ENGAGEMENT CATHETER DEVICES, SYSTEMS, AND METHODS TO USE THE SAME UNDER SUCTIONAL TISSUE ENGAGEMENT
Engagement catheter devices, systems, and methods to use the same under suctional tissue engagement. A method of the present disclosure comprises the steps of engaging a targeted tissue under suction/vacuum using an engagement catheter, delivering a substance to, into, or through the targeted tissue from within a lumen of the engagement catheter, and injecting a fluid within a different lumen of the engagement catheter to flush the catheter and target tissue area with the fluid, and subsequently suctionally removing the injected fluid from the target area and lumens of the engagement catheter.
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The present application is a continuation patent application of U.S. Nonprovisional patent application Ser. No. 15/784,824, filed Oct. 16, 2017 and issued as U.S. Pat. No. 11,040,175 on Jun. 22, 2021 which a) is related to, and claims the priority benefit of, U.S. Provisional Application Ser. No. 62/489,887, filed Apr. 25, 2017, b) is related to, and claims the priority benefit of, U.S. Provisional Application Ser. No. 62/408,093, filed Oct. 14, 2016, and c) is related to, claims the priority benefit of, and is a U.S. continuation-in-part patent application of, U.S. Nonprovisional patent application Ser. No. 13/419,879, filed Mar. 14, 2012, which is related to, and claims the priority benefit of, U.S. Nonprovisional patent application Ser. No. 13/084,102, filed Apr. 11, 2011 and issued as U.S. Pat. No. 8,540,674 on Sep. 24, 2013, which is related to, claims the priority benefit of, and is a continuation-in-part of, U.S. Nonprovisional patent application Ser. No. 12/881,953, filed Sep. 14, 2010 and issued as U.S. Pat. No. 9,050,064 on Jun. 9, 2015, which is related to, claims the priority benefit of, and is a continuation-in-part of, U.S. Nonprovisional patent application Ser. No. 12/596,968, filed Mar. 10, 2010 and issued as U.S. Pat. No. 8,075,532 on Dec. 13, 2011, which is related to, claims the priority benefit of, and is a U.S. national stage application of, International Patent Application No. PCT/US2008/056666, filed Mar. 12, 2008, which (i) claims priority to International Patent Application No. PCT/US2007/015207, filed Jun. 29, 2007, and U.S. Provisional Patent Application Ser. No. 60/914,452, filed Apr. 27, 2007. The contents of each of these applications are hereby incorporated by reference in their entirety into this disclosure.
BACKGROUNDIschemic heart disease, or coronary heart disease, kills more Americans per year than any other single cause. In 2004, one in every five deaths in the United States resulted from ischemic heart disease. Indeed, the disease has had a profound impact worldwide. If left untreated, ischemic heart disease can lead to chronic heart failure, which can be defined as a significant decrease in the heart's ability to pump blood. Chronic heart failure is often treated with drug therapy.
Ischemic heart disease is generally characterized by a diminished flow of blood to the myocardium and is also often treated using drug therapy. Although many of the available drugs may be administered systemically, local drug delivery (“LDD”) directly to the heart can result in higher local drug concentrations with fewer systemic side effects, thereby leading to improved therapeutic outcomes.
Cardiac drugs may be delivered locally via catheter passing through the blood vessels to the inside of the heart. However, endoluminal drug delivery has several shortcomings, such as: (1) inconsistent delivery, (2) low efficiency of localization, and (3) relatively rapid washout into the circulation.
To overcome such shortcomings, drugs may be delivered directly into the pericardial space, which surrounds the external surface of the heart. The pericardial space is a cavity formed between the heart and the relatively stiff pericardial sac that encases the heart. Although the pericardial space is usually quite small because the pericardial sac and the heart are in such close contact, a catheter may be used to inject a drug into the pericardial space for local administration to the myocardial and coronary tissues. Drug delivery methods that supply the agent to the heart via the pericardial space offer several advantages over endoluminal delivery, including: (1) enhanced consistency and (2) prolonged exposure of the drug to the cardiac tissue.
In current practice, drugs are delivered into the pericardial space either by the percutaneous transventricular method or by the transthoracic approach. The percutaneous transventricular method involves the controlled penetration of a catheter through the ventricular myocardium to the pericardial space. The transthoracic approach involves accessing the pericardial space from outside the heart using a sheathed needle with a suction tip to grasp the pericardium, pulling it away from the myocardium to enlarge the pericardial space, and injecting the drug into the space with the needle.
For some patients with chronic heart failure, cardiac resynchronization therapy (“CRT”) can be used in addition to drug therapy to improve heart function. Such patients generally have an abnormality in conduction that causes the right and left ventricles to beat (i.e., begin systole) at slightly different times, which further decreases the heart's already-limited function. CRT helps to correct this problem of dyssynchrony by resynchronizing the ventricles, thereby leading to improved heart function. The therapy involves the use of an implantable device that helps control the pacing of at least one of the ventricles through the placement of electrical leads onto specified areas of the heart. Small electrical signals are then delivered to the heart through the leads, causing the right and left ventricles to beat simultaneously.
Like the local delivery of drugs to the heart, the placement of CRT leads on the heart can be challenging, particularly when the target placement site is the left ventricle. Leads can be placed using a transvenous approach through the coronary sinus, by surgical placement at the epicardium, or by using an endocardial approach. Problems with these methods of lead placement can include placement at an improper location (including inadvertent placement at or near scar tissue, which does not respond to the electrical signals), dissection or perforation of the coronary sinus or cardiac vein during placement, extended fluoroscopic exposure (and the associated radiation risks) during placement, dislodgement of the lead after placement, and long and unpredictable times required for placement (ranging from about 30 minutes to several hours).
Clinically, the only approved non-surgical means for accessing the pericardial space include the subxiphoid and the ultrasound-guided apical and parasternal needle catheter techniques, and each methods involves a transthoracic approach. In the subxiphoid method, a sheathed needle with a suction tip is advanced from a subxiphoid position into the mediastinum under fluoroscopic guidance. The catheter is positioned onto the anterior outer surface of the pericardial sac, and the suction tip is used to grasp the pericardium and pull it away from the heart tissue, thereby creating additional clearance between the pericardial sac and the heart. The additional clearance tends to decrease the likelihood that the myocardium will be inadvertently punctured when the pericardial sac is pierced.
Although this technique works well in the normal heart, there are major limitations in diseased or dilated hearts—the very hearts for which drug delivery and CRT lead placement are most needed. When the heart is enlarged, the pericardial space is significantly smaller and the risk of puncturing the right ventricle or other cardiac structures is increased. Additionally, because the pericardium is a very stiff membrane, the suction on the pericardium provides little deformation of the pericardium and, therefore, very little clearance of the pericardium from the heart.
As referenced above, the heart is surrounded by a “sac” referred to as the pericardium. The space between the surface of the heart and the pericardium can normally only accommodate a small amount of fluid before the development of cardiac tamponade, defined as an emergency condition in which fluid accumulates in the pericardium. Therefore, it is not surprising that cardiac perforation can quickly result in tamponade, which can be lethal. With a gradually accumulating effusion, however, as is often the case in a number of diseases, very large effusions can be accommodated without tamponade. The key factor is that once the total intrapericardial volume has caused the pericardium to reach the noncompliant region of its pressure-volume relation, tamponade rapidly develops. Little W. C., Freeman G. L. (2006). “Pericardial Disease.” Circulation 113(12): 1622-1632.
Cardiac tamponade occurs when fluid accumulation in the intrapericardial space is sufficient to raise the pressure surrounding the heart to the point where cardiac filling is affected. Ultimately, compression of the heart by a pressurized pericardial effusion results in markedly elevated venous pressures and impaired cardiac output producing shock which, if untreated, it can be rapidly fatal. Id.
The frequency of the different causes of pericardial effusion varies depending in part upon geography and the patient population. Corey G. R. (2007). “Diagnosis and treatment of pericardial effusion.” http://patients.uptodate.com. A higher incidence of pericardial effusion is associated with certain diseases. For example, twenty-one percent of cancer patients have metastases to the pericardium. The most common are lung (37% of malignant effusions), breast (22%), and leukemia/lymphoma (17%). Patients with HIV, with or without AIDS, are found to have increased prevalence, with 41-87% having asymptomatic effusion and 13% having moderate-to-severe effusion. Strimel W. J. e. a. (2006). “Pericardial Effusion.” http://www.emedicine.com/med/topic1786.htm.
End-stage renal disease is a major public health problem. In the United States, more than 350,000 patients are being treated with either hemodialysis or continuous ambulatory peritoneal dialysis. Venkat A., Kaufmann K. R., Venkat K. (2006). “Care of the end-stage renal disease patient on dialysis in the ED.” Am J Emerg Med 24(7): 847-58. Renal failure is a common cause of pericardial disease, producing large pericardial effusions in up to 20% of patients. Task Force members, Maisch B. et al. (2004). “Guidelines on the Diagnosis and Management of Pericardial Diseases Executive Summary: The Task Force on the Diagnosis and Management of Pericardial Diseases of the European Society of Cardiology.” Eur Heart J 25(7): 587-610.
