Patent Grant
10786346
Field of the Invention
This invention relates to medical devices for use in surgical procedures. More specifically, the present invention is related to medical devices that can be used for blood vessel anastomosis procedures.
Background of the Related Art
In the United States alone, approximately 400,000 people have end-stage renal disease requiring chronic hemodialysis. Hemodialysis replaces kidney function by removing toxins from the blood that are normally removed by healthy kidneys. In order to effectively remove toxins, blood must be passed at a high blood flow rate through a hemodialysis machine. This high blood flow is best achieved by the creation of a permanent vascular access site that includes an arteriovenous (AV) anastomosis in which a vein is attached to an artery to form a high-flow shunt or fistula.
Typically, a vein may be directly attached to an artery, but it can take up to twelve weeks before the fistula has sufficiently matured (time between placement and cannulation for dialysis) to provide adequate blood flow for use with hemodialysis. Moreover, a direct anastomosis may not be feasible in all patients due to anatomical considerations. Other patients may require the use of artificial graft material to provide an access site between the arterial and venous vascular systems. Because of the length of time required for a fistula to mature a patient needing dialysis will typically require a temporary access device, such as a Quinton catheter, to be inserted for hemodialysis access until the fistula has matured. The use of a temporary catheter access exposes the patient to additional risk of bleeding and infection, as well as discomfort, and is associated with a 91% higher mortality rate compared to fistulas. In trying to increase the prevalence of fistulas in the U.S., a proportional rise in catheter use has been documented.
Another method of using an anastomotic connector is in a coronary bypass procedure to form an end-to-side anastomosis of a saphenous vein to a coronary artery.
What is needed is an improved anastomosis device that addresses the foregoing problems.
The present invention solves the foregoing problems and can find one non-limiting use in performing cardiac artery bypass grafts. In another non-limiting use the present invention can be used for procedures in which short-term and long-term vascular access is required. Another non-limiting use of the present invention is to provide an improved anastomotic connector for performing bypass operations.
In one non-limiting use, the present invention provides a percutaneous connection to be created between an artery and vein of a kidney failure patient without the need for surgery; which allows immediate cannulation of the shunt without reliance on catheter use; and which allows for the maturation of the outflow veins for subsequent conversion to a fistula.
In one aspect of the invention, an arterial anchor device is provided. Arterial anchor device includes a generally tubular main body having a distal end and a proximal end and defining a lumen therewithin. Generally tubular main body comprises a metal frame structure including struts and connector portions. The distal end, which is received within a vessel wall, includes a plurality of petal-like flanges circumferentially disposed about the distal end and integrally formed with tubular main body. The flanges may be configured to bend at an angle equal to or less than 90 degrees towards the longitudinal axis of the tubular main body portion or bend at an angle greater than 90 degrees away from the longitudinal axis of tubular main body portion. The flanges are configured to spread from a first reduced configuration to a second expanded configuration to anchor the arterial anchor device against the inner wall of an arterial fluid passageway. The distal end of the tubular main body portion is semi-rigid and configured to bend at an angle of approximately 90 degrees from the longitudinal axis of the tubular main body and maintain the bend. The struts and connectors that form the distal end, therefore, include a variable cutting pattern such that the frame-like structure of struts and connectors at the distal end are closer together than the struts and connectors that form the main body. The proximal end of tubular main body may optionally include a plurality of finger-like tines integrally formed with tubular main body. Finger-like tines extend outwardly at an acute angle from the longitudinal axis of the main body lumen. Finger-like tines are configured to securedly fasten a graft member in place when operably coupled with the tubular main body.
In another aspect of the present invention, a venous anchor device is provided. The venous anchor device includes a generally tubular main body having a distal end and a proximal end and defines a lumen therewithin. Generally tubular main body comprises a metal frame structure. The distal end, which is received within a vessel wall, includes first and second portions. In one embodiment the first and second portions are non-coated. Alternatively, the first portion may be coated and the second portion may be non-coated or exposed. The outer diameter of the distal end is larger than the outer diameter of the tubular main body portion. A plurality of barbs are circumferentially disposed about the second end and integrally formed with tubular main body. The plurality of barbs are configured to seat the venous anchor device in the vessel wall to ensure it does not dislodge from the vessel and also to prevent the further expansion of the vein when the barbs contact the vessel wall. A portion of the tubular main body is coated with PTFE in the manner described herein to prevent leaking. The second portion of the distal end of the venous anchor device is non-coated to ensure that barbs are free to secure the venous anchor device to the venous wall.
