CA2612130C - Devices, systems, and methods for creation of a peripherally located fistula - Google Patents
Devices, systems, and methods for creation of a peripherally located fistula Download PDFInfo
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- CA2612130C CA2612130C CA2612130A CA2612130A CA2612130C CA 2612130 C CA2612130 C CA 2612130C CA 2612130 A CA2612130 A CA 2612130A CA 2612130 A CA2612130 A CA 2612130A CA 2612130 C CA2612130 C CA 2612130C
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
- A61B17/083—Clips, e.g. resilient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/122—Clamps or clips, e.g. for the umbilical cord
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1139—Side-to-side connections, e.g. shunt or X-connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
- A61B2017/3413—Needle locating or guiding means guided by ultrasound
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/48—Diagnostic techniques
- A61B8/488—Diagnostic techniques involving Doppler signals
Abstract
Devices, systems and methods are disclosed for the formation of an arteriovenous fistula in the limb of the patient. Embodiments include a device (10) for the creation, modification and maintenance of a fistula that includes an integral fistula creation assembly (25) near its distal end that passes through the skin of the patient, through a first vessel such as an artery, and into a second vessel such as a vein. The fistula creation assembly (25) preferably includes an anastomotic implant (60) that is placed within the fistula t maintain long term blood flow there through. The devices, systems and methods can be used to treat patients with one or more numerous ailments including chronic obstructive pulmonary disease, congestive heart failure, hypertension, hypotension, respirator failure, pulmonary arterial hypertension, lung fibrosis and adult respiratory distress syndrome.
Description
DEVICES, SYSTEMS, AND METHODS FOR CREATION OF A
PERIPHERALLY LOCATED FISTULA
BACKGROUND OF THE INVENTION
[0001] Field of the Invention. The present invention relates generally to medical devices and methods. More particularly, the present invention relates to devices and methods for creating or modifying a fistula between a first vessel and a second vessel, such as for the treatment of chronic obstructive pulmonary disease.
PERIPHERALLY LOCATED FISTULA
BACKGROUND OF THE INVENTION
[0001] Field of the Invention. The present invention relates generally to medical devices and methods. More particularly, the present invention relates to devices and methods for creating or modifying a fistula between a first vessel and a second vessel, such as for the treatment of chronic obstructive pulmonary disease.
[0002] Chronic obstructive pulmonary disease affects millions of patients in the United States alone. The present standard of care is externally supplied oxygen therapy, which requires a patient to remain near a stationary oxygen source or carry a bulky oxygen source when away from home or a treatment facility. It is easy to appreciate that such oxygen therapy has many disadvantages.
[0003] Lung reduction surgery has recently been proposed for treating patients with chronic pulmonary disease. Such surgery, however, is not a panacea. It can be used on only a small percentage of the total patient population, requires long recovery times, and does not always provide a clear patient benefit. Even when successful, patients often continue to require supplemental oxygen therapy.
[0004] There is therefore a need for improved approaches, including both devices and methods, for treating patients suffering from chronic obstructive pulmonary disease. If would be desirable if such devices and methods were also useful for treating patients with other conditions, such as congestive heart failure, hypertension, lung fibrosis, adult respiratory distress syndrome, and the like. Such devices and methods should provide for effective therapy, preferably eliminating the need for supplemental oxygen therapy in the treatment of chronic obstructive pulmonary disease. There is a need for simplified devices and procedural methods that reduce costs to the patient and healthcare system, as well as decrease procedure times and minimize patient risks. Improved devices and procedures must be developed to apply to a broad base of patient populations with a wide range of applicable afteriovenous anatomies. At least some of these objectives will be met by the invention described hereinafter.
SUMMARY OF THE INVENTION
[004A] Various embodiments of this invention provide a device for creating a fistula in a patient comprising: an elongate tubular structure having a proximal end and a distal end, wherein the distal end is configured to pass first through the skin of the patient, then through a first vessel, and then into a second vessel; and a self expanding fistula creation assembly disposed near the distal end of the elongate tubular structure, said assembly for creating, maintaining or creating and maintaining a fistula that provides a flow of blood between the first vessel and the second vessel, wherein the tubular structure comprises an outer tube and a slidable core slidingly received by said outer tube, wherein the slidable core has a proximal end, a distal end, and a lumen therethrough, wherein the tubular structure comprises a second slidable core slidingly received by the first slidable core, wherein the second slidable core has a proximal end, a distal end, and a lumen therethrough and is configured to be advanced through tissue to form a penetration, and wherein the self-expanding fistula creation assembly is carried on the first slidable core and constrained by the tubular structure such that the outer tube can be retracted to release the fistular creation assembly in the penetration. The second slidable core may have a tapered, beveled or sharpened distal end. Also provided are systems for creating a fistula comprising such a device and an ultrasound visualization monitor and/or one or more of: a balloon catheter, an anastomotic implant deployment catheter, a flow measurement device, an angiography catheter, a venography catheter, a guidewire, an introducer, a needle, and a biopsy needle.
[004B] Various embodiments of this invention provide a kit for creating a long-term fistula in a patient to treat chronic obstructive pulmonary disease, said kit including: a first fistula creation device which is a device of this invention, said first fistula creation device for forming a fistula with a first geometry; a second fistula creation device which is a device of this invention, said second fistula creation device for forming a fistula with a second geometry, wherein either the first fistula creation device or the second fistula creation device is for use to create said long-term fistula, based on visualization of the patient.
SUMMARY OF THE INVENTION
[004A] Various embodiments of this invention provide a device for creating a fistula in a patient comprising: an elongate tubular structure having a proximal end and a distal end, wherein the distal end is configured to pass first through the skin of the patient, then through a first vessel, and then into a second vessel; and a self expanding fistula creation assembly disposed near the distal end of the elongate tubular structure, said assembly for creating, maintaining or creating and maintaining a fistula that provides a flow of blood between the first vessel and the second vessel, wherein the tubular structure comprises an outer tube and a slidable core slidingly received by said outer tube, wherein the slidable core has a proximal end, a distal end, and a lumen therethrough, wherein the tubular structure comprises a second slidable core slidingly received by the first slidable core, wherein the second slidable core has a proximal end, a distal end, and a lumen therethrough and is configured to be advanced through tissue to form a penetration, and wherein the self-expanding fistula creation assembly is carried on the first slidable core and constrained by the tubular structure such that the outer tube can be retracted to release the fistular creation assembly in the penetration. The second slidable core may have a tapered, beveled or sharpened distal end. Also provided are systems for creating a fistula comprising such a device and an ultrasound visualization monitor and/or one or more of: a balloon catheter, an anastomotic implant deployment catheter, a flow measurement device, an angiography catheter, a venography catheter, a guidewire, an introducer, a needle, and a biopsy needle.
[004B] Various embodiments of this invention provide a kit for creating a long-term fistula in a patient to treat chronic obstructive pulmonary disease, said kit including: a first fistula creation device which is a device of this invention, said first fistula creation device for forming a fistula with a first geometry; a second fistula creation device which is a device of this invention, said second fistula creation device for forming a fistula with a second geometry, wherein either the first fistula creation device or the second fistula creation device is for use to create said long-term fistula, based on visualization of the patient.
[0005] According to a first aspect of the invention, a device for creating a fistula in a patient is disclosed. The device comprises an elongate tubular structure comprising a proximal end and a distal end. The distal end is configured to penetrate or otherwise pass first through the skin of the patient, then through a first vessel, and then into a second vessel.
The device includes an integral assembly configured to create a fistula between two neighboring vessels. In a preferred embodiment, the first vessel is an artery and the second vessel is a vein. In an alternative, also preferred embodiment, the first vessel is a vein and the second vessel is an artery. The fistula is typically created at a location wherein the artery and vein vessel walls are within 20 mm of each other. The fistula is created to provide therapeutic benefit, such as for an acute period less than twenty-four hours, a sub-chronic period between twenty-four hours and thirty days, or for a chronic period greater than thirty days. The fistula creation assembly is preferably mounted on a core that is slidable within an outer sheath of the device. The fistula creation assembly can be uncovered from the sheath by an operator through advancement of the core, retraction of the sheath, or a combination of the two movements. In a preferred embodiment, a second slidable core, such as a slidable needle assembly with a sharpened, beveled tip, is slidingly received by the first core. When fully advanced, the needle assembly exits the distal end of both the sheath and the first core, and assists in penetrating first through the skin of the patient and then through the tissue that exists along the trajectory to the proposed fistula. Both the first core and the sheath preferably have tapered ends to assist in penetration and/or advancement through the skin and tissue up to the fistula site. In another preferred embodiment, the needle assembly includes a guidewire lumen for insertion of a guidewire from outside the patient's body, through the first vessel and into the lumen of the second vessel. In another embodiment, the needle assembly is removable. In a preferred embodiment, the device is rigid along a majority of its length. In an alternative embodiment, the device is flexible along a majority of its length, such as a flexible section that can be advanced down a segment of the first vessel prior to entering the second vessel. In another alternative embodiment, the device includes both flexible segments and rigid segments along its length.
The device includes an integral assembly configured to create a fistula between two neighboring vessels. In a preferred embodiment, the first vessel is an artery and the second vessel is a vein. In an alternative, also preferred embodiment, the first vessel is a vein and the second vessel is an artery. The fistula is typically created at a location wherein the artery and vein vessel walls are within 20 mm of each other. The fistula is created to provide therapeutic benefit, such as for an acute period less than twenty-four hours, a sub-chronic period between twenty-four hours and thirty days, or for a chronic period greater than thirty days. The fistula creation assembly is preferably mounted on a core that is slidable within an outer sheath of the device. The fistula creation assembly can be uncovered from the sheath by an operator through advancement of the core, retraction of the sheath, or a combination of the two movements. In a preferred embodiment, a second slidable core, such as a slidable needle assembly with a sharpened, beveled tip, is slidingly received by the first core. When fully advanced, the needle assembly exits the distal end of both the sheath and the first core, and assists in penetrating first through the skin of the patient and then through the tissue that exists along the trajectory to the proposed fistula. Both the first core and the sheath preferably have tapered ends to assist in penetration and/or advancement through the skin and tissue up to the fistula site. In another preferred embodiment, the needle assembly includes a guidewire lumen for insertion of a guidewire from outside the patient's body, through the first vessel and into the lumen of the second vessel. In another embodiment, the needle assembly is removable. In a preferred embodiment, the device is rigid along a majority of its length. In an alternative embodiment, the device is flexible along a majority of its length, such as a flexible section that can be advanced down a segment of the first vessel prior to entering the second vessel. In another alternative embodiment, the device includes both flexible segments and rigid segments along its length.
[0006] The fistula creation assembly of the present invention can be configured in numerous forms to produce the desired fistula. In a preferred embodiment, a cone shaped dilator is expanded and/or delivers energy to create the fistula. In another embodiment, an expandable balloon is used to create the fistula. An anastomotic implant is preferably 2a deployed to initially create the fistula and/or to improve the long-term potency of the fistula.
The implant can perform numerous functions, and may include self-expanding materials, plastically deformable materials, or a combination of self-expanding or plastically deformable materials. In a preferred embodiment, the anastomotic implant forms the fistula into an oval cross section. In an alternative embodiment, the anastomotic implant forms the fistula into a circular cross section. Numerous forms of energy can be used to create and/or improve the fistula, including energies selected from the group consisting of:
electrical energy such as radiofrequency or microwave energy; cryogenic energy; heat;
radiation;
chemical energy; light such as light delivered to photoreactive agents; and combinations thereof. The fistula creation assembly may deliver an agent to the fistula and its surrounding tissue, such agents selected from the group consisting of: anti-proliferative;
anti-biotic; anti-thrombogenic; and combinations thereof.
The implant can perform numerous functions, and may include self-expanding materials, plastically deformable materials, or a combination of self-expanding or plastically deformable materials. In a preferred embodiment, the anastomotic implant forms the fistula into an oval cross section. In an alternative embodiment, the anastomotic implant forms the fistula into a circular cross section. Numerous forms of energy can be used to create and/or improve the fistula, including energies selected from the group consisting of:
electrical energy such as radiofrequency or microwave energy; cryogenic energy; heat;
radiation;
chemical energy; light such as light delivered to photoreactive agents; and combinations thereof. The fistula creation assembly may deliver an agent to the fistula and its surrounding tissue, such agents selected from the group consisting of: anti-proliferative;
anti-biotic; anti-thrombogenic; and combinations thereof.
[0007] In a preferred embodiment, the device is configured to create a fistula to treat a patient suffering from COPD, such as via the fistula decreasing systemic vascular resistance of the patient. In these and other patient populations, the fistula may provide therapy by increasing the oxygen content of venous blood, such as blood supplied to a lung of the patient. The fistula may additionally cause oxygen content in arterial blood to also increase.
The fistulas of the present invention are configured to have blood flow through the fistula of at least 5 ml/min, and preferably greater than 50 ml/min.
The fistulas of the present invention are configured to have blood flow through the fistula of at least 5 ml/min, and preferably greater than 50 ml/min.
[0008] In yet another preferred embodiment, the device includes a handle at its proximal end. The handle includes one or more controls, such as controls to advance and/or retract a slidable core. In a preferred embodiment, one or more controls are included to perform a function selected from the group consisting of: initiate or modify the delivery of energy to an intended or existing fistula location; expand a distal portion of the device such as an expandable dilator or inflatable balloon; deploy an implant such as an anastomotic device which applies tension between the two vessels at the fistula location and/or scaffolds the lumen of the fistula; and combinations thereof.
[0009] In yet another preferred embodiment, the device is configured to create a fistula in a limb of a patient, such as between an artery and vein selected from the group consisting of:
axillary artery; brachial artery; ulnar artery; radial artery; profundal artery; femoral artery;
iliac artery; popliteal artery; carotid artery; saphenous vein; femoral vein;
iliac vein; popliteal vein; brachial vein; basilic vein; cephalic vein; medial forearm vein; medial cubital vein;
axillary vein; and jugular vein. In an alternative embodiment, the fistula is located in the abdomen or thorax of the patient.
axillary artery; brachial artery; ulnar artery; radial artery; profundal artery; femoral artery;
iliac artery; popliteal artery; carotid artery; saphenous vein; femoral vein;
iliac vein; popliteal vein; brachial vein; basilic vein; cephalic vein; medial forearm vein; medial cubital vein;
axillary vein; and jugular vein. In an alternative embodiment, the fistula is located in the abdomen or thorax of the patient.
[0010] In yet another preferred embodiment, the fistula creation device further comprises a flow measurement element, such as an ultrasound or Doppler ultrasound element, or a lumen that allows a flow measurement catheter to be inserted into the proximal end of the device and advanced to a location near or beyond the device's distal end. Flow measurement can be made directly using Doppler technologies and techniques, or indirectly by measuring flow channel geometries.
[0011] In yet another preferred embodiment, the fistula creation device further comprises flow adjustment means mounted to one or more of the outer sheath or an inner core. The flow adjustment means can be activated on demand by an operator and preferably includes:
an energy delivery element; an agent delivery element; an inflatable balloon;
an expandable dilator; a deployable implant such as a second implant of the fistula creation device; and combinations thereof.
an energy delivery element; an agent delivery element; an inflatable balloon;
an expandable dilator; a deployable implant such as a second implant of the fistula creation device; and combinations thereof.
[0012] According to a second aspect of the invention, a system for creating a fistula is disclosed. The system includes one or more of the embodiments of the fistula creation device of the first aspect of the invention, and an ultrasound visualization monitor. The visualization monitor may be configured to display information received from one or more ultrasound crystals integral to the fistula creation device, or may work with separate device such as an external or internal ultrasound probe.
[0013] According to a third aspect of the invention, a system for creating a fistula is disclosed. The system includes one or more of the embodiments of the fistula creation device of the first aspect of the invention, and an apparatus selected from the group consisting of: a balloon catheter; an anastomotic implant deployment catheter; a flow measurement device such as a flow catheter or an external Doppler probe; an angiography catheter; a venography catheter; a guidewire; an introducer; a needle; a biopsy needle;
and combinations thereof. In a preferred embodiment, the system further comprises an ultrasound visualization monitor configured to provide an image received from one or more of: an ultrasound element integral to the fistula creation device; an external ultrasound probe; and an internal ultrasound apparatus such as an intravascular ultrasound catheter; and an inserted probe such as a transesophageal probe.
and combinations thereof. In a preferred embodiment, the system further comprises an ultrasound visualization monitor configured to provide an image received from one or more of: an ultrasound element integral to the fistula creation device; an external ultrasound probe; and an internal ultrasound apparatus such as an intravascular ultrasound catheter; and an inserted probe such as a transesophageal probe.