Viral pericarditis is the most common infection of the pericardium Inflammatory abnormalities are due to direct viral attack, the immune response (antiviral or anticardiac), or both. Id. Purulent (bacterial) pericarditis in adults is rare, but always fatal if untreated. Mortality rate in treated patients is 40%, mostly due to cardiac tamponade, toxicity, and constriction. It is usually a complication of an infection originating elsewhere in the body, arising by contiguous spread or haematogenous dissemination. Id. Other forms of pericarditis include tuberculous and neoplastic.
The most common secondary malignant tumors are lung cancer, breast cancer, malignant melanoma, lymphomas, and leukemias. Effusions may be small or large with an imminent tamponade. In almost two-thirds of the patients with documented malignancy pericardial effusion is caused by non-malignant diseases, e.g., radiation pericarditis, or opportunistic infections. The analyses of pericardial fluid, pericardial or epicardial biopsy are essential for the confirmation of malignant pericardial disease. Id.
Management of pericardial effusions continues to be a challenge. There is no uniform consensus regarding the best way to treat this difficult clinical entity. Approximately half the patients with pericardial effusions present with symptoms of cardiac tamponade. In these cases, symptoms are relieved by pericardial decompression, irrespective of the underlying cause. Georghiou G. P., Stamler A., Sharoni E., Fichman-Horn S., Berman M., Vidne B. A., Saute M. (2005). “Video-Assisted Thoracoscopic Pericardial Window for Diagnosis and Management of Pericardial Effusions.” Ann Thorac Surg 80(2): 607-610. Symptomatic pericardiac effusions are common and may result from a variety of causes. When medical treatment has failed to control the effusion or a diagnosis is needed, surgical intervention is required. Id.
The most effective management of pericardial effusions has yet to be identified. The conventional procedure is a surgically placed pericardial window under general anesthesia. This procedure portends significant operative and anesthetic risks because these patients often have multiple comorbidities. Less invasive techniques such as blind needle pericardiocentesis have high complication and recurrence rates. The technique of echocardiographic-guided pericardiocentesis with extended catheter drainage is performed under local anesthetic with intravenous sedation. Creating a pericardiostomy with a catheter in place allows for extended drainage and sclerotherapy. Echocardiographic-guided pericardiocentesis has been shown to be a safe and successful procedure when performed at university-affiliated or academic institutions. However, practices in community hospitals have rarely been studied in detail. Buchanan C. L., Sullivan V. V., Lampman R., Kulkarni M. G. (2003). “Pericardiocentesis with extended catheter drainage: an effective therapy.” Ann Thorac Surg 76(3): 817-82.
The treatment of cardiac tamponade is drainage of the pericardial effusion. Medical management is usually ineffective and should be used only while arrangements are made for pericardial drainage. Fluid resuscitation may be of transient benefit if the patient is volume depleted (hypovolemic cardiac tamponade).
Surgical drainage (or pericardiectomy) is excessive for many patients. The best option is pericardiocentesis with the Seldinger technique, leaving a pigtail drainage catheter that should be kept in place until drainage is complete. Sagrista Sauleda J., Permanyer Miralda G., Soler Soler J. (2005). “[Diagnosis and management of acute pericardial syndromes].” Rev Esp Cardiol 58(7): 830-41. This less-invasive technique resulted in a short operative time and decreased supply, surgeon, and anesthetic costs. When comparing procedure costs of a pericardial window versus an echo-guided pericardiocentesis with catheter drainage at our institution, there was a cost savings of approximately $1,800/case in favor of catheter drainage. In an era of accelerating medical costs, these savings are of considerable importance. Buchanan C. L., Sullivan V. V., Lampman R., Kulkarni M. G. (2003). “Pericardiocentesis with extended catheter drainage: an effective therapy.” Ann Thorac Surg 76(3): 817-82.
Clearly, there is a clinical need for a mini-invasive, safe and effective approach to treatment of pericardial effusion and tamponade. The present application takes advantage of a safe and effective pericardial access approach previously disclosed in combination with a special catheter used specifically for fluid drainage, fluid diagnosis, resuscitation and therapy delivery to treat the underlying cause of the effusion.
Thus, there is need for an efficient, easy to use, and relatively inexpensive device, system and technique that can be used to access the heart for local delivery of therapeutic and diagnostic substances, as well as of CRT leads and other types of leads. There is also a need for an efficient, easy to use, and relatively inexpensive device, system and technique that can be used to access a space containing fluid within a tissue to remove the fluid and to optionally deliver a substance if necessary.
BRIEF SUMMARYDisclosed herein are various systems for engaging a bodily tissue and methods of using the same, including, but not limited to, systems and methods for accessing the internal and external tissues of the heart.
In at least one embodiment of a system for facilitating mammalian organ treatment of the present disclosure, such a system comprises a bodily access system, comprising an engagement catheter having an open distal end and defining a first lumen therethrough, the engagement catheter sized and shaped to fit within a mammalian luminal organ and configured to reversibly attach to a first mammalian tissue using suction, and a puncture device, the puncture device configured to fit at least partially within the first lumen of the engagement catheter, and a scanner configured to identify at least a portion of the bodily access system when positioned within the mammalian luminal organ and further configured to identify a distance between a second mammalian tissue and the at least a portion of the bodily access system, wherein when the system for facilitating mammalian organ treatment is used in connection with a therapeutic procedure, the distance between the second mammalian tissue and the at least a portion of the bodily access system is used to facilitate a puncture of the first mammalian tissue at a desired location relative to the second mammalian tissue. In another embodiment, the engagement catheter further comprises a skirt coupled thereto at or near the open distal end, the skirt comprising a proximal end having a circumference substantially similar to an outer circumference of the engagement catheter, the skirt further comprising a distal end having a circumference larger than the outer circumference of the engagement catheter. In yet another embodiment, the skirt is configured to form a reversible seal with the first mammalian tissue when a vacuum source is operatively attached to a vacuum port at or near a proximal end of the engagement catheter, and wherein the reversible seal stabilizes the first mammalian tissue relative to the skirt when the vacuum source is operatively attached to the vacuum port. In an additional embodiment, the scanner is selected from the group consisting of an echocardiogram, a transthoracic scanner, and a transesophageal scanner.
In at least one embodiment of a system for facilitating mammalian organ treatment of the present disclosure, such a system further comprises a sleeve comprising a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the sleeve configured to slidingly engage the engagement catheter when positioned around the engagement catheter. In an additional embodiment, such a system further comprises a sleeve comprising a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the sleeve configured to slidingly engage the engagement catheter when positioned around the engagement catheter, wherein when the sleeve is moved from a first position surrounding the skirt to a second position not surrounding the skirt, the skirt expands to an expanded configuration. In yet an additional embodiment, the puncture device comprises a delivery catheter having a proximal end, a distal end, and a lumen therethrough. In another embodiment, the delivery catheter further comprises a needle at the distal end of the delivery catheter, and wherein the lumen of the delivery catheter is configured to receive a guidewire therethrough.
In at least one embodiment of a system for facilitating mammalian organ treatment of the present disclosure, the puncture device defines a lumen therethrough, the lumen sized and shaped to permit a therapeutic delivery device having a therapeutic treatment device coupled thereto to fit therein.
In at least one embodiment of a method for facilitating mammalian organ treatment using a system for facilitating mammalian organ treatment of the present disclosure, the method comprises the steps of inserting the engagement catheter and puncture device into a mammalian body and into a right atrium of a heart, stabilizing an atrial septum at a first location using suction through the first lumen or a second lumen of the engagement catheter so that the open distal end reversibly engages the atrial septum at the first location, operating the scanner to obtain data relative to the distance between the second mammalian tissue and the at least a portion of the bodily access system positioned within the mammalian luminal organ, advancing at least part of the puncture device through the atrial septum at a fossa ovalis and into a left atrium to facilitate a therapy within the left atrium if/when the data relative to the distance between the second mammalian tissue and the at least a portion of the bodily access system is satisfactory, and performing the therapy within the left atrium, the therapy selected from the group consisting of delivering a mitral valve into the heart, placing a mitral valve within the heart, delivering a mitral valve prosthesis into the heart, placing a mitral valve prosthesis within the heart, delivering a mitral clip into the heart, placing a mitral clip within the heart, delivering a mitral ring into the heart, placing a mitral ring within the heart, treating mitral regurgitation, treating mitral stenosis, delivering a left atrial appendage occluder device into the heart, placing a left atrial appendage occluder device within the heart, treating stroke, reducing a risk of stroke, preventing a blood clot from a left atrial appendage from entering into a bloodstream, and delivering a drug therapy into the heart.
