CN117379667A - Dual guidewire delivery systems and methods - Google Patents

Dual guidewire delivery systems and methods Download PDF

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Publication number
CN117379667A
CN117379667A CN202310838814.1A CN202310838814A CN117379667A CN 117379667 A CN117379667 A CN 117379667A CN 202310838814 A CN202310838814 A CN 202310838814A CN 117379667 A CN117379667 A CN 117379667A
Authority
CN
China
Prior art keywords
guidewire
lumen
guidewire lumen
common
tapered tip
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202310838814.1A
Other languages
Chinese (zh)
Inventor
M·P·帕特尔
K·D·帕金斯
R·J·墨里
S·M·克拉森斯
H·M·金
N·N·扎韦尔
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Vascular Inc
Original Assignee
Medtronic Vascular Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/216,411 external-priority patent/US20240016632A1/en
Application filed by Medtronic Vascular Inc filed Critical Medtronic Vascular Inc
Publication of CN117379667A publication Critical patent/CN117379667A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0172Exchanging a guidewire while keeping the catheter in place

Abstract

In one aspect, the present disclosure provides a method comprising positioning a first guidewire within a main guidewire lumen of a multi-lumen tapered tip. A second guidewire is positioned within the secondary guidewire lumen and the common guidewire lumen of the multi-lumen tapered tip, the second guidewire preventing the first guidewire from entering the common guidewire tube. A delivery system including a multi-lumen tapered tip is advanced over the second guidewire. By advancing the delivery system over a single guidewire, any potential for multiple guidewires to become entangled during advancement of the delivery system is eliminated. The method also includes a guidewire exchange including releasing the second guidewire from the common guidewire lumen, advancing the first guidewire through and out of the common guidewire lumen, and advancing the delivery system over the first guidewire to the deployment location.

Description

Dual guidewire delivery systems and methods
Technical Field
The present technology relates generally to medical device systems and methods.
Background
Aneurysms and/or dissection may occur in blood vessels, and most typically occur in the aorta and peripheral arteries. Depending on the region of the aorta involved, the aneurysm may extend to a region with a vascular branch or aortic segment from which the smaller "branch" artery extends.
The aortic aneurysm region may be bypassed by using an endoluminal delivery tubular exclusion device (e.g., by a stent graft placed in a vessel that spans the vessel aneurysm portion) to seal the aneurysm portion from further exposure to blood flowing through the aorta. The use of stent grafts to internally bypass the aneurysm site is not without challenges within the aorta or within the flow lumen.
In particular, care must be taken so that critical branch vessels are not covered or occluded by the stent graft, which must seal against the aortic wall and provide a flow conduit for blood to flow through the aneurysm site. In the case of an aneurysm located immediately adjacent a branch vessel, it is necessary to deploy the stent-graft in an originating location extending partially or completely across the branch vessel from the aorta to ensure that the stent-graft seals to the arterial wall.
To accommodate the branch vessel, a main vessel stent graft having fenestrations or openings in its side walls may be used. The main vessel stent graft is positioned such that its fenestration is aligned with the ostium of the branch vessel. To positionally align the main vascular stent graft, the main guidewire is located within the aorta and the secondary guidewire is located within the side branch, with the second guidewire pre-routed within the fenestration of the main stent graft. The delivery system is advanced over the first and second guidewires to a deployment location and then deployed.
In some cases, the main vessel stent graft is supplemented by another stent graft (commonly referred to as a branched stent graft). A branched stent graft is deployed into a branched vessel through the fenestration to provide a conduit for blood flow into the branched vessel.
Disclosure of Invention
The technology of the present disclosure generally relates to an assembly having a multi-lumen tapered tip. The multi-lumen tapered tip includes a primary guidewire lumen, a secondary guidewire lumen, a common guidewire lumen, and a first and second guidewire junction at an intersection of the primary guidewire lumen, the secondary guidewire lumen, and the common guidewire lumen. The common guidewire lumen is configured to receive either the first guidewire or the second guidewire, but not both. This ensures that the first guidewire cannot extend distally beyond the multi-lumen tapered tip until the second guidewire is selectively released from the common guidewire lumen.
