Patent Application
20180154123
The present invention relates generally to implantable prosthetic assemblies. more particularly, the present invention pertains to pulmonary vein ostium and pulmonary vein prosthetic implants for creating a region of scar tissue (non-conductive) in or near one or more pulmonary veins and the superior vena cava.
Atrial fibrillation is a common and dangerous disease. For example, atrial fibrillation patients have a greatly increased risk of stroke mortality. The heart's normal sinus rhythm typically begins in the right atrium and proceeds in a single, orderly wavefront at rates of 60 to 100 beats per minute. Atrial fibrillation disrupts the normal sinus rhythm. During atrial fibrillation multiple wavefronts circulate rapidly and chaotically through the atria, causing them to contract in an uncoordinated and ineffective manner at increased rates from 300 to 600 beats per minute. Symptoms arise from the rapid, irregular pulse as well as the loss of cardiac pump function related to uncoordinated atrial contractions. These uncoordinated contractions also allow blood to pool in the atria and may ultimately lead to thromboembolism and stroke
Current therapies for atrial fibrillation include the use of anti-arrhythmic drugs and anti-coagulation agents. Anti-coagulation agents can reduce the risk of stroke, but often increase the risk of bleeding. Drugs are useful at reducing symptoms, but often include undesirable side effects. These may include pro-arrhythmia, long-term ineffectiveness, and even an increase in mortality, especially of those with impaired particular function. Drug therapy to slow the ventricular response rate, catheter ablation of the atrioventricular node with pacemaker implantation, or modification of the node without pacemaker implantation can be useful to facilitate ventricular rate control, but thromboembolic risk is unchanged, and therefore the patient must remain on anticoagulants with the problems noted above
Other therapies include surgical and catheter ablation of the pulmonary vein. However, these therapies are associated with high complication rates and long procedure times. In addition, administration of surgical and catheter ablation typically requires extensive training in the use and installation of complex technology.
The limitations and drawbacks of these therapies have caused investigators to search for alternative therapies for atrial fibrillation.
The present invention discloses implants and systems for creating a region/area of non-conductive tissue in one or more pulmonary veins. The impants and systems relate to pulmonary vein prosthetic implants which are capable of being delivered using endovascular techniques and being implanted at the pulmonary vein ostium and inside the pulmonary vein. The prosthetic implants of the present invention are well-suited for cardiac delivery via a femoral or subclavian artery approach using a delivery catheter.
According to some embodiments, the implants and systems disclosed herein are related to implanted devices that have improved safety profiles and which minimize or reduce collateral damage over current therapies. The implants are configured to create a block atrial tachycardia originating from the pulmonary veins and/or pulmonary vein foci.
One aspect of this disclosure provides a device method of treating an arrhythmia, comprising: selecting a patient, choosing a first implant device for insertion into a first pulmonary vein of the patient, inserting an implant device delivery catheter into the patient, wherein the implant delivery catheter comprises a distal end and a distal portion and the first implant device is positioned in the distal portion, advancing the distal portion of the implant delivery device into the first pulmonary vein, positioning the first implant device relative to the first pulmonary vein near the ostium and or left atrial—pulmonary vein junction; deploying the first implant device within the first pulmonary vein near the ostium and or left atrial—pulmonary vein junction, radially expanding to a diameter larger than the pulmonary vein the first implant device to cause an effect selected from the group consisting of:
According to some embodiments, the method includes radially expanding to a diameter larger than the pulmonary vein the first implant device to cause an effect selected from the group consisting of:
An additional aspect of the disclosure provides an implant delivery system for disrupting electrical signals traveling along a pulmonary vein by bidirectional stretching of the pulmonary vein wall, the system comprising a delivery catheter having a shaft with a distal end to a proximal end and lumen between the distal and proximal ends, the delivery catheter being configured for insertion into a patient's vascular system to position the distal end proximate a pulmonary vein location, one or more implants having a radial expandable ring or coil configured to deploy within the pulmonary vein, the ring or coil being configured to deliver a force against pulmonary vein wall to provide bidirectional stretching of the pulmonary vein wall in both a radial direction and axial direction to stretch and create micro-tears in the pulmonary vein wall and then to hold open at a diameter slightly larger than normal without recoil, and a delivery device having shaft with a distal end and proximal end, the one or more implants being positioned proximate the distal end of the delivery device, wherein as the implant exit distally from the delivery catheter lumen, exposing the implant within the pulmonary vein for radial deployment.