In another aspect of the invention, an anastomotic connector is provided that includes an arterial anchor device, a venous anchor device; and a graft member. The arterial anchor device and venous anchor devices are as described hereinbefore. A graft portion comprising a generally tubular main body having a reinforced wall is structured to join the arterial and venous anchor devices within a patient's body. The tubular body including first and second ends thereof and defines a lumen therewithin. The outer diameter of the stented tubular main body of the arterial anchor device is greater than the inner diameter of the graft lumen thus providing an interference fit when in operable engagement. Optional finger-like tines on the proximal end of the arterial anchor device may also exert force against graft portion and prevent graft portion from being easily removed from the arterial connector. The second end of graft member is similarly connected to the venous anchor device, which is received within the lumen of the venous anchor device, which is configured to be placed within a second fluid passageway. The OD of the venous anchor device is greater than the ID of the graft resulting in a compression or friction fit when operably coupled. In position the arterial and venous anchor devices fluidly couple a first fluid passageway to a second fluid passageway to form an anastomotic connector.
In another aspect of the present invention, the arterial and venous anchor devices are coated with a PTFE coating to prevent leakage of blood or other fluids from the portion of the device that transports fluid from the first anchor device through the graft and to the second anchor device. The PTFE coating is applied by a process including forming a dispersion of polymeric nanofibers, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs. The arterial and venous anchor devices are positioned over a tubular polymeric structure. Nanofibers from the dispersion are electrospun onto the tubular frame of the device and then the devices are heated. The process for coating the arterial and venous anchor devices is disclosed in U.S. 20110031656 and 20010030885 which are hereby incorporated by reference in their entirety. Alternatively, the arterial and venous anchor devices are coated by extruding tubes of polytetrafluoroethylene (PTFE) on the inside of the device and one on the outside. The two layers that are formed are heated to meld together. Other polymers that may be useful in coating the present devices are fluorinatedethylenepropylene (FEP), perfluoroalkoxy (PFA), polyvinylidene fluoride (PVDF), tetrafluoroethylene, hexafluoropropylene, polyethylenes such as HDPE, MDPE and LDPE, polyethylene terepthalate polyester (PET), polyetheretherketone (PEEK) and similar polymers having low coefficients of friction.
In another aspect of the invention, an anastomotic connector is provided that includes an arterial anchor device, a venous anchor device; and a graft member as hereinbefore described.
In another aspect of the present invention, a method of delivering an arterial anchor device within an arterial fluid passageway is provided. The method includes providing an arterial anchor device, the arterial anchor device including a generally tubular main body having a distal end and a proximal end, said distal end integrally defining a plurality of petal-like flanges circumferentially disposed about the distal end of said tubular main body, said tubular main body and said flanges movable between a loaded configuration and a preset expanded configuration; optionally providing a seating device comprising a wire shaft and a balloon member adapted to be inflated and deflated, said wire shaft positioned within a lumen of said tubular main body and said balloon member extending past said flanges; providing a delivery device, said delivery device including an outer sheath having a lumen; compressibly loading said seating device and said arterial anchor device within the lumen of said outer sheath; deploying the delivery device through an access site into a fluid passageway of a vessel; retracting the outer sheath to expose said flanges, wherein upon retracting the outer sheath said flanges revert to the preset expanded configuration; optionally inflating said balloon member and causing said flanges to engage an inner surface of the fluid passageway by moving said wire shaft proximally to cause said balloon member to adjacently abut said flanges thereby seating the arterial anchor device in the fluid passageway; removing said delivery device and seating device from said vessel. The tubular main body may exit the delivery device in a straight configuration and subsequently be bent into place at an angle of approximately 90 degrees by the surgeon. Alternatively, the tubular main body may be preset to bend at an approximate 90 degree angle such that when it exits the delivery device it reverts to the pre-set configuration.
In another aspect of the present invention, a method of delivering a venous anchor device within a venous fluid passageway is provided. The method includes providing a venous anchor device, the venous anchor device having a generally tubular main body having a distal end and a proximal end, said distal end integrally defining a plurality of barbs configured to engage a vessel wall, said tubular main body and said barbs movable between a loaded configuration and a preset expanded configuration; providing a delivery device, said delivery device including an outer sheath having a lumen; compressibly loading said venous anchor device within the lumen of said outer sheath; deploying the delivery device through an access site into a venous fluid passageway of a vessel; retracting the outer sheath to expose the distal end of the venous anchor device, wherein upon retracting the outer sheath the barbs revert to the pre-set expanded position and seat the device against the venous vessel wall; removing said delivery device.
