BACKGROUND OF THE INVENTION
Field of the Invention
Embodiments of the present invention relate to a stent delivery device, specifically a single-handed thumbwheel driven delivery handle.
Background
There are a number of medical conditions and procedures in which a device such as a stent is placed in the body to create or maintain a passage. There are a wide variety of stents used for different purposes, from expandable coronary, vascular and biliary stents, to plastic stents used to allow the flow of urine between kidney and bladder.
Self-expanding stents, as well as balloon expandable stents, may also be used to treat various issues with the vascular system, including, but not limited to May-Thurner Syndrome and Deep Vein Thrombosis.
Stents are usually delivered in a compressed condition to the target site and then, deployed at that location into an expanded condition to support the vessel and help maintain it in an open position. The delivery system is used to implant or deploy at the stent target site in the diseased vessel.
Stents are commonly delivered using a catheter delivery system. A common type of delivery system for delivering a self-expanding stent is called a pull back delivery system. This type of delivery system utilizes two catheters or shafts which are concentrically arranged, one around another. The stent is carried axially around the distal end of the inner catheter or shaft. The stent is carried to the delivery site on the distal end of the delivery device, held in its compressed delivery position by the outer shaft or catheter. Once at the desired placement site, the outer shaft is pulled back, releasing the stent to self-expand.
BRIEF SUMMARY OF THE INVENTION
Accordingly, the present invention is directed to a rotary handle stent delivery system and method that obviates one or more of the problems due to limitations and disadvantages of the related art.
In accordance with the purpose(s) of this invention, as embodied and broadly described herein, this invention, in one aspect, relates to a delivery device for withdrawing a sheath from a support shaft including a housing; a flexible timing belt, having a plurality of belt teeth on a surface thereof; a timing belt link coupled to the sheath such that movement of the timing belt link causes movement of the sheath; a barrel within the handle and having barrel teeth extending therefrom and corresponding to the belt teeth for directly engaging the belt teeth, the barrel rotatably coupled to the housing such that rotation of the barrel causes movement of the barrel such that the barrel teeth engage at least one of the belt teeth to cause movement of the timing belt causing movement of the sheath via the timing belt link. The timing belt link may include: a first part comprising an upper body portion and at least two extension arms extending in a common direction from the upper body portion and a second part comprising two end pieces having a cut out for a sheath to pass through and at least one rail extending between the end pieces to couple the end pieces to one another, wherein the first part is engageable with the second part with an interference fit between at least one of the extension arms and the second part such that the timing belt link is operatively coupleable with the sheath when the first part is engaged in the second part. The plurality of belt teeth may comprise a first plurality of belt teeth and a second plurality of belt teeth wherein the first plurality of belt teeth protrudes in a first direction from the timing belt and the second plurality protrudes in a second direction from the timing belt. The first direction may be different from the second direction. The first direction and the second direction may also be parallel. The upper body portion may comprise at least one protrusion between the extension arms. The upper body portion may also comprise at least one engagement groove complimentary to the belt teeth. The distal ends of the extension arms may also be biased towards or away from the timing belt. The extension arms may also comprise a protrusion for capturing the upper body portion in the lower body portion. The second part may also comprise an intermediate carrier connected to the at least one rail. The second part may also comprise a slot for receiving a protrusion on the upper body portion between the end pieces. The intermediate carrier may further comprise a notch for receiving a protrusion on the upper body portion. The second part may further comprise a slot for receiving a protrusion on the upper body portion between the end pieces and the intermediate carrier. The timing belt may be operatively coupleable to the sheath by a portion of the sheath having a protrusion complementary-sized to be received within the timing belt link.
In another aspect, a kit for delivery of an intraluminal stent according to principles described herein includes an intraluminal stent with the delivery device described above with a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft, wherein the intraluminal stent is between the inner core and outer sheath
In yet another aspect, a device for withdrawing a sheath from a support shaft may also comprise a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft; a continuous timing belt having a first plurality of belt teeth and a second plurality of belt teeth extending from the timing belt in a direction opposite the first plurality of belt teeth; a timing belt link coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath; a barrel having barrel teeth corresponding to and engaging a tooth of at least one of the first plurality of belt teeth and the second plurality of belt teeth; and a thumbwheel having an axis and joined with the barrel such that rotation of the thumbwheel about the axis causes movement of the barrel to cause movement of the timing belt to cause movement of the outer sheath. The timing belt link may include a first part comprising an upper body portion and at least two extension arms extending in a common direction from the upper body portion; and a second part comprising two end pieces having a cut out for the sheath to pass through and at least one rail extending between the end pieces to couple the end pieces to one another; wherein the first part is engageable with the second part with an interference fit between at least one of the extension arms and the second part.
Additional advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
Further embodiments, features, and advantages of the rotary handle stent delivery system and method, as well as the structure and operation of the various embodiments of the rotary handle stent delivery system and method, are described in detail below with reference to the accompanying drawings.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying figures, which are incorporated herein and form part of the specification, illustrate a rotary handle stent delivery system and method. Together with the description, the figures further serve to explain the principles of the rotary handle stent delivery system and method described herein and thereby enable a person skilled in the pertinent art to make and use the rotary handle stent delivery system and method.
FIGS. 1A-C show various embodiments of a stent delivery handle according to principles described herein.
FIG. 2 illustrates an exemplary catheter configuration according to principles described herein.
FIG. 3 illustrates is an exploded view of features of a delivery handle according to principles described herein.
FIG. 4 is cross-sectional view of an assembled handle according to principles described herein
FIG. 5 is a cross-sectional view illustrating motion of the thumbwheel and the timing belt.
FIGS. 6A-C are cross-sectional views of the delivery device according to principles described herein and illustrate motion of the timing belt link and outer sheath upon movement of the thumbwheel.
FIG. 7 is a top view of the delivery device according to principles described herein.
FIG. 8 illustrates a perspective view of the delivery device according to principles described herein, including the catheter device.
