 rotates and slides within the clutch needle roller. The resistance to further rotation is friction between at least the one-way needle roller bearing clutch 260 and the lower extension 262 of the lower pinion gear 168, which is disposed within the socket 1744 and one-way needle roller bearing clutch 260, into which the one-way needle roller bearing clutch 260 is press-fit. Upon approaching the vascular prosthesis to the surgical site where the vascular prosthesis will be deployed, the surgeon can release the central pin 170, thereby re-engaging the upper and lower pinion gears 168, 166.

[0042] Once the upper pinion gear 166 is re-engaged with the lower pinion gear 168 and the proximal handle 36 (e.g., 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 compressed longitudinally within the delivery device 10. When the surgeon releases the proximal handle 36, the vascular prosthesis exerts a proximal longitudinal force (toward the surgeon) against the first locking mechanism 36 and, consequently, the linkage gear assembly 158. Because the lower pinion gear mates with the gear rack 106, proximal longitudinal forces on the pinion gear assembly 164 urge 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 preventing further rotation in the same direction. Also, because the center pin 170 is not actuated, the lower pinion gear 168 and the upper pinion gear 166 are fixed, placing the ball bearing 178 in an interference relationship with the rotation of the upper pinion gear 166, thus preventing counter-rotation of the proximal handle 36 in a direction opposite to the direction of longitudinal advancement of the vascular prosthesis toward the surgical site and preventing longitudinal stretching of the vascular prosthesis caused by relief 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, to advance the vascular prosthesis toward 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 causing advancement, such as a counterclockwise direction. At any time before or after approaching the surgical site, the central pin 170 can be depressed to disengage the lower pinion gear 168 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] 46A, the nosecone 50 is secured to the guidewire catheter 12 at the distal end 16 of the guidewire catheter 12. A vascular prosthesis component 58 is positioned within the delivery device 10 proximal to the nosecone 50.

[0044] Figures 44 and 45 show perspective and cutaway views, respectively, of the proximal clasp assembly 184 components of the present invention. As can be seen in Figure 44, outer coupling 186 is slidable along the proximal end 34 of pushrod 32. Fixed component 188 is secured to the proximal end of the guidewire catheter by pin 192. Outer coupling 186 and fixed component 188 are in mating relationship at joint 190. A spring 194 within outer coupling 186 biases outer coupling 186 against fixed component 188. The proximal clasp assembly 184 is moved from the first position shown in Figures 44, 47B to the second position shown in Figure 51B by applying pressure to tongues 196 on either face of the outer coupling 186 and orienting the outer coupling 186 distally enough to allow ninety (90) degrees of rotation of the outer coupling 186, and then 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. Movement of the outer coupling 186 from the first position shown in Figure 44 to the position shown in Figure 51B causes the apex clasp assembly 52 to open, and the proximal capturing component is retracted from the first position in mating relationship with the distal capturing component 56 of the apex clasp assembly 52, shown in Figure 50B, to the second position shown in Figure 51C, where the proximal capturing component 54 is no longer in mating relationship with the distal capturing component 56. Proximal movement of the outer coupling 186 of the proximal clasp assembly 184 (FIGS. 44, 47B, 51B) relative to the fixed component 188 to separate the proximal capturing component 54 (FIG. 50B) from the distal capturing component 56 (FIGS. 50B, 51C) releases the apex 68 of the stent 66 at the proximal end 60 of the vascular prosthesis component 58.