In another aspect of the invention, a method of forming an anastomotic connector between two vessels in a body of a patient is provided. The method providing an arterial anchor device, said arterial anchor device including an arterial anchor tubular main body having a distal end and a proximal end, said distal end integrally defining a plurality of flanges circumferentially disposed about the distal end of said tubular main body, said arterial anchor tubular main body and said plurality of flanges movable between a loaded configuration and preset expanded configuration; providing a delivery device, said delivery device including an outer sheath defining a lumen therewithin; compressibly loading said arterial anchor device within the lumen of said outer sheath; deploying the delivery device through an access site into a first fluid passageway of a vessel to a predetermined position; retracting the sheath to expose said flanges and said balloon member, wherein upon retracting the sheath said flanges revert to the preset expanded configuration, wherein said flanges engage the surface of a wall of said first fluid passageway; further retracting said outer sheath to cause said tubular main body to revert to the preset expanded configuration outside the vessel wall; bending said tubular main body at an angle of ninety degrees from the longitudinal axis of the device; withdrawing said delivery device from said vessel; operably connecting a first end of a length of graft material to the proximal end of said arterial anchor tubular main body; providing a venous anchor device, said venous anchor device including a venous anchor tubular main body having a distal end and a proximal end, said distal end integrally defining a plurality of barbs thereon, said tubular main body and said plurality of barbs movable between a loaded configuration and preset expanded configuration; compressibly loading said venous anchor device within the lumen of said outer sheath of said delivery device; deploying the delivery device through an access site into a second fluid passageway of a vessel to a predetermined position; retracting the sheath to expose the distal end of said venous vessel anchor and said barbs, wherein upon retracting the sheath said barbs and said distal end revert to the preset expanded configuration; further retracting said outer sheath to cause said venous anchor tubular main body to revert to the preset expanded configuration outside the vessel wall; withdrawing said delivery device from said second vessel; and forming said anastomotic connector by operably connecting a second end of said length of graft material to the proximal end of said venous tubular main body.
These and other features of the invention will now be described in detail with reference to the accompanying Figures.
The invention is generally directed to an anastomotic connector structured to attach a graft between an artery and a vein, a novel arterial anchor device for anchoring the anastomotic connector to the artery and a novel venous anchor device for anchoring the anastomotic connector to the vein. The anastomotic connector in accordance with the invention may be placed percutaneously or subcutaneously and may be fabricated from any biocompatible material suitable for implantation into the human body. Further, the anchor devices preferably have a low cost and are readily replaceable. As will be appreciated by those of ordinary skill in the art based upon the following disclosure, the anastomotic connector of the invention may replace the use of catheters in those patients on hemodialysis who are permanently consigned to catheter use due to their inability (anatomically or otherwise) to sustain long-term fistula or graft options.
Numerous structural variations of an anastomotic connector device and arterial anchor devices are contemplated and within the intended scope of the invention. For purposes of discussion and not limitation, an exemplary embodiment will be described in detail below. As those of ordinary skill in the art will appreciate, although the anastomotic connector will be described with reference to placement within a vessel, it should be understood that the anastomotic connectors may be placed within various other fluid passageways without departing from the intended scope of the invention.
As best seen in
As illustrated in
As best seen in
For purposes of this disclosure, however, flanges 22 configured at an acute angle 21 offset from the longitudinal axis of main body 12 will be discussed. Tubular main body 12 comprises a metal frame structure that includes integrally formed struts 27 and connectors 26. Referring to
As further illustrated in the exemplary embodiment of
The central portion 25 also includes a plurality of rows 110-115 of openly-formed sinusoidal-shaped struts. The first row of struts 110 is connected at the curved portion 105 of the strut to the curved portion 106 of the last row of struts in the distal end. Each row of central portion struts 110-115 is connected to the subsequent row by two connecting members 126 that extend from a mid-portion of the strut to the curved portion of the strut in the subsequent row. Central portion 25 is approximately 28 mm.
The elongated proximal end includes a strut formation of two rows 201, 202. Each row includes a plurality of sinusoidal-shaped struts 227 with the second section 202 including double sinusoidal-shaped struts 228. First row 201 is connected by a plurality of connecting members 226 to the central portion 25. First row 201 is connected at the curved portion to the second double row 228.
Those of skill in the art will appreciate that the number of rows utilized in the anchor device can vary depending on the length of the anchor device desired.