In at least one embodiment of a system for facilitating mammalian organ treatment of the present disclosure, such a system comprises a bodily access system comprising an engagement catheter having an open distal end, a skirt coupled thereto at or near the open distal end, and a lumen defined therethrough, the engagement catheter sized and shaped to fit within a mammalian luminal organ and configured to reversibly attach to a first mammalian tissue using suction, the skirt comprising a proximal end having a circumference substantially similar to an outer circumference of the engagement catheter and a distal end having a circumference larger than the outer circumference of the engagement catheter, and a delivery catheter configured to fit at least partially within the first lumen of the engagement catheter, the delivery catheter having a proximal end, a distal end, and a lumen therethrough, and a scanner configured to identify at least a portion of the bodily access system when positioned within the mammalian luminal organ and further configured to identify a distance between a second mammalian tissue and the at least a portion of the bodily access system, wherein when the system for facilitating mammalian organ treatment is used in connection with a therapeutic procedure, the distance between the second mammalian tissue and the at least a portion of the bodily access system is used to facilitate a puncture of the first mammalian tissue at a desired location relative to the second mammalian tissue, wherein advancement of a therapeutic delivery device through the lumen of the delivery catheter, and delivery of a therapeutic treatment device from the therapeutic delivery device, is performed based upon the distance between the second mammalian tissue and the at least a portion of the bodily access system.
In at least one method for facilitating mammalian organ treatment of the present disclosure, the method comprises the steps of inserting at least part of a bodily access system into a mammalian body and into a right atrium of a heart, the bodily access system comprising an engagement catheter having an open distal end and defining a first lumen therethrough, a puncture device configured to fit at least partially within the first lumen of the engagement catheter, and a scanner configured to identify at least a portion of the bodily access system when positioned within the mammalian luminal organ and further configured to identify a distance between a second mammalian tissue and the at least a portion of the bodily access system, stabilizing an atrial septum at a first location using suction through the first lumen or a second lumen of the engagement catheter so that the open distal end reversibly engages the atrial septum at the first location, operating a scanner to obtain data relative to the distance between the second mammalian tissue and the at least a portion of the bodily access system positioned within the mammalian luminal organ, and advancing part of the bodily access system through the atrial septum at a fossa ovalis and into a left atrium to facilitate a therapy within the left atrium if/when the data relative to the distance between the second mammalian tissue and the at least a portion of the bodily access system is satisfactory. In another embodiment, if the data relative to the distance between the second mammalian tissue and the at least a portion of the bodily access system is unsatisfactory, the method, after the operating step and before the advancing step, further comprises the steps of releasing suction so to disengage the atrial septum, moving the engagement catheter to a different location at or near the atrial septum, and re-stabilizing the atrial septum at the different location using suction so that the open distal end reversibly engages the atrial septum at the different location, wherein the step of operating a scanner is performed during one or more of the releasing step, the moving step, and the re-stabilizing step. In yet another embodiment, if the data relative to the distance between the second mammalian tissue and the at least a portion of the bodily access system is unsatisfactory, the method, after the operating step and before the advancing step, further comprises the steps of releasing suction so to disengage the atrial septum, moving the engagement catheter to a different location at or near the atrial septum, re-stabilizing the atrial septum at the different location using suction so that the open distal end reversibly engages the atrial septum at the different location, and re-operating the scanner to obtain data relative to the distance between the second mammalian tissue and the at least a portion of the bodily access system positioned within the mammalian luminal organ.
In at least one method for facilitating mammalian organ treatment of the present disclosure, the data relative to the distance between the second mammalian tissue and the at least a portion of the bodily access system is selected from the group consisting of data relative to a distance between a mitral valve annulus and the at least a portion of the bodily access system, data relative to a distance between a mitral valve portion and the at least a portion of the bodily access system, data relative to a distance between a left atrial appendage opening and the at least a portion of the bodily access system, and data relative to a distance between a left atrial appendage portion and the at least a portion of the bodily access system. In an additional embodiment, the method further comprises the step of repeating one or more of the stabilizing step and the operating step, prior to the advancing step, until the data relative to the distance between the second mammalian tissue and the at least a portion of the bodily access system is satisfactory. In yet an additional embodiment, the method further comprises the step of performing the therapy within the left atrium. In another embodiment, the therapy is selected from the group consisting of delivering a mitral valve into the heart, placing a mitral valve within the heart, delivering a mitral valve prosthesis into the heart, placing a mitral valve prosthesis within the heart, delivering a mitral clip into the heart, placing a mitral clip within the heart, delivering a mitral ring into the heart, placing a mitral ring within the heart, treating mitral regurgitation, treating mitral stenosis, delivering a left atrial appendage occluder device into the heart, placing a left atrial appendage occluder device within the heart, treating stroke, reducing a risk of stroke, preventing a blood clot from a left atrial appendage from entering into a bloodstream, and delivering a drug therapy into the heart.
In at least one method for facilitating mammalian organ treatment of the present disclosure, the method further comprising the steps of preparing for performance of the therapy within the left atrium, and performing the therapy within the left atrium. In an additional embodiment, the step of advancing part of the bodily access system through the atrial septum and into a left atrium comprises the steps of puncturing the atrial septum using the puncture device comprising a delivery catheter having a needle tip, and wherein the step of preparing for performance of the therapy comprises the steps of advancing a guidewire through the puncture device so that a portion of the guidewire is present within the left atrium, removing the puncture device from the left atrium, releasing suction so to disengage the atrial septum, and withdrawing the engagement catheter and the puncture device, allowing at least a portion of the guidewire to remain within the left atrium.
In at least one method of the present disclosure, the method comprises the steps of engaging a targeted tissue under suction/vacuum using an engagement catheter; delivering a substance into or through the targeted tissue using a needle positioned within a first lumen of the engagement catheter; injecting a fluid within the first lumen of the engagement catheter to flush at least part of the first lumen with the fluid; and suctionally removing the injected fluid from within the first lumen of the engagement catheter. In at least one method of the present disclosure, the step of injecting is performed by injecting the fluid through an injection channel of the engagement catheter using a syringe in communication with the injection channel.
In at least one method of the present disclosure, the step of suctionally removing the injected fluid is performed using a syringe in communication with a vacuum channel of the engagement catheter. In at least one method of the present disclosure, the method is performed to inject saline into the first lumen of the engagement catheter at or near a skirt or suction cup positioned at a distal end of the engagement catheter, whereby the skirt or suction cup is used to engage the targeted tissue. In at least one method of the present disclosure, the method is performed to remove substance that has leaked from the targeted tissue after injection or that is otherwise present within the first lumen of the engagement catheter after injection.
In at least one method of the present disclosure, the engaging step is performed under suction/vacuum within a suction lumen defined within the engagement catheter having an outer wall and a concentric inner wall, the suction lumen defined outside the concentric inner wall. In at least one method of the present disclosure, the first lumen is defined inside the concentric inner wall. In at least one method of the present disclosure, the engaging step is performed under suction/vacuum within a suction lumen defined within the engagement catheter having an outer wall and a concentric inner wall, the suction lumen defined inside the concentric inner wall. In at least one method of the present disclosure, the first lumen is defined outside the concentric inner wall. In at least one method of the present disclosure, the engagement catheter comprises an outer wall and an extension portion coupled thereto, and wherein the step of engaging the targeted tissue under suction/vacuum using an engagement catheter is performed using suction/vacuum within suction lumen defined within the extension portion.
In at least one method of the present disclosure, the engaging step is performed to stabilize the targeted tissue, and wherein the method further comprises the step of mapping the stabilized targeted tissue using a mapping device so to generate a tissue map. In at least one method of the present disclosure, the method further comprises the step of performing a medical procedure based upon the tissue map. In at least one method of the present disclosure, the method further comprises the step of performing electroporation using an electroporation device so to increase uptake of the delivered substance by the targeted tissue.
In at least one method of the present disclosure, the method comprises the steps of stabilizing a targeted tissue under suction/vacuum using an engagement catheter; and mapping the stabilized tissue using a mapping device, whereby the mapping is performed to generate a tissue map. In at least one method of the present disclosure, the method further comprises the step of performing a medical procedure based upon the tissue map. In at least one method of the present disclosure, the medical procedure is an ablation procedure.
In at least one method of the present disclosure, the method comprises the steps of stabilizing a targeted tissue under suction/vacuum using an engagement catheter; delivering a substance into or through the targeted tissue using a needle positioned within a first lumen of the engagement catheter; and performing electroporation using an electroporation device so to increase uptake of the delivered substance by the targeted tissue. In at least one method of the present disclosure, the step of performing electroporation is performed during the step of delivering the substance. In at least one method of the present disclosure, the step of performing electroporation is performed after the step of delivering the substance. In at least one method of the present disclosure, the engagement catheter comprises a skirt or suction cup positioned at a distal end of the engagement catheter, and whereby the skirt or suction cup is used to stabilize the targeted tissue under suction/vacuum.
The present disclosure includes disclosure of devices, systems, and methods, as referenced herein.
The present disclosure includes disclosure of engagement catheters, as shown and described herein.
The present disclosure includes disclosure of a method, comprising the steps of stabilizing a targeted tissue under suction/vacuum using a device configured to perform the same, such as, for example, an engagement catheter of the present disclosure; and mapping the stabilized tissue using an exemplary device of the present disclosure, whereby the mapping, for example, is performed so to best evaluate the targeted tissue, such as to generate a map for consideration with a subsequently-performed medical procedure.