FIG. 9 is a cross-sectional line drawing showing detail of an exemplary embodiment of the thumbwheel assembly.
FIG. 10 illustrates a portion of a thumbwheel according to principles described herein.
FIG. 11 illustrates exemplary belt teeth.
FIG. 12 illustrates exemplary belt teeth.
FIG. 13 shows a prototype thumbwheel/barrel assembly with a timing belt.
FIG. 14 illustrates an exemplary barrel having two sets of teeth.
FIG. 15 illustrates a modular thumbwheel assembly according to principles described herein.
FIG. 16 illustrates an exemplary timing belt with timing belt teeth.
FIG. 17 illustrates an exemplary timing belt with timing belt teeth.
FIGS. 18A and 18B illustrates a idler that may be used with the posi-drive belt illustrated in FIG. 17.
FIG. 19 shows a prototype thumbwheel/barrel assembly with a timing belt.
FIG. 20 illustrates an alternative type of posi-drive belt that could be used in the delivery assembly according to principles described herein.
FIG. 21 illustrates an alternative type of posi-drive belt that could be used in the delivery assembly according to principles described herein
FIG. 22 illustrates a handle according to principles described herein.
FIG. 23 shows an exemplary thumbwheel lock for use with the handle described herein.
FIG. 24 illustrates an exemplary timing belt link for use with a posi-drive belt.
FIG. 25 illustrates an exemplary embodiment of the first part of the timing belt link of FIG. 24.
FIG. 26 illustrates an exemplary embodiment of the second part of the timing belt link of FIG. 24.
FIGS. 27 and 28 illustrate another embodiment of a timing belt link according to principles described herein.
FIGS. 29, 30, and 31 are photographs showing the chord structure of an example posi-drive belt, which may be used in a delivery device according to principles described herein.
DETAILED DESCRIPTION
Reference will now be made in detail to embodiments of the rotary handle stent delivery system and method with reference to the accompanying figures. Various embodiments disclosed herein illustrate a device and associated method for delivering expandable stents or other medical devices to implant or deploy a stent or other medical device to a target site in the diseased vessel.
FIGS. 1A-C show various embodiments of a stent delivery handle according to principles described herein. As illustrated, the handle 10 includes a housing 14 and a thumbwheel/thumbwheel assembly 18, with a triaxial catheter 22 extending therefrom. The catheter may extend through strain relief 26 from the housing 10. The strain relief 26 can take any form, such as being made of polyolefin or other similar flexible material.
Referring to FIG. 2, the catheter 22 includes three concentric or “coaxial” tubes/shafts (a triaxial design): inner core 42, outer sheath 34 and an outer support shaft 38. The outer sheath 34 may be tapered or stepped, as illustrated in FIG. 2, or may not be tapered, depending on the application. The outer support shaft 38 may be a PEEK (polyaryletheretherketone) tubing extrusion or other similar structure. The outer support shaft 38 can be manufactured from any semi-rigid material. PEEK exhibits good mechanical properties to provide support for the smaller diameter of the outer sheath and is flexible. PEEK is also an off-the-shelf component. A material other than PEEK may be used to form the outer support sheath, and the invention described herein is not limited to PEEK for use in the outer support shaft 38. Functionally, the outer support shaft 38 and inner core are fixed in position at the proximal end of the delivery system and the outer sheath translates coaxially over the inner core and inside the outer support shaft 38. A medical device such as a self-expanding stent (not shown) is held in a reduced delivery configuration for insertion and transport through a body lumen to a predetermined site for deployment. The stent (not shown) is carried axially around the inner core 42 and is held in its reduced delivery configuration by the outer sheath 34. The inner core 42 may be a braid reinforced tube that extends from the distal end to the proximal end of the device. In some embodiments, the inner core 42 may extend from the very distal end to the very proximal end (e.g. all the way from end to end). The inner diameter of the tube of the inner core 42 is sized for tracking over a guidewire and the outer diameter of the tube of the inner core 42 at the distal end is where the stent (not show) will be crimped between to inner core band markers (50). The outer support shaft 38 is used to stiffen the delivery device so that the arc of the inner core 42 will not change outside of the body when the outer sheath 34 is pulled back to release the stent (not shown) to self-expand. The outer support shaft 38 is connected to the handle 10 at the proximal end of the device, which stiffens the delivery system and reduces friction at the treatment insertion site so that the inner core 42 will not be urged forward as the middle shaft/outer sheath 34 is pulled backward. As illustrated in FIG. 2, the catheter 22 may include a distal tip 46. The inner core 42 may further include at least one inner core marker band 50 such that self-expanding stent is crimped and loaded at the distal end of the catheter and located over the inner core between two inner core marker bands 50 (only one is shown in FIG. 2) to prevent axial movement of the stent. The crimped and loaded self-expanding stent is circumferentially constrained by the outer sheath 34. The outer sheath 34 may also include an outer sheath marker band 54.
The triaxial design allows for more optimal delivery system stability and accurate placement during stent deployment as compared to a traditional 2-coaxial delivery system. The system in introduced into the body at an access location thorough an introducer sheath with hemostasis valve. Where the stent delivery system enters the introducer sheath into the body friction is generated at the hemostasis valve. Therefore, during deployment of a traditional 2-axis system as the outer sheath is being retracted, it wants to move relative to the introducer sheath due to friction, resulting in the inner core pushing out the stent versus retracting the outer sheath. The operator needs to compensate for this and move the entire delivery catheter while deploying the stent to maintain consistent placement during deployment. With long high radial force stents (such as venous stents) this can result in distal/proximal movement (accordion effect) of the entire delivery system during deployment of the stent and can result in inaccurate deployment or malposition of the stent. The triaxial design mitigates this effect as the outer support shaft 38 is inserted through the introducer sheath and therefore the friction between the outer sheath translation and introducer sheath hemostasis valve is eliminated.
