WO2022128707A1

WO2022128707A1 - Stent delivery system

Info

Publication number: WO2022128707A1
Application number: PCT/EP2021/084879
Authority: WO
Inventors: Cedar Decker; Andrew Scherer; Scott Robert WILSON; Jake MERTENS
Original assignee: Koninklijke Philips NV
Current assignee: Koninklijke Philips NV
Priority date: 2020-12-18
Filing date: 2021-12-09
Publication date: 2022-06-23
Anticipated expiration: 2023-06-18

Abstract

A stent delivery system (100) includes a first movable fastener (141), a second movable fastener (142), a third movable fastener (143) and a fourth movable fastener (144). The first movable fastener (141) is configured to fasten to a first inner lumen of a first stent. The second movable fastener (142) is configured to fasten to a second inner lumen of a second stent. The third movable fastener (143) is configured to fasten to a first outer sheath of the first stent. The fourth movable fastener (144) is configured to fasten to a second outer sheath of the second stent. The first movable fastener (141) is configured to move relative to the third movable fastener (143) and the second movable fastener (142) is configured to move relative to the fourth movable fastener (144).

Description

STENT DELIVERY SYSTEM

BACKGROUND

[0001] A stent is a tube inserted into a blocked passageway to keep the passageway open. Expandable metal stents may be delivered intravascularly to treat intravascular disease. Expandable metal stents may also be used to treat larger regions of anatomy such as the esophagus, biliary, and pulmonary systems. A physician may place a single stent to address a vessel narrowing or restriction. A physician may also deploy two adjoining stents to equally support two pathways at an arterial bifurcation or venous confluence. Arterial bifurcation is a term that describes branching or forking in the vascular system, and venous confluence is a term that describes when two veins converge in the vascular system. Currently, a physician may switch from operating one delivery mechanism for deploying one stent to another delivery mechanism for deploying the other stent, in an attempt to keep the deployments balanced.

SUMMARY

[0002] According to an aspect of the present disclosure, a stent delivery system includes a first movable fastener, a second movable fastener, a third movable fastener and a third movable fastener The first movable fastener is configured to fasten to a first inner lumen of a first stent. The second movable fastener is configured to fasten to a second inner lumen of a second stent. The third movable fastener is configured to fasten to a first outer sheath of the first stent. The fourth movable fastener is configured to fasten to a second outer sheath of the second stent. The first movable fastener is configured to move relative to the third movable fastener and the second movable fastener is configured to move relative to the fourth movable fastener.

[0003] According to another aspect of the present disclosure, a stent delivery system includes a primary wheel. The primary wheel couples and transfers motion to at least one of a first thumbwheel that contacts a first stent or a second thumbwheel that contacts a second stent. The primary wheel is configured to couple to at least one of a first handle on the first stent or a second handle on the second stent.

[0004] According to still another aspect of the present disclosure, a stent delivery system may include a first stent delivery sub-system and a second stent delivery sub-system. The first stent delivery sub-system may include a first wheel through which motion is transferred to a first stent, a first axle for the first wheel, a first drive member on a first side of the first axle of the first stent delivery sub-system, and a first drive receptacle on a second side of the first axle of the first stent delivery sub-system opposite the first side of the first axle of the first stent delivery sub-system. The second stent delivery sub-system may include a second wheel through which motion is transferred to a second stent, a second axle for the second wheel, a second drive member on a first side of the second axle of the second stent delivery sub-system, and a second drive receptacle on a second side of the second axle of the second stent delivery sub-system opposite the first side of the second stent delivery sub-system. The first drive receptacle on the second side of the first axle of the first stent delivery sub-system may be configured to receive the second drive member on the first side of the second axle of the second stent delivery sub-system, such that motion delivered to the first wheel of the first stent-delivery sub-system is delivered to the second wheel of the second stent delivery sub-system.

BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The example embodiments are best understood from the following detailed description when read with the accompanying drawing figures. It is emphasized that the various features are not necessarily drawn to scale. In fact, the dimensions may be arbitrarily increased or decreased for clarity of discussion. Wherever applicable and practical, like reference numerals refer to like elements.

[0006] FIG. 1 illustrates a stent delivery system, in accordance with a representative embodiment.

[0007] FIG. 2 illustrates another stent delivery system, in accordance with a representative embodiment.

[0008] FIG. 3A illustrates another stent delivery system, in accordance with a representative embodiment.

[0009] FIG. 3B also illustrates the stent delivery system in FIG. 3A, in accordance with a representative embodiment.

[0010] FIG. 3C also illustrates the stent delivery system in FIG. 3A, in accordance with a representative embodiment.

[0011] FIG. 4 illustrates another stent delivery system, in accordance with another representative embodiment.

[0012] FIG. 5 illustrates a flexible cable in the stent delivery system of FIG. 4, in accordance with a representative embodiment.

[0013] FIG. 6 illustrates a connector for the stent delivery system of FIG. 4, in accordance with a representative embodiment.

[0014] FIG. 7 illustrates another stent delivery system, in accordance with a representative embodiment.

[0015] FIG. 8 illustrates another stent delivery system, in accordance with another representative embodiment.

[0016] FIG. 9 illustrates another stent delivery system, in accordance with another representative embodiment.

