Delivery device for integrated imaging and medical device and method of use

Abstract

To provide an integrated imaging and medical device delivery device.SOLUTION: An integrated imaging and medical device delivery device includes: holding means for holding a foldable medical device 5; and an imaging probe lumen 10 dividing a navigation route passing the device. The navigation route makes it possible for an imaging probe 11 to mutually move in an axial direction via the device. The device is further provided with one or more reference points 7 along the navigation route. The device provides location information on the held foldable medical device 5.SELECTED DRAWING: Figure 4B

Description

[Technical field]

[0001] The present invention relates to an apparatus and method for use in imaging-guided vascular surgery, and in particular to a stent. The present invention relates to such an apparatus and method for delivering medical devices such as: [Background technology]

[0002] Imaging-guided vascular surgery is widely performed, usually under X-ray guidance, but pre- or post-treatment A vascular catheter attached to a stand-alone guiding catheter for later examination of the vascular site. In this regard, intravascular imaging probes are increasingly being adopted to support the treatment of vascular diseases. Intravascular imaging modalities known to be particularly effective in supporting Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OC T: Optical Coherence Tomography, and their respective advantages and disadvantages complement each other. The advantages of IVUS are that it does not require the use of contrast agents and that the IVUS imaging and deep depth of field, although IVUS can have clarity issues.

[0003] In comparison, OCT requires contrast agents and has a shallower sensory penetration depth, but provides better imaging results. This produces better image resolution and therefore better edge detection. Combine multiple imaging modalities into a single image to benefit from complementary capabilities. Combined with a scanning probe (e.g. ultrasonic and optical transducers) and a single head of such a probe) is advantageous. It is widely recognized that.

[0004] Standalone IVUS imaging probe uses contrast agent to detect branch vessels To eliminate the need for X-ray imaging during standard endovascular procedures, such as the treatment of aortic aneurysms, It is particularly known to use it in combination with other contrast agents, which is a good option for patients who are not compatible with contrast agents. The use of X-rays is an advantage because it allows doctors to roadmap blood vessels and improve the radiopacity of medical devices. It is standard practice during such procedures to detect transient markers, but other Imaging modalities can do the same with appropriate imaging registration capabilities. It is known that other imaging modalities have the ability to It is used interchangeably with, or replaces, X-rays entirely, thereby reducing the patient's exposure to radiation. This allows for reduced or eliminated exposure.

[0005] Procedurally, a separate guiding imaging catheter is used to deliver the medical device to the treatment site. The delivery to the patient requires a separate imaging catheter and the necessary medical device delivery equipment. Inserting and withdrawing adds an invasive procedural step.

[0006] In this regard, the use of an independent imaging catheter for medical devices such as stent grafts is The method for delivering and deploying the device typically involves the following steps: 1. Insert a guiding imaging catheter over a guidewire into the treatment site; 2. Turn on the X-rays and adjust the relative position of the imaging probe in detecting features of the vascular environment or by pulling the probe back through the vessel and taking a series of cross-sectional images. The images are used to reconstruct a linear representation of the blood vessel, and the probe is then again advanced toward the treatment site. This will roadmap the target vessels. 3. Insert the stent delivery device over another guidewire and optionally image it using x-ray. Verify the position of the stent relative to the stent probe. 4. Deploying the medical device at the treatment site. 5. The probe is external to the deployed medical device and is therefore not exposed to the labeling of the deployed device. Before re-advancing through the medical device lumen, the catheter is pulled out so that the bonding zone can be inspected. needs to be removed.

[0007] The above procedures are somewhat generalized and may be adapted to a variety of anatomical procedures and medical devices. For example, the bifurcation device should be placed just below the renal branch and above the aortic bifurcation. Yes, the leg device needs to be placed just above the iliac branch.