[0014] According to a fourth aspect of the invention, a method of creating a fistula is disclosed. The distal end of a fistula creation device is placed through the skin of the patient.
The distal end, which is preferably the distal end of a sharpened, beveled tip needle assembly, such as a removable needle assembly, is advanced through a first vessel, such as a vein or an artery. The distal end is then advanced into a second vessel at an existing-fistula or an intended-fistula location. A fistula is then created, or an existing fistula is maintained, such that a long-term flow of blood is provided between the first vessel and the second vessel. The fistula creation device includes an elongate tubular structure that may be rigid along a majority of its length, may be flexible along a majority of its length, or may include rigid and flexible portions such as two rigid portions attached with a flexible hinge.
In a preferred embodiment, blood flows from the first vessel to the second vessel. In an alternative, also preferred embodiment, blood flows from the second vessel to the first vessel.
At the intended fistula location of the patient, the vessels may lie in various geometric configurations, such as wherein the first vessel is "on top" of the second vessel such that the lumen of the first vessel lies relatively proximate the shortest line between the lumen of the second vessel at the fistula location and the surface of the patient's skin. In alternative fistula locations, the vessels may lie in a more "side-to-side" configuration. When inserted, the elongate body of the fistula creation device is positioned to lie relatively in the plane defined by the lumens of the two vessels near the intended fistula location. While maintaining position within this plane, the fistula creation device can be inserted at an angle relatively perpendicular to the surface of the patient's skin, or at a smaller angle, such as an angle between 20 and 80 degrees. This insertion angle may be chosen by the clinician to affect the fistula angular geometry between the two vessels, such as at a small insertion angle to correspond to a similarly small angle between the lumen of the first vessel and the lumen of the fistula. Such a small angle between the first vessel lumen and the fistula lumen may be desirous to reduce turbulent flow through the fistula. In alternative embodiments, an insertion angle approximating ninety degrees may be chosen in order to minimize the length of the fistula.
The distal end, which is preferably the distal end of a sharpened, beveled tip needle assembly, such as a removable needle assembly, is advanced through a first vessel, such as a vein or an artery. The distal end is then advanced into a second vessel at an existing-fistula or an intended-fistula location. A fistula is then created, or an existing fistula is maintained, such that a long-term flow of blood is provided between the first vessel and the second vessel. The fistula creation device includes an elongate tubular structure that may be rigid along a majority of its length, may be flexible along a majority of its length, or may include rigid and flexible portions such as two rigid portions attached with a flexible hinge.
In a preferred embodiment, blood flows from the first vessel to the second vessel. In an alternative, also preferred embodiment, blood flows from the second vessel to the first vessel.
At the intended fistula location of the patient, the vessels may lie in various geometric configurations, such as wherein the first vessel is "on top" of the second vessel such that the lumen of the first vessel lies relatively proximate the shortest line between the lumen of the second vessel at the fistula location and the surface of the patient's skin. In alternative fistula locations, the vessels may lie in a more "side-to-side" configuration. When inserted, the elongate body of the fistula creation device is positioned to lie relatively in the plane defined by the lumens of the two vessels near the intended fistula location. While maintaining position within this plane, the fistula creation device can be inserted at an angle relatively perpendicular to the surface of the patient's skin, or at a smaller angle, such as an angle between 20 and 80 degrees. This insertion angle may be chosen by the clinician to affect the fistula angular geometry between the two vessels, such as at a small insertion angle to correspond to a similarly small angle between the lumen of the first vessel and the lumen of the fistula. Such a small angle between the first vessel lumen and the fistula lumen may be desirous to reduce turbulent flow through the fistula. In alternative embodiments, an insertion angle approximating ninety degrees may be chosen in order to minimize the length of the fistula.
[0015] In a preferred embodiment, the method further comprises the step of determining the anatomical location for the fistula. Prior to creating the fistula, the fistula location is determined using one or more of: angiography; venography; extra-vascular ultrasound;
intravascular ultrasound; Doppler ultrasound; and MRI. The fistula location is determined based on an analysis of a parameter selected from the group consisting of:
first vessel diameter; second vessel diameter; artery diameter; vein diameter; ratio of artery to vein diameter; distance between the artery and vein lumens; geometric relationship between the artery and vein lumens; distance from an arterial side branch; distance from an venous side branch; arterial flow; venous flow; oxygen content in artery; oxygen content in vein; wall thickness of artery; wall thickness of vein; degree of calcification of artery; degree of calcification of vein; geometric relationship between the artery and vein lumens at the fistula site; hemodynamic factors; other parameters; and combinations thereof.
[00161 In another preferred embodiment, the method further comprises the step of performing a blood flow measurement procedure, such as a procedure performed prior to fistula creation, during fistula creation, after fistula creation, and combinations thereof. The information determined during the flow measurement procedure can be used to select the fistula site, modify the fistula such as a balloon dilation fistula modification procedure and/or otherwise treat the fistula.
[00171 In yet another preferred embodiment, an anastomotic implant is placed in the fistula.
The anastomotic implant is placed to provide a function selected from the group consisting of: scaffolding an opening between the first vessel and the second vessel;
reducing neointimal proliferation into the fistula flow path; preventing tissue from protruding into the fistula flow path; placing a portion of the first vessel wall in tension with the tissue of the second vessel wall; reducing bleeding of the tissue neighboring the fistula; enhancing healing of the tissue neighboring the fistula; and combinations thereof. The anastomotic implant may include one or more coatings, such as anti-bacterial; anti-thrombogenic and anti-prolific coatings. The anastomotic implant may additionally or alternatively include a covered portion, such as a partial covering, such covering materials selected from the group consisting of:
polytetrafluoroethylene; Dacron; Nitinol; stainless steel; and combinations thereof. The fistula creation device of the present invention preferably places the anastomotic implant.
10018] In yet another preferred embodiment, a guidewire is placed between the first and second vessel through the fistula, prior to, during, or after the fistula is created. The guidewire preferably remains in place after the fistula creation device is removed, or partially removed, such that a second catheter device can be placed over that guidewire.
The second catheter device can be used to perform a diagnostic event such as a radiographic dye injection catheter inserted to perform angiography or venography, or an ultrasound catheter used to visualize the fistula structure. The second catheter device can be used to modify the fistula such as a balloon catheter inserted to enlarge the fistula or an anastomotic implant deployment catheter inserted to increase or decrease flow through the fistula.
[0019] In yet another preferred embodiment, the fistula is created to provide therapeutic benefit that results from: a decrease is systemic vascular resistance; an increase in the oxygen content in at least a portion of the venous system such as the venous supply to a lung of the patient; and combinations thereof. Blood flow through the fistula is at least 5 ml/min and preferably greater than 50 ml/min. The fistula is preferably created between an artery and a vein at a location in a limb of the patient. The artery is selected from the group consisting of:
axillary artery; brachial artery; ulnar artery; radial artery; profundal artery; femoral artery;
iliac artery; popliteal artery; and carotid artery. The vein is selected from the group consisting of: saphenous; femoral; iliac; popliteal; brachial; basilic;
cephalic; medial forearm;
medial cubital; axillary; and jugular. The artery is preferably between 5 mm and 25 mm in diameter at the intended fistula location. The vein is preferably less than 35 mm in diameter at the intended fistula location. The fistula preferably has a non-circular or oval cross section, such that the major axis of the oval is greater than either the vein diameter or the artery diameter. In an alternative embodiment, the fistula has a circular cross section. The geometry of the cross section of the fistula is preferably matched with a similar geometry of an anastomotic implant placed during the disclosed method.
[0020] According to a fifth aspect of the invention, a kit for creating a long-term fistula in a patient for the treatment of COPD is disclosed. The kit includes a first fistula creation device for forming a fistula with a first geometry. The kit further includes a second fistula creation device for forming a fistula with a second geometry. Either the first or the second fistula creation device is used to create the long-term fistula based on an analysis of information gathered during a visualization procedure performed on the patient. The visualization procedure is preferably selected from the group consisting of: ultrasound visualization including intravascular ultrasound and extravascular ultrasound; angiography;
venography;
MRI; and combinations thereof. The first fistula creation device and the second fistula creation device can be configured to create a first fistula and a second fistula respectively.
The first fistula and the second fistula may have two different cross sectional geometries, such as a circular and an oval cross sections, two different circular cross sections or two different oval cross sections. Varied oval cross sections may include ovals with different major axes and different minor axes, and ovals with different major axes with similar minor axes.
[0021] Both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the embodiments of the invention as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various embodiments of the present invention, and, together with the description, serve to explain the principles of the invention. In the drawings:
[0023] Fig. 1 illustrates a partial cross sectional side view of a fistula creation apparatus consisting with the present invention;
[0024] Fig. 2a illustrates a cross sectional side view of a fistula creation apparatus consistent with the present invention shown with a slidable needle assembly in the advanced position;
[0025] Fig, 2b illustrates the fistula creation apparatus of Fig. 2a with the needle assembly removed;
[0026] Fig. 2c illustrates the fistula creation apparatus of Fig. 2b with an outer sheath retracted such that an integral anastornotic implant is partially expanded;
[0027] Fig. 2d illustrates the fistula creation apparatus of Fig. 2c with the outer sheath further retracted such that the integral anastomotic implant is fully expanded;
[0028] Fig. 3a is a cross sectional side view of a device and method for creating a fistula consistent with the present invention shown prior to advancement of the device through the patient's skin;
[0029] Fig. 3b illustrates the device and method of Fig. 3a shown with the distal end of a slidable needle assembly of the device having penetrated the skin and the first wall of an artery;
[0030] Fig. 3c illustrates the device and method of Fig. 3b shown with the needle assembly having further penetrated a second wall of the artery and a first wall of a vein, and a guidewire having been advanced down the vein through a lumen of the needle assembly;
[0031] Fig. 3d illustrates the device and method of Fig. 3c shown with the needle assembly having been retracted while leaving the guidewire seated in the vein;
[0032] Fig. 3e illustrates the device and method of Fig. 3d shown with an anastomotic implant of the device partially deployed in the vein;
[0033] Fig. 3f illustrates the device and method of Fig. 3e shown with the anastomotic implant of the device fully deployed in the fistula between the artery and the vein, and the device outer sheath partially retracted from the patient;
[0034] Fig. 4a is a cross sectional side view of a device and method for creating a fistula consistent with the present invention shown with advancement of the distal end of the device through the patient's skin and into an artery and an ultrasound probe located proximate the entry site;
[0035] Fig. 4b illustrates the ultrasound image produced by the ultrasound probe of Fig. 4a.
DETAILED DESCRIPTION OF THE INVENTION
[0036] Reference will now be made in detail to the present embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
[0037] Fig. 1 depicts a preferred embodiment of the fistula creation device of the present invention. Device 10 is configured to be inserted by an operator through the skin of a patient to create and/or maintain a fistula that provides a flow of blood between a first vessel and a second vessel, such as a long-term flow of blood to achieve a therapeutic benefit. Device 10 includes an elongate tubular structure with a proximal end and a distal end, the tubular structure comprising multiple tubes that surround or are slidingly received within a separate tube. Each tube may have a rigid, semi-rigid, and/or flexible construction and each tube comprises one or more materials such as: nylon; polyvinyl chloride;
polyethylene;
polypropylene; polyimide; PebaxTm; HytrelTM; polyurethane; silicone; steel;
NitinolTm;
blends, alloys and copolymers of the preceding, or other biocompatible materials, and may include a structural braid such as a nylon or metal braid commonly used in interventional guide catheters. Each tube may include a tapered, sharpened, beveled, expandable such as balloon expandable, and/or energy emitting distal end, and each tube may include one or more lumens, such as a Teflon-lined or Teflon-coated lumen. The elongate tubular structure may be rigid or flexible along a majority of its length, or may include both rigid and flexible portions such as two rigid portions separated by a flexible hinge portion.
Device 10 further includes, on its proximal end, handle 40, which is grasped by an operator to advance, retract, rotate, control, activate, and/or otherwise manipulate device 10 or a component or sub-assembly of device 10. Each advanceable and/or retractable tube of device 10 may be attached at its proximal end to one or more advancement and/or retraction controls, such as a tube that is operably attached to a control integral to or proximate to handle 40. Handle 40 may include additional controls, such as a control to enlarge a dilator, inflate a balloon, deploy an implant, initiate energy or agent delivery, activate a diagnostic device and/or perform another function.
[0038] The outermost tube, outer sheath 30, which preferably has a tapered distal end and is constructed of a bio compatible plastic, surrounds and slidingly receives a first slidable core, inner core 20, which includes conically tapered tip 21 and is preferably constructed of biocompatible metal and/or plastic. Fistula creation assembly 25 is mounted near the distal end of inner core 20 and is configured to create a fistula on demand by an operator. Fistula creation assembly 25 may include one or more of various means to create the fistula such as a cone shaped dilator, not shown, such as a dilator that is expandable and/or configured to deliver energy. Fistula creation assembly 25 may include a force-exerting balloon, such as a compliant or non-compliant balloon and/or a balloon to dilate an implant.
Alternatively or additionally, fistula creation assembly 25 may include a delivery assembly and an anastomotic implant, such as a vessel-to-vessel tensioning anastomotic clip and/or a fistula scaffolding assembly. Alternatively or additionally, fistula creation assembly 25 may include an energy delivery element such as an element configured to deliver electrical energy such as radiofrequency or microwave energy; cryogenic energy; heat; radiation;
chemical energy;
light; and/or other forms of energy. Energy may be delivered to ablate tissue, cut tissue and/or coagulate blood and tissue. Alternatively or additionally, fistula creation assembly 25 may include an agent delivery assembly, such as an agent delivery mechanism configured to deliver one or more of anti-proliferatives; anti-biotics; and anti-thrombogenics. In a preferred embodiment, fistula creation assembly 25 further is configured to modify an existing fistula, such as a fistula created by device 10 previously used to create the fistula, or by a separate device 10 or an alternative fistula creation device, such as during the same medical procedure or a previously performed procedure. In order to modify an existing fistula, fistula creation assembly 25 may include an anastomotic implant, such as a second anastomotic implant nested within a first implant, an expandable balloon, an energy or agent delivery element, a tissue removing element such as a forward or pull back atherectomy catheter, or other means.
Other fistula modifying events can be performed such as the placement of an implant, which partially covers the fistula from either the venous or arterial side.
[0039] Referring back to Fig. 1, fistula creation assembly 25 is operably attached to conduit 26, a flexible or rigid conduit which travels proximally to handle 40. Conduit 26 may include one or more of: a power or data transfer conduit such as one or more electrical wires and/or optical fibers, a tube such as an inflation lumen or cryogenic flow tube; and a slidable cable such as a pull wire. Conduit 26 is electrically attached through an electrical switch control, button 42, to another control on handle 40, port 41. Port 41 is an electrical jack that can be attached to an energy delivery unit such as an RF generator, not shown. An operator depresses button 42 to deliver energy to fistula creation assembly 25. In an alternative or additional embodiment, port 41 is attached to a balloon endoflator that is used to inflate a balloon integral to fistula creation assembly 25. In another alternative or additional embodiment, port 41 is attached to a drug delivery pump or supply to deliver drugs to fistula creation assembly 25. Outer sheath 30 is operably attached to a control on handle 40, sheath retraction knob 32, which can be slid proximally by an operator to retract outer sheath 30 and subsequently slid distally to advance outer sheath 30. Outer sheath 30 is retracted to expose fistula creation assembly 25, such as when fistula creation assembly 25 is an expandable balloon and/or an anastomotic implant delivery assembly such as an assembly including a self-expanding anastomotic implant. In an alternative embodiment, inner core 20 is advanced to expose fistula creation assembly 25, or a combination of advancing inner core 20 and retracting outer sheath 30 is performed. Inner core 20 is operably attached to core advancement knob 22 of handle 40 such that inner core 20 can be advanced and retracted by sliding core advancement knob 22 forward or back.