DETAILED DESCRIPTION

[0017] In the following detailed description, for the purposes of explanation and not limitation, representative embodiments disclosing specific details are set forth in order to provide a thorough understanding of an embodiment according to the present teachings. Descriptions of known systems, devices, materials, methods of operation and methods of manufacture may be omitted so as to avoid obscuring the description of the representative embodiments. Nonetheless, systems, devices, materials and methods that are within the purview of one of ordinary skill in the art are within the scope of the present teachings and may be used in accordance with the representative embodiments. It is to be understood that the terminology used herein is for purposes of describing particular embodiments only and is not intended to be limiting. The defined terms are in addition to the technical and scientific meanings of the defined terms as commonly understood and accepted in the technical field of the present teachings.

[0018] It will be understood that, although the terms first, second, third etc. may be used herein to describe various elements or components, these elements or components should not be limited by these terms. These terms are only used to distinguish one element or component from another element or component. Thus, a first element or component discussed below could be termed a second element or component without departing from the teachings of the inventive concept. [0019] The terminology used herein is for purposes of describing particular embodiments only and is not intended to be limiting. As used in the specification and appended claims, the singular forms of terms ‘a’, ‘an’ and ‘the’ are intended to include both singular and plural forms, unless the context clearly dictates otherwise. Additionally, the terms "comprises", and/or "comprising," and/or similar terms when used in this specification, specify the presence of stated features, elements, and/or components, but do not preclude the presence or addition of one or more other features, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

[0020] Unless otherwise noted, when an element or component is said to be “connected to”, “coupled to”, or “adjacent to” another element or component, it will be understood that the element or component can be directly connected or coupled to the other element or component, or intervening elements or components may be present. That is, these and similar terms encompass cases where one or more intermediate elements or components may be employed to connect two elements or components. However, when an element or component is said to be “directly connected” to another element or component, this encompasses only cases where the two elements or components are connected to each other without any intermediate or intervening elements or components.

[0021] The present disclosure, through one or more of its various aspects, embodiments and/or specific features or sub-components, is thus intended to bring out one or more of the advantages as specifically noted below. For purposes of explanation and not limitation, example embodiments disclosing specific details are set forth in order to provide a thorough understanding of an embodiment according to the present teachings. However, other embodiments consistent with the present disclosure that depart from specific details disclosed herein remain within the scope of the appended claims. Moreover, descriptions of well-known apparatuses and methods may be omitted so as to not obscure the description of the example embodiments. Such methods and apparatuses are within the scope of the present disclosure.

[0022] As described herein, two stents may be synchronously and simultaneously deployed. The two stents may be implantable vascular stents such as braided stents or laser-cut stents. The two stents may be coupled and then synchronously delivered. The two stents may be coupled using mechanical or magnetic coupling. Deployment of the two stents may be driven, such as pneumatically or by an electrical motor.

[0023] FIG. 1 illustrates a stent delivery system, in accordance with a representative embodiment.

[0024] In Fig. 1, a stent delivery system 100 includes a first handle 110 and a second handle 120. The first handle 110 includes a first connection member 111 that connects to two deployable stents and a first handle portion 112. The second handle 120 includes a second connection member 121 that connects to the two deployable stents and a second handle portion 122.

[0025] The first connection member 111 includes a first movable fastener 141configured to fasten to a first inner lumen 191 of a first stent and a second movable fastener 142 configured to fasten to a second inner lumen 193 of a second stent. Each movable fastener in the embodiment of FIG. 1 may be, for example, a clamp. The second connection member 121 includes a third movable fastener 143 configured to fasten to a first outer sheath 192 of the first stent and a fourth movable fastener 144 configured to fasten to a second outer sheath 194 of the second stent. The first movable fastener 141 is configured to move relative to the third movable fastener 143 and the second movable fastener 142 is configured to move relative to the fourth movable fastener 144.

[0026] The stent delivery system 100 is a pin-and-pull delivery system. The two stents may be catheters. The first handle 110 and the second handle 120 attach to or otherwise contact the multiple catheters so that the two catheters may be actuated in unison. The first handle 110 attaches to or otherwise contacts the inner lumens of the catheters and the second handle 120 attaches to or otherwise contacts the outer sheaths of the catheters. When the first handle 110 and the second handle 120 are actuated toward each other, the two catheters are simultaneously deployed. The first handle 110 and the second handle 120 may be attached to or otherwise contact the catheters using the first movable fastener 141, the second movable fastener 142, the third movable fastener 143 and the fourth movable fastener 144. When the four movable fasteners are clamps, the clamps may be actuated via a spring, a magnet, a screw or another mechanism for actuating clamps.

[0027] As described above, in the stent delivery system 100, the first handle 110 includes the first movable fastener 14 land the second movable fastener 142. The second handle 120 includes the third movable fastener 143 and the fourth movable fastener 144. Additionally, the first handle 110 and the second handle 120 are configured to synchronize actuation of the first stent and the second stent when the first handle 110 is driven relative to the second handle 120.

[0028] A method of implementing the stent delivery system 100 may include clamping the first handle 110 to the inner lumens of the first stent and the second stent, clamping the second handle 120 to the outer sheaths of the first stent and the second stent, and then manipulating the first handle 110 relative to the second handle 120. As a result of the clamping and the manipulating, the first stent and the second stent will advance along their intended pathways. The clamping in this method is used when the fasteners are clamps. However, the fasteners in the embodiments based on FIG. 1 and other embodiments described herein are not necessarily clamps, and may instead be magnets or other forms of attachment or contact mechanisms suitable for consistently and synchronously guiding a first stent and a second stent. In some embodiments, instead of fasteners, the stent delivery system 100 may also include frictional mechanisms which may frictionally contact the outer sheaths and inner lumens without fastening to or otherwise attaching to the outer sheaths and inner lumens.