[0008] Nevertheless, the key steps 2 and 3 are road mapping and measurement of the vascular environment. This requires exposure to X-rays or the presence of an intravascular imaging probe within the blood vessel. This requires either the device to be inserted into the delivery system or to be external to the delivery system, which may be traumatic. Step 5 may involve delivering the imaging catheter independently of the device delivery system. Shows additional steps for withdrawal and re-advancement, EVAR (Endovascular Aneurysm Repair) This procedure is more invasive than standard procedures such as endovascular aneurysm repair (EVA).

[0009] Therefore, a fixed imaging probe is usually attached to a stent graft, valve, or fixed The device can be fixed at a distal or proximal position to a fixture or other device, thereby reducing the time and number of steps required for the procedure. The integration of imaging devices into therapeutic catheters by shortening the width of the catheter is known. It is also a concept that is separate from the insertion and withdrawal of the stent graft delivery device. Repeated insertion and withdrawal of imaging catheters for vascular measurements and post-treatment examinations Reduces the traumatic effects of

[0010] In this regard, WO2004051579 (Patent Document 1) describes how vascular road mapping is This can also be accomplished by an IVUS probe that can be combined onto the same catheter as the stent. In such a case, the associated guide catheter is advanced to the site. and then pulled back through the vessel to roadmap the vessel and its branches, and then reinserted. The catheter is advanced to the appropriate location for deployment. The imaging probe is located on the same catheter. This allows inspection of stent apposition without having to withdraw the delivery device.

[0011] Fixed imaging at a specific location on the same catheter as a stent or similar medical device Use the imaging probe as an element or as an integration of a separate imaging probe. There are several disclosures of methods for using a prosthesis that is in a fixed position on the delivery device relative to the stent. Lobe integration has important procedural and practical limitations. These limitations include: be.

[0012] 1. In reality, many medical treatments require multiple medical devices to be deployed. Therefore, fixing the imaging probe to each delivery device is expensive and requires a large manufacturing cost. In addition, there is a risk of failure of one of the imaging probes.

[0013] 2. Fixing a probe to either end of the stent may be necessary to prevent blockage of the stent. A practical test was performed to confirm that the opposite blind end of the catheter had passed through all adjacent branch vessels. This limits the ability of the The combined catheter is then adjusted longitudinally to align the imaging probe with the vascular features. This can only be achieved by repeated manipulations in the direction.

[0014] 3. Separate imaging catheter lumens to various surgical devices, including therapeutic catheters Prior art disclosures of integration have demonstrated the ability to integrate the device without occluding the branching vessels at either end. How to solve the problem of unmet procedures in shipping and shipping inspection There is no disclosure of how such an assembly may be constructed.

[0015] Practical problems arising from the need to maintain the compactness of delivery devices that contain compressed intravascular devices There are also. [Prior art documents] [Patent documents]

[0016] [Patent Document 1] International Publication No. 2004051579 Brochure Summary of the Invention [Problem to be solved by the invention]

[0017] The present invention as such seeks to alleviate the problems identified above. [Means for solving the problem]

[0018] In accordance with the present invention, an integrated imaging and medical device delivery apparatus is provided, an imaging and medical device delivery apparatus; a retaining means for retaining a deployable medical device; an imaging probe lumen defining a navigation path through the device; Equipped with The navigation path allows the imaging probe to move axially relative to one another through the device. It allows us to be The device further comprises one or more reference points along the navigation path, the reference points being held Providing location information for a deployable medical device. In this way, integrating delivery and imaging functions into a single tool is a This means medical devices such as tents can be deployed more easily and safely.

[0019] Preferably, the one or more reference points are located along the length of the navigation path. An imaging probe is placed at such reference points to image branching vessels, etc. If a particular local feature is identified, it is a known distance from the marker, and the device This makes it possible to easily ascertain the relative position of the medical device carried by the In this way the position of the medical device can be adjusted as required for deployment.

[0020] Conveniently, the one or more fiducials are provided within the imaging probe lumen. Dimensioned to prevent further advancement of the imaging probe along the lobe lumen Also, the imaging probe includes a restricting portion. In this case, the restricting portion restricts the imaging probe to a known proximal position. The relative distance from the medical device is known, so the landing The equipment can be operated according to the needs of the user.

