The present invention relates to devices and methods for accessing and/or controlling vascular access puncture sites. More particularly, the present invention relates to devices and methods for sealing, accessing, and/or controlling entry through vascular puncture sites via self-adjusting entry devices.
The increasing success of interventional techniques to access and repair structural disorders of the heart and vascular system has led to increasing demand for such procedures. Methods to deploy either intra-vascular stents or valve repair devices generally utilize the insertion of catheters through arteries and veins in the upper or lower extremities. As the technology and the ability to treat a wider-range of medical conditions evolve, the devices delivered have increased in size. Accordingly, closure of larger sized holes left by larger diameter catheters may be problematic for a patient.
A common cause of patient morbidity for interventional techniques is vascular access site complications, such as hematomas, pseudoaneurysms, and retroperitoneal bleeding. Such complications are likely to increase in frequency and severity with anti-coagulation and the use of larger diameter catheters used to deliver the endovascular devices. These complications may lead to prolonged hospital stay, increased costs, and the possible need for transfusion or surgery. Additionally, complications may lead to patient dissatisfaction and discomfort.
Manual compression of a vascular access site is typically utilized to achieve hemostasis of the opening when the size of the catheter sheath used is 6 F or less. But endovascular treatment of larger aneurysms and valvular diseases in an anti-coagulated patient generally require catheter sheaths in the range of 18-24 F. Although a cut-down can be performed by a vascular surgeon to directly close the access site in the artery or vein, alternative and less invasive methods are desirable. Furthermore, dilation of the artery or vein by the increasing diameter catheters can lead to damage and tearing of the vessel wall, making them less amenable to direct closure.
Conventional methods and devices used to close vessel puncture sites or ports, typically in the 6-8 F range, generally fall into the following categories: direct pressure, sealant-based devices, suture-based devices, staple-based devices, and direct closure by cut-down and vascular suture. However, each of these methods and devices has their limitations. For instance, most of these methods and devices have failure rates of up to 30% when utilized on relatively large diameter holes, e.g., 18 F or greater. Moreover, suture or staple-mediated devices also have the disadvantage of potentially narrowing the artery caliber and thus are contraindicated for use in relatively small vessels, e.g., 5 mm or less.
Additionally, procedures requiring repeated access to vessels may require the creation or multiple access sites is closure by many conventional devices and methods fail to allow for repeated access through the same site.
Accordingly, there is a need for methods and devices which allow for the controlled access by any number of various sized devices to any number of various diameter vessels while maintaining hemostasis as well as for allowing repeated access to a vessel through a single access site as necessary or desirable.
Access and/or closure ports and methods of use for controlling access to vascular bodies may allow for a single access port which is adhered, connected, or otherwise attached to the wall of a hollow body lumen, e.g., vessels (arteries, veins, etc.), organs (bladder, stomach, etc.), etc., and allows for, but is not limited to, control of small to large sized vascular defects, use with anticoagulation agents, rapid sheath removal, early ambulation of the patient, access through the same port, maintaining a size of the vessel lumen after repair, etc. Moreover, such an access and/or closure port may allow a user to access and/or re-access the same hollow body lumen, such as an artery and/or vein, of patients utilizing various diameter catheters and instruments. Although examples of use of the device may be described herein in relation to vessels, it is to be understood that the devices and methods may also be utilized with other hollow body lumens such as the bladder, stomach, etc.
When an instrument or catheter is inserted through the flaps of such an access port, the flaps may be pushed inwardly into the vessel lumen to provide a channel for passage of the instrument or catheter sheath while the access port shields the vessel wall from damage. The outer periphery of the access port may remain intact and the flaps may allow the insertion of various sized catheter sheaths. Removal of the instrument or catheter may allow for the return of the patch flaps to a neutral position. The access port would allow re-access of the vessel, it necessary, even in the anti-coagulated patient.
Generally, the vascular closure device may comprise a first frame and a second frame having an access port secured between the respective frames, e.g. via adhesive, welding, etc. Each respective frame may be configured to include a support member which may be shaped in a variety of configurations, e.g., circular, elliptical, rectangular, triangular, etc. so long as an access opening is defined by the support member. A number of retaining members may extend radially from the respective support member and each retaining member may be configured so as to have an atraumatic form or shape to prevent injury to the surrounding, tissues.
Each retaining member may itself form a closed-loop structure to define an opening therethrough. Each support member may be integral with the retaining members to form a unitary structure although separate retaining members may also be connected or coupled to each respective support member in other variations. In either case, the frames may be fabricated from a variety of biocompatible materials, e.g., stainless steel, shape memory, alloys such as Nitinol, polymeric materials, etc. The access port may be secured between the frame members such that the access port forms the valved or flapped entry. The access port may be made from any variety of flexible biocompatible materials such as ePTFE, other fluoropolymers, polymers, polymeric blends thereof, elastomers, etc.
The frames may also be made from a bioabsorbable material such that they degrade or become absorbed into the patient body over a period of time. In such a variation, the device may be utilized to appose the edges of the tissue opening against one another such that healing of the tissue and closure of the opening is achieved with the eventual degradation and/or absorption of the device.
