Deployment-constrained sheath allows for gradual deployment of device sections

Abstract

To provide good medical devices and the like.SOLUTION: Various aspects of the present disclosure are directed to medical devices, systems and methods. The medical devices may include a portion having a radially expansive force greater than a radially expansive force in other portions of the device. In addition, the medical device may include one or more constraining mechanisms for deployment of the medical devices.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] Technical Field The present disclosure relates generally to medical devices, and more specifically to medical devices for connecting tissue layers to form an anastomosis, implantable devices for occluding, inhibiting or preventing the movement of material through an opening in tissue and enabling healing of a tissue defect, enabling the sealing and healing of defects in tissue, and the deployment of the medical devices discussed herein. [Background technology]

[0002] background An anastomosis is an interconnection between two tissue structures, such as blood vessels or the intestine. For example, in the context of coronary artery bypass graft surgery, the graft vessel is anastomosed to a native coronary artery so that blood can flow through the graft vessel.

[0003] Anastomoses can be formed in a variety of ways, including, but not limited to, end-to-end, end-to-side, and side-to-side anastomoses. Often, sutures are used to form such anastomoses. Summary of the Invention

[0004] overview Various aspects of the present disclosure are directed to a medical device system. The medical device system can include an expandable medical device having a first end, a second end, and an intermediate portion between the first end and the second end. The intermediate portion of the expandable medical device can have a radial expansion force that is greater than a radial expansion force of at least one of the first end and the second end. Additionally, the expandable medical device can include a first restraining mechanism configured to releasably restrain the expandable medical device, and a second restraining mechanism disposed between the expandable medical device and the first restraining mechanism and configured to reduce expansion of the intermediate portion of the expandable medical device in response to release of the first restraining mechanism.

[0005] Various aspects of the present disclosure are also directed to a system for deploying a medical device having a first flange, a second flange and an intermediate portion therebetween and having a delivery configuration and a deployed configuration, the system including a first restraining mechanism configured to restrain the expandable medical device in the delivery configuration and in response to release thereof to deploy the first and second flanges to the deployed configuration, and a second restraining mechanism disposed between the expandable medical device and the first restraining mechanism and configured in response to release of the first restraining mechanism to maintain the intermediate portion of the expandable medical device in the intermediate configuration.

[0006] Aspects of the present disclosure are also directed to a method of deploying an expandable medical device having a delivery configuration and a deployed configuration, the method including positioning an expandable medical device at a target location, the expandable medical device including a first end, a second end, and an intermediate section having a radial expansion force greater than the radial expansion force of the first end. The method also includes releasing a first restraining mechanism to deploy the first end and the second end to the deployed configuration and deploy the intermediate section to the intermediate configuration. Additionally, the method includes releasing a second restraining mechanism to deploy the intermediate section to the deployed configuration.

[0007] According to one example ("Example 1"), a medical device system includes an expandable medical device including a first end, a second end and an intermediate portion therebetween, where the intermediate portion has a radial expansion force greater than a radial expansion force of at least one of the first end and second end, a first restraining mechanism configured to releasably restrain the expandable medical device, and a second restraining mechanism disposed between the expandable medical device and the first restraining mechanism and configured to reduce expansion of the intermediate portion of the expandable medical device in response to release of the first restraining mechanism.

[0008] In addition to Example 1, according to another example ("Example 2"), the first and second restraining mechanisms are configured to deploy an intermediate portion of the expandable medical device to an intermediate configuration and to deploy the first and second ends of the expandable medical device to an expanded configuration in response to release of the first restraining mechanism.

[0009] In addition to Example 2, according to another example ("Example 3"), the second restraining mechanism is configured to release an intermediate portion of the expandable medical device to deploy to a deployed configuration.

[0010] In addition to Example 3, according to another example ("Example 4"), the second restraining mechanism is configured to release in response to a force applied thereto.

[0011] In addition to Example 4, according to another example ("Example 5"), the force is a radial force applied within an intermediate portion of the expandable medical device, and the second restraint mechanism is configured to remain coupled to the expandable medical device after the force is applied.

[0012] In addition to Example 1, according to another example ("Example 6"), the first end includes a first flange, the second end includes a second flange, and the intermediate portion includes a substantially cylindrical shape.

[0013] In addition to Example 6, according to another example ("Example 7"), the expandable medical device includes a first reentrant region between the first flange and the intermediate portion, a second reentrant region between the second flange and the intermediate portion, and the second restraint mechanism is disposed between the first reentrant region and the second reentrant region.

[0014] In addition to Example 1, according to another example ("Example 8"), the second restraint mechanism is coupled to the expandable medical device, and the first restraint mechanism is configured to deploy and decouple the expandable medical device from the expandable medical device in response to tension applied to the first restraint mechanism.

[0015] In addition to Example 1, according to another example ("Example 9"), the first restraining mechanism is configured to releasably restrain the expandable medical device in a substantially cylindrical delivery configuration.

[0016] In addition to Example 9, according to another example ("Example 10"), the first restraint mechanism extends from a proximal end of the expandable medical device to a distal end of the expandable medical device and extends back toward the proximal end of the expandable medical device.