[0021] Preferably, in use, the deployable medical device is configured such that the proximal end of the deployable medical device is It is positioned toward the proximal end of the device at a predetermined distance from the proximal end of the device.

[0022] In a preferred embodiment, the device includes an imaging probe at a position along the navigation path. The device further includes a locking means for locking the probe.

[0023] Conveniently, the imaging probe lumen is disposed within the deployed medical device being held. In this way, the imaging probe can be advanced and retracted inside the device. thus minimizing the trauma caused by such movements. Additionally, internalization of the imaging probe lumen changes the profile size of the delivery device. This means that there is no need to change or increase

[0024] Preferably, the imaging probe lumen extends through a central shaft of the device. Advantageously, at least a portion of the central shaft is formed from a spectrally transparent material. , thereby enhancing the available information.

[0025] Conveniently, the imaging probe lumen is externalized from the central shaft but retained The expandable medical device includes a first end portion extending through the first end portion of the expandable medical device.

[0026] Conveniently, the imaging probe lumen is adapted to receive a deployable medical device held within the device. In this way, the imaging probe can be used to image the medical device. The external environment above and below the medical device can be imaged before the device is deployed. Once the medical device is removed from the sheath, the imaging probe is inserted into the extended medical device. It can be advanced inside the chair to examine the area without damaging the blood vessel wall, for example. In this regard, in certain embodiments, a catheter may be provided external to the deployable medical device. the imaging probe lumen is a first probe lumen of a plurality of probe lumens; The second imaging probe lumen is disposed within a medical device in which the imaging probe can be deployed. The device passes through the center to allow the blood vessel to be introduced into the blood vessel.

[0027] Preferably, the apparatus further comprises an inner and an outer sheath, the inner sheath comprising a medical device. The outer sheath holds the catheter against deployment, and the inner sheath is provided between the inner sheath and the exterior of the device. Encapsulates the imaging probe lumen and therefore the medical device prior to sheath removal. During the delivery process, the outer sheath provides an outer covering or shield against contamination; Facilitates movement of the device within the local environment.

[0028] Conveniently, a deployable medical device for use with the apparatus is a substantially elongated tubular Preferably, the deployable medical device comprises a stent device. Stent devices such as these are expandable devices that are held in a compressed state by a sheath prior to deployment. It can be of any variety.

[0029] Conveniently, the device further comprises an atraumatic tip provided at the proximal end of the device. The or each imaging probe lumen extends to the tip.

[0030] Conveniently, the restriction in the imaging probe lumen passes through a predetermined point along said tip. In a preferred embodiment, the restriction prevents air from escaping from the lumen. a reduced diameter of the lumen that remains open to allow blood to flow out of the lumen; This is brought about by the section.

[0031] Preferably, the navigation path includes a visualization section and the reference point is an image. A visualization section is provided to allow measurement and orientation of the probe. Such a device may be used to assess the positioning of either end of a medical device relative to a site. The present invention provides measurable operability of the imaging probe for

[0032] According to a further aspect of the present invention, a medical device is deployed using the apparatus defined above. A method is provided, the method comprising the steps of: inserting an imaging probe into the distal-most extent of the navigation pathway; For one or more of imaging, roadmapping, or measurement of the site, advancing the imaging probe to a proximal extent of the device; and By stabilizing the position of the imaging probe on the instrument and moving the entire instrument, This is achieved by stabilizing the device position relative to the site and moving the imaging probe within the device. Thus, moving the imaging probe relative to the site.

[0033] In this regard, integrating imaging and deployment functions into a single tool usage This can enhance the deployment of medical devices such as stents.

[0034] Preferably, the imaging probe is adapted to position the imaging probe on the device at the site. The imaging probe can be detected prior to deployment of the medical device by stabilizing it in the desired position relative to the target. The device is then moved relative to the site by moving the entire device until the desired feature is visualized.

[0035] Conveniently, the imaging probe stabilizes the position of the device relative to the site and provides imaging within the device. Move the imaging probe to visualize the landing zone of the deployed medical device Therefore, the deployed device can be moved relative to the site as needed. Chairs can be inspected and rearranged.