[0029] FIG. 2 illustrates another stent delivery system, in accordance with a representative embodiment.

[0030] In FIG. 2, a stent delivery system 200 includes a first actuator 210, a second actuator 220, and a pumping system 230. The first actuator 210 includes a first movable member 211, a third movable member 212 and a first driver 213. The label for the second actuator 220 in FIG. 2 is offset from the elements of the second actuator 220 to avoid confusion. Nevertheless, the second actuator 220 includes a second movable member 221, a fourth movable member 222 and a second driver 223. The pumping system 230 includes a pump 231, a main flexible hose 232, a splitter 233, a first tubular structure 234 and a second tubular structure 235. In FIG. 2 the stent delivery system 200 includes a first pneumatically activated paired pin-and-pull delivery system via the first actuator 210, and a second pneumatically activated paired pin-and-pull delivery system via the second actuator 220.

[0031] The pump 231, the main flexible hose 232, the splitter 233 and the first tubular structure 234 provide fluid to the first driver 213 to drive the first movable member 211 and the third movable member 212 to move relative to one another. The pump 231, the main flexible hose 232, the splitter 233 and the second tubular structure 235 provide fluid to the second driver 223 to drive the second movable member 221 and the fourth movable member 222 to move relative to one another.

[0032] In FIG. 2, the stent delivery system 200 uses fluid pressure to drive the first actuator 210 and the second actuator 220, and the first actuator 210 and the second actuator 220 enable the delivery of multiple stents in unison. The catheter inner lumen of each stent is attached to one end of the respective actuator via the first movable member 211 or the second movable member 221, and the outer sheath of each stent is attached to the other end of the respective actuator via the third movable member 212 or the fourth movable member 222. When pressure is supplied to the stent delivery system 200, the pressure drives movement of the first actuator 210 and the second actuator 220 simultaneously to deploy the stents. The working fluid for the stent delivery system 200 may be air, water, or other gases or liquids.

[0033] The first movable member 211 includes a first movable fastener 241 configured to fasten to a first inner lumen 291 of a first stent. The third movable member 212 includes a third movable fastener 243 configured to fasten to a first outer sheath 292 of the first stent. Each movable fastener in the embodiment of FIG. 2 may be, for example, a clamp. The second movable member 221 includes a second movable fastener 242 configured to fasten to a second inner lumen 293 of the first stent. The fourth movable member 222 includes a fourth movable fastener 244 configured to fasten to a second outer sheath 294 of the second stent. The first movable fastener 241 is configured to move relative to the third movable fastener 243, and the second movable fastener 242 is configured to move relative to the fourth movable fastener 244. [0034] Accordingly, in FIG. 2 a stent delivery system 200 includes a first movable fastener 241 of the first movable member 211 configured to fasten to a first inner lumen 291 of a first stent, a second movable fastener 242 of a second movable member 221 configured to fasten to a second inner lumen 293 of a second stent, a third movable fastener 243 of a third movable member 212 configured to fasten to a first outer sheath 292 of the first stent, and a fourth movable fastener 244 of a fourth movable member 222 configured to fasten to a second outer sheath 294 of the second stent.

[0035] Additionally, in the stent delivery system 200, the first actuator 210 includes a first movable member 211 configured to attach to the first inner lumen 291 of the first stent and a third movable member 212 configured to attach to the first outer sheath 292 of the first stent, and the second actuator 220 includes a second movable member 221 configured to attach to the second inner lumen 293 of the second stent and a fourth movable member 222 opposite the second movable member 221 and configured to attach to the second outer sheath 294 of the second stent. In some embodiments, instead of movable members that attach, the stent delivery system 200 may include frictional mechanisms which may frictionally contact the outer sheaths and inner lumens without fastening to or otherwise attaching to the outer sheaths and inner lumens. The first movable member 211 and the third movable member 212 are configured to synchronize actuation of the first stent when the first movable member 211 is driven relative to the third movable member 212, and the second movable member 221 and the fourth movable member 222 are configured to synchronize actuation of the second stent when the second movable member 221 is driven relative to the fourth movable member 222. Accordingly, the stent delivery system 200 may include two actuators wherein each actuator is pneumatically driven. The two actuators in the stent delivery system 200 may be pneumatically driven using a gas or a liquid.

[0036] In other embodiments differentiable from the pneumatic features shown in FIG. 2, the stents may be delivered by electrically coupled motorized delivery systems. Each individual delivery mechanism such as the first actuator 210 and the second actuator 220 may be driven by an electrical motor corresponding to the pumping system 230 to assist in translocation of the stent sheathes. The embodiments with the electrical motor include an electronic connectivity feature in which both of the delivery systems are coupled through electrical control such as a printed circuit board. Alternatively, two delivery systems may be linked via Bluetooth, WiFi, or another mechanism to simultaneously deploy the stents. In some embodiments, the second actuator 220 may follow the first actuator 210 so that a clinician may operate one delivery system, and the operation of the second delivery system mimics the first.