The present disclosure includes disclosure of a method, further comprising the step of performing a medical procedure, such as ablation or another medical procedure.
The present disclosure includes disclosure of a method, comprising the steps of stabilizing a targeted tissue under suction/vacuum using a device configured to perform the same, such as, for example, an engagement catheter of the present disclosure; delivering a substance to the targeted tissue; and performing electroporation using an exemplary device of the present disclosure, whereby the electroporation, for example, is performed so to increase uptake of a delivered substance by the tissue.
The present disclosure includes disclosure of a method, comprising the steps of stabilizing a targeted tissue under suction/vacuum using a device configured to perform the same, such as, for example, an engagement catheter of the present disclosure; and delivering a substance to the targeted tissue while performing electroporation using an exemplary device of the present disclosure, whereby the electroporation, for example, is performed so to increase uptake of a delivered substance by the tissue.
For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of this disclosure is thereby intended.
The disclosed embodiments include devices, systems, and methods useful for accessing various tissues of the heart from inside the heart. For example, various embodiments provide for percutaneous, intravascular access into the pericardial space through an atrial wall or the wall of an atrial appendage. In at least some embodiments, the heart wall is aspirated and retracted from the pericardial sac to increase the pericardial space between the heart and the sac and thereby facilitate access into the space.
Unlike the relatively stiff pericardial sac, the atrial wall and atrial appendage are rather soft and deformable. Hence, suction of the atrial wall or atrial appendage can provide significantly more clearance of the cardiac structure from the pericardium as compared to suction of the pericardium. Furthermore, navigation from the intravascular region (inside of the heart) provides more certainty of position of vital cardiac structures than does intrathoracic access (outside of the heart).
Access to the pericardial space may be used for identification of diagnostic markers in the pericardial fluid; for pericardiocentesis; and for administration of therapeutic factors with angiogenic, myogenic, and antiarrhythmic potential. In addition, as explained in more detail below, epicardial pacing leads may be delivered via the pericardial space, and an ablation catheter may be used on the epicardial tissue from the pericardial space.
In the embodiment of the catheter system shown in
As shown in more detail in
A route of entry for use of various embodiments disclosed herein is through the jugular or femoral vein to the superior or inferior vena cavae, respectively, to the right atrial wall or atrial appendage (percutaneously) to the pericardial sac (through puncture).
Referring now to
Although aspiration of the atrial wall or the atrial appendage retracts the wall or appendage from the pericardial sac to create additional pericardial space, CO2 gas can be delivered through a catheter, such as delivery catheter 130, into the pericardial space to create additional space between the pericardial sac and the heart surface.
Referring now to
Other examples for sealing the puncture wound in the atrial wall or appendage are shown in
Internal cover 620 and external cover 610 may be made from a number of materials, including a shape-memory alloy such as nitinol. Such embodiments are capable of existing in a catheter in a folded configuration and then expanding to an expanded configuration when deployed into the body. Such a change in configuration can result from a change in temperature, for example. Other embodiments of internal and external covers may be made from other biocompatible materials and deployed mechanically.
After internal cover 620 is deployed, engagement catheter 600 releases its grip on the targeted tissue and is withdrawn, leaving the sandwich-type closure to seal the puncture wound, as shown in
In the embodiment shown in
In the embodiment shown in
Delivery catheter 1530 is shown after insertion through hole 1555 of atrial wall 1550. Closure member 1500 may be advanced through delivery catheter 1530 to approach atrial wall 1550 by pushing rod 1560. Rod 1560 may be reversibly attached to internal cover 1520 so that rod 1560 may be disconnected from internal cover 1520 after closure member 1500 is properly deployed. For example, rod 1560 may engage internal cover 1520 with a screw-like tip such that rod 1560 may be easily unscrewed from closure member 1500 after deployment is complete. Alternatively, rod 1560 may simply engage internal cover 1520 such that internal cover 1520 may be pushed along the inside of delivery catheter 1530 without attachment between internal cover 1520 and rod 1560.
Closure member 1500 is advanced through delivery catheter 1530 until external cover 1510 reaches a portion of delivery catheter 1530 adjacent to atrial wall 1550; external cover 1510 is then pushed slowly out of delivery catheter 1530 into the pericardial space. External cover 1510 then expands and is positioned on the outer surface of atrial wall 1550. When external cover 1510 is properly positioned on atrial wall 1550, joint 1540 is approximately even with atrial wall 1550 within hole 1555. Delivery catheter 1530 is then withdrawn slowly, causing hole 1555 to close slightly around joint 1540. As delivery catheter 1530 continues to be withdrawn, internal cover 1520 deploys from delivery catheter 1530, thereby opening into its expanded formation. Consequently, atrial wall 1550 is pinched between internal cover 1520 and external cover 1510, and hole 1555 is closed to prevent leakage of blood from the heart.
Other examples for sealing a puncture wound in the cardiac tissue are shown in
As shown in
Referring again to
As shown in
It should be noted that, in some embodiments, the wire is not withdrawn from the hole of the plug. For example, where the wire is a pacing lead, the wire may be left within the plug so that it operatively connects to the CRT device.
Referring now to
Referring again to
In this way, spider clip 1700 may be used to seal a wound or hole in a tissue, such as a hole through the atrial wall. For example,
Rod 1750 pushes spider clip 1700 through engagement catheter 1760 to advance spider clip 1700 toward cardiac tissue 1770. Rod 1750 simply engages head 1705 by pushing against it, but in other embodiments, the rod may be reversibly attached to the head using a screw-type system. In such embodiments, the rod may be attached and detached from the head simply by screwing the rod into, or unscrewing the rod out of, the head, respectively.
In at least some embodiments, the spider clip is held in its open position during advancement through the engagement catheter by the pressure exerted on the head of the clip by the rod. This pressure may be opposed by the biasing of the legs against the engagement catheter during advancement.
Referring to
Rod 1750 is then withdrawn, and engagement catheter 1760 is disengaged from cardiac tissue 1770. The constriction of cardiac tissue 1770 holds hole 1775 closed so that blood does not leak through hole 1775 after engagement catheter 1760 is removed. After a relatively short time, the body's natural healing processes permanently close hole 1775. Spider clip 1700 may remain in the body indefinitely.
Referring now to
As shown in
The embodiments shown in
As shown by the exemplary embodiments of
An exemplary embodiment of a system and/or device for engaging a tissue as described herein is shown in
In addition, and as shown in the exemplary embodiment of
The exemplary embodiment of an apparatus for engaging a tissue as shown in
It can also be appreciated that an exemplary embodiment of an apparatus of the present disclosure may be used to engage an internal portion of an organ. As previously referenced herein, such an apparatus may be used to engage the surface of a tissue. However, it can be appreciated that such a tissue may be an outer surface of any number of tissues, including, but not limited to, a heart, lungs, intestine, stomach, or any number of other organs or tissues. It can also be appreciated that some of these types of organs or tissues, including the heart for example, may have one or more internal tissue surfaces capable of being engaged by an apparatus of the present disclosure. For example, a user of such an apparatus may use the apparatus to engage the septum of the heart dividing one side of the heart from another. Such use may facilitate the delivery of a gas, liquid, and/or particulate(s) to a particular side of the heart, as such a targeted delivery may provide beneficial effects, including, but not limited to, the ability to deliver a lead to pace the inner wall of the left side of the heart.
Referring now to
Referring now to
As shown in
An engagement catheter, such as engagement catheter 700, may be configured to deliver a fluid or other substance to tissue on the inside of a wall of the heart, including an atrial wall or a ventricle wall. For example, lumen 740 shown in
Substances that can be locally administered with an engagement catheter include preparations for gene or cell therapy, drugs, and adhesives that are safe for use in the heart. The proximal end of lumen 740 has a fluid port 800, which is capable of attachment to an external fluid source for supply of the fluid to be delivered to the targeted tissue. Indeed, after withdrawal of a needle from the targeted tissue, as discussed herein, an adhesive may be administered to the targeted tissue by the engagement catheter for sealing the puncture wound left by the needle withdrawn from the targeted tissue.
Referring now to
It is useful for the clinician performing the procedure to know when the needle has punctured the atrial tissue. This can be done in several ways. For example, the delivery catheter can be connected to a pressure transducer to measure pressure at the tip of the needle. Because the pressure is lower and much less pulsatile in the pericardial space than in the atrium, the clinician can recognize immediately when the needle passes through the atrial tissue into the pericardial space.
Alternatively, as shown in
In some embodiments, a delivery catheter, such as catheter 850 shown in
Referring again to
In some embodiments, however, only a single delivery catheter is used. In such embodiments, the needle is not attached to the delivery catheter, but instead may be a needle wire (see
The various embodiments disclosed herein may be used by clinicians, for example: (1) to deliver genes, cells, drugs, etc.; (2) to provide catheter access for epicardial stimulation; (3) to evacuate fluids acutely (e.g., in cases of pericardial tampondae) or chronically (e.g., to alleviate effusion caused by chronic renal disease, cancer, etc.); (4) to perform transeptal puncture and delivery of a catheter through the left atrial appendage for electrophysiological therapy, biopsy, etc.; (5) to deliver a magnetic glue or ring through the right atrial appendage to the aortic root to hold a percutaneous aortic valve in place; (6) to deliver a catheter for tissue ablation, e.g., to the pulmonary veins, or right atrial and epicardial surface of the heart for atrial and ventricular arrythmias; (7) to deliver and place epicardial, right atrial, and right and left ventricle pacing leads (as discussed herein); (8) to occlude the left atrial appendage through percutaneous approach; and (9) to visualize the pericardial space with endo-camera or scope to navigate the epicardial surface of the heart for therapeutic delivery, diagnosis, lead placement, mapping, etc. Many other applications, not explicitly listed here, are also possible and within the scope of the present disclosure.