[0036] Preferably, the method comprises the steps of: The imaging probe is moved to a proximal range defined by one or more reference points. and Locating a desired site feature using a probe; Adjust the position of the apparatus as necessary so that the proximal end of the medical device is in the proper deployment position. A step located at the position; Further includes:

[0037] According to a further aspect of the present invention, a medical device is deployed using the apparatus defined above. A method is provided, in which an imaging probe lumen is provided within and held by a device. The method includes: Insert the imaging probe into the distal-most extent of the navigation pathway of the imaging lumen. and For one or more of imaging, roadmapping, or measurement of the site, advancing the imaging probe to a proximal extent of the device; By stabilizing the position of the imaging probe relative to the device and moving the entire device, or stabilizing the position of the device relative to the site and moving the imaging probe relative to the device. This allows the imaging probe to be moved relative to the site to properly image the medical device. Identifying a landing site; and After a suitable landing site for the deployable medical device has been determined, and Prior to deployment of the device, the imaging probe detects a distal marker on the deployable medical device. 4. Place the imaging probe in the imaging area until you have confirmed its position relative to the area. withdrawing distally along the lumen; deploying the device; Includes.

[0038] Preferably, the method includes inserting an imaging probe into the deployed medical device. and advancing within the deployed medical device for inspection of the site. and a second imaging lumen disposed within the deployed medical device. may be provided for this purpose.

[0039] In this manner, the method allows for advancement within a pre-deployed and expanded device. Imaging the external environment above and below the device to inspect the area without interference before it becomes It can be used for this purpose.

[0040] According to a further aspect of the present invention, there is provided a medical device delivery system, comprising: The delivery system is: 1. An integrated imaging and medical device delivery apparatus as defined above; a medical device with an expandable sheath held by said holding means; an imaging probe adapted to the imaging probe lumen; Equipped with.

[0041] Specific embodiments of the invention will now be described, by way of example, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0042] [Figure 1] 1 shows an overview of the device according to the invention. [Figure 2A] 1 shows a first embodiment of the present invention. [Figure 2B] 1 shows a first embodiment of the present invention. [Figure 2C] 1 shows a first embodiment of the present invention. [Figure 2D] 1 shows a first embodiment of the present invention. [Figure 2E] 1 shows a first embodiment of the present invention. [Figure 3A] 2 shows a second embodiment of the present invention. [Figure 3B] 2 shows a second embodiment of the present invention. [Figure 3C] 2 shows a second embodiment of the present invention. [Figure 4A] 3 shows a third embodiment of the present invention. [Figure 4B] 3 shows a third embodiment of the present invention. [Figure 5A] 4 shows a fourth embodiment of the present invention. [Figure 5B] 4 shows a fourth embodiment of the present invention. [Figure 5C] 4 shows a fourth embodiment of the present invention. [Figure 5D] 4 shows a fourth embodiment of the present invention. [Figure 5E] 4 shows a fourth embodiment of the present invention. Modes for carrying out the invention

[0043] FIG. 1 is a block diagram of a medical device delivery system incorporating an integrated imaging and medical device delivery apparatus in accordance with the present invention. 1 shows an overview of the elements of a medical device delivery system 1. In this regard, the device includes: The imaging probe includes a central shaft 2, and an imaging probe lumen is formed within the central shaft 2. Through the central shaft 2, an imaging probe moves along a navigation path 3. The visualization section 4 at the proximal end of the device can be achieved by a self-expanding catheter mounted within the device. It extends from the distal end of the stent graft 5 to the proximal end of the device.

[0044] A more detailed view of the first embodiment of the present invention is shown in Figures 2A to 2C. As shown, the compressed intravascular device 5 is attached to an outer shell within the proximal region of the device. The device is restrained by a base 6. A marker 7 is provided at a tip portion 8 at the proximal end of the device. There are.