[0040] Located in the distal portion of inner core 20 and in proximity to fistula creation element 25 is visualization element 70, preferably an ultrasound element such as a phased array of ultrasound crystals, signal and power wires not shown, or a rotating ultrasound crystal, rotating shaft and signal and power wires not shown. Visualization element 70 can be electrically connected to an ultrasound monitor, not shown, such that a cross sectional view of the tissue and other structures surrounding the distal portion of device 10 and fistula creation assembly 25 can be visualized. In alternative embodiments, visualization element 70 consists of a visualization marker, such as an ultrasonically reflective surface that can be visualized with an external ultrasound probe, a radiopaque marker that can be visualized under fluoroscopy, a magnetic marker, and other markers compatible with visualization equipment found in hospitals, doctor's offices and other health care settings.
An operator utilizes visualization element 70 during various procedural steps involving device 10, such as penetration of its distal end through the skin and vessels of the patient and rotational orientation of the device. Visualization element 70 also provides valuable information prior to, during, and after the activation of fistula creation element 25 such as information relating to the inflation of a balloon and/or placement of an anastomotic implant. In an alternative embodiment, device 10 further includes a flow measurement element, not shown, preferably embedded in visualization element 70, such as a Doppler ultrasound function.
In another alternative embodiment, a visualization catheter or flow measurement catheter is inserted in a lumen of device 10, such as within the lumen of inner core 20 in which needle assembly 50 is inserted, a separate lumen of inner core 20 not shown, or a lumen of outer sheath 30. In a preferred embodiment, device 10 further includes a visualization and/or flow measurement monitor, such as a Doppler ultrasound monitor.
[0041] A second slidable core, needle assembly 50, is slidingly received within a lumen of inner core 20. Needle assembly 50, which may be rigid or flexible along its length, is preferably constructed of one or more metals such as stainless steel and Nitinol. Needle assembly 50 can be retracted, and completely removed from the lumen of inner core 20 by retraction of yet another control of handle 40, needle retraction knob 52. In an alternative embodiment, full removal of needle assembly 50 is prevented by the inclusion of one or more mechanical stops. Needle assembly 50 has a sharpened distal tip 51, which is preferably sharp and beveled. Needle assembly 50 includes a lumen from its proximal end to its distal end, guidewire lumen 53, which is configured to allow a standard interventional guidewire to be advanced therethrough, and further configured to allow needle assembly 50 to be removed leaving the previously inserted guidewire to reside within the lumen of inner core 20 previously inhabited by needle assembly 50. In an alternative embodiment, needle tip 51 may be configured to deliver energy, such as RF energy used to assist in advancement, and/or to cauterize, cut and ablate tissue.
[0042] In a preferred embodiment, a kit is provided for the creation of multiple fistulas, in a single patient or multiple patients, includes multiple fistula creation devices of Fig. 1 with varied fistula creation elements in each device. An operator selects a specific fistula creation device based on the configuration of the fistula creation element included in that device. In one alternative, a first fistula creation device creates a fistula with a different geometry than a second fistula creation device, such as might be chosen to differentiate a fistula between vessels with a first set of luminal diameters and a second set of fistulas with different luminal diameters. Numerous fistula creation parameters can be varied between a first fistula creation device and a second fistula creation device such as use of energy, fistula diameter, fistula cross section geometry such as circular cross section versus elliptical cross section wherein the major diameter of the ellipse is at least 20 percent larger than the minor diameter of the ellipse. In a preferred embodiment, the major diameter of the fistula is at least twice the minor diameter. In another preferred embodiment, a kit includes a first fistula creation device with a target fistula cross section dimensions having unequal major and minor axes, and a second fistula creation device with a target fistula cross section dimensions have similar minor axis length and greater major axis length. In a preferred method, an operator selects either the first fistula creation device or the second fistula creation device based on a visualization procedure performed on the anatomy of the patient proximate the intended fistula creation site.
[0043] Referring now to Figs. 2a through 2d, a preferred embodiment of a fistula creation device of the present invention is shown in various stages of a preferred method of activation.
Referring specifically to Fig. 2a, device 10 is configured to be inserted by an operator through the skin of a patient to create and/or maintain a fistula that provides a flow of blood between a first vessel and a second vessel, such as a long-term flow of blood to achieve a therapeutic benefit. Device 10 includes an elongate tubular structure with a proximal end and a distal end, the tubular structure comprising multiple tubes that surround or are slidingly received within a separate tube. Each tube may have a rigid, semi-rigid, and/or flexible construction and each tube comprises one or more materials such as: nylon;
polyvinyl chloride; polyethylene; polypropylene; polyimide; Pebax-rm' HytrelTM;
polyurethane; silicone;
steel; NitinolTm; blends, alloys and copolymers of the preceding, or other biocompatible materials, and may include a structural braid such as a nylon or metal braid commonly used in interventional guide catheters.
[0044] The outermost tube, outer sheath 30, which preferably has a tapered distal end, surrounds and slidingly receives a first slidable core, inner core 20, which includes conically tapered tip 21. Outer sheath 30 includes on its proximal end sheath advancement knob 32, which is manipulated by an operator to advance and retract outer sheath 30.
Inner core 20 includes on its proximal end, core advancement knob 22, which is manipulated by an operator to advance and retract inner core 20. Balloon 25 is mounted near the distal end of inner core 20 and is expandable on demand by an operator, inflation lumen and endoflator attachment port not shown, such as to create the fistula and/or expand an implant placed to maintain the fistula. Balloon 25 may comprise a compliant or non-compliant balloon.
Surrounding balloon 25 is an anastomotic implant, clip 60, which is deployed in the fistula to perform one or more functions including but not limited to: scaffolding an opening between the first vessel and the second vessel; reducing neointimal proliferation into the fistula flow path; preventing tissue from protruding into the fistula flow path; placing a portion of the first vessel wall in tension with the tissue of the second vessel wall; and reducing bleeding of the tissue neighboring the fistula; enhancing healing of the tissue neighboring the fistula. In a preferred embodiment, the anastomotic implant includes an active agent, such as an anti-thrombogenic or anti-proliferative agent, and may also include a covering or partial covering.
[00451 A second slidable core, needle assembly 50, is slidingly received within a lumen of inner core 20. Needle assembly 50, which may be rigid or flexible along its length, is preferably constructed of one or more metals such as stainless steel and Nitinol. Needle assembly 50 can be retracted, and completely removed from the lumen of inner core 20 by retraction of needle retraction knob 52. In a preferred embodiment, Inner core 20 can also be retracted, and completely removed from the lumen of outer sheath 30, by retraction of knob 20. Needle assembly 50 has a sharpened distal tip 51, which is preferably sharp and beveled.
Needle assembly 50 includes a lumen from its proximal end to its distal end, guidewire lumen 53, which is configured to allow a standard interventional guidewire to be advanced therethrough, and further configured to allow needle assembly 50 to be removed leaving the previously inserted guidewire to reside within the lumen of inner core 20 previously inhabited by needle assembly 50. In an alternative embodiment, needle assembly 50 is partially retracted but remains within lumen of inner core 20. In another alternative embodiment, needle tip 51 may be configured to deliver energy, such as RF
energy used to assist in advancement, and/or to cauterize, cut and ablate tissue. In a preferred method, device 10 is advanced through the skin, through a first vessel and into the lumen of a second vessel with needle assembly 50 in the fully advanced position. A locking mechanism, not shown, may be engaged to prevent relative motion between needle assembly 50 and outer sheath 30 during insertion and subsequent advancement. A guidewire is then advanced through guidewire lumen 53 and further advanced down the lumen of the second vessel.
[0046] Referring now to Fig. 2b, needle assembly 50 has been completely removed from the lumen of inner core 20, such as when a guidewire has been successfully placed from a location outside the patient's skin to and into the second vessel. Referring now to fig. 2c, the distal end of clip 60 has been released from being constrained by outer sheath 30, either by retraction of outer sheath 30, advancement of inner core 20, or a combination of both movements. Clip 60 of Figs. 2a through 2d is self-expanding, such as a resiliently biased tubular structure made of Nitinol. In Fig. 2d, clip 60 has been fully released from being constrained and is in a fully expanded condition. Balloon 25 has been inflated, inflation lumen and endoflator attachment not shown, to provide additional expansion force to clip 60.
In an alternative embodiment, clip 60 is plastically deformable, or includes plastically deformable portions, such that balloon 25 is required to expand clip 60. In a preferred embodiment, device 10 of figs. 2a through 2d is used as a system in conjunction with one or more additional devices to create and/or maintain the fistula. Such additional devices include but are not limited to guidewires and various over-the-wire devices that are placed over the guidewire placed through needle assembly 50, after needle assembly 50 is removed. These additional over-the-wire devices may be placed within a lumen of inner core 20, within a lumen of outer sheath 30 with inner core 20 removed, or over the guidewire after device 10 has been completely removed. These over-the-wire devices include but are not limited to:
balloon catheters; anastomotic implant delivery devices and implants; flow measurement catheters; angiography catheters; venography catheters; and other over-the wire devices applicable to modifying the fistula, such as modifying the flow of the fistula, or to perform a procedure to otherwise enhance and/or maintain the long term benefit of the fistula.
[0047] Referring now to Figs. 3a through 3f, a preferred method of using the fistula creation device of the present invention is shown. A cross sectional view of a patient's anatomy at a proposed fistula location 111 is depicted wherein artery 130 is directly above vein 120 in relation to skin surface 105. Intended fistula location 111 may be determined using one or more visualization techniques including but not limited to:
angiography;
venography; extra-vascular ultrasound; intravascular ultrasound; and MRI.
Intended fistula location 111 may be determined using one or more flow measurement techniques such as Doppler ultrasound. The intended fistula location 111 may be selected based on parameters selected from the group consisting of: first vessel diameter; second vessel diameter; artery diameter; vein diameter; ratio of artery to vein diameter; distance between the artery and vein lumens; geometric relationship between the artery and vein lumens; distance from an arterial side branch; distance from an venous side branch; arterial flow; venous flow;
oxygen content in artery; oxygen content in vein; wall thickness of artery; wall thickness of vein; degree of calcification of artery; degree of calcification of vein; geometric relationship between the artery and vein lumens at the fistula site; hemodynamic factors; other parameters; and combinations thereof.
[0048] Artery 130 includes, in closest proximity to skin 105, arterial wall 131. Vein 120 includes, in closest proximity to artery 130, venous wall 121. At the intended fistula location 111 of the patient, the vessels may lie in various geometric configurations, such as the geometry of Figs. 3a through 3f wherein the first vessel is relatively "on top" of the second vessel such that the lumen of the first vessel lies relatively proximate the shortest line between the lumen of the second vessel at the fistula location and the surface of the patient's skin. In alternative fistula locations, the vessels may lie in a more "side-to-side"
configuration. When inserted, the elongate body of outer sheath 30 is positioned to lie relatively in the plane defined by the lumens of the two vessels near the intended fistula location. While maintaining position within this plane, the fistula creation device can be inserted at an angle relatively perpendicular to the surface of the patient's skin, or at a smaller angle as is shown in Fig 3a, such as an angle between 20 and 80 degrees. This insertion angle may be chosen by the clinician to form the resultant fistula angular geometry between the two vessels, such as at a small insertion angle to correspond to a similarly small angle between the lumen of the first vessel and the lumen of the fistula. Such a small angle between the first vessel lumen and the fistula lumen may be desirous to reduce turbulent flow through the fistula. In alternative embodiments, an insertion angle approximating ninety degrees may be chosen, such as to minimize the length of the resultant fistula. Vein 120 is preferably a vein located in a limb of the patient, such as a vein selected from the group consisting of: saphenous vein; femoral vein; iliac vein; popliteal vein;
brachial vein; basilic vein; cephalic vein; medial forearm vein; medial cubital vein; axillary vein;
and jugular vein.
Artery 130 is preferably an artery in a limb of the patient, such as an artery selected from the group consisting of: axillary artery; brachial artery; ulnar artery; radial artery; profundal artery; femoral artery; iliac artery; popliteal artery; carotid artery.
[0049] Referring now specifically to Fig. 3a, a fistula creation device is positioned with its distal end near an intended skin puncture site and includes outer sheath 30 with distal end 31.
Outer sheath 30 is preferably constructed of a biocompatible catheter material, such materials and construction methods described in detail hereabove. Extending beyond distal end 31 is the distal end of a slidable needle assembly including needle tip 51 and guidewire lumen 53.
The needle assembly is preferably constructed of a metal or metal alloy such as stainless steel or Nitinol, and needle tip 51 is a sharpened, beveled tip.
intravascular ultrasound; Doppler ultrasound; and MRI. The fistula location is determined based on an analysis of a parameter selected from the group consisting of:
first vessel diameter; second vessel diameter; artery diameter; vein diameter; ratio of artery to vein diameter; distance between the artery and vein lumens; geometric relationship between the artery and vein lumens; distance from an arterial side branch; distance from an venous side branch; arterial flow; venous flow; oxygen content in artery; oxygen content in vein; wall thickness of artery; wall thickness of vein; degree of calcification of artery; degree of calcification of vein; geometric relationship between the artery and vein lumens at the fistula site; hemodynamic factors; other parameters; and combinations thereof.
[00161 In another preferred embodiment, the method further comprises the step of performing a blood flow measurement procedure, such as a procedure performed prior to fistula creation, during fistula creation, after fistula creation, and combinations thereof. The information determined during the flow measurement procedure can be used to select the fistula site, modify the fistula such as a balloon dilation fistula modification procedure and/or otherwise treat the fistula.
[00171 In yet another preferred embodiment, an anastomotic implant is placed in the fistula.
The anastomotic implant is placed to provide a function selected from the group consisting of: scaffolding an opening between the first vessel and the second vessel;
reducing neointimal proliferation into the fistula flow path; preventing tissue from protruding into the fistula flow path; placing a portion of the first vessel wall in tension with the tissue of the second vessel wall; reducing bleeding of the tissue neighboring the fistula; enhancing healing of the tissue neighboring the fistula; and combinations thereof. The anastomotic implant may include one or more coatings, such as anti-bacterial; anti-thrombogenic and anti-prolific coatings. The anastomotic implant may additionally or alternatively include a covered portion, such as a partial covering, such covering materials selected from the group consisting of:
polytetrafluoroethylene; Dacron; Nitinol; stainless steel; and combinations thereof. The fistula creation device of the present invention preferably places the anastomotic implant.
10018] In yet another preferred embodiment, a guidewire is placed between the first and second vessel through the fistula, prior to, during, or after the fistula is created. The guidewire preferably remains in place after the fistula creation device is removed, or partially removed, such that a second catheter device can be placed over that guidewire.
The second catheter device can be used to perform a diagnostic event such as a radiographic dye injection catheter inserted to perform angiography or venography, or an ultrasound catheter used to visualize the fistula structure. The second catheter device can be used to modify the fistula such as a balloon catheter inserted to enlarge the fistula or an anastomotic implant deployment catheter inserted to increase or decrease flow through the fistula.
[0019] In yet another preferred embodiment, the fistula is created to provide therapeutic benefit that results from: a decrease is systemic vascular resistance; an increase in the oxygen content in at least a portion of the venous system such as the venous supply to a lung of the patient; and combinations thereof. Blood flow through the fistula is at least 5 ml/min and preferably greater than 50 ml/min. The fistula is preferably created between an artery and a vein at a location in a limb of the patient. The artery is selected from the group consisting of:
axillary artery; brachial artery; ulnar artery; radial artery; profundal artery; femoral artery;
iliac artery; popliteal artery; and carotid artery. The vein is selected from the group consisting of: saphenous; femoral; iliac; popliteal; brachial; basilic;
cephalic; medial forearm;
medial cubital; axillary; and jugular. The artery is preferably between 5 mm and 25 mm in diameter at the intended fistula location. The vein is preferably less than 35 mm in diameter at the intended fistula location. The fistula preferably has a non-circular or oval cross section, such that the major axis of the oval is greater than either the vein diameter or the artery diameter. In an alternative embodiment, the fistula has a circular cross section. The geometry of the cross section of the fistula is preferably matched with a similar geometry of an anastomotic implant placed during the disclosed method.
[0020] According to a fifth aspect of the invention, a kit for creating a long-term fistula in a patient for the treatment of COPD is disclosed. The kit includes a first fistula creation device for forming a fistula with a first geometry. The kit further includes a second fistula creation device for forming a fistula with a second geometry. Either the first or the second fistula creation device is used to create the long-term fistula based on an analysis of information gathered during a visualization procedure performed on the patient. The visualization procedure is preferably selected from the group consisting of: ultrasound visualization including intravascular ultrasound and extravascular ultrasound; angiography;
venography;
MRI; and combinations thereof. The first fistula creation device and the second fistula creation device can be configured to create a first fistula and a second fistula respectively.