In some embodiments, the bidirectional stretching creates a two-step biological response in the pulmonary vein wall to promote cellular decoupling, comprising first, an acute response is caused by pressure-induced apoptosis inhibiting chemical exchange of sodium/calcium and disrupting focal electrical wave propagation, and second, a biological response for chronic or long-term isolation/denervation is provided by causing focal endothelial cell proliferation at the implant site.
In some embodiments, the implant is self-expanding.
In some embodiments, the system further comprising one or more balloons to expand the implant.
In some embodiments, the system further comprising an imaging device.
In some embodiments, the system further comprising an ablation device.
In some embodiments, the delivery device is configured to deliver one implant at a time, so that multiple implants may be implanted into a pulmonary vein, or individual implants may be implanted into different pulmonary vein during the same procedure.
In some embodiments, the delivery catheter is constructed of sufficiently flexible material to allow insertion through the tortuosity imposed by the patient's vascular system.
In some embodiments, the delivery device shaft being constructed of sufficiently flexible material to allow insertion through lumen of the delivery catheter, either during insertion of the delivery catheter or inserted through lumen after the delivery catheter is positioned within the pulmonary vein.
An additional aspect of the disclosure provides an implant device for disrupting electrical signals traveling along a pulmonary vein by bidirectional stretching, the implant device comprising a radial expandable ring or coil configured to deploy within the pulmonary vein and deliver a force against pulmonary vein wall to provide bidirectional stretching of the pulmonary vein wall in the radial direction and axial direction, wherein bidirectional stretching creates a two-step biological response in the pulmonary vein wall to promote cellular decoupling, comprising an acute response is caused by pressure-induced apoptosis inhibiting chemical exchange of sodium/calcium and disrupting focal electrical wave propagation, and second, a biological response for chronic or long-term isolation/denervation is provided by causing focal endothelial cell proliferation at the implant site.
An additional aspect of the disclosure provides an implant device for disrupting electrical signals traveling along a pulmonary vein by bidirectional stretching, the implant device comprising a radial expandable ring or coil configured to deploy within the pulmonary vein and deliver a force against pulmonary vein wall to provide bidirectional stretching of the pulmonary vein wall in the radial direction and axial direction, wherein bidirectional stretching causes a first effect of stretching and micro-tears resulting in the creation of scar tissue formation, the scar tissue at least partially blocking and/or disrupting electrical conduction along the first pulmonary vein, and a second effect of outward pressure causing the myocytes to be compressed, reducing their ability to perform normal function.
An additional aspect of the disclosure provides a method of treating an arrhythmia by bidirectional stretching, comprising, selecting a patient, choosing a first implant device for insertion into a first pulmonary vein of the patient, inserting an implant device delivery catheter into the patient, wherein the implant delivery catheter comprises a distal end and a distal portion and the first implant device is positioned in the distal portion, advancing the distal portion of the implant delivery device into the first pulmonary vein, positioning the first implant device relative to the first pulmonary vein near the ostium and or left atrial—pulmonary vein junction, deploying the first implant device within the first pulmonary vein near the ostium and or left atrial—pulmonary vein junction, radially expanding to a diameter larger than the pulmonary vein, the first implant device to cause a first effect of stretching and micro-tears resulting in the creation of scar tissue formation, the scar tissue at least partially blocking and/or disrupting electrical conduction along the first pulmonary vein, and a second effect of outward pressure causing the myocytes to be compressed, reducing their ability to perform normal function, and withdrawing the distal end of the implant delivery device from the first pulmonary vein.
In some embodiments, the first effect is selected from the group consisting of:
In some embodiments, the second effect is selected from the group consisting of:
Embodiments of the invention will now be described with reference to the figures, wherein like numerals reflect like elements throughout. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive way, simply because it is being utilized in conjunction with detailed description of certain specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, no single one of which is solely responsible for its desirable attributes or which is essential to practicing the invention described herein. The words proximal and distal are applied herein to denote specific ends of components of the instrument described herein. A proximal end refers to the end of an instrument nearer to an operator of the instrument when the instrument is being used. A distal end refers to the end of a component further from the operator and extending towards the surgical area of a patient and/or the implant.
The present invention provides implants, systems and methods for creating a region/area of non-conductive tissue at the pulmonary vein ostium and/or within the pulmonary vein to disrupt (e.g., stop, slow, otherwise impact, etc.) electrical signals and/or nerves traveling along the pulmonary vein. The implant provides mechanical energy against tissue, eliminating the electrical refractory process of the myocytes on a cellular level and inhibiting the chemical reaction at the focal site of the implant, thus rendering the tissue electrically inert at the contact point of the implant and creating focal necrosis in a line of block. This can be accomplished by bidirectional stretching of the vessel or lumen in the radial direction and axial (or longitudinal) direction by the implant.
