Device and method for sensor deployment and fixation

Abstract

A delivery system for an intracorporeal device includes a sheath defining one or more lumens, the lumens being shaped to receive a delivery catheter or shaft and a guidewire. The system may include a delivery shaft having a distal coupling feature adapted to be releasably coupled to a proximal coupling feature of an intracorporeal device. The delivery system may also include a collector through which the delivery shaft and the guidewire pass. The delivery shaft may be coupled to a feature such as a knob that is capable of manipulating the delivery shaft to disengage a distal fixing feature from a proximal fixing feature of an intracorporeal device so as to deploy the intracorporeal device in a patient.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. non-provisional application serial number 16 / 162,147, filed on October 16, 2018, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present invention generally relates to implanting intracorporeal devices within a blood vessel, and to systems and methods for delivering such intracorporeal devices to a predetermined location within a blood vessel. Background Art

[0004] In recent years, the long-standing goal of implantable biosensors has begun to see realization and, in some cases, clinical use. As research and development of this concept have continued, issues regarding the in vivo fixation of sensors have come to light. Particularly within blood vessels, sensors are subject to continuous pulsatile flow. This is a difficult environment in which a sensor or other device must be reliably fixed without unduly restricting blood flow or damaging the vessel wall. One major vessel of interest in the field of cardiology is the pulmonary artery. The pulmonary artery is a particularly challenging location for fixation of in vivo devices because, in addition to the considerations mentioned above, this vessel is particularly thin, compliant, and prone to perforation.

[0005] Design considerations for an ideal fixation device for intravascular fixation are outlined below. The fixation device should be passive and maintain a certain distance between the sensor and the vessel wall to maintain blood flow past the sensor. The deployed size and radial strength of the device should be sufficient to prevent its migration into the vessel where the sensor size would occlude, while producing minimal stress concentrations at the location where the fixation device contacts the vessel wall. Alternatively, the in vivo device can be designed to be small enough so that when deployed in an organ or host with sufficient redundant blood flow, the device can self-embolize without damaging the organ or host. Finally, the fixation device should be versatile enough to be independent of the size of the vessel to maintain its position within a physiologically relevant range.

[0006]

[0006] Therefore, there is a need for devices and methods for securing devices within the body, particularly devices and methods that deliver and secure such devices in a safe, simple, and predictable manner. Summary of the invention

[0007] In one aspect of the present invention, an intracorporeal device delivery system is provided. The delivery system includes: a delivery shaft having a distal coupling feature, and a sheath adapted to receive a guidewire and define a delivery shaft lumen, the delivery shaft being disposed within the delivery shaft lumen. The delivery system also includes an intracorporeal device having a proximal coupling feature and a device body defining an axial envelope extending proximally from the device body. The distal coupling feature is releasably coupled to the proximal coupling feature such that, when coupled, the distal coupling feature is disposed within the axial envelope defined by the device body.

[0008] In certain embodiments, the sheath defines a guidewire lumen that is separate from the delivery shaft lumen and is configured to receive a guidewire.

[0009] In another embodiment, the distal coupling feature of the delivery shaft is a threaded extension extending distally from the delivery shaft, and the proximal coupling feature of the intracorporeal device is a threaded bore shaped to receive the distal coupling feature.

[0010] In yet another embodiment, the intracorporeal device delivery system further comprises a hub coupled to the proximal end of the delivery shaft. The hub may comprise a shaft manipulation feature coupled to the delivery shaft and configured to release the distal coupling feature from the proximal coupling feature when manipulated. In an exemplary embodiment, the shaft manipulation feature is a rotatable knob coupled to the delivery shaft such that rotation of the rotatable knob rotates the delivery shaft to disengage the distal coupling feature from the proximal coupling feature.

[0011] In certain embodiments, the hub includes at least one port in communication with a secondary lumen of the sheath such that the port is in fluid communication with the distal end of the sheath. In some embodiments, the secondary lumen may be one of a distal shaft lumen or a guidewire lumen.

[0012] In certain embodiments, the sheath can include a braided tube, such as a Pebax tube.

[0013] In certain embodiments, the intracorporeal device includes a guide defining a passageway shaped to receive a guidewire, the passageway being disposed outside of the axial envelope.

[0014] In another aspect of the present invention, an intracorporeal device delivery system is provided. The delivery system includes: a delivery shaft, which includes a distal coupling feature extending from the distal end of the delivery shaft and including a threaded extension. The delivery system also includes a sheath suitable for receiving a guide wire and defining an inner cavity of the delivery shaft, and the delivery shaft is disposed in the inner cavity of the delivery shaft. The delivery system also includes an intracorporeal device having a proximal coupling feature and a device body, the device body defining an axial envelope extending proximally from the device body, and the proximal coupling feature includes a threaded hole formed to receive the threaded extension of the delivery shaft. The distal coupling feature is releasably coupled to the proximal coupling feature so that when coupled, the distal coupling feature is disposed within the axial envelope defined by the device body.

[0015] In certain embodiments, the sheath defines a guidewire lumen that is separate from the delivery shaft lumen and is configured to receive a guidewire.

[0016] In another embodiment, the distal coupling feature of the delivery shaft is a threaded extension extending distally from the delivery shaft, and the proximal coupling feature of the intracorporeal device is a threaded bore shaped to receive the distal coupling feature.

[0017] In yet another embodiment, the intracorporeal device delivery system further comprises a hub coupled to the proximal end of the delivery shaft. The hub may comprise a rotatable knob coupled to the delivery shaft such that rotation of the rotatable knob rotates the delivery shaft to disengage the distal coupling feature from the proximal coupling feature. In certain embodiments, the rotatable knob may be coupled to the delivery shaft by a set screw extending through the rotatable knob.

[0018] In certain embodiments, the hub includes at least one port in communication with a secondary lumen of the sheath such that the port is in fluid communication with the distal end of the sheath. In some embodiments, the secondary lumen may be one of a distal shaft lumen or a guidewire lumen.

[0019] In certain embodiments, the sheath can include a braided tube, such as a Pebax tube.

[0020] In certain embodiments, the intracorporeal device includes a guide defining a passageway shaped to receive a guidewire, the passageway being disposed outside of the axial envelope.

[0021] In another aspect of the present invention, an intracorporeal device delivery system is provided. The delivery system includes: a sheath defining each of a delivery catheter lumen and a guidewire lumen separated from the delivery catheter lumen, and a delivery catheter extending through at least a portion of the delivery catheter lumen. The system also includes an intracorporeal device releasably connected to the distal portion of the delivery catheter and a collector connected to the proximal end of the sheath, the collector including a port. The cross-sectional area of ​​the delivery catheter lumen exceeds the cross-sectional area of ​​the delivery catheter, so that an annular space is defined between the delivery catheter and the inner wall of the delivery catheter defining the delivery catheter lumen, and the annular space is connected to the port.

[0022] Other objects, features and advantages of the present invention will become apparent when the following description is read in conjunction with the accompanying drawings and appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to describe the manner in which the above and other advantages and features of various aspects of the present invention can be obtained, the embodiments briefly described above will be described in more detail by reference to the specific embodiments thereof shown in the accompanying drawings. It should be noted that the drawings are not drawn to scale, and throughout the drawings, elements of similar structure or function are generally represented by similar reference numerals for illustrative purposes. These drawings depict only example embodiments of the present invention and therefore should not be considered as limiting the scope thereof. By using the accompanying drawings, embodiments of the present invention will be described and explained with additional specificity and detail.

[0024] Figure 1 is an isometric view of a first embodiment of an implant assembly according to the present invention having two opposing wire loops.

[0025] Figure 2 yes Figure 1 Top view of the implant component.

[0026] Figure 3 is a cross-sectional view of a blood vessel showing a Figure 1 implant components.

[0027] Figure 4 is a cross-sectional view of a pulmonary artery showing the Figure 1 implant components.

[0028] Figure 5 is a top view of a second embodiment of an implant assembly according to the present invention having opposing wire loops.

[0029] Figure 6 is a cross-sectional view of a blood vessel showing a Figure 5 implant components.

[0030] Figure 7 is a cross-sectional view of a pulmonary artery showing the Figure 5 implant components.

[0031] Figure 8 is a top view of a third embodiment of an implant component according to the present invention having two opposing wire loops.

[0032] Fig. 9 yes Figure 8 Isometric view of the implant components.

[0033] Fig.10 is a cross-sectional view of a blood vessel showing a Figure 8 implant components.

[0034] Fig.11 is a cross-sectional view of a pulmonary artery showing the Figure 8 implant components.

[0035] Fig.12 is a top view of a fourth embodiment of an implant assembly according to the present invention having opposing wire loops.

[0036] Fig.13 yes Fig.12 Isometric view of the implant components.

[0037] Fig.14 is a cross-sectional view of a blood vessel showing a Fig.12 implant components.

[0038] Fig.15 is a cross-sectional view of a pulmonary artery showing the Fig.12 implant components.

[0039] Fig.16 is an isometric view of a seventh embodiment of an implant assembly according to the present invention having a radial wire array expandable structure.

[0040] Fig.17 is a cross-sectional view of a blood vessel showing a Fig.16 implant components.