FIG. 3 illustrates an exploded view of features of a delivery handle according to principles described herein. The exemplary embodiment illustrated in FIG. 3 includes a two-part housing 114a and 114b, where the respective two parts 114a and 114b may be snap fit together for assembly. The thumbwheel 18 may comprise two wheels 118a and 118b, an axle 58, and a bearing 62. The wheels 118a and 118b may include teeth on an inner barrel 66 thereof. Although only one inner barrel is shown in FIG. 3 on wheel 118b, wheel 118a may also include an inner barrel with teeth. The teeth on the inner barrel 66 are sized to correspond with teeth on a timing belt 70. A timing belt link 74 connects the outer sheath 34 to the timing belt 70. The housing may include a bushing 78, which may be a separate component or may be integral to the housing 14. The bushing may be formed of PEEK or other suitable material. The exemplary handle of FIG. 3 further includes at least one idler pulley 82 for tensioning and guiding the timing belt. Also shown in FIG. 3 idler pulley axles 86 corresponding to the idler pulleys 82 of the embodiment of FIG. 3. The exemplary delivery handle of FIG. 3 further includes a tensioner assembly 90, the tensioner assembly 90 including a torsion spring 94, a tensioner arm 98, a tensioner pulley 102, a tensioner arm axle 106 and a tensioner pulley axle 112. In the presently described embodiment, the timing belt has teeth on one side (outer diameter or periphery) of the belt and the inner diameter (inner surface) is smooth or substantially smooth or flat. The smooth or flat surface of the timing belt 70 contacts the idler pulleys 82 and the tensioner pulley 102.
In the exemplary embodiment of FIG. 3, the outer support shaft 38 is fixed to the handle housing 14, and both the inner core 42 and outer sheath 34 are contained within the inner diameter of the outer shaft 38. The inner core 42 will be bonded at the proximal end along with a metal (e.g., stainless steel) shaft 30 to a female luer 116, which is coupled to or clamped into the handle body 14. In an aspect of the present invention, the metal shaft 30 may be bonded to the outer diameter of the inner core 42 to provide support/rigidity at the proximal end where the inner core 42 is unsupported in the handle body 10. The support of the metal shaft 30 over the inner core 42 mitigates potential deformation/buckling of proximal unsupported inner core 42 during stent deployment. As the outer sheath 34 is pulled back to release/deploy the stent, the inner core 42 is put into compression, therefore the unsupported proximal end of the inner core could deform. The bonded metal shaft 30 provides support and column strength to unsupported proximal inner core 42. The metal shaft 30 may be sized such that is slides over the outer diameter of the inner core 42 and through the inner diameter of the outer sheath 34. The metal shaft 30 does not impact the inner diameter of the inner core 42, so a guidewire (not shown) can still pass through entire assembly. A material other than metal may be used to for the support shaft, and the invention described herein is not limited to metal for use in the support shaft 30.
The outer sheath 34 is coupled to or bonded to the timing belt link 74 to deliver the stent by retracting the outer sheath 34 by movement of the thumbwheel, which in turn engages the teeth of the timing belt 70 via the inner barrel 66 and the teeth on the inner barrel 66. The metal shaft 30 that is coupled to or bonded to the inner core 42/female luer 116 is a guide rail that the outer sheath 34 and timing belt link 74 move proximally over during deployment.
FIG. 4 is a cross-sectional view of an assembled handle according to principles described herein. The exemplary embodiment illustrated in FIG. 4 shows one part 114b of the two-part housing, where the respective two parts may be snap fit together for assembly. Other assembly methods may be used to mate the two parts together such as welding, bonding, gluing or other method. It is contemplated that each side of the two part housing is symmetrical and complementary, but such configuration is not required. The parts of the thumbwheel assembly 18 may be formed by molding, such as injection molding. The housing 14 may be unitary.
FIG. 4 illustrates one wheel of the thumbwheel assembly 18 that may comprise two wheels 118a and 118b, an axle 58, and a bearing 62. The bearing may include a ball bearing with an inner and outer grooved bearing race. The bearing serves to reduce rotational friction between the thumbwheel and the axle and may be eliminated if the frictional forces are acceptable. An acetal bushing or other method of friction reduction may be used in place of the bearing 62.
The wheels 118a and 118b may include teeth on an inner barrel 66 thereof. Although only one inner barrel is shown in FIG. 4 on wheel 118b, wheel 118a may also include an inner barrel with teeth. The teeth on the inner barrel 66 are sized to correspond with a timing belt 70. The inner barrel may be formed by molding, such as injection molding, and the teeth may be formed as part of the molding or other method such that the teeth are integral to the inner barrel 66. In another aspect, the teeth may be separable from the inner barrel 66.
As shown, the timing belt link 74 connects the outer sheath 34 to the timing belt 70. The exemplary handle of FIG. 4 further includes at least one idler pulley 82 for tensioning and guiding the timing belt 70. Also shown in FIG. 4 idler pulley axles 86 corresponding to the idler pulleys 82 of the embodiment of FIG. 4. The exemplary delivery handle of FIG. 4 further includes a tensioner assembly 90, the tensioner assembly 90 including a torsion spring 94, a tensioner arm 98, a tensioner pulley 102, a tensioner arm axle 106 and a tensioner pulley axle 112. In the exemplary embodiment of FIG. 4, the outer support shaft 38 is fixed to the handle housing 14, and both the inner core 42 and outer sheath 34 are contained within the inner diameter of the outer shaft 38. The inner core 42 will be bonded at the proximal end along with a metal (e.g., stainless steel) shaft 30 to a female luer 116, which is coupled to or clamped into the handle body 14.