The bidirectional stretching of the vessel or lumen creates a two-step biological response to promote cellular decoupling. First, an acute response is caused by pressure-induced apoptosis inhibiting chemical exchange of sodium/calcium and disrupting focal electrical wave propagation. Second, a biological response for chronic or long-term isolation/denervation is provided by causing focal endothelial cell proliferation at the implant site. As a result, the implant causes disruption of electrical or neural conduction along the vessel or body lumen. In some embodiments, such an initial acute response can be followed by a chronic response, in which fibrogen (e.g., collagen fibers) can fill the interstitial spaces that have been increased due to strain-based myocyte displacement. In turn, in some embodiments, this can create a long-term (e.g., permanent) non-conducting modification of the substrate of the vessel or other body lumen. As noted above, such a stretching (e.g., in the radial and axial directions) can be accomplished using any of the implants disclosed herein.
In some embodiments, the implant is configured to apply and maintain a radial force or substantially radial force at the pulmonary vein ostium and/or along the circumference of the pulmonary vein in which it is implanted. The radial force imparted from the implant on the pulmonary vein wall is found to electrically isolate the pulmonary vein.
While the implants, systems and methods are described in relation to treatment of the pulmonary vein, they may also be used in other parts of the body, such as a renal artery, another type of blood vessel, an airway, a urinary tract vessel, a lumen of the gastroenterological system, etc., as desired or required for the treatment of a particular disease or condition.
System 100 includes a delivery catheter 105, a delivery device 125 and one or more implants 140a, 140b, 140c. Delivery catheter 105 is constructed and arranged for insertion into a body location, such as the pulmonary vein. Delivery catheter 105 includes a shaft 110 having a distal end 115 and proximal end 120 constructed of sufficiently flexible material to allow insertion through the tortuosity imposed by the patient's vascular system. Shaft 110 includes a lumen 112 traveling from the proximal end 115 to the distal end 120. Lumen 112 is constructed and arranged to allow delivery device 125 to be slidingly received by lumen 112. Lumen 112 can be further configured to slidingly receive additional catheters or other elongate devices, such as a dilator 150, an imaging device 160, an ablation device 170 and a transseptal sheath 180.
Implant 140 may have a ring or coil design, and may be made from a variety of materials, such as: stainless steel, Elgiloy, nickel, titanium, nitinol, polymers, shape memory polymers, bioresorbable materials, etc. Implant 140 is configured to provide a continuous pressure against the pulmonary vein and ostium wall. Implant 140 may be resiliently biased (i.e. self-expanding), plastically deformable (i.e. balloon expandable) and/or include both resiliently biased and plastically deformable sections. Implant 140 may be used with a dilator for implantation, such as balloon dilator 150. Implant 140 may be a two part implant having differing materials or construction, such as combination of metal and non-metal parts. This may allow implant 140 to have a conductive portion and a non-conductive portion. Implant 140 may be bioresorbable and made from a bioresorbable material, such as poly-L-lactic acid, PLLA, PLDA, PCL-PLA blends, or any bioresorbable polymer with suitable material properties for radial strength retention and degradation. Implant 140 may have a coating. In some embodiments, the coating may create scar tissue. In other embodiments, the coating may be a drug coating.
Shaft 110 may include one or more functional elements 145. In one embodiment, functional elements 145 are configured to provide imaging with one or more ultrasound transducers, and provide imaging information to a console 190. In another embodiment, functional elements 145 are configured to provide heat using one or more electrodes, for example, using radiofrequency (RF), to a deployed implant. The generated heat facilitates electrical isolation of the PV from the chamber.
System 100 may also include a handle 122 positioned on shaft's proximal end 115. Handle 122 may include a controller for advancement and deployment of implant one or more implants 140a, 140b, 140c. Handle 122 may control dilating a balloon, if included. Handle 122 may provide force feedback of applied force during a procedure.
Delivery device 125 includes a shaft 127 having a distal end 130 and proximal end 135 constructed of sufficiently flexible material to allow insertion through lumen 112 of the delivery catheter 105. One or more implants may be positioned proximate the distal end 130. There are three implants 140a, 140b, 140c shown in the figure. Delivery device 125 may be positioned within lumen 112 during insertion of the delivery catheter 105, or may by inserted through lumen 112 after delivery catheter 105 is positioned within the pulmonary vein. In some embodiments, the implants are self expanding, so as distal end 130 exits distally from lumen 112, exposing implant 140, implant 140 may expand away from shaft 127. In some embodiments, delivery device 125 may include one or more balloons positioned under the implants 140 for balloon expandable deployment of the implants. Delivery device 125 is configured to deliver one implant at a time, so that multiple implants may be implanted into a single pulmonary vein, or individual implants may be implanted into different pulmonary veins during the same procedure. For example, the three implants 140 shown in the figures may be implanted into one, two or three pulmonary veins.