In one aspect, the present disclosure provides a method comprising positioning a first guidewire within a main guidewire lumen of a multi-lumen tapered tip. A second guidewire is positioned within the secondary guidewire lumen and the common guidewire lumen of the multi-lumen tapered tip, the second guidewire preventing the first guidewire from entering the common guidewire tube. A delivery system including a multi-lumen tapered tip is advanced over the second guidewire. By advancing the delivery system over a single guidewire, any potential for multiple guidewires to become entangled during advancement of the delivery system is eliminated. The method also includes a guidewire exchange including releasing the second guidewire from the common guidewire lumen, advancing the first guidewire through and out of the common guidewire lumen, and advancing the delivery system over the first guidewire to the deployment location.
In another aspect, the present disclosure provides an assembly including a multi-lumen tapered tip including a main guidewire lumen, a first guidewire within the main guidewire lumen, a common guidewire lumen, and a second guidewire within the common guidewire lumen. The second guidewire prevents the first guidewire from entering the shared guidewire lumen.
The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the technology described in this disclosure will be apparent from the description and drawings, and from the claims.
Drawings
Fig. 1 is a top perspective view of a double lumen conical tip according to one embodiment.
Fig. 2 is a side view of the dual lumen tapered tip of fig. 1 according to one embodiment.
Fig. 3 is a perspective view of the dual lumen tapered tip of fig. 1 according to one embodiment.
Fig. 4 is a proximal end view of the dual lumen tapered tip of fig. 1 according to one embodiment.
Fig. 5 is a perspective view of a delivery system including the dual lumen tapered tip of fig. 1 according to one embodiment.
Fig. 6 is a cross-sectional view of the delivery system of fig. 5 taken along line VI-VI according to one embodiment.
Fig. 7 is a cross-sectional view of a vascular assembly during deployment of a main vascular stent graft of the delivery system of fig. 5-6 according to one embodiment.
Fig. 8 is a cross-sectional view of the delivery system of fig. 5-6 at a later stage of main vessel stent graft deployment according to one embodiment.
Fig. 9 is a cross-sectional view of the delivery system of fig. 8 at a later stage of deployment of the main vessel stent graft according to one embodiment.
Fig. 10 is a cross-sectional view of the vascular assembly of fig. 7 at a later stage of deployment of the main vascular stent-graft, according to one embodiment.
Fig. 11 is a cross-sectional view of the vascular assembly of fig. 10 at a later stage of deployment of the main vascular stent-graft, according to one embodiment.
Fig. 12 is a cross-sectional view of the vascular assembly of fig. 11 at a later stage in the deployment of a branched stent graft, according to one embodiment.
Detailed Description
Fig. 1 is a top perspective view of a dual lumen conical tip 100 according to one embodiment. Fig. 2 is a side view of the dual lumen tapered tip 100 of fig. 1 according to one embodiment. Fig. 3 is a perspective view of the dual lumen tapered tip 100 of fig. 1 according to one embodiment. Fig. 4 is a proximal end view of the dual lumen tapered tip 100 of fig. 1 according to one embodiment. Fig. 5 is a side view of a delivery system 500 (sometimes referred to as a dual guidewire delivery system) including the dual lumen tapered tip 100 of fig. 1, according to one embodiment. Fig. 2 and 5 show internal features for ease of understanding, however it should be appreciated that internal features may not be visible in actual use.
Referring now to fig. 1-5, the double lumen tapered tip 100 is sometimes referred to as a transcatheter delivery system nose cone for tracking with two guide wires without filament entanglement. The double lumen tapered tip 100 has a proximal end 102 and a distal end 104. A distal guidewire lumen port 106 (e.g., an opening) is located at the distal end 104. A proximal primary guidewire lumen port 108 and a proximal secondary guidewire lumen port 110 (e.g., openings) are located at the proximal end 102.