[0017] According to one example ("Example 11"), there is provided a system for deploying a medical device having a first flange, a second flange and an intermediate portion therebetween, a delivery configuration and a deployed configuration. In Example 11, the system includes a first constraining mechanism configured to constrain the medical device in the delivery configuration, the first constraining mechanism configured to deploy the first and second flanges to a deployed configuration in response to release of the first constraining mechanism, and a second constraining mechanism disposed between the medical device and the first constraining mechanism, the second constraining mechanism configured to maintain the intermediate portion of the medical device in the intermediate configuration in response to release of the first constraining mechanism.

[0018] In addition to Example 11, according to another example ("Example 12"), the intermediate portion has a radial expansion force that is greater than a radial expansion force of at least one of the first flange and the second flange.

[0019] In addition to Example 11, according to another example ("Example 13"), the second restraining mechanism is coupled to the medical device and secured to the intermediate portion.

[0020] In addition to Example 11, according to another example ("Example 14"), the second restraining mechanism is disposed around a middle portion of the medical device.

[0021] In addition to Example 11, according to another example ("Example 15"), the diameter of the intermediate portion in the intermediate configuration is about 40% to 80% smaller than the diameter of the intermediate portion in the deployed configuration.

[0022] In addition to Example 11, according to another example ("Example 16"), the first restraining mechanism is configured to deploy the medical device and be decoupled from the medical device in response to release of the first restraining mechanism.

[0023] According to one example ("Example 17"), there is a method of deploying an expandable medical device having a delivery configuration and a deployed configuration. In Example 17, the method includes positioning an expandable medical device at a target location, the expandable medical device including a first end, a second end, and an intermediate section therebetween, where the intermediate section has a radial expansion force greater than a radial expansion force of the first end, releasing a first constraining mechanism to deploy the first end and the second end to a deployed configuration, deploying the intermediate section to the intermediate configuration, and releasing a second constraining mechanism to deploy the intermediate section to the deployed configuration.

[0024] In addition to Example 17, according to another example ("Example 18"), releasing the second restraint mechanism includes applying a force to the second restraint mechanism to deploy the intermediate section from the intermediate configuration to the deployed configuration.

[0025] In addition to Example 17, according to another example ("Example 19"), the diameter of the intermediate portion in the intermediate configuration is about 40% to 80% smaller than the diameter of the intermediate portion in the deployed configuration.

[0026] In addition to Example 17, according to another example ("Example 20"), releasing the first restraint mechanism includes decoupling the first restraint mechanism from the expandable medical device, and releasing the second restraint mechanism includes maintaining at least a portion of the second restraint mechanism attached to an intermediate portion of the expandable medical device.

[0027] According to one example ("Example 21"), a medical device system includes an expandable medical device including a first end, a second end, and an intermediate portion therebetween, where the intermediate portion has a radial expansion force greater than a radial expansion force of at least one of the first end and second end, a first restraining mechanism configured to releasably restrain the expandable medical device, and a second restraining mechanism disposed between the expandable medical device and the first restraining mechanism and configured to reduce expansion of the intermediate portion of the expandable medical device in response to release of the first restraining mechanism.

[0028] In addition to Example 21, according to another example ("Example 22"), the first and second restraining mechanisms are configured to deploy an intermediate portion of the expandable medical device to an intermediate configuration and deploy first and second ends of the expandable medical device to an expanded configuration in response to release of the first restraining mechanism.

[0029] According to another example ("Example 23") in addition to any one of Examples 21-22, the second restraint mechanism is configured to release an intermediate portion of the expandable medical device and deploy it to a deployed configuration.

[0030] In addition to Example 23, according to another example ("Example 24"), the second restraining mechanism is configured to release in response to a force applied thereto.

[0031] In addition to Example 24, according to another example ("Example 25"), the force is a radial force applied within an intermediate portion of the expandable medical device, and the second restraint mechanism is configured to remain coupled to the expandable medical device after the force is applied.

[0032] According to another example ("Example 26") in addition to any one of Examples 21-25, the first end includes a first flange, the second end includes a second flange, and the intermediate portion includes a substantially cylindrical shape.

[0033] In addition to Example 26, according to another example ("Example 27"), the expandable medical device includes a first reentrant region between the first flange and the intermediate portion, a second reentrant region between the second flange and the intermediate portion, and the second restraint mechanism is disposed between the first reentrant region and the second reentrant region.

[0034] In addition to any one of Examples 21-27, according to another example ("Example 28"), the second restraint mechanism is coupled to the expandable medical device, and the first restraint mechanism is configured to deploy and decouple the expandable medical device from the expandable medical device in response to tension applied to the first restraint mechanism.

[0035] According to another example ("Example 29"), in addition to any one of Examples 21-28, the first restraint mechanism is configured to releasably restrain the expandable medical device in a substantially cylindrical delivery configuration.

[0036] In addition to Example 29, according to another example ("Example 30"), the first restraint mechanism extends from a proximal end of the expandable medical device to a distal end of the expandable medical device and extends back toward the proximal end of the expandable medical device.