FIG. 5 further illustrates motion of the thumbwheel 18, timing belt 70 and timing belt link 74 for deployment of a stent according to principles described herein. As illustrated in FIG. 5, outer sheath 34 is translated proximally over guide tube/inner core 42 by the timing belt 70 by rotating the thumbwheel in the direction of the arrow. The timing belt 70 is driven by an operator via dual thumbwheel assembly 18, which may comprise integrally molded gear teeth, the pitch and shape of which correspond to teeth of the timing belt 70 for synchronizing/engaging the timing belt and causing movement of the timing belt to cause movement of the timing belt link 74, which is coupled to the outer sheath 34 to cause movement thereof for unsheathing (deploying) a stent provided therein. The diameter of the inner barrel 66, number of teeth on timing belt 70, and the pitch/frequency of the teeth on the timing belt 70 may each be adjusted/modified to allow for variable mechanical advantage during stent deployment and variable translation ratio. In addition, variable speed delivery may also be achieved by actuating the thumbwheel assembly 18 at the desired speed.
In the embodiment illustrated in FIG. 5, rotation of the portion thumbwheel 18 external to the handle proximally (in the direction of the arrow) causes an upper portion of the portion of the timing belt adjacent the portion of the thumbwheel internal to the handle to move distally (in the direction of the arrow). The timing belt 70 extends around an idler pulley 82 such that a portion of the timing belt 70 adjacent the timing belt link 74 move proximally (in the direction of the arrow), engaging the timing belt link 74 to move the timing belt link 74 proximally, which moves the outer sheath 34 coupled thereto proximally, thereby unsheathing the stent for deployment. Movement may be reversed for re-sheathing of catheter following stent deployment.
FIGS. 6A-C are cross-sectional views of the delivery device according to principles described herein and illustrates motion of the timing belt link 74 and outer sheath 34 upon movement of the thumbwheel 18 counterclockwise in the context of FIGS. 6A-C. It should be appreciated that the direction of thumbwheel rotation described herein is described in the context of the cross-section provide, but that it is contemplated that the portion of thumbwheel external to the handle 14 will be rotated rearward (in a proximal direction). It is also contemplated that the configuration of the timing belt 70 may be adjusted (for example, looped over the thumbwheel) to modify the direction of rotation of the thumbwheel corresponding to the proximal movement (retraction) of the outer sheath 34.
As shown in FIG. 6A, in an introducing position, the timing belt link is at a distal end of the handle housing. As the thumbwheel 18 is actuated in a predetermined direction, e.g. in the context of the cross-section shown, counter-clockwise, the timing belt link/shuttle 74 moves proximally. Because the timing belt link/shuttle 74 is coupled to the outer sheath 34, the outer sheath moves proximally with the timing belt link/shuttle to expose a stent or other medical device mounted on the inner core 42 (not shown). FIG. 6B illustrates the positioning of the timing belt link/shuttle in a partially deployed position (e.g. the stent is partially deployed (not shown)). As the thumbwheel 18 is further rotated in a timing belt link/shuttle 74 further translates proximally to allow for full deployment of the stent or medical devices from the of the inner core 42, as shown in FIG. 6C. In the embodiment here described, the thumbwheel 18 is actuated such that the upper side (external portion) of the thumbwheel is rotated proximally to cause the timing belt link/shuttle 74 to transit proximally. It is appreciated that the configuration/path of the timing belt 70 may be configured such that a distal rotation of the upper side (external portion) of the thumbwheel 18 may cause the timing belt link/shuttle 74 to transit proximally to cause the outer sheath 34 to retract from the inner core 42 to allow deployment of the medical device (not shown).
Although not shown in the figures, the thumbwheel may be a single thumbwheel with appropriate teeth corresponding to the teeth of the timing belt. As illustrated in the top view of FIG. 7, a thumbwheel comprising two wheels allows for a balanced design in which the catheter may exit the handle at a central portion of the distal end of the handle. FIG. 7 shows an assembled handle 10 and housing 14, and a thumbwheel assembly 18 having a first thumbwheel 118a and a second thumbwheel 118b separated by inner barrel 66. This configuration facilitates operation of the delivery device by holding the handle from either the left or the right side, allowing for comparable operation regardless of whether the operator is left or right handed.
FIG. 8 illustrates a perspective view of the delivery device according to principles described herein, including the catheter device. As shown in FIG. 8, the timing belt 70 extends around idler pulleys 82 and the tensioner pulley 102 of tensioner 90. The tensioner pulley 102 is coupled to the torsion spring 94 via the tensioner arm 98. Tension is maintained on the timing belt by torsion spring 94 on tensioner arm axle 106, which urges the tensioner pulley 102 into contact with the timing belt 70 via the tensioner arm 98. An example idler pulley 82 is illustrated in FIGS. 18A and 18B.
FIG. 9 is a cross-sectional line drawing showing detail of an exemplary embodiment of the thumbwheel assembly 18 and the timing belt link 74. As illustrated in FIG. 9, one part 118b of a two-part thumbwheel 18 has an outer surface 122 that may be textured for ease of use. The thumbwheel part 118b may also include an inner surface or rim 126. An inner barrel 66 extends from the thumbwheel part 118b and has a plurality of barrel teeth 130 thereon. The barrel teeth 130 on the inner barrel 66 are sized to correspond with a timing belt (not shown). Although not illustrated, the barrel teeth 130 may have a standard periodicity (pitch) or may have a variable periodicity (pitch) such that actuation of the thumbwheel assembly may cause movement of the timing belt (not shown) and thus translation of outer sheath 34 at a first rate when barrel teeth of a first periodicity engage the timing belt (not shown) and at a second rate when barrel teeth of a second periodicity engage the timing belt (not shown). Such variable rate may be imparted by having different spacing/periodicity/pitch of the teeth on the timing belt instead of or in addition to having different spacing/periodicity/pitch of the barrel teeth 130 on the inner barrel 66. FIG. 9 further illustrates the thumbwheel bearing 62 and the thumbwheel axle 58.
A safety locking feature (not shown) may be incorporated in the handle design such to mitigate inadvertent actuation of the handle during transit and storage. The safety locking feature may be a removal/disposal or toggle feature that engages the teeth on the inner barrel to lock it in place and prevent rotation. The safety locking feature may also be a feature that engages the timing belt link to prevent its translation.