As used herein, the proximal end of a prosthesis, such as a main vessel stent graft (discussed below with reference to fig. 11), is the end closest to the heart via the path of blood flow, while the distal end is the end furthest from the heart during deployment. In contrast and notably, the distal end of the delivery system 500 including the double lumen tapered tip 100 is generally identified as the end furthest from the operator/handle, while the proximal end is the end closest to the operator/handle.
For clarity of discussion, as used herein, the distal end of the delivery system 500 is the end furthest from the operator (the end furthest from the handle) and the distal end of the main vessel stent graft is the end closest to the operator (the end closest to the handle), i.e., the distal end of the delivery system 500 and the proximal end of the main vessel stent graft are the ends furthest from the handle and the proximal end of the delivery system 500 and the distal end of the main vessel stent graft are the ends closest to the handle. However, those skilled in the art will appreciate that the description of the main vessel stent graft and delivery system 500 may be consistent or reversed in actual use, depending on the location of the inlet.
Between the distal end 104 and the proximal end 102, the dual lumen tapered tip 100 includes a tapered portion 112, an intermediate portion 114, a sheath portion 116, and a proximal portion 118, respectively. As used herein, the longitudinal direction is a direction along the length or longitudinal axis of the dual lumen conical tip 100, and the transverse or radial direction is a direction perpendicular to the longitudinal direction.
The diameter of the tapered portion 112 increases from and extends longitudinally between the distal end 104 and the cylindrical portion 114. In other words, the tapered portion 112 tapers or flares from the distal end 104 to the intermediate portion 114. The taper of the tapered portion 112 facilitates insertion and passage of the delivery system 500, including the dual lumen tapered tip 100, through a blood vessel, as discussed further below.
The intermediate portion 114 has a uniform outer diameter in this embodiment and extends between the tapered portion 112 and the sheath portion 116. The intermediate portion 114 includes a lateral sheath stop surface 120 extending outwardly from the sheath portion 116. In the loaded configuration as shown in fig. 5, the sheath 502 of the delivery system 500 abuts the sheath stop surface 120.
The sheath portion 116 fits within and supports the distal end of the sheath 502, as shown in fig. 5. Sheath portion 116 includes a proximal taper to facilitate sliding of sheath 502 over sheath portion 116. However, in one embodiment, the sheath portion 116 has a uniform outer diameter. The sheath portion 116 includes a lateral secondary guidewire port surface 122 extending outwardly from the proximal portion 118. Proximal secondary guidewire lumen port 110 is located within secondary guidewire port surface 122.
According to this embodiment, the proximal portion 118 is located at the proximal end 102 of the double lumen tapered tip 100 and has a uniform diameter. The proximal portion 118 includes a transverse primary guidewire port surface 124 at the proximal end 102. The proximal main guidewire lumen port 108 is located within the main guidewire port surface 124.
The dual lumen tapered tip 100 includes a primary guidewire lumen 126, a secondary guidewire lumen 128, and a common guidewire lumen 130. The intersection of the primary guidewire lumen 126, the secondary guidewire lumen 128, and the common guidewire lumen 130 define a first second guidewire junction 132, such as a Y-junction.
The guidewire lumen 126 extends between the proximal guidewire lumen port 108 and the first and second guidewire junctions 132. A secondary guidewire lumen 128 extends between the proximal secondary guidewire lumen port 110 and the first and second guidewire junctions 132. In this embodiment, the secondary guidewire lumen 128 is bent inward to meet the primary guidewire lumen 126 and the common guidewire lumen 130 at a first second guidewire junction 132. In other words, the secondary guidewire lumen 128 redirects the second guidewire 506 from the outside toward the center of the dual lumen tapered tip 100.