Referring now to
In the embodiment of
Referring now to
Although steering wire system 1040 has only two steering wires, other embodiments of steering wire systems may have more than two steering wires. For example, some embodiments of steering wire systems may have three steering wires (see
If a steering wire system includes more than two steering wires, the delivery catheter may be deflected at different points in the same direction. For instance, a delivery catheter with three steering wires may include two steering wires for deflection in a certain direction and a third steering wire for reverse deflection (i.e., deflection in the opposite direction). In such an embodiment, the two steering wires for deflection are attached at different locations along the length of the delivery catheter. Referring now to
Referring again to
Each of bend 1134 of lumen 1130 and bend 1144 of lumen 1140 forms an approximately 90-degree angle, which allows respective outlets 1136 and 1146 to face the external surface of the heart as the catheter is maneuvered in the pericardial space. However, other embodiments may have bends forming other angles, smaller or larger than 90-degrees, so long as the lumen provides proper access to the external surface of the heart from the pericardial space. Such angles may range, for example, from about 25-degrees to about 155-degrees. In addition to delivering leads and Doppler tips, lumen 1130 and lumen 1140 may be configured to allow, for example, the taking of a cardiac biopsy, the delivery of gene cell treatment or pharmacological agents, the delivery of biological glue for ventricular reinforcement, implementation of ventricular epicardial suction in the acute myocardial infarction and border zone area, the removal of fluid in treatment of pericardial effusion or cardiac tamponade, or the ablation of cardiac tissue in treatment of atrial fibrillation.
For example, lumen 1130 could be used to deliver a catheter needle for intramyocardial injection of gene cells, stems, biomaterials, growth factors (such as cytokinase, fibroblast growth factor, or vascular endothelial growth factor) and/or biodegradable synthetic polymers, RGD-liposome biologic glue, or any other suitable drug or substance for treatment or diagnosis. For example, suitable biodegradable synthetic polymer may include polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyamides, and polyurethanes. In certain embodiments, the substance comprises a tissue inhibitor, such as a metalloproteinase (e.g., metalloproteinase 1).
The injection of certain substances (such as biopolymers and RGD-liposome biologic glue) is useful in the treatment of chronic heart failure to reinforce and strengthen the left ventricular wall. Thus, using the embodiments disclosed herein, the injection of such substances into the cardiac tissue from the pericardial space alleviates the problems and risks associated with delivery via the transthoracic approach. For instance, once the distal end of the delivery catheter is advanced to the pericardial space, as disclosed herein, a needle is extended through a lumen of the delivery catheter into the cardiac tissue and the substance is injected through the needle into the cardiac tissue.
The delivery of substances into the cardiac tissue from the pericardial space can be facilitated using a laser Doppler tip. For example, when treating ventricular wall thinning, the laser Doppler tip located in lumen 1140 of the embodiment shown in
Referring again to
Torque system 1210 further includes a first rotatable dial 1240 and a second rotatable dial 1250. First rotatable dial 1240 is attached to first rotatable spool 1220 such that rotation of first rotatable dial 1240 causes rotation of first rotatable spool 1220. Similarly, second rotatable dial 1250 is attached to second rotatable spool 1230 such that rotation of second rotatable dial 1250 causes rotation of second rotatable spool 1230. For ease of manipulation of the catheter, torque system 1210, and specifically first and second rotatable dials 1240 and 1250, may optionally be positioned on a catheter handle (not shown) at the proximal end of tube 1010.
Steering wire system 1170 can be used to direct a delivery catheter through the body in a similar fashion as steering wire system 1140. Thus, for example, when first rotatable dial 1240 is rotated in a first direction (e.g., clockwise), steering wire 1180 is tightened and the delivery catheter is deflected in a certain direction. When first rotatable dial 1240 is rotated in the other direction (e.g., counterclockwise), steering wire 1180 is loosened and the delivery catheter straightens to its original position. When second rotatable dial 1250 is rotated in one direction (e.g., counterclockwise), steering wire 1190 is tightened and the delivery catheter is deflected in a direction opposite of the first deflection. When second rotatable dial 1250 is rotated in the other direction (e.g., clockwise), steering wire 1190 is loosened and the delivery catheter is straightened to its original position.
Certain other embodiments of steering wire system may comprise other types of torque system, so long as the torque system permits the clinician to reliably tighten and loosen the various steering wires. The magnitude of tightening and loosening of each steering wire should be controllable by the torque system.
Referring again to
Treatment of cardiac tamponade, by the removal of a pericardial effusion, may be accomplished using an apparatus of the present disclosure as described below. A typical procedure would involve the percutaneous intravascular insertion of a portion of an apparatus into a body, which can be performed under local or general anesthesia. A portion of the apparatus may then utilize an approach described herein or otherwise known by a user of the apparatus to enter the percutaneous intravascular pericardial sac. It can be appreciated that such an apparatus may be used to access other spaces within a body to remove fluid and/or deliver a gas, liquid, and/or particulate(s) as described herein, and that such an apparatus is not limited to heart access and removal of pericardial effusions.
Exemplary embodiments of a portion of such an apparatus are shown in
It can be appreciated that the internal lumen within perforated delivery catheter 2100 may define multiple internal channels. For example, perforated delivery catheter 2100 may define two channels, one channel operably coupled to one or more suction/injection apertures 2110 to allow for a vacuum source coupled to one end of the channel to provide suction via the suction/injection apertures 2110, and one channel operably coupled to one or more other suction/injection channels to allow for the injection of gas, liquid, and/or particulate(s) to a target site.
As described in further detail below, when perforated drainage catheter 2100 enters a space in a body, for example a pericardial sac, perforated drainage catheter 2100 may be used to remove fluid by the use of suction through one or more suction/injection apertures 2110. Perforated drainage catheter 2100 may also be used to deliver gas, liquid, and/or particulate(s) to a target site through one or more suction/injection apertures 2110.
Another exemplary embodiment of a portion of a perforated drainage catheter 2100 is shown in
A procedure using perforated drainage catheter 2100 may be performed by inserting perforated drainage catheter 2100 into a pericardial sac, following the cardiac surface using, for example, fluoroscopy and/or echodoppler visualization techniques. When perforated drainage catheter 2100 is inserted into a pericardial sac, a pericardial effusion present within the pericardial sac, may be removed by, for example, gentle suction using a syringe. In one example, a 60 cc syringe may be used to remove the effusion with manual gentle suction. When the effusion has been removed, the patients hemodynamic parameters may be monitored to determine the effectiveness of the removal of the effusion. When the pericardial sac is empty, determined by, for example, fluoroscopy or echodoppler visualization, the acute pericardial effusion catheter may be removed, or it may be used for local treatment to introduce, for example, an antibiotic, chemotherapy, or another drug as described below.
An exemplary embodiment of a portion of a perforated drainage catheter 2100 present within a pericardial sac is shown in
When perforated drainage catheter 2100 is used to remove some or all of a pericardial effusion (or other fluid present within a space within a body), it may also be used to deliver a gas, liquid, and/or particulate(s) at or near the space where the fluid was removed. For example, the use of perforated drainage catheter 2100 to remove a pericardial effusion may increase the risk of infection. As such, perforated drainage catheter 2100 may be used to rinse the pericardial sac (or other space present within a body) with water and/or any number of beneficial solutions, and may also be used to deliver one or more antibiotics to provide an effective systemic antibiotic therapy for the patient. While the intrapericardial instillation of antibiotics (e.g., gentamycin) is useful, it is typically not sufficient by itself, and as such, it may be combined with general antibiotics treatment for a more effective treatment.
An exemplary embodiment of a system for engaging a tissue of the present disclosure is shown in
As shown in
A vacuum port, such as vacuum port 770 or vacuum ports 1870 previously disclosed herein, may be located at or near the proximal end 710 of engagement catheter 1810 and operatively connected to lumen 730 of engagement catheter 1810, and may be capable of operative connection to a vacuum source (not shown) to introduce a vacuum/suction as previously disclosed herein. In addition, lumen 730 of engagement catheter 1810 may include a suction port, such as suction ports 95, 780, and/or 1765 previously disclosed herein and located at or near the distal end 1820 of engagement catheter 1810, wherein the suction port(s) is/are configured to allow the distal end 1837 of skirt or suction cup 1830 to removably engage a surface of a bodily tissue 1850 such that skirt or suction cup 1830 is capable of forming a reversible seal with the surface of tissue 1850 when a vacuum source is operatively attached to the vacuum port.