FIG. 10 illustrates a portion of a thumbwheel according to principles described herein. The thumbwheel may comprise two wheel parts 120a and 120b, as shown in at least FIG. 3. As illustrated in FIG. 10, one of the wheel parts 120a may be a body 222 including a portion of the thumbwheel 218a (e.g. the outer circumference a portion of which extends through the housing such that a user can rotate the thumbwheel to actuate the device) and a portion of the barrel 266a (e.g. a portion of which engages the timing belt (not shown) to move the timing belt). The wheel part 120a may be unitary such that the thumbwheel portion 218a that extends through the housing and the barrel portion 266a may be unitary (e.g., they can be formed in a single molding process). The other wheel (not shown) may also include both a portion of the thumbwheel for actuation and a portion of the barrel such that the two “wheels” may be fit together to form the thumbwheel and barrel assembly. In other words, the other wheel may be a mirror image of the wheel described above. In some configurations, the two “wheels” may be the same, such that only one mold may be used. It is also possible that the thumbwheel assembly is formed as a single unit to include both the barrel and the thumbwheel portions.
As shown in the exemplary embodiment of FIG. 10, the exemplary wheel part barrel portion 266a includes grooves 232 that are substantially equally/evenly spaced to engage the pitch of a corresponding timing belt (not shown). The timing belt includes a plurality of substantially equally/evenly spaced teeth along a face of the belt to engage the grooves 232 on the corresponding barrel 266. FIG. 11 illustrates exemplary belt teeth. The belt shown in FIG. 11 is exemplary only, as it only shows two teeth, but the belt is designed to have teeth along enough of the belt to sufficiently deploy the stent.
Exemplary belt teeth are shown in FIG. 12. As illustrated in FIG. 12, exemplary belt teeth 471 may have a tapered shape with a flat top, e.g., trapezoidal cross-section, to allow for engagement with the barrel teeth 230 or groove 232. Although a trapezoidal cross section is shown, the teeth are not so limited and may be of any cross section that may engage with the barrel teeth sufficiently to allow belt movement to be actuated by barrel rotation. Other possible shapes, without limitation, include; without limitation, include circular, cylindrical, diamond, square, triangular or any variation thereof.
In some cases, the timing belt may be looped over the barrel of the thumbwheel to provide more full engagement of the timing belt with the barrel. In this embodiment, a longer timing belt would be used such approximately 360 degrees of engagement may be achieved between the belt and the barrel. FIG. 13 shows a prototype thumbwheel/barrel assembly 522 with a timing belt 570 where the barrel width is sized to allow for the timing belt 570 shown to be looped around the barrel 566 at least one full revolution. For example, cylindrical surface of the barrel 566 with the teeth could be sized to be twice the width of the timing belt 570 to accommodate the timing belt 570 being looped over the barrel 566 twice. The widened barrel 566 might thus have that the two parts of the thumbwheel 518a and 518b be spaced further apart than if the timing belt only engaged the barrel 566 at a fraction of the circumference of the barrel 566. In one aspect, the thumbwheel outer cylindrical edge could be modified to cause some over the outer edge of each portion of the thumbwheel to “overhang” the barrel to allow a more surface area for user engagement.
In another aspect, the barrel may be substantially cylindrical, such that an end of the cylinder has a set of teeth and/or grooves and the other end of the cylinder has a set of teeth and/or grooves. The barrel may further comprise a core region between the ends having teeth and/or grooves. The barrel with such teeth may be a unitary piece or may be two parts that are fitted together. The ends of the substantially cylindrical barrel are spaced apart sufficient to receive a central portion of a belt therebetween. A timing belt for use with the barrel thus described has a plurality of protrusions on opposite sides of the belt, for example, extending perpendicular to a pitch axis of the belt. The protrusions are designed to engage corresponding teeth and/or grooves on the barrel to transfer torque from the barrel to the belt, which is coupled to the outer sheath as described above, to cause deployment of the stent. The barrel may further comprise a groove therein for receiving a portion of the belt, such that the barrel itself may not be substantially cylindrical.
The barrel assembly may be formed by placing two disks with appropriately spaced teeth on circumferential edge thereof a distance apart sufficient to allow teeth on each of the disks to engage teeth of the timing belt. A cylindrical core may extend between each of the disks. The cylindrical core and “disks” may actually be a unitary piece that is substantially cylindrical, such that an end of the cylinder has a set of teeth and/or grooves and the other end of the cylinder has a set of teeth and/or grooves with a core region therebetween. The teeth and/or grooves on the two ends may be substantially aligned.
FIG. 14 illustrates an exemplary barrel 666 having two sets of teeth 681 with grooves therebetween. Between the two sets of teeth 681, which are arranged around the circumference of a circular cross section, is a surface 668 spacing the sets of teeth 681 apart from one another. As illustrated, the surface is smooth, but is not so limited. Moreover, although a surface is illustrated, the surface is not necessary. The teeth may be spaced apart merely be separating two disks with teeth and/or grooves on the periphery an appropriate distance apart, perhaps with both disks mounted on common axle (not shown). As discussed in detail, above, the barrel assembly 666 may be unitary, or may be unitary with the thumbwheels (not shown in FIG. 14). As illustrated in FIG. 15, the thumbwheel assembly with the barrel 666 may modular such that a first lateral portion of the barrel 666a and a first lateral portion of the thumbwheel 618a may be unitary and fit together with another unitary piece comprising as second lateral portion of the barrel 666b and a second lateral portion of the thumbwheel 618b. The lateral parts thumbwheel assembly may also include surfaces 668a and 668b that when fitted together form a surface to allow for spacing of the sets of teeth apart from one another.
An exemplary timing belt with timing belt teeth are illustrated in FIG. 16. A timing belt for use with the barrel thus described has a plurality of protrusions on opposite sides of the belt, for example, extending perpendicular to a pitch axis of the belt. The belt shown in FIG. 16 is exemplary only, as it only shows three sets of teeth, but the belt is designed to have teeth along enough of the belt to sufficiently deploy the stent.