[0037] In the embodiment based on FIG. 2, a stent delivery system based on the stent delivery system 200 may include a first motorized delivery mechanism that includes the first movable fastener 24 land the third movable fastener 243, and a second motorized delivery mechanism that includes the second movable fastener 242 and the fourth movable fastener 244. The stent delivery system based on the stent delivery system 200 may also include a motor configured to drive the first motorized delivery mechanism to actuate the first stent and to drive the second motorized delivery mechanism to actuate the second stent. Additionally, the first motorized delivery mechanism may be primarily driven by the motor, and the second motorized delivery mechanism may be secondarily driven by the motor to mimic or otherwise follow the first motorized delivery mechanism. Additionally, the first motorized delivery mechanism may be mechanically independent of the second motorized delivery mechanism.

[0038] A method of implementing the stent delivery system 200 may include clamping the first movable member 211 and the second movable member 221 to the inner lumens of the first stent and the second stent, clamping the third movable member 212 and the fourth movable member

222 to the outer sheaths of the first stent and the second stent, and then activating the pumping system 230 to delivery air or fluid to the first driver 213 via the main flexible hose 232, the splitter 233, and the first tubular structure 234, and to deliver the air or fluid to the second driver

223 via the main flexible hose 232, the splitter 233, and the second tubular structure 235. As a result of the clamping and the pumping, the outer sheaths will be moved apart from the inner lumens, and the first stent and the second stent will advance along their intended pathways. The clamping in this method is used when the fasteners are clamps. However, the fasteners in the embodiments based on FIG. 2 and other embodiments described herein are not necessarily clamps, and may instead be magnets or other forms of attachment mechanisms suitable for consistently and synchronously guiding a first stent and a second stent. Additionally, as described herein, the pneumatic drive system may be replaced with an electrical drive system that similarly drives the first driver 213 and the second driver 223, and fasteners may be replaced with frictional mechanisms.

[0039] FIG. 3 A illustrates another stent delivery system, in accordance with a representative embodiment.

[0040] In FIG. 3A, a stent delivery system 300 includes a primary thumbwheel 310, a drive roller 320, and a detachable cover 340. The stent delivery system 300 uses the primary thumbwheel 310 to transfer motion to one or more secondary thumbwheels. The stent delivery system 300 in FIG. 3 A is a design for synchronized deployment that attaches to existing stent deployment handles that couple the deployment motion of each of the existing stent deployment handles. In FIG. 3 A, two stents are synchronized by using the primary thumbwheel 310 to deploy the stents. The coupling mechanism uses the primary thumbwheel 310 to transfer motion to both stent thumbwheels at the same time through the drive roller 320. The coupling mechanism may snap over tops of the two individual stent handles thus allowing each stent to be positioned independently prior to coupling the two individual stents for deployment.

[0041] In some embodiments described below, instead of a primary thumbwheel 310, a thumbwheel in a stent handle may be used to drive a thumbwheel in another stent handle either directly by connecting axles of the thumbwheels as in FIG. 8 or indirectly using a flexible cable 430 as in FIG. 4.

[0042] In FIG. 3 A, the synchronizing mechanism implemented by the stent delivery system 300 is an external add on to existing delivery system handles. With synchronizing technology designed into each of the existing delivery system handles, coupled motion may alternatively be achieved using magnets or nesting drive mechanisms that engage when the existing delivery system handles are connected together.

[0043] In the embodiment of FIG. 3 A, a stent delivery system 300 may include the primary thumbwheel 310 as a primary wheel that couples and transfers motion to a first thumbwheel 391 that contacts a first stent and that couples and transfers motion to a second thumbwheel 392 that contacts a second stent. In embodiments described below, instead of the primary thumbwheel 310, the first thumbwheel 391 may serve as a primary wheel that transfers motion to the second thumbwheel, such as by using the flexible cable 430 as in FIG. 4.

[0044] The primary thumbwheel 310 as a primary wheel in FIG. 3 A may be configured to couple to a first handle 396 on the first stent and to a second handle 397 on the second stent. The primary thumbwheel 310 as the primary wheel couples to the handles via the detachable cover 340 that snaps over the handles or otherwise directly connects to and attaches to the handles. The stent delivery system 300 may also include the primary thumbwheel 310 through which the motion is transferred from the primary thumbwheel 310 as the primary wheel to the first thumbwheel 391 that contacts the first stent and to the second thumbwheel 392 that contacts the second stent. The drive roller 320 is configured to couple to the first handle 396 on the first stent and to the second handle 397 on the second stent via the detachable cover 340 that snaps over the handles or otherwise directly connects to and attaches to the handles.

[0045] The stent delivery system 300 of FIG. 3A may be designed and manufactured specifically with dimensions to fit an existing first stent and second stent, such as an existing brand, model type, size or other form of existing stent. A method of implementing the stent delivery system 300 may include fitting the detachable cover 340 of the stent delivery system 300 onto handles of the first stent and the second stent so that the primary thumbwheel 310 may evenly convey motion to the handles via the drive roller 320, and then manipulating the primary thumbwheel 310 such that motion is passed to the first thumbwheel 391 that contacts the first stent and the second thumbwheel 392 that contacts the second stent. As a result of the fitting and the manipulating, the outer sheaths will be moved apart from the inner lumens, and the first stent and the second stent will advance along their intended pathways.