[0037] According to one example ("Example 31"), a system for deploying a medical device having a first flange, a second flange and an intermediate portion therebetween, a delivery configuration and a deployed configuration includes a first restraining mechanism configured to restrain the medical device in the delivery configuration, the first restraining mechanism configured to deploy the first and second flanges to a deployed configuration in response to release of the first restraining mechanism, and a second restraining mechanism disposed between the medical device and the first restraining mechanism and configured to maintain the intermediate portion of the medical device in the intermediate configuration in response to release of the first restraining mechanism.

[0038] In addition to Example 31, according to another example ("Example 32"), the intermediate portion has a radial expansion force that is greater than a radial expansion force of at least one of the first flange and the second flange.

[0039] According to another example ("Example 33") in addition to any one of Examples 31-32, the second restraining mechanism is coupled to the medical device and secured to the intermediate portion.

[0040] According to another example ("Example 34") in addition to any one of Examples 31-33, the second restraining mechanism is disposed around a middle portion of the medical device.

[0041] According to another example ("Example 35") in addition to any one of Examples 31-34, the diameter of the intermediate portion in the intermediate configuration is about 40%-80% smaller than the diameter of the intermediate portion in the deployed configuration.

[0042] In addition to any one of Examples 31-35, according to another example ("Example 36"), the first restraint mechanism is configured to deploy the medical device and be decoupled from the medical device in response to release of the first restraint mechanism.

[0043] According to one example ("Example 37"), a method of deploying an expandable medical device having a delivery configuration and a deployed configuration, the method includes positioning an expandable medical device including a first end, a second end and an intermediate portion therebetween at a target location, where the intermediate portion has a radial expansion force greater than a radial expansion force of the first end, releasing a first restraining mechanism to deploy the first end and the second end to a deployed configuration, deploying the intermediate portion to the intermediate configuration, and releasing a second restraining mechanism to deploy the intermediate portion to the deployed configuration.

[0044] In addition to Example 37, according to another example ("Example 38"), releasing the second restraint mechanism includes applying a force to the second restraint mechanism to deploy the intermediate section from the intermediate configuration to a deployed configuration.

[0045] According to another example ("Example 39") in addition to any one of Examples 37-38, the diameter of the intermediate portion in the intermediate configuration is about 40% to 80% smaller than the diameter of the intermediate portion in the expanded configuration.

[0046] In addition to any one of Examples 37-39, according to another example ("Example 40"), releasing the first restraint mechanism includes decoupling the first restraint mechanism from the expandable medical device, and releasing the second restraint mechanism includes maintaining at least a portion of the second restraint mechanism attached to an intermediate portion of the expandable medical device. [Brief description of the drawings]

[0047] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1] FIG. 1 illustrates a cutaway perspective view of an exemplary expandable medical device implanted within a patient, according to various embodiments of the present disclosure.

[0048] [Diagram 2] FIG. 2 illustrates a delivery system for an expandable medical device according to various embodiments of the present disclosure.

[0049] [Figure 2A] FIG. 2A illustrates a delivery system for an expandable medical device according to various embodiments of the present disclosure.

[0050] [Figure 2B] FIG. 2B illustrates a delivery system for an expandable medical device according to various embodiments of the present disclosure.

[0051]

[0052]

[0053] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0054] Detailed Description Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the accompanying figures referenced herein are not necessarily to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the figures should not be construed as limiting.

[0055] Various aspects of the present disclosure are directed to medical devices for connecting tissue layers to avoid ductal or organ obstruction, for example, by forming an anastomosis that forms a direct passageway between tissue structures to facilitate the flow of material therebetween. The expandable medical device can be endoscopically deployable or deliverable via a catheter and can be self-expandable to facilitate a firm connection between tissue structures. The present disclosure discusses one or more restraining mechanisms that facilitate the deployment of the expandable medical device to facilitate its delivery and reduce misdeployment.

[0056] 1 is a cutaway perspective view of an exemplary expandable medical device 100 implanted within a patient, according to various aspects of the present disclosure. The expandable medical device 100 is configured to be implanted into a patient to create a fluid connection between spaces, tissue structures, ducts, organs, and the like, and combinations thereof. As shown in FIG. 1, for example, the expandable medical device 100 can be used to connect a gallbladder 102 (defining an interior gallbladder space 104) to an intestine 106 (defining an interior intestinal space 108). As a result, the expandable medical device 100 acts as a fluid shunt device between the interior gallbladder space 104 and the interior intestinal space 108.

[0057] Such an appliance can provide beneficial therapy to a patient, for example, when there is a flow obstruction in the natural anatomical conduit connecting the internal gallbladder space 104 and the internal intestinal space 108. In certain instances, a patient may have one or more gallstones that cause a blockage in the patient's cystic duct 110 and / or common bile duct 112. In such cases, the expandable medical device 100 can provide a fluid passageway to allow bile from the gallbladder 102 to flow into the intestine 106.

[0058] The expandable medical device 100 can include a first end 114, a second end 116, and an intermediate section 118 therebetween. The intermediate section 118 defines a lumen 120 extending longitudinally from the first end 114 to the second end 116. The lumen 120 can act as a connection (e.g., a shunt passageway) between two spaces (e.g., tissue structures, ducts, organs) that the expandable medical device 100 connects. In the example shown in FIG. 1, the lumen 120 acts as a connection between the interior gallbladder space 104 and the interior intestinal space 108 such that the interior gallbladder space 104 is in fluid communication with the interior intestinal space 108 through the expandable medical device 100.