[0045] 46A-46C are cross-sectional views of a portion of a delivery device 10 of the present invention, showing a vascular prosthesis component 58 in an undeployed state within the distal end 202 of the delivery device 10. Specifically, as shown in FIG. 46A, the vascular prosthesis component 58 is within a delivery sheath 200. The distal end 62 of the vascular prosthesis component 58 abuts the buttress 204. The buttress 204 then engages the pushrod 32 at its distal end 206, and the proximal end 60 of the vascular prosthesis component 58 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, as shown in FIG. The apex clasp assembly 52 includes a distal capturing component 56 at the distal end 16 of the guidewire catheter 12, and a 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 apex release catheter 154 and the guidewire catheter 12 extend through the vascular prosthesis component 58 and the pushrod 32 to the proximal clasp assembly 184 ( FIG. 45 ). As can be seen in FIG. 46C , a delivery sheath 200 is secured at its proximal end to the distal end 30 of the delivery catheter 28 and extends around the vascular prosthesis component 58 to the apex clasp assembly 52. ​​Returning to FIG. 46A , the nosecone 50 is secured distally to the distal capturing component 56 of the apex clasp assembly 52 on the guidewire catheter 12. The outer catheter 48 extends from the distal handle nose 44 (FIG. 1), around the delivery catheter 28 and delivery sheath 200 to the 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 closed (Figure 50B). The apex of the vascular prosthesis 58 is secured by the apex clasp assembly 52 when the proximal clasp assembly 184 is in the first position. The apex clasp assembly 52 is then secured to the distal end 16 of the guidewire catheter 12, and the shift knob 42 is in the first position when the pin 108 is within the slot 110 (Figure 47C), and longitudinal movement of the proximal handle 36 moves the pusher rod 32. The prosthesis 58 is advanced to a location distal to a vascular treatment site in a subject by rotation of the proximal handle 36 in a first direction about the handle body portion 20 of the delivery device 10, which has a distal end 26 through which the guidewire catheter 12 extends. The guidewire catheter 12 is disposed within the pusher rod 32 that also extends through the handle body portion 20, where the guidewire catheter 12 is secured to the pusher rod 32, such as by a pin 192 (FIG. 44) at the proximal end of the guidewire catheter 12 or the pusher rod 32, and rotation of the proximal handle 36 causes longitudinal movement of the guidewire catheter 12 and the pusher rod 32 along the handle body portion 20, thereby advancing the prosthesis 58 at least partially from the outer catheter 48, as can be seen in FIGS. 48A-48B. 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 portion 20, thereby allowing manual advancement of vascular prosthesis 58 to the subject's vascular treatment site without rotation of proximal handle 36 around handle body portion 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] 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 a 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, the push button 82 of the actuator 80 can be depressed, thereby releasing the rotation of the proximal handle 36 from the handle body 20, thereby completely retracting the delivery sheath 200 from the vascular prosthesis 58 without rotation of the proximal handle 36 around the handle body 20, as can be seen in FIG.

[0049] The proximal clasp assembly 184 is then actuated by compressing the outer coupling 186, first moving the outer coupling 186 distally, then rotating the outer coupling 186 90°, and then retracting the outer coupling 186 to a second position, as shown in FIG. 51B, thereby retracting the apex release catheter 154 into the pushrod 32 ( FIGS. 10 and 11 ) and retracting the proximal capturing component 54 from the distal capturing 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 releasing the prosthesis 58 from the delivery device 10, as can be seen in FIG. 51C. The shift knob 42 is then moved from the second position to a third position, where the pin 108 is disposed in the slot 114 between the first slot 110 and the second slot 112, as can be seen in FIG. 52B, thereby releasing the pushrod 32 from the handle body portion 20. The pushrod 32 and guidewire catheter 12 are then withdrawn from the vascular prosthesis 58 by pulling the pushrod 32 through the handle body portion 20, thereby completing delivery of the vascular prosthesis 58 to the treatment site, as can be seen in FIG. 52A.