The first fistula and the second fistula may have two different cross sectional geometries, such as a circular and an oval cross sections, two different circular cross sections or two different oval cross sections. Varied oval cross sections may include ovals with different major axes and different minor axes, and ovals with different major axes with similar minor axes.
[0021] Both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the embodiments of the invention as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various embodiments of the present invention, and, together with the description, serve to explain the principles of the invention. In the drawings:
[0023] Fig. 1 illustrates a partial cross sectional side view of a fistula creation apparatus consisting with the present invention;
[0024] Fig. 2a illustrates a cross sectional side view of a fistula creation apparatus consistent with the present invention shown with a slidable needle assembly in the advanced position;
[0025] Fig, 2b illustrates the fistula creation apparatus of Fig. 2a with the needle assembly removed;
[0026] Fig. 2c illustrates the fistula creation apparatus of Fig. 2b with an outer sheath retracted such that an integral anastornotic implant is partially expanded;
[0027] Fig. 2d illustrates the fistula creation apparatus of Fig. 2c with the outer sheath further retracted such that the integral anastomotic implant is fully expanded;
[0028] Fig. 3a is a cross sectional side view of a device and method for creating a fistula consistent with the present invention shown prior to advancement of the device through the patient's skin;
[0029] Fig. 3b illustrates the device and method of Fig. 3a shown with the distal end of a slidable needle assembly of the device having penetrated the skin and the first wall of an artery;
[0030] Fig. 3c illustrates the device and method of Fig. 3b shown with the needle assembly having further penetrated a second wall of the artery and a first wall of a vein, and a guidewire having been advanced down the vein through a lumen of the needle assembly;
[0031] Fig. 3d illustrates the device and method of Fig. 3c shown with the needle assembly having been retracted while leaving the guidewire seated in the vein;
[0032] Fig. 3e illustrates the device and method of Fig. 3d shown with an anastomotic implant of the device partially deployed in the vein;
[0033] Fig. 3f illustrates the device and method of Fig. 3e shown with the anastomotic implant of the device fully deployed in the fistula between the artery and the vein, and the device outer sheath partially retracted from the patient;
[0034] Fig. 4a is a cross sectional side view of a device and method for creating a fistula consistent with the present invention shown with advancement of the distal end of the device through the patient's skin and into an artery and an ultrasound probe located proximate the entry site;
[0035] Fig. 4b illustrates the ultrasound image produced by the ultrasound probe of Fig. 4a.
DETAILED DESCRIPTION OF THE INVENTION
[0036] Reference will now be made in detail to the present embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
[0037] Fig. 1 depicts a preferred embodiment of the fistula creation device of the present invention. Device 10 is configured to be inserted by an operator through the skin of a patient to create and/or maintain a fistula that provides a flow of blood between a first vessel and a second vessel, such as a long-term flow of blood to achieve a therapeutic benefit. Device 10 includes an elongate tubular structure with a proximal end and a distal end, the tubular structure comprising multiple tubes that surround or are slidingly received within a separate tube. Each tube may have a rigid, semi-rigid, and/or flexible construction and each tube comprises one or more materials such as: nylon; polyvinyl chloride;
polyethylene;
polypropylene; polyimide; PebaxTm; HytrelTM; polyurethane; silicone; steel;
NitinolTm;
blends, alloys and copolymers of the preceding, or other biocompatible materials, and may include a structural braid such as a nylon or metal braid commonly used in interventional guide catheters. Each tube may include a tapered, sharpened, beveled, expandable such as balloon expandable, and/or energy emitting distal end, and each tube may include one or more lumens, such as a Teflon-lined or Teflon-coated lumen. The elongate tubular structure may be rigid or flexible along a majority of its length, or may include both rigid and flexible portions such as two rigid portions separated by a flexible hinge portion.
Device 10 further includes, on its proximal end, handle 40, which is grasped by an operator to advance, retract, rotate, control, activate, and/or otherwise manipulate device 10 or a component or sub-assembly of device 10. Each advanceable and/or retractable tube of device 10 may be attached at its proximal end to one or more advancement and/or retraction controls, such as a tube that is operably attached to a control integral to or proximate to handle 40. Handle 40 may include additional controls, such as a control to enlarge a dilator, inflate a balloon, deploy an implant, initiate energy or agent delivery, activate a diagnostic device and/or perform another function.
[0038] The outermost tube, outer sheath 30, which preferably has a tapered distal end and is constructed of a bio compatible plastic, surrounds and slidingly receives a first slidable core, inner core 20, which includes conically tapered tip 21 and is preferably constructed of biocompatible metal and/or plastic. Fistula creation assembly 25 is mounted near the distal end of inner core 20 and is configured to create a fistula on demand by an operator. Fistula creation assembly 25 may include one or more of various means to create the fistula such as a cone shaped dilator, not shown, such as a dilator that is expandable and/or configured to deliver energy. Fistula creation assembly 25 may include a force-exerting balloon, such as a compliant or non-compliant balloon and/or a balloon to dilate an implant.
Alternatively or additionally, fistula creation assembly 25 may include a delivery assembly and an anastomotic implant, such as a vessel-to-vessel tensioning anastomotic clip and/or a fistula scaffolding assembly. Alternatively or additionally, fistula creation assembly 25 may include an energy delivery element such as an element configured to deliver electrical energy such as radiofrequency or microwave energy; cryogenic energy; heat; radiation;
chemical energy;
light; and/or other forms of energy. Energy may be delivered to ablate tissue, cut tissue and/or coagulate blood and tissue. Alternatively or additionally, fistula creation assembly 25 may include an agent delivery assembly, such as an agent delivery mechanism configured to deliver one or more of anti-proliferatives; anti-biotics; and anti-thrombogenics. In a preferred embodiment, fistula creation assembly 25 further is configured to modify an existing fistula, such as a fistula created by device 10 previously used to create the fistula, or by a separate device 10 or an alternative fistula creation device, such as during the same medical procedure or a previously performed procedure. In order to modify an existing fistula, fistula creation assembly 25 may include an anastomotic implant, such as a second anastomotic implant nested within a first implant, an expandable balloon, an energy or agent delivery element, a tissue removing element such as a forward or pull back atherectomy catheter, or other means.
Other fistula modifying events can be performed such as the placement of an implant, which partially covers the fistula from either the venous or arterial side.
[0039] Referring back to Fig. 1, fistula creation assembly 25 is operably attached to conduit 26, a flexible or rigid conduit which travels proximally to handle 40. Conduit 26 may include one or more of: a power or data transfer conduit such as one or more electrical wires and/or optical fibers, a tube such as an inflation lumen or cryogenic flow tube; and a slidable cable such as a pull wire. Conduit 26 is electrically attached through an electrical switch control, button 42, to another control on handle 40, port 41. Port 41 is an electrical jack that can be attached to an energy delivery unit such as an RF generator, not shown. An operator depresses button 42 to deliver energy to fistula creation assembly 25. In an alternative or additional embodiment, port 41 is attached to a balloon endoflator that is used to inflate a balloon integral to fistula creation assembly 25. In another alternative or additional embodiment, port 41 is attached to a drug delivery pump or supply to deliver drugs to fistula creation assembly 25. Outer sheath 30 is operably attached to a control on handle 40, sheath retraction knob 32, which can be slid proximally by an operator to retract outer sheath 30 and subsequently slid distally to advance outer sheath 30. Outer sheath 30 is retracted to expose fistula creation assembly 25, such as when fistula creation assembly 25 is an expandable balloon and/or an anastomotic implant delivery assembly such as an assembly including a self-expanding anastomotic implant. In an alternative embodiment, inner core 20 is advanced to expose fistula creation assembly 25, or a combination of advancing inner core 20 and retracting outer sheath 30 is performed. Inner core 20 is operably attached to core advancement knob 22 of handle 40 such that inner core 20 can be advanced and retracted by sliding core advancement knob 22 forward or back.
[0040] Located in the distal portion of inner core 20 and in proximity to fistula creation element 25 is visualization element 70, preferably an ultrasound element such as a phased array of ultrasound crystals, signal and power wires not shown, or a rotating ultrasound crystal, rotating shaft and signal and power wires not shown. Visualization element 70 can be electrically connected to an ultrasound monitor, not shown, such that a cross sectional view of the tissue and other structures surrounding the distal portion of device 10 and fistula creation assembly 25 can be visualized. In alternative embodiments, visualization element 70 consists of a visualization marker, such as an ultrasonically reflective surface that can be visualized with an external ultrasound probe, a radiopaque marker that can be visualized under fluoroscopy, a magnetic marker, and other markers compatible with visualization equipment found in hospitals, doctor's offices and other health care settings.
An operator utilizes visualization element 70 during various procedural steps involving device 10, such as penetration of its distal end through the skin and vessels of the patient and rotational orientation of the device. Visualization element 70 also provides valuable information prior to, during, and after the activation of fistula creation element 25 such as information relating to the inflation of a balloon and/or placement of an anastomotic implant. In an alternative embodiment, device 10 further includes a flow measurement element, not shown, preferably embedded in visualization element 70, such as a Doppler ultrasound function.
In another alternative embodiment, a visualization catheter or flow measurement catheter is inserted in a lumen of device 10, such as within the lumen of inner core 20 in which needle assembly 50 is inserted, a separate lumen of inner core 20 not shown, or a lumen of outer sheath 30. In a preferred embodiment, device 10 further includes a visualization and/or flow measurement monitor, such as a Doppler ultrasound monitor.
[0041] A second slidable core, needle assembly 50, is slidingly received within a lumen of inner core 20. Needle assembly 50, which may be rigid or flexible along its length, is preferably constructed of one or more metals such as stainless steel and Nitinol. Needle assembly 50 can be retracted, and completely removed from the lumen of inner core 20 by retraction of yet another control of handle 40, needle retraction knob 52. In an alternative embodiment, full removal of needle assembly 50 is prevented by the inclusion of one or more mechanical stops. Needle assembly 50 has a sharpened distal tip 51, which is preferably sharp and beveled. Needle assembly 50 includes a lumen from its proximal end to its distal end, guidewire lumen 53, which is configured to allow a standard interventional guidewire to be advanced therethrough, and further configured to allow needle assembly 50 to be removed leaving the previously inserted guidewire to reside within the lumen of inner core 20 previously inhabited by needle assembly 50. In an alternative embodiment, needle tip 51 may be configured to deliver energy, such as RF energy used to assist in advancement, and/or to cauterize, cut and ablate tissue.
[0042] In a preferred embodiment, a kit is provided for the creation of multiple fistulas, in a single patient or multiple patients, includes multiple fistula creation devices of Fig. 1 with varied fistula creation elements in each device. An operator selects a specific fistula creation device based on the configuration of the fistula creation element included in that device. In one alternative, a first fistula creation device creates a fistula with a different geometry than a second fistula creation device, such as might be chosen to differentiate a fistula between vessels with a first set of luminal diameters and a second set of fistulas with different luminal diameters. Numerous fistula creation parameters can be varied between a first fistula creation device and a second fistula creation device such as use of energy, fistula diameter, fistula cross section geometry such as circular cross section versus elliptical cross section wherein the major diameter of the ellipse is at least 20 percent larger than the minor diameter of the ellipse. In a preferred embodiment, the major diameter of the fistula is at least twice the minor diameter. In another preferred embodiment, a kit includes a first fistula creation device with a target fistula cross section dimensions having unequal major and minor axes, and a second fistula creation device with a target fistula cross section dimensions have similar minor axis length and greater major axis length. In a preferred method, an operator selects either the first fistula creation device or the second fistula creation device based on a visualization procedure performed on the anatomy of the patient proximate the intended fistula creation site.
[0043] Referring now to Figs. 2a through 2d, a preferred embodiment of a fistula creation device of the present invention is shown in various stages of a preferred method of activation.
Referring specifically to Fig. 2a, device 10 is configured to be inserted by an operator through the skin of a patient to create and/or maintain a fistula that provides a flow of blood between a first vessel and a second vessel, such as a long-term flow of blood to achieve a therapeutic benefit. Device 10 includes an elongate tubular structure with a proximal end and a distal end, the tubular structure comprising multiple tubes that surround or are slidingly received within a separate tube. Each tube may have a rigid, semi-rigid, and/or flexible construction and each tube comprises one or more materials such as: nylon;
polyvinyl chloride; polyethylene; polypropylene; polyimide; Pebax-rm' HytrelTM;
polyurethane; silicone;
steel; NitinolTm; blends, alloys and copolymers of the preceding, or other biocompatible materials, and may include a structural braid such as a nylon or metal braid commonly used in interventional guide catheters.
[0044] The outermost tube, outer sheath 30, which preferably has a tapered distal end, surrounds and slidingly receives a first slidable core, inner core 20, which includes conically tapered tip 21. Outer sheath 30 includes on its proximal end sheath advancement knob 32, which is manipulated by an operator to advance and retract outer sheath 30.
Inner core 20 includes on its proximal end, core advancement knob 22, which is manipulated by an operator to advance and retract inner core 20. Balloon 25 is mounted near the distal end of inner core 20 and is expandable on demand by an operator, inflation lumen and endoflator attachment port not shown, such as to create the fistula and/or expand an implant placed to maintain the fistula. Balloon 25 may comprise a compliant or non-compliant balloon.
Surrounding balloon 25 is an anastomotic implant, clip 60, which is deployed in the fistula to perform one or more functions including but not limited to: scaffolding an opening between the first vessel and the second vessel; reducing neointimal proliferation into the fistula flow path; preventing tissue from protruding into the fistula flow path; placing a portion of the first vessel wall in tension with the tissue of the second vessel wall; and reducing bleeding of the tissue neighboring the fistula; enhancing healing of the tissue neighboring the fistula. In a preferred embodiment, the anastomotic implant includes an active agent, such as an anti-thrombogenic or anti-proliferative agent, and may also include a covering or partial covering.
[00451 A second slidable core, needle assembly 50, is slidingly received within a lumen of inner core 20. Needle assembly 50, which may be rigid or flexible along its length, is preferably constructed of one or more metals such as stainless steel and Nitinol. Needle assembly 50 can be retracted, and completely removed from the lumen of inner core 20 by retraction of needle retraction knob 52. In a preferred embodiment, Inner core 20 can also be retracted, and completely removed from the lumen of outer sheath 30, by retraction of knob 20. Needle assembly 50 has a sharpened distal tip 51, which is preferably sharp and beveled.
Needle assembly 50 includes a lumen from its proximal end to its distal end, guidewire lumen 53, which is configured to allow a standard interventional guidewire to be advanced therethrough, and further configured to allow needle assembly 50 to be removed leaving the previously inserted guidewire to reside within the lumen of inner core 20 previously inhabited by needle assembly 50. In an alternative embodiment, needle assembly 50 is partially retracted but remains within lumen of inner core 20. In another alternative embodiment, needle tip 51 may be configured to deliver energy, such as RF
energy used to assist in advancement, and/or to cauterize, cut and ablate tissue. In a preferred method, device 10 is advanced through the skin, through a first vessel and into the lumen of a second vessel with needle assembly 50 in the fully advanced position. A locking mechanism, not shown, may be engaged to prevent relative motion between needle assembly 50 and outer sheath 30 during insertion and subsequent advancement. A guidewire is then advanced through guidewire lumen 53 and further advanced down the lumen of the second vessel.
[0046] Referring now to Fig. 2b, needle assembly 50 has been completely removed from the lumen of inner core 20, such as when a guidewire has been successfully placed from a location outside the patient's skin to and into the second vessel. Referring now to fig. 2c, the distal end of clip 60 has been released from being constrained by outer sheath 30, either by retraction of outer sheath 30, advancement of inner core 20, or a combination of both movements. Clip 60 of Figs. 2a through 2d is self-expanding, such as a resiliently biased tubular structure made of Nitinol. In Fig. 2d, clip 60 has been fully released from being constrained and is in a fully expanded condition. Balloon 25 has been inflated, inflation lumen and endoflator attachment not shown, to provide additional expansion force to clip 60.