[0059] Although FIG. 1 illustrates the expandable medical device 100 connecting the gallbladder 102 and intestine 106 of a patient, the expandable medical device 100 can be used with a variety of body tissue structures and organs, including, but not limited to, the stomach, colon, small intestine, pancreas, blood vessels, bladder, kidneys, and ducts.

[0060] 2 illustrates a delivery system 200 for an expandable medical device, according to various aspects of the present disclosure. The delivery system 200 can include a catheter body 202 in which an expandable medical device (not shown) can be placed. The delivery system 200 also includes a first restraining mechanism 204 configured to restrain the expandable medical device in a delivery or restrained configuration. The first restraining mechanism 204 can be used in conjunction with a second restraining mechanism (as shown and discussed in further detail below with reference to FIGS. 3-6).

[0061] To deploy an expandable medical device disposed with the delivery system 200, tension can be applied to a deployment line 206 coupled to the first restraining mechanism 204. The deployment line 206 is accessible to a user, such as a physician, and can be disposed within the catheter body 202 through a port 208. In response to tension applied to the deployment line 206, the first restraining mechanism 204 can open, retract, or invert from an end of the delivery system 200, such as the distal tip 210, toward the port 208. In some embodiments, the first restraining mechanism 204 can have multiple layers that restrain the expandable medical device and thus can move multiple times from one end of the delivery zone to the other during deployment. In certain instances, the delivery system 200 can also include a skirt 212 disposed around the first restraining mechanism 204 before the delivery system 200 is moved to a target location within a patient.

[0062] 3 illustrates an expandable medical device 300 in a delivery configuration, according to various aspects of the present disclosure. As shown in FIG. 3, a first restraining mechanism 302 is configured to restrain the expandable medical device 300 in the delivery configuration. The first restraining mechanism 302 extends from a proximal end 306 of the expandable medical device 300 to a distal end 308 of the expandable medical device 300. Furthermore, the expandable medical device 300 can be disposed on a delivery catheter or delivery system 310. In certain instances, the delivery catheter or delivery system 310 is routed to a target location within a patient for delivery of the expandable medical device 300.

[0063] To deploy the expandable medical device 300, tension can be applied to a deployment line 312 coupled to the first restraining mechanism 302, which is accessible to a user, such as a physician. In response, the first restraining mechanism 302 can open, retract, or invert from the proximal end 306 toward the distal end 308, and then continue back toward the proximal end 306 of the expandable medical device 300. Releasing the first restraining mechanism 302 in this manner allows the distal end 308 of the expandable medical device 300 to be deployed prior to deploying the remainder of the expandable medical device 300.

[0064] 4 illustrates the expandable medical device 300 after deployment of the distal end 308 of the expandable medical device 300. As shown therein, the expandable medical device 300 can include a first flange 314 disposed at the distal end 308. The first flange 314 can be deployed after the first restraining mechanism 302 is pulled past the first flange. The user can continue to apply tension to the deployment line 312 of the first restraining mechanism 302 to continue deployment of the expandable medical device 300.

[0065] 5 illustrates the expandable medical device 300 after deployment of the proximal end 306 of the expandable medical device 300. As shown therein, the expandable medical device 300 can include a second flange 316 disposed at the proximal end 306. The first restraining mechanism 302 is released beyond the proximal end 306 of the expandable medical device 300 and is released and decoupled from the expandable medical device 300. Thus, in response to its release, the first restraining mechanism 302 is configured to release the first flange 314 and the second flange 316 and deploy to a fully deployed configuration. However, the intermediate portion 318 of the expandable medical device 300 remains in the intermediate configuration as shown in FIG.

[0066] The second restraining mechanism 304, disposed between the expandable medical device 300 and the first restraining mechanism 302 in the delivery configuration shown in Figures 2 and 3, is configured to maintain the intermediate portion 318 of the expandable medical device 300 in the intermediate configuration after release of the first restraining mechanism 302. The intermediate portion 318 of the expandable medical device 300 can have a radial expansion force that is greater than the radial expansion force of either or both of the first flange 314 and the second flange 316 when restrained by the first restraining mechanism 302. As shown with reference to Figures 6A and 6B, for example, the expandable medical device 300 can include a plurality of elongate elements. The plurality of elongate elements can have a greater density and / or winding pattern at the intermediate portion 318 of the expandable medical device 300 than at either or both of the first flange 314 and the second flange 316. Additionally, and as a result, the middle portion 318 of the expandable medical device 300 is more resistant to compressive forces (has greater radial strength) than one or both of the first flange 314 and the second flange 316 .

[0067] In certain instances, the middle portion 318 is generally cylindrical, while the first flange 314 and the second flange 316 extend generally perpendicular to the middle portion 318, such that the expandable medical device 300 comprises an hourglass shape with a lumen of an intermediate configuration (shown in FIG. 5). The second restraining mechanism 304 is coupled to the expandable medical device 300 and secured to the middle portion 318. The second restraining mechanism 304 is disposed about the middle portion 318 of the expandable medical device 300.