[0045] The guidewire and imaging probe lumens 9, 10 run from the distal end to the proximal end of the device. The lumens extend through the shaft 2 and extend through the compressed stent graft 5. It extends hand-wise and inward.

[0046] 2D and 2E, in the method of operating the device of the first embodiment, the device The pullback imaging device is inserted into the blood vessel to image and reconstruct the blood vessel. In the case of a guiding probe, the probe 11 is advanced beyond the tip to the treatment site, where it is then Alternatively, the catheter of the delivery device can be pulled back until it is positioned within the delivery device. is advanced using a probe 11 mounted at its proximal limit and then pulled back, Afterwards, it can be advanced again to the site. This allows imaging while advancing the entire delivery device through the blood vessels to the site. do.

[0047] The integrated probe 11 is identified by one or more reference points such as markers 7. When at the proximal limit, it is at a defined distance from the on-board medical device 5 . Thus, the probe can identify the location of the branch vessel, and the delivery device can so that the proximal end of the is a relatively known distance from the branch vessel above and in the proper deployment position. This can be adjusted as needed, so this is happening at the same time as the roadmapping. can.

[0048] Once in place, the medical device 5 can be unsheathed. To check or adjust the imaging probe, along with its visualization section The landing zone for the medical device can be extended to allow the device to be withdrawn. Since they can be inspected from within, they can be rearranged if necessary.

[0049] By using such a device, the method of use is to treat abdominal aortic aneurysms (AAA). Particularly suitable for multi-device deployment procedures such as standard procedures to treat ortic aneurysm It becomes.

[0050] Accordingly, the present invention provides an integrated imaging and medical device delivery apparatus, system, and methods for integrated imaging and medical device delivery apparatus, systems, The system and method preferably include one or more of the following: a) a self-expanding stent graft medical device, comprising: -With radiopaque markers; - compressed around a central shaft; and -Restrained by the introducer sheath, Self-expanding stent graft medical device b) a central shaft, - A designated navigation path for the imaging probe integrated in the device. having a hollow lumen; - at the distal end of the shaft, having an open proximal end; and - made of a spectrally transparent material, Central Shaft c) One or more fixed features (spectral, depending on the selected imaging modality) (detectable automatically) - Markers, etc.; - At a known distance along the visualization section relative to the edge of the medical device, allowing measurement and orientation of the imaging probe; and - Defines the proximal limit of the visualization section at a known distance from the proximal end of the medical device At the forefront of One or more fixed features d) an imaging probe on a separate catheter, - of a size compatible with the specified shaft lumen; and - To prevent unwanted displacement of the imaging probe, use a standard valve such as a Tuohy Borst valve. It can be advanced, withdrawn, or locked into place, controlled by the component. R, Imaging probe on a separate catheter

[0051] Thus, the present invention consolidates and eliminates the need for a compatible and separate intravascular imaging probe. The present invention relates to an intravascular imaging and medical device delivery apparatus and system for The imaging and medical device delivery apparatus and systems preferably comprise one or more of the following: has multiple: A. On-board medical devices with radiopaque markers. B. From the distal-most extent of the delivery device where the imaging probe can be inserted or removed, is defined as the length to the nearest extent that the navigation probe can be navigated into the delivery device. Integrated navigation path. C. Imaging probes at known distances from each end of the on-board medical device. A portion of a navigation path whose ends are conceptually bounded by features detectable by a probe. Visualization section, defined as minutes. D. The spectral visibility window of the environment external to the delivery device.