In various embodiments, system 2500 is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds the heart by retracting the targeted tissue away from the pericardial sac.
In at least one exemplary embodiment, and as shown in
In at least one exemplary embodiment, and as shown in
In various embodiment, inducer sheath 2510 may be comprised of or coated with Teflon and/or another material so that inducer sheath may slidingly engage engagement catheter 1810 and so that dilator 2530 may slidingly engage inducer sheath 2510. In at least one embodiment, inducer sheath 2510 has a wall thickness from about 0.2 mm to about 0.3 mm, whereby the relatively thin thickness improves sheath-to-dilator transition and assuring less puncture resistance. In various embodiments, inducer sheath 2510 has a length of no more than about 5 mm to about 6 mm of a length of engagement catheter 2510. To prevent unintentional advancement and/or retraction of inducer sheath 2510 within engagement catheter 1810, the proximal portion 2513 of inducer sheath 2510 is affixed to the proximal end 710 of engagement catheter 1810.
In at least one embodiment, inflatable balloon 2520 is comprised of a radiopaque material so that inflatable balloon 2520 appears under fluoroscopy and/or another system capable of visualizing a radiopaque material within a mammalian body. In various embodiments, the radiopaque material comprises a polyamide elastomer and tungsten.
As shown in
In at least one embodiment, and as shown in
In
At least another embodiment of a system for engaging a tissue of the present disclosure is shown in
As shown in
System 2500 may further comprise one or more elements and/or features of various other devices and/or systems of the present disclosure. For example, skirt or suction cup 1830 may comprises a deformable configuration as previously described herein, wherein the deformable configuration of skirt or suction cup 1830 is capable of expanding to an expanded configuration. Furthermore, system 2500 may further comprise a sleeve 1800, as shown in
In various embodiments, and as described herein in further detail, system 2500 (or portions thereof) can be used to engage and puncture an atrial wall (an exemplary tissue) to provide access to the pericardial space surrounding the heart.
Method 2600, in at least one embodiment and as shown in
Method 2600, in various embodiments, further comprises the steps of advancing inducer sheath 2510 and dilator 2530 into the tissue aperture so that balloon 2520 is positioned within a space behind the targeted tissue (an exemplary advancement step 2640), and inflating balloon 2520 to reversibly secure inducer sheath 2510 to the targeted tissue (an exemplary balloon inflation step 2650). In at least one embodiment, advancement step 2640 further comprises withdrawal of needle 1890 from at least part of the lumen 2550 of dilator 2530. Needle withdrawal may be performed while dilator 2530 and inducer sheath 2510 are advanced into the tissue aperture or after advancement is completed. Advancement of dilator 2530 and inducer sheath 2510, in at least one embodiment, is only from about 4 mm to about 5 mm into the space behind the targeted tissue. Various embodiments of method 2600 may include procedures performed through the left atrial cavity (including, but not limited to, lead delivery, use of an ablation catheter, internal occlusion of the left atrial appendage, etc), as the atrial septum can be held by device 2500 using skirt or suction cup 1830 and/or balloon 2520, as applicable with various embodiments of systems 2500.
In addition to the foregoing, and in at least one embodiment, method 2600 may further comprise the steps of removing dilator 2530 from the inducer sheath 2510 (an exemplary dilator removal step 2660, such as removal of dilator 2530 in the direction of arrow A shown in
An exemplary embodiment of a system for engaging a tissue of the present disclosure is shown in
As shown in
A vacuum port, such as vacuum port 770 or vacuum ports 1870 previously disclosed herein, may be located at or near the proximal end 710 of engagement catheter 1810 and operatively connected to second lumen 740 of engagement catheter 1810, and may be capable of operative connection to a vacuum source (not shown) to introduce a vacuum/suction as previously disclosed herein. In addition, lumen 730 of engagement catheter 1810 may include a suction port, such as suction ports 95, 780, and/or 1765 previously disclosed herein and located at or near the distal end 1820 of engagement catheter 1810, wherein the suction port(s) is/are configured to allow the distal end 1837 of skirt or suction cup 1830 to removably engage a surface of a bodily tissue 1850 such that skirt or suction cup 1830 is capable of forming a reversible seal with the surface of tissue 1850 when a vacuum source is operatively attached to the vacuum port.
In various embodiments, system 2500 is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds the heart by retracting the targeted tissue away from the pericardial sac.
In at least one exemplary embodiment, and as shown in
In at least one exemplary embodiment of system 2500, and as shown in at least
In at least one exemplary embodiment, and as shown in
In at least one exemplary embodiment, and as shown in
In at least one exemplary embodiment, and as shown in
In various embodiment, inducer sheath 2510 may be comprised of or coated with Teflon and/or another material so that inducer sheath may slidingly engage engagement catheter 1810 and so that dilator 3030 may slidingly engage inducer sheath 2510. In at least one embodiment, inducer sheath 2510 has a wall thickness from about 0.2 mm to about 0.3 mm, whereby the relatively thin thickness improves sheath-to-dilator transition and assuring less puncture resistance. In various embodiments, inducer sheath 2510 has a length of within about 5 mm to about 6 mm of the length of engagement catheter 2510. To prevent unintentional advancement and/or retraction of inducer sheath 2510 within engagement catheter 1810, and in at least one exemplary embodiment, the proximal portion 2513 of inducer sheath 2510 is affixed to the proximal end 710 of engagement catheter 1810.
In at least one embodiment, inflatable balloon 2520 is comprised of a radiopaque material so that inflatable balloon 2520 appears under fluoroscopy and/or another system capable of visualizing a radiopaque material within a mammalian body. In various embodiments, the radiopaque material comprises a polyamide elastomer and tungsten.
As shown in
In at least one embodiment, and as shown in
In
Method 3200, in at least one embodiment and as shown in
Method 3200, in various embodiments, further comprises the steps of advancing inducer sheath 2510 and dilator 3030 into the tissue aperture so that balloon 2520 is positioned within a space behind the targeted tissue (an exemplary advancement step 3240), and inserting at least part of a catheter into the space behind the targeted tissue (an exemplary inserting step 3250). The targeted tissue, in at least one embodiment, may be the atrial septum, and the advancement step 3240 may advance at least part of the inducer sheath 2510 and dilator 3030 into an atrial septum aperture and into the left atrium. Following advancement step 3240, in at least one embodiment, balloon 2520 may be inflated to reversibly secure inducer sheath 2510 to the targeted tissue (an exemplary balloon inflation step 3260). In at least one embodiment, advancement step 3240 further comprises withdrawal of needle 1890 from at least part of the lumen 2550 of dilator 3030. Needle withdrawal may be performed while dilator 3030 and inducer sheath 2510 are advanced into the tissue aperture or after advancement is completed. Advancement of dilator 3030 and inducer sheath 2510, in at least one embodiment, is only from about 4 mm to about 5 mm into the space behind the targeted tissue. Various embodiments of method 3200 may include procedures performed through the left atrial cavity (including, but not limited to, lead delivery, use of an ablation catheter, internal occlusion of the left atrial appendage, etc), as the atrial septum can be held by device 2500 using skirt or suction cup 1830 and/or balloon 2520, as applicable with various embodiments of systems 2500.
In addition to the foregoing, and in at least one embodiment, method 3200 may further comprise the steps of removing dilator 3030 from the inducer sheath 2510 (an exemplary dilator removal step 3270, such as removal of dilator 3030 in the direction of arrows shown in
In addition, methods to treat neoplastic pericardial effusions without tamponade may be utilized using a device, system and/or method of the present disclosure. For example, a systemic antineoplastic treatment may be performed to introduce drugs to inhibit and/or prevent the development of tumors. If a non-emergency condition exists (e.g., not a cardiac tamponade), a system and/or method of the present disclosure may be used to perform a pericardiocentesis. In addition, the present disclosure allows for the intrapericardial instillation of a cytostatic/sclerosing agent. It can be appreciated that using one or more of the devices, systems and/or methods disclosed herein, the prevention of recurrences may be achieved by intrapericardial instillation of sclerosing agents, cytotoxic agents, or immunomodulators, noting that the intrapericardial treatment may be tailored to the type of the tumor. Regarding chronic autoreactive pericardial effusions, the intrapericardial instillation of crystalloid glucocorticoids could avoid systemic side effects, while still allowing high local dose application.
A pacing lead may be placed on the external surface of the heart using an engagement catheter and a delivery catheter as disclosed herein. For example, an elongated tube of an engagement catheter is extended into a blood vessel so that the distal end of the tube is in contact with a targeted tissue on the interior of a wall of the heart. As explained above, the targeted tissue may be on the interior of the atrial wall or the atrial appendage. Suction is initiated to aspirate a portion of the targeted tissue to retract the cardiac wall away from the pericardial sac that surrounds the heart, thereby enlarging a pericardial space between the pericardial sac and the cardiac wall. A needle is then inserted through a lumen of the tube and advanced to the heart. The needle is inserted into the targeted tissue, causing a perforation of the targeted tissue. The distal end of a guide wire is inserted through the needle into the pericardial space to secure the point of entry through the cardiac wall. The needle is then withdrawn from the targeted tissue.