[0046] FIG. 3B also illustrates the stent delivery system in FIG. 3A, in accordance with a representative embodiment.

[0047] In FIG. 3B, the primary thumbwheel 310 and the drive roller 320 are shown in more detail relative to the first thumbwheel 391 and the second thumbwheel 392 which are shown directly under and in contact with the drive roller 320. Motion from the primary thumbwheel 310 is clockwise and conveys motion to the drive roller 320 which is counterclockwise. The counterclockwise motion from the drive roller 320 is conveyed to the first thumbwheel 391 and the second thumbwheel 392 beneath the drive roller 320. The resultant motion of the first thumbwheel 391 and the second thumbwheel 392 beneath the drive roller 320 is again clockwise. [0048] FIG. 3C also illustrates the stent delivery system in FIG. 3 A, in accordance with a representative embodiment.

[0049] In FIG. 3C, the primary thumbwheel 310 and the drive roller 320 are again shown in more detail relative to one of the first thumbwheel 391 and the second thumbwheel 392 which is shown directly under and in contact with the drive roller 320. Motion from the primary thumbwheel 310 at S351 is clockwise and conveys motion to the drive roller 320 at S352 which is counterclockwise. The counterclockwise motion from the drive roller 320 is conveyed to the first thumbwheel 391 and the second thumbwheel 392 beneath the drive roller 320 at S353. The resultant motion of the first thumbwheel 391 and the second thumbwheel 392 beneath the drive roller 320 is again clockwise. Accordingly, the relationships of motion between the primary thumbwheel 310, the drive roller 320 and one of the first thumbwheel 391 and the second thumbwheel 392 is shown in FIG. 3C. [0050] FIG. 4 illustrates another stent delivery system, in accordance with another representative embodiment.

[0051] In FIG. 4, a stent delivery system 400 includes a first stent delivery system 410, a second stent delivery system 420, and a flexible cable 430. The stent delivery system 400 includes a flexible cable 430 joining delivery system handles. The first stent delivery system 410 includes a first thumbwheel 411 (sometimes referred to herein as primary thumbwheel), a first protective cover 412, a first connector 413, a first transmission axle 414 and a catheter shaft (not numbered). The second stent delivery system 420 includes a second thumbwheel 421, a second protective cover 422, a second connector 423, a second transmission axle 424 and a second catheter shaft (not numbered). The flexible cable 430 is connected between the first connector 413 and the second connector 423.

[0052] The first stent delivery system 410 and the second stent delivery system 420 may be known stent delivery systems that use thumbwheels to manipulate the delivery sheath and deploy self expanding stents. The thumbwheels and outer sheaths are connected, such that rotating the thumbwheels causes the sheaths to retract, uncovering the stents. The flexible cable 430 is provided to transmit torque such as 1: 1 torque to connect the thumbwheel axle shafts of the first stent delivery system 410 and the second stent delivery system 420. The flexible cable 430 allows a user to control the first stent delivery system 410 and the second stent delivery system 420 while manipulating a single delivery system handle.

[0053] The handles of the first stent delivery system 410 and the second stent delivery system 420 may have connections on both sides. In FIG. 4, the first transmission axle 414 has a first protective cover 412 on the outside and the first connector 413 on the inside. The second transmission axle 424 has a second protective cover 422 on the outside and the second connector 423 on the inside. The flexible cable 430 is connected to and between the first connector 413 and the second connector 423. To connect the first stent delivery system 410 and the second stent delivery system 420, the flexible cable 430 is connected to transmit the torque from one delivery system to the other. When the user rotates the thumbwheel of the first stent delivery system 410 or the second stent delivery system 420, the thumbwheel of the other of the first stent delivery system 410 and the second stent delivery system 420 rotates in the same direction. As a result, the flexible cable 430 is configured to be driven by the primary wheel among the first thumbwheel 411 and the second thumbwheel. The flexible cable 430 is configured to linearly transmit torque from a first axle among the first transmission axle 414 and the second transmission axle 424, and to a second axle among the first transmission axle 414 and the second transmission axle 424.

[0054] A method of implementing the stent delivery system 400 in FIG. 4 may include aligning and fitting the flexible cable 430 to the first transmission axle 414 via the first connector 413 and to the second transmission axle 424 via the second connector 423, and then manipulating either the first thumbwheel 411 or the second thumbwheel 421. Motion from the manipulated thumbwheel is passed via the flexible cable 430 to the other thumbwheel. As a result of the aligning, fitting and manipulating, the outer sheaths will be moved apart from the inner lumens, and the first stent and the second stent will advance along their intended pathways.

[0055] FIG. 5 illustrates a flexible cable in the stent delivery system of FIG. 4, in accordance with a representative embodiment.

[0056] In FIG. 5, the stent delivery system 500 includes the flexible cable 530. The flexible cable 530 include an outer jacket 531, an internal drive cable 532, a first cable tip 533 and a second cable tip 534, the first connector 513 and the second connector 523.