[0052] Additionally, the present invention preferably incorporates a compatible and independent intravascular imaging probe. The present invention provides a method of using a medical device delivery apparatus and system for delivering and removing a medical device. The method of using the device delivery device and system includes one or more of the following: 1. Insertion or removal of an independent imaging probe at the most distal extent of (B). 2. (B) The direction in which the imaging probe is advanced or withdrawn along its length. Freedom of movement in each country. 3. Imaging probes to image, roadmap, and measure blood vessels Advance to the nearest range of (D). 4. Moving one of the imaging probe and the medical device delivery apparatus longitudinally; (C) along with the medical device delivery apparatus by stabilizing the other in a stationary state. Free displacement of the imaging probe. a. Stabilize the imaging probe at rest in the desired position relative to the vessel and The delivery device is inserted into the blood vessel until the probe visualizes a detectable feature, such as a radiopaque marker. (C) displaces the imaging probe along the Prior to device deployment, the medical device is roadmapped against the vascular environment, including branches. are placed as intended. b. Stabilize the delivery device stationary relative to the blood vessel and place the imaging probe within the delivery device. (C) Displace the imaging probe along the extended Visualize the landing zone of your therapeutic device, allowing you to inspect or reposition the device if needed to.

[0053] 3A to 3C show a second embodiment of the present invention. Similar to the above, but with a marker at the tip to define the proximal limit of the imaging probe. Instead, the proximal limit is a stepped portion of a designated lumen 10 at a known distance from the device. The stepped profile 12 is therefore defined by the open-ended pipe. The proximal end of the lumen, where the lumen diameter is reduced and the imaging probe is It therefore prevents the stent device 5 from advancing beyond a known position or provides a reference point. However, the reduced diameter section of the lumen is open ended. This allows air to escape from the lumen.

[0054] 4A and 4B show a third embodiment, which includes an imaging probe and a shaft. externalize it from port 2 but still place it inside the compressed device, thereby The lobe emerges from a portion of the navigation path.

[0055] Thus, the imaging probe is a shaft tube within the multi-lumen tube of the delivery device. The visualization section is primarily intended to Pressure distribution across the distance between the exit of the navigation pathway lumen at the distal end and the tip of the shaft. The free space between the inside of the retracted device 5 and the outside of the shaft 2, and the tip of the shaft The imaging probe enters to find its proximal limit. The proximal limit is determined by the previous According to the embodiment, the shaft tip portion 8 is defined by a marker 7 or a stepped profile. It can be done.

[0056] A fourth embodiment is shown in Figures 5A-5E, which further includes a dual sheath configuration. Externalize the imaging probe.

[0057] In this regard, the imaging probe lumen 10 is an internal lumen that constrains the compressed device 5. The marker 7 extends between the exterior of the sheath 13 and the interior of the outer sheath 14. It is provided in.

[0058] The method of using the fourth embodiment will be described with reference to FIGS. 5C to 5E. The delivery of medical devices involves the use of devices to roadmap blood vessels. The device may detect environmental cues (e.g., markers on other devices or vascular features) By detecting the position, the target is advanced to the appropriate position.

[0059] To deploy the device, the prosthesis must be inserted into the device before the sheath is removed, as shown in Figure 5D. The probe detects the distal markers on the device and maps them to the roadmapped branch vessels. The imaging probe is withdrawn distally in the visualization pathway until the location of the Above that location the device should be deployed.

[0060] FIG. 5E shows probe exchange and repositioning.

[0061] In this regard, in the case of a multi-implant procedure using multiple delivery devices, the probe may be It can be withdrawn from one suitable delivery device and inserted into another suitable delivery device. This is because the previous delivery device was in a partially deployed state while another device was being deployed. Must remain in the anatomy and require a probe for the first device to complete deployment. This is particularly useful when

[0062] To check or adjust apposition, the imaging probe is aligned with the end stent. The repositionable device is aligned along the visualization section within the delivery device. This allows real-time imaging of stent repositioning.