[0041] Fig.18 is a cross-sectional view of a pulmonary artery showing the Fig.16 implant components.

[0042] Fig.19 is an isometric view of an eighth embodiment of an implant assembly according to the present invention having a daisy-petal-shaped wire expandable structure.

[0043] Fig. 20 is an isometric view of a ninth embodiment of an implant assembly according to the present invention having daisy-petal-like expandable structures on each end of the in vivo device.

[0044] Fig.21 is an isometric view of a tenth embodiment of an implant assembly of the present invention having a daisy-petal-shaped wire expandable structure.

[0045] Fig. 22 is an isometric view of an eleventh embodiment of an implant assembly according to the present invention having a daisy-petal-shaped wire expandable structure.

[0046] Fig.23 is a cross-sectional view of a blood vessel showing a Fig.19 implant components.

[0047] Fig.24 is a cross-sectional view of a pulmonary artery showing the Fig.19 implant components.

[0048] Fig.25 is a side cross-sectional view of a first embodiment of a delivery device according to the present invention.

[0049] Fig.26 yes Fig.25 Side view of the wire tie of the delivery device.

[0050] Fig. 27 yes Fig.25 Side view of the core wire of the delivery device.

[0051] Fig.28 yes Fig.25 Side view of the guidewire of the delivery device.

[0052] Fig.29 yes Fig.25 A side sectional view of a delivery system of , wherein the implant assembly is coupled to the delivery system.

[0053] Fig.30 is used to deliver Figure 5 A side cross-sectional view of a second embodiment of a delivery system for an in vivo device is shown.

[0054] Fig.31 is used to deliver Figure 5 A side cross-sectional view of a distal portion of a third embodiment of a delivery system for an in vivo device is shown.

[0055] Fig.32 yes Fig.31 Side elevation view of the proximal portion of the delivery system.

[0056] Figure 33-34 Yes, you can Fig.31 Cross-sectional view of a sheath used in a delivery system.

[0057] Fig.35 yes Fig.34 A cross-sectional view of a sheath comprising a delivery catheter and a guidewire disposed therein.

[0058] Fig.36 is a side view of a distal portion of a delivery system including an in vivo device.

[0059] Fig.37 Does not include in-body devices Fig.36 Side elevation view of the distal portion of the delivery system.

[0060] Fig.38 yes Figure 36-37 Side elevation view of the proximal portion of the delivery system. DETAILED DESCRIPTION

[0061] Implant assembly as described in the present invention generally comprises in vivo equipment and the anchoring structure for the in vivo equipment of stabilizing body (such as in blood vessel).Also provide implant assembly deployment (deploy) and be fixed in the delivery system of desired position in blood vessel, this delivery system generally comprises delivery device and implant assembly to be delivered.In some embodiments, in vivo equipment can be pressure sensor, further described below.Anchoring structure can be the structure that can be introduced into body and then be placed in blood vessel via the delivery device such as catheter.Anchoring structure of the present invention can comprise following structure, this structure comprises opposite silk thread loop (opposed wire loops), radial silk thread array structure and daisy petal-shaped structure, all these will be further described below.

[0062] All implant assemblies of the present invention have all blocked about 50% or less of the cross-sectional area of ​​the blood vessel that it is arranged.In some embodiments, the implant assembly can block 20% or less of the cross-sectional area of ​​blood vessel.Minimizing the intravascular flow obstruction allows the device in the body to remain fixed in the proper position in the blood vessel, and can not have a significant impact on the intravascular flow.In addition, implant assembly disclosed herein relies on the physical size of the anchoring structure of expansion and the rigidity of the silk thread that is used to construct the anchoring structure usually, to prevent further distal motion.This is opposite to the mechanism of support or intracaval filter type, and in the mechanism of support or intracaval filter type, fixing is to realize by radially applied power and / or hook or barb attachment feature.

[0063] The anchoring structure of the present invention can be formed by metal or polymer and can be in the form of a wire structure. The wire diameter of the currently disclosed anchoring structure is in the range of about 0.001 to about 0.015 inches. The material comprising the wire can be any biocompatible material known in the art, which has sufficient elasticity to be handy. In one embodiment, the material constituting the wire is a polymer. In an alternative embodiment, the material constituting the wire can be a metal, such as nitinol, stainless steel, eligiloy, cobalt-chromium alloy or any other suitable metal. In a further embodiment, if the wire is composed of a metal material, the biocompatible wire is coated with a dielectric material, such as but not limited to PTFE, polyurethane, polyparaxylene and diamond-like carbon (DLC), so that when the device includes a radio frequency sensor, it will not cause electromagnetic interference to the function of the device in the body. The term "wire" used in this document should be interpreted as but not limited to embodying the entire content of this paragraph.

[0064] As used herein, the phrase "in vivo device" includes any and all implantable devices. Such devices may include, for example, sensors that measure chemical and / or physical parameters, devices configured to perform, for example, a function (e.g., a drug delivery device), and combinations thereof. An in vivo device may communicate with an external electronic device wirelessly or by physically contacting the electronic device, such as through a wire.

[0065] The exemplary devices disclosed herein describe the coating as a feature. It should be understood that the present invention includes in vivo devices constructed of polymeric materials, and the same construction techniques used to establish anchoring structures can be used by passing the silk thread directly through the polymeric material of the device. In addition, the material used to construct such in vivo devices, coatings or other methods can be any biocompatible polymer. These materials include, but are not limited to, biocompatible silicone rubber, FEP, PTFE, urethane, PVC, nylon and polyethylene.

[0066] An intracorporeal device for coupling to an anchoring structure described below has a width of about 0.5 to about 4 mm, a height of about 0.5 to about 4 mm, and a length of about 0.5 to about 12 mm. In one embodiment, the intracorporeal device has a width of about 3.2 mm, a height of about 2 mm, and a length of about 10 mm. Examples of such devices are disclosed in commonly owned U.S. Patent Nos. 6,855,115; 7,147,604; 7,481,771; 7,574,792; 7,699,059; and 9,265,428, each of which is incorporated herein by reference.

[0067] A.Wire loop structure

[0068] An exemplary implant assembly suitable for endovascular deployment and fixing comprises a device in vivo and a wire structure with a wire loop. These loops can traverse the length of the device, or can be limited to one end of the device. Figure 1 and Figure 2 Shown, an embodiment of the implant assembly 30 with double ring structure 32 is included in the silk thread 34 that is attached to the internal device 36 at the attachment site (not shown).Silk thread 34 passes an end of the internal device 36 at hole 38.Anchor point is formed by a piece of metal being crimped on the silk thread and trimming off unnecessary silk thread so that the metal of crimping constitutes the end of the silk thread.This metal end also provides radiopaque marking, is used for the fluoroscopic observation of equipment.

[0069] After the wire 34 passes through the hole 38 at one end of the device, the wire is pulled with sufficient force to firmly embed the anchor into the coating of the intracorporeal device. The wire 34 is then looped to form a double loop structure 32. The second free end is also inserted under the coating and the anchor is embedded in the coating to secure the anchor. In this way, the end of the wire is inserted under the coating of the intracorporeal device 36.

[0070] Figure 3 Deployment of implant assembly 30 within a stenosed blood vessel is shown. Figure 3 Arrow 39 shown in indicates the direction of blood flow.After being released in the blood vessel, the silk thread loop 34 will contact the inner surface 40 of the wall of blood vessel 42.Depend on the structure of implant assembly 30 and the internal diameter of blood vessel 42, this contact can occur immediately when deploying.Alternately, implant assembly can be configured so that the silk thread 34 of implant assembly 30 does not contact the inner surface 40 of blood vessel 42 at first, but advances downwards in the narrowed blood vessel, until the blood vessel is narrowed to such a degree at a certain point, so that the silk thread loop 34 contacts the inner surface 40 of blood vessel 42.Depend on the compliance of the silk thread loop 34 of vascular system and implant assembly 30, when producing interference fit, the silk thread structure can be radially inwardly compressed or bent backward.Perhaps, depend on the compliance of the silk thread comprising implant assembly, anchoring structure 42 can yield, thereby allow implant assembly 30 to further travel downstream. The implant assembly 30 will eventually reach a point in the stenosed vessel 42 where the interference fit between the wire loop 34 and the vessel will seat and hold the implant assembly in place to prevent any further movement.

[0071] Another method of anchoring implant assembly 30 is based on making device in vivo be placed in the bifurcation in patient's blood vessel.As an example, the pulmonary artery originating from right ventricle is divided into left and right pulmonary artery branches, and each branch points to each lung.These arterial branches are then subdivided, and finally artery is delivered to all bronchopulmonary segments of the different lobes of each lung.The diameter of pulmonary artery blood vessel all can obviously reduce when they branch at each time.