In some embodiments, system 100 may further include a dilator device 150 configured to be slidingly received by lumen 112 of delivery catheter 105. Dilator device 150 includes a handle 152 fixedly attached to a flexible shaft 154 having a distal end 156 and an expansion portion 158. Expansion portion 158 may be an inflatable balloon. Handle 152 may control dilating the balloon. Expansion portion 158 is configured to apply force to the pulmonary vein wall, either before or after placement of implant 140. The applied force enhances stretching and/or micro tearing of the tissue. The stretching may be between 1 mm and 10 mm. The stretching may increase the inside diameter of the pulmonary vein 1.5 to 2.5 times the original size. Expansion portion 158 may also expand the pulmonary vein in multiple steps. Dilator device 150 may be integrated with delivery device 125.
In some embodiments, system 100 may include an imaging device 160 configured to be slidingly received by lumen 112 of delivery catheter 110. Imagining device 160 includes a handle 162 fixedly attached to a flexible shaft 164 having a distal end 166 and an imaging portion 168. Imaging portion 168 may be fluoroscope, x-ray or ultrasound. Imaging portion 168 may include one or more electrodes or one or more ultrasound transducers mounted to shaft 164 configured to provide information to a console 190. Console 190 may include an output device 192, such as a visual display, to provide a visual image of the patient's anatomy.
In some embodiments, system 100 may further include an ablation device 170 configured to be slidingly received by lumen 112 of delivery catheter 110. Ablation device 170 includes a handle 172 fixedly attached to a flexible shaft 174 having a distal end 176 and at least one ablation element 178. Ablation element 178 is constructed and arranged to deliver energy to tissue when attached to a source of energy, such as console 190.
In some embodiments, system 100 may include a transseptal sheath 180 having a handle 182 fixedly attached to a flexible shaft 184 having a distal end 186 and lumen 188. Lumen 188 is constructed and arranged to allow delivery catheter 105 to be slidingly received by lumen 188. Lumen 188 can be further configured to slidingly receive additional catheters or other elongate devices, such as dilator 150, imaging device 160 and ablation device 170.
In some embodiments, the steps may also include identify the myocardial sleeve using a mapping catheter, such as a circular mapping catheter or a basket catheter, and placing the implant such that it is contacting the myocardial sleeve.
One method for using delivery device 525 include the steps of:
Expansion portion 658 is configured to apply force to expand an implant within the pulmonary vein with enough pressure against the pulmonary vein wall to achieve electrical isolation. If needed, expansion portion 658 may be rotated between expansions (e.g. 90°). This may be repeated as needed until electrical isolation is achieved. Expansion portion 658 may also be used to apply a force to the pulmonary vein wall, either before or after expansion of the implant. The applied force enhances bidirectional stretching and/or micro tearing of the tissue. The stretching may be between 1 mm and 10 mm. The stretching may increase the inside diameter of the pulmonary vein 1.5 to 2.5 times the original size. Expansion portion 658 may also expand the pulmonary vein in multiple steps, and may be rotated between expansions (e.g. 90°).
While the foregoing has described what are considered to he the best mode and/or other preferred embodiments, it is understood that various modifications can be made therein and that the invention or inventions can be implemented in various forms and embodiments, and that they can be applied in numerous applications, only some of which have been described herein. it is intended by the following claims to claim that which is literally described and all equivalents thereto, including all modifications and variations that fall within the scope of each claim.
This application claims benefit of priority to U.S. Provisional Patent Application Ser. No. 62/166,767, filed May 27, 2015, incorporated by reference herein. This application is also related to U.S. patent application Ser. No. 13/106,343, filed May 12, 2011 and published as U.S. Publication No. 2011/0282343, U.S. patent application Ser. No. 13/457,033, filed Apr. 26, 2012 and published as U.S. Publication No. 2012/0277842, U.S. patent application Ser. No. 13/655,351, filed Oct. 18, 2012 and published as U.S. Publication No. 2013/0109987 and U.S. patent application Ser. No. 13/830,040, filed Mar. 14, 2013 and published as U.S. Publication No. 2013/0204311, all of which are owned by the assignee of the present application and are incorporated by reference herein in their entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US16/34877 | 5/27/2016 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62166767 | May 2015 | US |