[0063] In a fourth embodiment, an integrated imaging and medical device delivery apparatus, system, and and methods are provided for providing an integrated imaging and medical device delivery apparatus, system, and The method may include one or more of the following preferred features: a) a self-expanding stent graft medical device, comprising: -With radiopaque markers; - compressed and constrained by an inner sheath; Self-expanding stent graft medical device b) A navigation path defined by: At the distal end, a designated lumen outside any lumen of a multi-lumen tube is The designated lumen carries the supporting elements of the tent graft and inner sheath and is used for imaging. Allows the probe to emerge outside the inner sheath and the medical device contained therein. that it is open to -A visualization section extending from the open end of a designated lumen to the proximal limit of the delivery device; - optionally, at the proximal end, a lumen within the catheter tip; and - Optionally, the imaging probe can be moved through the visualization section without deviating from a straight line path. The catheter is inserted into the outside of the inner sheath or the inside of the outer sheath so that it can be guided from the distal end to the proximal end of the catheter. One or more intermediate guiding elements attached. c) Multi-lumen shaft with integrated imaging probe and inner sheath and an outer sheath enclosing the compression device constrained by the d) an imaging probe on a separate catheter, - of a size suitable for the designated lumen; and - An inner sheath that houses a medical device and is housed in an outer sheath until the sheath is withdrawn. outside the source; - To prevent unwanted displacement of the imaging probe, use a standard valve such as a Tuohy Borst valve. It can be advanced, withdrawn, or locked into place, controlled by the component. R, Imaging probe on a separate catheter e) at a tip that defines the proximal limit of the visualization path at a known distance from the proximal end of the medical device Attached, spectrally detectable marker.

[0064] The methods of use also reflect different device embodiments as well as procedural applications. It can be embodied in different ways to reflect the

[0065] Another method of using the essential features of the present invention (in any physical embodiment) is the same Exchange the same probe for a different delivery device (e.g., for a device placed directly above a branch vessel) and integrating the first delivery (e.g., of a device placed just below a branch) The aim is to reuse imaging probes already in use within the system.

[0066] The first and second embodiments with a navigation path in the central shaft are Allows integration of imaging probes without changing or increasing profile size do.

[0067] A fourth embodiment is a multi-lumen enclosure for a medical device that is part of the same multi-lumen enclosure. With its external dual sheath and navigation pathway, the device can be viewed prior to device deployment. This allows imaging of the external environment above and below the vessel, without interfering with the vessel wall. To inspect the site, an expanded device can be advanced inside.

[0068] All embodiments are intended to be imaging probe type agnostic. , the diameter of the imaging catheter relative to its size along the length of the navigation pathway Limited by conformance only.

[0069] All embodiments further provide for the ability to exchange imaging probes between delivery devices during a surgical procedure. It seeks to provide interoperability for

[0070] All embodiments further include a method for determining whether or not a vascular roadmap is being used for a medical device. It seeks to provide measurable maneuverability of the imaging probe to assess positioning. do.

Claims

1. 1. An integrated imaging and medical device delivery apparatus comprising: A retaining means for retaining a deployable medical device; an imaging probe lumen defining a navigation path through the device; Equipped with The navigation path is such that the imaging probes are axially aligned with each other through the device. and The device further comprises one or more reference points along the navigation path. Integrated imaging to provide position information for deployed medical devices held in place and medical device delivery apparatus.

2. The one or more reference points may be markers located along the length of the navigation path. The apparatus of claim 1 including a car.

3. The one or more fiducials are located within the imaging probe lumen and the imaging Dimensioned to prevent further advancement of the imaging probe along the probe lumen. The device of claim 1 , further comprising a restrictor.

4. In use, the deployable medical device is adapted to have a proximal end that is adapted to be attached to the device. and disposed toward the proximal end of the device at a predetermined distance from the proximal end of the 4. The apparatus according to any one of 1 to 3.

5. The imaging probe lumen extends through the interior of the deployed medical device being held. The device according to any one of claims 1 to 4.

6. The imaging probe lumen extends through a central shaft of the device.

6. The apparatus according to any one of 1 to 5.

7. At least a portion of the central shaft is formed from a spectrally transparent material.

7. The apparatus of claim 6.

8. The imaging probe lumen is adapted to receive a deployable medical device held within the apparatus. The device according to any one of claims 1 to 5, wherein the device extends outside of the

9. The imaging probe lumen is adapted to receive a deployable medical device held within the apparatus.

5. The device according to claim 1, which extends externally to the chair.

10. An imaging probe lumen external to the deployed medical device being held is a first probe lumen of the plurality of probe lumens, and a second imaging probe lumen The cavity allows an imaging probe to be introduced inside the deployable medical device 10. The apparatus of claim 9, wherein the device is passed through a center thereof to effect a measurement of the temperature.