[0068] To facilitate gradual deployment of the expandable medical device 300, the second restraining mechanism 304 can be configured to reduce premature expansion of the intermediate section 318. The expandable medical device 300, in certain instances, is self-expanding and therefore biased to deploy from a delivery configuration to a fully deployed configuration. In certain instances, the intermediate section 318 and the first flange 314 and / or the second flange 316 having different radial forces can result in the force from the intermediate section 318 attempting to be in the deployed configuration pushing the first restraining mechanism 302 away from the expandable medical device 300. The second restraining mechanism 304 is configured to reduce expansion of the intermediate section 318 by deploying the intermediate section 318 to the intermediate configuration as opposed to directly deploying to the deployed configuration.

[0069] The second restraining mechanism 304 is configured to release in response to a force applied thereto. In certain instances, the force is applied from within the intermediate portion 318 of the expandable medical device 300, causing the second restraining mechanism 304 to break, fracture or expand. In certain instances, the second restraining mechanism 304 remains coupled to the intermediate portion 318 of the expandable medical device 300 after its release. The intermediate portion 318 of the expandable medical device 300 can deploy to a fully deployed configuration after release of the second restraining mechanism 304, for example, as shown in FIG. 6B.

[0070] 6A illustrates an expandable medical device 600 in an intermediate configuration and a restraining mechanism 602, according to various embodiments of the present disclosure. The expandable medical device 600 can include a first end 604 having a flange shape, a second end 606 having a flange shape, and an intermediate portion 608 extending therebetween.

[0071] Additionally, the first end 604, the second end 606, and the intermediate section 608 are formed by a framework of elongate elements 610. As shown in FIG. 6A, the elongate elements 610 at the intermediate section 608 have a greater density than the first end 604 and the second end 606. The expandable medical device 600 can include a covering material 612 (also referred to herein as a "covering"). In certain instances, the covering material 612 is disposed on some or all of the first end 604, the second end 606, and the intermediate section 608. The elongate elements 610 at the intermediate section 608 include a greater integrity or greater windings than the first end 604 and the second end 606. Thus, the intermediate section 608 has a greater resistance to radial forces than the first end 604 and the second end 606. In certain instances, the difference in density of the elongate elements 610 at the intermediate portion 608 and the first end 604 and the second end 606 causes the intermediate portion 608 to have a greater radial expansion force at the first end 604 and the second end 606 than the first end 604 and the second end 606.

[0072] Further, in certain cases, the intermediate portion 608 comprises a radial expansion force that is greater than the radial expansion force of one or both of the first end 604 and the second end 606 in the delivery (constrained) configuration. The expandable medical device 600 is deployed by releasing the first constraint mechanism (e.g., as shown in FIG. 3). A second constraint mechanism, such as the constraint mechanism 602 shown in FIG. 6A, can be configured to reduce the expansion of the intermediate portion 608 of the expandable medical device 600 in response to the release of the first constraint mechanism. In certain examples, as shown in FIG. 6A, the second constraint mechanism 602 can be positioned to extend across the intermediate portion 608 of the expandable medical device 600. Further, as shown in FIG. 6A, the second constraint mechanism 602 is configured to deploy the intermediate portion 608 of the expandable medical device 600 to an intermediate configuration between the delivery configuration (shown in FIGS. 2 and 3) and the fully deployed configuration shown in FIG. 6B in response to the release of the first constraint mechanism.

[0073] In addition to deploying the intermediate portion 608 of the expandable medical device 600 to the intermediate configuration, after release of the first restraining mechanism, the first end 604 and the second end 606 are deployed to the deployed configuration (e.g., Figures 3-5).

[0074] In the intermediate configuration, the intermediate portion 608 of the expandable medical device 600 can have a diameter smaller than the diameter of the intermediate portion 608 of the expandable medical device 600 in the deployed configuration. The diameter of the intermediate portion 608 in the intermediate configuration can be about 40% to 80% smaller than the diameter of the intermediate portion 608 in the deployed configuration. The second restraining mechanism 602 can restrain the intermediate portion 608 in the intermediate configuration until the second restraining mechanism 602 is released. For example, the second restraining mechanism 602 is configured to release the intermediate portion 608 of the expandable medical device 600 and expand to the fully deployed configuration. The second restraining mechanism 602 is released in response to a force applied thereto. In certain instances, the force can be a radial force applied within the intermediate portion 608 of the expandable medical device 600. Additionally, the force can be applied by an inflatable balloon or other force applied within the intermediate portion 608 of the expandable medical device 600.

[0075] The second restraining mechanism 602 can release, burst, expand, or otherwise break in response to the force. Additionally, the second restraining mechanism 602 can be configured to remain coupled to the expandable medical device 600 after a force is applied thereto, and the first restraining mechanism can be configured to deploy and decouple the expandable medical device 600 from the expandable medical device 600 in response thereto. The second restraining mechanism 602 can surround or enclose a perimeter of the middle portion 608 of the expandable medical device 600. Additionally, the second restraining mechanism 602 can be a flexible film (e.g., formed from polytetrafluoroethylene (ePTFE)) and can be attached (and remain attached after release of the first restraining mechanism) to one or more portions of the middle portion 608 of the expandable medical device 600 with a medical adhesive (e.g., fluorinated ethylene propylene (FEP), polymers of tetrafluoroethylene, hexafluoropropylene and vinylidene fluoride (THV) and other biocompatible adhesives).