A common guidewire lumen 130 extends between the distal guidewire lumen port 106 and a first and second guidewire junction 132. In this embodiment, the main guidewire lumen 126 and the common guidewire lumen 130 lie on a common straight line, sometimes referred to as being linear, and extend in a longitudinal direction. In one embodiment, the dual lumen tapered tip 100 is mounted on a tube 503 that is inserted into the main guidewire lumen 126.
In this embodiment, the main guidewire lumen 126 is dedicated to receiving a first guidewire 504, as shown in fig. 5. The secondary guidewire lumen 128 is dedicated to receiving a second guidewire 506, as shown in fig. 5. As discussed further below, the common guidewire lumen 130 is configured to receive either the first guidewire 504 or the second guidewire 506, but not both. More specifically, as shown in fig. 5, when the second guidewire 506 (and optionally the surrounding guide tube 508) is positioned within the common guidewire lumen 130, the second guidewire 506 (or the surrounding guide tube 508) acts as a stop to prevent the first guidewire 504 from traveling and into the common guidewire lumen 130. This ensures that the first guidewire 504 cannot extend distally beyond the double lumen tapered tip 100 until the second guidewire 506 is removed from the common guidewire lumen 130.
With particular attention to fig. 2, 4, to provide space for the secondary guidewire lumen 128, the primary guidewire lumen 126 may be offset from the central longitudinal axis L of the dual lumen tapered tip 100. More specifically, the primary guidewire lumen 126 is displaced below the longitudinal axis L relative to the secondary guidewire lumen 128. By offsetting the primary guidewire lumen 126, additional area may be provided for the secondary guidewire lumen 128 as compared to having the primary guidewire lumen 126 located at the longitudinal axis L. This allows the overall size (sometimes referred to as profile) of the double lumen tapered tip 100 to be minimized, thereby increasing the range of anatomical applications and reducing trauma to the vessel during delivery.
With particular attention to fig. 1 and 3, to further reduce the overall size of the dual lumen tapered tip 100, the secondary guidewire lumen 128 may be an open channel as compared to a sealed lumen. By providing the secondary guidewire lumen 128 as an open channel, the material thickness necessary to enclose the secondary guidewire lumen 128 is avoided as compared to a sealed lumen. This allows the overall size of the double lumen conical tip 100 to be further reduced, further increasing the scope of anatomical applications and reducing trauma to the vessel during delivery.
According to this embodiment, the depth of the secondary guidewire lumen 128 varies. Accordingly, as shown in fig. 1 and 3, the width of the opening of the secondary guidewire lumen 128 varies with depth. However, in one embodiment, the depth and width of the secondary guidewire lumen 128 is constant and uniform.
In one embodiment, the diameter of the second guidewire 506 is 0.035", for example, see width W4 in fig. 6. However, in other embodiments, the diameter of the second guidewire 506 is reduced to less than 0.035", such as 0.018" or 0.014". By reducing the diameter of the second guidewire 506, the depth of the secondary guidewire lumen 128 can be reduced, thereby reducing the profile of the dual lumen tapered tip 100.
While both an offset main guidewire lumen 126 and an open channel secondary guidewire lumen 128 are discussed above, in one embodiment, the dual lumen tapered tip 100 includes either the offset main guidewire lumen 126 or the open channel secondary guidewire lumen 128, but not both. In yet another embodiment, the dual lumen tapered tip 100 includes an axially aligned primary guidewire lumen 126 and an initially sealed secondary guidewire lumen 128.
Fig. 6 is a cross-sectional view of the delivery system 500 of fig. 5 taken along line VI-VI according to one embodiment. Referring now to fig. 5 and 6 together, the common guidewire lumen 130 is an open channel according to this embodiment. The width W1 of the opening 602 of the common guidewire lumen 130 is less than the width W2 of the body 604 of the common guidewire lumen 130. The common guidewire lumen 130 is sometimes referred to as an undercut groove because the cross-sectional width of the common guidewire lumen 130 increases from the width W1 of the opening 602 to the width W2 of the body 604. In other words, according to this embodiment, the common guidewire lumen 130 is a circular groove.
