DEVICE AND METHOD FOR ESTABLISHING AN ARTIFICIAL ARTERIO-VENOUS FISTULA
A shunt rivet for implantation in the aorta and inferior vena cava to treat chronic obstructive pulmonary disease, and a method of treating chronic obstructive pulmonary disease are disclosed. The shunt rivet can have a first pair of clinch members that extend along a first axis and a second pair of clinch members that extend along a second axis transverse to the first axis.
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This application is a continuation of U.S. patent application Ser. No. 11/356,876, filed Feb. 17, 2006, which is a continuation-in-part of U.S. patent application Ser. No 10/927,704, filed Aug. 27, 2004, now abandoned. Both of these applications are herein incorporated by reference in their entirety
FIELD OF THE INVENTIONThe inventions described below relate to treatments for pulmonary hypertension and vascular surgery.
BACKGROUND OF THE INVENTIONChronic obstructive pulmonary disease (COPD), chronic hypoxia, hypertension, and left ventricular hypertrophy and pulmonary hypertension are diseases of the cardiopulmonary system. Chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema, is a slowly progressive lung disease caused primarily by smoking. In COPD, the lungs are damaged and the airways are partly obstructed, making it difficult to breath and leading to a gradual loss of lung function. Symptoms of COPD include chronic cough, excessive sputum production, low blood oxygen levels and severe disabling shortness of breath. COPD represents the fourth leading cause of death in the United States. Chronic hypoxia (reduction of oxygen supply to the body despite adequate blood flow through the body), hypertension, and left ventricular hypertrophy are related conditions which may be symptomatic of COPD or coincident with COPD.
These serious conditions affect many people, and the primary treatments are merely ameliorative. The primary treatments for COPD include avoidance of irritants such as tobacco smoke and breathing supplemental oxygen. In advanced cases of COPD, lung reduction surgery is sometimes performed, but it is not clear that it helps. There is no known cure for COPD.
An aortocaval fistula (ACF) is a rare clinical condition that can be either spontaneous (80% of the cases), related to abdominal aortic aneurysm, or the result of some trauma such as lumbar disk surgery. It is currently seen as a defect that should be cured with surgery and, possibly, stent-graft implantation in the aorta.
Contrary to this understanding, an intentionally formed aortocaval fistula appears to be a viable treatment for COPD. Recently, in our co-pending U.S. patent application Ser. No. 10/820,169 (Attorney Docket Number S03-013/US) filed Apr. 6, 2004, entitled Implantable Arteriovenous Shunt Device and listing John L. Faul, Toshihiko Nishimura, Peter N. Kao & Ronald G. Pearl as inventors (the entirety of which is hereby incorporated by reference), we propose creation of an artificial aortocaval fistula as a treatment for COPD, and we disclose the method of creating the fistula and an implantable shunt for maintaining the aortocaval fistula.
Shunts or stems for connecting blood vessels have been proposed for the treatment of coronary artery disease. Makower, Device, System And Method For Interstitial Transvascular Intervention, U.S. Pat. No. 6,746,464 (Jun. 8, 2004) (filed Oct. 28, 1998) discloses a stent with a short tubular section spanning the thickness of a coronary artery and an adjacent parallel coronary vein. This stent includes “clovers” on either end of the stent, and these clovers fold radially outwardly to obstruct movement of the stent through the vessel walls. Two clovers on the proximal end of the stent are orthogonal (relative to the radial cross section of the stent) to two clovers on the distal end of the stent, and the interconnecting wires are parallel to the longitudinal axis of the device.
SUMMARY OF THE INVENTIONThe devices and methods described below provide for treatment of COPD, hypertension, and left ventricular hypertrophy, and chronic hypoxia. A vascular shunt rivet is disclosed which serves to hold contiguous points of the patient's aorta and inferior vena cava (or other arteries and there associated veins, such as the femoral artery and femoral vein, or the carotid artery and the carotid vein) together and maintain an open flow path from the aorta to the vena cava. The device functions as a rivet, holding the two vessel walls in close proximity, and as a shunt, permitting and maintaining flow from one blood vessel to the other. The device is implanted, between the aorta and inferior vena cava, as a treatment for pulmonary hypertension, COPD and chronic hypoxia.
The shunt rivet is provided in the form of an expandable wire frame structure adapted for transcutaneous delivery and deposit at the desired implantation site. The wire frame structure may be compressed into a small diameter configuration to fit within the distal tip off delivery catheter. Upon expulsion from the catheter, the wire frame structure resiliently or pseudoelastically expands into a flow-through rivet comprising a tube with expanded heads at either end. When the rivet is released within an artificial fistula formed through the aorta and vena cava walls, it expands to trap the walls between the two expanded heads. The tubular section between the two expanded head may resiliently expand, and may also be balloon-expanded or otherwise plastically deformed to enlarge the flow-through lumen of the tubular section.