[0076] As discussed above, the intermediate portion 608 has a radial expansion force that is greater than the radial expansion force of one or both of the first and second ends 604, 606 in the constrained (delivery) configuration. Thus, the second restraining mechanism 602 can be configured to mitigate premature deployment of the expandable medical device 600. The intermediate portion 608 has a radial expansion force that is greater than the radial expansion force of one or both of the first and second ends 604, 606 that may cause the first restraining mechanism (not shown) to be removed / released from the expandable medical device 600 without a user applying tension to remove the first restraining mechanism. The second restraining mechanism 602 is configured to reduce the expansion of the intermediate portion 608, thereby mitigating the possibility that the intermediate portion 608 may push the first restraining mechanism from the expandable medical device 600 without a user removing the first restraining mechanism.

[0077] Additionally, the second restraining mechanism 602 can be disposed between the first restraining mechanism (prior to its release) and the middle portion 608 of the expandable medical device 600. Additionally, the second restraining mechanism 602 can be disposed within the confines of the middle portion 608 of the expandable medical device 600, as shown in FIG. 5A. The expandable medical device 600 can include a first re-entrant region 614 between the first end 604 and the middle portion 608, and a second re-entrant region 616 between the second end 606 and the middle portion 608. The first re-entrant region 614 and the second re-entrant region 616 can transition the substantially cylindrical shape of the middle portion 608 to the first end 604 and the second end 606, respectively. Additionally, the second restraining mechanism 602 can be disposed to extend between the first re-entrant region 614 and the second re-entrant region 616. The second restraint mechanism 602, which extends between but does not cover the first reinwardly curved region 614 and the second reinwardly curved region 616, can facilitate deployment of the first end 604 and the second end 606 by not interfering with or encroaching upon the first end 604 and the second end 606 while maintaining gradual deployment of each portion of the expandable medical device 600.

[0078] In certain instances, the intermediate section 608 of the expandable medical device 600 is configured to have a tailored radial strength, for example, by varying the amplitude, angle, number of vertices per row, number of rows, and / or wire diameter of the sine waves of the elongate elements 610 (or other similar structures). Additionally, the intermediate section 608 of the expandable medical device 600 provides radial strength to resist circumferential loads from surrounding tissue. In certain instances, the radial strength of the intermediate section 608 of the expandable medical device 600 promotes remodeling of tissue outside the intermediate section 608 to approximate the outer diameter of the intermediate section 608 in size. When the expandable medical device 600 (and other expandable medical devices discussed herein) is implanted to form an anastomosis, the radial strength of the intermediate section 608 can provide resistance to hoop forces exerted by the surrounding tissue. Thus, the expandable medical device 600 substantially maintains an open lumen at a desired dimension.

[0079] FIG 6B illustrates the expandable medical device 600 shown in FIG 6A in a fully deployed configuration, according to various embodiments of the present disclosure. The middle portion 608 of the expandable medical device 600 is no longer constrained by the second constraining mechanism 602. Thus, the middle portion 608 is in a fully deployed configuration. As shown by comparison in FIG 6A and FIG 6B, the middle portion 608 expands from the intermediate configuration to a larger diameter. The second constraining mechanism 602, in certain instances, remains coupled to the middle portion 608 of the expandable medical device 600 after release of the constraining force.

[0080] The expandable medical device, as discussed herein, can form a connection between two regions. The connection may also be referred to herein as a "shunt," "passageway," "shunt passageway," or "tunnel." In certain instances, the expandable medical devices discussed herein are configured to be removable after implantation. For example, the expandable medical device is implanted and remains in place until the gallbladder and / or its associated ducts are unobstructed, after which the device can be removed. In another instance, the expandable medical device can remain implanted until the body grows tissue anastomoses around the device, after which the device is removed. In other instances, tissue ingrowth into and / or around the device permanently embeds the expandable medical device, and the expandable medical device is not removed. The expandable medical devices discussed herein can provide an alternative treatment for patients who are not suitable candidates for other types of treatments (e.g., gallbladder removal surgery) and / or to avoid known complications of other types of treatments (e.g., external biliary drainage).

[0081] In certain instances, the elongate elements or framework of the expandable medical device can be treated in various ways to increase the radiopacity of the expandable medical device and enhance radiological visualization. In some embodiments, the expandable medical device is at least partially a draw-fill type NiTi with a different material in the core, such as a material with enhanced radiopacity. In some embodiments, the device includes a radiopaque cladding or plating on at least a portion of the expandable medical device. In certain instances, one or more radiopaque markers are attached to the expandable medical device. In certain instances, the elongate elements and / or other portions of the expandable medical devices provided herein can also be ultrasound visible and include portions with enhanced echogenicity.

[0082] Additionally, the covering material disposed over the expandable medical device can be generally fluid impermeable. For example, the covering material can be made of a material that inhibits or reduces the passage of blood, bile, and / or other bodily fluids and materials through the covering material. In certain instances, the covering material has a material composition and configuration that inhibits or prevents tissue ingrowth and / or endothelialization or epithelialization into the covering material. Additionally, the covering material can be configured to inhibit or prevent tissue ingrowth and / or endothelialization such that the expandable medical device is more easily removed from the patient at some future date. In certain instances, the covering material, or portions thereof, can include a microporous structure that provides a scaffold for tissue ingrowth for durable sealing and / or supplemental anchoring strength of the expandable medical device.