Alternatively, rather than having a port which is accessible or re-accessible therethrough, the port may be closed or sealed entirely in which case the closed-loop structure forms an integral device which is solid rather than defining an opening. The area defined by the frame may be comprised of the same material and/or integral with the frame or it may utilize any one of the materials to cover the area to provide for a complete integral seal. In this example, the device may be utilized to completely seal the opening to the hollow body lumen, e.g., after completion of a procedure, rather than providing for an entry or re-entry pathway in the body lumen. Accordingly, the device may be utilized for various purposes, e.g., access to a body lumen, closure or sealing of an opening to the body lumen, and/or re-access to a body lumen after placement of the device along the body lumen, or any combination thereof.
The adjoining frames may be secured to one another directly via welding or vial other securement mechanisms such as clips, screws, adhesives, etc. to compress or secure the periphery of the access port between the support member. Additionally, the retaining members from each respective frame may be positioned such that they define an alternating pattern. Alternatively, the retaining members may be aligned with respect to one another.
When deployed, the vascular access or entry device may have its radially extending retaining members retracted in a low-profile delivery configuration such that they extend radially when free from the constraints of the delivery instrument to compress or “sandwich” the tissue therebetween which surrounds the tissue opening to securely position the device along the vessel % all. To accommodate any curvature of the vessel wall, the frames may be configured to be suitably pliable to conform to any curved tissue when extended. Alternatively, the frames may be preformed to have a range of curvatures over a plane of the device such that the device may form a curved access or entry port which conforms to the natural curvature of the vessel.
Vascular access and/or sealing control devices and methods of use may allow for a single access port which is adhered, connected, or otherwise attached to the wall of a hollow body lumen. e.g., vessels (arteries, veins, etc.), organs (bladder, stomach, etc.), etc., and allows for, but is not limited to, control of small to large sized openings such as vascular defects (e.g., large sized vascular defects or openings may range anywhere from 12 F to 24 F or greater), use with anticoagulation agents, rapid sheath removal, early ambulation of the patient, access through the same port, maintaining a size of the vessel lumen after repair, etc. Although examples of use of the device may be described herein in relation to vessels, it is to be understood that the devices and methods may also be utilized with other hollow body lumens such as the bladder, stomach, etc.
Moreover, such an access port may allow a user to access and/or re-access the same artery and/or vein of patients utilizing various diameter catheters and instruments. For instance, patients who may require long-term indwelling catheters or those who require repeated intravascular access, e.g., hemodialysis patients, may benefit. Thus, after a procedure utilizing the access port, the tissue region surrounding the access port may be closed upon the port and left implanted in the patient as the access port provides hemostasis of the vessel. If re-entry or further access is desired to the vessel for any further procedures, the access port may again be entered through the tissue region for the re-entry or re-introduction of one or more instruments or catheters through the same port without having to create ally additional entry paths into the vessel lumen. The re-entry or further access through the access port may be obtained intra-procedurally or post-procedurally spanning anywhere from hours, days, weeks, months, or even years from an initial procedure. Moreover, the access port may be left implanted within the patient permanently, if so desired, to provide this re-entry path into the vessel for future use or it may be optionally removed at any time and the opening through the vessel may be closed surgically.
Examples of such devices are described in greater detail in U.S. Pat. App. 11/864,446 filed Sep. 28, 2007, which is incorporated herein by reference in its entirety. Generally, a vessel entry assembly may allow a user to create a controlled vascular opening by maintaining a vascular puncture while protecting the vessel during insertion and/or withdrawal of relatively large diameter sheaths, catheters, or instruments. A vascular access or entry assembly may be deployed within or against the vessel wall where the access port may allow for the automatic closure and sealing of a vascular opening to maintain hemostasis when instruments or catheters are withdrawn from the device.
Turning now to
Each retaining member 24, 24′ may itself form a closed-loop structure to define an opening 26, 26′ therethrough. The variation illustrated shows retaining members 24, 24′ defining an arcuate portion along its contour although other shapes and contours may be utilized so long as the shape presents an atraumatic surface to the contacted tissue. Each support member 20, 20′ may be integral with retaining members 24, 24′ to form a unitary structure although separate retaining members 24, 24′ may also be connected or coupled to each respective support member 20, 20′ in other variations. In either case, frames 12, 14 may be fabricated from a variety of biocompatible materials, e.g., stainless steel, shape memory alloys such as Nitinol, polymeric materials, etc.
The frames 12, 14 may also be made from a bioabsorbable material such that they degrade or become absorbed into the patient body over a period of time. In such a variation, the device may be utilized to appose the edges of the tissue opening against one another such that healing of the tissue and closure of the opening is achieved with the eventual degradation and/or absorption of the device.