[0057] The flexible cable 530 may be a flexible drive cable with an inner braided cable represented by the internal drive cable 532, the outer jacket 531, and the first connector 513 and the second connector 523 on each end to connect to the handles. The first cable tip 533 and the second cable tip 534 are tips of the internal drive cable 532 and can be provided as a locking geometrical shape such as a square, hexagonal, or a torx drive head. An example of the locking geometrical shapes is provided on the left side in FIG. 5, and is shown with the locking geometrical shape as a protrusion from a circular element. For example, the locking geometrical shapes may protrude from the first connector 513 and the second connector 523. The first cable tip 533 and the second cable tip 534 may be inserted to a mating receptacle on the corresponding thumbwheel axis of the corresponding handle. The internal drive cable 532 may be a braided cable that provides a flexible connection between the handles and may deliver torque such as 1: 1 torque. As a result of the flexible cable 530, rotation of the first thumbwheel 411 in FIG. 4 transmits the same rotation to the second thumbwheel 421 in FIG. 4.

[0058] In some embodiments based on FIG. 4 and FIG. 5, the first thumbwheel 411 of FIG. 4 serves as a primary wheel that conveys motion via the flexible cable 530 of FIG. 5 to the second thumbwheel 421 of FIG. 4 as a secondary wheel.

[0059] FIG. 6 illustrates a connector for the stent delivery system of FIG. 4, in accordance with a representative embodiment.

[0060] In the embodiment of FIG. 6, the stent delivery system 600 includes a thumbwheel 611, a handle 612 and a receptacle for the cable tip 634. As shown, the receptacle may be a square, hexagonal, or a torx drive head that mates to the first cable tip 533 and/or the second cable tip 534 from FIG. 5.

[0061] A process for connecting handles using the stent delivery system 600 may include removing the corresponding protective caps on both handles to allow cable connections, and then inserting the cable tip 634 such as one of the first cable tip 533 and the second cable tip 534 into a first handle and then turning the corresponding connector to lock the first cable tip 533 and the second cable tip 534 in place. The process may then include inserting another cable tip such as the other of the first cable tip 533 and the second cable tip 534 into the second handle and then turning the corresponding connector to lock the other of the first cable tip 533 and the second cable tip 534 in place. Once connected, rotating the thumbwheel of either handle will control both handles for a synchronized stent delivery.

[0062] FIG. 7 illustrates another stent delivery system, in accordance with a representative embodiment.

[0063] In the embodiment of FIG. 7, the stent delivery system 700 includes a thumbwheel 711, a drive member 723, and a drive receptacle 734. As shown, turning the thumbwheel 711 will result in turning the drive member 723. The drive receptacle 734 is for receiving another drive member 723 from another stent delivery system, so that torque transmitted from the other tent delivery system via a corresponding drive member may be transmitted to the stent delivery system 700 via the drive receptacle 734, and vise versa.

[0064] That is, in the embodiment of FIG. 7, a delivery system handle may include a thumbwheel axle having two sides. A drive member such as the drive member 723 extending from either side such as the left side as shown in FIG. 7 may be provided opposite to a drive receptacle such as the drive receptacle 734 on the opposing side such as the right side as shown. The drive member may be a square, hexagon, torx or another shape with one or more straight edges. The drive receptacle may be configured to accept a square, hexagon, torx or other shape with one or more straight edges. The configuration shown in FIG. 7 allows multiple handles to be connected together at the drive axles, without a need for a separate drive cable. As should be evident, the stent delivery system 700 shown in FIG. 7 may be provided adjacent to and on either side of another stent delivery system with comparable capabilities and a comparable configuration.

[0065] Using the stent delivery system 700 in FIG. 7, a delivery system handle is configured with a thumbwheel axle having two sides, a drive member extending from one side, and a drive receptacle on the opposite side. The stent delivery system 700 enables connection of multiple handles together at the drive axles by joining the axles without requiring a separate drive cable. [0066] Additionally, as shown in FIG. 7, an alignment pin at the bottom may be provided on one side and a corresponding alignment receptacle may be provided on an opposite side opposite the alignment pin. Accordingly, the stent delivery system 700 may be aligned and temporarily locked in place with another stent delivery system by aligning the drive member 723 and the alignment pin into a corresponding receptacle and alignment receptacle on the other stent delivery system.

[0067] FIG. 8 illustrates another stent delivery system, in accordance with another representative embodiment. As shown, the stent delivery system 800 includes a first stent delivery sub-system 810 and a second stent delivery sub-system 820. At the uppermost portion of FIG. 8, the first stent delivery sub-system 810 and the second stent delivery sub-system 820 are spaced apart, and in the lowermost portion of FIG. 8, the first stent delivery sub-system 810 and the second stent delivery sub-system 820 are connected together. The first stent delivery sub-system 810 and the second stent delivery sub-system 820 in FIG. 8 may each be instantiations of the stent delivery system 700 in FIG. 7, and may each include a thumbwheel 711 as a wheel, a drive member 723 as a drive member, and the drive receptacle 734 as a receptacle. When the stent delivery system 700 is provided in multiple instantiations, the different instantiations may include a first wheel and a second wheel based on the thumbwheel 711, a first drive member and a second drive member based on the drive member 723, and a first drive receptacle and a second drive receptacle based on the drive receptacle 734.

[0068] The stent delivery system 800 in FIG. 8 shows multiple handles assembled together. As shown, the configuration in FIG. 8 allows a user to control both stents with one thumbwheel. A method of implementing the stent delivery system 800 may include aligning the first stent delivery sub-system 810 and the second stent delivery sub-system 820 so that the drive member of one fits to the receptacle of the other and so that the alignment pin of the one fits to the alignment receptacle of the other, and then manipulating the thumbwheel of the other so that motion is conveyed via the drive axles to the thumbwheel of the other. As a result of the aligning and the manipulating, the outer sheaths of the first stent and the second stent will be moved apart from the inner lumens of the first stent and the second stent.