In an alternative embodiment, clip 60 is plastically deformable, or includes plastically deformable portions, such that balloon 25 is required to expand clip 60. In a preferred embodiment, device 10 of figs. 2a through 2d is used as a system in conjunction with one or more additional devices to create and/or maintain the fistula. Such additional devices include but are not limited to guidewires and various over-the-wire devices that are placed over the guidewire placed through needle assembly 50, after needle assembly 50 is removed. These additional over-the-wire devices may be placed within a lumen of inner core 20, within a lumen of outer sheath 30 with inner core 20 removed, or over the guidewire after device 10 has been completely removed. These over-the-wire devices include but are not limited to:
balloon catheters; anastomotic implant delivery devices and implants; flow measurement catheters; angiography catheters; venography catheters; and other over-the wire devices applicable to modifying the fistula, such as modifying the flow of the fistula, or to perform a procedure to otherwise enhance and/or maintain the long term benefit of the fistula.
[0047] Referring now to Figs. 3a through 3f, a preferred method of using the fistula creation device of the present invention is shown. A cross sectional view of a patient's anatomy at a proposed fistula location 111 is depicted wherein artery 130 is directly above vein 120 in relation to skin surface 105. Intended fistula location 111 may be determined using one or more visualization techniques including but not limited to:
angiography;
venography; extra-vascular ultrasound; intravascular ultrasound; and MRI.
Intended fistula location 111 may be determined using one or more flow measurement techniques such as Doppler ultrasound. The intended fistula location 111 may be selected based on parameters selected from the group consisting of: first vessel diameter; second vessel diameter; artery diameter; vein diameter; ratio of artery to vein diameter; distance between the artery and vein lumens; geometric relationship between the artery and vein lumens; distance from an arterial side branch; distance from an venous side branch; arterial flow; venous flow;
oxygen content in artery; oxygen content in vein; wall thickness of artery; wall thickness of vein; degree of calcification of artery; degree of calcification of vein; geometric relationship between the artery and vein lumens at the fistula site; hemodynamic factors; other parameters; and combinations thereof.
[0048] Artery 130 includes, in closest proximity to skin 105, arterial wall 131. Vein 120 includes, in closest proximity to artery 130, venous wall 121. At the intended fistula location 111 of the patient, the vessels may lie in various geometric configurations, such as the geometry of Figs. 3a through 3f wherein the first vessel is relatively "on top" of the second vessel such that the lumen of the first vessel lies relatively proximate the shortest line between the lumen of the second vessel at the fistula location and the surface of the patient's skin. In alternative fistula locations, the vessels may lie in a more "side-to-side"
configuration. When inserted, the elongate body of outer sheath 30 is positioned to lie relatively in the plane defined by the lumens of the two vessels near the intended fistula location. While maintaining position within this plane, the fistula creation device can be inserted at an angle relatively perpendicular to the surface of the patient's skin, or at a smaller angle as is shown in Fig 3a, such as an angle between 20 and 80 degrees. This insertion angle may be chosen by the clinician to form the resultant fistula angular geometry between the two vessels, such as at a small insertion angle to correspond to a similarly small angle between the lumen of the first vessel and the lumen of the fistula. Such a small angle between the first vessel lumen and the fistula lumen may be desirous to reduce turbulent flow through the fistula. In alternative embodiments, an insertion angle approximating ninety degrees may be chosen, such as to minimize the length of the resultant fistula. Vein 120 is preferably a vein located in a limb of the patient, such as a vein selected from the group consisting of: saphenous vein; femoral vein; iliac vein; popliteal vein;
brachial vein; basilic vein; cephalic vein; medial forearm vein; medial cubital vein; axillary vein;
and jugular vein.
Artery 130 is preferably an artery in a limb of the patient, such as an artery selected from the group consisting of: axillary artery; brachial artery; ulnar artery; radial artery; profundal artery; femoral artery; iliac artery; popliteal artery; carotid artery.
[0049] Referring now specifically to Fig. 3a, a fistula creation device is positioned with its distal end near an intended skin puncture site and includes outer sheath 30 with distal end 31.
Outer sheath 30 is preferably constructed of a biocompatible catheter material, such materials and construction methods described in detail hereabove. Extending beyond distal end 31 is the distal end of a slidable needle assembly including needle tip 51 and guidewire lumen 53.
The needle assembly is preferably constructed of a metal or metal alloy such as stainless steel or Nitinol, and needle tip 51 is a sharpened, beveled tip.
16 [0050] Referring now to Fig. 3b, needle tip 51 has been advanced through skin 105, through artery wall 31, and into the lumen of artery 130. Distal end 31 of outer sheath 30 has also passed through skin 105 without any significant displacement between needle tip 51 and distal end 31, either by a releasable fixation device, not shown but integral to the fistula [0051] Referring now to Fig. 3e, a self-expanding anastomotic implant, clip 60, is partially 30 such as while maintaining the longitudinal position of clip 60; or by a combination of [0052] Shown in Fig. 3f, the fistula creation device is being withdrawn, such that distal end 31 of outer sheath 30 is almost removed from entering skin 105. Guidewire 80 remains in
17 place, such that one or more additional devices can be placed over-the-wire and easily access either the artery 130 or venous 120 side of fistula 110. These subsequent over-the-wire devices, described in detail in reference to Fig. 2d, can be used to assess the fistula such as an ultrasound catheter to visualize the fistula, or a Doppler ultrasound catheter to measure fistula flow. The over-the-wire devices can be used to modify the fistula such as to modify the flow rate through the fistula, or to otherwise improve the therapeutic benefit of the fistula such as to increase the long-term patency of the fistula or to minimize adverse side effects of the fistula. In a preferred embodiment, an over-the-wire or other procedure is performed to measure flow through the fistula. If inadequate flow is determined, a flow modification procedure may be performed, such as an over-the-wire flow modification procedure utilizing an inflatable balloon or a tissue removing device to increase fistula flow. In a preferred embodiment, the inflatable balloon has a non-circular geometry which corresponds to a fistula created with a non-circular geometry. The balloon may be integral to the fistula creation device, or a separate over-the-wire catheter, and may be inflated to apply force to clip 60, or a second implant, all not shown. Other flow modification procedure may also be performed, such as procedures which place implants, within or external to the flow path, to increase or decrease fistula flow to maximize therapeutic benefit and/or reduce adverse side effects. Other flow modification procedures that may be performed include application of an agent such as an anti-biotic, anti-thrombogenic or anti-proliferative agent, or delivery of energy such as radiation delivery to prevent neointimal growth.
[00531 The method and device of Figs. 3a through 3f are used to create a fistula for therapeutic benefit such as to treat a patient with COPD. The fistula can be created for various purposes such as: increasing the oxygen content of venous blood supplying a lung of the patient, increase the oxygen content of arterial blood; and/or decreasing systemic vascular resistance. The fistula can be created for an acute period less than twenty-four hours, a sub-chronic period between twenty-four hours and thirty days, as well as for a chronic period longer than thirty days. The fistula preferably provides a flow of blood from the arterial system to the venous system of greater than 5 ml/min, typically greater than 50 ml/min. Clip 60 provides one or more functions including but not limited to: scaffolding an opening between the first vessel and the second vessel; reducing neointimal proliferation into the fistula flow path; preventing tissue from protruding into the fistula flow path; placing a portion of the first vessel wall in tension with the tissue of the second vessel wall; reducing bleeding of the tissue neighboring the fistula; enhancing healing of the tissue neighboring the
[00531 The method and device of Figs. 3a through 3f are used to create a fistula for therapeutic benefit such as to treat a patient with COPD. The fistula can be created for various purposes such as: increasing the oxygen content of venous blood supplying a lung of the patient, increase the oxygen content of arterial blood; and/or decreasing systemic vascular resistance. The fistula can be created for an acute period less than twenty-four hours, a sub-chronic period between twenty-four hours and thirty days, as well as for a chronic period longer than thirty days. The fistula preferably provides a flow of blood from the arterial system to the venous system of greater than 5 ml/min, typically greater than 50 ml/min. Clip 60 provides one or more functions including but not limited to: scaffolding an opening between the first vessel and the second vessel; reducing neointimal proliferation into the fistula flow path; preventing tissue from protruding into the fistula flow path; placing a portion of the first vessel wall in tension with the tissue of the second vessel wall; reducing bleeding of the tissue neighboring the fistula; enhancing healing of the tissue neighboring the
18 fistula; and combinations thereof. While clip 60 has been described as a self-expanding device such as a resiliently biased Nitinol component, anastomotic implants that are plastically deformable or include both self-expanding sections and balloon expandable portions are also preferred. In an alternative embodiment, clip 60 includes a covering, such as a covering that surrounds the interior of the tissue within the fistula between the artery and vein lumens. The covering is a biocompatible material such as polytetrafluoroethylene;
Dacron; Nitinol; stainless steel; or combinations thereof. In another alternative embodiment, clip 60 includes an agent, such as an agent that is eluded over time including anti-bacterial, anti-thrombogenic and/or anti-prolific agents. While, the method of Figs. 3a through 3f illustrate an artery to vein connection method, a vein to artery approach is also a preferred method of this invention.
[0054] The device and method of Figs. 3a through 3f create an initial puncture through the skin of the patient, subsequently penetrating into and through the first vessel, and into the lumen of the second vessel. In an alternative, also preferred embodiment, not shown, a standard vessel introducer and sheath is utilized, making the initial puncture through the skin of the patient and into the first vessel. The fistula creation device distal end is then inserted into the sheath, passing through the skin and into the first vessel. The fistula creation device distal end exits the end of the sheath and further exits the lumen of the first vessel at the intended fistula location site by penetrating through the first vessel wall, and enters the lumen of the second vessel by penetrating through the second vessel wall. The intended fistula location may be proximate the site that the vessel introducer entered the first vessel, or at a location remote from this site, such as at a location greater than 20 mm from the first vessel entry site. Fistulas may be created remote from the first vessel entry site by intraluminally advancing the introducer sheath and/or the fistula creation device down the lumen of the first vessel prior to the distal end of the fistula creation device exiting the first vessel lumen and penetrating into the second vessel.
[0055] Referring now to Figs. 4a and 4h, a method and system for creating a fistula is shown in which an operator utilizes a fistula creation device and ultrasound visualization system in combination. A cross sectional view of a patient's anatomy at a proposed fistula location 111 is depicted wherein artery 130 is directly above vein 120 in relation to skin surface 105. Intended fistula location 111 may be determined using one or more visualization techniques including but not limited to: angiography;
venography; extra-vascular ultrasound; intravascular ultrasound; and MRI. Intended fistula location 111 may be
Dacron; Nitinol; stainless steel; or combinations thereof. In another alternative embodiment, clip 60 includes an agent, such as an agent that is eluded over time including anti-bacterial, anti-thrombogenic and/or anti-prolific agents. While, the method of Figs. 3a through 3f illustrate an artery to vein connection method, a vein to artery approach is also a preferred method of this invention.
[0054] The device and method of Figs. 3a through 3f create an initial puncture through the skin of the patient, subsequently penetrating into and through the first vessel, and into the lumen of the second vessel. In an alternative, also preferred embodiment, not shown, a standard vessel introducer and sheath is utilized, making the initial puncture through the skin of the patient and into the first vessel. The fistula creation device distal end is then inserted into the sheath, passing through the skin and into the first vessel. The fistula creation device distal end exits the end of the sheath and further exits the lumen of the first vessel at the intended fistula location site by penetrating through the first vessel wall, and enters the lumen of the second vessel by penetrating through the second vessel wall. The intended fistula location may be proximate the site that the vessel introducer entered the first vessel, or at a location remote from this site, such as at a location greater than 20 mm from the first vessel entry site. Fistulas may be created remote from the first vessel entry site by intraluminally advancing the introducer sheath and/or the fistula creation device down the lumen of the first vessel prior to the distal end of the fistula creation device exiting the first vessel lumen and penetrating into the second vessel.
[0055] Referring now to Figs. 4a and 4h, a method and system for creating a fistula is shown in which an operator utilizes a fistula creation device and ultrasound visualization system in combination. A cross sectional view of a patient's anatomy at a proposed fistula location 111 is depicted wherein artery 130 is directly above vein 120 in relation to skin surface 105. Intended fistula location 111 may be determined using one or more visualization techniques including but not limited to: angiography;
venography; extra-vascular ultrasound; intravascular ultrasound; and MRI. Intended fistula location 111 may be
19 determined using one or more flow measurement techniques such as Doppler ultrasound.
The intended fistula location 111 may be selected based on parameters selected from the group consisting of: first vessel diameter; second vessel diameter; artery diameter; vein diameter; ratio of artery to vein diameter; distance between the artery and vein lumens;
geometric relationship between the artery and vein lumens; distance from an arterial side branch; distance from an venous side branch; arterial flow; venous flow;
oxygen content in artery; oxygen content in vein; wall thickness of artery; wall thickness of vein; degree of calcification of artery; degree of calcification of vein; geometric relationship between the artery and vein lumens at the fistula site; hemodynamic factors; other parameters; and combinations thereof [0056] Artery 130 includes, in closest proximity to skin 105, arterial wall 131. Vein 120 includes, in closest proximity to artery 130, venous wall 121. While vein 120 and artery 130 are shown in a line relatively perpendicular to skin 105, adjusting the orientation of outer sheath 30 can not only vary insertion angles, but also accommodate anatomies with vessels in a relatively side-by-side configuration (relatively equidistant from skin surface 105) as has been described hereabove in reference to Figs. 3a through 3f In a preferred method, the fistula creation device enters the skin at an angle relatively perpendicular to skin 105. In another preferred embodiment, the fistula creation device penetrated the skin at an angle between 20 and 80 degrees relative to the surface of the skin 105. Vein 120 is preferably a vein located in a limb of the patient, such as a vein selected from the group consisting of:
saphenous vein; femoral vein; iliac vein; popliteal vein; brachial vein;
basilic vein; cephalic vein; medial forearm vein; medial cubital vein; axillary vein; and jugular vein. Artery 130 is preferably an artery in a limb of the patient, such as an artery selected from the group consisting of: axillary artery; brachial artery; ulnar artery; radial artery;
profundal artery;
femoral artery; iliac artery; popliteal artery; carotid artery.
[0057] Referring now to specifically to Fig. 4a, a fistula creation device is positioned with its distal end at an intended fistula site 111. The fistula creation device includes outer sheath 30, which is preferably constructed of a bio compatible catheter material, such materials and construction methods described in detail hereabove. Extending beyond distal end 31 of outer sheath 30 is the distal end of a slidable needle assembly including needle tip 51 and guidewire lumen 53. The needle assembly is preferably constructed of a metal or metal alloy such as stainless steel or Nitinol, and needle tip 51 is a sharpened, beveled tip. Needle tip 51 has been advanced through skin 105, through artery wall 31, and into the lumen of artery 130 residing near intended fistula site 111. Distal end 31 of outer sheath 30 has also passed through skin 105 without any significant displacement between needle tip 51 and distal end 31, either by a releasable fixation device, not shown but integral to the fistula creation device, or by stabilization of both the outer sheath 30 and the needle assembly by the operator.
[0058] Also shown in Fig. 4a is ultrasound probe 71, which is positioned relatively orthogonal to the surface of skin 105, and preferably held by an operator, operator not shown, to provide a visual cross sectional image of intended fistula site 111, as well as artery 130, vein 120, and any devices crossing through the imaging plane of ultrasound probe 71.
Ultrasonic coupling gel 74, common to external ultrasound probe use, is first placed on the skin, in the area to be visualized, to enhance the image produced by ultrasound probe 71 via improved acoustic coupling between ultrasound probe 71 and skin 105. Referring additionally to Fig. 4b, ultrasound probe 71 is attached to an ultrasound generator, not shown, as well as ultrasound monitor 72 which displays on imaging area 73 the cross sectional image associated with the imaging plane of Fig. 4a. Manipulation of probe 71, either in the position of contact with skin 105 and/or the relative angle made with the surface of skin 105, modifies the location of the imaging plane and the associated image displayed on monitor 72.
Ultrasound probe 71 and monitor 72 are used and manipulated by an operator as a system including the fistula creation device of the present invention. This system is used to assess and pre-determine the location of intended fistula location 111. The visualization equipment is also used to view and confirm advancements of the percutaneous devices such as catheter, sheath, inner tube and guidewire advancements; confirm device locations such as device distal end (tip) locations; and assist in other preferred fistula creation steps of the present invention in which real-time visualization of the procedure can be made available to an operator. In an alternative, also preferred embodiment, as an alternative to or in conjunction with ultrasound probe 71, an internal ultrasound probe provides an image to monitor 72. The internal probe, not shown, is selected from the group consisting of: an ultrasound catheter such as a rotational or phased array intravascular ultrasound catheter; an inserted probe such as a transesophageal probe; and combinations thereof.