Exemplary belt teeth are shown in FIG. 17. As illustrated in FIG. 17, exemplary belt teeth may have a cylindrical shape with a flat top, e.g., trapezoidal cross-section, to allow for engagement with the barrel teeth. Although a trapezoidal cross section is shown, the teeth are not so limited and may be of any cross section that may engage with the barrel teeth sufficiently to allow belt movement to be actuated by barrel rotation. Other possible shapes, without limitation, include; without limitation, rounded, trapezoidal, cylindrical, diamond, square, triangular or any variation thereof.
FIG. 18A illustrates an idler 1182 that may be used with the posi-drive belt illustrated in FIG. 17. FIG. 18B illustrates a cross-section of the example idler pulley of FIG. 18A with the posi-drive belt.
FIG. 19 shows a prototype thumbwheel/barrel assembly 922 having a cylindrical core 968 and thumbwheel portions 918 with a timing belt 970 having protrusions 971 on two edges of the timing belt 970, such as a single core posi-drive belt. A cylindrical core 968 can be seen between two sets of teeth/grooves 981.
FIGS. 20 and 21 illustrate an alternative type of posi-drive belt 1171 that could be used in the delivery assembly according to principles described herein. The illustrated posi-drive belt 1170 is “twin core” such that there is a recess or opening 1177 between each “crossbar” or tooth 1171 of the belt. The thumbwheel assembly and pulleys described herein may be adapted to engage the openings between the teeth of the belt to perform the movement described herein without impacting the overall function of the delivery device.
FIG. 22 is a cross-sectional view of an exemplary handle 1010 according to principles described herein in combination with an exemplary thumbwheel lock 1011 and an exemplary timing belt link 1074. FIG. 23 shows an exemplary thumbwheel lock 1011 for use with the handle 1010 described herein. As shown, the exemplary thumbwheel lock 1011 is a levered lock that can be pinched to disengage a portion of the lock 1011 from the barrel teeth 1081. More particularly, the thumbwheel lock 1011 includes a plurality of teeth 1015 (which may be integral to or unitary with the thumbwheel lock or otherwise fixed to the thumbwheel lock 1011) that correspond to barrel teeth or to teeth on the surface of the thumbwheel (not shown). The exemplary thumbwheel lock 1011 includes two “lever” arms 1013 connected by a pivot bar 1016. The pivot bar 1016 provides pivot or fulcrum points for each of the lever arms 1013. One end of each lever arm 1013 includes teeth 1015 to engage a corresponding structure on the thumbwheel assembly 1018 of the handle 1010. The pivot/lever arms 1013 have sufficient spring force to clamp onto the thumbwheel assembly 1018 and be held in place by the engagement of the teeth 1015 of the thumbwheel lock 1011 and the thumbwheel assembly teeth 1081. The other ends of each of the lever arms 1013 has a sufficient length and width to allow them to be grasped and pinched together to cause the teeth 1015 of the thumbwheel lock 1013 to move away from the corresponding structure on the thumbwheel assembly 1018 (e.g., disengage from the thumbwheel assembly barrel teeth 1081) and thus be removed from the handle 1010 to allow the thumbwheel assembly 1018 to be actuated or rotated.
FIG. 24 illustrates an exemplary timing belt link 1074 for use with a posi-drive belt 1070. As illustrated, the exemplary timing belt link 1074 comprises two parts 1074a and 1074b that can be coupled together. Each part may be injection molded or formed by any appropriate process. The first part 1074a fits over the timing belt teeth 1071 of the timing belt 1070 and around the outer-sheath 1034, trapping a cylindrical feature or “catch” 1035 affixed to or integral to the outer-sheath 1034. Although illustrated as cylindrical, the cylindrical feature or catch may be of any shape without departing from the spirit and scope of any of the disclosed embodiments. For example, the feature may be spherical, polygonal or any other shape to function according to the descriptions herein. The cylindrical feature 1035 may be integral to the outer sheath 1034 or otherwise affixed to the outer sheath 1034 such that the outer sheath 1034 may move with the movement of the cylindrical feature 1035. The second part 1074b snaps onto the outer sheath 1034 from below to create support system around the first part 1074a to provide rigidity. The second part 1074b provides the strength necessary to withstand deployment forces. The intent is of this design is to allow rotation of the outer sheath 1034 with respect to the belt 1070. According to an aspect of the present design, there is clearance between the timing belt link parts 1074a and 1074b and the outer sheath 1034 and the cylindrical feature or catch 1035 to allow the outer sheath 1034 to spin freely without significant interference from the timing belt link 1074 yet allow linear movement of the timing belt link 1074 to cause movement of the outer sheath 1034 for deployment of the stent (not shown). Such movement is caused by the “entrapment” of the cylindrical feature or catch 1035 by the timing belt link 1074. Thus, the system may remain functional when the distal end of the catheter is fixed and the proximal end (handle) is fully rotated 360° about the axis of the catheter (not shown).
FIG. 25 illustrates an exemplary embodiment of the first part 1074a of the timing belt link 1074a of FIG. 24. The first part 1074a includes an upper body portion 1076; extension arms 1084 extending in a common direction from the upper body portion 1076 and engagement grooves 1096 complimentary to the teeth 1071 of the timing belt 1070. As illustrated, each extension arm 1084 extends from a corner 1077 of the upper body portion 1076, but this the design is not so limited. Distal ends 1085 of the extension arms 1084 may be curved so as to engage around the cylindrical outer sheath 1034, e.g. to provide a rough interference or snap fit. In the illustrated embodiment, there are four extension arms 1084, each extending from a corner 1077 of the upper body portion 1076. The upper body portion 1076 has a long dimension 1087 and a short dimension 1088, where the long dimension 1087 is parallel to the axial direction of the outer sheath 1034 when engaged with the outer sheath 1034 and the short dimension 1088 is roughly perpendicular to the axial direction of the outer sheath 1034 when engaged with the outer sheath 1034. In the exemplary embodiment shown, the engagement grooves 1096 are formed along the long dimension 1087 such that there are at least two grooves 1096 between two extension arms 1084 on one of the long dimensions 1087 of the upper body portion 1076. The grooves 1096 illustrated are U-shaped, such that when there are two such grooves 1096, there is a protrusion 1089 from the upper body 1076 at a location between corners 1077 of the upper body 1076 along the long dimension 1087 of the upper body 1076 forming two grooves 1096. While two grooves 1096 are illustrated, more grooves can be formed by more protrusions from the upper body such that more than two linearly adjacent belt teeth can be engaged. Also, there may be protrusions extending from both long edges/dimensions of the upper body such that grooves on both sides of a posi-drive belt can be engaged. In the presently illustrated embodiment, a longitudinal cross-section of the upper body 1076 may be U-shaped to fit over the outer sheath 1034.