The arterial anchor device in accordance with the invention is expandable from a first retained configuration to a second expanded configuration as seen in
Plurality of flanges 22 are structured to move between a loaded position (inside a delivery sheath, not shown) prior to deployment and an expanded in situ position as illustrated in
Alternatively, the arterial and venous anchor devices may be coated by extruding tubes of polytetrafluoroethylene (PTFE) on the inside of the device and one on the outside. The two layers that are formed are heated to meld together. Other polymers that may be useful in coating the present devices are fluorinatedethylenepropylene (FEP), perfluoroalkoxy (PFA), polyvinylidene fluoride (PVDF), tetrafluoroethylene, hexafluoropropylene, polyethylenes such as HDPE, MDPE and LDPE, polyethylene terepthalate polyester (PET), polyetheretherketone (PEEK) and similar polymers having low coefficients of friction.
Arterial anchor device 10 may be either self-expanding, such as so-called shape-memory materials, or non self-expanding, such as stainless steel. One benefit of using a self-expanding material is that plurality of flanges 22 will expand when deployed within a vessel without the need for a separate expansion device, thus eliminating additional equipment and steps during the deployment process.
As best seen in
One class of materials which meet these qualifications is so-called shape memory alloys. Such alloys tend to have a temperature induced phase change which will cause the material to have a preferred configuration which can be fixed by heating the material above a certain transition temperature to induce a change in the phase of the material. When the alloy is cooled back down, the alloy will “remember” the shape it was in during the heat treatment and will tend to assume that configuration unless constrained from so doing.
One particularly preferred shape memory alloy for use in the present method is Nitinol, an approximately stoichiometric alloy of nickel and titanium, which may also include other minor amounts of other metals to achieve desired properties. NiTi alloys such as nitinol, including appropriate compositions and handling requirements, are well known in the art and such alloys need not be discussed in detail here.
Such NiTi alloys are preferred, at least in part, because they are commercially available, have a high yield strain and more is known about handling such alloys than other known shape memory alloys. NiTi alloys are also very elastic—they are said to be “superelastic” or “pseudoelastic.” This elasticity will help a device of the invention return to a present expanded configuration for deployment into a blood vessel. However, any suitable self-expanding material may be used as will be appreciated by those of ordinary skill in the art.
As hereinafter described, prior to implantation the arterial anchor device 10 is collapsed inside a delivery device or sheath. Upon introduction into a vessel, the distal end of the anchoring structure freely self-expands to its original dimensions. The self-expanding behavior of the arterial anchor device 10 is due to the relatively high modulus of elasticity of the shape-memory material, which imparts superior spring-like properties to the arterial anchor device 10.
Referring now to
As best seen in
As can be seen in
As will be appreciated by those of ordinary skill in the art, the venous anchor device 400 in accordance with the invention, and as best seen in
As described previously and as alternatively depicted in
Those of skill in the art will appreciate that although it is contemplated that the venous anchor device 400 is coated there is no backflow in the venous device due to the arterial pressure of the blood flowing through it. This minimizes any leakage that may occur at the entry point of the device in the venous wall.
Venous anchor device 400 may be either self-expanding, such as so-called shape-memory materials, or non-self-expanding, such as stainless steel. In forming the exemplary venous anchor device 400, a tubular length of metal is used to cut the venous anchor device 400 and integrally form the struts and connectors of tubular main body 412 as well as barbs 421. As discussed previously, the metal material used in the exemplary venous anchor device 400 should be both resilient and capable of being heat treated to substantially set a desired shape. Preferably, the metal from which venous anchor device 400 is cut exhibits a high modulus of elasticity that is biocompatible and has superior compressibility allowing the venous anchor device 400 to be self-expandable.
One class of materials which meet these qualifications is so-called shape memory alloys. Such alloys tend to have a temperature induced phase change which will cause the material to have a preferred configuration which can be fixed by heating the material above a certain transition temperature to induce a change in the phase of the material. When the alloy is cooled back down, the alloy will “remember” the shape it was in during the heat treatment and will tend to assume that configuration unless constrained from so doing.
One particularly preferred shape memory alloy for use in the present method is Nitinol, an approximately stoichiometric alloy of nickel and titanium, which may also include other minor amounts of other metals to achieve desired properties. NiTi alloys such as nitinol, including appropriate compositions and handling requirements, are well known in the art and such alloys need not be discussed in detail here.