In the initial deployment configuration as shown in fig. 5 and 6, the second guidewire 506 and guide tube 508 are located within the secondary guidewire lumen 128 and the common guidewire lumen 130. The second guidewire 506 is positioned within a guide tube 508 (sometimes referred to as a PEEK lumen). The guide tube 508 has a width W3 (sometimes referred to as an outer diameter) that is approximately equal to the width W2 of the body 604 of the common guidewire lumen 130 and greater than the width W1 of the opening 602. Thus, the guide tube 508 cannot pass through the opening 602 and is constrained within the common guidewire lumen 130.
Thus, when the guide tube 508 is positioned within the common guidewire lumen 130, the second guidewire 506 is also constrained within the common guidewire lumen 130. However, the second guidewire 506 has a width W4 (sometimes referred to as an outer diameter) that is less than the width W1 of the opening 602. Thus, as the guide tube 508 is retracted from the common guidewire lumen 130, the second guidewire 506 is released and can pass through the opening 602 and out of the common guidewire lumen 130.
Although the use of the guide tube 508 to control selective release of the second guidewire 506 is shown and discussed, in other embodiments, other mechanisms are used to control selective release of the second guidewire 506 from the common guidewire lumen 130. For example, a wire 606 (sometimes referred to as a trigger wire) may be looped over the opening 602 of the common guidewire lumen 130. The wire 606 may be retracted, releasing the opening 602 of the common guidewire lumen 130 and releasing the second guidewire 506. Although both the wire 606 and the guide tube 508 are shown in fig. 6 and may be used together in embodiments, either the wire 606 or the guide tube 508 is typically present, but not both.
Fig. 7 is a cross-sectional view of a vascular assembly 700 during deployment of a main vascular stent graft 701 of the delivery system 500 of fig. 5-6 according to one embodiment. Referring together to fig. 5-7, the thoracic aorta 702 has a number of arterial branches. The arch of the aorta 702 has three main branches extending therefrom, all of which generally originate from the convex upper surface of the arch. The brachiocephalic artery BCA originates from the anterior tracheal. The brachiocephalic artery BCA is divided into two branches, the right subclavian artery RSA (supplying blood to the right arm) and the right common carotid artery RCC (supplying blood to the right side of the head and neck). The left common carotid LCC artery originates from the arch of the aorta 702 to the left of the point of origin of the brachiocephalic artery BCA. The left common carotid LCC supplies blood to the left side of the head and neck. The third branch, the left subclavian LSA, which originates from the aortic arch originates after and to the left of the left common carotid LCC and supplies blood to the left arm.
However, a large percentage of people have only two large branch vessels from the aortic arch, while others have four large branch vessels from the aortic arch. Thus, while a particular anatomical geometry of the aortic arch is shown and discussed, those skilled in the art will appreciate in light of this disclosure that the geometry of the aortic arch has anatomical variations and that various structures as disclosed herein will be modified accordingly.
Aneurysms, dissection, penetrating ulcers, intramural hematomas, and/or transection, an affected area commonly referred to as the aorta 702, can occur in the aortic arch and peripheral arteries BCA, LCC, LSA. For example, a thoracic aortic aneurysm includes an aneurysm present in the ascending thoracic aorta, the aortic arch, and one or more branch arteries BCA, LCC, LSA emanating therefrom. Thoracic aortic aneurysms also include aneurysms present in the descending thoracic aorta and branch arteries emanating therefrom. Thus, the aorta 702 as shown in fig. 7 may have a lesion region similar to any of the regions discussed above, which will be bypassed and excluded as discussed below.
Initially, a second guidewire 506 is introduced via the femoral portal. In a particular embodiment, the second guidewire 506 is inserted into the femoral artery and is directed up through the abdominal aorta into the thoracic aorta. The second guidewire 506 is captured or otherwise moved into the left subclavian LSA, e.g., the physician has cannulated the left subclavian LSA.