[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) an outer catheter (48) extending distally from the distal handle (40) and around the delivery catheter (28) when the delivery catheter (28) is in the first, retracted position; 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) comprising: Section 2 Item 1, a delivery device, wherein when the clutch is engaged, rotation of the proximal handle (36) around 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). 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) mated with the gear rack (106) and selectively mated with the upper pinion gear (166), wherein the clutch (260) engages the lower pinion gear (168) when the gear assembly is oriented in a 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. Item 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 the side opening (180) and the upper pinion gear opening (182) of the upper pinion gear (166) together define an interference opening (183) that, when occupied, prevents rotation of the upper pinion gear (166) and the lower pinion gear (168) relative to one another; d) a ball bearing (178) within at least one of each side opening (180), said ball bearing (178) having a diameter greater than the thickness of the wall defining said side opening (180); e) a central 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 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, wherein movement of the frusto-conical portion (176) of the central pin (170) causes radial outward displacement of the ball bearings (178) 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) a spring (184) on the lower pinion gear (168) that provides a radially outward bias for the central pin (170) from the longitudinal axis (22) of the handle body portion (20); the ball bearing (178) is directed radially outward through the side opening (180), thereby creating an interference relationship between the upper pinion gear (166) and the lower pinion gear (168); and depressing the central pin (170) removes the outward displacement of the ball bearing (178), eliminating the interference relationship between the rotation of the upper pinion gear (166) and the lower pinion gear (168), resulting in rotation of the proximal handle (36) independent of longitudinal movement of the delivery catheter (28) along the longitudinal axis (22) relative to the handle body portion (20); Item 5. The delivery device of item 4, comprising: Section 11 The gear assembly a) a pinion gear assembly (164) that mates with the gear rack (106); and b) 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), 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. Item 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 (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 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 Item 14. The delivery device of item 13, wherein the pin is integral with or fused to at least one of the locking mechanism assembly and the housing (81). Item 15 Item 14. The delivery device of item 13, wherein 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 16 Item 16. The delivery device of item 15, wherein the clutch engages the pin when the gear assembly is oriented proximally. Item 17 Item 17. The delivery device of paragraph 16, wherein rotation of the proximal handle (20) that directs 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. 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 Item 17. The delivery device of item 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 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 A delivery device as described in item 13, wherein the linking gear assembly (158) further includes a second clutch that engages the linking gear assembly (158) with the pinion gear assembly (164) 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 27 27. The delivery device of claim 26, wherein the second clutch is a second one-way needle roller clutch bearing press-fit into the first or second socket through which the pin extends, and wherein the second one-way needle roller clutch bearing engages the 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 resistance to proximal movement of the pinion gear assembly while the second one-way needle roller clutch is engaged is caused by at least one of resistance to rotation of the second roller needle clutch bearing within the socket into which the one-way needle roller bearing is press-fit or interference between the pin and the second one-way needle roller clutch, 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 Item 27. A delivery device as described in item 26, wherein the second clutch is a coil spring fixed at one end to the housing (81), 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 connecting 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). Section 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) a lower pinion gear (168) axially aligned with the pinion gear axis of the upper pinion gear (166) and defining a lower pinion gear opening; 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 within the upper pinion gear opening, wherein the pinion gear extension defines the pinion gear extension opening and at least one side opening (180), and wherein the side opening (180) of the upper pinion gear (166) and the non-circular pinion gear opening (182) together define an interference opening (183), which, when occupied, prevents rotation of the upper pinion gear (166) and the lower pinion gear (168) relative to one another; iv. a ball bearing (178) within at least one of each side opening (180), said ball bearing having a diameter greater than the thickness of the wall defining said side opening (180); v. a central 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 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, wherein movement of the frusto-conical portion (176) of the central pin (170) causes radial outward displacement of the ball bearings into the interference openings (183), thereby creating an interference relationship between the rotation of the upper pinion gear and the lower pinion gear; and vi. a spring (184) on the lower pinion gear (168) that provides a radially outward bias for the central pin (170) from the longitudinal axis (22) of the handle body portion (20); at least ball bearings (178) directed radially outward through their respective side openings (180) into 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) removes the outward displacement of the ball bearings (178) and eliminates 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); rotation of the shift knob (42) actuates the first locking mechanism (38), thereby engaging or disengaging the proximal handle (36) and the push rod (32); engagement of the proximal handle (36) and the push rod (32) causes distal movement of the proximal handle (36), which moves the push rod (32) and delivery catheter (28) from 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 Item 33. A delivery device as described in paragraph 32, wherein rotation of the shift knob (42) in a direction to release the proximal handle (36) from the push rod (32) causes the second locking mechanism (132) to engage with the push rod (32), and subsequent proximal movement of the proximal handle (36) causes retraction of the delivery catheter (28) from the push rod (32). Section 34 Item 33. The delivery device of item 32, wherein rotation of the shift knob (42) to a position intermediate between the locking of the first locking mechanism (38) to the push rod (32) and the locking of the second locking mechanism (132) to the push rod (32) causes the push rod (32) to be unlocked to either the first locking mechanism (38) or the second locking mechanism (132), and the push rod (32) 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 stationary component (188), the outer coupling (186) being secured to the apex-release catheter (154) and in interference with the stationary component (188) in a first position that secures the proximal capturing component (54) in mating relationship with the distal capturing component (56) in the first position, and movable from a first position to a second position relative to the stationary component (188) that is not in mating relationship with the distal capturing component (56) to move the proximal capturing component (54) away from the distal capturing component (56); 36. The device of paragraph 35, comprising: Section 37 37. The delivery device of claim 36, wherein the proximal capture component (54) includes distally extending tines, the distal capture component (56) defines recesses for receiving the tines in mating relationship, the apex (68) of the exposed stent (66) of the vascular prosthesis component (58) loaded within the delivery device (10) is captured by the apex clasp assembly (52) prior to implantation, and movement of the outer coupling (186) of the proximal clasp assembly (184) from a first position to a second position releases the exposed stent (66) during implantation of the vascular prosthesis component (58) at the surgical site. 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). Section 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) 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) moves the proximal handle (36) and delivery catheter (28) along the longitudinal axis (22) relative to the gear rack (106), wherein 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 (38) that secures the delivery catheter to the pushrod when the locking mechanism is in a first locked position, wherein 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 within the first socket (174) and the second socket; 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; k) an actuator (80) including a gear assembly, said actuator comprising: 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 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, 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 when the gear assembly is oriented proximally, the clutch engages the pin and the connecting gear assembly, and rotation of the proximal handle (20), which orients the gear assembly proximally, 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 43. The delivery device of paragraph 42, wherein the coil spring extends around the pin and is secured at one end to the upper linkage gear. 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) moves the proximal handle (36) and the delivery catheter (28) 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) 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 (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; k) an actuator (80) including a gear assembly, said actuator comprising: 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 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 selectively engaging the pin and the interlocking gear assembly, the engagement depending on the direction of rotation of the proximal handle (36) about 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) 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) moves the proximal handle (36) and delivery catheter (28) relative to the gear rack (106) along the longitudinal axis (22), wherein the gear assembly: 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 (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; k) an actuator (80) including a gear assembly, said actuator comprising: 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 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 selectively engaging the pin and the interlocking gear assembly when the gear assembly is oriented in a proximal direction; 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), the second clutch being a coil spring fixed at one end to the housing (81), 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:

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 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) when the delivery catheter (28) is in the first, retracted position; 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) translates the proximal handle (36) and delivery catheter (28) along the longitudinal axis (22) relative to the gear rack (106); i. said gear assembly:

1. a pinion gear assembly (164) that mates with the gear rack (106); and 2. A linkage gear assembly (158), wherein the linkage gear assembly (158) is an upper link gear (160) that engages with the teeth (156) of the positioning handle (36); An upper connecting gear (160) between the gear (160) and the longitudinal axis (22) of the handle body portion (20). a lower connecting gear (162) fixed to the pinion gear assembly (164) and The upper and lower connecting gears (166, 162) have mating teeth. having a common axis of rotation perpendicular to the longitudinal axis (22) of the drum body portion (20); further comprising The upper linkage gear (160) and the lower linkage gear (162) each define a central opening along a common axis of rotation; i) a clutch in the gear assembly, wherein the 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 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); The clutch engages when the gear assembly is oriented proximally along the longitudinal axis; j) a pushrod (32) extending around the guidewire catheter (12) and into the delivery catheter (28), wherein the pushrod (32) is 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); and k) 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; locking mechanism (38), and ii. When the locking mechanism assembly is in the second locked position, the push rod (32) is inserted into the handle body. a second locking mechanism secured to the distal end (26) of the handle body portion (20); Mechanism(132) wherein the first locked position and the second locked position are mutually exclusive; and l) an actuator (80) including a gear assembly, wherein the actuator (80) comprises: i. a proximal end and a distal end extending around the handle body portion (20) and defining a proximal opening; a housing (81) having a distal end defining an opening, said housing (81) further defining an aperture between the proximal opening and the distal opening; and ii. A central hole extending through the central openings of the upper connecting gear (160) and the lower connecting gear (162) pin, wherein the central pin is a counter pin located in the locking mechanism assembly and housing (81). a clutch selectively engaging the pin and the connecting gear assembly; The engagement is dependent on the direction of rotation of the proximal handle (36) around the handle body portion (20). Exists, further comprising: A delivery device (10) comprising: m) the linkage gear assembly (158) further includes a second clutch that engages 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 engagement of the linkage gear assembly (158) with the pinion gear assembly (164); n) A delivery device (10) wherein the second clutch is a second one-way needle roller clutch bearing press-fit into the first or second socket into which the pin extends, and wherein the second one-way needle roller clutch bearing mates with the linkage gear assembly (158) and the pin 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 resistance to proximal movement of the pinion gear assembly while the second one-way needle roller clutch is engaged is caused by at least one of resistance to rotation of the second roller needle clutch bearing within the socket into which the one-way needle roller bearing is press-fit or interference between the pin and the second one-way needle roller clutch, and the resistance is less than the resistance between the first roller needle clutch and the pin.

2. The gear assembly a) an upper pinion gear (166) mated with the proximal handle (36), wherein the upper pinion gear (166) defines a non-circular pinion gear opening (182) and is 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), wherein the lower pinion gear (168) is engaged with the gear rack (106) and selectively engaged with the upper pinion gear (166), and wherein a clutch (260) engages the lower pinion gear (168) when the gear assembly is oriented in a proximal direction; The delivery device of claim 1 , further comprising a pinion gear assembly (164) comprising:

3. 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 the side opening (180) and the upper pinion gear opening (182) of the upper pinion gear (166) together define an interference opening (183) that, when occupied, prevents rotation of the upper pinion gear (166) and the lower pinion gear (168) relative to one another; d. a ball bearing (178) within at least one of each side opening (180), wherein said ball bearing (178) has a diameter greater than the thickness of the wall defining said 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, wherein the center pin (170) includes 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 center pin (170) being disposed within the upper pinion gear opening, and wherein movement of the frusto-conical portion (176) of the center pin (170) causes radial outward displacement of the ball bearings (178) 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. a spring (184) on the lower pinion gear (168) that provides a radially outward bias for the central pin (170) from the longitudinal axis (22) of the handle body portion (20), wherein the ball bearing (178) is directed radially outward through the side opening (180), thereby creating an interference relationship between the upper pinion gear (166) and the lower pinion gear (168); and depressing the central pin (170) removes the outward displacement of the ball bearing (178), eliminating the interference relationship between the rotation of the upper pinion gear (166) and the lower pinion gear (168), resulting in rotation of the proximal handle (36) independent of longitudinal movement of the delivery catheter (28) along the longitudinal axis (22) relative to the handle body portion (20); The delivery device of claim 2 , comprising:

4. A delivery device as described in claim 1, wherein the pin is integrated with or fused to at least one of the locking mechanism assembly and the housing (81).

5. 2. The delivery device of claim 1, wherein 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.

6. The delivery device of claim 5 , wherein a clutch engages the pin when the gear assembly is oriented proximally.

7. 7. The delivery device of claim 6, wherein rotation of the proximal handle (36) 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.

8. 7. The delivery device of claim 6, wherein rotation of the proximal handle (36) to direct the gear assembly in a proximal direction is resisted by an interference relationship between the clutch and at least one of the first socket and the second socket.

9. 7. The delivery device of claim 6, wherein rotation of the proximal handle (36) to direct the gear assembly proximally is resisted by an interference relationship between the clutch and the pin.

10. 2. The delivery device of claim 1, wherein the second clutch is a coil spring fixed at one end to the first locking mechanism (38), and wherein the pin 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 linking gear assembly (158) and the pinion gear assembly (164).

11. 2. The delivery device of claim 1, wherein the second clutch is a coil spring fixed at one end to the housing (81), and a pin 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 linking gear assembly (158) and the pinion gear assembly (164).

12. 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), 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), wherein rotation of the proximal handle (36) about the longitudinal axis (22) moves the proximal handle (36) and delivery catheter (28) 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 said linkage gear assembly (158) is The upper connecting gear (160) engages with the teeth (156) of the handwheel (36), and the upper connecting gear (160) and the handwheel (36) A lower link gear (160) is fixed to the upper link gear (160) between the longitudinal axis (22) of the drum body portion (20). a gear (162) having teeth that mate with a pinion gear assembly (164); Including, The upper connecting gear (166) and the lower connecting gear (162) have a common axis of rotation 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), wherein the pushrod (32) is 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); j. a locking mechanism assembly extending about 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 a first of the locking mechanisms (38) defines a first socket (174) and The housing (81) defines a second socket, and the opposite end of the pin is inserted into the first socket. (174) and disposed within 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. a second locking mechanism secured to the distal end (26) of the handle body portion (20); a mechanism (132), wherein the first locked position and the second locked position are mutually exclusive; Includes; k. an actuator (80) including a gear assembly, wherein said actuator (80) comprises: i. a proximal end and a distal end extending around the handle body portion (20) and defining a proximal opening; a housing (81) having a distal end defining an opening, said housing (81) further defining an aperture between the proximal opening and the distal opening; and ii. A central coupling extending through the central openings of the upper and lower coupling gears (160, 162). A center pin, where the pin is located in the locking mechanism assembly and the housing (81). including the side ends, and l. a clutch on the gear assembly, wherein the clutch 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, and 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 wherein the clutch engages the pin and the connecting gear assembly when the gear assembly is oriented proximally, and rotation of the proximal handle (36) that orients the gear assembly proximally 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) comprising: m. the linkage gear assembly (158) further includes a second clutch 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) and the pinion gear assembly (164), the second clutch being a second one-way needle roller clutch bearing press-fit into the first socket or the second socket through which the pin extends, and the pinion gear assembly (164) mates with the gear rack (106) during mating of the linkage gear assembly (158) and the pinion gear assembly (164), the second clutch being a second one-way needle roller clutch bearing press-fit into the first socket or the second socket through which the pin extends, a second one-way needle roller clutch bearing engages the pin with the linkage gear assembly (158) when the pinion gear assembly is oriented proximally along the linkage gear assembly (106), and resistance to proximal movement of the pinion gear assembly while the second one-way needle roller clutch is engaged is caused by at least one of resistance to rotation of the second roller needle clutch bearing within a socket in which the one-way needle roller bearing is press-fit or interference between the pin and the second one-way needle roller clutch, and the resistance is less than the resistance between the first roller needle clutch and the pin.

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