Although not illustrated, the positioning of the extension arms is not limited to being at the corners of the upper body. In other words, as long as the extension arms are sufficient to fit around the outer sheath and grooves to engage the timing belt, the position from which they extend from the outer body can vary. For example, the extension arms may extend from a mid-point of the long dimension of the upper body, while the protrusions may extend from the corner 1077 or end regions of the upper body. Additional protrusions may extend from upper body to allow for additional timing belt teeth to be engaged by the upper body. The timing belt link 1074 may include only the first part but may further include a second part to provide additional strength to the assembly, e.g., to withstand deployment forces.
As shown in FIG. 26, an exemplary second part 1074b of may include a lower body portion 1075 having two U-shaped end pieces 1079 having a substantially circular center cut out 1080 sized to receive the circumference of the outer sheath 1034. The ends 1083 of each “U” are separated by a distance less than the outer diameter of the outer sheath 1034 such that the outer sheath 1034 can be pushed into the substantially circular center cut out 1080 of the “U” shaped end 1079. The U-shaped ends 1079 are connected by two upper side rails 1091 extending between upper parts of each of the “U”s 1079 to connect the two end pieces 1079.
The outer sheath 1034 can thus be coupled to the drive belt 1070 by the first part 1074a of the timing link 1074 extending over an upper portion of the outer sheath 1034 with the extension arm ends 1085 extending under a lower portion of the outer sheath 1034. The second part 1074b of the timing belt link 1074 is located over the extension arms 1084 of the first part and snap fit around the outer sheath 1034 by inserting the outer sheath 1034 into the substantially circular center cut outs 1080 of the U-shaped ends 1079 of the second part 1074b. The outer sheath 1034 may further include a cylindrical body 1035 sized to be between the extension arms 1084 of the upper body 1076 when the upper body 1076 is on the outer sheath 1034. For example, the cylindrical body 1035 may be permanently fixed to the outer sheath 1034 and thus be engaged by the timing belt link 1074 to hold the timing belt link 1074 in appropriate position with respect to the outer sheath 1034.
FIGS. 27 and 28 illustrate an additional exemplary timing belt link 2074 for use with a timing belt such as a posi-drive belt 1070. As illustrated, the exemplary timing belt link 2074 comprises two parts 2074a and 2074b that can be coupled together. Each part may be injection molded or formed by any appropriate process. The first part 2074a fits around an outer surface of the outer-sheath 1034, such that a portion of the cylindrical feature or catch 1035 is encompassed or trapped by the first part 2074a. The cylindrical feature or catch is operatively connected to the outer sheath. For example, the cylindrical feature or catch 1035 may be integral to the outer sheath 1034 or otherwise affixed to the outer sheath 1034 such that the outer sheath 1034 may move with the movement of the cylindrical feature or catch 1035. The first part 2074a may also fit around the timing belt teeth 1071 of the timing belt 1070. The second part 2074b fits around the outer sheath 1034 from below to create support system around the first part 2074a to provide rigidity. The second part 2074b provides the strength necessary to withstand deployment forces. The intent is of this design is to allow partial or full rotation of the outer sheath 1034 with respect to the belt 1070, which provides resistance to damage in the event of unintentional axial rotation while the outer support shaft is pinned or fixed at the distal end. According to an aspect of the present design, there is clearance between the timing belt link parts 2074a and 2074b and the outer sheath 1034 and the cylindrical feature or catch 1035 to allow the outer sheath 1034 to spin with a degree of freedom without significant interference from the timing belt link 2074, yet allow linear movement of the timing belt link 2074 to cause movement of the outer sheath 1034 for deployment of the stent (not shown). Such movement is caused by the “entrapment” of the cylindrical feature or catch 1035 by the timing belt link 2074. Thus, the system may remain functional when the distal end of the catheter is fixed and the proximal end (handle) is fully rotated 360° about the axis of the catheter (not shown). An additional advantage of this exemplary embodiment is that the coupled fit between 2074a and 2074b does not require any additional process steps, such as adhesive application, to secure the outer sheath 1034 and cylindrical feature or catch 1035 with the link 2074.
FIG. 28 illustrates an exemplary embodiment of the first part 2074a of the timing belt link 2074 of FIG. 27. The first part 2074a includes an upper body portion 2076 and extension arms 2084 extending in a common direction from the upper body portion 2076. The first part 2074a may further include engagement grooves 2096 complimentary to the teeth 1071 of the timing belt 1070. As illustrated, each extension arm 2084 extends from a corner 2077 of the upper body portion 2076, but this the design is not so limited. Distal ends 2085 of the extension arms 2084 may further have a protrusion 2095 outward so as to fit into receiving slots 2086 in the second part 2074b while engaging around the cylindrical outer sheath 1034, e.g. to provide a rough interference or snap fit. In the illustrated embodiment, there are four extension arms 2084, each extending from a corner 2077 of the upper body portion 2076, but the design is not limited to four extension arms. The upper body portion 2076 has a long dimension 2087 and a short dimension 2088, where the long dimension 2087 is parallel to the axial direction of the outer sheath 1034 when engaged with the outer sheath 1034 and the short dimension 2088 is roughly perpendicular to the axial direction of the outer sheath 1034 when engaged with the outer sheath 1034.