[0072] The basic theory of the alternative method of anchoring implant assembly is that the implant assembly comprising silk thread loop can advance along the first blood vessel along with the flow of blood, but when the implant assembly reaches bifurcation, the implant assembly is too large to pass any less branch vessel. Therefore the implant assembly is placed at the bifurcation, and because it is too large and cannot fully comply with to adapt to the branch vessel, it is therefore stopped from moving downstream, and because the blood flows through the artery and is stopped from moving upstream. In one embodiment, the diameter of the implant assembly is equal to or greater than the internal diameter of the first blood vessel. In this case, the implant assembly has enough compliance, therefore can not produce interference fit when it advances along the blood vessel, but when the implant assembly arrives bifurcation subsequently, the expected orientation of the implant assembly is retained indeed. In alternative embodiments, the diameter of the implant assembly is less than the internal diameter of the arterial vessel, so that there is no specific orientation to be effectively retained, but the implant assembly is too large and too hard to pass subsequent branch vessel.

[0073] In any case, the implant assembly is configured to make after the short period of time, for example after 30 days, by the position where tissue contacts with the vascular wall, tissue is grown on the silk thread ring, thereby further strengthens the deployment position.In this regard, main fixing mechanism is the connection of tissue and silk thread, and the implant assembly can't be removed easily and can't damage blood vessel.

[0074] Reference Figure 4 , implant assembly 30 has been released in the first blood vessel 49.Implant assembly freely advances along the direction shown in the arrow 51 along the flow of blood through the first blood vessel 49.At bifurcation 53, first blood vessel 49 is divided into less blood vessel 55,56.Because implant assembly 30 is in fact greater than the cross section of any less blood vessel 55,56, implant assembly can not continue to advance, but is placed in bifurcation 53.

[0075] Reference now Figure 5 , the ring structure with " figure of 8 " shape is shown.More specifically, the implant assembly 31 with double ring structure 33 is included in the silk thread 35 that is attached to the device body 37 in the body at the attachment site (not shown).As described in the previous example, the end of silk thread 35 is inserted into below the coating of the device body 37 in the body.

[0076] The purpose of the "figure 8" or double ring structure 33 is to stabilize the in vivo device body so that it does not roll, rotate or fall over in the blood vessel, thereby ensuring that the connecting elements of the in vivo device body remain correctly oriented relative to the optimal interrogation angle via the external communication and data acquisition equipment when the wireless sensing element includes the in vivo device. The length of the "figure 8" or double ring structure 33 of the disclosed embodiment can be approximately 5 cm. However, it should be understood that the size depends on the inner diameter of the blood vessel into which it is incorporated within a relatively wide tolerance range, and the size of the "figure 8" or double ring structure 33 can be modified to accommodate any specific blood vessel. According to one aspect of the present invention, the total length of the in vivo device body plus the double ring structure 33 is at least twice the diameter of the blood vessel, and in some embodiments, at least about five times the diameter of the blood vessel.

[0077] Reference Figure 6 When the implant component 31 according to the first method is deployed, the implant component 31 is anchored by the interference fit between the wire 35 and the inner surface 41 of the wall of the blood vessel 43. Arrow 51 indicates the direction of blood flow.

[0078] Figure 7 Another kind of method for anchoring implant assembly 31 is shown, wherein implant assembly 31 is deployed in for example first pulmonary artery blood vessel 49, the order of magnitude of the cross section of this first pulmonary artery blood vessel 49 is the order of magnitude of the cross section of implant 10 assemblies.Therefore, implant assembly advances through first blood vessel 49 along the blood flow direction shown in arrow 51.At bifurcation 53, first blood vessel 49 is divided into less blood vessel 55,56.Because the cross-sectional diameter of implant assembly 31 is substantially greater than any one cross section in less blood vessel 55,56, and is not enough to comply with so that implant assembly is further deformed and is placed in bifurcation 53.

[0079] In the example shown, the opposed ring structures 33 of the implant component 31 are composed of a monofilament. However, it will be understood that the opposed ring structures 33 can be composed of more than one filament.

[0080] exist Figure 8 , 9, 12 and 13, the structure includes a plurality of wire loops 44 surrounding an in-vivo device 46. The wire 48 passes through one or more holes 50 on each end of the in-vivo device in an annular manner from one end to the other to form a loop. After the ring structure is completed, the free end of the wire is used to establish another anchor point, as described above. The second free end is then pulled back into the coating with sufficient force to fix the second anchor in the coating. In one embodiment, the position of the second anchor is located on the opposite side of the in-vivo device from the first anchor. This construction is useful so that the anchor is positioned away from the sensing or actuating element and / or a means is provided for determining the orientation of the device when observed via a fluoroscopic inspection device. The wire loops are then arranged by a mechanical device to form a wire member that is substantially evenly distributed radially around the longitudinal axis of the in-vivo device.

[0081] like Figure 8 As shown, the wire loop can be attached to the in vivo device 40 by passing through a hole 50 located near the edge of the device 46 (relative to the longitudinal axis of the device 46). Fig.12 As shown, the wire loop may be attached to the intracorporeal device 46 by passing through a plurality of holes 50 located near each edge of the device 46 .

[0082] Figure 8 , 9 , 12 and 13 implant assembly can be according to any one deployment in above-mentioned two methods.The implant assembly can be constructed so that they are anchored by the interference fit between the wall 52 of implant assembly and blood vessel 54, as Fig.10 and 14 Shown in and as previously mentioned.Perhaps, the implant assembly can be configured so that they are allowed to advance along blood vessel and be placed in bifurcation, as previously mentioned. Fig.10 , 11 The arrows 51 shown in FIGS. 14 and 15 indicate the direction of blood flow.

[0083] Reference now Figure 35-37, implant assembly 130 comprises in vivo equipment 131, elongated " figure of 8 " silk thread loop 132 and a pair of wing-shaped silk thread loops 134. Wing-shaped silk thread loop 134 has the longest dimension on the plane orthogonal to the longitudinal axis of blood vessel. This longest dimension has the order of magnitude of the blood vessel inner diameter to be introduced into implant assembly 130 within a wide tolerance range, so as to allow implant assembly to move downward along blood flow, until it is placed in bifurcation. The length of " figure of 8 " silk thread loop 132 is greater than the diameter of blood vessel to be introduced into implant assembly 130, so as to prevent implant assembly from overturning end to end in blood vessel. The length of " figure of 8 " silk thread loop 132 can be at least twice of the diameter of blood vessel to be introduced into implant assembly 130, and the length of " figure of 8 " silk thread loop 132 can be about five times of the diameter of blood vessel. This feature is useful for maintaining implant assembly 130 with respect to the desired orientation of intravascular fluid flow. In certain embodiments, the "figure 8" wire loop lies in a plane, and the wing-shaped wire loop is oriented substantially perpendicular to the plane defined by the wire loop.

[0084] B. Radial Wire Array Structure

[0085] Another implant assembly according to the present invention comprises an internal device and an anchoring structure with a parabolic profile basically, such as Figure 16-18 As shown, implant assembly 58 includes intracorporeal device 60 and radial wire array 62, which includes wire members 64. Member 62 can be attached to intracorporeal device 60 at anchor points, as described below.

[0086] like Fig.16 As shown, the radial wire array 62 can be attached to the intracorporeal device 60 by passing the wire member 64 through a hole 66 located near the edge of the intracorporeal device 60. Alternatively, as shown in FIG. Fig. 20 As shown in , a radial wire array 62 can be attached to an in-vivo device 60 by passing a wire member 64 through two holes 66 located near the edge of the device 60. The ends of the wires are press-fit into a coating covering the surface of the device to secure the ends. The radial wire array can be formed by crimping a piece of metal at a point approximately mid-length of the wire bundle, and then passing the wire bundle through a hole near the edge of the in-vivo device, thereby placing an anchor in the silicone material filling the hole. The anchor secures the ends of the radial wires between the surface of the device and the coating covering the surface of the device. The crimped metal anchor provides a radiopaque marker for fluorescent visualization of the device.

[0087] When the implant assembly is deployed, the radial wire is inserted into the blood vessel through an interference fit (eg, Fig.21 ), or by moving the implant assembly within the vessel until it is positioned at the bifurcation (as shown in Fig. 22 As shown), the implant component can be anchored.

[0088] In one embodiment, the radial wire array is self-supporting due to the physical properties of the material. Alternatively, the radial wire array may include a mechanical expansion structure to support the array to expand and contact the vessel wall. For example, a catheter balloon may be inflated to allow the wire structure to reach and maintain an expanded configuration.

[0089] The in-vivo device 60 can be positioned outside of the radial wire array 62 such that one end 72 of the in-vivo device 60 is secured to a point at or near the apex of the radial wire array 62, such as Fig.16 The in-vivo device 60 can also be positioned inside the radial wire array so that one end of the device is fixed to a point at or near the apex of the radial wire array, such as Fig.17 In another embodiment, the intrabody device can have two radial wire arrays 62 attached to the intrabody device 60, such that one end of the intrabody device is attached to a vertex on the outside of one of the radial wire arrays, and the opposite end of the device is attached to a vertex on the inside of the second radial wire array, as shown. Fig.18 shown.