The delivery system 500 is introduced via the femoral portal and advanced (sometimes referred to as being tracked) over the second guidewire 506 into the aorta 702. The delivery system 500 is positioned at a desired location proximate to the left subclavian artery LSA.
During advancement of the delivery system 500 over the second guidewire 506, the first guidewire 504 is blocked by the second guidewire 506 and prevented from advancing out of the delivery system 500, as described above. Alternatively, the first guidewire 504 may not be inserted into the delivery system during this tracking phase, but may be inserted later (or just before) when the second guidewire 506 exits the tapered tip. In one embodiment, the second guidewire 506 is less stiff than the first guidewire 504, thus simplifying placement of the second guidewire 506 and advancement of the delivery system 500.
Fig. 8 is a cross-sectional view of the delivery system 500 of fig. 5-6 at a later stage of deployment of the main vessel stent graft 701 according to one embodiment. Referring now to fig. 5-8 together, upon reaching the parking zone near the left subclavian artery LSA, the second guidewire 506 is swapped with the first guidewire 504. More specifically, the guide tube 508 is retracted, releasing the second guidewire 506 from the common guidewire lumen 130 and the secondary guidewire lumen 128 as shown in fig. 8, and allowing the physician to orient the second guidewire 506 toward the left subclavian artery LSA, the second guidewire 506 having been extended through the left airway LSA. This releases the common guidewire lumen 130 to allow the first guidewire 504 to travel therein, as shown in fig. 9. In other words, the second guidewire 506 is withdrawn from the guide tube 508 and released from the common guidewire lumen 130, allowing the first guidewire 504 to be advanced.
As described above, the delivery system 500 is first advanced over the second guidewire 506 to approximate the left subclavian artery LSA. By advancing the delivery system 500 over a single guidewire (i.e., the second guidewire 506), any potential for multiple guidewires to become entangled during advancement of the delivery system 500 is eliminated as compared to advancing the delivery system 500 over two or more guidewires. In other words, by avoiding tangling of the plurality of guide wires, unraveling the wires, including manipulating the delivery system 500 by applying torque to the delivery system 500 and axially moving the delivery system 500 back and forth, is avoided. This shortens the surgical time, reduces radiation exposure, and reduces the risk of embolism for the patient. Reducing wire wrap in the arch may be particularly important because any procedure to address wire wrap may increase the risk of stroke. In addition, the second guidewire 506 is more flexible than the first guidewire 504, thus simplifying the procedure.
Fig. 9 is a cross-sectional view of the delivery system 500 of fig. 8 at a later stage of deployment of the main vessel stent graft 701 according to one embodiment. Referring now to fig. 9, a first guidewire 504 is advanced through the common guidewire lumen 130 and extends distally from the common guidewire lumen 130. The first guidewire 504 is advanced into the aortic arch. The release of the first guidewire 504 from the common guidewire lumen 130 is prevented by the molded feature 127 between the primary guidewire lumen 126 and the secondary guidewire lumen 128, as shown in fig. 9.
In another embodiment, the width W5 of the first guidewire 504 is greater than the width W1 of the opening 602 and less than or approximately equal to the width W2 of the body 604 of the common guidewire lumen 130. The width W5 is shown in fig. 9, and the width W1 of the opening 602 and the width W2 of the body 604 are shown in fig. 6. Thus, when the first guidewire 504 is positioned within the common guidewire lumen 130, the first guidewire 504 is constrained within the common guidewire lumen 130. For example, when the second guidewire 506 has a width W4 that is less than the width W5 of the first guidewire 504, the second guidewire 506 may be disengaged from the common guidewire lumen 130 while preventing the first guidewire 504 from being disengaged from the common guidewire lumen 130 even without the molded features 127. In this embodiment, the interference fit between the first guidewire 504 and the common guidewire lumen 130 ensures that the first guidewire 504 exits the distal guidewire lumen port 106 and is not pulled and released through the opening 602. For example, the first guidewire 504 has a width W5 of 0.035", and the second guidewire 506 has a width W4 that is less than the width W5, such as less than 0.035", such as 0.018 "or 0.014".