In the exemplary embodiment shown, the engagement grooves 2096 are formed along the long dimension 2087 by a protrusion 2089 between the extension arms 2084 such that there are at least two grooves 2096 between two extension arms 2084 on one of the long dimensions 2087 of the upper body portion 2076. The grooves 2096 illustrated are U-shaped, such that when there are two such grooves 2096, there is a protrusion 2089 from the upper body 2076 at a location between corners 2077 of the upper body 2076 along the long dimension 2087 of the upper body 2076 forming two grooves 2096. While two grooves 2096 are illustrated, more grooves can be formed by more protrusions from the upper body such that more than two linearly adjacent belt teeth can be engaged. Also, there may be protrusions extending from both long edges/dimensions of the upper body such that grooves on both sides of a posi-drive belt can be engaged. Similarly, there may be more, fewer or no protrusions from the upper body, so long as the timing belt and the catch 1035, which is illustrated as cylindrical, but can be of any shape, on the outer sheath are cooperatively coupled to move together. In the presently illustrated embodiment, a longitudinal cross-section of the upper body 2076 may be U-shaped to fit over the outer sheath 1034.
FIG. 28 further illustrates an exemplary embodiment of the second part 2074b of the timing belt link 2074 of FIG. 27. An exemplary second part 2074b may include two U-shaped end pieces 2079 having a substantially circular center cut out 2080 sized to receive the circumference of the outer sheath 1034. The second part 2074b may further include an intermediate carrier 2081 that has a substantially circular center cut out 2080 sized to receive the circumference of outer sheath 1034. The intermediate carrier 2081 may further have a notch 2082 for receiving the protrusion 2089 on the first part 2074a. The ends 2083 of each “U” are separated by a distance less than the outer diameter of the outer sheath 1034 such that the outer sheath 1034 can be pushed into the substantially circular center cut out 2080 of the “U” shaped end 2079. The U-shaped ends 2079 are connected by two upper side rails 2091 extending between upper parts of each of the “U”s 2079 to connect the two end pieces 2079. The intermediate carrier 2081 and upper side rails 2091 form a receiving slot 2086 in which the distal ends 2085 and protrusion 2095 of the first part 2074a are engaged when the first part 2074a and second part 2074b are combined. When the distal ends 2085 are inserted into the slot 2086 the first part 2074a is sufficiently captured in the second part 2074b without the need for further process steps, such as the addition of adhesive to bond the first part 2074a and second part 2074b. To that end, the extension arms 2084 may have an outward bias (away from an axial orientation of the link), so as to form an interference fit between the arms and the portion of the side rails 2091. In addition or alternatively, the side rails 2091 may be biased inwardly to provide additional fit or force between the two parts.
FIGS. 29, 30, and 31 are show the chord structure of an example posi-drive belt, which may be used in a delivery device according to principles described herein.
As described herein, a device for withdrawing a sheath from a support shaft may comprise: a housing; a flexible timing belt, having a plurality of belt teeth on a surface thereof; a timing belt link coupled to the sheath such that movement of the timing belt link causes movement of the sheath; a barrel within the handle and having barrel teeth extending therefrom and corresponding to the belt teeth for directly engaging the belt teeth, the barrel rotatably coupled to the housing such that rotation of the barrel causes movement of the barrel such that the barrel teeth engage at least one of the belt teeth to cause movement of the timing belt causing movement of the sheath via the timing belt link. The timing belt link may include: a first part comprising an upper body portion and at least two extension arms extending in a common direction from the upper body portion and a second part comprising two end pieces having a cut out for a sheath to pass through and at least one rail extending between the end pieces to couple the end pieces to one another, wherein the first part is engageable with the second part with an interference fit between at least one of the extension arms and the second part such that the timing belt link is operatively coupleable with the sheath when the first part is engaged in the second part. The plurality of belt teeth may comprise a first plurality of belt teeth and a second plurality of belt teeth wherein the first plurality of belt teeth protrudes in a first direction from the timing belt and the second plurality protrudes in a second direction from the timing belt. The first direction may be different from the second direction. The first direction and the second direction may also be parallel. The upper body portion may comprise at least one protrusion between the extension arms. The upper body portion may also comprise at least one engagement groove complimentary to the belt teeth. The distal ends of the extension arms may also be biased towards or away from the timing belt. The extension arms may also comprise a protrusion for capturing the upper body portion in the lower body portion. The second part may also comprise an intermediate carrier connected to the at least one rail. The second part may also comprise a slot for receiving a protrusion on the upper body portion between the end pieces. The intermediate carrier may further comprise a notch for receiving a protrusion on the upper body portion. The second part may further comprise a slot for receiving a protrusion on the upper body portion between the end pieces and the intermediate carrier. The timing belt may be operatively coupleable to the sheath by a portion of the sheath having a protrusion complementary-sized to be received within the timing belt link.
In accordance with the principles described herein, a kit may include: an intraluminal stent with the delivery device described above with a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft, wherein the intraluminal stent is between the inner core and outer sheath.
In accordance with the principles described herein, the delivery device may also comprise a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft; a continuous timing belt having a first plurality of belt teeth and a second plurality of belt teeth extending from the timing belt in a direction opposite the first plurality of belt teeth; a timing belt link coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath; a barrel having barrel teeth corresponding to and engaging a tooth of at least one of the first plurality of belt teeth and the second plurality of belt teeth; and a thumbwheel having an axis and joined with the barrel such that rotation of the thumbwheel about the axis causes movement of the barrel to cause movement of the timing belt to cause movement of the outer sheath. The timing belt link may include a first part comprising an upper body portion and at least two extension arms extending in a common direction from the upper body portion; and a second part comprising two end pieces having a cut out for the sheath to pass through and at least one rail extending between the end pieces to couple the end pieces to one another; wherein the first part is engageable with the second part with an interference fit between at least one of the extension arms and the second part.
It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.
While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the present invention. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments but should be defined only in accordance with the following claims and their equivalents.
Patent Application
20220339015