100591 In subsequent steps, not shown but similar to steps 3c through 3f hereabove, needle tip 51 will be advanced out of artery 130, through venous wall 121 and into the lumen of vein 120. A guidewire, not shown, will be advanced from the proximal end of the fistula creation device, through guidewire lumen 53 and down the lumen of vein 120. The needle assembly will then be retracted such that needle tip 51 will be retracted proximal to distal end 31 of outer sheath 30, while leaving the guidewire deep seated into vein 120. An anastomotic implant, not shown, is deployed such as by retraction of sheath 30 while maintaining the position of the anastomotic implant. The anastomotic implant is configured such that the resultant fistula has an oval cross-section, with a major axis at least twenty percent greater than the minor axis of the oval. The fistula creation device is then withdrawn, such that distal end 31 of outer sheath 30 is almost removed from entering skin 105. The guidewire preferably remains in place, such as through a standard vessel introducer, not shown. In a preferred embodiment, outer sheath 30 performs as the vessel introducer.
Leaving the guidewire in place allows one or more additional devices to be placed over-the-wire and easily access either the venous or arterial side of the fistula. These subsequent over-the-wire devices, described in detail in reference to Fig. 2d, can be used to assess the fistula such as an ultrasound catheter to visualize the fistula, or a Doppler ultrasound catheter to measure fistula flow. The over-the-wire devices can be used to modify the fistula such as to modify the flow rate through the fistula, or to otherwise improve the therapeutic benefit of the fistula such as to increase the long-term patency of the fistula or to minimize adverse side effects of the fistula. In a preferred embodiment, an over-the-wire or other procedure is performed to measure flow through the fistula. If inadequate flow is determined, a flow modification procedure may be performed, such as an over-the-wire flow modification procedure utilizing an inflatable balloon or a tissue-removing device to increase fistula flow. In a preferred embodiment, the inflatable balloon has a non-circular geometry that corresponds to a fistula created with a non-circular geometry. The balloon may be integral to the fistula creation device, or a separate over-the-wire catheter, and may be inflated to apply force to clip 60, or a second implant, all not shown. Other flow modification procedure may also be performed, such as procedures that place implants, within or external to the flow path, to increase or decrease fistula flow to maximize therapeutic benefit and/or reduce adverse side effects.
[0060] Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only.
The intended fistula location 111 may be selected based on parameters selected from the group consisting of: first vessel diameter; second vessel diameter; artery diameter; vein diameter; ratio of artery to vein diameter; distance between the artery and vein lumens;
geometric relationship between the artery and vein lumens; distance from an arterial side branch; distance from an venous side branch; arterial flow; venous flow;
oxygen content in artery; oxygen content in vein; wall thickness of artery; wall thickness of vein; degree of calcification of artery; degree of calcification of vein; geometric relationship between the artery and vein lumens at the fistula site; hemodynamic factors; other parameters; and combinations thereof [0056] Artery 130 includes, in closest proximity to skin 105, arterial wall 131. Vein 120 includes, in closest proximity to artery 130, venous wall 121. While vein 120 and artery 130 are shown in a line relatively perpendicular to skin 105, adjusting the orientation of outer sheath 30 can not only vary insertion angles, but also accommodate anatomies with vessels in a relatively side-by-side configuration (relatively equidistant from skin surface 105) as has been described hereabove in reference to Figs. 3a through 3f In a preferred method, the fistula creation device enters the skin at an angle relatively perpendicular to skin 105. In another preferred embodiment, the fistula creation device penetrated the skin at an angle between 20 and 80 degrees relative to the surface of the skin 105. Vein 120 is preferably a vein located in a limb of the patient, such as a vein selected from the group consisting of:
saphenous vein; femoral vein; iliac vein; popliteal vein; brachial vein;
basilic vein; cephalic vein; medial forearm vein; medial cubital vein; axillary vein; and jugular vein. Artery 130 is preferably an artery in a limb of the patient, such as an artery selected from the group consisting of: axillary artery; brachial artery; ulnar artery; radial artery;
profundal artery;
femoral artery; iliac artery; popliteal artery; carotid artery.
[0057] Referring now to specifically to Fig. 4a, a fistula creation device is positioned with its distal end at an intended fistula site 111. The fistula creation device includes outer sheath 30, which is preferably constructed of a bio compatible catheter material, such materials and construction methods described in detail hereabove. Extending beyond distal end 31 of outer sheath 30 is the distal end of a slidable needle assembly including needle tip 51 and guidewire lumen 53. The needle assembly is preferably constructed of a metal or metal alloy such as stainless steel or Nitinol, and needle tip 51 is a sharpened, beveled tip. Needle tip 51 has been advanced through skin 105, through artery wall 31, and into the lumen of artery 130 residing near intended fistula site 111. Distal end 31 of outer sheath 30 has also passed through skin 105 without any significant displacement between needle tip 51 and distal end 31, either by a releasable fixation device, not shown but integral to the fistula creation device, or by stabilization of both the outer sheath 30 and the needle assembly by the operator.
[0058] Also shown in Fig. 4a is ultrasound probe 71, which is positioned relatively orthogonal to the surface of skin 105, and preferably held by an operator, operator not shown, to provide a visual cross sectional image of intended fistula site 111, as well as artery 130, vein 120, and any devices crossing through the imaging plane of ultrasound probe 71.
Ultrasonic coupling gel 74, common to external ultrasound probe use, is first placed on the skin, in the area to be visualized, to enhance the image produced by ultrasound probe 71 via improved acoustic coupling between ultrasound probe 71 and skin 105. Referring additionally to Fig. 4b, ultrasound probe 71 is attached to an ultrasound generator, not shown, as well as ultrasound monitor 72 which displays on imaging area 73 the cross sectional image associated with the imaging plane of Fig. 4a. Manipulation of probe 71, either in the position of contact with skin 105 and/or the relative angle made with the surface of skin 105, modifies the location of the imaging plane and the associated image displayed on monitor 72.
Ultrasound probe 71 and monitor 72 are used and manipulated by an operator as a system including the fistula creation device of the present invention. This system is used to assess and pre-determine the location of intended fistula location 111. The visualization equipment is also used to view and confirm advancements of the percutaneous devices such as catheter, sheath, inner tube and guidewire advancements; confirm device locations such as device distal end (tip) locations; and assist in other preferred fistula creation steps of the present invention in which real-time visualization of the procedure can be made available to an operator. In an alternative, also preferred embodiment, as an alternative to or in conjunction with ultrasound probe 71, an internal ultrasound probe provides an image to monitor 72. The internal probe, not shown, is selected from the group consisting of: an ultrasound catheter such as a rotational or phased array intravascular ultrasound catheter; an inserted probe such as a transesophageal probe; and combinations thereof.
100591 In subsequent steps, not shown but similar to steps 3c through 3f hereabove, needle tip 51 will be advanced out of artery 130, through venous wall 121 and into the lumen of vein 120. A guidewire, not shown, will be advanced from the proximal end of the fistula creation device, through guidewire lumen 53 and down the lumen of vein 120. The needle assembly will then be retracted such that needle tip 51 will be retracted proximal to distal end 31 of outer sheath 30, while leaving the guidewire deep seated into vein 120. An anastomotic implant, not shown, is deployed such as by retraction of sheath 30 while maintaining the position of the anastomotic implant. The anastomotic implant is configured such that the resultant fistula has an oval cross-section, with a major axis at least twenty percent greater than the minor axis of the oval. The fistula creation device is then withdrawn, such that distal end 31 of outer sheath 30 is almost removed from entering skin 105. The guidewire preferably remains in place, such as through a standard vessel introducer, not shown. In a preferred embodiment, outer sheath 30 performs as the vessel introducer.
Leaving the guidewire in place allows one or more additional devices to be placed over-the-wire and easily access either the venous or arterial side of the fistula. These subsequent over-the-wire devices, described in detail in reference to Fig. 2d, can be used to assess the fistula such as an ultrasound catheter to visualize the fistula, or a Doppler ultrasound catheter to measure fistula flow. The over-the-wire devices can be used to modify the fistula such as to modify the flow rate through the fistula, or to otherwise improve the therapeutic benefit of the fistula such as to increase the long-term patency of the fistula or to minimize adverse side effects of the fistula. In a preferred embodiment, an over-the-wire or other procedure is performed to measure flow through the fistula. If inadequate flow is determined, a flow modification procedure may be performed, such as an over-the-wire flow modification procedure utilizing an inflatable balloon or a tissue-removing device to increase fistula flow. In a preferred embodiment, the inflatable balloon has a non-circular geometry that corresponds to a fistula created with a non-circular geometry. The balloon may be integral to the fistula creation device, or a separate over-the-wire catheter, and may be inflated to apply force to clip 60, or a second implant, all not shown. Other flow modification procedure may also be performed, such as procedures that place implants, within or external to the flow path, to increase or decrease fistula flow to maximize therapeutic benefit and/or reduce adverse side effects.
[0060] Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only.
Claims (22)
1. A device for creating a fistula in a patient comprising:
an elongate tubular structure having a proximal end and a distal end, wherein the distal end is configured to pass first through the skin of the patient, then through a first vessel, and then into a second vessel; and a self expanding fistula creation assembly disposed near the distal end of the elongate tubular structure, said assembly for creating, maintaining or creating and maintaining a fistula that provides a flow of blood between the first vessel and the second vessel, wherein the tubular structure comprises an outer tube and a slidable core slidingly received by said outer tube, wherein the slidable core has a proximal end, a distal end, and a lumen therethrough, wherein the tubular structure comprises a second slidable core slidingly received by the first slidable core, wherein the second slidable core has a proximal end, a distal end, and a lumen therethrough and is configured to be advanced through tissue to form a penetration, and wherein the self-expanding fistula creation assembly is carried on the first slidable core and constrained by the tubular structure such that the outer tube can be retracted to release the fistular creation assembly in the penetration.
an elongate tubular structure having a proximal end and a distal end, wherein the distal end is configured to pass first through the skin of the patient, then through a first vessel, and then into a second vessel; and a self expanding fistula creation assembly disposed near the distal end of the elongate tubular structure, said assembly for creating, maintaining or creating and maintaining a fistula that provides a flow of blood between the first vessel and the second vessel, wherein the tubular structure comprises an outer tube and a slidable core slidingly received by said outer tube, wherein the slidable core has a proximal end, a distal end, and a lumen therethrough, wherein the tubular structure comprises a second slidable core slidingly received by the first slidable core, wherein the second slidable core has a proximal end, a distal end, and a lumen therethrough and is configured to be advanced through tissue to form a penetration, and wherein the self-expanding fistula creation assembly is carried on the first slidable core and constrained by the tubular structure such that the outer tube can be retracted to release the fistular creation assembly in the penetration.
2. The device of claim 1, wherein the second slidable core has a tapered, beveled or sharpened distal end.
3. The device of claim 1 or 2, wherein the device is configured to be advanced or advanced and retracted over a guidewire contained within a lumen of the second slidable core.
4. The device of claim 1, 2 or 3, wherein the fistula creation assembly comprises one or more of a cone shaped dilator, an expandable assembly, an energy delivery element, an agent delivery element, and an anastomotic implant.
5. The device of claim 4, wherein the expandable assembly comprises a balloon.
6. The device of claim 1, 2 or 3, wherein the self-expanding fistula creation assembly comprises an anastomotic implant constructed of materials selected from the group consisting of stainless steel, Nitinol, plastically deformable materials, and combinations thereof.
7. The device of claim 6, wherein the fistula creation assembly further comprises an expandable balloon configured to apply radial force to at least a portion of the anastomotic implant, said radial force applied to said anastomotic implant during deployment of the anastomotic implant in the fistula, after deployment of the anastomotic implant in the fistula or both.
8. The device of claim 6 or 7, wherein the anastomotic implant is configured to perform one or more of the following functions: apply a radial force to the fistula, apply a compressive force to the first and second vessels, and cause flow in the fistula to tend toward laminar flow.
9. The device of any one of claims 1 to 8, wherein the fistula creation assembly further comprises an agent delivery element, said delivery element configured to deliver agents selected from the group consisting of anti-proliferative, anti-biotic, anti-thrombogenic, and combinations thereof.
10. The device of any one of claims 1 to 9, wherein the fistula is for:
providing a therapy for chronic obstructive pulmonary disease, increase venous oxygen level, increase arterial oxygen level, decrease systemic vascular resistance, or a combination thereof.
providing a therapy for chronic obstructive pulmonary disease, increase venous oxygen level, increase arterial oxygen level, decrease systemic vascular resistance, or a combination thereof.
11. The device of any one of claims 1 to 10, further comprising a handle on the proximal end and at least one slidable core; wherein the handle includes one or more controls configured to activate or otherwise control at least a portion of the fistula creation assembly.
12. The device of claim 11, wherein the activation or control is of one or more of:
expansion of balloon deployment of an anastomotic implant; apply force to an anastomotic implant; delivery of energy; delivery of an agent; advance or retract the slidable core; and combinations thereof.
expansion of balloon deployment of an anastomotic implant; apply force to an anastomotic implant; delivery of energy; delivery of an agent; advance or retract the slidable core; and combinations thereof.
13. The device of any one of claims 1 to 12, wherein the first vessel is selected from the group consisting of axillary artery, brachial artery, ulnar artery, radial artery, profundal artery, femoral artery, iliac artery, popliteal artery, carotid artery, saphenous vein, femoral vein, iliac vein, popliteal vein, brachial vein, basilic vein, cephalic vein, medial forearm vein, medial cubital vein, axillary vein, and jugular vein.
14. The device of any one of claims 1 to 13, wherein the second vessel wall is within 20 mm of the first vessel wall.
15. The device of any one of claims 1 to 14, wherein the elongate tubular structure includes a lumen from its proximal end to its distal end, wherein the device is configured to reside in the patient with a guidewire in said lumen, said device further configured to be withdrawn from the patient leaving the guidewire to remain passing through the skin and into the patient, through the first vessel, through the fistula, and into the second vessel.
16. The device of any one of claims 1 to 15, wherein the tubular structure includes a flow measurement element configured to measure flow of the patient's blood.
17. The device of any one of claims 1 to 16 further comprising flow adjustment means, said flow adjustment means comprising one or more of: an inflatable balloon; an implant which impedes flow in the fistula, and an implant which enlarges the fistula.
18. The device of any one of claims 1 to 16 further comprising flow adjustment means, said flow adjustment means comprising an implant for deployment in the fistula or for deployment within a pre-existing implant.
19. A system for creating a fistula comprising a device as defined in any one of claims 1 to 18 and an ultrasound visualization monitor.
20. A system for creating a fistula comprising:
a device as defined in any one of claims 1 to 18 and one or more of:
a balloon catheter, an anastomotic implant deployment catheter, a flow measurement device, an angiography catheter, a venography catheter, a guidewire, an introducer, a needle and a biopsy needle.
a device as defined in any one of claims 1 to 18 and one or more of:
a balloon catheter, an anastomotic implant deployment catheter, a flow measurement device, an angiography catheter, a venography catheter, a guidewire, an introducer, a needle and a biopsy needle.
21. The system of claim 20, wherein the flow measurement device is a flow catheter or an external Doppler probe.
22. A kit for creating a long-term fistula in a patient to treat chronic obstructive pulmonary disease, said kit including:
a first fistula creation device which is a device as defined in any one of claims 1 to 18, said first fistula creation device for forming a fistula with a first geometry;
a second fistula creation device which is a device as defined in any one of claims 1 to 18, said second fistula creation device for forming a fistula with a second geometry, wherein either the first fistula creation device or the second fistula creation device is for use to create said long-term fistula, based on visualization of the patient.
a first fistula creation device which is a device as defined in any one of claims 1 to 18, said first fistula creation device for forming a fistula with a first geometry;
a second fistula creation device which is a device as defined in any one of claims 1 to 18, said second fistula creation device for forming a fistula with a second geometry, wherein either the first fistula creation device or the second fistula creation device is for use to create said long-term fistula, based on visualization of the patient.