Such NiTi alloys are preferred, at least in part, because they are commercially available, have a high yield strain and more is known about handling such alloys than other known shape memory alloys. NiTi alloys are also very elastic--they are said to be “superelastic” or “pseudoelastic.” This elasticity will help a device of the invention return to a present expanded configuration for deployment into a blood vessel. However, any suitable self-expanding material may be used as will be appreciated by those of ordinary skill in the art.
As hereinafter described, prior to implantation the venous anchor device 400 is collapsed inside a delivery device or sheath. Upon introduction into a vessel, the distal end of the anchoring structure freely self-expands to its original dimensions. The self-expanding behavior of the venous anchor device 400 is due to the relatively high modulus of elasticity of the shape-memory material, which imparts superior spring-like properties to the venous anchor device 400.
Referring generally to
Referring to
Wire shaft 713 is removed from the system leaving the arterial anchor device 10 seated in the arterial vessel fluid passageway and operably coupled to graft material 24. The foregoing process is then repeated with the venous vessel anchor 400 in a venous fluid passageway to form the anastomotic connector in accordance with the invention. However, the balloon member is optionally eliminated from seating the venous device as the barbs 421 will self-expand to anchor the device against the venous wall.
Additionally, it may be preferable to provide the anastomotic connectors of the invention with an inner surface that is contoured to allow smooth arterial or venous blood flow into and out of the connector device. As those of ordinary skill in the art will appreciate, providing a non-thrombogenic surface minimizes the creation of recirculation or stagnation zones with high shear or dwell times that could otherwise lead to clotting.
It is also contemplated that the inner or outer surface of the anastomotic connectors of the invention be configured to deliver and release therapeutic substances such as anti-microbial agents, anti-inflammatory agents, anti-proliferative agents (e.g. taclipaxel), growth factors, stem cells, collagen and the like. Those of ordinary skill in the art will appreciate that these therapeutic agents may be coupled with the connector and/or the external or internal surface of the connector by means such as being encased or embedded in a polymeric or other biocompatible coating, applied to a textured external surface of the connector; contained within pockets of the connector on either an internal or external surface, and the like.
As will be appreciated by those of ordinary skill in the art, the same general process described herein may be followed in order to place a connector within other types of fluid passageways. Although a method of deploying an anastomotic connector having a self-expanding anchor member has been generally described herein, the method may be adapted for deploying an anastomotic connector having a non self-expanding anchor member.
Based upon the present disclosure and after viewing the exemplary embodiment of the anastomotic connector presented herein, the many advantages and benefits provided by the invention will be appreciated by those of ordinary skill in the art. One advantage is that the geometry of the anastomotic connector allows continuous and uninterrupted arterial or venous flow during use for dialysis or other applications, thereby eliminating or substantially reducing any loss of circulation to the downstream, distal extremities. Stated alternatively, the geometry of the anastomotic connectors allows “full” flow into the graft as well as “full” flow to the downstream anatomy. Thus, distal arterial flow is not “cut-off” due to the presence of the anastomotic connector. Another advantage is that the anastomotic connectors of the invention are true percutaneous devices that do not require a “cut down” as in an “open surgery” approach. The implantation method is therefore less invasive for the patient and faster for the surgeon. Yet another advantage is that the present invention allows for maturation of the distal vein in preparation for secondary AVF while avoiding a central dialysis catheter.
Although the present invention has been described with reference to preferred embodiments, those of ordinary skill in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.
This application is a divisional of U.S. application Ser. No.: 14/405,088 filed on Dec. 2, 2014, which is a 371(c) application claiming priority to International Appln. Ser. No.: PCT/US2012/067561, filed on Dec. 3, 2012, which claims the benefit of priority to U.S. Prov. Appln. Ser. No.: 61/683,898, filed on Aug. 16, 2012; and which International Appln. Ser. No.: PCT/US2012/067561 claims priority to International Appln. Ser. No.: PCT/US2012/042639, filed on Jun. 15, 2012, and International Appln. Ser. No.: PCT/US2012/042666, filed on Jun. 15, 2012, and International Appln. Ser. No.: PCT/US2012/042688, filed on Jun. 15, 2012; the entireties of which are hereby incorporated by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 20170196677 A1 | Jul 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61683898 | Aug 2012 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14405088 | US | |
| Child | 15468884 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2012/042639 | Jun 2012 | US |
| Child | 14405088 | US | |
| Parent | PCT/US2012/042666 | Jun 2012 | US |
| Child | PCT/US2012/042639 | US | |
| Parent | PCT/US2012/042688 | Jun 2012 | US |
| Child | PCT/US2012/042666 | US |