[0090] C. Daisy petal-like structure

[0091] An implant assembly according to another aspect of the present invention comprises an intracorporeal device and an anchoring structure having a daisy petal shape, such as Figure 19-22 The implant assembly 76 includes an in vivo device 78 and a daisy-petal-shaped wire structure 80 that contacts an inner surface 82 of a wall of a blood vessel 84, such as Fig.23 As shown in. The implant assembly of this embodiment can be anchored by the interference fit between the wall of implant assembly and blood vessel. In an alternative, the implant assembly can be configured to be in a wide tolerance, with the diameter that has for the magnitude of the blood vessel inner diameter that will introduce implant assembly 130, thereby allow the implant assembly to travel downwards along the blood flow until it is placed in bifurcation, as Fig.24 As shown. Fig.23 and 24 Arrows 51 are shown to indicate the direction of blood flow.

[0092] The daisy-petal-shaped wire structure 80 is positioned so that the structure lies in a plane normal to the longitudinal axis of the in-vivo device 78. The daisy-petal-shaped wire structure 80 can be composed of a single wire or a plurality of wires. Fig.19 As shown, the daisy-petal-shaped wire structure 80 includes a plurality of petals 92. The structure can have an even or odd number of petals. Fig. 20 As shown, the intracorporeal device 78 may have two daisy-petal-like wire structures 80 attached to the device at opposite ends 94 , 96 and positioned along the longitudinal axis 90 .

[0093] like Fig.21 As shown, the daisy-petal-shaped wire structure 80 can be attached to the in vivo device 78 by passing through a single hole 98 located near the edge of the device 78. Alternatively, as shown in FIG. Fig.19 and 22 As shown, the daisy-petal-shaped wire structure 80 can be attached to the intracorporeal device 78 by passing through two holes 98 located near the edge of the device 78.

[0094] In one embodiment, the daisy petal-shaped wire structure 80 is attached to the intracorporeal device at the anchor point. The anchor is made by crimping a piece of metal onto the wire and trimming off the excess wire so that the crimped metal constitutes the end of the wire. The metal end also provides a radiopaque marker for fluorescent visualization of the device. The wire is passed through one or more holes on one end of the intracorporeal device and the wire is pulled out with sufficient force to firmly bury the anchor in the coating. The wire is then passed through one or more holes at the end of the intracorporeal device from top to bottom in a circular manner to form a daisy petal-shaped structure. After the daisy petal-shaped structure is completed, the free end of the wire will be used to establish another anchor point. The second free end is then pulled back into the coating with sufficient force to firmly bury the second anchor in the coating. The wire loop is then arranged by a mechanical device to form a wire member that is substantially evenly distributed radially around the longitudinal axis of the intracorporeal device.

[0095] D. Delivery Systems and Methods

[0096] The present invention further provides a delivery system for securing, delivering and deploying an implant assembly having an anchoring mechanism coupled to an in vivo device. Fig.25 –29, showing the various components of the delivery system. Fig.25 As shown, the delivery device 100 includes a main lumen 102 adapted to receive a core wire 104 ( Fig. 27 ); and a secondary inner cavity, which includes a first portion 106A and a second portion 106B, and is suitable for accommodating a tether wire 108 ( Fig.26 ).like Fig. 27As shown in Figure 1, core wire 104 provides column rigidity to delivery assembly 100, thereby promotes the advancement of delivery assembly by vascular system. In addition, when the tie wire is pulled to the proximal end during the implant assembly deployment, core wire 104 also prevents delivery assembly 100 from tying a knot. The diameter of core wire 104 is reduced toward its distal end 105, thereby rigidity is gradually reduced from the proximal end to the distal end of delivery assembly 100. Conical core wire 104 can extend through guide wire orifice 112, to strengthen the potential kink point (kink point) in delivery device 100 and promote guide wire to be advanced into vascular system. Use adhesive, hot pressing or any other suitable fixing mechanism that core wire 104 is fixed in main inner chamber 102. When guide wire 110 is in guide wire orifice 112 (such as Fig.33 When the core wire 104 enters the main lumen 102 of the delivery device 100, the fixation of the core wire 104 prevents the core wire from being damaged. Fig.28 Interference of the guidewire 110 is shown.

[0097] Fig.26 The tie wire 108 shown in FIG. 1 is slidably positioned within the first secondary lumen portion 106A and exits the first secondary lumen portion at an aperture 114 in the device wall. Fig.29 As shown, the tie wire 108 then passes through the coating of the intracorporeal device 30 and exits on the opposite side of the device. The free end 118 of the tie wire 108 enters the second portion 106B of the secondary lumen at the orifice 109.

[0098] Fig.30 shows a method suitable for deploying Figure 5-7 Another embodiment of a delivery device for such an intracorporeal device is shown in FIG. 31. Due to the length of the wire loop 35 of the intracorporeal device 31, the proximal and distal ends of the loop must be fixed to the delivery device so that when the delivery device is bent, the loops will follow the curvature of the delivery device. For this purpose, Fig.30 The secondary inner chamber of the delivery device of 100 is divided into four parts 124A-D. Tie wire 108 leaves the first part 124A of secondary inner chamber and passes through the silk loop 55, so that implant assembly 51 is attached to delivery device 100. Tie wire enters the second part 124B of secondary inner chamber then. Tie wire leaves the second part 124B of secondary inner chamber then and passes the coating of device 31 in the body. Tie wire enters the third part 124C of secondary inner chamber then. Next, tie wire leaves the third part 124C of secondary inner chamber, passes the silk loop 35, and enters the fourth part 124D of secondary inner chamber.

[0099] In yet another configuration, an overtube may be provided to constrain the expandable structure and slidably position the overtube over the double lumen tube.

[0100] Deployment and fixation implant assembly can be completed passively by interference fit or be placed in bifurcation.In one embodiment, the implant assembly comprising the anchoring structure of sufficient size and / or compliance is delivered in the blood vessel, and allows it to advance in the blood flow until it is placed in the bifurcation.After being placed in the blood vessel, due to the structure of the implant assembly, blood flow is maintained.In another embodiment, the implant assembly comprises the anchoring structure of sufficient compliance, and this anchoring structure produces interference fit when the blood vessel narrows, thereby basically prevents the equipment from further advancing along the blood vessel.In the 3rd embodiment, the device in the body is embolic when there is no anchoring structure.It may be preferred to eliminate the needs for the fixed device, and allow the device in the body to reside in the sufficiently small blood vessel, to prevent the further movement of the device in the body.As an illustration, it is suspected that due to the redundancy of blood flow in the lung on the small blood vessel level, the small size of the device in the body will not have a harmful effect on lung function.

[0101] Describe below a kind of method of deployment according to the present invention and fixing implant assembly.Obtain and enter vascular system, and vascular introducer is placed on intervention site.The intervention site of vascular introducer can be right internal jugular vein, subclavian artery, right femoral vein or any other suitable intervention site.Guide wire is placed in the vascular system, and by means of for example Swan-Ganz catheter, diagnostic catheter or any other suitable catheter positioning on the deployment site of expectation, after guide wire is in place, such catheter is removed.

[0102] The delivery system is loaded into the vascular introducer and navigates to the deployment site. According to the intervention site selected, the length of the delivery system can be increased or reduced according to standard practice. In one embodiment, the deployment site is a blood vessel, and can be any artery or arteriole in the pulmonary artery vascular system. Alternatively, the implant assembly is oriented to a preferred orientation. Then, by pulling the tie wire to the proximal end so that the implant assembly is separated from the delivery device, the implant assembly is deployed. During deployment, the implant assembly is allowed to advance in the vascular system, until interference fit is produced, or it is placed in the next bifurcation in the vascular system, which depends on the fixed mode of expection. The delivery assembly and guide wire are then removed from health.

[0103] In the alternative embodiment of the method, an outer sleeve is provided to constrain expandable anchoring structure, so that the sliding outer sleeve allows expandable anchoring structure to expand to the proximal end.Depend on the fixing mode of expection, allow the anchoring structure to expand, the implant assembly advances along the blood vessel, until producing interference fit, or it is placed in the next bifurcation of vascular system.Then delivery assembly and guide wire are taken off from health.

[0104] For the purpose of illustration, the pulmonary artery is selected as the deployment site of the device in the body. In this example, the considerations related to the placement of the pressure sensor are disclosed. Through modifying the example disclosed in this article, other devices in the body can be placed in alternative positions, and according to the disclosure provided herein, such position and method are obvious to those skilled in the art. In order to deploy the implant assembly in the pulmonary artery blood vessel, the right femoral vein is selected as the intervention site. The user can intervene in the femoral vein via percutaneous puncture or incision. The vascular introducer is placed at this position. The Swan-Ganz catheter or guide catheter is manipulated into the pulmonary artery. The path leading to the pulmonary artery is as follows: the femoral vein leads to the lower internal vena cava. The catheter passes through the right atrium from the lower internal vena cava and arrives at the right ventricle, and finally arrives at the pulmonary artery. At this point, the right branch or left branch of the pulmonary artery is selected, and the Swan-Ganz catheter or guide catheter is placed in the descending branch of the right or left pulmonary artery. A guide wire is placed at the deployment site, and then the Swan-Ganz or guide catheter is removed. At this point, the delivery catheter is loaded on the proximal end of the guide wire. Alternatively, guiding catheter can be loaded on the near end of guide wire and delivery catheter, until the far end of this guiding catheter is positioned at the near end point of the implant assembly on the delivery catheter next to it.On the guide wire, delivery catheter (and optional guiding catheter) is tracked to the deployment site.The silk thread will be pulled to the near end, so that the implant assembly is disengaged from the delivery device.