Fig. 10 is a cross-sectional view of the vascular assembly 700 of fig. 7 at a later stage during deployment of the main vascular stent-graft 701, according to one embodiment. Once the first guidewire 504 is placed into the aortic arch as shown in fig. 10 and discussed above with respect to fig. 9, the delivery system 500 is advanced over the guidewires 504, 506 and rotationally aligned to be in the deployed position. The delivery system 500 travels a minimum distance to minimize and substantially eliminate any possibility of tangling of the guide wires 504, 506.
Fig. 11 is a cross-sectional view of the vascular assembly 700 of fig. 10 at a later stage of deployment of a main vascular stent-graft 701, according to one embodiment. Referring now to fig. 10 and 11 together, once the delivery system 500 is in the deployed position, the sheath 502 is retracted and the main vascular stent graft 701 with the mobile external coupling 1102 (MEC 1102) is deployed. Although a mobile external coupling is shown, stent graft 701 alternatively has a standard coupling or fenestration (e.g., opening). The second guidewire 506 extends through the mobile outer coupler 1102 and into the left subclavian artery LSA, thereby ensuring rotational alignment of the mobile outer coupler 1102 with the left subclavian artery LSA. A main vessel stent graft with a mobile external coupling is described in U.S. patent No. 9,839,542 to Bruszewski et al, issued 12.12.2017, which is incorporated herein by reference in its entirety, including a deployment similar to main vessel stent graft 701 and mobile external coupling 1102.
Fig. 12 is a cross-sectional view of the vascular assembly 700 of fig. 11 at a later stage in the deployment of the branched stent graft 1112, according to one embodiment. Referring now to fig. 11 and 12 together, a delivery system 1110 including a branched stent graft 1112 is advanced over the second guidewire 506 through the mobile external coupling 1102 and into the left subclavian artery LSA. A branched stent graft 1112 is deployed into the mobile external coupling 1102 and branches it into the left subclavian artery LSA, as shown in fig. 12. Although the delivery system 1110 is shown as being introduced via a femoral portal, it is alternatively introduced via an on-aortic portal (e.g., with corresponding adjustments to the loading of the stent graft 1112).
Although the aorta 702 as the main vessel and the left subclavian artery LSA as the branch vessel are discussed above, in other embodiments, the double lumen tapered tip 100 is used to deploy a main vessel stent graft in other main vessels and associated branch vessels in a similar manner. For example, for iliac branch treatment delivery, the second guidewire 506 is used to facilitate cannulation of the internal iliac artery.
Further, while the dual lumen tapered tip 100 is discussed as being used with two guidewires 504, 506, in other embodiments, a similar tapered tip is used to selectively advance three or more guidewires. Generally, the tapered tip 100 is sometimes referred to as a multi-lumen tapered tip and has two or more lumens therein. In such embodiments, multiple guide wires may be in a retracted position during initial tracking, similar to the first guide wire 504, such that tracking may still occur on a single wire to avoid wire entanglement. There may also be a plurality of secondary lumens (e.g., grooved lumens) configured to allow the wire to be released to orient toward the branch vessel ostium at a later stage of deployment. For example, similar to fig. 7, the third wire may be retracted during initial tracking and then extended outwardly once toward the brachiocephalic artery BCA or left common carotid artery LCC at the desired location. The third wire may then be advanced into the branch artery via manual manipulation or may be captured.
It should be understood that the various aspects disclosed herein may be combined in different combinations than specifically presented in the specification and drawings. It should also be appreciated that, depending on the example, certain acts or events of any of the processes or methods described herein can be performed in a different order, may be added, combined, or omitted entirely (e.g., not all of the described acts or events may be required to perform the techniques). Additionally, although certain aspects of the present disclosure are described as being performed by a single module or unit for clarity, it should be understood that the techniques of the present disclosure may be performed by a unit or combination of modules associated with, for example, a medical device.