A delivery catheter, as described herein, is inserted into the lumen of the tube of the engagement catheter and over the guide wire. The delivery catheter may be a 14 Fr. radiopaque steering catheter. The distal end of the delivery catheter is advanced over the guide wire through the targeted tissue into the pericardial space. Once in the pericardial space, the delivery catheter is directed using a steering wire system as disclosed herein. In addition, a micro-camera system may be extended through the lumen of the delivery catheter to assist in the direction of the delivery catheter to the desired location in the pericardial space. Micro-camera systems suitable for use with the delivery catheter are well-known in the art. Further, a laser Doppler system may be extended through the lumen of the delivery catheter to assist in the direction of the delivery catheter. The delivery catheter is positioned such that the outlet of one of the lumens of the delivery catheter is adjacent to the external surface of the heart (e.g., the external surface of an atrium or a ventricle). A pacing lead is extended through the lumen of the delivery catheter onto the external surface of the heart. The pacing lead may be attached to the external surface of the heart, for example, by screwing the lead into the cardiac tissue. In addition, the pacing lead may be placed deeper into the cardiac tissue, for example in the subendocardial tissue, by screwing the lead further into the tissue. After the lead is placed in the proper position, the delivery catheter is withdrawn from the pericardial space and the body. The guide wire is withdrawn from the pericardial space and the body, and the engagement catheter is withdrawn from the body.
The disclosed embodiments can be used for subendocardial, as well as epicardial, pacing. While the placement of the leads is epicardial, the leads can be configured to have a long screw-like tip that reaches near the subendocardial wall. The tip of the lead can be made to be conducting and stimulatory to provide the pacing to the subendocardial region. In general, the lead length can be selected to pace transmurally at any site through the thickness of the heart wall. Those of skill in the art can decide whether epicardial, subendocardial, or some transmural location stimulation of the muscle is best for the patient in question.
In addition to the foregoing, the disclosure of the present application also provides disclosure of a system and method for localization of a puncture site on an atrial wall relative to a mitral valve and/or a left atrial appendage (LAA), for example, of the heart. Current technology to deliver mitral valve devices (such as clips, rings, valves, and/or valve prostheses, including the MitraClip device of Abbott Laboratories) involves relatively bulky delivery devices, such as 24 Fr. catheters, that require a precise distance between the mitral valve device and the mitral valve leaflets upon delivery. Accessing the atrial wall at the right distance from the mitral valve is critical for proper delivery and ultimate placement of a mitral valve clip. Furthermore, delivery of left atrial appendage closure devices (such as with the WATCHMAN device of Boston Scientific Corporation) would also require delivery at the correct distance from the atrial wall puncture location to ensure proper delivery within the LAA.
The preferred site of access, for delivery of a mitral valve/clip/ring/prosthesis and/or other device (such as an LAA closure device) through the atrial wall into the left atrium, is the fossa ovalis. The fossa ovalis is typically—3 cm in diameter, but can dilate to twice that size in patients with a mitral insufficiency. Given that relatively small size, it is difficult to target the desired position within the fossa ovalis so that once the user crosses to the left side of the heart using an access/delivery device, the position above the mitral valve is within reach of the mitral clip, or the position of the LAA is within reach of the closure device, for example. An additional complicating factor, aside from the small size of the access point, is that the atrial wall is typically dilated and thin and therefore moves with relative ease.
The present disclosure addresses these complicating factors and provides a system and method for accessing the left side of the heart with precision so to be in a position to deliver a mitral valve, clip, ring, and/or prosthesis, a LAA occlusion device, or other device within the left side of the heart. In doing so, the systems of the present disclosure stabilize a portion of the access device on the fossa ovalis (by substantially or completely eliminating motion thereof), so that a scanning mechanism (such as an echocardiogram, including 2D or 3D transthoracic or transesophageal scanners) can be used to measure the distance between the site of potential access through the fossa ovalis and the mitral valve plane, for example. By using an exemplary device of the present disclosure and a sufficient scanning mechanism, the user can will know with certainty that not only will the access route through the fossa ovalis be the proper distance from the valve plane, but also that the access route is through an optimal atrial septal puncture area and not through another portion that would have negative consequences.
As shown in
Another undesired access route is the anterior atrial septum region 4106, as shown in
In addition to the foregoing, two other undesired access routes are at the coronary sinus 4108 and at the lateral and inferior left atrial wall region 4110, as shown in
Any inadvertent puncture of the aorta 4112 (as confirmed by contrast injection or pressure recording, for example), is usually uneventful if the needle is withdrawn immediately. However, should the operator unknowingly advance the catheter into the aorta 4112, it should not be withdrawn, and the patient should be sent for emergency surgery with the catheter left in the aorta.
As such, and as demonstrated above, there are several regions along the atrial wall that, if punctured, could cause several complications. In view of the same, and as shown in
Within a general patient population, 10% have a relatively small left atrium, 50% have a usual-sized left atrium (approximately 4-5 cm), and the remaining 40% have a large left atrium (larger than 5 cm), with 5% of that remaining population having a “giant” left atrium (greater than or equal to about 7 cm). If the atrial septum bulges markedly toward the right atrium, especially in cases of a giant left atrium, it is difficult to align the catheter tip of an access device with the “midline” and perpendicular to the septum. As such, not only location, but also stabilization of the atrial wall, is critical for a precise and safe atrial wall puncture.
Use of an exemplary system of the present disclosure in accordance with the foregoing is shown in
In an embodiment of an engagement catheter 1810 having a skirt or suction cup 1830 coupled thereto, engagement catheter 1810 can be used in connection with a vacuum source 1910 coupled thereto to reversibly engage the atrial septum 4206. A scanner 4300 (as shown in the block diagram of
An exemplary method 4400 of using such a system 4200 is described as follows and shown in the step diagram of
After performance of left atrium advancement step 4408, an exemplary method 4400 of the present disclosure optionally involves preparation for performance of a therapy within the left atrium (an exemplary therapy preparation step 4414), which may be performed prior to the performance of a therapy within the left atrium (an exemplary therapeutic step 4416). For example, an exemplary left atrium advancement step 4408 may involve the sub-steps of puncturing the atrial septum 4206 and advancing a delivery catheter 1840 with a needle 1890 tip into the left atrium 4116, with the puncture performed using the needle 1890 tip. An exemplary therapy preparation step 4114 of the present disclosure may involve, for example, advancing a guidewire 1910 through the delivery catheter 1840 so that a portion of guidewire 1910 is present within the left atrium 4116, removing the delivery catheter 1840 from the left atrium, performing releasing step 4410 to release suction and disengage the atrial septum 4206, and/or withdrawing engagement catheter 1810 and delivery catheter 1840 so that only guidewire 1910 remains within the patient's body. As an exemplary therapeutic step 4416 may be performed without any additional preparation, an exemplary method 4400 of the present disclosure may include performing step 4416 directly after performing step 4408.
An exemplary therapeutic step 4416 of the present disclosure, as referenced generally herein, may include the delivery and/or placement of a mitral valve, a mitral clip, a mitral ring, and/or a mitral valve prosthesis (each referred to herein as a therapeutic device 4350, as shown in block diagram form in
There are several advantages to using the devices and methods of the present disclosure as identified above. The advantages include (i) relatively easy and fast localization and insertion of part of the device over the fossa ovalis using a scanning technology, (ii) easy engagement of the septum at the fossa ovalis level, avoiding damage of the heart structure due to the suction (such as with small, large, or giant left atria and septum aneurysms), and (iii) that the suction engagement catheter allows the possibility to choose the target point to puncture the septum in order to obtain the optimal distance between the exit puncture point at the left atrium septum and the central orifice of the mitral valve for optimally managing the device for balloon mitral valvuloplasty, mitral clip delivery, mitral ring delivery, mitral valve delivery, and/or mitral valve prosthesis delivery. In addition, use of such an access device in accordance with the present disclosure would also reduce the overall procedure risk in connection with left atrial appendage closure device implantation (such as with the WATCHMAN device of Boston Scientific Corporation), as devices of the present disclosure can maintain the septum at a fixed location and provide a correct measurement of the distance between the septum and the left atrial appendage. Furthermore, and as the devices of the present disclosure use suction to engage heart tissue, the access sheath used (such as a 12 Fr transeptal access sheath) can be evacuated of entrapped air before any entry into the left atrial cavity, reducing the known risk of procedure-related stroke due to procedures using sheaths at or near that size.