Alternatively, rather than having a port which is accessible or re-accessible therethrough, the port may be closed or sealed entirely in which case the closed-loop structure forms an integral device which is solid rather than defining an opening. The area defined by the frame may be comprised of the same material and/or integral with the frame or it may utilize any one of the materials to cover the area to provide for a complete integral seal. In this example, the device may be utilized to completely seal the opening to the hollow body lumen, e.g., after completion of a procedure, rather than providing for an entry or re-entry pathway in the body lumen. Accordingly, the device may be utilized for various purposes, e.g., access to a body lumen, closure or sealing of an opening to the body lumen, and/or re-access to a body lumen after placement of the device along the body lumen, or any combination thereof.
Access port 16 may be secured between the frame members 12, 14 such that access port 16 forms the valved or flapped entry over access openings 22, 22′. Moreover, access port 16 may define one or more partitions or seams 18, e.g., one partition or two transversely defined relative to one another as shown, over access port 16 to form the valved or flapped opening through which one or more instruments may be, inserted through. Access port 1.6 may be made from any variety of flexible biocompatible materials such as ePTFE, other fluoropolymers, polymers, polymeric blends thereof, elastomers, etc. and access port 16 may also optionally incorporate expandable biomaterials along the seams 18 to allow for swelling and expansion and sealing of the seams 18 when placed in contact with blood or when temperature is increased. Additionally in other alternatives, access port 16 and/or frames 12, 14 may also incorporate drug-eluting agents to facilitate the healing of the acute wound site. Once vascular entry device 10 has been desirably placed within or along the vessel and one or more procedures through access port 1.6 has been accomplished, access port 16 may be simply left or partitions 18 may be securely tightened, e.g., via adhesives or sutures.
The perspective view of
When deployed, vascular access or entry device 10 may have its radially extending retaining members 24, 24′ retracted in a low-profile delivery configuration, as illustrated in the perspective exploded & assembly views of
In deploying and placing the vascular entry device, the targeted vessel V along which the device is to be placed may be pierced via needle 30 to create an initial vessel opening 36, as illustrated in the partial cross-sectional perspective view of
In other variations, access to the targeted vessel V may be obtained by cutting down through the surrounding skin and accessing the vessel. An opening may then be cut directly along the vessel wall to form the initial entry into the vessel lumen VL. In yet another alternative, after dilation of the opening or in place of an initial dilation, a tissue punch instrument may be inserted into the initial opening and used to remove tissue surrounding the initial opening to create a larger diameter opening for access into the vessel lumen VL.
With the tissue opening 44 dilated or otherwise widened, the dilating instrument 38 (if used) may be removed from guidewire 34 and a separate delivery instrument 50 may be advanced along guidewire 34 and inserted at least partially into tissue opening 44, as illustrated in the perspective view of
With second frame 14 positioned distally of first frame 12 within instrument lumen 56 and with the distal opening of delivery instrument 50 inserted at least partially into tissue opening 44, plunger 52 may be pushed distally via plunger shaft 54 to abut against first frame 12 such that device 10 is urged distally through instrument lumen 56. Device 1.0 may be urged distally until the constrained retaining members 24′ of second frame 14 are free to extend radially within the vessel lumen VL and into contact against the inner surface of the vessel V, as shown in
To accommodate any curvature of the vessel wall, the frames 12, 14 may be configured to be suitably pliable to conform to any curved tissue when extended. Alternatively, frames 12, 14 may be preformed to have a range of curvatures over a plane of the device 10 such that when retaining members 24, 24′ and support members 20, 20′ are freed from the constraints of delivery instrument 50, device 10 may form a curved access or entry port which conforms to the natural curvature of the vessel V, as illustrated in
With the retaining members 24, 24′ secured against or along the vessel outer and inner surfaces OS, IS, guidewire 34 may be withdrawn from vessel lumen VL and from access port 16 to allow the valve or flaps of access port 16 to fully close and maintain hemostasis such that blood or fluids are prevented from leaking through the seams 18 of access port 16, as illustrated in the top view of
The radial retaining members 66 may each define an opening 68 such that the retaining members 66 have a width of about, e.g., 0.010 in., and although five members are illustrated, fewer than five or more than five members may be utilized. If the five retaining members 66 are used, they may be uniformly positioned circumferentially around support member 62 at an angle of, e.g., 72′ relative to adjacent retaining members 66. Alternatively, retaining members 66 may be positioned along support member 62 at non-uniform angles for placement, for instance, along narrow vessels. These values relating to thickness, width, etc. for device 10 are merely intended to be illustrative and are given as examples of size considerations and are not intended to be limiting in any way of the scope of this disclosure.
In yet another variation of the device of
In another variation of the vascular access device, another configuration for the frame is illustrated in the top and perspective views of
In yet another alternative, the valve support members may be formed on a single frame e.g., support member 62, to form the port. Thus, when the frame members are overlaid atop one another, the set of frame members on a single frame may form the port rather than having overlapped valves alone, adjacent frames.
In yet another variation,
The applications of the devices and methods discussed above are not limited to controlling, access to vessel lumens but may include other body lumens. Modification of the above-described assemblies and methods for carrying out the invention, combinations between different variations as practicable, and variations of aspects of the invention that are obvious to those of skill in the art are intended to be within the scope of the claims.