Claims (20)

1. An assembly, comprising:
a multi-lumen tapered tip, the multi-lumen tapered tip comprising:
a main guidewire lumen;
a secondary guidewire lumen;
sharing a guidewire lumen; and
a first and second guidewire junctions located at intersections of the primary guidewire lumen, the secondary guidewire lumen, and the common guidewire lumen.
2. The assembly of claim 1, wherein the multi-lumen tapered tip further comprises:
a distal guidewire lumen port, the common guidewire lumen extending between the distal guidewire lumen port and the first and second guidewire junctions.
3. The assembly of claim 1, wherein the multi-lumen tapered tip further comprises:
a proximal guidewire lumen port, the guidewire lumen extending between the proximal guidewire lumen port and the first and second guidewire junctions.
4. The assembly of claim 1, wherein the multi-lumen tapered tip further comprises:
a proximal secondary guidewire lumen port, the secondary guidewire lumen extending between the proximal secondary guidewire lumen port and the first and second guidewire junctions.
5. The assembly of claim 4, wherein the secondary guidewire lumen is bent inward to the first and second guidewire junctions.
6. The assembly of claim 1, wherein the main guidewire lumen and the common guidewire lumen are linear.
7. The assembly of claim 1, wherein the main guidewire lumen is offset from a central longitudinal axis of the multi-lumen tapered tip.
8. The assembly of claim 1, wherein the common guidewire lumen comprises an open groove.
9. The assembly of claim 1, wherein the secondary guidewire lumen comprises an open groove.
10. An assembly, comprising:
a multi-lumen tapered tip, the multi-lumen tapered tip comprising:
a main guidewire lumen;
a first guidewire within the main guidewire lumen;
sharing a guidewire lumen; and
a second guidewire within the common guidewire lumen, the second guidewire preventing the first guidewire from entering the common guidewire lumen.
11. The assembly of claim 10, further comprising a guide tube within the common guidewire lumen, the second guidewire being located within the guide tube.
12. The assembly of claim 11, wherein the common guidewire lumen comprises a groove comprising an opening having a width.
13. The assembly of claim 12, wherein the width of the opening is less than a width of the guide tube and greater than a width of the second guidewire.
14. The assembly of claim 10, further comprising a secondary guidewire lumen within which the second guidewire is located.
15. The assembly of claim 14, further comprising a first second guidewire junction at an intersection of the primary guidewire lumen, the secondary guidewire lumen, and the common guidewire lumen.
16. A method, comprising:
positioning a first guidewire within a main guidewire lumen of a multi-lumen tapered tip; and
a second guidewire is positioned within the secondary guidewire lumen and the common guidewire lumen of the multi-lumen tapered tip, the second guidewire preventing the first guidewire from entering the common guidewire lumen.
17. The method of claim 16, further comprising:
advancing a delivery system comprising the multi-lumen tapered tip over the second guidewire; and
releasing the second guidewire from the common guidewire lumen.
18. The method of claim 17, further comprising:
advancing the first guidewire through and out of the common guidewire lumen; and
advancing the delivery system over the first guidewire to a deployment location.
19. The method of claim 18, further comprising deploying a main vessel stent graft from the delivery system, wherein the second guidewire extends through a coupling or fenestration of the main vessel stent graft.
20. The method of claim 19, further comprising:
advancing a delivery system comprising a branched stent graft over the second guidewire and into the coupling or fenestration; and
deploying the branched stent graft within the coupling or fenestration.
CN202310838814.1A 2022-07-12 2023-07-10 Dual guidewire delivery systems and methods Pending CN117379667A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US63/388,444 2022-07-12
US18/216,411 2023-06-29
US18/216,411 US20240016632A1 (en) 2022-07-12 2023-06-29 Mutli-lumen tapered tip

Publications (1)

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CN117379667A true CN117379667A (en) 2024-01-12

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CN (1) CN117379667A (en)

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