A needle 40, 890, 1890 (as referenced herein, such as shown in
Needle 40, 890, 1890 and/or delivery catheter 30, 130, 1530, 1840, for example, can be used to deliver a substance 1776 to tissue 1770 (such as before tissue 1770 relative to the side of tissue 1770 engagement or onto tissue 1770), into tissue 1770 itself (such as to form a bolus 4520 of substance 1776), or through tissue 1770 (such as by way of puncture aperture or channel 4510 extending through tissue 1770). In any of the aforementioned delivery mechanisms/methods, some substance 1776 may be freely present within lumen 730 of engagement catheter 1830, such as at or near skirt or suction cup 1830 or otherwise within lumen 730) that is either not delivered to, upon, in, or through tissue 1770, or that may have been delivered but subsequently escapes or detaches from tissue 1770. That freely present substance 1776 is referred to and shown as escaped substance 4500 in
Removal of escaped substance 4500, for example, can occur under vacuum/suction through lumen 730 of engagement catheter 1810. However, and under many circumstances, said escaped substance 4500 cannot be removed using vacuum/suction alone, and requires something to facilitate removal, such as flushing the area at or near tissue 1770 with a fluid, such as saline. Various engagement catheter 1810 embodiments of the present disclosure can be configured to permit fluid flushing as referenced herein.
As shown in
Referring now to
As shown in
As noted herein, and in various embodiments, engagement catheters 1810 of the present disclosure can comprise one lumen (730 or 740) or two or more lumens 730, 740. In embodiments having two lumens 730, 740, one lumen (lumen 730 or 740) can be used to inject a fluid to flush the region with engagement catheter 1810 while engagement catheter 1810 is suctionally attached to tissue 1770, and the other lumen (the other of lumen 730 and 740) can aspirate/remove the fluid via suction/vacuum.
As shown in
In various embodiments, such as shown in
However, and even using a needle 1890 of the present disclosure to inject a bolus 4190 of substance 1776 into a tissue 1770, leakage of said substance 1776 may still occur, such as shown in
Suction can be applied as long as desired, such as for a duration whereby the user of system 1805 is comfortable that no additional substance 1776 will leak out of tissue 1770, such as whereby closure or relative closure of puncture aperture 4195 can occur, and/or whereby substance 1776 has an opportunity to congeal, coagulate, harden, etc. In such a situation, suction can cease, such as indicated within
The present disclosure includes disclosure of devices, systems, and methods of using the same to stabilize tissue, perform electrical mapping of the stabilized tissue/region, and utilize electroporation to increase the permeability of a cell member. An exemplary device, such as an engagement catheter 1810 of the present disclosure having a skirt or suction cup 1830 at its distal end, can be used as referenced herein, so to suctionally engage cardiac tissue 1770 or other mammalian tissue under vacuum/suction. The vacuum seal enables suction port 780 (as referenced herein) and skirt or suction cup 1830 to grip, stabilize, and retract tissue 1770.
Said stabilization can be performed so to facilitate mapping of the stabilized tissue. There are generally negative effects in connection with mapping mobile (not stabilized) tissue, such as artifacts and uncertainty in the specific region of tissue that requires mapping. There are also complex geometric regions in the subendocardial surface (e.g., trabeculations, papillary muscles, etc.) where the mapping catheter/device can move across significant spatial gradients if the region is not immobilized. As such, the present disclosure includes disclose of devices and systems to perform electrical mapping, and methods of performing the same, during tissue stabilization on suction.
Such an exemplary method is shown in block step format in
An exemplary system 1805 is shown in block component format in
Said stabilization can be performed prior to electroporation, namely the introduction of an electrical field to increase the permeability of the cell membrane to take up drugs, DNA, and the like. Electroporation is a fairly common procedure, but the use of electroporation on a stabilized tissue after stabilization using a stabilizing device (such as an engagement catheter 1810 of the present disclosure) is novel to the present disclosure. Electroporation is generally difficult to implement endovascularly (vessels, heart, bladder, stomach, etc.) without some form of isolation. The present disclosure includes disclosure of electroporation performed in connection with stabilization, as the skirt or suction cup 1830 of engagement catheter 1810 can provide the isolation and localization of electroporation and hence improved therapy delivery.
Skirt or suction cup 1830 of engagement catheter 1810 can be used to stabilize the targeted tissue (tissue 1770) under vacuum/suction, and an additional device 5500 configured as an electroporation device could be used to generate an electric field. The same device 5500, a different device 5500, engagement catheter 1810, delivery catheter 1840, or needle 1890, for example, could then be used to deliver (such as by injection or general introduction, for example) a substance 1776 to or into tissue 1770, as may be desired. Electroporation could be performed during or after delivery (introduction/injection) of substance 1776 to or into tissue 1770, so to increase the overall uptake of substance 1776 by tissue 1770.
Such an exemplary method is shown in block step format in
While various embodiments of devices, systems, and methods have been described in considerable detail herein, the embodiments are merely offered by way of non-limiting examples of the disclosure described herein. It will therefore be understood that various changes and modifications may be made, and equivalents may be substituted for elements thereof, without departing from the scope of the disclosure. Indeed, this disclosure is not intended to be exhaustive or to limit the scope of the disclosure.
Further, in describing representative embodiments, the disclosure may have presented a method and/or process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. Other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations of the present disclosure. In addition, disclosure directed to a method and/or process should not be limited to the performance of their steps in the order written. Such sequences may be varied and still remain within the scope of the present disclosure.
Claims
1. A method for flushing area of targeted tissue:
- applying a suction or vacuum through a first lumen of an engagement catheter having a skirt or suction cup coupled thereto and contacting a targeted tissue with the skirt or suction cup such that the targeted tissue is suctionally attached;
- delivering a substance to, into, or through the targeted tissue such that some substance remains on the side of the targeted tissue engaged by the engagement catheter;
- introducing a fluid through a second lumen of the engagement catheter, such that the introduced fluid contacts the escaped substance; and
- suctionally removing the fluid and the remaining substance through the first lumen of the engagement catheter.
2. The method of claim 1, wherein the step of introducing a fluid through a second lumen is performed while the skirt or suction cup is suctionally attached to the targeted tissue.
3. The method of claim 1, wherein suction is applied through the entire procedure.
4. The method of claim 1, wherein the step of introducing a fluid through the second lumen further comprises the step of providing a continuous flow of fluid; and
- the step of suctionally removing the fluid and escaped substance is performed simultaneously with the step of providing a continuous flow of fluid.
5. The method of claim 1, wherein the wherein the step of introducing a fluid through the second lumen further comprises the step of providing an intermittent flow of fluid.
6. The method of claim 1, wherein the introduced fluid is introduced at or near the targeted tissue to flush the environment within the skirt or suction cup.
7. The method of claim 1, wherein the first lumen is disposed radially outside the second lumen.
8. The method of claim 1, wherein the first wherein the second lumen is disposed radially outside the first lumen.
9. The method of claim 1, wherein the second lumen is ring shaped.
10. The method of claim 1, wherein the engagement catheter comprises multiple vacuum ports at a distal end, wherein the vacuum ports are connected to the first lumen.
11. A method for flushing area of targeted tissue:
- contacting a targeted tissue with a skirt or suction cup coupled to distal end of an engagement catheter;
- applying a suction or vacuum through a first lumen of an engagement catheter such that a targeted tissue is suctionally attached to the skirt or suction cup;
- delivering a substance to, into, or through the targeted tissue such that some of the substance remains on the side of the targeted tissue engaged by the engagement catheter, wherein said remaining substance is escaped substance;
- flushing a fluid through a second lumen of the engagement catheter into the environment within the skirt or suction cup, such that the introduced fluid contacts the escaped substance; and
- suctionally removing the escaped substance through the first lumen of the engagement catheter.
12. The method of claim 11, wherein the step of flushing a fluid through a second lumen is performed while the skirt or suction cup is suctionally attached to the targeted tissue.
13. The method of claim 12, wherein the introduced fluid is introduced at or near the targeted tissue to flush the environment within the skirt or suction cup.
14. The method of claim 13, wherein the step of introducing a fluid through the second lumen further comprises the step of providing a continuous flow of fluid; and
- the step of suctionally removing the fluid and escaped substance is performed simultaneously with the step of providing a continuous flow of fluid.
15. The method of claim 13, wherein the wherein the step of introducing a fluid through the second lumen further comprises the step of providing an intermittent flow of fluid.
16. The method of claim 12, wherein the first wherein the first lumen is disposed within the second lumen.
17. The method of claim 12, wherein the first wherein the second lumen is disposed within the first lumen.
18. A method for flushing an escaped substance from a target tissue:
- contacting a targeted tissue with a skirt or suction cup coupled to an engagement catheter having a first lumen, wherein a vacuum is applied through the first lumen such that the skirt or suction cup forms a reversible seal with the targeted tissue;
- delivering a substance to, into, or through the targeted tissue, wherein after delivery an escaped substance is present within the engagement catheter;
- introducing a fluid through a second lumen of the engagement catheter such that the fluid contacts the escaped substance; and
- removing the introduced fluid and escaped substance from the environment of the skirt or suction cup using the vacuum applied through the first lumen.
19. The method of claim 17, wherein the step of delivering a substance is performed in the second lumen.
20. The method of claim 19, wherein the second lumen is disposed concentrically within the first lumen.
Type: Application
Filed: Jun 22, 2021
Publication Date: Oct 14, 2021
Applicant: CVDevices, LLC (San Diego, CA)
Inventors: Ghassan S. Kassab (La Jolla, CA), Jose A. Navia (Buenos Aires)
Application Number: 17/354,666