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| US60/696,319 | 2005-06-30 | ||
| PCT/US2006/024858 WO2007005386A1 (en) | 2005-06-30 | 2006-06-26 | Devices, systems, and methods for creation of a peripherally located fistula |
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| CA2612130A1 CA2612130A1 (en) | 2007-01-11 |
| CA2612130C true CA2612130C (en) | 2014-05-06 |
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| CA2612130A Active CA2612130C (en) | 2005-06-30 | 2006-06-26 | Devices, systems, and methods for creation of a peripherally located fistula |
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| EP (1) | EP1898811B1 (en) |
| AU (1) | AU2006266149B2 (en) |
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Families Citing this family (127)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8241274B2 (en) | 2000-01-19 | 2012-08-14 | Medtronic, Inc. | Method for guiding a medical device |
| US7756583B2 (en) | 2002-04-08 | 2010-07-13 | Ardian, Inc. | Methods and apparatus for intravascularly-induced neuromodulation |
| US8150519B2 (en) | 2002-04-08 | 2012-04-03 | Ardian, Inc. | Methods and apparatus for bilateral renal neuromodulation |
| US8347891B2 (en) | 2002-04-08 | 2013-01-08 | Medtronic Ardian Luxembourg S.A.R.L. | Methods and apparatus for performing a non-continuous circumferential treatment of a body lumen |
| US7617005B2 (en) | 2002-04-08 | 2009-11-10 | Ardian, Inc. | Methods and apparatus for thermally-induced renal neuromodulation |
| DE202004021942U1 (en) | 2003-09-12 | 2013-05-13 | Vessix Vascular, Inc. | Selectable eccentric remodeling and / or ablation of atherosclerotic material |
| US7828814B2 (en) | 2004-08-27 | 2010-11-09 | Rox Medical, Inc. | Device and method for establishing an artificial arterio-venous fistula |
| US9706997B2 (en) | 2004-08-27 | 2017-07-18 | Rox Medical, Inc. | Device and method for establishing an artificial arterio-venous fistula |
| US20060047337A1 (en) | 2004-08-27 | 2006-03-02 | Brenneman Rodney A | Device and method for establishing an artificial arterio-venous fistula |
| GB0419954D0 (en) | 2004-09-08 | 2004-10-13 | Advotek Medical Devices Ltd | System for directing therapy |
| US8396548B2 (en) | 2008-11-14 | 2013-03-12 | Vessix Vascular, Inc. | Selective drug delivery in a lumen |
| US9713730B2 (en) | 2004-09-10 | 2017-07-25 | Boston Scientific Scimed, Inc. | Apparatus and method for treatment of in-stent restenosis |
| US9125667B2 (en) | 2004-09-10 | 2015-09-08 | Vessix Vascular, Inc. | System for inducing desirable temperature effects on body tissue |
| US8226592B2 (en) | 2004-12-15 | 2012-07-24 | Rox Medical, Inc. | Method of treating COPD with artificial arterio-venous fistula and flow mediating systems |
| EP1898811B1 (en) | 2005-06-30 | 2019-03-06 | Rox Medical, Inc. | Devices and systems for creation of a peripherally located fistula |
| US20130190676A1 (en) | 2006-04-20 | 2013-07-25 | Limflow Gmbh | Devices and methods for fluid flow through body passages |
| US8019435B2 (en) | 2006-05-02 | 2011-09-13 | Boston Scientific Scimed, Inc. | Control of arterial smooth muscle tone |
| US20080039746A1 (en) | 2006-05-25 | 2008-02-14 | Medtronic, Inc. | Methods of using high intensity focused ultrasound to form an ablated tissue area containing a plurality of lesions |
| EP2029025B1 (en) * | 2006-06-02 | 2011-03-23 | St. Michael's Hospital | Ultrasonic evaluation of venous structures |
| AU2007310986B2 (en) | 2006-10-18 | 2013-07-04 | Boston Scientific Scimed, Inc. | Inducing desirable temperature effects on body tissue |
| AU2007310988B2 (en) | 2006-10-18 | 2013-08-15 | Vessix Vascular, Inc. | Tuned RF energy and electrical tissue characterization for selective treatment of target tissues |
| WO2010030389A2 (en) * | 2008-09-15 | 2010-03-18 | University Of Pittsburgh -Of The Common Wealth System Of Higher Education | An echo-specific k-space reordering approach to compatible dual-echo arteriovenography |
| WO2010039862A1 (en) * | 2008-09-30 | 2010-04-08 | Rox Medical, Inc. | Methods for screening and treating patients with compromised cardiopulmonary function |
| US20100106161A1 (en) * | 2008-10-23 | 2010-04-29 | Marwan Tabbara | Surgical methods, devices, and kits |
| AU2009314133B2 (en) | 2008-11-17 | 2015-12-10 | Vessix Vascular, Inc. | Selective accumulation of energy with or without knowledge of tissue topography |
| KR20130108067A (en) | 2010-04-09 | 2013-10-02 | 베식스 바스큘라 인코포레이티드 | Power generating and control apparatus for the treatment of tissue |
| US9192790B2 (en) | 2010-04-14 | 2015-11-24 | Boston Scientific Scimed, Inc. | Focused ultrasonic renal denervation |
| US8473067B2 (en) | 2010-06-11 | 2013-06-25 | Boston Scientific Scimed, Inc. | Renal denervation and stimulation employing wireless vascular energy transfer arrangement |
| US9084609B2 (en) | 2010-07-30 | 2015-07-21 | Boston Scientific Scime, Inc. | Spiral balloon catheter for renal nerve ablation |
| US9408661B2 (en) | 2010-07-30 | 2016-08-09 | Patrick A. Haverkost | RF electrodes on multiple flexible wires for renal nerve ablation |
| US9155589B2 (en) | 2010-07-30 | 2015-10-13 | Boston Scientific Scimed, Inc. | Sequential activation RF electrode set for renal nerve ablation |
| US9463062B2 (en) | 2010-07-30 | 2016-10-11 | Boston Scientific Scimed, Inc. | Cooled conductive balloon RF catheter for renal nerve ablation |
| US9358365B2 (en) | 2010-07-30 | 2016-06-07 | Boston Scientific Scimed, Inc. | Precision electrode movement control for renal nerve ablation |
| US8974451B2 (en) | 2010-10-25 | 2015-03-10 | Boston Scientific Scimed, Inc. | Renal nerve ablation using conductive fluid jet and RF energy |
| US9220558B2 (en) | 2010-10-27 | 2015-12-29 | Boston Scientific Scimed, Inc. | RF renal denervation catheter with multiple independent electrodes |
| US9028485B2 (en) | 2010-11-15 | 2015-05-12 | Boston Scientific Scimed, Inc. | Self-expanding cooling electrode for renal nerve ablation |
| US9089350B2 (en) | 2010-11-16 | 2015-07-28 | Boston Scientific Scimed, Inc. | Renal denervation catheter with RF electrode and integral contrast dye injection arrangement |
| EP2640280B1 (en) | 2010-11-16 | 2022-03-16 | TVA Medical, Inc. | Devices for forming a fistula |
| US9668811B2 (en) | 2010-11-16 | 2017-06-06 | Boston Scientific Scimed, Inc. | Minimally invasive access for renal nerve ablation |
| US9326751B2 (en) | 2010-11-17 | 2016-05-03 | Boston Scientific Scimed, Inc. | Catheter guidance of external energy for renal denervation |
| US9060761B2 (en) | 2010-11-18 | 2015-06-23 | Boston Scientific Scime, Inc. | Catheter-focused magnetic field induced renal nerve ablation |
| US9192435B2 (en) | 2010-11-22 | 2015-11-24 | Boston Scientific Scimed, Inc. | Renal denervation catheter with cooled RF electrode |
| US9023034B2 (en) | 2010-11-22 | 2015-05-05 | Boston Scientific Scimed, Inc. | Renal ablation electrode with force-activatable conduction apparatus |
| US20120157993A1 (en) | 2010-12-15 | 2012-06-21 | Jenson Mark L | Bipolar Off-Wall Electrode Device for Renal Nerve Ablation |
| WO2012100095A1 (en) | 2011-01-19 | 2012-07-26 | Boston Scientific Scimed, Inc. | Guide-compatible large-electrode catheter for renal nerve ablation with reduced arterial injury |
| CA2832311A1 (en) | 2011-04-08 | 2012-11-29 | Covidien Lp | Iontophoresis drug delivery system and method for denervation of the renal sympathetic nerve and iontophoretic drug delivery |
| EP2701623B1 (en) | 2011-04-25 | 2016-08-17 | Medtronic Ardian Luxembourg S.à.r.l. | Apparatus related to constrained deployment of cryogenic balloons for limited cryogenic ablation of vessel walls |
| CN103813745B (en) | 2011-07-20 | 2016-06-29 | 波士顿科学西美德公司 | In order to visualize, be directed at and to melt transcutaneous device and the method for nerve |
| JP6106669B2 (en) | 2011-07-22 | 2017-04-05 | ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． | A neuromodulation system having a neuromodulation element that can be placed in a helical guide |
| WO2013055826A1 (en) | 2011-10-10 | 2013-04-18 | Boston Scientific Scimed, Inc. | Medical devices including ablation electrodes |
| US10085799B2 (en) | 2011-10-11 | 2018-10-02 | Boston Scientific Scimed, Inc. | Off-wall electrode device and methods for nerve modulation |
| US9420955B2 (en) | 2011-10-11 | 2016-08-23 | Boston Scientific Scimed, Inc. | Intravascular temperature monitoring system and method |
| US9364284B2 (en) | 2011-10-12 | 2016-06-14 | Boston Scientific Scimed, Inc. | Method of making an off-wall spacer cage |
| EP2768568B1 (en) | 2011-10-18 | 2020-05-06 | Boston Scientific Scimed, Inc. | Integrated crossing balloon catheter |
| WO2013058962A1 (en) | 2011-10-18 | 2013-04-25 | Boston Scientific Scimed, Inc. | Deflectable medical devices |
| EP2775948B1 (en) | 2011-11-08 | 2018-04-04 | Boston Scientific Scimed, Inc. | Ostial renal nerve ablation |
| US9119600B2 (en) | 2011-11-15 | 2015-09-01 | Boston Scientific Scimed, Inc. | Device and methods for renal nerve modulation monitoring |
| US9119632B2 (en) | 2011-11-21 | 2015-09-01 | Boston Scientific Scimed, Inc. | Deflectable renal nerve ablation catheter |
| CN103999216B (en) | 2011-12-19 | 2017-06-13 | 英特尔公司 | III N transistors for being integrated with on-chip system (SOC) structure of power management and radio circuit |
| US9265969B2 (en) | 2011-12-21 | 2016-02-23 | Cardiac Pacemakers, Inc. | Methods for modulating cell function |
| WO2013096916A2 (en) | 2011-12-23 | 2013-06-27 | Vessix Vascular, Inc. | Methods and apparatuses for remodeling tissue of or adjacent to a body passage |
| US9433760B2 (en) | 2011-12-28 | 2016-09-06 | Boston Scientific Scimed, Inc. | Device and methods for nerve modulation using a novel ablation catheter with polymeric ablative elements |
| US9050106B2 (en) | 2011-12-29 | 2015-06-09 | Boston Scientific Scimed, Inc. | Off-wall electrode device and methods for nerve modulation |
| US10660703B2 (en) | 2012-05-08 | 2020-05-26 | Boston Scientific Scimed, Inc. | Renal nerve modulation devices |
| GB2503668B (en) * | 2012-07-03 | 2018-02-07 | Univ Hospitals Of Leicester Nhs Trust | Delivery apparatus |
| US10321946B2 (en) | 2012-08-24 | 2019-06-18 | Boston Scientific Scimed, Inc. | Renal nerve modulation devices with weeping RF ablation balloons |
| US9173696B2 (en) | 2012-09-17 | 2015-11-03 | Boston Scientific Scimed, Inc. | Self-positioning electrode system and method for renal nerve modulation |
| US10398464B2 (en) | 2012-09-21 | 2019-09-03 | Boston Scientific Scimed, Inc. | System for nerve modulation and innocuous thermal gradient nerve block |
| US10549127B2 (en) | 2012-09-21 | 2020-02-04 | Boston Scientific Scimed, Inc. | Self-cooling ultrasound ablation catheter |
| CA2883209A1 (en) * | 2012-09-28 | 2014-04-03 | Rox Medical, Inc. | Methods, systems and devices for treating hypertension |
| CN104869930B (en) | 2012-10-10 | 2020-12-25 | 波士顿科学国际有限公司 | Renal neuromodulation apparatus and methods |
| US9486276B2 (en) | 2012-10-11 | 2016-11-08 | Tva Medical, Inc. | Devices and methods for fistula formation |
| US11406498B2 (en) | 2012-12-20 | 2022-08-09 | Philips Image Guided Therapy Corporation | Implant delivery system and implants |
| US10448953B2 (en) | 2013-01-23 | 2019-10-22 | Rox Medical, Inc. | Methods, systems and devices for treating cardiac arrhythmias |
| JP6609479B2 (en) | 2013-03-08 | 2019-11-20 | リムフロウ・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | Method and system for providing or maintaining fluid flow through a body passage |
| US9956033B2 (en) | 2013-03-11 | 2018-05-01 | Boston Scientific Scimed, Inc. | Medical devices for modulating nerves |
| US9693821B2 (en) | 2013-03-11 | 2017-07-04 | Boston Scientific Scimed, Inc. | Medical devices for modulating nerves |
| US9808311B2 (en) | 2013-03-13 | 2017-11-07 | Boston Scientific Scimed, Inc. | Deflectable medical devices |
| EP3566740A1 (en) | 2013-03-14 | 2019-11-13 | TVA Medical, Inc. | Fistula formulation/formation devices |
| EP2967734B1 (en) | 2013-03-15 | 2019-05-15 | Boston Scientific Scimed, Inc. | Methods and apparatuses for remodeling tissue of or adjacent to a body passage |
| US10265122B2 (en) | 2013-03-15 | 2019-04-23 | Boston Scientific Scimed, Inc. | Nerve ablation devices and related methods of use |
| US9297845B2 (en) | 2013-03-15 | 2016-03-29 | Boston Scientific Scimed, Inc. | Medical devices and methods for treatment of hypertension that utilize impedance compensation |
| CN103142336B (en) * | 2013-03-29 | 2014-12-10 | 孙思予 | Integrated bracket embedder |
| EP3010437A1 (en) | 2013-06-21 | 2016-04-27 | Boston Scientific Scimed, Inc. | Renal denervation balloon catheter with ride along electrode support |
| CN105473092B (en) | 2013-06-21 | 2019-05-17 | 波士顿科学国际有限公司 | The medical instrument for renal nerve ablation with rotatable shaft |
| US9707036B2 (en) | 2013-06-25 | 2017-07-18 | Boston Scientific Scimed, Inc. | Devices and methods for nerve modulation using localized indifferent electrodes |
| WO2015002787A1 (en) | 2013-07-01 | 2015-01-08 | Boston Scientific Scimed, Inc. | Medical devices for renal nerve ablation |
| EP3019106A1 (en) | 2013-07-11 | 2016-05-18 | Boston Scientific Scimed, Inc. | Medical device with stretchable electrode assemblies |
| WO2015006480A1 (en) | 2013-07-11 | 2015-01-15 | Boston Scientific Scimed, Inc. | Devices and methods for nerve modulation |
| WO2015010074A1 (en) | 2013-07-19 | 2015-01-22 | Boston Scientific Scimed, Inc. | Spiral bipolar electrode renal denervation balloon |
| WO2015013205A1 (en) | 2013-07-22 | 2015-01-29 | Boston Scientific Scimed, Inc. | Medical devices for renal nerve ablation |
| US10695124B2 (en) | 2013-07-22 | 2020-06-30 | Boston Scientific Scimed, Inc. | Renal nerve ablation catheter having twist balloon |
| WO2015027096A1 (en) | 2013-08-22 | 2015-02-26 | Boston Scientific Scimed, Inc. | Flexible circuit having improved adhesion to a renal nerve modulation balloon |
| EP3041425B1 (en) | 2013-09-04 | 2022-04-13 | Boston Scientific Scimed, Inc. | Radio frequency (rf) balloon catheter having flushing and cooling capability |
| WO2015038947A1 (en) | 2013-09-13 | 2015-03-19 | Boston Scientific Scimed, Inc. | Ablation balloon with vapor deposited cover layer |