[0105] Depending on the relationship between pulmonary artery pressure, alveolar pressure and pulmonary vein pressure, lung can be divided into three regions.In region 1 at the top of lung, alveolar pressure is greater than the pressure of pulmonary artery or pulmonary vein, thereby causes vascular collapse in each respiratory cycle.(Region 1 condition does not usually occur in humans.) In region 2, alveolar pressure is less than pulmonary artery pressure, but greater than pulmonary vein pressure, causes partial vascular collapse.But, in region 3 at lung bottom, because the pressure of pulmonary artery and vein is all greater than alveolar pressure, therefore all blood vessels all keep fully open during whole respiratory cycle.Implant assembly is released in the descending branch of right or left pulmonary artery, because this will cause device in vivo to be placed in region 3 of lung.It is not known whether vascular collapse can produce any harmful effect to the pressure measured by sensor, but by placing sensor in the position that the possibility of this phenomenon is minimized, the position according to the present invention of equipment can eliminate this unknown.

[0106] E. Delivery system including an outer sheath

[0107] As previously discussed, a general process for implanting a device in vivo, such as those described herein, includes identifying a deployment site for the device and obtaining access to the vasculature corresponding to the deployment site, such as by percutaneous puncture or incision. A Swan-Ganz catheter or similar guide catheter may then be inserted through the access site and delivered to the deployment site. A guide wire (e.g., Figure 28-29 The guide wire 110 shown in FIG. 1 is inserted into the deployment site through the guide catheter. Once the guide wire is correctly placed, the guide catheter can be removed and the proximal end of the guide wire can be inserted into the delivery catheter of the delivery device, such as Figure 29-30 As shown. Then, the delivery catheter connected to the intracorporeal device to be implanted can be translated along the guidewire so that the intracorporeal device is delivered to the implantation site. Once properly positioned, the intracorporeal device can be deployed as previously described in the present invention, for example, by withdrawing the tie wire that connects the intracorporeal device to the delivery catheter.

[0108] In an embodiment according to the present invention, an additional sheath or catheter can be arranged around each of the delivery catheter and the guidewire. Such a sheath provides a variety of benefits. For example, but not limited to, the sheath can provide additional protection during the insertion of the delivery catheter. The sheath can also provide multiple lumens, which can be used to inject contrast agents or obtain pressure measurements. The lumen of the sheath can also be used to guide other tools to adjust, reposition or rewire the device in the body during the deployment process. In some embodiments, the sheath can also be used to provide a proximal "stop" for the device in the body to reduce the possibility of migration of the device in the body during deployment.

[0109] Reference Fig.31 , a delivery system 300 for delivering an in vivo device 30 is provided. Generally, the system 300 includes Figure 25-29 The system 100 shown in FIG. 1 is disposed within a sheath 302 that extends over a substantial length of each of the delivery catheter 303 and the guidewire 110 . Fig.25 The delivery system of –29 and its components are suitable for the following description.

[0110] like Fig.31 As shown, in some embodiments, the sheath 302 can define multiple separate lumens, such as a delivery catheter lumen 304 and a guidewire lumen 306. In other embodiments, the sheath 302 can include a single lumen through which both the delivery catheter 303 and the guidewire 110 pass. In other embodiments, the sheath 302 can define more than two lumens to facilitate the insertion of additional tools or otherwise in a hub of the delivery system (hereinafter referred to as Fig.32 Provide additional channels between the deployment location and the deployment location.

[0111] In addition to facilitating delivery of the intracorporeal device 30, the lumen of the sheath 302 can also be used to provide other functions. For example, but not limited to, one or more lumens of the sheath 302 can be used to inject a fluid, such as a contrast agent, near the deployment site of the intracorporeal device 30 to enable more accurate monitoring of the delivery process using fluoroscopy or the like. One or more lumens of the sheath 302 can also serve as a conduit from which pressure measurements can be obtained. Regardless of the additional functionality to be provided, the lumen of the sheath 302 used to provide such functionality must generally have a cross-sectional area sufficient to allow fluid communication between the deployment site and the manifold 310 (e.g., Fig.32 303 and will be discussed in detail below). Thus, for example, the lumen for providing additional functionality can be separate and independent of any lumen containing the delivery catheter 303 and / or the guidewire 110. Alternatively, if the lumen contains one or both of the delivery catheter 303 and the guidewire 110, the lumen can be oversized to provide excess cross-sectional area for the additional functionality. For example, the cross-sectional area of ​​the delivery catheter lumen 304 can be greater than the cross-sectional area of ​​the delivery catheter 303, so that the annular space 307 is defined between the delivery catheter 303 and the wall defining the delivery catheter lumen 304. The collector 310 can then include a port or similar access point in fluid communication with the annular space 307 to allow injection or removal of fluids, insertion of tools, measurement using various gauges, or other similar functions that require a path to be established between the exterior of the collector and the deployment location.

[0112] For purposes of the present invention, a lumen that provides functionality other than receiving a delivery catheter and / or guidewire is referred to as a "secondary lumen." Thus, a secondary lumen may correspond to a lumen that is separate and distinct from the delivery catheter lumen and the guidewire lumen, or may be a catheter lumen and / or guidewire lumen when the delivery catheter lumen and / or guidewire lumen are oversized to accommodate the delivery shaft / guidewire and any additional space required to perform the additional functionality.

[0113] exist Figure 33-34 Examples of sheaths according to the present invention are shown in FIG. 1 , each of which shows a cross-section of a sheath 302 according to the present invention. As shown, Figure 33-34 Each sheath 302 is shown to include a delivery catheter lumen 304 and a guidewire lumen 306. Fig.33 In the embodiment, each of the delivery catheter lumen 304 and the guidewire lumen 306 is substantially semicircular in shape. Fig.34 The sheath 302 includes a crescent-shaped delivery catheter lumen 304 and a circular guidewire lumen 306. Fig.33 and 34Each of the sheaths 302 includes two separate lumens, but the sheath according to the present invention may include one or more lumens. Moreover, although each lumen of the sheath is intended to receive one of the delivery catheter 303 and the guide wire 110, the delivery catheter 303 and the guide wire 110 can share a single lumen. In addition, the sheath 302 may include multiple lumens, and the delivery catheter 303 and the guide wire 110 are not arranged in the multiple lumens. Such a secondary lumen can be used to promote the delivery of other silk threads, catheters, instruments, etc., or an additional fluid path through the delivery system 300 can be provided.

[0114] The sheath 302 can be formed of various materials, including one or more of biocompatible polymers and metals. For example, in some embodiments, the sheath 302 can be formed of an extruded polymer. In other embodiments, the sheath 302 can include a polymer or metal structure embedded in a polymer matrix. For example, a braided wire formed by a biocompatible metal (such as nitinol or stainless steel) can be embedded in a matrix of nylon, Pebax or other biocompatible polymers. The sheath according to the present invention can also include one or both of an inner lining and an outer lining, and the inner lining and the outer lining can also be formed by a biocompatible polymer or metal. The specific size of the sheath 302 can vary according to the specific application used. For example, but not limited to, in one embodiment, the size of the sheath can be 5Fr. One or more radiopaque markers can also be provided on the sheath 302, embedded in the sheath 302 or otherwise connected to the sheath 302, and used in combination with fluoroscopy or similar machines to provide increased visibility of the sheath 302 during implantation.

[0115] Fig.35 Shows Fig.34 The sheath 302 is a sheath 302, wherein the delivery catheter 303 and the guidewire 110 are disposed in the delivery catheter lumen 304 and the guidewire lumen 306, respectively. As shown, the cross-section of the delivery catheter lumen 304 is substantially larger than the cross-section of the delivery catheter 303. Therefore, an annular space 307 is defined between the delivery catheter 303 and the inner wall of the delivery catheter lumen 304. The annular space 307 can be used, among other things, to inject or remove fluids (e.g., contrast agents) into or from the deployment site; to enable additional wires, catheters, tools, etc. to be delivered to the deployment site; or to establish a tap at the deployment site that can be used to measure pressure or other parameters.

[0116] Fig.32 310 of the delivery system 300 according to the present invention. As shown, the collector 310 includes a distal collector portion 312 and a proximal collector portion 314 that are separable from each other. However, in other embodiments, each of the distal collector portion 312 and the proximal collector portion 314 can be integrated into a one-piece structure.

[0117] like Fig.32 As shown, the distal collector part 312 includes a distal collector body 316, and the sheath 302 extends distally from the distal collector body. The distal collector part 312 may further include one or more ports, such as port 318, to facilitate various functions. For example, in some embodiments, port 318 may be suitable for enabling the distal collector part 312 to be flushed. Port 318 may also be suitable for allowing the injection of contrast agents or other fluids to be delivered to the deployment position of the device in the body. In other cases, port 318 can be connected to the deployment position fluid via one or more lumens of the sheath 302, so that a pressure gauge or similar pressure measuring device can be connected to port 318 to measure the pressure in the deployment position. In other cases, port 318 can be used to insert a silk thread, a catheter, an instrument or other articles to be delivered to the deployment position via the sheath 302. As shown, the distal collector part 312 also includes a distal seal 320 and a proximal seal 322. For example, without limitation, each of the distal seal 320 and the proximal seal 322 can be a Tuohy-Borst type adapter that prevents backflow associated with instruments inserted therein.