After the tube is cut as described above, it is formed into its eventual resiliently expanded configuration illustrated in
As illustrated, the construction provides several pairs of longitudinally opposed (that is, they bend to come into close proximity to each other, and perhaps but not necessarily, touch) and aligned (they are disposed along the same longitudinal line) distal and proximal petaloids. Overall, the petaloid frames of the distal section form a “corolla” (analogous to the corolla of a flower) flange or rivet clinch, which impinges on the vena cava wall and prevents expulsion into the aorta, and the petaloid frames of the proximal section form a corolla, flange or rivet clinch (this clinch would be analogous to a rivet head, but it is formed like the clinch after insertion of the rivet), which impinges on the aorta wall and prevents the expulsion of the shunt rivet into the vena cava, and the central section 17 forms a short length of rigid tubing to keep the fistula open. The resilient apposition of the two distal and proximal flanges or corollas so formed will securely hold the shunt rivet in place by resiliently clamping the walls of the aorta and vena cava (even over a considerable range of wall thickness or “grip range”).
Referring to
As shown in
Then the outer sheath is pulled further proximally to release the proximal petaloids, as shown in
The final form of the shunt rivet is, according to the above description, accomplished with the method that includes forming the generally tubular structure having a central section with a first diameter, a proximal clinch section defined by one or more clinch members, and a distal clinch section defined by one or more clinch members, training the proximal and distal clinch members to make them resiliently biased to bend radially outwardly from the central section; then resiliently compressing the tubular structure to maintain a generally tubular shape and restraining the compressed tubular structure in a compressed configuration suitable for percutaneous insertion into the body; inserting the structure through apposing apertures in the aorta wall and vena cava wall of a patient such that the distal clinch members protrude into the vena cava of the patient and the central section is disposed within the apertures; and then releasing the distal clinch members to permit resilient expansion of the distal clinch members followed by expanding the central section through plastic deformation to larger diameter and releasing the proximal clinch members to permit resilient expansion of the proximal clinch members (the proximal clinch members may be released before or after expansion of the central section).
The shunt rivet illustrated above may be modified as shown in
The shunt rivet may be modified as shown in
The device may thus be described, in their open and unconstrained conditions, as comprising two parallel tool clips secured at their closed ends to two parallel tension springs, at the midpoints of the tension springs, to create an orthogonal or cruciform grouping of alternating spring clips and tension springs. Adopting the botanical language used for other embodiments, each side of the device comprises a pair of petaloids arcing outwardly from the axial centerline of the device without everting (without a substantial arc in the proximal direction), and a pair of petaloids arcing outwardly and evening with a substantial arc in the distal direction, with corresponding petaloid structures being joined at their proximal ends without an intervening waist segment. Each petaloid is formed in an open frame V-shape. Though illustrated with a pair of clips and a pair of tension springs, the device may be formed with additional tension springs or clips, as dictated by the local anatomy of a particular installation. In appropriate anatomical conditions, the device may comprise four clips in the tool clip configuration, or the comparable everting petaloid pairs (in which all clinch members evert substantially to close upon the vessel wall), arranged orthogonally, where the tool clips are arranged in a circular arrangement with the closed end of each clip being secured to the closed and of an adjacent clip, such that the open end of each tool clip is directed outwardly from the circular arrangement. The device may also include additional arcuate tension springs and/or tool clip portions, thus departing from the cruciform configuration shown while achieving the benefit of substantial spacing of the vessel contacting tips from the arterio-venous fistula.
The devices described above may be provided with coatings or additional structures which serve as matrices for various therapeutic compounds. Drug eluting coatings, additional drug eluting strut members, drug eluting membranes surrounding the central section or drug eluting masses filling the cells of the device may be added to the devices. For the aortocaval application and the arterio-venous application, therapeutic agents such as heparin and other anti-coagulants and paclitaxol, rapamycin (Sirolumis™), everolimus and other anti-stenotic compounds can be applied to the stent in polymer matrices which permit elution of these drugs over a period of time ranging from several hours to several months after implantation. Polymers such as polyurethane can be used as the matrix.
While the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the inventions. Other embodiments and configurations may be devised without departing from the spirit of the inventions and the scope of the appended claims.
Claims
1. An intravascular connector comprising:
- a first pair of clinch members that extend along a first axis; and
- a second pair of clinch members that extend along a second axis transverse to the first axis,
- wherein each of the first pair of clinch members comprises a first portion that extends away from the first axis, a second portion that extends toward the first axis, and a third portion that extends away from the first axis,
- wherein a distal portion of each of the first pair of clinch members is biased to close toward the first axis, and wherein a distal portion of each of the second pair of clinch members is biased to exert pressure away from the second axis.
2. The intravascular connector of claim 1, wherein each of the second pair of clinch members comprises a first portion that extends away from the second axis and a second portion that extends toward the second axis.
3. The intravascular connector of claim 2, wherein the distal portion of each of the first pair of clinch members comprises part of the second and third portions of the first pair of clinch members, and wherein the distal portion of each of the second pair of clinch members comprises part of the first and second portions of the second pair of clinch members.
4. The intravascular connector of claim 1, wherein the distal portion of each of the first pair of clinch members is proximate to one another when the first pair of clinch members is in a deployed configuration, and wherein the distal portion of each of the second pair of clinch members is spaced apart from one another when the second pair of clinch members is in a deployed configuration.