[0069] As set forth above, a stent delivery system 700 from FIG. 7 may be provided as the first stent delivery sub-system 810 as a first stent delivery sub-system, and as the second stent delivery sub-system 820 as a second stent delivery sub-system. The first stent delivery subsystem then includes a first wheel through which motion is transferred to a first stent, a first axle for the first wheel, a first drive member on a first side of the first axle of the first stent delivery sub-system, and a first drive receptacle on a second side of the first axle of the first stent delivery sub-system opposite the first side of the first stent delivery sub-system. The second stent delivery sub-system then includes a second wheel through which motion is transferred to a second stent, a second axle for the second wheel, a second drive member on a first side of the second axle of the second stent delivery sub-system, and a second drive receptacle on a second side of the second axle of the second stent delivery sub-system opposite the first side of the second axle of the second stent delivery sub-system. As noted, the first stent delivery sub-system 810 and the second stent delivery sub-system 820 each may include some or all of the features of the stent delivery system 700 in FIG. 7. Accordingly, as stent delivery sub-systems, the first drive receptacle on the second side of the first axle of the first stent delivery sub-system may be configured to receive the second drive member on the first side of the second axle of the second stent delivery sub-system, such that motion delivered to the first wheel of the first stent-delivery sub-system is delivered to the second wheel of the second stent delivery sub-system.

[0070] FIG. 9 illustrates another stent delivery system, in accordance with another representative embodiment.

[0071] FIG. 9 shows a first stent “a” and a second stent “b” being advanced in accordance with stent delivery systems described with respect to embodiments herein. The first stent “a” includes the inner lumen al and the outer jacket a2, wherein the inner lumen al is moved relative to the outer jacket a2 by the stent delivery systems described herein. Synchronously, the second stent “b” includes the inner lumen bl and the outer jacket b2, wherein the inner lumen bl is moved relative to the outer jacket b2 by the stent delivery systems described herein. Accordingly, in FIG .9 two stents are synchronously and simultaneously deployed.

[0072] As described above, accurate placement of expandable stents is provided by the different stent delivery systems described herein. The stent delivery systems described herein avoid requiring vacillation when a physician is manipulating adjoining stents in the context of arterial bifurcations and venous confluences. As a result, the adjoining stents may be deployed evenly and synchronously. The stent delivery systems described herein pair control for two stents being deployed, either by adding a mechanism which may be used independently of the basic delivery system to drive both systems with a joining component, or by driving a second delivery system to follow a first delivery system through mechanical, pneumatic, or electrical control mechanisms. In each embodiment described herein, the stent delivery system synchronizes movement of the stent outer shaft mechanism and the stent inner shaft mechanisms. The synchronized movement may be achieved by engaging a wheel (e.g., thumbwheel) mechanism of both stents in unison. The synchronized movement may alternatively be achieved by directly driving the inner drive components of each stent. Each embodiment provides for additional mechanisms beyond what is provided by the two underlying stents being synchronized.

[0073] Although stent delivery system has been described with reference to several exemplary embodiments, it is understood that the words that have been used are words of description and illustration, rather than words of limitation. Changes may be made within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of stent delivery system in its aspects. Although stent delivery system has been described with reference to particular means, materials and embodiments, stent delivery system is not intended to be limited to the particulars disclosed; rather stent delivery system extends to all functionally equivalent structures, methods, and uses such as are within the scope of the appended claims. [0074] The illustrations of the embodiments described herein are intended to provide a general understanding of the structure of the various embodiments. The illustrations are not intended to serve as a complete description of all of the elements and features of the disclosure described herein. Many other embodiments may be apparent to those of skill in the art upon reviewing the disclosure. Other embodiments may be utilized and derived from the disclosure, such that structural and logical substitutions and changes may be made without departing from the scope of the disclosure. Additionally, the illustrations are merely representational and may not be drawn to scale. Certain proportions within the illustrations may be exaggerated, while other proportions may be minimized. Accordingly, the disclosure and the figures are to be regarded as illustrative rather than restrictive.

[0075] One or more embodiments of the disclosure may be referred to herein, individually and/or collectively, by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any particular invention or inventive concept. Moreover, although specific embodiments have been illustrated and described herein, it should be appreciated that any subsequent arrangement designed to achieve the same or similar purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all subsequent adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the description.

[0076] The Abstract of the Disclosure is provided to comply with 37 C.F.R. § 1.72(b) and is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, various features may be grouped together or described in a single embodiment for the purpose of streamlining the disclosure. This disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter may be directed to less than all of the features of any of the disclosed embodiments. Thus, the following claims are incorporated into the Detailed Description, with each claim standing on its own as defining separately claimed subject matter.

[0077] The preceding description of the disclosed embodiments is provided to enable any person skilled in the art to practice the concepts described in the present disclosure. As such, the above disclosed subject matter is to be considered illustrative, and not restrictive, and the appended claims are intended to cover all such modifications, enhancements, and other embodiments which fall within the true spirit and scope of the present disclosure. Thus, to the maximum extent allowed by law, the scope of the present disclosure is to be determined by the broadest permissible interpretation of the following claims and their equivalents and shall not be restricted or limited by the foregoing detailed description.