[0118] like Fig.32 As further shown, the proximal hub portion 314 includes a proximal hub body 324, which includes a first branch 325A for receiving the guidewire 110 and a second branch 325B for inserting the delivery catheter. The proximal hub body 324 may further include one or more caps or seals, such as a guidewire cap 326 and a proximal seal 328.

[0119] accomplish Fig.32 The method of the aggregator 310 is generally as follows. As previously described in Figure 25-30 As described in the context of FIG. 3 , the in vivo device 30 is loaded onto the delivery catheter 303. The loaded delivery catheter 303 is then inserted through the sheath 302 and each of the distal collector portion 312 and the proximal collector portion 314. In embodiments where the sheath 302 includes a delivery catheter lumen 304, the insertion of the loaded delivery catheter 303 typically includes passing the proximal end of the delivery catheter 303 into and through the delivery catheter lumen 304.

[0120] For the patient, an access point is formed, for example, by percutaneous puncture or incision, and a Swan-Ganz or similar guide catheter is inserted through the patient's access point and delivered to the deployment site. The guide wire 110 is then inserted through the guide catheter so that the distal end of the guide wire 110 is delivered to the deployment site of the device 30 in the body. Once the guide wire 110 is properly positioned, the guide catheter is removed. It is noteworthy that the process of loading the delivery catheter 303 and the delivery of the guide wire 110 are separate processes that can occur in any order.

[0121] Then, the delivery catheter 303 and the hub 310 are loaded onto the guidewire 110. Typically, the process includes inserting the proximal end of the guidewire 110 into the lumen of the sheath 302 (e.g., the guidewire lumen 306), and passing the delivery catheter 303 and the hub 310 along the guidewire 110 so that the distal end of the delivery catheter 303 is positioned at the deployment location of the intracorporeal device 30. Once so positioned, the intracorporeal device 30 is released from the delivery catheter 303, for example, by withdrawing the tie wire 108 used to connect the intracorporeal device 30 to the delivery catheter 303. After deployment of the intracorporeal device 30, each of the delivery catheter 303, the sheath 302, and the guidewire 110 can be removed from the patient's body.

[0122] In the embodiment where the intracorporeal device 30 is deployed by withdrawing the tie wire 108, the friction of the tie wire 108 between the intracorporeal device 30 and the tie wire 108 may cause the intracorporeal device 30 to shift toward the proximal end as the tie wire 108 is withdrawn. In order to avoid such a shift, the sheath 302 may be extended distally so that when the intracorporeal device 30 is loaded onto the delivery catheter 303, the distal end of the sheath 302 is adjacent to the intracorporeal device 30. Then, any proximal displacement of the intracorporeal device 30 will cause the intracorporeal device 30 to abut against the sheath 302, thereby preventing the intracorporeal device 30 from shifting toward the proximal end during deployment. Alternatively, the sheath 302 may be configured to translate along the guide wire 110 so that before the intracorporeal device 30 is deployed, the sheath 302 may translate distally to prevent the intracorporeal device 30 from shifting toward the proximal end during deployment.

[0123] F. Delivery system including online delivery axis

[0124] The previously discussed embodiments of the present invention generally include an intracorporeal device that is releasably coupled to a distal portion of a delivery catheter. More specifically, the intracorporeal device is coupled to the delivery catheter by positioning the intracorporeal device near the distal portion of the delivery catheter and then tying the intracorporeal device to one side of the delivery catheter using a tie wire. The assembly can then be loaded onto the guidewire by inserting the proximal end of the guidewire through a lumen defined by the delivery catheter or by a sheath through which the delivery catheter extends.

[0125] Although sideways mounting of an intracorporeal device on a delivery catheter enables delivery of the device to a deployment location within the patient's vasculature, the sideways mounting approach has certain limitations. For example, the overall width of the delivery system must be limited to be no less than the combined width of the intracorporeal device, delivery catheter, and guidewire. The wire-tie-based approach also requires that the delivery catheter substantially extend beyond the distal end of the intracorporeal device (e.g., Fig.29 and 30) to secure the distal end of the tie wire to the delivery catheter. In practice, such additional length is typically about 1.25 inches. Thus, the deployment locations available for a side-mounted delivery approach may be limited based on various imposed size constraints.

[0126] As in the side-mounting method discussed previously, the use of tie wires may also bring about certain problems related to the deployment accuracy of the intracorporeal device. For example, when the tie wire is withdrawn from the intracorporeal device during deployment, the friction between the tie wire and the intracorporeal device may cause the intracorporeal device to be pulled proximally, thereby moving the intracorporeal device out of its intended deployment position. Such displacement may also occur due to the withdrawal of the delivery catheter after the intracorporeal device has been released. For example, when the delivery catheter is withdrawn, due to the friction between the delivery catheter and the intracorporeal device, it may contact the intracorporeal device, knocking the intracorporeal device out of place or pulling the intracorporeal device proximally.

[0127] In order to solve the aforementioned problems, the present invention provides an alternative delivery system for deploying an intracorporeal device. In contrast to the side mounting method previously discussed, the disclosed delivery system alternatively allows the intracorporeal device to be releasably coupled to the distal end of the shaft. For example, in one embodiment, the delivery system includes a delivery shaft with a threaded end that can be coupled to a corresponding recessed hole formed in the proximal end of the intracorporeal device. Therefore, after placing the intracorporeal device, the delivery shaft can be reversely rotated to unscrew the end from the hole, thereby releasing the intracorporeal device. As a result, the intracorporeal device and the delivery shaft are maintained in a substantially coaxial arrangement so that when the intracorporeal device is coupled to the delivery system, their total width does not exceed the total width of the intracorporeal device.

[0128] In certain embodiments, the overall width of the delivery system is further reduced by including a guide feature on the intracorporeal device that is shaped to receive a guide wire during delivery and deployment. As a result, the guide wire is held relatively close to the intracorporeal device compared to a side-mounted delivery system that passes the guide wire through the lumen of the delivery catheter.

[0129] In addition to reducing the overall size of the delivery system compared to a side-mounted configuration, certain embodiments of the end-mounted delivery system reduce the likelihood of migration of the intracorporeal device during deployment. For example, in embodiments using a threaded connection between the delivery catheter and the intracorporeal device, deployment of the intracorporeal device requires rotation of the delivery catheter, but generally does not require proximal pulling of the delivery catheter, which may cause movement of the intracorporeal device.

[0130] In view of the foregoing, the reduced size of the end-mounted delivery system according to the present invention increases the number of deployable locations of the in vivo device compared to the side-mounted configuration. In addition, in certain embodiments, the accuracy of such deployment can also be improved by reducing the amount of proximal pull of the delivery catheter required to deploy the in vivo device.

[0131] Figure 36-37 is a side elevation view of the distal end 401 of a delivery system 400 in accordance with the present invention. Fig.36 A delivery system 400 is shown including an in vivo device 450, and Fig.37 For clarity, the in-vivo device 450 is excluded and other aspects of the delivery system 400 are shown. Although the in-vivo device 450 is shown as wireless, embodiments of the present invention may also be used with wired in-vivo devices.

[0132] As shown, the delivery system 400 generally includes a sheath 402 through which each delivery shaft 404 passes and in which a guidewire 406 can be received. More specifically, during an implantation operation for the intracorporeal device 450, the guidewire 406 can be inserted into the patient's body such that the guidewire 406 extends from the exterior of the patient to the desired deployment location of the intracorporeal device 450. Thus, in order to deliver the intracorporeal device 450 to the desired deployment location, the delivery system 400 is loaded onto the proximal end of the guidewire 406 and translated along the guidewire 406 until the intracorporeal device 450 is properly positioned.

[0133] The sheath 402 may define one or more lumens. Figure 36-37 As shown, the sheath 402 includes each of a delivery shaft lumen 406 and a guide wire lumen 408 shaped to receive a delivery shaft 404 and a guide wire 406, respectively. The delivery shaft 404 and the guide wire 406 can alternatively be received by the same lumen. In addition, in addition to those lumens for receiving the delivery shaft 404 and the guide wire 406, the sheath 402 can define additional lumens.

[0134] In some embodiments, instead of receiving the delivery shaft 404 and the guide wire 406, or in addition to receiving the delivery shaft 404 and the guide wire 406, one or more lumens of the sheath 402 can be used to provide additional functions. For example, but not limited to, the lumen of the sheath 402 can be adapted to enable contrast agents or other fluids to be injected into the deployment position. As another example, the lumen can be adapted to enable fluids to be removed from the deployment position or to sample the fluid. As yet another example, a pressure gauge or other sensor device can be connected to the lumen to monitor or measure physiological parameters such as blood pressure at the deployment position. Such additional functions can be achieved by providing additional lumens other than those lumens adapted to receive the delivery shaft 404 and the guide wire 406. Alternatively, the lumen for receiving the delivery shaft 404 and / or the guide wire 406 can be oversized so that the annular space around the delivery shaft 404 and / or the guide wire 406 can be used to facilitate additional functions.