11. Further comprising inner and outer sheaths; the inner sheath holds the medical device against deployment; The outer sheath encapsulates the first lumen between the inner sheath and the exterior of the device.

11. The device according to claim 9 or 10,

12. The deployable medical device of any one of claims 1 to 11, wherein the deployable medical device comprises a substantially elongated tubular member.

13. The apparatus according to any one of claims 1 to 12.

13. 13. The method of claim 1, wherein the deployable medical device comprises a stent device.

3. The device according to claim 1 .

14. Any of claims 1 to 13, further comprising an atraumatic tip at the proximal end of the device.

13. The apparatus according to any one of claims 1 to 12.

15. 15. The method of claim 14, wherein the or each imaging probe lumen extends to the tip. Device.

16. The method according to claim 3 , wherein the restricting portion prevents movement of the imaging probe along the tip. The equipment.

17. the navigation path includes a visualization section; The reference points are located in front of the imaging probe to allow measurement and orientation of the imaging probe. An apparatus according to any one of claims 1 to 16, arranged within said visualisation section.

18.

18. A method for deploying a medical device using an apparatus according to any one of claims 1 to 17. There was, The method comprises: inserting an imaging probe into a distal-most extent of the navigation path; For one or more of imaging, roadmapping, or measuring the site, advancing the imaging probe to a proximal extent of the device; Stabilizing the position of the imaging probe on the device and moving the entire device. or by stabilizing the position of the device relative to the site to image the image within the device. The imaging probe is moved relative to the site by moving the imaging probe. A scrubbing step; A method comprising:

19. The imaging probe is adapted to adjust the position of the imaging probe on the device. and stabilizing the imaging probe in a desired position relative to the imaging site prior to deployment of the medical device. The entire device is then moved to the site until the probe visualizes a detectable feature.

20. The method of claim 18, wherein the moving object is moved in a direction parallel to the axis of the optical axis.

20. The imaging probe stabilizes the position of the device relative to the site and 4. Moving the imaging probe within a landing position of the deployed medical device.

20. The method of claim 18 or 19, wherein the zone is visualized and moved relative to the site. The method described.

21. The imaging plane extends to the proximal extent defined by the one or more reference points. moving the probe; using said probe to locate a desired site feature; Adjust the position of the apparatus as necessary so that the proximal end of the medical device is a step located in a suitable deployment position; The method of any one of claims 18 to 20, further comprising:

22. A method for deploying a medical device using an apparatus according to any one of claims 8 to 10. There was, The method comprises: a distal-most extent of the navigation path of the imaging lumen and an imaging probe; wherein the imaging lumen is inserted into a retained expandable medical device. extending outside the device; For one or more of imaging, roadmapping, or measuring the site, advancing the imaging probe to a proximal extent of the device; Stabilizing the position of the imaging probe relative to the device and moving the entire device or by stabilizing the position of the device relative to the site and The imaging probe is moved relative to the site. moving the probe to identify a suitable landing site for the medical device; After a suitable landing site for the deployable medical device is determined, and and a distal end of the imaging probe on the deployable medical device prior to deployment of the device. The imaging probe is then rotated until the marker is detected and its location relative to the site is confirmed. withdrawing the needle distally along the imaging lumen; deploying the device; A method comprising:

23. inserting an imaging probe; advancing within the expanded medical device for inspection of the site; 23. The method of claim 22, further comprising:

24. The imaging probe is adapted to position the apparatus within the expanded medical device.

24. The method of claim 23, wherein the imaging device is advanced through the centrally passing second imaging lumen. method.

25. 1. A medical device delivery system comprising: An integrated imaging and medical device according to any one of claims 1 to 17. A service delivery device and a medical device with an expandable sheath held by said holding means; an imaging probe adapted to the imaging probe lumen; A medical device delivery system comprising:

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