Claims

CLAIMS:

1. A stent delivery system (100/200), comprising: a first movable fastener (141/241) configured to fasten to a first inner lumen (191/291) of a first stent; a second movable fastener (142/242) configured to fasten to a second inner lumen (193/293) of a second stent; a third movable fastener (143/243) configured to fasten to a first outer sheath (192/292) of the first stent; and a fourth movable fastener (144/244) configured to fasten to a second outer sheath (194/294) of the second stent, wherein the first movable fastener (141/241) is configured to move relative to the third movable fastener (143/243) and the second movable fastener (142/242) is configured to move relative to the fourth movable fastener (144/244).

2. The stent delivery system (100) of claim 1, further comprising: a first handle (110) comprising the first movable fastener (141) and the second movable fastener (142); and a second handle (120) comprising the third movable fastener (143) and the fourth movable fastener (144).

3. The stent delivery system (100) of claim 2, wherein the first handle (110) and the second handle (120) are configured to synchronize actuation of the first stent and the second stent when the first handle (110) is driven relative to the second handle (120).

4. The stent delivery system (200) of claim 1, further comprising: a first actuator (210) comprising a first end configured to contact the first inner lumen (291) of the first stent and a second end opposite to the first end and configured to contact the first outer sheath (292) of the first stent, and a second actuator (220) comprising a first end configured to contact the second inner lumen (293) of the second stent, and a second end opposite the first end and configured to contact the second outer sheath (294) of the second stent.

5. The stent delivery system (100) of claim 4, wherein the first end (241/242) and the second end (243/244) of each of the first actuator (210) and the second actuator (220) are configured to synchronize actuation of the first stent and the second stent when the first end (241/242) is driven relative to the second end (243/244).

6. The stent delivery system (200) of claim 4, wherein the first actuator (210) and the second actuator (220) are pneumatically driven.

7. The stent delivery system (200) of claim 4, wherein the first actuator (210) and the second actuator (220) are pneumatically driven using one of a gas or a liquid.

8. The stent delivery system (200) of claim 1, further comprising: a first motorized delivery mechanism comprising the first movable fastener (241) and the third movable fastener (243); and a second motorized delivery mechanism comprising the second movable fastener (242) and the fourth movable fastener (244), and a motor configured to drive the first motorized delivery mechanism to actuate the first stent and to drive the second motorized delivery mechanism to actuate the second stent.

9. The stent delivery system (200) of claim 8, wherein the first motorized delivery mechanism is primarily driven by the motor, and the second motorized delivery mechanism is secondarily driven by the motor to mimic the first motorized delivery mechanism.

10. The stent delivery system (200) of claim 8, wherein the first motorized delivery mechanism is mechanically independent of the second motorized delivery mechanism.

11. A stent delivery system (300/400), comprising: a primary wheel (310/411) that couples and transfers motion to at least one of a first thumbwheel (391/421) that contacts a first stent or a second thumbwheel (392) that contacts a second stent; and wherein the primary wheel (310/411) is configured to couple to at least one of a first handle (396) on the first stent or a second handle (397) on the second stent.

12. The stent delivery system (300) of claim 11, further comprising: a drive roller (320) through which the motion is transferred from the primary wheel to the first thumbwheel (391) and to the second thumbwheel (392), wherein the drive roller (320) is configured to couple to the first handle (396) on the first stent and to the second handle (397) on the second stent.

13. The stent delivery system (400) of claim 11, further comprising: a flexible cable (430) configured to be driven by the primary wheel (411) and configured to linearly transmit torque from a first axle of the primary wheel (411) that contacts the first stent and to a second axle of the first thumbwheel (411) that contacts the second stent.

14. The stent delivery system (400) of claim 13, wherein the flexible cable (430) comprises: an inner braided cable with a first tip on a first end and a second tip on a second end opposite to the first end; an outer jacket (531); and a first connector (513) on the first tip and a second connector (523) on the second tip, wherein the first connector (513) connects to the first axle of the primary wheel (411) to linearly transmit torque to the first axle and the second connector (523) connects to the second axle of the first thumbwheel (411) to linearly transmit torque to the second axle.

15. The stent delivery system (400) of claim 14, wherein the first connector (413) is configured to mate to the first axle and the second connector (423) is configured to mate to the second axle.

16. A stent delivery system (800), comprising: a first stent delivery sub-system (810/700) comprising a first wheel through which motion is transferred to a first stent, a first axle for the first wheel, a first drive member on a first side of the first axle of the first stent delivery sub-system (810/700), and a first drive receptacle on a second side of the first axle of the first stent delivery sub-system (810/700) opposite the first side of the first stent delivery sub-system (810/700); and a second stent delivery sub-system (820/700) comprising a second wheel through which motion is transferred to a second stent, a second axle for the second wheel, a second drive member on a first side of the second axle of the second stent delivery sub-system (820/700), and a second drive receptacle on a second side of the second axle of the second stent delivery subsystem (820/700) opposite the first side of the second axle of the second stent delivery subsystem (820/700), wherein the first drive receptacle on the second side of the first axle of the first stent delivery sub-system (810/700) is configured to receive the second drive member on the first side of the second axle of the second stent delivery sub-system (820/700), such that motion delivered to the first wheel of the first stent delivery sub-system (810/700) is delivered to the second wheel of the second stent delivery sub-system (820/700).