[0083] The covering material and restraining mechanism can include a fluoropolymer membrane, such as expanded polytetrafluoroethylene (ePTFE) polymer, polyvinylidene fluoride (PVDF) or polyvinylidene acetate (PVDA). In other examples, the covering material includes polyester, silicone, urethane, biocompatible polymer, polyethylene terephthalate (e.g., Dacron), bioabsorbable materials, copolymers or combinations thereof. Additionally, the covering material can include a bioabsorbable web. Expanded polytetrafluoroethylene (ePTFE) membranes prepared according to the methods described in U.S. Pat. No. 7,306,729 to Bacino et al., U.S. Pat. No. 3,953,566 to Gore, U.S. Pat. No. 5,476,589 to Bacino or U.S. Pat. No. 5,183,545 to Branca et al. can be used as the covering material herein. Additionally, expanded modified PTFE and expanded PTFE copolymers, such as those described in U.S. Patent No. 5,708,044 to Branca, U.S. Patent No. 6,541,589 to Baillie, U.S. Patent No. 7,531,611 to Sabol et al., U.S. Patent No. 8,637,144 to Ford, and U.S. Patent No. 9,139,669 to Xu et al., can be used herein. In other embodiments, the bioabsorbable material can also provide anti-migration characteristics by promoting adhesion between the expandable medical device and tissue until the bioabsorbable material is absorbed.

[0084] The covering material (or a portion thereof) may be modified by one or more chemical or physical processes that enhance one or more properties of the coating. For example, a hydrophilic coating may be applied to the covering material to improve the wettability and echo translucency of the covering. In certain instances, the covering material or a portion thereof may be modified with chemical moieties that promote one or more of endothelial cell attachment, endothelial cell migration, endothelial cell proliferation, and resistance or promotion to thrombosis. In certain instances, the covering material or a portion thereof may be modified to resist biofouling. Additionally, the covering material or a portion thereof may be modified with one or more covalently attached medicinal substances (e.g., heparin, antibiotics, etc.) or impregnated with one or more medicinal substances. The medicinal substances may be released in situ to promote healing, reduce tissue inflammation, reduce or inhibit infection, and promote various other therapeutic procedures and outcomes. In some embodiments, the pharmaceutical agent can be, but is not limited to, a corticosteroid, a human growth factor, an antimitotic agent, an antithrombotic agent, a stem cell material, or dexamethasone sodium phosphate. Additionally, drugs can be delivered to the target site separately from the covering material to promote tissue healing or tissue growth.