[0135] Similar to lumen 302, a lumen that provides other functions besides receiving a delivery catheter and / or guidewire is referred to herein as a "secondary lumen." Thus, a secondary lumen may correspond to a lumen that is separate and distinct from the delivery shaft lumen and the guidewire lumen, or may refer to the delivery shaft lumen and / or the guidewire lumen when the delivery shaft lumen and / or the guidewire lumen are oversized to accommodate the delivery shaft / guidewire and any additional space required to perform other functions.

[0136] In some embodiments, the sheath 402 can be Figure 31-35 The sheath 302 discussed in the context of is substantially similar. Therefore, the foregoing discussion regarding the design of the sheath 302 is equally applicable to the sheath 402 of the delivery system 400.

[0137] The delivery shaft 404 includes a distal coupling feature 410 adapted to releasably couple with a corresponding proximal coupling feature 452 of an in-vivo device 450. Figure 36-37 In the illustrated embodiment, for example, the distal coupling feature 410 of the delivery shaft 404 is an externally threaded end, and the proximal coupling feature 452 of the in-vivo device 450 is an internally threaded hole. Thus, by screwing the distal coupling feature 410 into and out of the proximal coupling feature 452, the delivery shaft 404 can be releasably coupled.

[0138] The delivery shaft 404 and the intracorporeal device 450 are maintained in a substantially coaxial arrangement when coupled via the distal coupling feature 410 and the proximal coupling feature 452. More generally, the delivery shaft 404 is maintained within the outer boundaries of the intracorporeal device 450 such that, when coupled, the delivery shaft 404 is located within an axial envelope 454 defined by the body 451 of the intracorporeal device 450. Thus, the shaft 404 does not increase the overall width of the delivery system 400 when coupled to the intracorporeal device 450.

[0139] The threaded connection between the delivery shaft 404 and the intracorporeal device 450 is merely one example of a potential coupling feature that may be used to couple the delivery shaft 404 and the intracorporeal device 450. If the delivery shaft 404 is maintained within an axial envelope 454 defined by the body 451 of the intracorporeal device 451, and the coupling of the delivery shaft 404 to the intracorporeal device 450 is sufficiently secure to maintain the intracorporeal device 450 on the delivery shaft 404, a variety of other coupling mechanisms may be implemented. For example, in an alternative embodiment, the distal coupling feature 410 and the proximal coupling feature 452 may be coupled via a twist-lock mechanism. In another example embodiment, the distal coupling feature 410 may be selectively expandable such that it may expand the proximal coupling feature 452 to couple the delivery shaft 404 to the intracorporeal device 450. In yet another example embodiment, the distal coupling feature 410 may be electromagnetically coupled to the proximal coupling feature 452. In such an embodiment, the delivery coupling feature 410 may include an electromagnet that can be selectively activated or deactivated to respectively retain or release the intracorporeal device 450. In yet another embodiment, the distal coupling feature 410 may include a snare or hook formed to engage and retain the proximal coupling feature 452 such that by extending or expanding the snare or hook, the delivery shaft 404 and the intracorporeal device 405 may be selectively coupled and decoupled.

[0140] As used herein, the term "delivery shaft" generally means a flexible, elongated body having a distal end that is releasably coupled to the proximal end of the in vivo device 450. In some embodiments, the delivery shaft can be formed by a single wire or strand, or can include multiple wires or strands that are wound or otherwise coupled to a cable. The delivery shaft can be formed by one or more biocompatible materials, including but not limited to one or more biocompatible polymers (e.g., polyetheretherketone (PEEK), polyvinyl chloride (PVC), polypropylene (PP), polyethylene (PE), polystyrene (PS), nylon, polyethylene terephthalate (PET), polyimide (PA), polycarbonate (PC), acrylonitrile butadiene (ABS) or polyurethane (PU)) or metals (e.g., stainless steel, titanium, steel alloys and titanium alloys, such as nitinol). In some embodiments, the delivery shaft can include multiple material elements. For example, the shaft can include a reinforcing braid made of a relatively hard metal or polymer embedded in a relatively flexible polymer body.

[0141] like Fig.36As shown, the intracorporeal device 450 can include a guide 456 adapted to receive the guide wire 406. The guide 456 generally provides a passage 458 or channel through which the guide wire 406 can extend. In the illustrated embodiment, for example, the guide 456 is disposed on a side of the intracorporeal device 450 near the distal end of the intracorporeal device 450. As a result, the guide 456 extends from the bottom side 455 of the intracorporeal device 450 such that the passage 458 is offset relative to the body 451 of the intracorporeal device 450. In other embodiments, if the passage 458 is sufficiently offset relative to the body 451 of the intracorporeal device (e.g., positioned outside the axial envelope 454), the guide 456 can be alternatively coupled to a top surface, a side surface, a proximal surface, or a distal surface of the intracorporeal device 450 provided.

[0142] Fig.38 4 is a side elevation view of the proximal end 403 of the delivery system 400. The proximal end 403 generally includes a hub 430 adapted to receive and manipulate each of a guidewire 406 and a delivery shaft 404. The sheath 402 of the delivery system 400 is coupled to the distal end of the hub 430 and extends therefrom. The hub 430 also includes a guidewire passage 432 and a delivery shaft passage 434 each shaped to receive and guide the guidewire 406 and the delivery shaft 404, respectively. The hub 430 is arranged in a y-shape such that the guidewire passage 430 extends parallel to the sheath 402, while the delivery shaft passage 432 extends at an angle relative to each of the guidewire passage 434 and the delivery shaft passage 432.

[0143] The y-shaped arrangement of the manifold 430 is only one arrangement contemplated by the present invention. In other embodiments, the delivery shaft passage 434 and the guidewire passage 432 may be configured in other arrangements. In other embodiments, the manifold 430 may also include one or more additional passages suitable for inserting tools, injecting or removing fluids from the manifold 430, flushing the manifold, or various other functions. Fig.38 The manifold 430 is shown as having a substantially unitary construction in FIG. 1 , but in other embodiments, the manifold 430 may include multiple separate parts that are joined together using appropriate seals and connectors. For example, the manifold 430 may include a plurality of separate parts that are connected to the manifold 430. Fig.32 The shown collector 310 has similar proximal and distal portions to each.

[0144] As previously in Figure 36-37 As discussed in the context of , the delivery shaft 404 includes a distal coupling feature 410 in the form of an externally threaded end. Thus, the hub 430 is adapted to rotate the delivery shaft 404 to facilitate coupling and decoupling of the delivery shaft 404 with the in-vivo device 450. For example, Fig.38In the embodiment shown in FIG. 4 , the delivery shaft 404 is coupled to the knob 440, such as by a set screw 442, such that rotation of the knob 440 rotates the delivery shaft 404. Thus, after positioning the intracorporeal device 450 at a deployment location within the patient's body, the knob 440 can be rotated to cause the threads of the distal coupling feature 410 to unscrew and ultimately disengage from the intracorporeal device 450.

[0145] The knob 440 is one example of a feature of the hub 430 that is adapted to enable manipulation of the delivery shaft 404, and in particular, to facilitate detachment of the delivery shaft 404 from the intracorporeal device 450. In other embodiments, the hub 430 may include one or more other features, such as buttons, sliders, knobs, switches, locks, pumps, etc., adapted to manipulate the delivery shaft 404 and / or its distal coupling feature 410.

[0146] Delivery of an in vivo device using delivery system 400 typically includes first inserting a guide wire 406 into the patient's body. For example, in some applications, an access point is formed, such as by percutaneous puncture or incision, and a Swan-Ganz or similar guide catheter is inserted through the patient's access point and delivered to the deployment site. The guide wire 406 is then inserted through the guide catheter so that the distal end of the guide wire 406 is delivered to the deployment site of the in vivo device 450. Once the guide wire 406 is properly positioned, the guide catheter is removed.

[0147] Before, during, or after the process of implanting the guidewire 406, the intracorporeal device 450 can be loaded onto the delivery system 400. Typically, loading includes inserting the delivery shaft 404 through the hub 430 and the sheath 402 so that the delivery shaft 404 protrudes from the distal end of the sheath 402 and coupling the distal coupling feature 410 of the delivery shaft 404 to the corresponding proximal coupling feature 452 of the intracorporeal device 450. In embodiments where the distal coupling feature 410 is an externally threaded end and the proximal coupling feature 452 is a corresponding internally threaded hole, for example, the distal coupling feature 410 of the delivery shaft 404 and the proximal coupling feature 452 of the intracorporeal device 450 can be coupled together by contacting the external threads with the internal threads and rotating the delivery shaft 404 to engage the threads. In certain embodiments, such rotation is achieved by rotating a knob or similar feature of the hub 430 to which the delivery shaft 404 is coupled. Thus, the loading process can further include coupling the delivery shaft 404 to the knob 440 of the hub 430. As previously discussed, other arrangements of coupling mechanisms other than threads may be used to achieve coupling of the delivery shaft 404 to the intracorporeal device 450. In such embodiments, the loading process generally includes coupling the delivery shaft 404 to the intracorporeal device 450 according to the particular coupling mechanism of the embodiment. Such coupling may include manipulation of one or more features of the hub 430 adapted to manipulate coupling features of the delivery shaft 404 or otherwise control the release of the coupling between the delivery shaft 404 and the intracorporeal device 450.