5. The intravascular connector of claim 1, wherein a base of each of the first pair of clinch members and the distal portion of each of the first pair of clinch members are proximate the first axis, and wherein a base of each of the second pair of clinch members is proximate one of the bases of the first pair of clinch members.
6. The intravascular connector of claim 1, wherein the distal portion of each of the first pair of clinch members forms an atraumatic surface configured to impinge a wall of a first or second vessel, and wherein the distal portion of each of the second pair of clinch members forms an atraumatic surface configured to impinge a wall of the first or second vessel.
7. The intravascular connector of claim 1, wherein each of the first pair of clinch members comprises a first section and a second section, wherein each of the first sections extends a first distance from the first axis, wherein each of the second sections extends a second distance from the first axis, and wherein the second distance is less than the first distance.
8. The intravascular connector of claim 1, wherein each of the first pair of clinch members defines a first recess and a second recess when viewed from a first side of the connector, wherein the first recesses face toward the first axis, and wherein the second recesses face away from the first axis,
9. The intravascular connector of claim 8, wherein each of the second pair of clinch members defines a third recess when viewed from a second side of the connector, and wherein the third recesses face toward the second axis.
10. The intravascular connector of claim 1, wherein the second pair of clinch members define an angle relative to the first pair of clinch members
11. The intravascular connector of claim 1, further comprising a drug coating or a drug membrane partially covering the connector.
12. An intravascular connector comprising:
- a first pair of clinch members that extend along a first axis; and
- a second pair of clinch members that extend along a second axis transverse to the first axis,
- wherein a distal portion of each of the first pair of clinch members forms an atraumatic surface configured to impinge a wall of a first or second vessel, and wherein a distal portion of each of the second pair of clinch members forms an atraumatic surface configured to impinge a wall of the first or second vessel, and
- wherein the distal portion of each of the first pair of clinch members is biased to close toward the first axis, and wherein the distal portion of each of the second pair of clinch members is biased to exert pressure away from the second axis.
13. The intravascular connector of claim 12, wherein a first part of the distal portion of each of the first pair of clinch members extends toward the first axis, wherein a second part of the distal portion of each of the first pair of clinch members extends away from the first axis, wherein a first part of the distal portion of each of the second pair of clinch members extend away from the second axis, and wherein a second part of the distal portion of each of the second pair of clinch members extends toward the second axis.
14. The intravascular connector of claim 12, wherein the distal portion of each of the first pair of clinch members is proximate to one another when the first pair of clinch members is in a deployed configuration, and wherein the distal portion of each of the second pair of clinch members is spaced apart from one another when the second pair of clinch members is in a deployed configuration.
15. The intravascular connector of claim 12, wherein each of the first pair of clinch members defines a first recess and a second recess when viewed from a first side of the connector, wherein each of the second pair of clinch members defines a third recess when viewed from a second side of the connector, wherein the first recesses open toward the first axis, wherein the second recesses open away from the first axis, and wherein the third recesses open toward the second axis.
16. The intravascular connector of claim 12, wherein the second pair of clinch members define an angle relative to the first pair of clinch members
17. An intravascular connector comprising:
- a first pair of clinch members that extend along a first axis; and
- a second pair of clinch members that extend along a second axis transverse to the first axis,
- wherein each of the first pair of clinch members comprises a first section and a second section, wherein each of the first sections extends a first distance from the first axis, wherein each of the second sections extends a second distance from the first axis, and wherein the second distance is less than the first distance, and
- wherein each of the first pair of clinch members defines a first recess and a second recess when viewed from a first side of the connector, wherein each of the second pair of clinch members defines a third recess when viewed from a second side of the connector, wherein the first recesses open toward the first axis, wherein the second recesses open away from the first axis, and wherein the third recesses open toward the second axis.
18. The intravascular connector of claim 17, wherein a distal portion of each of the first pair of clinch members forms an atraumatic surface configured to impinge a wall of a first or second vessel, wherein a distal portion of each of the second pair of clinch members forms an atraumatic surface configured to impinge a wall of the first or second vessel, wherein the distal portion of each of the first pair of clinch members is biased to close toward the first axis, and wherein the distal portion of each of the second pair of clinch members is biased to exert pressure away from the second axis.
19. The intravascular connector of claim 17, Wherein first part of the distal portion of each of the first pair of clinch members extends toward the first axis, wherein a second part of the distal portion of each of the first pair of clinch members extends away from the first axis, wherein a first part of the distal portion of each of the second pair of clinch members extend away from the second axis, and wherein a second part of the distal portion of each of the second pair of clinch members extends toward the second axis.
20. The intravascular connector of claim 17, wherein a base of each of the first pair of clinch members and the distal portion of each of the first pair of clinch members are proximate the first axis, and wherein a base of each of the second pair of clinch members is proximate one of the bases of the first pair of clinch members.
Type: Application
Filed: May 18, 2017
Publication Date: Sep 14, 2017
Applicant: ROX Medical, Inc. (San Clemente, CA)
Inventor: Rodney A. BRENNEMAN (San Juan Capistrano, CA)
Application Number: 15/599,073