[0085] Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the accompanying figures referred to herein are not necessarily to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the figures should not be construed as limiting. (Aspect) (Aspect 1) an expandable medical device including a first end, a second end and an intermediate portion therebetween; a first restraining mechanism configured to releasably restrain the expandable medical device; a second restraining mechanism disposed between the expandable medical device and the first restraining mechanism and configured to reduce expansion of an intermediate portion of the expandable medical device in response to release of the first restraining mechanism; wherein the intermediate portion has a radial expansion force greater than a radial expansion force of at least one of the first end and second end. (Aspect 2) The system of embodiment 1, wherein the first and second restraint mechanisms are configured to deploy an intermediate portion of the expandable medical device to an intermediate configuration and to deploy first and second ends of the expandable medical device to an expanded configuration in response to release of the first restraint mechanism. (Aspect 3) 3. The system of embodiment 2, wherein the second restraint mechanism is configured to release an intermediate portion of the expandable medical device to deploy to a deployed configuration. (Aspect 4) 4. The system of embodiment 3, wherein the second restraint mechanism is configured to release in response to a force applied thereto. (Aspect 5) The system of embodiment 4, wherein the force is a radial force applied within an intermediate portion of the expandable medical device, and the second restraint mechanism is configured to remain coupled to the expandable medical device after the force is applied. (Aspect 6) 2. The system of embodiment 1, wherein the first end comprises a first flange, the second end comprises a second flange, and the intermediate portion comprises a substantially cylindrical shape. (Aspect 7) The system of embodiment 6, wherein the expandable medical device includes a first reentrant region between the first flange and the intermediate portion, a second reentrant region between the second flange and the intermediate portion, and the second restraint mechanism is disposed between the first reentrant region and the second reentrant region. (Aspect 8) The system of embodiment 1, wherein the second restraint mechanism is coupled to the expandable medical device and the first restraint mechanism is configured to deploy the expandable medical device and decouple from the expandable medical device in response to tension applied to the first restraint mechanism. (Aspect 9) 2. The system of embodiment 1, wherein the first restraining mechanism is configured to releasably restrain the expandable medical device in a substantially cylindrical delivery configuration. (Aspect 10) 10. The system of embodiment 9, wherein the first restraint mechanism extends from a proximal end of the expandable medical device to a distal end of the expandable medical device and extends back toward the proximal end of the expandable medical device. (Aspect 11) 1. A system for deploying a medical device having a first flange, a second flange and an intermediate portion therebetween, a delivery configuration and a deployed configuration, the system comprising: a first restraint configured to restrain the medical device in a delivery configuration; a first restraining mechanism configured to deploy the first flange and the second flange to the deployed configuration in response to release of the first restraining mechanism; a second restraining mechanism disposed between the medical device and the first restraining mechanism and configured to maintain an intermediate portion of the medical device in an intermediate configuration in response to release of the first restraining mechanism; Including, the system. (Aspect 12) 12. The system of embodiment 11, wherein the intermediate portion has a radial expansion force greater than a radial expansion force of at least one of the first flange and the second flange. (Aspect 13) 12. The system of embodiment 11, wherein the second restraining mechanism is coupled to the medical device and secured to the intermediate portion. (Aspect 14) 12. The system of embodiment 11, wherein the second restraining mechanism is disposed about an intermediate portion of the medical device. (Aspect 15) 12. The system of embodiment 11, wherein a diameter of the intermediate portion in the intermediate configuration is about 40%-80% smaller than a diameter of the intermediate portion in the deployed configuration. (Aspect 16) 12. The system of embodiment 11, wherein the first restraining mechanism is configured to deploy the medical device and decouple from the medical device in response to release of the first restraining mechanism. (Aspect 17) 1. A method of deploying an expandable medical device having a delivery configuration and a deployed configuration, the method comprising: positioning an expandable medical device at a target location, the expandable medical device including a first end, a second end and an intermediate portion therebetween; releasing a first restraining mechanism to deploy the first end and second end to the deployed configuration and the middle section to an intermediate configuration; Releasing a second restraint mechanism to deploy the intermediate section to the deployed configuration; and wherein the intermediate portion has a radial expansion force greater than a radial expansion force of the first end portion. (Aspect 18) 20. The method of embodiment 17, wherein releasing the second restraining mechanism comprises applying a force to the second restraining mechanism to deploy the intermediate section from the intermediate configuration to the deployed configuration. (Aspect 19) 18. The method of embodiment 17, wherein a diameter of the intermediate portion in the intermediate configuration is about 40%-80% smaller than a diameter of the intermediate portion in the expanded configuration. (Aspect 20) The method of embodiment 17, wherein releasing the first restraint mechanism comprises decoupling the first restraint mechanism from the expandable medical device, and releasing the second restraint mechanism comprises maintaining at least a portion of the second restraint mechanism attached to an intermediate portion of the expandable medical device.

Claims

1. A catheter body; an expandable anastomosis device disposed on the catheter body; A first restraining mechanism; and a deployment line coupled to the first restraint mechanism; a skirt attached distally to the first restraining mechanism so as to cover a portion of the circumference of the first restraining mechanism; Including, 1. A delivery system for an expandable medical device, comprising: the expandable anastomosis device includes a first end, a second end, and an intermediate section therebetween, the first end transitioning to the intermediate section at a first re-entrant region and the second end transitioning to the intermediate section at a second re-entrant region when the expandable anastomosis device is in a deployed configuration; the first restraining mechanism is configured to releasably restrain at least a portion of the expandable anastomosis device in a substantially cylindrical delivery configuration; the first restraining mechanism extends from a proximal end of the expandable anastomotic device to a distal end of the expandable anastomotic device and back toward the proximal end of the expandable anastomotic device; the deployment line is operable to release the first restraint mechanism from the expandable anastomosis device in response to tension applied to the deployment line. Delivery system.

2. The delivery system of claim 1 , wherein the skirt is disposed around the first restraining mechanism as the delivery system is advanced toward a target location within a patient.

3. The delivery system of claim 1 , further comprising a distal tip disposed at a distal end of the catheter body.

4. The delivery system of claim 3 , wherein the first restraining mechanism is operable to reverse from the distal tip toward the proximal end of the catheter body.

5. The delivery system of claim 4, further comprising a second restraint mechanism disposed between the expandable anastomosis device and the first restraint mechanism and configured to reduce expansion of an intermediate portion of the expandable anastomosis device in response to release of the first restraint mechanism, the second restraint mechanism being disposed around the intermediate portion of the expandable anastomosis device.

6. The delivery system of claim 5 , wherein the first restraining mechanism is disposed about the first end, the second end and the middle section of the expandable anastomosis device.

7. 7. The delivery system of claim 6, wherein the first restraining mechanism is operable to release the first and second ends of the expandable anastomosis device such that in response to the release, the second restraining mechanism deploys the expandable anastomosis device to a fully deployed configuration in which an intermediate portion is not restrained.

8. 8. The delivery system of claim 7, wherein the second restraining mechanism restrains the middle section in an intermediate configuration that is between the delivery configuration and the fully deployed configuration after release of the first restraining mechanism, and the first end and the second end of the expandable anastomosis device are in the fully deployed configuration.

9. The delivery system of claim 8 , wherein the second restraining mechanism is disposed between the first restraining mechanism and the expandable anastomosis device when in the delivery configuration.

10. The delivery system of claim 9 , wherein the middle portion of the expandable anastomosis device exerts a radial expansion force greater than a radial expansion force of the first end and the second end of the expandable anastomosis device.

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