[0148] Once the intracorporeal device 450 is loaded, the delivery system 400 is loaded onto the guidewire 406. Typically, the process includes inserting the proximal end of the guidewire 406 into a lumen of the sheath 402 (such as the guidewire lumen 408) and passing the delivery catheter 404 and the hub 430 along the guidewire 406 so that the distal end of the delivery shaft 404 is located in a deployment position for the intracorporeal device 450. Once so positioned, the intracorporeal device 450 is released from the delivery shaft 404. In the current example, such deployment is achieved by withdrawing the guidewire 406 from the guide 456 of the intracorporeal device 450 (and optionally from the patient entirely), and then counter-rotating the delivery shaft 404, thereby unscrewing the distal coupling feature 410 and the proximal coupling feature 452 of the delivery shaft 404 from the intracorporeal device 450. Once fully unscrewed, the intracorporeal device 450 is released from the delivery shaft 404 and the sheath 402, delivery shaft 404 and guidewire 110 can be removed from the patient, leaving the intracorporeal device 450 in place.

[0149] As previously described, the sheath 402 can be configured to have an oversized lumen for receiving a guidewire 406 or a delivery shaft 404 or an additional lumen suitable for introducing additional tools, injecting fluids into the patient, extracting fluids from the patient, obtaining pressure or other physiological measurements, and one or more of similar additional functions. Thus, any such function can be performed during delivery of an in-vivo device 450 using the delivery system 400. For example, during delivery of the in-vivo device 450, an initial pressure reading can be obtained to confirm that the patient is stable and / or that there are no local irregularities in the deployment position of the in-vivo device 450. As another example, a contrast agent can be periodically injected through the sheath 402 as the delivery system 400 moves along the guidewire 406 to confirm (using a fluoroscopic examination or similar system) the advancement of the in-vivo device 450 and to determine whether and when the in-vivo device 450 is in its final deployment position.

[0150] Unless otherwise specified, the terms used in this document, such as "top", "bottom", "upper", "lower", "left", "right", "front", "back", "proximal", "distal", etc., are only used for the convenience of description and are not intended to limit the scope of the present invention to any particular direction.

[0151] With regard to additional details related to the present invention, materials and manufacturing techniques may be employed within the level of a person skilled in the relevant art. With regard to the method-based aspects of the present invention, the same applies in terms of additional actions that are usually or logically employed. Moreover, it is contemplated that any optional features of the described invention variations may be set forth and claimed independently or in combination with any one or more features described herein. Likewise, references to singular items include the possibility of the presence of multiple identical items. More specifically, as used herein and in the appended claims, the singular forms "one", "and", "said" and "the" include plural objects unless the context clearly indicates otherwise. It should also be noted that the claims may be written to exclude any optional elements. Therefore, this statement is intended to serve as a prior basis for the use of exclusive terms such as "only", "only" and the like in association with the narration of the claim elements, or a prior basis for the use of "negative" restrictions. Unless otherwise defined herein, all technical and scientific terms used herein have the same meaning as those generally understood by ordinary technicians in the field to which the present invention belongs. The breadth of the present invention is not limited by the subject specification, but only by the simple meaning of the claim items used.

[0152] Finally, it will be understood that the embodiments herein have been disclosed by way of example and that other modifications may occur to those skilled in the art without departing from the scope and spirit of the appended claims.

Claims

1. An in vivo device delivery system comprising: a delivery shaft including a distal coupling feature; a sheath adapted to receive the guidewire and define a delivery shaft lumen within which the delivery shaft is disposed; and an in-vivo device comprising a proximal coupling feature and a device body defining an axial envelope extending proximally from the device body, wherein the in-vivo device is a pressure sensor configured to be positioned and secured in a blood vessel; Therein, the distal coupling feature is releasably coupled to the proximal coupling feature such that when coupled, the distal coupling feature is disposed within an axial envelope defined by the device body.

2. The in vivo device delivery system according to claim 1, wherein: The sheath defines a guidewire lumen separate from the delivery shaft lumen and shaped to receive a guidewire.

3. The in vivo device delivery system according to claim 1, wherein: The distal coupling feature of the delivery shaft is a threaded extension extending distally from the delivery shaft, and the proximal coupling feature of the intracorporeal device is a threaded bore shaped to receive the distal coupling feature.

4. The intracorporeal device delivery system of claim 1, further comprising a hub coupled to the proximal end of the delivery shaft.

5. The in vivo device delivery system according to claim 4, wherein: The hub includes a shaft manipulation feature coupled to the delivery shaft, the shaft manipulation feature being configured to release the distal coupling feature from the proximal coupling feature.

6. The in vivo device delivery system according to claim 5, wherein: The shaft manipulation feature is a rotatable knob coupled to the delivery shaft such that rotation of the rotatable knob rotates the delivery shaft to disengage the distal coupling feature from the proximal coupling feature.

7. The in vivo device delivery system of claim 4, wherein: The hub includes at least one port in communication with the secondary lumen of the sheath such that the port is in fluid communication with the distal end of the sheath.

8. The in vivo device delivery system of claim 7, wherein: The secondary lumen is one of the delivery shaft lumen or the guidewire lumen.

9. The in vivo device delivery system of claim 1, wherein: The sheath comprises a braided tube.

10. The in vivo device delivery system of claim 1, wherein: The intracorporeal device includes an anchoring structure coupled to the device body, the anchoring structure including one or more wires configured to expand to stabilize the intracorporeal device in a blood vessel.

11. An in vivo device delivery system comprising: a delivery shaft including a distal coupling feature; a sheath adapted to receive the guidewire and define a delivery shaft lumen within which the delivery shaft is disposed; and an in-vivo device comprising a proximal coupling feature and a device body defining an axial envelope extending proximally from the device body, wherein the in-vivo device is a pressure sensor configured to be positioned and secured in a blood vessel; wherein the distal coupling feature is releasably coupled to the proximal coupling feature such that when coupled, the distal coupling feature is disposed within an axial envelope defined by the device body, Wherein, the in-vivo device includes a guide member defining a passageway shaped to receive the guidewire, the passageway being disposed outside of the axial envelope.

12. An in vivo device delivery system comprising: a delivery shaft including a distal coupling feature extending from a distal end of the delivery shaft, the distal coupling feature including a threaded extension; a sheath adapted to receive the guidewire and define a delivery shaft lumen within which the delivery shaft is disposed; and an in-vivo device comprising a proximal coupling feature and a device body, the device body defining an axial envelope extending proximally from the device body, and the proximal coupling feature comprising a threaded aperture shaped to receive a threaded extension of the delivery shaft, wherein the in-vivo device is a pressure sensor configured to be positioned and secured in a blood vessel; Therein, the distal coupling feature is releasably coupled to the proximal coupling feature such that when coupled, the distal coupling feature is disposed within an axial envelope defined by the device body.

13. The in vivo device delivery system of claim 12, wherein: The sheath defines a guidewire lumen separate from the delivery shaft lumen and shaped to receive the guidewire.

14. The intracorporeal device delivery system of claim 12, further comprising a hub coupled to the proximal end of the delivery shaft.

15. The in vivo device delivery system of claim 14, wherein: The hub includes a rotatable knob coupled to the delivery shaft such that rotation of the rotatable knob rotates the delivery shaft to disengage the distal coupling feature from the proximal coupling feature.

16. The in vivo device delivery system of claim 15, wherein: The rotatable knob is coupled to the delivery shaft via a set screw extending through the rotatable knob.

17. The in vivo device delivery system of claim 14, wherein: The hub includes at least one port that communicates with the secondary lumen of the sheath such that the port is in fluid communication with the distal end of the sheath.

18. The in vivo device delivery system of claim 12, wherein: The sheath comprises a braided tube.

19. The in vivo device delivery system of claim 12, wherein: The intracorporeal device includes an anchoring structure coupled to the device body, the anchoring structure including one or more wires configured to expand to stabilize the intracorporeal device in a blood vessel.

20. An in vivo device delivery system comprising: a delivery shaft comprising a distal coupling feature extending from a distal end of the delivery shaft, the distal coupling feature comprising a threaded extension; a sheath adapted to receive the guidewire and define a delivery shaft lumen within which the delivery shaft is disposed; and an in vivo device comprising a proximal coupling feature and a device body defining an axial envelope extending proximally from said device body, and said proximal coupling feature comprising a threaded aperture shaped to receive a threaded extension of said delivery shaft, wherein said in vivo device is a pressure sensor configured to be positioned and secured in a blood vessel; wherein the distal coupling feature is releasably coupled to the proximal coupling feature such that when coupled, the distal coupling feature is disposed within an axial envelope defined by the device body, Wherein, the in-vivo device includes a guide member defining a passage shaped to receive the guide wire, the passage being disposed outside the axial envelope.

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