| US11246654B2 (en) | 2013-10-14 | 2022-02-15 | Boston Scientific Scimed, Inc. | Flexible renal nerve ablation devices and related methods of use and manufacture |
| CN105592778B (en) | 2013-10-14 | 2019-07-23 | 波士顿科学医学有限公司 | High-resolution cardiac mapping electrod-array conduit |
| AU2014334574B2 (en) | 2013-10-15 | 2017-07-06 | Boston Scientific Scimed, Inc. | Medical device balloon |
| US9770606B2 (en) | 2013-10-15 | 2017-09-26 | Boston Scientific Scimed, Inc. | Ultrasound ablation catheter with cooling infusion and centering basket |
| CN105636538B (en) | 2013-10-18 | 2019-01-15 | 波士顿科学国际有限公司 | Foley's tube with flexible wire and its correlation technique for using and manufacturing |
| CN105658163B (en) | 2013-10-25 | 2020-08-18 | 波士顿科学国际有限公司 | Embedded thermocouple in denervation flexible circuit |
| WO2015103617A1 (en) | 2014-01-06 | 2015-07-09 | Boston Scientific Scimed, Inc. | Tear resistant flex circuit assembly |
| JP6325121B2 (en) | 2014-02-04 | 2018-05-16 | ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． | Alternative placement of temperature sensors on bipolar electrodes |
| US11000679B2 (en) | 2014-02-04 | 2021-05-11 | Boston Scientific Scimed, Inc. | Balloon protection and rewrapping devices and related methods of use |
| US9687240B2 (en) | 2014-03-14 | 2017-06-27 | Cook Medical Technologies Llc | Implant for facilitating sutureless side-to-side arteriovenous fistula creation and maintaining patency |
| US10695534B2 (en) | 2014-03-14 | 2020-06-30 | Tva Medical, Inc. | Fistula formation devices and methods therefor |
| CN106255457B (en) * | 2014-04-11 | 2020-08-21 | 皇家飞利浦有限公司 | Implant delivery system and implant |
| US10709490B2 (en) | 2014-05-07 | 2020-07-14 | Medtronic Ardian Luxembourg S.A.R.L. | Catheter assemblies comprising a direct heating element for renal neuromodulation and associated systems and methods |
| WO2016033374A1 (en) | 2014-08-27 | 2016-03-03 | Tva Medical, Inc. | Cryolipopysis devices and methods therefor |
| US10603040B1 (en) * | 2015-02-09 | 2020-03-31 | Tva Medical, Inc. | Methods for treating hypertension and reducing blood pressure with formation of fistula |
| US9789294B2 (en) | 2015-10-07 | 2017-10-17 | Edwards Lifesciences Corporation | Expandable cardiac shunt |
| CN108778171A (en) * | 2016-01-15 | 2018-11-09 | Tva医疗公司 | System and method for adhering to blood vessel |
| JP6894440B2 (en) | 2016-01-15 | 2021-06-30 | ティーブイエー メディカル， インコーポレイテッド | Devices and methods for forming fistulas |
| AU2017207507B2 (en) | 2016-01-15 | 2021-11-11 | Tva Medical, Inc. | Devices and methods for advancing a wire |
| US10874422B2 (en) | 2016-01-15 | 2020-12-29 | Tva Medical, Inc. | Systems and methods for increasing blood flow |
| CA3037525A1 (en) | 2016-09-25 | 2018-03-29 | Tva Medical, Inc. | Vascular stent devices and methods |
| USD810941S1 (en) | 2016-10-06 | 2018-02-20 | Edwards Lifesciences Corporation | Cardiac shunt |
| EP4299086A2 (en) | 2017-04-10 | 2024-01-03 | LimFlow GmbH | Devices for treating lower extremity vasculature |
| CN110997036A (en) * | 2017-06-19 | 2020-04-10 | 加利福尼亚大学董事会 | Device and method for non-invasive and percutaneous arteriovenous fistula formation |
| CN112543619A (en) * | 2018-08-03 | 2021-03-23 | 艾维努医疗股份有限公司 | Vascular fixation for establishing a percutaneous fistula |
| WO2020076833A1 (en) | 2018-10-09 | 2020-04-16 | Limflow Gmbh | Devices and methods for catheter alignment |
| CA3129020A1 (en) | 2019-02-07 | 2020-08-13 | Nxt Biomedical, Llc | Rivet shunt and method of deployment |
| EP4051174A4 (en) | 2019-11-01 | 2023-11-22 | LimFlow GmbH | Devices and methods for increasing blood perfusion to a distal extremity |
| WO2022099246A1 (en) | 2020-11-09 | 2022-05-12 | Venova Medical, Inc. | Endovascular implants and devices and methods for accurate placement |
| EP4284477A1 (en) * | 2021-01-29 | 2023-12-06 | Pierce Holdings, FLP | Intravascular catheter and method of use |
| EP4108197A1 (en) | 2021-06-24 | 2022-12-28 | Gradient Denervation Technologies | Systems for treating tissue |
| CN113476312A (en) * | 2021-08-20 | 2021-10-08 | 上海市第一人民医院 | Multifunctional water bag type gastrostomy tube |
Family Cites Families (73)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4733665C2 (en) * | 1985-11-07 | 2002-01-29 | Expandable Grafts Partnership | Expandable intraluminal graft and method and apparatus for implanting an expandable intraluminal graft |
| US4946457A (en) * | 1987-12-03 | 1990-08-07 | Dimed, Incorporated | Defibrillator system with cardiac leads and method for transvenous implantation |
| US4950227A (en) * | 1988-11-07 | 1990-08-21 | Boston Scientific Corporation | Stent delivery system |
| US4961729A (en) * | 1988-12-13 | 1990-10-09 | Vaillancourt Vincent L | Catheter insertion assembly |
| EP0408245B1 (en) * | 1989-07-13 | 1994-03-02 | American Medical Systems, Inc. | Stent placement instrument |
| US5242410A (en) * | 1991-04-15 | 1993-09-07 | University Of Florida | Wireless high flow intravascular sheath introducer and method |
| US5201757A (en) * | 1992-04-03 | 1993-04-13 | Schneider (Usa) Inc. | Medial region deployment of radially self-expanding stents |
| US5456284A (en) * | 1993-05-10 | 1995-10-10 | Applied Medical Resources Corporation | Elastomeric valve assembly |
| US5445646A (en) * | 1993-10-22 | 1995-08-29 | Scimed Lifesystems, Inc. | Single layer hydraulic sheath stent delivery apparatus and method |
| US5989280A (en) * | 1993-10-22 | 1999-11-23 | Scimed Lifesystems, Inc | Stent delivery apparatus and method |
| US5443497A (en) * | 1993-11-22 | 1995-08-22 | The Johns Hopkins University | Percutaneous prosthetic by-pass graft and method of use |
| US5743874A (en) * | 1994-08-29 | 1998-04-28 | Fischell; Robert E. | Integrated catheter for balloon angioplasty and stent delivery |
| US5827216A (en) * | 1995-06-07 | 1998-10-27 | Cormedics Corp. | Method and apparatus for accessing the pericardial space |
| US20060024359A1 (en) * | 1995-06-07 | 2006-02-02 | Walker Jeffrey P | Drug delivery system and method |
| US6283951B1 (en) * | 1996-10-11 | 2001-09-04 | Transvascular, Inc. | Systems and methods for delivering drugs to selected locations within the body |
| CA2234389A1 (en) * | 1995-10-13 | 1997-04-17 | Transvascular, Inc. | A device, system and method for interstitial transvascular intervention |
| JP2001508318A (en) * | 1996-02-02 | 2001-06-26 | トランスバスキュラー インコーポレイテッド | Apparatus, systems and methods for interstitial transvascular intervention |
| US6709444B1 (en) * | 1996-02-02 | 2004-03-23 | Transvascular, Inc. | Methods for bypassing total or near-total obstructions in arteries or other anatomical conduits |
| CN1218414A (en) * | 1996-02-02 | 1999-06-02 | 血管转换公司 | Methods and apparatus for blocking flow through blood vessels |
| US5830224A (en) * | 1996-03-15 | 1998-11-03 | Beth Israel Deaconess Medical Center | Catheter apparatus and methodology for generating a fistula on-demand between closely associated blood vessels at a pre-chosen anatomic site in-vivo |
| US5810780A (en) * | 1996-05-10 | 1998-09-22 | Becton Dickinson And Company | Multiple cross section needle and elastic plug assembly for a medical device |
| US5755682A (en) * | 1996-08-13 | 1998-05-26 | Heartstent Corporation | Method and apparatus for performing coronary artery bypass surgery |
| US6123712A (en) * | 1996-08-23 | 2000-09-26 | Scimed Life Systems, Inc. | Balloon catheter with stent securement means |
| US5843090A (en) * | 1996-11-05 | 1998-12-01 | Schneider (Usa) Inc. | Stent delivery device |
| US5810871A (en) * | 1997-04-29 | 1998-09-22 | Medtronic, Inc. | Stent delivery system |
| US20040215168A1 (en) * | 1997-04-30 | 2004-10-28 | Beth Israel Deaconess Medical Center | Kit for transvenously accessing the pericardial space via the right atrium |
| AU754067B2 (en) * | 1997-11-14 | 2002-11-07 | Boston Scientific Limited | Multi-sheath delivery catheter |
| US6241667B1 (en) * | 1998-01-15 | 2001-06-05 | Lumend, Inc. | Catheter apparatus for guided transvascular treatment of arterial occlusions |
| US6530902B1 (en) * | 1998-01-23 | 2003-03-11 | Medtronic, Inc. | Cannula placement system |
| EP0943300A1 (en) * | 1998-03-17 | 1999-09-22 | Medicorp S.A. | Reversible action endoprosthesis delivery device. |
| US7335220B2 (en) * | 2004-11-05 | 2008-02-26 | Access Closure, Inc. | Apparatus and methods for sealing a vascular puncture |
| JP2002524196A (en) * | 1998-09-10 | 2002-08-06 | パーカーディア，インコーポレイティド | Transmyocardial shunt for left ventricular revascularization and its mounting mechanism |
| US6196230B1 (en) * | 1998-09-10 | 2001-03-06 | Percardia, Inc. | Stent delivery system and method of use |
| US6290728B1 (en) * | 1998-09-10 | 2001-09-18 | Percardia, Inc. | Designs for left ventricular conduit |
| US6692482B2 (en) * | 1999-06-14 | 2004-02-17 | Scimed Life Systems, Inc. | Adjustable length conversion adapter for dilatation catheters |
| US6280412B1 (en) * | 1999-06-17 | 2001-08-28 | Scimed Life Systems, Inc. | Stent securement by balloon modification |
| US6387116B1 (en) * | 1999-06-30 | 2002-05-14 | Pharmasonics, Inc. | Methods and kits for the inhibition of hyperplasia in vascular fistulas and grafts |
| US7892246B2 (en) * | 1999-07-28 | 2011-02-22 | Bioconnect Systems, Inc. | Devices and methods for interconnecting conduits and closing openings in tissue |
| US7815590B2 (en) * | 1999-08-05 | 2010-10-19 | Broncus Technologies, Inc. | Devices for maintaining patency of surgically created channels in tissue |
| US6726659B1 (en) * | 1999-12-09 | 2004-04-27 | John E. Stocking | Catheter assembly having a fenestrated dilator |
| US6508824B1 (en) * | 2000-02-18 | 2003-01-21 | Transvascular, Inc. | Catheter-based methods for enlarging blood vessels to facilitate the formation of penetration tracts, fistulas and/or blood flow channels |
| WO2002015796A2 (en) * | 2000-08-24 | 2002-02-28 | Surgical Connections, Inc. | Surgical stabilizer devices |
| US6616684B1 (en) * | 2000-10-06 | 2003-09-09 | Myocor, Inc. | Endovascular splinting devices and methods |
| US20040092879A1 (en) * | 2000-11-06 | 2004-05-13 | Medamicus, Inc. | Safety introducer apparatus and method therefor |
| US6620122B2 (en) * | 2001-04-26 | 2003-09-16 | Scimed Life Systems, Inc. | Gastric pseudocyst drainage and stent delivery system for use therein |
| US7892247B2 (en) * | 2001-10-03 | 2011-02-22 | Bioconnect Systems, Inc. | Devices and methods for interconnecting vessels |
| AU2002367387B2 (en) * | 2001-12-26 | 2009-05-21 | Yale University | Vascular access device |
| SE0200370D0 (en) * | 2002-02-08 | 2002-02-08 | Gambro Lundia Ab | Method and apparatus for determining access flow |
| US7008397B2 (en) * | 2002-02-13 | 2006-03-07 | Percardia, Inc. | Cardiac implant and methods |
| US7004964B2 (en) * | 2002-02-22 | 2006-02-28 | Scimed Life Systems, Inc. | Apparatus and method for deployment of an endoluminal device |
| US7235095B2 (en) * | 2002-02-22 | 2007-06-26 | Scimed Life Systems, Inc. | Method and system for deploying multi-part endoluminal devices |
| EP1613373A4 (en) * | 2003-04-08 | 2008-09-10 | Univ Leland Stanford Junior | Implantable arteriovenous shunt device |
| US8308682B2 (en) * | 2003-07-18 | 2012-11-13 | Broncus Medical Inc. | Devices for maintaining patency of surgically created channels in tissue |
| WO2005049113A1 (en) * | 2003-11-20 | 2005-06-02 | Gambro Lundia Ab | Method, apparatus and software program for measurement of a parameter relating to a heart-lung system of a mammal. |
| US20050149096A1 (en) * | 2003-12-23 | 2005-07-07 | Hilal Said S. | Catheter with conduit traversing tip |
| US20090187116A1 (en) * | 2004-04-05 | 2009-07-23 | Yasuharu Noishiki | Method for harvesting bone marrow and its medical apparatus |
| JP4643328B2 (en) * | 2004-04-07 | 2011-03-02 | オリンパス株式会社 | Medical ligature suturing device |
| EP1765451B1 (en) * | 2004-06-14 | 2021-11-17 | Edwards Lifesciences Corporation | Devices for arterio-venous fistula creation |
| US8409167B2 (en) * | 2004-07-19 | 2013-04-02 | Broncus Medical Inc | Devices for delivering substances through an extra-anatomic opening created in an airway |
| US20060047337A1 (en) * | 2004-08-27 | 2006-03-02 | Brenneman Rodney A | Device and method for establishing an artificial arterio-venous fistula |
| US7828814B2 (en) * | 2004-08-27 | 2010-11-09 | Rox Medical, Inc. | Device and method for establishing an artificial arterio-venous fistula |
| US20060111704A1 (en) * | 2004-11-22 | 2006-05-25 | Rox Medical, Inc. | Devices, systems, and methods for energy assisted arterio-venous fistula creation |
| EP1830713B1 (en) * | 2004-11-29 | 2011-03-16 | Granit Medical Innovations, LLC | Rotating fine needle for core tissue sampling |
| WO2006062862A1 (en) * | 2004-12-06 | 2006-06-15 | Cook Incorporated | Inflatable occlusion devices, methods, and systems |
| US20060130591A1 (en) * | 2004-12-21 | 2006-06-22 | Perkins, Corban Enterprises | Venous needle dislodgement sensor |
| WO2007046850A2 (en) * | 2005-03-30 | 2007-04-26 | Access Scientific, Inc. | Vascular access |
| US20060271196A1 (en) * | 2005-05-26 | 2006-11-30 | Saal Jeffrey A | Spinal disc annulus augmentation |
| EP1898811B1 (en) | 2005-06-30 | 2019-03-06 | Rox Medical, Inc. | Devices and systems for creation of a peripherally located fistula |
| EP1912592A4 (en) * | 2005-07-26 | 2016-01-06 | Rox Medical Inc | Devices, systems, and methods for peripheral arteriovenous fistula creation |
| US7846179B2 (en) * | 2005-09-01 | 2010-12-07 | Ovalis, Inc. | Suture-based systems and methods for treating septal defects |
| US20080161904A1 (en) * | 2006-01-25 | 2008-07-03 | Heuser Richard R | Connection of adjacent blood vessels |
| US7374567B2 (en) * | 2006-01-25 | 2008-05-20 | Heuser Richard R | Catheter system for connecting adjacent blood vessels |
| US9439746B2 (en) * | 2007-12-13 | 2016-09-13 | Insightra Medical, Inc. | Methods and apparatus for treating ventral wall hernia |
-
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- 2006-06-26 EP EP06774036.5A patent/EP1898811B1/en active Active
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| US20140121685A1 (en) | 2014-05-01 |
| CA2612130A1 (en) | 2007-01-11 |
| AU2006266149B2 (en) | 2012-04-12 |
| EP1898811A4 (en) | 2013-06-12 |
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